Here Comes The Sunshine Act -- And It's All Right

The Affordable Care Act (ACA), also known as Obamacare, is one of the most controversial pieces of legislation enacted in the last decade. One reason is certainly going to be evident in the next few weeks when, on August 1, the Physician Payment Sunshine Act (Sunshine Act) goes into effect. The Sunshine Act, created under Section 6002 of the ACA, is designed to highlight the dubious financial relationships enjoyed by many doctors with the manufacturers of medical devices and pharmaceuticals -- such as rampant gifts, five-star dinners, trips, and money paid to physicians by drug and medical device companies for decades.

As a Florida lawyer who sues prescription drug and medical device manufacturers, I believe the Sunshine Act will curtail the incestuous love affair enjoyed by the triumvirate of pharmaceutical companies, healthcare providers, and the insurance industry, by curbing any inappropriate influence on research, education, and clinical decision making.

Under the Sunshine Act, all manufacturers of pharmaceuticals, medical devices, and biologicals will be forced to report to the National Physician Payment Transparency Program at the Centers for Medicare & Medicaid Services (CMS). They must disclose how much money they pay doctors and hospitals as well as how much stock doctors and their families own in the particular manufacturer's company. There are several reporting exceptions, such as gifts under $10, product samples, and educational materials to be given to patients. So far, the new law affects only the drug companies -- but doctors will be given a chance to verify or contest the accuracy of what is being reported.

Not all payments made to doctors by drug companies are wrong, especially when a doctor is responsible for inventing new medicines or surgical techniques. I believe those who create and innovate should be justly compensated; the risk lies when companies like Minneapolis-based medical device manufacturer Medtronic compromise the validity of test results.

Medtronic's Infuse, for example, was touted as a medical breakthrough when it was approved by the FDA over a decade ago -- because it provided patients needing spinal fusions an alternative to having a piece of their hip bone sliced out and re-inserted into their backsides; instead, Infuse is the an artificial genetically-engineered goo that literally grows new bone.
However, patients who have had surgery with Infuse and their surgeons began noticing an increasing number of adverse outcomes, raising questions about the validity of the research that was conducted by Medtronic to obtain the FDA's approval.

This caught the attention of a United States Senate Investigation led by Senate Finance Committee Chairman Max Baucus (D-Mont.) and senior member Chuck Grassley (R-Iowa). They conducted a 16-month investigation into Medtronic, which revealed the questionable ties between Medtronic and the doctors it paid $210 million to over a 15-year period to research and test Infuse. The Senate Investigation found that the doctors inaccurately edited segments of their published studies and misrepresented Infuse's risks.

Why would the FDA continue to approve Infuse when more and more patients are experiencing problems and the lawsuits against Medtronic are mounting? The obvious reason is money -- money for insurance companies, hospitals, doctors, and of course, Medtronic.

Documents obtained by this reporter show how Medtronic goes to enormous lengths to make sure that Infuse continues to be used by surgeons across the country and that the surgeons are able to bill and collect from patients' insurance companies. To ensure payment, Medtronic has sent physicians a 26-page reimbursement guide that explains the exact language and billing codes needed to "obtain coverage and reimbursement."

The Sunshine Act will give patients a treasure trove of valuable information when making important decisions about their health, in selecting their doctors, and deciding what kinds of medications to take. It shines a bright light into the dark side of the pharmaceutical drug industry in our country, where corporations value profits over patient safety.