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Government Misses Deadline for Rules Forcing Disclosure of Industry Payments to Doctors

The Obama administration has yet to draft rules on the disclosure of industry payments to doctors, missing a deadline set out in last year’s health-care law. Drug and device companies, which are required to begin collecting payment data starting next year, are still awaiting such guidance.

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(Joe Raedle/Getty Images)

Count it as a health-care deadline missed. The federal government has yet to write rules — mandated as part of last year’s health-care law — that would force drug and medical-device companies to disclose their gifts, fees and payments to doctors.

Last year’s Affordable Care Act required that disclosure rules be drafted “not later than October 1, 2011,” a deadline that came and went quietly and without any explanation from the Obama administration.

Since October 2010, ProPublica has been reporting on the ethical issues that can arise when doctors have substantial financial ties to the drug companies that aim to influence their prescribing habits. We put together a database of payments from 12 companies that have already begun disclosing such data — some as result of legal settlements with the federal government. But as we’ve also noted, physician payments from potentially hundreds of drug and device companies operating in the United States are still secret for the time being.

The payment-disclosure rules, once finally implemented, will offer the first complete picture of what’s likely to be billions of industry dollars flowing to doctors each year.

While the health-care law gives the government until the end of September 2013 to make the payments from all companies public and searchable, the companies are supposed to begin collecting the data at the start of next year. But the delay in drafting the rules means companies may have to wait for further instructions about what exactly to collect.  

The agency in charge of drafting the rules, the Centers for Medicare and Medicaid Services, recently received a stern letter [PDF] from the two lawmakers who had proposed the specific provision in the health-care law known as the Physician Payments Sunshine Act.

“We write today to express our severe disappointment in the Centers for Medicare and Medicaid Services,” wrote Sens. Charles Grassley and Herb Kohl. “... We are concerned that CMS’s failure to implement the statutory provisions on time with clear guidance, standards and definitions will create confusion among both manufacturers and consumers, potentially placing taxpayer dollars at risk.”

Asked about the rules, CMS declined to explain the delay. “We have received Congressional correspondence on this issue and will respond directly to Senators Grassley and Kohl,” said agency spokeswoman Ellen Griffith. “We will not have anything to say to the press until we have responded to the Senators.”

At the moment, the agency is charged with implementing a number of provisions from the health-care law, acknowledged Allan Coukell, director of the Pew Prescription Project, a consumer safety campaign that advocated the disclosure law.

“I have sympathy for the agency in terms of all the things they have to implement right now. But this is an area that there’s bipartisan consensus, where both industry and consumer groups are saying, ‘Yes, this is a priority,’” Coukell said. “A lot of work went into this provision, and they need to get it done.”

The sword cuts both ways in terms of conflicts of interest. I would appreciate it if Propublica presented both sides of the issue. For example, government employees are likewise conflicted when they present data that can result in promotions and pay increases.

“The payment-disclosure rules, once finally implemented, will offer the first complete picture of what’s likely to be billions of industry dollars flowing to doctors each year.”

Awww, it’s so cute that you think the rules won’t be riddled with loopholes and stymied by drug companies sucking up the piddly fines.

Plus, I imagine any hearings on non-compliance run something like, “gosh, Mr. Senator, those are some mighty fine prescription pharmaceuticals you rely on for your survival.  I’d be a shame if something…happened to them.”

I find it interesting that, outside of the bill itself, this is the first I’ve heard anybody mention the disclosure aspect.  Heck of a coincidence that a provision nobody’s implementing goes unmentioned in the wider media, ain’t it?

In response to John’s message (2nd comment posted) - the federal government and its myriad regulatory bodies routinely and regularly miss Congressionally mandated deadlines by which to issue regulations; missing deadlines is much more likely than meeting deadlines.  No conspiracy here - just inefficient government doing what it does best.  Disclosure and transparency are very important, and hopefully these regulations will provide our citizens with useful information about their doctors… but other than a few Congresspersons and the liberal media, no one really seems to care about this. Several large pharma companies have been releasing this data for awhile, yet, very little has changed, nor has any scandal emerged.  Certainly there must be a better (and cheaper, and less regulatory) way to hold pharma’s feet to the fire over inappropriate marketing and over-the-top financial arrangements with doctors.  Are you going to second guess your doctor if he/she has been treated to lunch by 12 different pharma companies over the last year?  I doubt it.

paperpushermj

Oct. 12, 2011, 6:12 p.m.

Why would anyone want to remain or become a Physician? It will not be long before seeing a Doctor will be a thing of the past. The reality of fewer Doctors will be meet by injecting layers of other health care professionals separating yourself from the Doctor

David, I assume it’s not what you meant, but I read your comments as suggesting that, even though transparency is important, we’re too stupid to take advantage of it, so we should just trust the drug companies and doctors.

And yes, I do second-guess every doctor, after too many friends falling ill due to trivial drug interactions prescribed by the same doctor.  Always new, name-brand drugs, too, which to me points to a pattern.

Is it possible that the government is merely chronically late?  Sure, but that doesn’t mean the regulation is somehow wasteful as you imply.

And keep in mind that the drug companies live by regulation.  Patent law prevents (rightly, within reason) people from copying their drug and controlling pricing and distribution.  Due to treaty, this is sometimes worldwide, allowing them to—picking an example from a few years back—sieze AIDS drugs being shipped to Africa from India where royalty rates were negotiated down.

Granted power by the government over lives like that on an international scale, they really need to stop whining every time a regulation demands they shoulder a burden.

I really think that we are missing the elephant in the room.  Our country CANNOT sustain the mass poisoning of the patient population any longer.  With their toxic treatments, scans and drugs they create more disease and symptoms and then more drugs and treatments to combat their toxic treatments, scans and drugs.  It’s a Ponzi scheme just like the banks with derivatives.  Whether Joe the Plumber,  you or I realize what is going on doesn’t matter.  We cannot sustain this level of poisoning any longer.  For Pete’s sake one in one-hundred and ten kids are autistic and PhRMA controlled medicine can’t figure it out?  How about increased rates of MS, Lupus, FM, CIDS, RA and many more where medicine says we don’t know what causes these diseases but we’ll create and profit from experimental corporate welfare controlled patent protection treatments and drugs.  Well medical industrial complex, perhaps it’s the toxic heavy -metal you are injecting us with for your revenue streams from the multi-million dollar scanning machines to obtain pretty pictures?  Or perhaps it’s the GMO foods we are eating that are sprayed with herbicide at a rate that would kill the healthiest among us?  Or perhaps it’s the drugs or the medical devices that are causing this?  Or the mercury laced vaccinations and recommended ridiculous vaccination schedule.  Or perhaps it’s poisoning from toxic water bottles we use filled with tap water that are not only destroying our environment but poisoning us from within. 

And then we blame the health insurance companies that shouldn’t have to pay for the mass poisoning of the population and now because they can’t kick the sick and dying off their roles will have to take care of the sick poisoned population. I have no great love for the insurance industry but they shouldn’t be forced to pay for poisonous treatments just because PhRMA is more powerful.  Now I’m no rocket scientist but doesn’t this seem unsustainable to you?

Sharon. I agree in entirety with your last sentence.

In response to Sharon’s comment about increased diagnosis of this, that, and the other.  Maybe these increases are false and intended to place more of the population on medications?  It really doesn’t matter too much, when people feel like every behavior or “sx” can be treated with medication what sort of outcomes would you expect?  I don’t mean to be critical or imply conspiracy, it just simply seems like people have become more and more dependent on some professional to make it all better.  So who can blame drug companies, doctors and government officials for succoming to the society supported “take what you can get” mentality rather than simply “what you need”.  Just my opinion, your’s are valid as well as others.

wsg, I went to the website and will likely buy his book.  He has the right idea. re: Dr. Jerome Kassirer’s Book On The Take: How Medicine’s Complicity With Big Business Can Endanger Your Health. 

However the reviewer on the website shows an appalling lack of depth and substance when he states that academia will need to be weaned off the teats of PhRMA. He seems willing to believe what the crony capitalists feed him and generally so does the public.  And we believe the crony capitalists from the banking industry and look where we are; occupying Wall Street. 

No worthwhile research or patented drugs will result from the rigged clinical trials that exist between PhRMA and academia; crony capitalism will prevail and rig the outcome to what’s in their best interest and of course with PhRMA it’s their profits, first, second and last not patient safety.  Academia simply has to go cold turkey if it wants to restore any credibility and they must do so soon before the bubble bursts and the public starts to grasp their Ponzi scheme. We’ll likely see a similar demise with medical doctors as we are seeing with economists. Economists have lied to the point of no return and there is even talk of doing away with that profession, at least the freshwater economists anyway.  Why they are clueless and detrimental to our economy and may go down in history as the biggest joke ever.  Of course medical doctors that continue to lie to us and tell us things like injecting 70+ vaccines mostly laced with mercury is good for us and we need this protection why.  Right doc let me out the room please.  I can honestly say that I have no confidence in MDs anymore.  I do trust a few of them but as a profession they have become so distorted and contorted that they believe the crony creationism they are spoon fed and will even recommend poison to their families.  It goes without saying that this is my opinion and should not be construed as medical advice.

Jason, I totally agree that the patient population has become brainwashed into thinking they need drugs and surgery to survive.  But know that the medical profession is booming because of it.  It is part of their Ponzi scheme business model and the principle of on-going concern drives the treatment choices and drugs they prescribe.  Your point about it’s the “patient’s fault” for wanting a “quick fix” is misconstrued and this is why.  When PhRMA spends billions trying to convince us we need these drugs or those surgeries and treatments and the average American is working two and three jobs they take the quickest solution possible to get well quickly so that they can continue working at their low paying jobs. The bourgeoisie in our country has become so hostile towards Americans that they have ensured their demise. Their decisions (the ruling class) to treat Americans as commodities have put them in an unsustainable position.  They have impoverished the American proletariat and those that are still treading water are doing so at a high cost.  The average Joe simply can’t afford their products anymore (medical treatments and drugs).  They have priced themselves out of the market.  What I don’t understand is why they didn’t see this coming.  They still have blinders on. 

Take as an example the cable, telecom and satellite industries.  They rely totally on Americans for their revenue streams and 99% of their revenues come from average Americans.  The 99%, if you will, so you would think that they would want to keep wages high and jobs in this country.  But instead many of them outsourced their technical and call center jobs to other countries.  And they chipped away at the wages of US workers year after year.  Now the industry is scrambling and doesn’t know what to do.  The first thing to go in a recession is entertainment so they are bleeding subscribers.  But do they get it?  No, it’s not even on their radar.  This is the same for the medical industrial complex.  Looking forward they have sealed their demise.  I really don’t hold out hope that they can recover, like all bubbles this one must burst.  Perhaps then the arrogant doctors will look in the mirror and realize how they have contributed to the detrimental situation they find themselves in.  Nah!

In the majority of cases the relationship between doctors and drug companies is ethically questionable.  However,  it has caused some unintended consequences for patient’s with limited resources.  I worked at a large medical center that banned visits by drug reps and also the contribution of drug samples from these same companies. Often these free samples were the only source of a drug for low income patients who could not afford the expense of a non-generic drug.  It seems a shame that this must happen.  Pharmaceutical, dental, and eye problems have very poor coverage even for people with health insurance.  How is the land of the ipod, Starbucks, and consumer crap a third world country when it comes to these kinds of services?

I hope the payment-disclosure rules that your thorough reporting show are needed will cast a net large enough to include expensive gifts. Such items could be used as an indirect payment in exchange for promoting a drug or device.

This article is part of an ongoing investigation:
Dollars for Doctors

Dollars for Doctors: How Industry Money Reaches Physicians

ProPublica is tracking the financial ties between doctors and medical companies.

The Story So Far

ProPublica is investigating the financial ties between the medical community and the drug and device industry. In October 2010, ProPublica compiled the list of payments that drug companies make to physicians and built a publicly searchable database so that patients could look up their doctors.

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