Insightec wins expanded Medicare coverage for essential tremor treatment

Insightec updated logoIncisionless neurosurgery company Insightec said it has won Medicare coverage for its Neuravive MR-guided focused ultrasound device in 13 more states, effective April 1, 2019.

Health insurance administrator Noridian extended coverage to Medicare recipients in Alaska, Arizona, California, Hawaii, Idaho, Montana, Nevada, North Dakota, Oregon, South Dakota, Utah, Washington, and Wyoming. Insightec’s Neuravive technology is designed to treat essential tremor that has not responded to medication. The approval extends coverage for the procedure to a total of 38 U.S states.

Get the full story on our sister site, Medical Design & Outsourcing.

The post Insightec wins expanded Medicare coverage for essential tremor treatment appeared first on MassDevice.

Medicare’s bundled ortho payments yield modest savings

Medicare’s randomized trial of a new bundled payment model for hip and knee replacement surgeries led to $812 in savings per procedure, a 3.1% reduction in costs when compared with traditional means of paying for care, according to new research.

The study from Harvard T.H. Chan School of Public Health and Harvard Medical School found that the bundled payment model was also associated with a reduction in the use of skilled nursing care after hospitalization, but had no effects on complication rates among patients.

Published online today in the New England Journal of Medicine, the study confirms what an earlier Medicare study had found in terms of savings. In September, the Centers for Medicare & Medicaid Services (CMS) announced that Medicare payments for lower extremity joint replacement care fell by 3.3% among participating hospitals compared to a control group in the first year of its bundled payment pilot program. Quality of care was maintained in both settings, the federal health insurer said.

“Interest in bundled payments has exploded the past few years,” said Michael Barnett, one of the lead authors on the study and assistant professor of health policy and management at Harvard Chan School. “The big question has always been whether this new model can lead hospitals to meaningfully reduce spending without harming patients. This study indicates that with the right financial incentive, hospitals can save money without compromising quality by sending more patients home rather than to a nursing facility.”

Bundled payments are an alternative payment strategy that health plans, Medicare, and Medicaid are experimenting with to reduce expenses. Unlike traditional fee-for-service payments, bundled payments provide a single, fixed payment for a procedure and follow-up care rather than individually paying all parties separately.

In January 2016, CMS required all hospitals in 67 geographic areas to participate in the five-year “Comprehensive Care for Joint Replacement” (CJR) program aimed at lowering healthcare costs and improving outcomes. The program bundles payments for hip and knee replacements from hospital admission to 90 days after discharge.

Under the model, hospitals in the selected cities received bonuses or penalties depending on how much they spent on follow-up care 90 days after joint-replacement patients were discharged. The program is the largest randomized policy experiment in Medicare to date of a new payment model.

To determine if the bundled payment model was effective at reducing costs and complications, the Harvard researchers analyzed data from the first two years of the program (2016-2017). They compared costs associated with 280,161 joint replacement procedures in 803 hospitals that were required to participate in the bundled payment program with 377,278 procedures in 962 hospitals that were not participating in the program.

The analysis showed that before accounting for administrative costs, bonuses and penalties, the bundled payment model resulted in a modest 3% savings for each patient and that complications rates did not increase. The cost savings were driven almost exclusively from reducing the use of post-acute care nursing facilities, the researchers said.

One concern that has been expressed over bundled payments is that such models may incentivize hospitals to avoid operating on sicker, more costly patients. The Harvard study, however, showed that the model had little impact on the number of higher-risk patients who received lower extremity joint replacements.

The study adds to the growing body of evidence that bundled payment models reduce spending without sacrificing quality of care, the researchers said. They added that the cost savings associated with bundled payments grew during the 18-month study period and that it is likely savings would continue to grow as the bundled payment model matured.

“While there is widespread agreement that we need to move away from our typical payment system, how to do so remains unclear,” said Ateev Mehrotra, senior author and associate professor of health care policy at Harvard Medical School. “We need more rigorous experiments such as this one.”


The post Medicare’s bundled ortho payments yield modest savings appeared first on MassDevice.

Medtech reporting would change under new opioid law

A section of the recently-passed bill to address the opioid crisis could have implications for medtech.

The 250-page Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT for Patients and Communities Act) contains a provision that would require manufacturers of certain medical devices, drugs and biologics covered by Medicare, Medicaid, or the Children’s Health Insurance Program to report payments or other transfers of value made to “covered recipients.”

“Covered recipients,” as originally written in the sunshine provision of the Affordable Care Act, were only physicians and teaching hospitals. Section 6111 of SUPPORT would expand that to include physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and certified nurse-midwives as of January 1, 2022. Also known as H.R. 6, the bill has passed both houses of Congress and is awaiting President Trump’s signature.

The reporting changes needn’t have anything to do with opioids, and this provision’s effective date is ambiguous, according to an FDA law blog post by the Washington, D.C. law firm Hyman, Phelps & McNamara. Stay tuned for CMS to clear this up in forthcoming regulations.






The post Medtech reporting would change under new opioid law appeared first on MassDevice.

Value-based care: CMS’s new administrator wants more of it

CMS Seema-Verma

Seema Verma, CMS’s administrator

Seven months into her tenure, CMS administrator Seema Verma is turning out to be highly supportive of value-based care models. In fact, she recently told an audience in Cleveland that she wants them implemented faster.

The situation appears to dispel doubts that alternative payment models – such as Accountable Care Organizations or “comprehensive care” models for such big-ticket items as joint replacements – would remain a priority under President Donald Trump’s administration. The move toward paying for “value” versus the old fee-for-service models are a big deal for the medical device industry, which have been shifting their strategies and focus in response.

Alternative payment methods are important for driving innovation and driving value and cost-effective care, Verma said during an appearance at the annual Cleveland Clinic Medical Innovation Summit, which took place Oct. 23–25 in Cleveland. Different models will help drive the market toward value and quality and away from a fee-for-service system, according to Verma, who shared the stage with Cleveland Clinic CEO Toby Cosgrove.

Get the full story on our sister site, Medical Design & Outsourcing.

Can “pre-hospice” programs support the push towards value-based care?

Gerald Chinchar isn’t quite at the end of life, but the end is not far away. The 77-year-old fell twice last year, shattering his hip and femur, and now gets around his San Diego home in a wheelchair. His medications fill a dresser drawer, and congestive heart failure puts him at high risk of emergency room visits and long hospital stays.

Chinchar, a Navy veteran who loves TV Westerns, said that’s the last thing he wants. He still likes to go watch his grandchildren’s sporting events and play blackjack at the casino. “If they told me I had six months to live or go to the hospital and last two years, I’d say leave me home,” Chinchar said. “That ain’t no trade for me.”

Most aging people would choose to stay home in their last years of life. But for many, it doesn’t work out: They go in and out of hospitals, getting treated for flare-ups of various chronic illnesses. It’s a massive problem that costs the health care system billions of dollars and has galvanized health providers, hospital administrators and policymakers to search for solutions.


Sharp HealthCare, the San Diego health system where Chinchar receives care, has devised a way to fulfill his wishes and reduce costs at the same time. It’s a pre-hospice program called Transitions, designed to give elderly patients the care they want at home and keep them out of the hospital.

Social workers and nurses from Sharp regularly visit patients in their homes to explain what they can expect in their final years, help them make end-of-life plans and teach them how to better manage their diseases. Physicians track their health and scrap unnecessary medications. Unlike hospice care, patients don’t need to have a prognosis of six months or less, and they can continue getting curative treatment for their illnesses, not just for symptoms.

Before the Transitions program started, the only option for many patients in a health crisis was to call 911 and be rushed to the emergency room. Now, they have round-the-clock access to nurses, one phone call away.

“Transitions is for just that point where people are starting to realize they can see the end of the road,” said San Diego physician Dan Hoefer, one of the creators of the program. “We are trying to help them through that process so it’s not filled with chaos.”

The importance of programs like Transitions is likely to grow in coming years as 10,000 baby boomers — many with multiple chronic diseases — turn 65 every day. Transitions was among the first of its kind, but several such programs, formally known as home-based palliative care, have since opened around the country. They are part of a broader push to improve people’s health and reduce spending through better coordination of care and more treatment outside hospital walls.

But a huge barrier stands in the way of pre-hospice programs: There is no clear way to pay for them. Health providers typically get paid for office visits and procedures, and hospitals still get reimbursed for patients in their beds. The services provided by home-based palliative care don’t fit that model.

In recent years, however, pressure has mounted to continue moving away from traditional payment systems. The Affordable Care Act has established new rules and pilot programs that reward the quality rather than the quantity of care. The health reform law, for example, set up “accountable care organizations” networks of doctors and hospitals that share responsibility for providing care to patients. They also share the savings when they rein in unnecessary spending by keeping people healthier. Those changes are helping to make home-based palliative care a more viable option.

In San Diego, Sharp’s palliative care program has a strong incentive to reduce the cost of caring for its patients, who are all in Medicare managed care. The nonprofit health organization receives a fixed amount of money per member each month, so it can pocket what it doesn’t spend on hospital stays and other costly medical interventions.

‘Something that works’

Palliative care focuses on relieving patients’ stress, pain and other symptoms as their health declines, and it helps them maintain their quality of life. It’s for people with serious illnesses, such as cancer, dementia and heart failure. The idea is for patients to get palliative care and then move into hospice care, but they don’t always make that transition.

The 2014 report “Dying in America,” by the Institute of Medicine, recommended that all people with serious advanced illness have access to palliative care. Many hospitals now have palliative care programs, delivered by teams of social workers, chaplains, doctors and nurses, for patients who aren’t yet ready for hospice. But until recently, few such efforts had opened beyond the confines of hospitals.

Kaiser Permanente set out to address this gap. Nearly 20 years ago, it created a home-based palliative care program, testing it in California and later in Hawaii and Colorado. Two studies by Kaiser and others found that participants were far more likely to be satisfied with their care and more likely to die at home than those not in the program. (Kaiser Health News, which produces California Healthline, is not affiliated with Kaiser Permanente.)

One of the studies, published in 2007, found that 36 percent of people receiving palliative care at home were hospitalized in their final months, compared with 59 percent of those getting standard care. The overall cost of care for those who participated in the program was a third less than for those who didn’t.

“We thought, ‘Wow. We have something that works,’” said Susan Enguidanos, an associate professor at the University of Southern California’s Leonard Davis School of Gerontology, who worked on both studies. “Immediately we wanted to go and change the world.”

But Enguidanos knew that Kaiser Permanente was unlike most health organizations. It was responsible for both insuring and treating its patients, so it had a clear financial motivation to improve care and control costs. Enguidanos said she talked to medical providers around the nation about this type of palliative care, but the concept didn’t take off at the time. Providers kept asking the same question: How do you pay for it without charging patients or insurers?

“I liken it to paddling out too soon for the wave,” she said. “We were out there too soon. … But we didn’t have the right environment, the right incentive.”

A bold idea

Dan Hoefer’s medical office is in the city of El Cajon, which sits in a valley in eastern San Diego County. Hoefer, a former hospice and home health medical director and nursing home doctor, has spent years treating elderly patients. He learned an important lesson when seeing patients in his office: Despite the medical care they received, “they were far more likely to be admitted to the hospital than make it back to see me.”

When his patients were hospitalized, many would decline quickly. Even if their immediate symptoms were treated successfully, they would sometimes leave the hospital less able to take care of themselves. They would get infections or suffer from delirium. Some would fall.

His patients were like cars with 300,000 miles on them, he said. They had a lot of broken parts. “You can’t just fix one thing and think you have solved the problem,” he said.

And trying to do so can be very costly. About a quarter of all Medicare spending for beneficiaries 65 or older is to treat people in their last year of life, according to a report by the Kaiser Family Foundation. (Kaiser Health News, which produces California Healthline, is an editorially independent program of the foundation.)

Hoefer’s colleague, Suzi Johnson, a nurse and administrator in Sharp’s hospice program, saw the opposite side of the equation. Patients admitted into hospice care would make surprising turnarounds once they started getting medical and social support at home and stopped going to the hospital. Some lived longer than doctors had expected.

In 2005, the pair hatched and honed a bold idea: What if they could design a home-based program for patients before they were eligible for hospice?

Thus, Transitions was born. They modeled their new program in part on the Kaiser experiment, then set out to persuade doctors, medical directors and financial officers to try it. But they met resistance from physicians and hospital administrators who were used to getting paid for seeing patients.

“We were doing something that was really revolutionary, that really went against the culture of health care at the time,” Johnson said. “We were inspired by the broken system and the opportunity we saw to fix something.”

Despite the concerns, Sharp’s foundation board gave the pair a $180,000 grant to test out Transitions. And in 2007, they started with heart failure patients and later expanded the program to those with advanced cancer, dementia, chronic obstructive pulmonary disease and other progressive illnesses. They started to win over some doctors who appreciated having additional eyes on their patients, but they still encountered “some skepticism about whether it was really going to do any good for our patients,” said Jeremy Hogan, a neurologist with Sharp. “It wasn’t really clear to the group … what the purpose of providing a service like this was.”

Nevertheless, Hogan referred some of his dementia patients to the program and quickly realized that the extra support for them and their families meant fewer panicked calls and emergency room trips.

Hoefer said doctors started realizing home-based care made sense for these patients — many of whom were too frail to get to a doctor’s office regularly. “At this point in the patient’s life, we should be bringing health care to the patient, not the other way around,” he said.

Across the country, more doctors, hospitals and insurers are starting to see the value of home-based palliative care and are figuring out how to pay for it, said Kathleen Kerr, a health care consultant who researches palliative care.

“It is picking up steam,” she said. “You know you are going to take better care of this population, and you are absolutely going to have lower health care costs.”

Providers are motivated in part by a growing body of research. A study published in January showed that in the last three months of life, medical care for patients in a home-based palliative care program cost $12,000 less than for patients who were getting more typical treatment. Patients in the program also were more likely to go into hospice and to die at home, according to the study.

Two studies of Transitions in 2013 and 2016 reaffirmed that such programs save money. The second study, led by outside evaluators, showed it saved more than $4,200 per month on cancer patients and nearly $3,500 on those with heart failure.

The biggest differences occurred in the final two months of life, said one of the researchers, Brian Cassel, who is palliative care research director at the Virginia Commonwealth University School of Medicine in Richmond.

One reason for the success of these programs is that the teams really get to know patients, their hopes and aspirations, said Christine Ritchie, a professor at UC San Francisco’s medical school. “There is nothing like being in someone’s home, on their turf, to really understand what their life is like,” she said.

A home visit

Nurse Sheri Juan and social worker Mike Velasco, who both work for Sharp, walked up a wooden ramp to the Chinchars’ front door one recent January morning. Juan rolled a small suitcase behind her containing a blood pressure cuff, a stethoscope, books, a laptop computer and a printer.

Mary Jo Chinchar was already familiar with Transitions because her mother had been in the program before entering hospice and dying in 2015 at the age of 101. Late last year, Gerald Chinchar’s doctor recommended he enroll in it, explaining that his health was in a “tenuous position.”

Chinchar, who has nine grandchildren and four great-grandchildren, likes to tell stories about his time in the Navy, about traveling the country for jobs and living in San Francisco as a young man.

He has had breathing problems much of his life, suffering from asthma and chronic obstructive pulmonary disease — ailments he partly attributes to the four decades he spent painting and sandblasting fuel tanks for work. Chinchar also has diabetes, a disease that led to his mother’s death. He recently learned he had heart failure.

“I never knew I had any heart trouble,” he said. “That was the only good thing I had going for me.”

Now he’s trying to figure out how to keep it from getting worse: How much should he drink? What is he supposed to eat?

That’s where Juan comes in. Her job is to make sure the Chinchars understand Gerald’s disease so he doesn’t have a flare-up that could send him to the emergency room. She sat beside the couple in their living room, its bookshelves filled with titles on gardening and baseball. A basket of cough drops and a globe sat on a side table.

Any pain today? Juan asked. How is your breathing? Are you more fatigued than before? Is your weight the same? He replied that he had gained a few pounds recently but knew that was because he’d eaten too much bacon.

At this point in the patient’s life, we should be bringing health care to the patient, not the other way around.

Posted on the couple’s refrigerator was a notice advising them to call the nurse if Gerald had problems breathing, increased swelling or new chest pain.

Juan checked his blood pressure and examined his feet and legs for signs of more swelling. She looked through his medications and told him which ones the doctor wanted him to stop taking. “What we like to do as a palliative care program is streamline your medication list,” she said. “They may be doing more harm than good.”

Mary Jo Chinchar said she appreciates the visits, especially the advice about what Gerald should eat and drink. Her husband doesn’t always listen to her, she said. “It’s better to come from somebody else.”

A nearly impossible decision

On a rainy January day, doctors, nurses and social workers gathered in a small conference room for their bimonthly meeting to discuss patient cases. Information about the patients — their hospitalizations, medications, diagnoses — was projected on the wall. Their task: to decide if new patients were appropriate for Transitions and if current patients should remain there.

It’s nearly impossible to predict how long someone will live. It’s an inexact algorithm based on the severity of their disease, depression, appetite, social support and other factors. Nevertheless, the team tries to do just that, and they may recommend hospice for patients expected to live less than six months.

That was the case with an 87-year-old woman suffering from Alzheimer’s disease. She had fallen many times, slept about 16 hours a day and no longer had much of an appetite. Those were all signs that the woman may be close to death, so she was referred to hospice.

Patients typically stay in Transitions about seven or eight months, but some last as long as two years before they stabilize and are discharged from the program. Others go directly to hospice, and still others die while they are still in Transitions.

The group turned its attention to an 89-year-old woman with dementia, who believed she was still a young Navy wife. She suffered from depression and kidney disease, and had been hospitalized twice last year.

“She’s a perfect patient for Transitions,” Hoefer told the team, adding that she could benefit from extra help. Another good candidate, Hoefer said later, was El Cajon resident Evelyn Matzen, who is 94 and has dementia. She had started to lose weight and was having more difficulty caring for herself. They took her in because “we were worried that it was going to start what I call the revolving door of hospitalization,” Hoefer said.

About eight months after she joined the program, Matzen sat in Hoefer’s office as he checked her labs and listened to her chest. Her body was starting to slow down, but she was still doing well, he told her. “Whatever you are doing is working.”

Bill Matzen, who accompanied his mom to the appointment, said she had started to stabilize since going onto Transitions. “She is on less medication, she is in better condition, physically, mentally, the whole nine yards,” he said.

Hoefer explained that frail elderly patients have fewer reserves to tolerate medical treatment and especially hospitalization. Bill Matzen said his mother leaned that the hard way after a recent fall. Though the Transitions nurse had come to see her, the Matzens decided to go to the hospital because they were still concerned about a bruise on her head. While she was in the hospital, Evelyn Matzen started hallucinating and grew agitated.

Being in the hospital “kicks her back a notch or two,” her son said. “It takes her longer to recover than if she had been in a home environment.”

A changed climate

Outpatient palliative care programs are cropping up in various forms. Some new ones are run by insurers, others by health systems or hospice organizations. Others are for-profit, including Aspire Health, which was started by former senator Bill Frist in 2013.

Sutter Health operates a project called Advanced Illness Management to help patients manage symptoms and medications and plan for the future. The University of Southern California and Blue Shield of California recently received a $5 million grant to provide and study outpatient care.

“The climate has changed for palliative care,” said Enguidanos, the lead investigator on the USC-Blue Shield project.

Ritchie said she expects even more home-based programs in the years to come, especially if palliative care providers work alongside primary care doctors. “My expectation is that much of what is being done in the hospital won’t need to be done in the hospital anymore and it can be done in people’s homes,” she said.

Challenges remain, however. In addition to questions about reimbursement, not enough trained providers are available. And some doctors are unfamiliar with the approach, and patients may be reluctant, especially those who haven’t clearly been told they have a terminal diagnosis.

Now, some palliative care providers and researchers worry about the impact of President Donald Trump’s plans to repeal the Affordable Care Act and revamp Medicare.

“It would be horrible,” Kerr said. “Before, we had an inkling that this was helping a lot of folks. Now we know it is really helping.”

Gerald Chinchar, who grew up in Connecticut, said he never expected to live into old age. His father, a heavy drinker, died of cirrhosis of the liver at 47. In his family, Chinchar said, “you’re an old-timer if you make 60.”

Chinchar said he gave up drinking and is trying to eat less of his favorite foods — steak sandwiches and fish and chips. He just turned 77, a milestone he credits partly to the pre-hospice program.

“If I make 80, I figured I did pretty good,” he said. “And if I make 80, I’ll shoot for 85.”

KHN’s coverage in California is funded in part by Blue Shield of California Foundation.

Photo: IvelinRadkov, Getty Images

Dexcom will reap benefit as CMS posts criteria for Medicare coverage of CGMs

The Centers for Medicare and Medicaid Services has released guidelines on Medicare coverage for continuous glucose monitors, and one medtech company stands to make a whole lot of money from the change.

San Diego-based DexCom is the only manufacturer of a continuous glucose monitor (CGM) defined as therapeutic, meaning patients can make treatment decisions using the device. The DexCom G5 Mobile System provides the glucose level, the direction and rate of change, and uses built-in customizable alarms to alert wearers when their glucose is too low or too high. Low glucose levels can induce seizures, loss of consciousness, coma and death.

DexCom, diabetes professional societies, endocrinologists, the American Diabetes Association and the Juvenile Diabetes Research Foundation (JDRF) have been working on this with CMS for years, according to DexCom CEO Kevin Sayer.


“It does expand our patient base to a group of people who really need this technology,” Sayer said in a phone interview. “It’s more than a nice business opportunity. It’s going to be a life-changing experience for these people. It will be something that will be fun to be part of.”

CMS announced its decision to cover the monitors for Medicare patients in January, and this week said that patients who have either Type 1 or Type 2 diabetes and who must intensively manage their insulin will be able to obtain reimbursement for the devices.

To get the coverage, beneficiaries must meet four criteria, according to CMS:

  • Have a diagnosis of Type 1 or Type 2 diabetes;
  • Have used a home blood glucose monitor and performing four or more blood sugar tests per day;
  • Take multiple daily injections of insulin or use a continuous subcutaneous insulin infusion pump;
  • Have a treatment regimen that requires them to make frequent adjustments based on their blood sugar test results.

“These definitions would apply to almost everyone with Type 1 diabetes,” JDRF senior vice president for advocacy and policy Cynthia Rice said in a phone interview. “It might not apply to everyone with Type 2 diabetes.”

JDRF raises money for research and awareness of Type 1 diabetes, which is usually diagnosed in children and young adults. People aged 65 and older who have Type 1 diabetes have usually been suffering from it for decades, and are more susceptible to low blood sugar because their bodies are less able to detect it, Rice explained.

“Lows can happen at night or during the day,” Rice said. “But at night, one of the advantages of the alarm is that other family members can hear it.”

DexCom began ramping up its production following CMS’ January decision. The company plans to open a second factory, in Arizona, in 2018, Sayer said. About 75 percent of the 200,000 patients who use the G5 are based in the United States and most are covered by commercial insurance, he added. Sales have grown from $66 million in 2011 to $571 million in 2016.

Medicare will reimburse for CGMs at a rate of $250 to $275 per month or about $3,000 per year, which covers rental of a durable component and purchase of disposable accessories, Sayer noted. The other major manufacturer of CGMs, Medtronic, does not have the proper FDA labeling for to obtain Medicare coverage. The company did not respond to requests for comment.

Private insurers began covering CGMs in 2008 and 2009, according to Rice.

“It took a long time to get CMS here, but it’s wonderful that they have taken this step,” Rice said. “We’re really pleased with their decision in January, and what happened yesterday really makes it real, makes it ready to implement. So many people will benefit from having access to this important technology.”

Photo: Jirsak, Getty Images

The top medtech stories of early 2017

  • Little or no audit preparation common device QMS problem

    By Stewart Eisenhart, Emergo Group In the second in a series of blog posts examining common problems medical device firms deal with related to quality management system audits, Emergo discusses how lack of proper internal audit preparation leads to last-minute scrambles and business headaches. Get the full story here at the Emergo Group’s blog. The […]

  • House delays vote on Trumpcare bill

    The U.S. House of Representatives today indefinitely delayed its vote on the Trumpcare legislation, which looks to begin dismantling Obamacare and replacing it with a GOP-supported framework. The Trump administration and the GOP had hoped the day would signal a significant turn for conservatives, with Trump and House Republican leaders planning the vote on the […]

  • How Phononic is upping the game on hospital refrigeration

    Solid-state heating and cooling technology company Phononic recently got its Evolve refrigerators into the new North Carolina Heart & Vascular Hospital at UNC Rex in Raleigh, N.C. UNC Rex Healthcare is using a combination of 1.8 and 5.5 CuFt Evolve refrigerators in its pharmacy, patient support areas and medicine rooms in conjunction with medication management systems, […]

  • This Trumpf laser could solve your UDI compliance problems

    Trumpf is touting a new laser and software module that enables UDI marking from a single source. Medical device makers can create corrosion-resistant marks on highly reflective materials using ultra-short pulsed lasers. By combining a marking laser with a UDI software module, Trumpf offers both components from a single source. This helps manufacturers to comply with […]

  • The stem cell ‘skin gun’ that’s aiming to disrupt wound care

    RenovaCare’s SkinGun uses a patient’s own stem cells to heal their wounds faster and more efficiently than a traditional skin graft. Pennsylvania state police officer Matthew Uram suffered severe second-degree burns to his face, right arm and leg after a friend’s bonfire got out of control. Uram was facing months of painful skin grafts, the […]

  • The stem cell therapy that could reverse hearing loss

    Frequency Therapeutics is betting that it can change the lives of millions of Americans with hearing loss through a cell therapy that triggers the body’s natural ability to heal itself. Researchers have used cells in regenerative medicine for decades – in 1931, the father of cell therapy, Paul Niehans, treated a patient with material from […]

  • Trump proposes higher FDA fees for drug, medical device FDA registrants

    By Stewart Eisenhart, Emergo Group US Food and Drug Administration user fee increases in the Trump Administration’s proposed 2018 federal budget would disproportionately impact smaller medical device companies, as these firms make up the majority of the US medical device industry. Get the full story here at the Emergo Group’s blog. The opinions expressed in […]

  • David Timmersman appointed president of Vitaldyne

    David Timmersman has been appointed president of Vitaldyne, a contract manufacturer specializing in the manufacture, assembly and packaging of medical devices and components. Timmersman assumes the position held by Mariellyn Kuske, a founder of the company who will be retiring once the transition to new leadership is complete. Mariellyn Kuske, along with her husband Mike, began Vitaldyne […]

  • 6 visual impairment breakthroughs you need to know

    About 285 million people have some form of visual impairment in the world, according to the World Health Organization. Of that number, 39 million are considered blind, and 246 million have low vision. Three-fifths of all vision impairment can be prevented or cured. Uncorrected refractive errors are one of the main causes of vision impairment in […]

  • How to make ultrasound zap tumors in a moving organ

    Researchers led by the Fraunhofer Institute for Medical Image Computing think they’ve overcome the challenges standing in the way of using ultrasound to kill cancer tumors in organs that move with breathing. Until now, health practitioners have mostly limited ultrasound to treating prostate cancer, bone metastases and uterine myoma, according to the Fraunhofer Institute (Bremen, Germany). Organs […]

  • Do patient advocacy organizations have a conflict of interest?

    At least 83% of U.S. patient advocacy organizations receive financial support from medical device, drug and biotechnology companies, according to new research out of the University of Pennsylvania’s Department of Medical Ethics and Health Policy. The Penn research team – which included Matthew McCoy, Harald Schmidt and Ezekiel Emanuel – examined websites and annual reports for 104 organizations […]

  • Mayo Clinic’s CEO attempts a do-over

    Dr. John Noseworthy (l), CEO of Mayo Clinic being interviewed by Dave Lee, morning host of WCCO radio in Minneapolis at the Economic Club of Minnesota.

    The CEO of Mayo Clinic, castigated recently for telling staff to prioritize care for privately insured patients over those with government insurance, said Wednesday that his remarks had been taken out of context.

    Dr. John Noseworthy, added that he regrets having used the word “prioritization” in the videotaped talk he gave to employees and first reported by the Star Tribune in Minneapolis.

    “I can see why it may have led to a sense that there must be a policy change, but nothing was meant,” Noseworthy told reporters following an address to the Economic Club of Minnesota. “I regret the heartache that that has caused to many patients, because our Minnesota Medicaid and our contracted Medicare patients have exactly the same access to Mayo Clinic for serious and urgent medical issues.”

    Noseworthy added that he meant Mayo employees should focus on measures that will help generate savings to cover the cost care for patients whose government-provided reimbursement falls short of private payers’ rates.

    “There will be continuous pressure and reduced reimbursement for the work that we do,” Noseworthy told club members. “All the healthcare providers will have to find a way to improve quality and reduce their costs.”

    Noseworthy implied that Mayo and other healthcare systems that produce good outcomes should be reimbursed better for their efforts.

    “You would think that in healthcare, that if you get the diagnosis right and if you do better procedures with less morbidity and mortality, if you change people’s lives, if you reduce their medications, if you support them and so on, that there would be value added to that and the reimbursement might reflect that,” he said. “That’s not currently the case. We’re working with CMS on this.”

    The agency should employ risk adjustment to properly reimburse health systems that care for patients who are most likely to have the most expensive hospitalization, Noseworthy told reporters separately. That analysis should include a consideration that the patient’s home hospital could not provide the level of care that a system like Mayo could, he added.

    Mayo has also been working with the Trump administration on reforming the Veterans Administration health system. It has not been asked for advice on the American Health Care Act, but Noseworthy offered it anyway.

    He expressed concern about President Trump’s plan to cut funding of the National Institutes of Health by 18.3 percent, or about $5.8 billion. Noseworthy said he spoke with President Trump, emphasizing the importance of stable research funding to produce new treatments, commercialize biomedical discoveries and foster medical research careers. Under President Barack Obama, NIH gave Mayo a $142 million grant to serve as the nation’s precision medicine biobank.

    He also took said Trump’s immigration policies could harm medical research and patients’ health.

    “I made the point to Reince Priebus that the nation needs a global talent pool for research and medicine and that sick patients from all over the world must be able to come to America and to the Mayo Clinic for their health,” Noseworthy recalled saying to Trump’s chief of staff.

    Headquartered in Rochester, Minnesota, Mayo Clinic employs 64,000 in five states. It treats 1.3 million patients per year from 50 states and 140 countries, and invests more than $900 million in research and education annually, Noseworthy noted. 

    Mayo has been making strategic investments in improving quality and reducing costs since 2009, according to Noseworthy. It weathered the recession and changes wrought by the Affordable Care Act, and continues to work with CMS to demonstrate how it has been cutting costs while providing care to patients with complex medical needs.

    “It’s been a wild ride, a time of unprecedented change, but these challenges present wonderful opportunities for Mayo Clinic and its staff to make organizational adjustments and to innovate,” he said.

    Photo: Economic Club


    Old video surfaces showing Mayo Clinic CEO prioritizing patients with private insurance

    Left to right, Mayo Clinic CEO John Noseworthy, VA Under Secretary for Health Dr. David J. Shulkin and former VA Secretary James B. Peake discuss telemedicine at ATA 2016.

    Looks like Paul Ryan isn’t the only one being embarrassed by the surfacing of old videos.

    Mayo Clinic CEO Dr. John Noseworthy is under fire after telling employees of the Rochester, Minnesota-based health system they should “prioritize” treating patients with commercial insurance over those with Medicare or Medicaid if their conditions are the same.

    In a 2016 videotaped speech to employees, of which the Star Tribune obtained a transcript, Dr. Noseworthy said,


    We’re asking … if the patient has commercial insurance, or they’re Medicaid or Medicare patients and they’re equal, that we prioritize the commercial insured patients enough so … we can be financially strong at the end of the year to continue to advance, advance our mission.

    Addressing employees, Dr. Noseworthy noted the Mayo Clinic had reached a
    “tipping point” with a 3.7 percent increase in Medicaid patients. He cautioned that without balancing out the number of commercially insured patients, Mayo’s finances would suffer.

    “If we don’t grow the commercially insured patients, we won’t have income at the end of the year to pay our staff, pay the pensions, and so on, so we’re looking for a really mild or modest change of a couple percentage points to shift that balance,” he said.

    In 2016, Mayo Clinic, which sees more than 1.3 million patients annually, reported net operating income of $475 million. The same year, the health system also said it provided $629.7 million in care to individuals in need, including $83.3 million in charity care and $546.4 million that wasn’t covered by Medicaid or other programs that care for the uninsured or underinsured.

    Last Friday, Dr. Noseworthy released a statement in response to the Star Tribune article:

    Patient medical need will always be the primary factor in determining and setting an appointment. In an internal discussion I used the word ‘prioritized’ and I regret this has caused concerns that Mayo Clinic will not serve patients with government insurance. Nothing could be further from the truth. In fact, about half of the total services we provide are for patients who have government insurance, and we’re committed to serving those patients.

    Changing demographics, aging of Americans and budgetary pressures at state and federal government pose challenges to the fiscal sustainability in healthcare today. While these discussions are uncomfortable, they are critical for us to be able to meet the needs of all our patients.”

    Mayo Clinic confirmed to MedCity Dr. Noseworthy’s comment is the most up-to-date statement.

    Minnesota Department of Human Services Commissioner Emily Piper told the Star Tribune the department will be examining whether Mayo violated patients’ rights or its Medicaid contracts with the state.

    Dr. Noseworthy’s comments are especially ironic in a state that expanded the Medicaid program under the Affordable Care Act.

    Photo: Twitter user Arizona Telemedicine 

    Surgeons wary of ortho bundles delay and deny procedures

    The annual meeting of the American Academy of Orthopaedic Surgeon kicks off Tuesday and in advance of it, a new analyst report shows that when it comes to bundled care, surgeons are being cautious to do joint replacement procedures.

    The Comprehensive Care for Joint Replacement (CJR) rolled out to several areas nationwide last April, in a bid to control costs related to hip and knee replacement. Through this, Medicare gives hospitals a lump sum amount for a 90-day period involving each patient’s procedure. If the cost of the procedure and associated care is below that amount, hospitals come out on top. If not, hospitals have to stomach the extra expenditure and repay Medicare although that is not required in the first year of the five-year-program.

    “There will be no responsibility to repay Medicare in Performance Year 1,” the report confirmed. “However, responsibility will be capped at 5% of target prices in Performance Year 2, 10% in Year 3, and 20% in Years 4 and 5.”

    The goal is to pay for good outcomes. At the 2016 annual meeting of the AAOS, there were worries about how there might be reticence among physicians to treat certain kinds of patients.

    And a report from Brandon Henry, an analyst with RBC Capital Markets who surveyed surgeons ahead of the AAOS meeting found that surgeons are denying or delaying the procedure on average to 14 percent more of their hip/knee patients. Of the 51 surgeons surveyed, 56 percent, a majority, said they are part of the CJR program.

    Screen Shot 2017-03-13 at 10

    So who are these patients that are being denied the procedure or being asked to delay it?

    Surgeons answered in a variety of ways, but there’s a clear indication of who surgeons feel are high-risk patients who are likely to have poor outcomes after the procedure: They are those who are morbidly obese, heavy smokers, with poorly controlled diabetes.

    Aside from these, patients who have multiple comorbidities, as well as those surgeons deem to be at a higher risk of infection are also being denied.

    Meanwhile, paradoxically, Henry noted that even though the trend to deny or delay is present, he has not noticed it reflected in lower volume of hip/knee procedures. Indeed, surgeons say there is interest in clearing a backlog in the next six to 12 months.

    The CJR program is not the first bundled payment program that the ortho industry has seen although it is not a voluntary program given that it is in effect in 67 metropolitan statistical areas. Its previous version, Bundled Payments for Care Improvement (BPCI) was optional.

    Photo: BrynDonaldson, Getty Images