WASHINGTON -- On Oct. 3, Sens. Chuck Grassley (R-Iowa) and Herb Kohl (D-Wis.) wrote to the administrator of the Centers for Medicare and Medicaid Services (CMS), seeking an explanation for the agency's missed deadline for drafting the implementing details of the Physician Payment Sunshine Act (Sunshine Act), a new law requiring public disclosure of the financial relationships between physicians and the pharmaceutical, medical device and biologics industries.  The administrator responded.  The senators made the following comments on the response.

Sen. Grassley comment: "The administrator's response doesn't tell us anything new.  There's no explanation for the delay and no indication of when to expect completion.   It's an inadequate response any way you look at it.  Meanwhile, the U.S. government just settled with a medical device maker for $2.4 million over allegations of kickbacks to doctors to use the company's products.  The payments to doctors are the kind that might be prevented through disclosure as soon as the Sunshine Act is in place.  The longer we wait, the more taxpayers miss out on the benefits.   I'll continue to press for answers from CMS."

Sen. Kohl comment: "Given how straightforward and detailed the Sunshine Act provisions were, it's troubling that the response to our letter would come a month late without any indication on progress, a timeline or what caused the delay.  With medical device and pharmaceutical companies facing the January 1, 2012 deadline to begin collecting information about all payments to physicians, the lack of guidance leaves a great deal of uncertainty and I'm sure that's why many of the affected companies have joined us in calling for swift implementation." 

Here's an article describing the settlement referred to in Sen. Grassley's comment.

Fraud and Abuse

California Medical Device Maker to Pay $2.4 Million to Settle Kickback Charges

By Tom Gilroy

LOS ANGELES–A San Jose, Calif., maker of devices to treat spinal fractures has agreed to pay the United States $2.4 million to settle Department of Justice allegations that the company paid kickbacks to induce physicians to use its products, DOJ said in an Oct. 26 announcement (United States ex rel. Eberhard v. DFine Inc., W.D. Tenn., No. 10-CV-2474, settlement announced 10/26/11).

The settlement, which came as a result of a qui tam whistleblower lawsuit brought under the False Claims Act, resolves the government's contention that DFine Inc. used customer surveys, known as User Preference Evaluations (UPEs), to pay participating doctors illegal kickbacks to induce them to use DFine's vertebral augmentation devices.

"Although DFine ostensibly collected product information from participating physicians, each UPE survey required use of a new DFine device in a patient, the majority of which were Medicare beneficiaries," DOJ noted.

$500 Payment to Fill Out Survey

In each case, DFine paid the physicians $500 per patient to participate in the survey, DOJ added. The government also alleged that DFine provided improper remuneration in the form of travel expenses, lavish dinners, entertainment, and promotional speaker fees to doctors located in Chicago and Little Rock, Ark. DFine also solicited doctors to convert their business from a competitor's product and/or persuaded the physicians to continue to use DFine products, DOJ alleged.DOJ charged that DFine's alleged conduct violated the anti-kickback statute, which prohibits offering or paying remuneration to induce referrals or services covered by Medicare, Medicaid, or other federally funded programs. The lawsuit was filed in U.S. District Court for the Western District of Tennessee. The investigation of the case was handled by the DOJ's Civil Division, the U.S. Attorney's Office for the Western District of Tennessee, and the Office of Inspector General at the U.S. Department of Health and Human Services.

Company Admits No Wrongdoing

In a statement, DFine said it fully cooperated with the investigation and "continues to deny all of DOJ's unproven allegations."The terms of the agreement specifically state that DFINE and its employees admit no wrongdoing, liability or illegal activity," the statement said. "The decision to settle prior to completing the full investigation was a very difficult one, but one we felt was best for the company based upon the significant disruption and associated costs to continue the investigation, as well as the uncertainty regarding its duration."According to the settlement, the company was represented by Leo Cunningham and Lee-Anne V. Mulholland of Wilson Sonsini Goodrich & Rosati. The settlement is at http://op.bna.com/hl.nsf/r?Open=bbrk-8n3rv2.

Every November for the last two years, as part of their local Chiropractic club (Maximized Living), students have spent Friday nights and Saturday mornings near the corner of 14th and Brady. They are asking for selfless donations of change and spare blankets from drivers at stoplights, as part of their annual blanket drive.

"I grew up in a home where there was always food on the table and a blanket to cover up with when it was cold" says club Co-President Cassie Kelley. " Being involved with the blanket drive for 3 years now has taught me to be more thankful for what I have."

Last year the student's collected over $2,000 which was donated to a local church, The Center, to help fund their food drive program for the homeless and needy.

"Children under the age of 18 accounted for 39% of the homeless population and 42% of these children were under the age of five. The Blanket Drive is not ultimately a cause to raise money and blankets, but this event is about human beings who need our help," says Kelley.

As part of their Chiropractic training, the Maximized Living club has focused on helping and giving back to their community. They have demonstrated the importance of giving not only their money, but their time through various activities. The club mentors students at the Lydia Home, works with Kids Against Hunger, volunteers to help at Thomas Jefferson Elementary School, and makes donations to various organizations and individuals.

"As humans, we take many things for granted. I believe in not only giving money and material things, but giving of myself and my time," says Kelley. "As a club, we are excited to have the opportunity to serve our community and those in need to a much greater capacity. It's a great example of how a group of students working together within the community can make a substantial difference in the lives of many."

The blanket drive will begin Friday, November 11th at 4pm and continue through that Saturday at noon. Donations of blankets and spare change will be collected at the stoplights of 14th and Brady.

The club is part of a larger organization called Maximized Living which consists of hundreds of Doctors of Chiropractic worldwide that seek to change the way people view and manage their health through the inside-out. They do this by educating and delivering the Five Essentials of Health: Mindset, Nervous System, Nutrition, Exercise, and Detoxification.

For more information, visit www.MaximizedLiving.com.

Dress for Success® Quad Cities,a new local affiliate of the international not-for-profit organization, will open its local center/boutique on Nov. 1. The new offices and boutique space are located in the Union Arcade Building, 111 East Third Street, Suite 710, Davenport.

Since suiting the first client in 1997, Dress for Success has served more than 600,000 women internationally by providing them with business-appropriate clothing, mentoring and professional development programs. This brand-new affiliate will join more than 110 others
around the globe.

"Dress for Success changes lives; it's as simple as that. We are about much more than just suits - we empower women to thrive in  work and in life," says Joi Gordon, CEO of Dress for Success Worldwide. "And we are thrilled that women in the Quad Cities area will now be able to access the numerous programs that we offer. It is clear that the community has already embraced our mission and that this new affiliate will be a tremendous success."

Women come to Dress for Success Quad Cities by referral only after having completed job training programs offered by local social service agencies and non-profit organizations. Each client receives one interview suit in her first visit and, once she finds work, receives
additional attire, either separates or a second suit, and an invitation to join the Professional Women's Group (PWG). The PWG program, along with Career Center and mentoring services, provides ongoing support to clients as they grow professionally, strive to turn their jobs into successful careers and journey towards economic independence.

"Before embarking on this endeavor, I spoke with staff from over a dozen local non- profits and organizations that help to prepare disadvantaged women for the workforce. I asked if they would refer women to us and whether their clients would benefit from a new Dress for Success affiliate in the Quad Cities. Every single one responded with a resounding 'yes!'" said Regina Haddock Clewell, founder of Dress for Success Quad Cities. "Now with over 25 potential referral partners lining up for the start of our services, we can't wait to begin suiting clients on November 1st!"

A group of motivated Quad-City area volunteers, led by Haddock Clewell, has worked tirelessly for more than a year to become an affiliate of Dress for Success. The process included developing business plans, filing for incorporation, earning 501(c)(3) status, receiving formal approval by Dress for Success Worldwide, seating an initial Board of Directors, early fundraising and clothing donations and more.

For more information, to volunteer, or to donate, please visit www.dressforsuccess.org/quadcities , e-mail quadcities@dressforsuccess.org, or find Dress for Success Quad Cities on Facebook at www.facebook.com/dfsqc.

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Nebraska City, Neb. - Celebrate the holiday season with friends and loved ones this year and give back to the Earth at the same time with the help of the nonprofit Arbor Day Foundation.

Send holiday greetings and plant a tree - all at the same time - by using the Foundation's Give-A-Tree cards. Give-A-Tree cards are unique in that every card plants a tree in one of our National Forests in honor of the recipient. By sending Give-A-Tree cards, you are helping to replant forests that have been devastated by wildfires, insects and disease. Give-A-Tree holiday cards come in 20 varieties. This year, an option is available to customize Give-A-Tree cards, including using your favorite picture in a Give-A-Tree photo card.

When you give the gift of Arbor Day Specialty Coffee, you're helping to preserve the Earth's precious rain forests. Arbor Day Specialty Coffee is shade-grown under the canopy of Latin American rain forests. Unlike sun-grown coffee plantations, this traditional shade-grown method gives the coffee a delicious, rich flavor and helps preserve the rain forest as part of the Foundation's Rain Forest Rescue program.

The Foundation's Trees in Celebration program allows the giver to honor loved ones while at the same time making a positive impact on the environment. Trees in Celebration includes a certificate for the recipient, and for each dollar donated a tree is planted in a damaged forest.

Give special friends a membership to the Arbor Day Foundation, and they will also receive 10 free trees. A membership costs $10, and includes many great benefits, including 10 free trees that will be shipped at the right time of year for planting.

"The holidays are a time for thinking about others, and as you do, take a moment to think about what you can do to protect the beauty and splendor of the Earth," said John Rosenow, chief executive of the Arbor Day Foundation. "We encourage everyone to give gifts that will have a lasting impact on the world for generations to come."

To purchase holiday gifts that give back to the Earth, go to arborday.org.

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