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.

The National Federation of Republican Assemblies, NFRA, held a Presidential Preference Convention in Des Moines, Iowa this last Saturday, October 29, to measure all the candidates' popularity among Ronald Reagan/Barry Goldwater conservatives. The Convention was promoted on the NFRA website as "the last major straw poll before the Iowa Caucuses" and The NFRA is one of the oldest and largest GOP grassroots organizations and promotes Reagan and Goldwater conservatism, small government, lower taxes, free market capitalism, a strong defense, the right to life, and a decent America.

430 votes were cast and it was no surprise that Ron Paul won 82% among Reagan/Goldwater conservatives in Iowa. What WAS a surprise to many was the condemnation of the Ron Paul supporters by, Eric Golub a.k.a. the "preeminent politically conservative comedian", one of the guest speakers during the luncheon, questioning Paul supporters to be "good little soldiers and fall in line when Ron Paul is not the party's nominee" which immediately erupted into boo's by many of the members of the Convention. Then to add insult to injury, the 94 NFRA delegates representing 26 of the 37 states where the NFRA operates, later disregarded their own convention members' vote for Ron Paul and nominated instead Rick Santorum, the third place candidate with less than 1% of the vote, as their organization's official endorsement.

Rick Santorum is known for his stance against privacy rights and his interest in perpetual war and nation building like the Bush and Obama presidential administrations of the past and present. This is hardly a Reagan/Goldwater Conservative favorite, as indicated by his poor support at the Convention by Iowa members. "If this is what the leadership of this organization really represents, then I doubt they will continue to exist in the near future as the liberty movement continues to grow across this country," said Michael Elliott, one of the Iowa voters and attendees at the Convention.

One thing is for certain, Ron Paul and his supporters were definitely the life of the Party at this convention and could very well be the life of the Republican Party so long as Republican Party leaders don't miss this window of opportunity to boost its membership and popularity. Michael Elliott added, "As the old saying goes, hindsight is 20/20, let's see if the other Republican leaders are wise enough to learn from the NFRA's missed opportunity."

Iowans For Accountability (IFA) is fighting to hold politicians accountable to we the people, and make sure government works for all of us, not just wealthy special interests and the well-connected. IFA is a Non-Party Political Organization (NPPO) that actively supports or opposes ballot issues or candidates, regardless of party affiliation and when necessary, IFA runs its own candidates. Michael D. Elliott is the IFA Chairman. Website: www.ScottcountyIFA.com

Physical Fitness training activities at the River's Edge include Commanders, NCOs, and Family Leadership group members participating in soccer in the River's Edge indoor soccer area, as well as broomball in the ice rink. Physical Fitness training events are designed to foster cohesion, team spirit and physical fitness.

Lt. Gen. Mick Bednarek is hosting the first commander's and Family Leadership Conference held by First Army in the Quad Cities area. The conference participants include unit Commanders, their top Noncommissioned Officers, and each unit's Family Readiness Group Leaders. The conference participants, from military installations across the United States, will attend conference sessions November 8-9.

The Family Leadership Conference will provide information on military installation and community support systems for Soldiers and Family members. Family Leaders, in turn, will provide First Army Soldiers and their spouses a better understanding of the First Army mission.

Media wishing to attend the Physical Fitness training event at the River's Edge should contact First Army Public Affairs Public Information, Tony Lopez at 309.782.9717 or Tony.Lopez6@us.army.mil or First Army Director, Public Affairs, Lt. Col. Mike Kenfield 309.782.9200 or Michael.w.kenfield.mil@mail.mil.

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