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Transparency might not prevent every unnecessary surgery, but it's a good place to start.

Senator Hatch and I will be referring information about this allegation and about possible Sunshine Act violations to the Inspector General.

The fraud and abuse risks, as well as (and more importantly) the patient safety concerns related to PODs, are equally applicable to physician-owned O&P laboratories.

Today, we are here to explore the various issues surrounding the growth and prevalence of Physician-Owned Distributors, or PODs.

While these arrangements are not always problematic, we are seeing more and more of these physician-salespeople using the very devices they sell in the surgeries and procedures they perform.

Simply put, PODs are medical device businesses in which a physician is both an investor and a distributor--essentially a salesperson--of either the devices or some of the components.

We believe these findings will say quite a bit about the lack of accountability for these types of business relationships or arrangements.

The patient has a right to know, and then, of course, taxpayers, because you have public payers, the people of this country, through the Medicare program.

I hope that today's hearing will be another important step in our ongoing efforts to provide appropriate oversight and enforcement on this issue.

Ranking Member Wyden and I will be making a formal referral to the HHS Office of Inspector General and the Department of Justice on at least one case we feel deserves review for potential criminal action.

The proliferation of PODs and the lack of guidance as to how these arrangements square with existing Federal law.

There is really an urgent need for more transparency.

I think we have assumed a disproportionate responsibility for global security in the United States.

FDA's proposal to regulate LDTs is a significant change that would impose considerable new burdens on regulated parties.

Do you believe, as prior commissioners have--every one has told me this--that the Dietary Supplement Health and Education Act, DSHEA, provides adequate authority to regulate the dietary supplement industry and protect consumers from unsafe…

One issue that significantly affects many entities in my home State is the FDA's October 2014 proposed guidance on the regulation of LDTs, laboratory-developed tests.

If we don't allow enough data exclusivity time, we're not going to develop these therapies, especially in bio, because bio is one of four or five places, four or five techniques, where we can actually find treatments and cures.

If we reduce that data exclusivity time, especially with regard to bio, you're talking about having to charge a lot more...