The OIG Exclusions List

In the literal sense, the OIG Exclusion’s List is a list of businesses and individuals who have violated federally funded health care programs.“ For many years the Congress of the United States has worked diligently to protect the health and welfare of the nation's elderly and poor by implementing legislation to prevent certain individuals and businesses from participating in Federally-funded health care programs….Bases for exclusion include convictions for program-related fraud and patient abuse, licensing board actions and default on Health Education Assistance Loans.” (Office of Inspector General Exclusions Program).
However, due to government programs it protects, a large amount of the list consists of pharmacies, pharmacists, pharmacy techs and nurses.

In essence, this simply means that no Federal Government program, including Medicare and Medicaid will pay for … “any items or services furnished, ordered, or prescribed by an excluded individual or entity.” (Office of Inspector General Exclusions Program). This is not just idle chatter by the OIG, they mean business and issue very heavy fines and stiff monetary penalties for hiring anyone on the list. In addition to the OIG, Social Security can also come down on any pharmacy or business that practices in fraudulent business actions or hires an employee whose name is on the list. A pharmacy owner in Georgia was fined $400,000 by Social Security after hiring a pharmacist who was on the OIG list. The fine was the total cost of all the medications the hired pharmacist had helped to dispense plus the dispensing fee. And that was just Social Security fines. “If this was the action by OIG, the federal agency could have also imposed an additional $10,000 fine for each medication dispensed by the excluded pharmacist.” (OIG exclusions list: Sounding alarm for awareness”, Pharmacy Today, 10/08).

Of course, there is always the flip side of the coin to argue - those who are mistakenly put on the list and those cleared of any wrongdoing but whose names remain on the list. In these cases, a great deal of time and money are spent trying to get your name cleared and off the OIG list, not to mention the money spent on an education in a career you can no longer practice. In the end, there is no doubt the list was put into effect to provide a safe harbor for the elderly and the poor who have little resources to check those in charge of prescribing and dispensing their medications. Just another way that Uncle Sam watches out for his citizens. But you can also check to see if the health care provider you use is on the list. Just log on to the OIG website and follow the instructions.

In addition to being required to check the OIG list, Pharmaceutical Strategies has the resources to stringently check pharmacists and allied health professionals for licensing discrepancies so our clients never have to worry about the professional health of our candidates.

Please contact us at www.pharmaceuticalstrategies.com

Are All Health Supplements Healthy?

We live in a very unique time in history. People today have access to more information than any other generation before us. As a result, we must be aware of what is good and what is bad data - what to let in as valid information and what to net out. Hard to do when we are inundated with tempting phrases like, “No dieting! Just take one Hoopdedoo pill a day and be twenty pounds thinner in just one week!” Our brain tells us that’s just nonsense, but then a little voice goes off and says “Hmm…I wonder if its true…” Some unscrupulous manufacturers count on that little voice. These manufacturers are allowed to advertise with little constraint due to U.S. marketing laws regarding anything under the banner of “health supplements”. The Food and Drug Administration (FDA) is engaged in an ongoing crusade to regulate some health supplements that could cause severe potential health risks and even death, however, Congress isn’t making the struggle any easier. “In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA), which effectively allowed manufacturers of everything from weight loss pills to cholesterol-lowering supplements to put their products in front of consumers without regulatory oversight.” (Dangerous Supplements Pose Challenges to FDA - article on www.HG.org. Sept. 29, 2009 provided by the Law Offices of Tyler & Perry).

As a result, supplements not regulated by the FDA can and do make it to local pharmacy shelves and are freely advertised on television and radio. The problem is, though the FDA is trusted with the daunting task of approving prescription and over the counter drugs, costing hundreds of thousand of dollars and requiring years of testing before being brought to market, they have to fight with one hand tied behind their back when it comes to regulating health supplements. In fact, the FDA faces law suits brought by some companies based on First and Fifth Amendments rights. “The plaintiffs contend that the FDA is guilty of censorship, overzealous application of the qualified health claims system and the imprecise wording of the Good Manufacturing Practices regulations.” (Dangerous Supplements…Sept. 29, 2009, HG.org).

There are some regulations in place, however, they seem to be paper in nature and lend little substance in stopping untested supplements from getting on the market. Though each potential manufacturer must file a petition under the Qualified Health Claims section of the FDA guidelines, where they must outline the specific use and claims of the supplement, no further testing or studies are required to back up the claims. This allows many untested supplements to fly under the regulatory radar. To make matters worse, the FDA can only move on a supplement after it is on the market and complaints have been issued against it by consumers or healthcare professionals. By that time, many consumers have bought and ingested the product. A good case in point were the complaints lodged against the supplement Hydroxycut, which had been advertised extensively on television, radio, newspapers, and magazines before finally being pulled after an FDA warning - “In May 2009, the FDA issued warnings stating that the weight-loss product Hydroxycut may cause serious liver damage. After the warning was issued, the manufacturer instituted an immediate voluntary recall of the product.” (Dangerous Supplements…Sept. 29, 2009, HG.org). As always, the best source for questions regarding any drug or health supplement is your local pharmacist

Read Dangerous Supplements Pose Challenges to FDA article on HG.org in its entirety.

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