affordable care act

Will the Sunshine Act Curb Pharma Payments to Doctors?

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Just two weeks ago, as part of the Affordable Care Act, the Centers for Medicare and Medicade Services published its final rule on the reporting mandates for physician payments from pharmaceutical and medical device makers. Called the Physician Payment Sunshine Act, this law requires:

applicable manufacturers of drugs, devices, biologicals, or medical supplies covered by Medicare, Medicaid or the Children’s Health Insurance Program (CHIP) to report annually to the Secretary certain payments or transfers of value provided to physicians or teaching hospitals (“covered recipients”).

Why Is This Important?

For too many physicians, the medications they choose to prescribe are influenced by these payments. A case control study at a university hospital found that physicians who requested a new drug be added to the formalary were 19X more likely to have received money or gifts from the drug company. According to the New England Journal of Medicine as of 2007 fully 94% of all physicians accepted gifts from pharma, although by 2009, only 84% of physicians accepted gifts from pharma.

In their Dollars for Docs series, Propublica not only detailed the trail of money from the pharmaceutical industry to physicians and the changes in prescribing practices that ensued, but also, found that over 250 of the physicians receiving these payments had been disciplined by their state’s medical boards with the public never the wiser.

Wouldn’t you want to know if your physician was receiving payments to ‘consult’ on a particular drug or medical device? What if that drug or device turned out to be dangerous like, Avandia or Vioxx or in the case of women’s health Yasmin, Yaz or Ocella or even the vaginal mesh implants?  I would. And soon, you will be able to find this information, at least for those physicians that accept medicare or medicade. For the remaining physicians, we’ll have to rely on the stellar, investigative reporting of organizations like Propublica.

What Is the Physician Payment Sunshine Act?

The Physician Payment Sunshine Act mandates payments or ‘transfer of value’ to physicians be reported to the Secretary of Health and Human Services. Collection of this information is set to begin in August with full compliance and reporting expected in 2014.

The cool thing about this act, if it is implemented correctly, is that payment or transfer of value includes money for marketing activities, such as promotional or conference talks and consultation services. It also will include research grants and “charitable” contributions (which usually come with some promotional strings attached), funding to attend conferences, honoraria and royalties and license fees. The pharmaceutical and device companies making these payments will be required to list names, address, amount of payment, date of payment(s) and describe the service for the payment made for anything over $10. The database will be searchable so that patients can determine what monies their physicians received from pharma or device companies.

Where the Sunshine Act Fails

From the original to the final regulations, a work-around for paying physicians to speak at pharma sponsored continuing medical education (CME) events was added. According to the regulations, so long as the sponsoring company doesn’t pay the physician/speaker directly, those fees are acceptable and need not be listed publicly. Instead, the pharma company must pay a third party vendor to arrange and pay the speakers. CME conferences are where most physicians learn the latest drug therapy, device or medical technique. It is unlikely that speakers at these conferences will speak against the sponsor’s product. Funneling the payments through a third party vendor, who is also paid by the sponsor, is no more than a quick pass at laundering the fees.

What Do Physicians Think About the Sunshine Act?

The opinions are mixed, at least publicly. Some physicians are fully behind the new efforts in transparency and have begun their own campaigns to disentangle the marketing relationships between pharma and physicians. The National Physicians Alliance sponsors the Unbranded Doctor campaign:

The National Physicians Alliance’s Unbranded Doctor is unmasking the pharmaceutical industry’s bogus claim that its marketing efforts are just educational ventures for physicians. By signing up physicians to renounce gifts, lecture fees, and “education” from companies, the Alliance is championing objectivity, integrity, and professionalism.

—Jerome Kassirer, MD
former Editor-in-Chief, New England Journal of Medicine

Similarly, the British Medical Journal (BMJ) has positioned itself as a lead proponent of transparency and open data. On the other hand, CME released a survey of over 500 physicians asking if the new regulations to list publicly whether industry sponsored their attendance at CMEs would curtail their attendance. The result was a resounding – yes.

  • 75% of physicians said the disclosure rules would affect their decision to attend at least somewhat.
  • 47%  of physicians said the disclosure rules would affect their decision to attend to a great extent.
  • 46% of CME speakers said the disclosure rule would affect their decision to participate as a panelist or presenter to a great extent
  • 25% percent said it would somewhat affect their participation

Will the Sunshine Act Curb Pharma Payments to Doctors?

Probably not. Unless and until full transparency about medical research, clinical trials and adverse events are made open and accessible to patients and physicians, medical marketing, fabricated data or omitted data, publication bias, and conflicts of interest will continue to pervade our healthcare system. Dangerous medications like the Yasmin suite of birth control pills and unsafe medical devices like J&J’s Gynecare Prolift will remain on the marketplace long after any reasonable person could vouch for their safety.

The Sunshine Act will, however, give patients one more tool to evaluate their physicians and give researchers, investigators and others a way to identify and publicize bad behavior. Who knows, maybe it will even save some money.

To find out if your physician receives money from the pharmaceutical industry go to Dollars for Docs.

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Photo by kike vega on Unsplash.

Photo by Hush Naidoo Jade Photography on Unsplash.

 

 

Women Eligible for No-Cost Preventive Services

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Women are 33% more likely to visit the doctor than men, yet studies have shown that health costs have deterred women from seeking medical attention, even when they are insured. As of August 1, 2012, under the new Affordable Care Act, women can take advantage of certain preventive services without having to pay out-of-pocket costs for new, non-grandfathered private health plans. Keep Reading

Rights Versus Mandates: The Health Insurance Debate

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I’m 30 years old, I eat right, exercise, get lots of sunshine and minimize the known carcinogens I put in and on my body, but an accident can happen to anyone, right? Last September, I was laid off and COBRA insurance would have cost me $1200 per month to continue coverage, so I decided to take a risk. Bad things happen to good people, but I simply cannot afford to continue coverage at that rate while on unemployment (or working full time for that matter). Those who know I am a veteran might remark, “Oh but you have the VA for insurance.” Yes, I am enrolled in the VA’s health care system, but it is NOT insurance. I have access to health care at the VA on a sliding scale rate based on my income, but this is not “free insurance” as so many civilians have tried to argue with me. If I am treated at a non-VA facility or have to take a joyride in an ambulance, which will take you to the nearest public hospital, I am 100% responsible for that bill. So, no, I don’t have health insurance and the health care I am eligible for at the VA I earned. I’ve never applied for insurance outside of what my employer provided, but I have a pre-existing condition. I’m an unemployed, uninsured statistic, but I refuse to put my individual wants over the laws of the Constitution, the rights of the States and the individuals.

According to Reason Magazine, the individual health insurance mandate is a clear violation of the American contract law because, “American contract law rests on the principle of mutual assent. If I hold a gun to your head and force you to sign a contract, no court of law will honor that document since I coerced you into signing it. Mutual assent must be present in order for a contract to be valid and binding.” Under the Individual Mandate the government will be unlawfully forcing individuals into a contract with private companies.

Where will it stop? On March 27, the second day of the Supreme Court hearing, Chief Justice Roberts asked if the Federal Government was going to force people to own cell phones so they could contact emergency services; a clear example of the slippery slope we are sliding down. If this passes, I would like to propose that we have Home Invasion Insurance and force every American to own a gun, like is required in Switzerland. If everyone owned a gun, who’s going to break into homes? Statistically, the more guns the public owns, the lower the crime rate and Switzerland has the lowest violent crime rates in the world. So, if all of my neighbors own a shotgun, I’m far less likely to fall victim of home invasion and, therefore, have Home Invasion Insurance.

Furthermore, justification for the individual mandate of the Affordable Health Care Act is that it falls under the Commerce Clause of the Constitution. Article I, Section 8, Clause 3 states:

[The Congress shall have Power] To regulate Commerce with foreign Nations, and among the several States, and with the Indian tribes.

This clause authorizes Congress to, “regulate commerce in order to ensure that the flow of interstate commerce is free from local restraints imposed by various states. When Congress deems an aspect of interstate commerce to be in need of supervision, it will enact legislation that must have some real and rational relation to the subject of regulation.” (The Free Legal Dictionary). This clause does not give Congress free reign to regulate any inter/intrastate commerce solely because commerce has taken place. This clause was actually written to protect the States and promote free markets. It is kept in check by the Tenth Amendment, or rather should be. The Tenth Amendment states:

The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States, respectively, or to the people.

And down we slide! In the past year, numerous sting operations have been conducted on Amish farmers selling raw milk to buyers who are fully aware that the product is unpasteurized. In one specific incident, the investigation lasted a year until the milk seller crossed state lines and a SWAT team could arrest him under guise of the Commerce Clause. Yet, does this fall under the Commerce Clause? It shouldn’t – it does not impede the milk companies in the states where the Amish farmers went to sell their villainous raw milk. In response, Congressman, and Presidential candidate, Dr. Ron Paul introduced the bill, HR 1830, to allow the shipment and distribution of unpasteurized milk and milk products for human consumption across state lines. Will we soon have to pass individual laws for every aspect of interstate commerce?

It is no longer even restricted to interstate commerce. “In the 1942 case of Wickard v. Filburn, the Court held that the Commerce Clause allowed Congress to forbid an Ohio farmer named Roscoe Filburn from growing twice the amount of wheat permitted by the Agricultural Adjustment Act and then consuming that extra wheat on his own farm. In 2005, the Court reinforced this decision, holding in Gonzales v. Raich that medical marijuana cultivated and consumed entirely within the state of California still counted as commerce “among the several States” and was therefore open to federal regulation” (Reason Magazine). Again, I ask, where will it stop? Will we have to have another Civil War to defend the State’s Constitutional rights? If so, sign me up.

If this passes the Supreme Court, which is there, not to judge its necessity, but rather its lawfulness, I will be punished. I can’t afford insurance so I’ll be penalized with yet another tax. Last year, my income was taxed 25% for Federal Income Tax, 9.3% by California State Income Tax and on top of that I had to pay 7.75% Sales Tax, the hidden tax. That adds up to 42% of my income! Now, I’m going to be penalized for not purchasing a product I don’t want from a private company? That doesn’t sound like America to me.

And will it even lower health care costs to the individual? NO! I am not an economist, so I will simply refer you to these sites for more information: Charity, Health Care and the Free Market, Find it Hard to Defend Free-Market Medicine. If you can expand more on how this legislation will impede the free market and raise the cost of health care rather than lower it, please join the conversation below.

Our founding fathers wrote great liberties into our constitution, but with these great liberties comes even greater responsibility; the responsibility to fight for those freedoms at all costs. Americans are ready to throw away State rights and individual liberties in order to have health insurance mandated and provided for everyone. However, the Bill of Rights doesn’t include health care, nor should it be up to the government to provide this service. Is the health care system broken? Yes. Do we need the Federal Government to fix it by force, taking away the fundamental rights and choices of individuals, States, private companies, doctors, etc., and thus creating more and more laws, regulations and taxes until we no longer have any freedoms or income? That, my fellow citizens, is up to us and whether we stand up and fight for our rights as bestowed upon us by the Constitution.