EPA tightens limits on a chemical used to sterilize medical equipment, citing cancer risk

BEHALF. NOW, CATHETERS ARE CAUSING THE PROBLEM. REPORTER IF THE OLD ADAGE TIME IS MONEY IS TRUE, THAT WAS THE WORST ONE TO SEE THAT AMOUNT. THEN LET THE MEDICARE STATEMENTS STACKED ON BARB VANDENBERG’S KITCHEN TABLE BE THE PROOF. IT UPSETS ME EVERY TIME I SEE IT TWICE. ALMOST TO THE DAY, MEDICARE PAID ALMOST THREE GRAND FOR TWO CATHETERS. VANDENBERG NEVER WANTED AND NEVER USED. LOOKING AT THE AMOUNTS AND THAT THAT COULD PAY SOMEONE’S PREMIUM AT LEAST FOR A YEAR. SAME GOES FOR KEVIN UNDERWOOD. MEDICARE PAID MORE THAN $3,400 FOR FOUR CATHETERS ON HIS BEHALF. I’M WONDERING WHAT MEDICARE NEEDS TO DO TO BE ABLE TO CATCH SOME OF THIS FRAUD. WHEN YOU’RE SUPPLEMENTAL INSURANCE CATCHES IT RIGHT AWAY. BUT HERE’S WHERE THE TIME EQUALS THE MONEY. UNDERWOOD DID NOT RECEIVE A STATEMENT SAYING MEDICARE PAID THOUSANDS FOR CATHETERS UNTIL NINE MONTHS LATER. MEDICARE IS BASICALLY ASKING YOU TO CATCH FRAUD THAT YOU DON’T EVEN KNOW IS HAPPENING. CORRECT. UNTIL IT’S UNTIL IT’S TOO LATE. JUST LIKE VANDENBERG, COMPANIES BILLED MEDICARE MONTHLY ON UNDERWOOD’S BEHALF. MEDICARE TYPICALLY ONLY SENDS THESE STATEMENTS QUARTERLY, MEANING AT BEST, SOMEONE CAN CATCH THE FRAUD THREE MONTHS AFTER IT HAPPENED. THIS IS A MEDICARE SUMMARY NOTICE. INGRID KÜNDINGER IS THE DIRECTOR OF THE SENIOR MEDICARE PATROL PROGRAM. THE ONLY GROUP ON THE GROUND IN WISCONSIN COLLECTING INFO ON THIS AND OTHER MEDICARE FRAUD. HER OFFICE HAS RECEIVED 45 COMPLAINTS OF CATHETER FRAUD. SO WE’RE BASICALLY SCRATCHING THE SURFACE OF WHAT IS ACTUALLY HAPPENING OUT THERE, CORRECT. THE COMPANY’S BILLING. WISCONSINITES ARE ACROSS THE COUNTRY FROM TEXAS TO NEW YORK. THE ONE THAT KEEPS POPPING UP PRETTY IN PINK BOUTIQUE REGISTERED TO A BUSINESS PARK IN EL PASO. THE NUMBER YOU DIALED IS NOT IN SERVICE LIKE WE’VE SEEN BEFORE. THEIR PHONE WAS DISCONNECTED. PEOPLE ON MEDICARE AND TAXPAYERS AREN’T THE ONLY ONES CAUGHT IN THE MIDDLE OF THE BILLING SCHEME. WE’LL GET, YOU KNOW, 15 TO 25 CALLS WITHIN A 2 OR 3 DAY PERIOD ABOUT ONCE A MONTH. PAM LUDWIG IS THE FOUNDER AND OWNER OF A DIFFERENT, LEGITIMATE, PRETTY AND PINK BOUTIQUE NEAR NASHVILLE. HER COMPANY, ORIGINALLY OPENED UP TO HELP WOMEN BATTLING BREAST CANCER. THE COMPANY RECEIVED MORE THAN 100 PHONE CALLS FROM PEOPLE THINKING THEY FRAUDULENTLY BILLED MEDICARE ON THEIR BEHALF. IT’S BEYOND FRUSTRATING. IT’S INFURIATING, REALLY, BECAUSE WE REALLY ARE OUT HERE TRYING TO MAKE SOME GOOD IN THE WORLD, 12 NEWS INVESTIGATES HAS ALREADY UNCOVERED THE SAME ISSUE WITH COVID 19 TESTS AND UNCOVERED $74 MILLION AND WHAT THE FEDS CALL FRAUD FROM TWO CHICAGO COMPANIES. THIS MAN CHARGED WITH BILLING MEDICARE FOR MILLIONS OF TESTS AND BILKING THE FEDS OUT OF $31 MILLION. YOU CAN TALK TO MY ATTORNEY FOR NOW. WE CAN’T TALK TO YOU. NO, I’M SORRY, CONGRESSMAN BRIAN STYLE SAYS MORE RESOURCES SHOULD BE GIVEN TO DOJ TO ARREST MORE PEOPLE. IF WE’RE RAMPING UP THE DOJ TO INVESTIGATE, THAT’S THAT’S AFTER IT’S ALREADY HAPPENED. YEAH. WHAT SHOULD WE BE DOING ON THE FRONT END TO STOP IT? WE NEED A MORE ROBUST PROCESS AS TO HOW THESE PAYMENTS ARE GOING OUT THE DOOR IN THE FIRST PLACE, STYLE SAYS HIS OFFICE AND OTHERS HAVE CONTACTED MEDICARE REGARDING FRAUD. WHY CAN’T MEDICARE STOP IT? ON THE FRONT END WHEN A PRIVATE COMPANY IS FOR AN INSURER? YES. CMS NEEDS TO BE ABLE TO ANSWER THAT QUESTION AND I DON’T THINK ANYBODY SHOULD BE SATISFIED UNTIL CMS HAS AN ANSWER AS TO WHY THEY’RE GETTING HOODWINKED BY THE PRIVATE SECTOR. IS NOT CMS. THE CENTER FOR MEDICARE AND MEDICAID SERVICES WOULD NOT ANSWER ANY OF OUR DIRECT QUESTIONS, AND DENIED MULTIPLE REQUESTS FOR AN INTERVIEW. CMS GAVE VIRTUALLY THE SAME STATEMENT. IT HAS THROUGHOUT OUR MONTHS OF REPORTING, SAYING IT IS, QUOTE, COMMITTED TO PREVENT FRAUD AND PROTECTING PEOPLE WITH MEDICARE FROM FALLING VICTIM TO FRAUD. WHAT IS THE BREAKING POINT WHEN IT COMES TO TO STOPPING THIS, EITHER FROM CONGRESS OR FROM CMS? AND FROM MY STANDPOINT, IT’S PUBLIC EXPOSURE LIKE YOU’RE DOING HERE WITH THIS REPORT. UH, TO CREATE THE THE OUTRAGE THAT SOMETHING BE DONE. SENATOR RON JOHNSON HAS PREVIOUSLY CALLED ON CMS AND CONGRESS TO INVESTIGATE MEDICARE FRAUD, TWEETING OUR STORY AFTER WE SPOKE TO HIM IN SEPTEMBER. JOHNSON IS THE RANKING MEMBER ON THE PERMANENT SUBCOMMITTEE ON INVESTIGATIONS, WHO CAN INVESTIGATE THE ISSUE? YOU HAVE THE POWER TO AT LEAST PARTIALLY STOP THIS. WHY NOT DO IT? NO, I WILL TRY AGAIN. I’M HERE DOING THIS INTERVIEW, TRYING TO MAKE IT PUBLIC. BUT, YOU KNOW, BEING A RANKING MEMBER, I CAN’T FORCE THE INVESTIGATION ON MY ON MY CHAIRMAN WITH DEMOCRATS IN CHARGE, WITH THEM BEING CHAIRMAN, THAT THEY’RE NOT PARTICULARLY INTERESTED IN INVESTIGATING GOVERNMENT. THEY DON’T WANT TO HIGHLIGHT THE ABUSE OF TAXPAYER MONEY WITHIN THESE PROGRAMS. THE FEDERAL GOVERNMENT PAYING TAXPAYER MONEY FOR CATHETERS, DOZENS, IF NOT HUNDREDS OF TIMES. YOU NEVER REQUESTED THE CATHETERS? NO. NEVER REQUESTED THE COVID TESTS? NO. BUT EVERY TIME MEDICARE FOOTED THE BILL, EVERY TIME MEDICARE FOOTED THE BILL. JAMES, WHAT CAN PEOPLE DO IF THIS HAS HAPPENED TO THEM? OF COURSE THEY CAN CALL MEDICARE, REPORT THE FRAUD THERE. THEY CAN ALSO REPORT IT TO THE STATE’S SENIOR MEDICARE PATROL PROGRAM. OF COURSE, BETWEEN THE CATHETER ISSUE, THE COVID 19 TEST THAT WE’VE REPORTED ON, WE’RE KEEPING A LIST AS WELL. LET US KNOW IF THIS HAS HAPPENED TO YOU. WISN.COM/TIPS. WE DID REACH OUT TO LAWMAKERS ON BOTH SIDES OF THE AISLE STYL

The Environmental Protection Agency is imposing stricter limits on a chemical used to sterilize medical equipment after finding a higher-than-expected cancer risk at facilities that use ethylene oxide to clean billions of devices, including catheters and syringes.A rule finalized Thursday will reduce ethylene oxide emissions by about 90% by targeting nearly 90 commercial sterilization facilities across the country, the EPA said. The companies will also have to test for the antimicrobial chemical in the air and make sure their pollution controls are working properly.Video above: Thousands in taxpayer money spent on catheters no one wantsThe new rule will "safeguard public health from this pollution – including the health of children, who are particularly vulnerable to carcinogens early in life,'' said EPA Administrator Michael Regan. “We’ve arrived at a historically strong rule that will protect the most exposed communities from toxic air pollution while also ensuring ... safeguards (to) our nation’s critical supply of sterilized medical equipment.”The American Lung Association called the rule an important step forward to protect human health from cancer caused by ethylene oxide emissions.“The science on health risks from ethylene oxide shows both short-term and long-term exposure are dangerous for health,'' said Harold Wimmer, the group's president and CEO.People who live near commercial sterilization facilities are more likely to develop cancer over their lifetimes, Wimmer said, adding: “No one should have to live with elevated cancer risk because of air pollution in their community.''Patients with lung disease and other health problems “also need access to safe and clean medical supplies,'' he said. “We appreciate the work EPA put into ensuring that this final rule both cleans up harmful emissions and ensures continued access to sterilized medical equipment.''Darya Minovi, a senior research analyst with the Union of Concerned Scientists, called the EPA action overdue.“For far too long, communities across the country — especially Black and Brown people and those who do not speak English as a first language — have been exposed to the cancer-causing chemical ethylene oxide,'' Minovi said in a statement.“Make no mistake: politically powerful industries sought to weaken the rule’s health-protective standards, but the public health benefits that will be afforded to communities through this action are a testament to the efforts of grassroots advocates and public health experts who didn’t let up in their demands,'' she added.The tightened safeguards are driven by the EPA’s better understanding that ethylene oxide’s threat is severe, Regan said. The chemical is classified as a pesticide. A worker in a medical sterilizing plant, over the course of a career, could see their risk shoot up by as much as one extra case of cancer for every 10 people exposed. The EPA’s generally acceptable increase in lifetime cancer risk is 1 in 10,000.Ethylene oxide is a gas used to sterilize roughly half of all medical devices and is also used to ensure the safety of certain spices and other food products. It is used to clean everything from catheters to syringes, pacemakers and plastic surgical gowns. Brief exposure isn’t considered a danger, but breathing it long term elevates the risk of breast cancer and lymphoma, the EPA said.In 2016, the EPA updated its assessment of ethylene oxide’s danger based on information about exposed workers at sterilizing facilities, finding the chemical was many times more threatening than previously known. Analysis released by the agency two years later found that cancer risk was too high near some medical sterilization plants and some other facilities that release ethylene oxide.In 2022, the EPA laid out the risk faced by residents who live near medical sterilization facilities. In Laredo, Texas, for example, residents and activists fought to clean up a sterilization facility run by Missouri-based Midwest Sterilization Corp. It was one of 23 sterilizers in the United States that the EPA said posed a risk for people nearby.Sterigenics, a major sterilization company, shuttered a medical sterilization plant in a Chicago suburb after monitoring found emissions spikes in nearby neighborhoods. They eventually settled numerous lawsuits.Many facilities have sharply reduced ethylene oxide emissions in recent years, but those that haven’t will now have to meet stricter requirements, the EPA said.The EPA said it worked closely with the Department of Health and Human Services and other agencies to develop a final rule that centers on public health. The rule provides sufficient time and flexibility for commercial facilities to come into compliance, while offering strong public health protection for nearby communities and minimizing any potential impacts to the medical device supply chain, officials said.Health and Human Services Secretary Xavier Becerra hailed the rule as a victory for workers and fence-line communities that face ongoing dangers from ethylene oxide pollution.Scott Whitaker, president and CEO of the Advanced Medical Technology Association, said medical sterilizers provide a vital service and many devices can't be sterilized by another method.The industry group appreciates EPA's update and will be reviewing the rule, Whitaker said in a statement Thursday. The industry has emphasized the need for adequate time to implement the rule, “flexibility in technologies to remove emissions and the ability to achieve EPA targets that would not force resubmission of medical devices for FDA approval,'' Whitaker said.He said he remains hopeful that the rule “will not have a negative impact on the healthcare system or the patients we serve.”

A rule finalized Thursday will reduce ethylene oxide emissions by about 90% by targeting nearly 90 commercial sterilization facilities across the country, the EPA said. The companies will also have to test for the antimicrobial chemical in the air and make sure their pollution controls are working properly.

Video above: Thousands in taxpayer money spent on catheters no one wants

The new rule will "safeguard public health from this pollution – including the health of children, who are particularly vulnerable to carcinogens early in life,'' said EPA Administrator Michael Regan. “We’ve arrived at a historically strong rule that will protect the most exposed communities from toxic air pollution while also ensuring ... safeguards (to) our nation’s critical supply of sterilized medical equipment.”

The American Lung Association called the rule an important step forward to protect human health from cancer caused by ethylene oxide emissions.

“The science on health risks from ethylene oxide shows both short-term and long-term exposure are dangerous for health,'' said Harold Wimmer, the group's president and CEO.

People who live near commercial sterilization facilities are more likely to develop cancer over their lifetimes, Wimmer said, adding: “No one should have to live with elevated cancer risk because of air pollution in their community.''

Patients with lung disease and other health problems “also need access to safe and clean medical supplies,'' he said. “We appreciate the work EPA put into ensuring that this final rule both cleans up harmful emissions and ensures continued access to sterilized medical equipment.''

Darya Minovi, a senior research analyst with the Union of Concerned Scientists, called the EPA action overdue.

“For far too long, communities across the country — especially Black and Brown people and those who do not speak English as a first language — have been exposed to the cancer-causing chemical ethylene oxide,'' Minovi said in a statement.

“Make no mistake: politically powerful industries sought to weaken the rule’s health-protective standards, but the public health benefits that will be afforded to communities through this action are a testament to the efforts of grassroots advocates and public health experts who didn’t let up in their demands,'' she added.

The tightened safeguards are driven by the EPA’s better understanding that ethylene oxide’s threat is severe, Regan said. The chemical is classified as a pesticide. A worker in a medical sterilizing plant, over the course of a career, could see their risk shoot up by as much as one extra case of cancer for every 10 people exposed. The EPA’s generally acceptable increase in lifetime cancer risk is 1 in 10,000.

Ethylene oxide is a gas used to sterilize roughly half of all medical devices and is also used to ensure the safety of certain spices and other food products. It is used to clean everything from catheters to syringes, pacemakers and plastic surgical gowns. Brief exposure isn’t considered a danger, but breathing it long term elevates the risk of breast cancer and lymphoma, the EPA said.

In 2016, the EPA updated its assessment of ethylene oxide’s danger based on information about exposed workers at sterilizing facilities, finding the chemical was many times more threatening than previously known. Analysis released by the agency two years later found that cancer risk was too high near some medical sterilization plants and some other facilities that release ethylene oxide.

In 2022, the EPA laid out the risk faced by residents who live near medical sterilization facilities. In Laredo, Texas, for example, residents and activists fought to clean up a sterilization facility run by Missouri-based Midwest Sterilization Corp. It was one of 23 sterilizers in the United States that the EPA said posed a risk for people nearby.

Sterigenics, a major sterilization company, shuttered a medical sterilization plant in a Chicago suburb after monitoring found emissions spikes in nearby neighborhoods. They eventually settled numerous lawsuits.

Many facilities have sharply reduced ethylene oxide emissions in recent years, but those that haven’t will now have to meet stricter requirements, the EPA said.

The EPA said it worked closely with the Department of Health and Human Services and other agencies to develop a final rule that centers on public health. The rule provides sufficient time and flexibility for commercial facilities to come into compliance, while offering strong public health protection for nearby communities and minimizing any potential impacts to the medical device supply chain, officials said.

Health and Human Services Secretary Xavier Becerra hailed the rule as a victory for workers and fence-line communities that face ongoing dangers from ethylene oxide pollution.

Scott Whitaker, president and CEO of the Advanced Medical Technology Association, said medical sterilizers provide a vital service and many devices can't be sterilized by another method.

The industry group appreciates EPA's update and will be reviewing the rule, Whitaker said in a statement Thursday. The industry has emphasized the need for adequate time to implement the rule, “flexibility in technologies to remove emissions and the ability to achieve EPA targets that would not force resubmission of medical devices for FDA approval,'' Whitaker said.

He said he remains hopeful that the rule “will not have a negative impact on the healthcare system or the patients we serve.”

EPA tightens limits on a chemical used to sterilize medical equipment, citing cancer risk

GET LOCAL BREAKING NEWS ALERTS

Top Picks