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Recalls and News You Can Use

  PRODUCT RECALLS

Please contact BRRG for guidance if you  are using one of these products!

 

 

2017 / 2021 Year to Date Medical Device Recalls

Device Name and Recall Date

  Please check the FDA Website for Details

Website: http://www.fda.gov 

It is the responsibility of our Clients to understand the impact of these recalls an how they affect their Patients. BRRG is not responsible for their decision to continue using an item that as been recalled.

https://www.fda.gov/medical-devices/medical-device-recalls/2020-medical-device-recalls

Medtronic Recalls MiniMed Insulin Pumps for Incorrect Insulin Dosing

  • The FDA has identified this as a Class I recall, the most serious type of recall.  Use of these devices may cause serious injuries or death.

Recalled Product

  • MiniMed 600 Series Insulin Pumps

    • Model 630G (MMT-1715) - all lots before October 2019

    • Model 670G (MMT-1780) - all lots before August 2019

  • Distribution Dates:

    • Model 630G - September 2016 to October 2019

    • Model 670G - June 2017 to August 2019

  • Devices Recalled in the U.S.: 322,005

  • Date Initiated by Firm: November 21, 2019

Device Use

People who have Type 1 diabetes may use the MiniMed insulin pump to deliver insulin for the management of their diabetes.

  • The Model 630G insulin pump may be used by persons sixteen years of age and older.

  • The Model 670G insulin pump may be used by persons seven years of age and older.

Reason for Recall

Medtronic is recalling the specified insulin pumps due to a missing or broken retainer ring which helps to lock the insulin cartridge into place in the pump's reservoir compartment. If the cartridge is not locked firmly into place, under or over delivery of insulin may occur, which could result in hypoglycemia or hyperglycemia. Severe hyperglycemia can result in a loss of consciousness, seizure, and death.

The firm has received a total of 26,421 complaints in which the device malfunctioned in this manner. The firm is aware of 2,175 injuries and 1 death.

Who May be Affected

  • Any person with diabetes who uses an affected Medtronic MiniMed insulin pump

  • Health care providers who treat people with diabetes using the affected MiniMed insulin pumps

What to Do

On November 21, 2019 Medtronic notified affected customers and advised them to:

  • Examine the retainer ring of their pump.

  • Stop use of the pump and contact Medtronic for a replacement pump if the reservoir does not lock into the pump or if the retainer ring is loose, damaged, or missing. If you stop using the pump, you should follow your doctor's recommendations and perform manual insulin injections.

  • Continue using the pump if the reservoir locks in place correctly.

  • If the pump is dropped by accident, check the pump and retainer ring for damage and stop use if it is damaged.

  • Check the pump retainer ring and verify that the reservoir is locked correctly at every set change.

Contact Information

Customers who have questions or need additional information or support about this recall should call the 24-hour Medtronic Technical Support at 877-585-0166.

Terrific Care, LLC. / Medex Supply Recalls CoaguChek XS PT Test Strips Used to Monitor Blood Thinner Warfarin Due to Inaccurate Test Results

  • The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

  • CoaguChek XS PT Test Strips purchased from Terrific Care, LLC. or Medex Supply

  • Lot Numbers: All lot numbers sold by Terrific Care LLC. or Medex Supply

  • Manufacturing Dates: October 2017 to May 2018

  • Distribution Dates: December 27, 2017 to December 15, 2018

  • Devices Recalled in the U.S.: 759 boxes

  • Date Initiated by Firm: December 21, 2018

Beckman Coulter Life Sciences Recalls DxH800 and DxH600 and DxH 900 Hematology Analyzers Due to Risk of Inaccurate Results

  • UniCel DxH 800 Coulter Cellular Analysis System, UniCel DxH 600 Coulter Cellular Analysis System, and UniCel DxH 900 Coulter Cellular Analysis System

  • Product Catalog/Reference Numbers (Part numbers for device models): B23858, C11478, 629029, B24465, B24802, B68304, B66445, B63322

  • Distribution Dates: January 2008 to present (DxH 800 and DxH 600); April 2018 to present (DxH 900)

  • Manufacturing Dates: January 2008 to present (DxH 800 and DxH 600); April 2018 to present (DxH 900)

  • Devices Recalled in the U.S.: 3428

  • Date Initiated by Firm: July 30, 2018

Physio-Control Recalls LIFEPAK15 Monitor/Defibrillator Due to Risk of Device "Lockup" (Freezing)02/27/19

ICU Medical Recalls ChemoLock Vial Spike (20mm) Due to Risk of Detached Plastic Particles02/22/19

Smiths Medical, Recalls Sterile Saline and Sterile Water for Inhalation Due to Potential Exposure to Infectious Agents as a Result of Leaking Containers02/04/19

 

Terrific Care, LLC. / Medex Supply Recalls CoaguChek XS PT Test Strips Used to Monitor Blood Thinner Warfarin Due to Inaccurate Test Results02/01/19

Roche Diagnostics Recalls CoaguChek XS PT Test Strips Due to Inaccurate INR Test Results 11/1/18

Medtronic HeartWare HVAD System Recalled Due to Unintended Intermittent Electrical Disconnection between The Power Source and The Controller 06/01/18

 

Vyaire Medical Recalls AirLife Resuscitation Devices and Broselow Convenience Kits Due to Risk of Malfunction Caused by Error in Product Design 05/11/18

 

Terumo Recalls Sarns™ TCM and TCM II Cooling and Heating Systems and HX2™ Temperature Management Systems Due to Revised Cleaning Instructions 05/07/18

 

 

Becton Dickinson (BD) and Company Recalls Vacutainer® EDTA Blood Collection Tubes Due to Chemical Interference with Certain Tests 03/23/18

Monteris Medical NeuroBlate System Recalled Due to Unexpected Heating of Laser Delivery Probes 03/22/18

Medtronic Recalls Cardiac Resynchronization Therapy and Implantable Cardioverter Defibrillators Due to Manufacturing Error Preventing Electrical Shock Delivery 02/26/18

Vyaire Medical Recalls AirLife Humidification Chamber & Heated Breathing Circuit Kits Due to Manufacturing Error 01/30/18

Edwards Lifesciences LLC. Recalls Certitude Delivery System Due to Mold Overflow Defect Which May Obstruct Blood Flow 01/11/18

Sterilmed Reprocessed Agilis Steerable Introducer Sheath recalled due to improper seal of the sheath hub 01/02/18

Phillips Healthcare recalls HeartStart MRx Monitor/Defibrillator due to electrical issues that may prevent the device from operating properly

03/24/17

Medtronic Recalls SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps Due to Failure of Priming Bolus – Update Related to May 2013 Recall

03/14/17

Physio-Control Inc. Recalls LIFEPAK 1000 Defibrillator Due to an Electrical Issue Which May Cause the Device to Shut Down Unexpectedly

03/08/17

Zimmer Biomet Recalls Comprehensive Reverse Shoulder due to a High Fracture Rate

02/15/17

Physio-Control Recalls LIFEPAK15 Monitor/Defibrillator Due to Failure of Electrical Shock Delivery

02/10/17

 

 

             Drugs and Biologics 

                     Shortages

Visit the Link to the FDA Site Below:

 

https://www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm

 

Date Notification/ Brand Name Product Description / Reason/ Problem/ Company

 

 

  

NEWS YOU CAN USE

 

 

Link to CDC COVID Vaccine Website 

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/faq.html?  CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fvaccines%2Fkeythingstoknow.html

 

Link to Johns Hopkins COVID Website

https://coronavirus.jhu.edu/

Estimates 124K more physicians will be needed by 2034, with the largest gap among specialists

by Jacqueline Renfrow | 

 January 15, 2022 10:10am

The estimates in the Association of American Medical Colleges survey do not include the additional 180,400 physicians the association believes the country would need if there were fewer barriers to access for minority populations as well as if people living in rural communities and people without health insurance were included. (Getty/Geber86)

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The U.S. is going to have a massive shortage of physicians in primary and specialty care by 2034, according to new estimates.

The Association of American Medical Colleges (AAMC) projects a shortage between 37,800 and 124,000 physicians, with the largest disparities being in the area of specialty doctors.

The seventh annual study by the life science division of IHS Markit was conducted in 2019, prior to the start of the COVID-19 pandemic, and looked at data such as physician work hours, retirement and other trends in the healthcare workforce.

"The COVID-19 pandemic has highlighted many of the deepest disparities in health and access to health care services and exposed vulnerabilities in the health care system,” AAMC President and CEO David Skorton, M.D., said in a statement. “The pandemic also has underscored the vital role that physicians and other healthcare providers play in our nation’s healthcare infrastructure and the need to ensure we have enough physicians to meet America’s needs.”

RELATED: Physician shortage: The numbers keep climbing, now estimated at 122,000 by 2032

One of the biggest concerns for the future of physicians is the rise in clinician burnout, which—intensified by the pandemic—has led workers to cut hours or accelerate retirement. Before the pandemic, in 2019, 40% of U.S. physicians felt burned out at least once a week. And according to the survey, more than two out of every five active physicians in the U.S. will reach the age of 65 or older within 10 years.

“We are taking a closer look at the well-being of healthcare workers,” Janis Orlowski, M.D., chief healthcare officer for the AAMC, told Fierce Healthcare. “We had a summit right before COVID with CEOs to discuss what we could do nationally to standardize metrics for credentials and licensing to take the burden of paperwork and overhead from physicians.”

Simultaneously, she said the industry needs to make sure teams are working together locally to improve well-being for all healthcare staff, and ultimately, patients.

Shortage or not, factors within the U.S. population are speeding up the need for more healthcare workers. For example, from 2019 to 2031, the population is projected to grow by 10.6%, with an increase of 42.4% of those aged 65 and above.

RELATED: Physician shortage could hit 130K by 2033, AAMC projects

Looking at the data specifically, primary care shortages will range between 17,800 and 48,000 physicians. And within specialties, surgical shortages will be one of the highest, between 15,800 and 30,200 physicians.

Orlowski notes the number of medical schools and medical education enrollment are up, which is a positive step toward increasing the number of physicians in the U.S.

And at the end of 2020, Congress added 1,000 new Medicare-supported graduate medical education positions—200 per year for five years—targeted at underserved rural and urban communities. New bipartisan legislation called The Doctors of Community (DOC) Act, introduced in the House of Representatives Tuesday and expected to be released in the Senate next week, would permanently authorize the Teaching Health Center Graduate Medical Education program that aims to train primary care medical and dental doctors. The legislation would increase annual funding by more than $500 million per year from 2024 through 2033.

Finally, the pandemic has put a spotlight on disparities in health and access to care among underserved populations in the U.S. The estimates in the survey do not include the additional 180,400 physicians AAMC believes the country would need if there were fewer barriers to access for minority populations as well as if people living in rural communities and people without health insurance were included.

“The issue that I’m probably most worried about is equity,” said Orlowski. “As we take a look at equity throughout the U.S. and how different populations are affected by COVID, it strikingly points out the differences of access and utilization. If everyone had the same access to physicians as those who are living in an urban center, white, not low-income, we would still need more than 180,000 physicians to build equity. And that’s not 15 years from now, that’s today.”

 

 

 

From CNBC, June 4th, 2020

https://www.cnbc.com/2020/06/04/astrazeneca-is-set-to-make-two-billion-doses-of-a-coronavirus-vaccine.html

 

 

Coronavirus Test To Reach ‘General Population’

 

Bruce JapsenSenior Contributor April 17, 2020

I write about healthcare business and policy

  • Abbott Laboratories hopes to begin rolling out its rapid diagnostic test for the Coronavirus strain ... [+]

ASSOCIATED PRESS

Abbott Laboratories hopes to begin rolling out its rapid diagnostic test for the Coronavirus strain COVID-19 to the general population beyond “frontline healthcare workers” in May and into June.

The effort to get the ID NOW COVID-19 test to healthcare workers on the frontlines of the battle against the deadly virus has been the first priority of Abbott amid the daunting diagnostic effort under way in the U.S. Abbott’s ID NOW COVID-19 test can deliver positive results in as little as five minutes and negative results in 13 minutes.

“Our first phase was to roll this out to ensure that the frontline healthcare workers were tested and protected,” Abbott chief executive officer Robert Ford told analysts Thursday on a call to discuss the global medical product company’s first quarter earnings.

Today In: Healthcare

Abbott has been shipping out 50,000 ID NOW tests per day since April 1 and has been delivering on that commitment. “I get to see the manufacturing and the shipment output, and we haven’t fallen behind that,” Ford said. “In several days we’ve beaten that number and able to get more tests out.”

But as Abbott starts to ramp up manufacturing for ID NOW in May and into June, Ford said the company will “start to roll this out into a second phase where we’ll start to be able to test more of the general population.” Abbott will ramp up from production of 1.3 million ID NOW tests a month to 2 million in June.

CDC to providers on coronavirus: 'Have a high index of suspicion'

by

Tina Reed | Fierce Healthcare

Jan 27, 2020 7:05am

Federal officials are urging providers to monitor patients for potential symptoms of the coronavirus that has sparked an outbreak in China—and to quickly report any suspicions of disease. 

In a call with reporters Sunday, the Centers for Disease Control and Prevention (CDC) confirmed a total of five cases of the 2019 novel coronavirus have been detected in the U.S. so far with two cases in California, one in Arizona, one in Illinois and one in Washington.

So far, 80 people have died and there have been more than 2,700 confirmed cases of the virus, which originated in Wuhan, China, CNN reported.

Case Study

 

Officials said they do not have evidence the virus is spreading in the U.S. and that all cases of the disease were in people who recently traveled to Wuhan, but they warned it is likely more cases will be reported in the coming days.

"The threat to the general American public is low at this time, but the threat is serious and our public health response is aggressive," said Nancy Messonnier, director of the CDC's National Center for Immunization and Respiratory Diseases. “Our guidance and approach may need to be modified.” 

RELATED: Study: MERS easily spread in hospitals

In all, more than 100 patients are under investigation over provider concerns they could have the virus, and 26 of those cases have since been ruled out through diagnostic tests.

"Since we’ve announced the first state, multiple states and clinicians have reached out," Messonnier said. "We are getting calls all day, all night from clinicians. That’s what we want. We want people to have a high index of suspicion and to call if they have a patient they are concerned about.” 

Chinese officials warned that the virus can be spread before any symptoms appear. Messonnier acknowledged the situation was rapidly evolving and that the CDC had seen reports out of China.

"We at CDC don’t have any clear evidence of patients being infectious before symptom onset but we are actively investigating that possibility," she said. "That is part of the reason we are working with state health partners to investigate close contacts.”  

On Friday, the CDC posted the entire genetic sequence of the virus from the first patient detected to have the illness in Washington for researchers across the U.S. to examine and compare against the genetic sequence of the virus that was originally detected in Wuhan.

CDC officials said they are working to develop rapid lab diagnostic testing that will first be available at the CDC but also made available at the state and local levels. But it could take a few weeks, Messonnier said. 

RELATED: Lawmakers ask GAO to examine predictive modeling for infectious disease tracking

Some hospitals around the U.S. are adding additional screening measures for coronavirus.

"If you are a healthcare provider, be on the lookout out for people with travel history to Wuhan China and fever and respiratory symptoms," she said. "If you are a healthcare provider caring for a 2019 novel coronavirus patient, please take care of yourself and follow recommended infection control procedures."

CDC: Flu vaccines 36% effective at preventing infection

by Paige Minemyer | Fierce Healthcare

Feb 16, 2018

This year's crop of flu vaccines is effective in preventing about one-third of flu cases, but is less successful in protecting people from one of the most virulent influenza strains, according to new data from the Centers for Disease Control and Prevention.

The CDC published interim estimates on vaccine effectiveness, and found that overall effectiveness against influenza A and influenza B since November 2017 has been 36%. However, the vaccines are only 25% against the influenza A strain H3N2, which has been behind some of the most severe flu cases this season. 

Most years, flu vaccines prevent between 40% and 60% of flu cases, the CDC estimates

The CDC found that 69% of flu cases are H3N2, according to the latest report. This particular strain has posed a vaccine challenge since the 2011-2012 flu season.

RELATED: Here's what doctors, other clinicians should tell patients in one of the worst flu seasons 

This flu season has been one of the worst in recent years, and the CDC expects a record number of hospitalizations before the season ends. Twenty-two pediatric deaths were reported between Feb. 4 and Feb. 10, according to the latest weekly update from CDC, and thus far 84 children have died this flu season.  

There is good news, however—despite the relatively low overall vaccine effectiveness, the CDC found that they're 59% effective for children between the ages of 6 months and 8 years old. 

RELATED: CDC quietly postpones nuclear war prep briefing to focus on the flu epidemic instead  

Department of Health and Human Services Secretary Alex Azar noted at a press briefing Thursday that there is still time for people to get flu shots and protect themselves from the virus. 

"Getting the flu shot is the same kind of sensible precaution as buckling your seatbelt, and there is still time for these precautions to make a difference," Azar said. 

Equal Employment Opportunity Commission sues hospital following choice to rescind job offer over flu vaccine 

 

Too many EHR-generated messages contributing to physician burnout: study

by Heather Landi | Fierce Healthcare

Jul 2, 2019

There are ongoing concerns about physician workloads and time spent doing "desktop medicine," such as documenting in electronic health records and sorting through emails.

It turns out, most physicians' EHR inboxes are clogged up with system-generated messages—rather than messages from patients or colleagues—a problem linked to greater job dissatisfaction and burnout, according to a new study published in Health Affairs.

Almost half of all weekly in-basket messages came from EHR algorithms, such as emails generated by population health management algorithms that remind physicians to order certain tests, the study found. And physicians that receive an above-average number of these messages also tend to have more burnout symptoms and expressed an intention to reduce their clinical work hours.

Read  the Entire Article Here:

https://www.fiercehealthcare.com/practices/too-many-ehr-generated-messages-contributing-to-physician-burnout-study

Americans are living longer — But we may not have enough physicians

Kelly Gooch - Tuesday, April 23rd, 2019 Print  | Email

  

The U.S. could face a shortage of nearly 122,000 physicians by 2032, according to data from the Association of American Medical Colleges.

“The nation’s population is growing and aging, and as we continue to address population health goals like reducing obesity and tobacco use, more Americans will live longer lives. These factors and others mean we will need more doctors,” said AAMC President and CEO Darrell G. Kirch, MD, in a news release. “Even with new ways of delivering care, America’s doctor shortage continues to remain real and significant.”

The new data is part of a fifth annual study conducted by the life sciences division of IHS Markit, a global information company, and includes insights on changes expected in the physician workforce by 2032.

Seven takeaways from the study:

1. The projected shortfall for 2032 ranges from 46,900 to 121,900 physicians and is similar to the projected shortfall for 2030 of 44,900 to 121,300 physicians in the 2018 report.

2. The latest study’s projected shortfall includes primary care (between 21,100 and 55,200) and specialty care (between 24,800 and 65,800).

3. The projected shortfall for 2032 comes as demand growth for physicians continues to outpace supply growth, according to the study.

4. Association officials said the primary driver of increasing demand for physicians through 2032 is still demographics — particularly, population growth and aging.

5. Achieving population health goals — such as reducing excess body weight and reducing smoking  — will increase demand for physicians in the long term, according to the study. “Although prevention efforts likely will reduce demand for some specialties, like endocrinology, demand for other specialties, like geriatric medicine, will increase,” AAMC added.

6. Regarding supply, IHS Markit analyzed American Medical Association data and found that more than two out of five currently active physicians will be 65 or older within 10 years, and changes in physician retirement decisions could affect supply the most.

7. The AAMC, along with more than 70 healthcare stakeholders, is backing legislation that would help address the national physician workforce shortage by adding 15,000 Medicare-supported residency positions between 2021 and 2025.

Sanofi turns to subscriptions to offer patients insulin at $99 per month

by Eric Sagonowsky | Fierce Healthcare

Apr 10, 2019 5:00am

Sanofi on Wednesday unveiled a new subscription model to allow diabetes patients access to its insulins. (Sanofi)

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Big Pharma grilled on the Hill: International pricing, AbbVie CEO's bonus and bye-bye rebates.

by Eric Sagonowsky | Fierce Healthcare

Feb 26, 2019 12:34pm

Seven pharma executives faced a U.S. Senate committee at a drug pricing hearing on Tuesday. (C-SPAN)

It didn't take long for sparks to fly Tuesday when the cadre of Big Pharma executives sat down before the Senate Finance Committee to defend their price-setting decisions.

Sen. Ron Wyden, the committee's ranking member, dug right in on stock dividends, buybacks and price hikes, saying the companies engage in “two-faced scheming and profiteering" while blaming regulators, middlemen and others for their pricing decisions.  

It’s “long past time to drop these excuses and take concrete action” to make drugs affordable in the U.S. And on pharmacy benefit managers, which he called “wasteful and secretive,” Sen. Wyden said they’ll “have their day before the committee” as well. 

 

Private equity companies' acquisition of physician practices likely to accelerate

by Joanne Finnegan | Fierce Healthcare

Jan 10, 2019

Private equity firms are buying up physician practices, a trend expected to continue in 2019. (Getty/Kritchanut)

First it was hospitals. Now it’s private equity companies that are buying up physician practices.

Acquisition of physician practices by private equity firms has increased dramatically during the past few years, according to a new study published in the Annals of Internal Medicine.

Researchers from Weill Cornell Medicine in New York found that the current healthcare environment is accelerating the disappearance of independent physician practices. 

The healthcare sector remains in flux as policy, regulation, technology and trends shape the market. FierceHealthcare subscribers rely on our suite of newsletters as their must-read source for the latest news, analysis and data impacting their world. Sign up today to get healthcare news and updates delivered to your inbox and read on the go.

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It’s a trend that the lead author of the study, Lawrence P. Casalino, M.D., chief of the division of health policy and economics at Weill Cornell Medicine, says is likely to accelerate over the next few years.

RELATED: Regulatory changes and technology demands will drive physician practice mergers and acquisitions in 2018

“The ultimate outcome is not known, but certainly this trend will increase the corporate transformation of healthcare, for better or for worse,” Casalino said in an email to Fierce Healthcare.

One thing for sure? “It is definitely another nail [in the coffin for independent practices],” he said.

A database that tracks such activity indicated that private equity firms acquired 102 practices in 2017, although that number might be low since some acquisitions, especially of smaller practices, may have been missed.

The researchers said the acquisition of practices by private equity firms is a significant phenomenon with unknown consequences for both physicians and patients. It’s also a trend that has received little attention from researchers and policymakers.

To get a handle on the current situation, the researchers interviewed 21 people from across the country, including consultants, attorneys, investment bankers and leaders of private equity firms, physician practices and health insurers.

The acquisition setup

Here’s how it works. Private equity firms invest in private practices using their capital and anticipate average annual returns of 20% or more, the study said. To achieve those returns, private equity firms focus on acquiring “platform practices” described as large, well-managed practices that are reputable in their community.

RELATED: Hospitals are buying up physician practices at a record pace

The private equity firms then sell the practices after increasing their value by recruiting additional physicians, acquiring smaller practices, increasing revenues by taking steps such as bringing pathology services into a dermatology practice and decreasing costs, such as using more physician assistants, the researchers said.

“Growth makes it possible to spread fixed costs, exploit synergies across merged practices, expand ancillary revenues and increase negotiating leverage with health insurers,” the researchers said.

The private equity firms typically take anywhere from 60% to $80% ownership, although they will sometimes accept minority ownership in a very large practice. The amount paid to practice owners varies but can be as much as $1 million to $2 million per physician, the researchers said. The equity firms look to sell the practice within three to seven years.

The focus has been on specialties that have the potential to bring in additional income from elective procedures and ancillary services. Dermatology has been a major focus, with an increase in interest in ophthalmology, urology and gastroenterology practices.

Edgemont Partners, a healthcare investment banking firm, said mergers and acquisitions of physician practices in specialties such as orthopedics and radiology were a part of its record 2018 transaction volume. The company said the healthcare sector is likely to continue to consolidate in 2019.

RELATED: MGMA18—Dinosaurs? Hardly. A renaissance in independent physician practices, doctors say

In a rapidly changing healthcare environment which is moving to value-based purchasing, more physicians are interested in selling their practices, those interviewed told the researchers. Many of the largest practices have already been acquired by a hospital, insurer or private equity firm.

An unknown impact

The impact remains to be seen, the study said. No peer-reviewed studies have looked at the effect on the quality and cost of patient care, physician professionalism, and the experience of patients, physicians or staff.

Most private equity sales of physician practices are to other private equity firms. However, if the ability to sell at higher gains declines, the ultimate buyers could be hospitals or health insurers.

“In any case, for better or worse, acquired practices surrender control of their destiny,” the researchers concluded.

It’s not something everyone wants. One group of doctors thinks the pendulum—in which doctors were once flocking to hospital employment—is now swinging the other way. They say independent practices are now seeing a resurgence.

However, as of mid-2015, one in four medical practices was hospital-owned, according to one study. Hospitals acquired 31,000 physician practices, a 50% increase, from 2012 to 2015, according to the report. And 2016 marked the first year in which physician practice ownership was no longer the majority arrangement, with physicians evenly distributed between being owners and employees: 47.1% of doctors own their own practice, with the same percentage employed and 5.9% independent contractors.

Patients aren’t convinced the loss of independent practices is good for healthcare. A study found that most Americans are concerned about the trend of hospital consolidation, specifically the rate at which hospitals are purchasing independent physician practices, a move which they see as a threat to affordable care.

 

 

Athena Health Sold

by Evan Sweeney  Fierce Healthcare

Nov 12, 2018 9:00am

Six months after forcing Athenahealth to consider a sale, Elliott Management is teaming up with private equity firm Veritas Capital to buy the company for $5.7 billion. 

Elliott subsidiary Evergreen Coast Capital has joined Veritas in the acquisition, according to a joint announcement on Monday morning. The deal is expected to close in the first quarter of 2019 subject to regulatory and shareholder approval. 

The private equity firms plan to combine Athenahealth with Virence Health a value-based care solution that Veritas purchased for $1 billion from GE Healthcare earlier this year. The new company will operate under the Athenahealth brand, with Virence CEO Bob Segert leading the company with an executive team made up of leaders from both companies.

 

 

MGMA18: Dinosaurs? Hardly. A renaissance in independent physician practices, doctors say

by Joanne Finnegan | October 9, 2018 Fierce Healthcare

BOSTON—If you think independent physician practices are going the way of the dinosaur, you’d be wrong.

That's according to one group of doctors who say the pendulum—in which doctors were once flocking to hospital employment—is now swinging the other way.

RELATED: Which kind of doctors experience dramatically lower levels of burnout? Study offers new perspective

“Our intent today is to create a new national forum for a re-energized sector,” said Michael Nachomovitz, M.D., senior vice president and chief clinical integration and network development officer at NewYork-Presbyterian Healthcare's Physician Services Division in New York.

Nachomovitz was one of four doctors who shared their experiences leading independent practices at the Medical Group Management Association (MGMA) annual conference in Boston last week. At a time when 47.1% of physicians are employed by hospitals and healthcare systems, there’s a new focus on the independent medical practice, Nachomovitz said: “Consolidation has not delivered on its promise."

RELATED: 1 in 4 physician practices now hospital-owned

Dale Owen, M.D., CEO of Tryon Medical Partners in Charlotte, North Carolina, told FierceHealthcare he thinks the shift has to happen. Owen shared his story of how a group of 88 doctors left Atrium Health to form a new independent practice.

“Physicians are now being called providers. It’s become more corporate, more autocratic,” he said about hospital employment.

Independent practices empower the doctor-patient relationship, he said: “The two people who care the most about patients are patients and doctors.”

As of mid-2015, one in four medical practices was hospital-owned, according to one study. Hospitals acquired 31,000 physician practices, a 50% increase, from 2012 to 2015, according to the report. And 2016 marked the first year in which physician practice ownership was no longer the majority arrangement, with physicians evenly distributed between being owners and employees: 47.1% of doctors own their own practice, with the same percentage employed and 5.9% independent contractors.

But that didn’t necessarily lead to physician satisfaction, Nachomovitz said. A recent study, in fact, found that physicians in small, independent primary care practices reported dramatically lower levels of burnout when compared to the national average.

Patrick Carter, M.D., medical director for care coordination and quality improvement at the Kelsey Sebold Medical Group in Houston, said the practice has gone full circle, from its origins as an independent practice in 1949 to its sale to a physician management company to ownership by a hospital and back. “I call it the long and winding road to independence. … We are independent, for-profit and physician-owned,” he told the conference audience.

RELATED: Regulatory changes and technology demands will drive physician practice mergers and acquisitions in 2018

Being an independent practice allows doctors to control their destiny, said Robert Kent, D.O., president of Unity Health Network in Cuyahoga Falls, Ohio, a collaboration of 90 physicians. It is northeast Ohio’s largest independent physician network offering primary care services and specialty care.

Being independent has allowed the network to improve quality and increase both patient and physician satisfaction, he said. To succeed as an independent, a practice needs to have a truly aligned physician culture, as well as a sophisticated and supported infrastructure, he said.

CDC: Cases of Polio-Like illness on the rise among children

Written by Mackenzie Bean | November 05, 2018 

Federal health officials on Nov. 5 said cases of the rare, polio-like illness called acute flaccid myelitis are still on the rise among children in the U.S., according to NBC News.

At present, the CDC has identified 219 reports of possible AFM cases across 25 states this year, 80 of which the agency has confirmed.

The nation sees a spike in AFM cases every other year, with the CDC confirming:

  • 120 cases in 2014

  • 22 cases in 2015

  • 149 cases in 2016

  • 33 cases in 2017

 

Atrium Health agrees to part ways with Mecklenburg Medical Group after physicians sue for independence

by Paige Minemeyer | April 3, 2018 Fierce Healthcare

 

A medical group under Charlotte, North Carolina-based Atrium Health sued the system on Monday to be freed from their employment contracts and noncompete clauses. 

The nonprofit health system, which was until recently known as Carolinas HealthCare System, agreed to allow the Mecklenburg Medical Group operate independently, according to a statement emailed to FierceHealthcare.  

The lawsuit (PDF), obtained by Charlotte Agenda, includes 92 of the 104 doctors that work for Mecklenburg. The physicians claim that Atrium's "self-serving monopolistic and anticompetitive actions" hinder their ability to provide high-quality care to their patients. 

According to the suit, the health system has "complained" that it loses money backing the MMG doctors, but still refused to allow them to operate independently. 

"Atrium is acting as the exact opposite of the nonprofit health provider it claims to be," the physicians said in the suit. "Intervention of the court is required to prevent Atrium's corporate ambitions from causing irreparable harm to the plaintiff physicians and the thousands of citizens of Charlotte they serve every year." 

RELATEDNo slowdown in consolidation—Hospitals acquire 5,000 independent practices in 1 year 

In its statement, Atrium officials said they are determining the best way to deal with the noncompete agreements and hope physicians will stay with the system. The lawsuit, according to Atrium, was a "surprise," since officials have been in negotiations with the medical group as recently as last week.

The system and physicians at MMG have been discussing a future path since October, they said. 

"We worked hard to find a solution that would be mutually agreeable to everyone—and most importantly would ensure that our patients continue to get the best care possible," Atrium officials said in the statement. 

RELATED13 healthcare M&A deals that made headlines in 2017 

Several other physicians working under Atrium Health revealed last month that they also intended to leave the system. Atrium's new compensation contracts spurred these doctors' exits which would require some physicians to take a salary cut. Atrium said at the time that only a few of the system's physicians had chosen not to sign the contracts. 

The system has been an active player in the merger market of late. Last year, it was in talks with UNC Health Care but ultimately suspended those negotiations. In February, Atrium announced it intends to merge with Georgia-based Navicent Health.  

Tipping point: AMA study finds physician practice owners no longer the majority

by Joanne Finnegan | Jun 1, 2017 Fierce Healthcare

The year 2016 marked a tipping point for physician practices. Physician practice owners are no longer the majority, according to a survey by the American Medical Association.

Less than half of practicing physicians own their own practice, the first time that has happened, according to an AMA Wire article. The 2016 data was collected in a national survey of 3,500 U.S. physicians and reported in a Physician Practice Benchmark Survey (PDF).

It marks the first year in which physician practice ownership is no longer the majority arrangement, with physicians evenly distributed between owners and employees—47.1% of doctors own their own practice, with the same percentage employed and 5.9% independent contractors.

RELATED: 1 in 4 physician practices now hospital-owned

The share of physicians with an ownership stake in a medical practice dropped 6 percentage points from 53.2% in 2012, when the AMA began its survey. At the same time, the share of doctors with employed positions increased about 5%, up from 41.8% in 2012. In most cases doctors are working for other doctors, as 55.8% of doctors continue to work in practices that are wholly owned by physicians. 

High Tech Means High Costs for Physician Practices

                                                Source: Fierce Healthcare, Septermber 25th, 2016

Keeping up in the digital age is proving to be a continuing expense for physician practices, with the cost of health information technology reaching more than $32,500 per doctor annually, according to a new analysis from the Medical Group Management Association.

That figure reflects a continued rise in costs, as physician-owned multi-specialty practices spent more than $32,500 in 2015 for each full-time doctor on health IT equipment, staff, maintenance and other related costs, the MGMA said in an announcement.

- find the MGMA report (purchase required)

Aetna Whole Health–Duke Health & WakeMed form ACO 

September 1st, 2016

 In a broad partnership, those who buy health insurance from Aetna (NYSE: AET) can access a new health care network that combines Duke Health and WakeMed Health and Hospitals. At a high level, the health providers formed an accountable care model with the insurer. These kinds of partnerships are proliferating and health care experts say they have the potential to cut down on costs because providers and payers share in the financial responsibility of keeping patients healthy – not just treating them when they are sick.

The co-branded product is called Aetna Whole Health–Duke Health & WakeMed and includes the WakeMed Key Community Care (WKCC) network of physicians, an accountable care organization (ACO) created by WakeMed Health and Hospitals, WakeMed Physician Practices and Key Physicians.

Read: Tracking the flow of money from pharma to physicians

Aetna provides health benefits to 550,000 people in North Carolina, making it still a smaller player in this state. Blue Cross and Blue Shield of North Carolina, for example, has roughly 3.9 million customers. Insurers see these new partnerships as one of many ways to attract new customers.

 

 

AMA: Independent practice alive and well

 

July 14, 2016 | By Debra Beaulieu-Volk

While some recent headlines may give the impression that physicians are making a mad dash away from private practice toward employment, new research from the American Medical Association (AMA) reveals that the shift may be far less dramatic.

 

"These data show that the majority (60.7 percent) of physicians were in small practices of 10 or fewer physicians, and that practice size changed very little between 2012 and 2014 in the face of profound structural reforms to healthcare delivery," said AMA President-elect Andrew W. Gurman, M.D, in an announcement.

 

  • A majority (56.8 percent) of physicians worked in practices that were wholly owned by physicians in 2014, down from 60.1 percent in 2012.

  • In 2014, 32.8 percent of physicians worked directly for a hospital or practice that had some hospital ownership, up from 29 percent in 2012.

  • The share of physicians who were practice owners dropped from 53.2 percent in 2012 to 50.8 percent in 2014.

  • The proportion of physicians who were in solo practice decreased from 18.4 percent in 2012 to 17.1 percent in 2014.

 

The AMA's results differ slightly from data reported by physician recruiting firmMerritt Hawkins, noted an article from MedPage Today.

"The one number that is probably significantly different from ours is they have 60.7 percent physicians in practices of 10 or fewer and our number is at around 50 percent," Travis Singleton, a senior vice president with the firm, told MedPage."The core message of what they are saying is that independent and small practices are alive and well and a large portion of our delivery system."

 

Some of the differences in data sets, Singleton added, may relate to "semantics," such as the way the AMA isolates physicians in groups owned wholly by hospitals from those run by physician organizations. At the end of the day, both sets of physicians are working in an environment that operates like traditional hospital ownership, he said.

 

 

Breaches in Data Security Health Records

 

TUESDAY, April 14, 2016 (HealthDay News) -- Breaches in data security exposed

more than 29 million health records to potential criminal misuse between 2010 and 2013, a new study found.

Most of the breaches occurred due to simple theft of a computer, with some criminal grabbing a tablet or laptop that contained sensitive and unencrypted medical records, researchers at Kaiser Permanente in California and Stanford University found. But electronic health records also are increasingly vulnerable to exposure through hacking, the researchers reported.

Security breaches involving hacking have nearly doubled in recent years, rising to 8.7 percent in 2013 compared with 4.7 percent in 2010, according to the study, published in the April 15 issue of the Journal of the American Medical Association.

 

                                                      

 

 

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