Week in Review, Friday, April 13, 2012

The PharmaCertify™ Team

There’s a certain chill in the air…a shudder of fear and trepidation that is sweeping through the nation. No, it is not that today is Friday the 13th, but that tax day looms before us this weekend. Oh, the paper cuts from receipts, oh the hours spent with a calculator, oh the humanity of if all! Okay maybe that’s a bit much, but tax day is just around the corner on April 17th. We certainly hope you will be sitting back laughing, or feeling pity, for those whose weekend will be spent hunched over a desk diligently working to make the deadline. And if you need a little something to read when you take a break from the 1040s and the line items, we present this week’s News Week in Review?

How long of an “extension” are Senators Grassley and Kohl willing to give CMS to finalize the rules for the Sunshine Act? Only a few more months, according to a letter the Senators sent the acting head of CMS. In the letter, the senators expressed their disappointment (again) that the regulations were not completed by the deadline specified in the law, and demanded (make that “asked”) if CMS could have the regulations ready by the summer. They also asked if the Agency had ramped up its staff and allocated the funds needed to implement the Act. The letter included a request for a response by April 18th. Stay tuned.

Let the receipt collecting begin! Finance experts for the healthcare industry suggest that hospitals begin collecting information from physicians now about their financial relationships with industry, rather than wait to see how the final regulations shake out for the Sunshine Act. That includes understanding how the information will be perceived by the public. According to one finance expert, there is no down side in the hospital having this information on file now, and as long as all the relationships are on the level, there is no downside for the physician.

Repealing the medical device tax is high on Senator Scott Brown’s list. The topic was a top agenda item during the Senator’s recent visit to three Massachusetts device manufacturers.  Brown says he became aware of the tax when campaigning for his seat back in 2010. His concern is that the tax will lead to a loss of jobs, and negatively impact the economy of the communities that surround the manufacturing facilities. Brown has introduced a bill to repeal the tax, and he encourages device manufacturers to communicate their concerns to their congressional representatives.

No more deductions, revisions or other changes are needed as the FDA has delivered final guidance on agency and medical device industry guidelines for requests for information and applicable user fees. The requests for information, known as 513(g) requests, are generally for device classification, and a user fee is imposed for facilitation. The fees for the 2012 calendar year range from $1,700 to $3,400.

HHS recently handed down the first civil penalties for violations reported under HITECH’s breach notification rule. As part of the Resolution Agreement, Blue Cross Blue Shield of Tennessee (BCBST) agreed to pay $1.5 million in penalties and enter into a Corrective Action Program. BCBST self-reported the theft of 57 hard drives containing the PHI of one million people. The hard drives were left in a network data closet in a building BCBST no longer occupied. The CAP will require BCBST to create policies and procedures addressing risk assessment, risk management and physical security. The company must also increase training and monitoring of its HIPAA policies.

A former VP of sales for a medical device company brought a taxing situation to an end by pleading guilty to violating the Anti-kickback Statute. He faces up to five years in prison and $250,000 in fines and forfeiture. The government claimed the man established a sham consulting agreement with a NY surgeon in order to induce the surgeon to use his company’s bone growth stimulator. The surgeon never actually performed any consulting services for the company. When he became concerned about government scrutiny about such arrangements, the former VP and a territory manager worked with the surgeon to backdate time sheets to make it seem as if the consulting work had happened. Sentencing is set for July.

That brings us to the end of this week’s News Week in Review, and the end of our distraction from completing those lovely tax forms. We hope your Friday is full of good luck. We end with congratulations to Eli Lily CEO, John Lechleiter, who has been named the new chairman of PhRMA.

Have a great and un-taxing weekend everyone!

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