Could One Company Be . . . Medtronic? St. Jude?

Replacing Faulty Heart Devices Costs Medicare $1.5 Billion in 10 Years

By FRED SCHULTE and CHRISTINA JEWETT   OCT. 2, 2017  The New York Times

WASHINGTON — Medicare paid at least $1.5 billion over a decade to replace seven types of defective heart devices, a government watchdog says. The devices apparently failed for thousands of patients.

A report released on Monday by the inspector general’s office for Health and Human Services said officials needed to do a better job tracking these costly product failures to protect patients from harm. More detailed reporting could lead to earlier recognition of serious problems with medical devices and faster recalls of all types of “poorly performing” ones, the inspector general’s office said.

The report marks the first effort by anyone in government to assess the losses to taxpayers and patients 65 and older from medical gear that proves faulty.

Officials said the $1.5 billion lost from the seven devices from 2005 through 2014 was a “conservative estimate.” Patients also paid $140 million in out-of-pocket costs for this care, the report noted.

The report found that nearly 73,000 people on Medicare had one of the seven devices replaced because of recalls, premature failures, medically necessary upgrades or infections. It did not outline specific injuries that patients suffered as a result.

The inspector general did not identify the manufacturers of the seven devices, but officials said they included implanted cardio defibrillators and a pacemaker that had either been recalled because of flaws or had “prematurely failed.” Pacemakers and implantable defibrillators are small devices placed under the skin to help treat irregular heartbeats.

How best to identify these defects and cut Medicare spending associated with fixing them has been under consideration at various times since 2007, according to the report. But it remains a contentious issue.

The inspector general recommended that hospitals and doctors be required to submit detailed information identifying failed devices, like serial and batch numbers, during the billing process.

“This could help reduce Medicare costs by identifying poorly performing devices more quickly, which could also protect beneficiaries from unnecessary costs and improve their chances of receiving appropriate follow-up care more quickly,” the report said.

David Lamir, an official in the inspector general’s Boston office, said the $1.5 billion figure represented a “drop in the bucket” of the true costs to Medicare from medical products that malfunction. He said device failures not only waste money, but also can expose patients to a “high risk of illness,” including needless surgeries.

The report said that medical device recalls nearly doubled from 2003 through 2012 and noted that they have probably cost Medicare billions of dollars. In the past five to six years, more than 200 cardiac devices have been recalled, according to the inspector general’s office. In most cases, manufacturers withdrew their products voluntarily after reports surfaced of injuries or malfunctions. Device makers are required to report problems they learn of, often from doctors and hospitals, to a database run by the Food and Drug Administration.

Diana Zuckerman, president of the National Center for Health Research who has testified before Congress on device safety, said her organization supports making hospitals report malfunctioning devices when they seek Medicare payments to cover an implant surgery. She said the change would help officials pinpoint faulty devices before issuing a recall for tens of thousands of products in patients.

“It would be much more obvious much more quickly which implanted devices were causing problems,” she said.

Ms. Zuckerman noted that the report did not touch on other high-profile device failures, like metal-on-metal hip implants or vaginal mesh.

Medical device companies and some doctors have opposed tighter reporting, arguing that it would be costly and difficult to integrate with existing payment claim forms and might not yield useful information.

“It is abundantly clear that data collected in electronic health records is a far superior and more cost-effective method for monitoring the performance of medical devices,” said Mark Leahey, who heads the Medical Device Manufacturers Association. The trade group represents nearly 300 device companies.

Mr. Leahey said that the electronic health record “captures the full clinical history of the patient, their changing health status and detailed information on their medical treatments,” including any surgically implanted devices.

A spokesman for the Centers for Medicare and Medicaid Services said the agency had not seen the report and would have no comment.

But in written remarks included in the report, Seema Verma, the agency’s administrator, said the tighter reporting requirement was “under consideration” and that the agency would “carefully evaluate the potential that this policy would impose a burden on physicians unnecessarily.”

This article was produced in collaboration with Kaiser Health News, an editorially independent program of the Kaiser Family Foundation. 

• https://www.nytimes.com/2017/10/02/health/heart-devices-medicare.html?_r=0

Medical Device Implants lead national hospital costs data.

	National Inpatient Hospital Costs: The Most Expensive Conditions by Payer, 2011
	Celeste M. Torio, Ph.D., M.P.H. and Roxanne M. Andrews, Ph.D.  Statistical Brief #160, August 2013
Introduction Health care costs continue to grow faster than the economy, and the health share of the Gross Domestic Product (GDP) has maintained its upward trend, reaching 17.9 percent in 2011.

▪   The top five conditions—septicemia; osteoarthritis; complication of device, implant or graft; liveborn (newborn) infants; and acute myocardial infarction—accounted for nearly one-fifth of the total aggregate cost for hospitalizations. Complication of device, implant or graft #3 most expensive condition treated in U.S. hospitals, all payers 2011 #3 most expensive condition billed to Medicaid #4 most expensive condition billed to Medicare

Osteoarthritis was ranked the second most expensive condition only for Medicare ($8.0 billion) and private insurance ($5.7 billion). Over 90 percent of the hospitalizations for osteoarthritis involved a knee or hip replacement.

About HCUP HCUP is a family of powerful health care databases, software tools, and products for advancing research. Sponsored by the Agency for Healthcare Research and Quality (AHRQ), HCUP includes the largest all-payer encounter-level collection of longitudinal health care data (inpatient, ambulatory surgery, and emergency department) in the United States, beginning in 1988. HCUP is a Federal-State—Industry Partnership that brings together the data collection efforts of many organizations—such as State data organizations, hospital associations, private data organizations, and the Federal government to create a national information resource.

Consumers Union, Dr. Marty Makary Testimony April 25, 2013

Begins at minute 13

http://oversight.house.gov/hearing/examining-the-lack-of-transparency-and-consumer-driven-market-forces-in-u-s-health-care/

Patient harm is profitable!

(@NewHealthDialog)

New drugs and devices should be considered experimental after approval until proven otherwise. bit.ly/Mj4tUm

 Letting Big Pharma Review Its Own Drugs — What Could Go Wrong?

By SHANNON BROWNLEE & JOE COLUCCI

JUL 11 2012, 11:11 AM ET 1  (FiDA blog bold)

http://www.theatlantic.com/health/archive/2012/07/letting-big-pharma-review-its-own-drugs-8212-what-could-go-wrong/259666/

We can't trust drug companies to disclose product safety hazards when they stand to gain so much from fudging the facts.

When British drugmaker GlaxoSmithKline (GSK) agreed to pay $3 billion in criminal and civil fines for illegal marketing of several drugs and hiding safety from the U.S. Food and Drug Administration (FDA), it probably seemed to many people like fitting punishment. It's the largest fine ever levied against a pharmaceutical company, and the civil and criminal charges against GSK included marketing its antidepressants Paxil and Wellbutrin for unapproved (read: unproven) uses, giving Medicaid false information about prices it was charging for the drugs, and failing to report patient safety data about diabetes medication Avandia to the FDA. But even $3 billion is probably not going to get GSK to change its ways -- and fines do virtually nothing to protect patients.

When it submitted false price information to Medicaid, GSK was harming taxpayers, a financial crime that is amply repaid by the $300 million the company is paying for that offence. But discouraging future bad behavior is a different story, because GSK is one of the world's biggest drug makers, with annual revenue of more than $40 billion. A $300 million fine starts to look like just the cost of doing business when spread over the period of time when the company was bilking Medicaid.

Fines are even less effective when it comes to preventing patients from being physically harmed. GSK is accused of illegally marketing two antidepressants -- Paxil for depression in adolescents, and Wellbutrin for weight loss, substance addiction, ADHD and other problems. Paxil has been shown to have significant side-effects, including triggering suicidal thoughts and behavior in some patients, and neither antidepressant is much more effective than a sugar pill in the vast majority of patients with depression. Fining the company after the fact doesn't do much for the patients who have already been hurt by their marketing practices.

That's even more the case for GSK's egregious behavior regarding its diabetes drug Avandia. When a new drug comes on the market, sometimes the FDA will ask or require that the manufacturer to do a study, called a post-marketing trial, to look for rare side effects and establish whether the drug is safe over the long term. That's important because often the clinical trials that are done before a drug is approved aren't big enough, and don't last long enough, to say whether a drug is safe to use over a long period.

With Avandia, GSK fudged the results of those post-marketing trials. The company claimed that its RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes) trial showed no evidence that Avandia caused heart attacks or other cardiac diseases. But when outside researchers looked at the data they found massive irregularities and plenty of cases of harm, including patients who died and then mysteriously disappeared from the clinical trial records.

GSK hasn't admitted anything more than "inadvertently" failing to inform the FDA of problems, and the fine isn't going to protect patients from future Avandias. What we really need is a better system for tracking drugs once they are on the market.

Right now, we leave this crucial task to the very companies that have every reason to fudge data, ignore problems -- even deaths -- and keep doctors and patients in the dark, because they are making too much money to do otherwise. At its peak, Avandia earned GSK $2.2 billion a year. It was a phenomenally lucrative drug. The $250 million levied against the company for that part of the fine amounts to less than a slap on the wrist.

The solution isn't stiffer punishments for fraud -- we should take away the power to do harm in the first place. That means we need to stop giving drug companies the opportunity to sell out patient safety in exchange for another few months or years on the market. The simplest way to do that is to have automatic, external post-market surveillance for all new drugs.

Any new drug should be considered by both patients and doctors to be experimental for the first few months, or even years it is on the market, and the FDA should treat the approval of the drug as provisional. (The same goes for new medical devices.) For at least two years, any patient who might receive a new drug or medical device has to be fully informed of its known side effects, and of its experimental status. Data on those patients should be tracked (anonymously), and compared to patients receiving other treatments. Most importantly, automatic algorithms can search those data for patterns revealing any negative effects of the new product, so safety problems can be caught quickly.

An automatic review system would be a huge improvement on our existing review process. It would take the burden of reporting off manufacturers, and let them focus on developing new treatments instead of monitoring old ones. It would remove the financial conflict of interest that encourages companies to hurt patients in order to squeeze a few more months or years of sales out of a new product before problems finally surface. (The only reason Avandia's tendency to kill patients came to light as quickly as it did is because a sharp-eyed cardiologist named Steve Nissen at the Cleveland Clinic happened to be looking at European data that clearly showed the drug was dangerous.)

Perhaps most importantly, it would force us to admit that we don't truly know that our treatments are safe when we start using them -- and that would give patients a chance to be more informed about their choices. That seems like a better system that letting companies kill patients, and then pretending to fix the problem by slapping them with fines every few years.

SHANNON BROWNLEE & JOE COLUCCI - Shannon Brownlee is the acting director of the health policy program at the New America Foundation. She has written previously for The Atlantic, New York Times Magazine, and The New Republic, among others. Joe Colucci is a research associate in the New America Foundation's Health Policy Program and editor of the program's New Health Dialogue blog.