51 Hospitals Pay US More Than $23 Million to Resolute False Claims Act Allegations Regarded to Implantation of Cardiac Tools

The Department of Justice has gained settlements with 51 hospitals in fifteen states for more than $23 million regarded to cardiac devices that were implanted in Medicare sufferers in violation of Medicare coverage needs, the Department of Justice declared today.  These settlements reflect the final stage of a nationwide investigation into the practices of various hospitals improperly billing Medicare for these tools.  With these extra agreements, the Justice Department's investigation has now acquired settlements with more than 500 hospitals totaling more than $280 million.

"These settlements indicate the Department's sustained vigilance in attracting hospitals and health systems that breach Medicare's national coverage rules," stated Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department's Civil Division.  "We will hold accountable those who don’t abide by the rules of government in order to secure the federal fisc and, more significantly, sufferer health."

An implantable cardioverter defibrillator, or ICD, is an electronic tool that is implanted near and linked to the heart.  It tracks and treats chaotic, immensely fast, life-threatening heart rhythms, called fibrillations, by giving a shock to the heart, restoring the normal rhythm of heart.  It is same in function to an external defibrillator except that it is little enough to be implanted in a sufferer's chest.  Merely sufferers with few clinical characteristics and threat factors qualify for an ICD covered by Medicare.

Medicare coverage for the tool, which costs nearly $25,000, is governed by a National Coverage Determination (NCD).  The CMS (Centers for Medicare and Medicaid Services) implemented the NCD deployed on clinical trials and the instruction and testimony of cardiologists and other health care contributors, professional cardiology societies, cardiac device manufacturers and sufferer advocates.  The NCD offers that ICDs normally should not be implanted in sufferers who have now suffered a heart attack or recently had heart bypass surgery or angioplasty.  The medical intention of a waiting time - 40 days for a heart attack and 90 days for bypass/angioplasty - is to offer the heart a chance to make better function on its own to the point that an ICD may not be essential.  The NCD mostly prohibits implantation of ICDs during these waiting times, with few exceptions.  The Department of Justice alleged that from the time period of 2003 to 2010, each of the settling hospitals implanted ICDs during the times prohibited by the NCD.

"The settlements declared last October and today indicate the Department of Justice's devotion to secure Medicare dollars and federal health advantages," claimed U.S. Attorney Wifredo A. Ferrer of the Southern District of Florida.  "Directed by a panel of leading cardiologists and the review of thousands of sufferers' charts, the extreme investigation behind the settlements was strongly impacted by evidence-based medicine.  In view of the number of defendants, this is one of the greatest whistleblower lawsuits in the US and represents 1 of this office's most important recoveries to date.   Our office will sustain to vigilantly secure the Medicare program from possible false billing claims."

"We won’t stand idly by while Medicare coverage rules are neglected," claimed Inspector General Daniel R. Levinson of the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG).  "OIG worked closely with the Department of Justice to make certain such violators made substantial payments to fix these false billing claims."

The department initially settled with 457 hospitals for more than $250 million.

The settlements declared today include 51 hospitals, which are mentioned on the attached chart.  Many of the settling defendants were named in a qui tam, or whistleblower, lawsuit brought under the False Claims Act, which allows private people to bring lawsuits on behalf of the US and gain a section of the proceeds of any settlement or judgment granted against a defendant.  The lawsuit was submitted in federal district court in the Southern District of Florida by Leatrice Ford Richards, a cardiac nurse and Thomas Schuhmann, a health care reimbursement consultant.  The whistleblowers have acquired more than $3.5 million from the settlements declared today.

The settlements were the outcome of a coordinated attempt among the Civil Division's Commercial Litigation Branch, the U.S. Attorney's Office of the Southern District of Florida and HHS-OIG's Office of Investigations and Office of Counsel to the Inspector General.

This settlement explains the government's emphasis on combating health care deception and marks another success for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was declared in the month of May 2009 by the Attorney General and the Secretary of Health and Human Services.  The partnership between the 2 departments has focused attempts to mitigate and stop Medicare and Medicaid financial fraud through modified cooperation.  One of the strongest tools in this attempt is the False Claims Act.  Since the month of January 2009, the Justice Department has recovered a total of more than $27.4 billion through False Claims Act cases, with more than $17.4 billion of that rate recovered in cases including deception against federal health care programs.

The claims solved by these settlements are allegations merely and there has been no indication of liability.

Medicare Part B News - Jurisdiction H

Medicare News

Delay in Implementing NCD for Single Chamber and Dual Chamber Cardiac Pacemakers

On August 13, 2013, the CMS issued a final decision memorandum regarding coverage of implanted permanent cardiac pacemakers, single chamber or dual chamber, and determined they are reasonable and necessary for the treatment of non-reversible symptomatic bradycardia due to sinus node dysfunction and second and/or third degree atrioventricular block. On February 6, 2014, CMS directed Medicare Administrative Contractors to implement national coverage determination (NCD) 20.8.3 on July 7, 2014, for claims with dates of service on and after August 13, 2013, for those beneficiaries who meet the specific coverage criteria. See MLN Matters® Article MM8525.

There is a temporary delay in implementing NCD 20.8.3. CMS will advise you of the new implementation date in the near future.

Doing Nothing About CVD Will Cost $47 Trillion

September 17, 2012 (Geneva, Switzerland) — One year after a United Nations (UN) High-Level Meeting on Non-Communicable Diseases (NCDs) that set a target of reducing premature mortality by 25% by the year 2025, the major cardiovascular societies across the globe have come together to publicize the important steps that now need to be taken to achieve this goal, given that CVD accounts for nearly half of all NCD deaths [1].

"What was agreed upon a year ago was a major step forward. This is a coming together, a coalescence--at least between the societies and foundations worldwide--looking at how we can work together and with the World Health Organization [WHO] to move beyond the 25% target, to see how we can actually get there," president of the World Heart Federation, Dr Sidney Smith (University of North Carolina, Chapel Hill), told heartwire in an interview. "We are putting some teeth into the jaws of what can happen," says Smith, who is lead author of a new paper outlining the main objectives in the fight to prevent deaths from heart disease and stroke, published simultaneously today in a number of journals, including Circulation, the European Heart Journal, the Journal of the American College of Cardiology, and Global Heart.

Doing nothing is going to cost the world $47 trillion in the next 25 years, including $500 billion a year in low- and middle-income countries, where 80% of deaths from CVD now occur.

"This statement reflects the desires of the leaders from the major CVD societies to say, 'We are on board, and these are the measures we think can really make a difference,' " he says.

And Smith notes that detailing how much it will cost countries if they fail to act on CVD prevention and treatment is vital. "Doing nothing is going to cost the world $47 trillion in the next 25 years, including $500 billion a year in low- and middle-income countries, where 80% of deaths from CVD now occur," Smith observes. In contrast, estimates by the WHO of how much it will cost to implement various measures they have recommended vary between just $11 billion and $13 billion a year, he says.

Look at "Best-Buy" Targets as a Menu; Effective Surveillance Is Key

The WHO has now identified a core set of 10 low-cost strategies called "best buys" to address NCDs, including, for example, a 25% relative reduction in prevalence of hypertension, 30% relative reduction in mean population intake of salt, and a 30% relative reduction in prevalence of tobacco smoking.

It's important to have all the best buys, but it's not necessary for each country to do all of them.

"But we have to balance several considerations," Smith notes. "The more people have to do, the less likely it is they are going to get everything done. It's important to have all the best buys, but it's not necessary for each country to do all of them. Let's have each country decide on specific areas," he says, although he urges that this still requires treading carefully. "If you eliminate targets on obesity, for example, do you send the wrong message?

"We have to look at the targets as a menu, and every country around the world will have to ask, 'What are the big problems in our country?' If you go to China, it's hypertension, sodium, and smoking. If we are going to choose three where we invest our money, let's choose the ones that are most appropriate."

It will also be important that any outcomes from the actions chosen can be effectively measured, he says. "Many countries just don't have the data, so getting good surveillance in place is critical."

Getting Everyone Involved Is Imperative

Also vital is the involvement of the right personnel in each place, he says, including physicians, who need to become more politically active to help achieve these aims. "And it's important to note that almost everywhere there have been successes, there has been a committed government leader. But it's not going to be just a minister of health you need to engage, it is agriculture and finance too," he observes.

Smith goes on to give one simple example of how revenue could be generated to achieve the aims laid out, citing a calculation made by Bill Gates [2]. "If we were to tax cigarettes 10¢ per pack in developed nations, 6¢ per pack in middle-income nations, and 2¢ per pack in those with a lower income, it would result in $10.8 billion a year that could be used to save millions of lives."

We do have a chance, and one that we cannot afford to miss. This is an epidemic that need not happen.

And lessons can be learned from other campaigns too, he notes--for example, with regard to availability of medications. "Statins are generic, aspirin is inexpensive, and there are cheap medicines for high blood pressure. In the same way we started talking about the ways we could get medications for HIV/AIDS available, let's do it for somebody who's had a stroke or heart attack or somebody who's at very high risk, and that ought to be a focus if we are really going to get a 25% reduction [in mortality] by 2025."

CVD is striking down people in their prime in developing nations, "in their 40s and 50s, people with jobs and families, resulting in crippling blows for countries that are trying to advance," Smith stresses. "With the UN behind this, reporting from every country in the world, we do have a chance, and one that we cannot afford to miss. This is an epidemic that need not happen."