Trump Nominations for US Health Agencies Spark Controversy, Criticism, Praise

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President-elect Donald Trump’s vision for the nation’s top health agencies is coming into focus with three nominations announced Nov. 22 that drew both criticism and praise:

  • Surgeon and health researcher Martin A. Makary, MD, MPH, to lead the US Food and Drug Administration (FDA).
  • Former Republican congressman and physician David J. Weldon, MD, for director of the US Centers for Disease Control and Prevention (CDC).
  • Fox News contributor Janette Nesheiwat, MD, for surgeon general.

Earlier in November, Trump nominated vaccine skeptic and former presidential candidate Robert F. Kennedy Jr. to lead the US Department of Health and Human Services (HHS). 

Here’s what to know about the latest nominees, who, like Kennedy, must be confirmed by the US Senate.

 

Martin A. Makary

Currently a professor at the Johns Hopkins School of Medicine and chief of islet transplant surgery at Johns Hopkins Hospital, Makary co-invented in 2006 a surgery checklist that became a widely-used patient safety tool. 

As a US FDA commissioner, Makary would preside over a $6.5 billion agency with more than 18,000 employees. The agency, part of HHS, oversees human and animal drugs and vaccines, medical devices, food, tobacco and other products. Some of Makary’s views align closely with those of HHS nominee Kennedy. 

Makary is also chief medical officer of telehealth platform Sesame.

Makary was primarily known as a health researcher and author of books about price transparency and the cost of health care until the COVID-19 pandemic, when he became an outspoken critic of the federal response, lambasting restrictions and mandates advocated by the CDC and other public health officials. 

In 2023, Makary told the House Select Subcommittee on the COVID Pandemic that federal officials had ignored what he called “natural immunity.” Studies have shown that natural immunity is “at least as effective as vaccinated immunity, and probably better,” testified Makary.

Makary called for an overhaul of the US FDA in a 2021 Fox News opinion, saying that its culture was “defined by counterproductive rigidity and a refusal to adapt.”

Blind Spots, his most recent book, takes on what he calls “medical dogma” and challenges conventional views on subjects ranging from the microbiome to marijuana to cancer prevention, hormone replacement therapy, antibiotics and peanut allergies.

In an interview he posted to X, Makary blames inappropriate use of antibiotics for a variety of childhood illnesses. He cites increases in obesity, learning disabilities, attention deficit disorder, asthma, celiac disease, ulcerative colitis and Crohn’s disease as all potentially causally related to antibiotics given in childhood.

Makary is an advisor to two conservative think tanks, the Foundation for Research on Equal Opportunity, and to Paragon Health Institute, begun in 2021 by two former top officials in the previous Trump administration.

Makary would “cut the bureaucratic red tape at the agency to make sure Americans get the medical cures and treatments they deserve,” Trump said on his social media platform, Truth Social, and in a press release.

While Los Angeles Times owner and physician-entrepreneur Patrick Soon-Shiong, MBBCh, MSc, praised the nomination of Makary (and the two other nominees) as “inspired,” other physicians criticized Makary for his anti-COVID mandate views and “fear-mongering” over COVID vaccine side effects.

 

Janette Nesheiwat

As surgeon general, Nesheiwat would serve as the top “health communicator in chief” and oversee the 6000 member US Public Health Service Commissioned Corps.

She is a frequent medical contributor to Fox News and serves as a medical director for a group of urgent care clinics in New York. She received her medical degree from the American University of the Caribbean School of Medicine and completed a family medicine residency at the University of Arkansas for Medical Sciences. She is board-certified in family medicine.

Nesheiwat sells vitamin supplements on her website and in December will publish a book on “miracles in medicine” and her Christian faith. 

Trump said in a statement that Nesheiwat “is a fierce advocate and strong communicator for preventive medicine and public health. She is committed to ensuring that Americans have access to affordable, quality healthcare, and believes in empowering individuals to take charge of their health to live longer, healthier lives.”

While Nesheiwat was critical of COVID mandates, she voiced more support for COVID vaccines and mask-wearing during the pandemic than her fellow nominees, leading some Trump supporters to criticize her nomination. 

“A good appointment, happy about this: I got to know @DoctorJanette during the pandemic, exchanging information. She is very smart, thoughtful, interested in learning, and a compassionate doctor, and…a truly nice person,” noted vaccine researcher Peter Hotez, MD, PhD, said on X.

 

David J. Weldon

If confirmed, former congressman Weldon would oversee the sprawling CDC, an agency with a roughly $17 billion budget, 15,000 employees or contractors, and numerous centers covering everything from health statistics to vaccines to epidemiology.

After earning his medical degree from the University at Buffalo School of Medicine, Weldon served in the US Army and US Army reserve. The Republican later served for 14 years in Congress representing Florida’s 15th district, which covers the Tampa region.

He now practices as an internist in Brevard County, Florida.

In Congress, Weldon raised concerns about the safety of some vaccines and promoted the false narrative that a former vaccine ingredient, thimerosal, caused autism, the Washington Post reported. Thimerosal has not been used in child vaccines for more than two decades. He also introduced a bill to move vaccine safety oversight from the CDC to an independent agency within HHS.

Trump said in a statement that Weldon “will proudly restore the CDC to its true purpose, and will work to end the Chronic Disease Epidemic.” 

But some physicians criticized Weldon for what they called his anti-vaccine views.

A version of this article first appeared on Medscape.com.

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President-elect Donald Trump’s vision for the nation’s top health agencies is coming into focus with three nominations announced Nov. 22 that drew both criticism and praise:

  • Surgeon and health researcher Martin A. Makary, MD, MPH, to lead the US Food and Drug Administration (FDA).
  • Former Republican congressman and physician David J. Weldon, MD, for director of the US Centers for Disease Control and Prevention (CDC).
  • Fox News contributor Janette Nesheiwat, MD, for surgeon general.

Earlier in November, Trump nominated vaccine skeptic and former presidential candidate Robert F. Kennedy Jr. to lead the US Department of Health and Human Services (HHS). 

Here’s what to know about the latest nominees, who, like Kennedy, must be confirmed by the US Senate.

 

Martin A. Makary

Currently a professor at the Johns Hopkins School of Medicine and chief of islet transplant surgery at Johns Hopkins Hospital, Makary co-invented in 2006 a surgery checklist that became a widely-used patient safety tool. 

As a US FDA commissioner, Makary would preside over a $6.5 billion agency with more than 18,000 employees. The agency, part of HHS, oversees human and animal drugs and vaccines, medical devices, food, tobacco and other products. Some of Makary’s views align closely with those of HHS nominee Kennedy. 

Makary is also chief medical officer of telehealth platform Sesame.

Makary was primarily known as a health researcher and author of books about price transparency and the cost of health care until the COVID-19 pandemic, when he became an outspoken critic of the federal response, lambasting restrictions and mandates advocated by the CDC and other public health officials. 

In 2023, Makary told the House Select Subcommittee on the COVID Pandemic that federal officials had ignored what he called “natural immunity.” Studies have shown that natural immunity is “at least as effective as vaccinated immunity, and probably better,” testified Makary.

Makary called for an overhaul of the US FDA in a 2021 Fox News opinion, saying that its culture was “defined by counterproductive rigidity and a refusal to adapt.”

Blind Spots, his most recent book, takes on what he calls “medical dogma” and challenges conventional views on subjects ranging from the microbiome to marijuana to cancer prevention, hormone replacement therapy, antibiotics and peanut allergies.

In an interview he posted to X, Makary blames inappropriate use of antibiotics for a variety of childhood illnesses. He cites increases in obesity, learning disabilities, attention deficit disorder, asthma, celiac disease, ulcerative colitis and Crohn’s disease as all potentially causally related to antibiotics given in childhood.

Makary is an advisor to two conservative think tanks, the Foundation for Research on Equal Opportunity, and to Paragon Health Institute, begun in 2021 by two former top officials in the previous Trump administration.

Makary would “cut the bureaucratic red tape at the agency to make sure Americans get the medical cures and treatments they deserve,” Trump said on his social media platform, Truth Social, and in a press release.

While Los Angeles Times owner and physician-entrepreneur Patrick Soon-Shiong, MBBCh, MSc, praised the nomination of Makary (and the two other nominees) as “inspired,” other physicians criticized Makary for his anti-COVID mandate views and “fear-mongering” over COVID vaccine side effects.

 

Janette Nesheiwat

As surgeon general, Nesheiwat would serve as the top “health communicator in chief” and oversee the 6000 member US Public Health Service Commissioned Corps.

She is a frequent medical contributor to Fox News and serves as a medical director for a group of urgent care clinics in New York. She received her medical degree from the American University of the Caribbean School of Medicine and completed a family medicine residency at the University of Arkansas for Medical Sciences. She is board-certified in family medicine.

Nesheiwat sells vitamin supplements on her website and in December will publish a book on “miracles in medicine” and her Christian faith. 

Trump said in a statement that Nesheiwat “is a fierce advocate and strong communicator for preventive medicine and public health. She is committed to ensuring that Americans have access to affordable, quality healthcare, and believes in empowering individuals to take charge of their health to live longer, healthier lives.”

While Nesheiwat was critical of COVID mandates, she voiced more support for COVID vaccines and mask-wearing during the pandemic than her fellow nominees, leading some Trump supporters to criticize her nomination. 

“A good appointment, happy about this: I got to know @DoctorJanette during the pandemic, exchanging information. She is very smart, thoughtful, interested in learning, and a compassionate doctor, and…a truly nice person,” noted vaccine researcher Peter Hotez, MD, PhD, said on X.

 

David J. Weldon

If confirmed, former congressman Weldon would oversee the sprawling CDC, an agency with a roughly $17 billion budget, 15,000 employees or contractors, and numerous centers covering everything from health statistics to vaccines to epidemiology.

After earning his medical degree from the University at Buffalo School of Medicine, Weldon served in the US Army and US Army reserve. The Republican later served for 14 years in Congress representing Florida’s 15th district, which covers the Tampa region.

He now practices as an internist in Brevard County, Florida.

In Congress, Weldon raised concerns about the safety of some vaccines and promoted the false narrative that a former vaccine ingredient, thimerosal, caused autism, the Washington Post reported. Thimerosal has not been used in child vaccines for more than two decades. He also introduced a bill to move vaccine safety oversight from the CDC to an independent agency within HHS.

Trump said in a statement that Weldon “will proudly restore the CDC to its true purpose, and will work to end the Chronic Disease Epidemic.” 

But some physicians criticized Weldon for what they called his anti-vaccine views.

A version of this article first appeared on Medscape.com.

President-elect Donald Trump’s vision for the nation’s top health agencies is coming into focus with three nominations announced Nov. 22 that drew both criticism and praise:

  • Surgeon and health researcher Martin A. Makary, MD, MPH, to lead the US Food and Drug Administration (FDA).
  • Former Republican congressman and physician David J. Weldon, MD, for director of the US Centers for Disease Control and Prevention (CDC).
  • Fox News contributor Janette Nesheiwat, MD, for surgeon general.

Earlier in November, Trump nominated vaccine skeptic and former presidential candidate Robert F. Kennedy Jr. to lead the US Department of Health and Human Services (HHS). 

Here’s what to know about the latest nominees, who, like Kennedy, must be confirmed by the US Senate.

 

Martin A. Makary

Currently a professor at the Johns Hopkins School of Medicine and chief of islet transplant surgery at Johns Hopkins Hospital, Makary co-invented in 2006 a surgery checklist that became a widely-used patient safety tool. 

As a US FDA commissioner, Makary would preside over a $6.5 billion agency with more than 18,000 employees. The agency, part of HHS, oversees human and animal drugs and vaccines, medical devices, food, tobacco and other products. Some of Makary’s views align closely with those of HHS nominee Kennedy. 

Makary is also chief medical officer of telehealth platform Sesame.

Makary was primarily known as a health researcher and author of books about price transparency and the cost of health care until the COVID-19 pandemic, when he became an outspoken critic of the federal response, lambasting restrictions and mandates advocated by the CDC and other public health officials. 

In 2023, Makary told the House Select Subcommittee on the COVID Pandemic that federal officials had ignored what he called “natural immunity.” Studies have shown that natural immunity is “at least as effective as vaccinated immunity, and probably better,” testified Makary.

Makary called for an overhaul of the US FDA in a 2021 Fox News opinion, saying that its culture was “defined by counterproductive rigidity and a refusal to adapt.”

Blind Spots, his most recent book, takes on what he calls “medical dogma” and challenges conventional views on subjects ranging from the microbiome to marijuana to cancer prevention, hormone replacement therapy, antibiotics and peanut allergies.

In an interview he posted to X, Makary blames inappropriate use of antibiotics for a variety of childhood illnesses. He cites increases in obesity, learning disabilities, attention deficit disorder, asthma, celiac disease, ulcerative colitis and Crohn’s disease as all potentially causally related to antibiotics given in childhood.

Makary is an advisor to two conservative think tanks, the Foundation for Research on Equal Opportunity, and to Paragon Health Institute, begun in 2021 by two former top officials in the previous Trump administration.

Makary would “cut the bureaucratic red tape at the agency to make sure Americans get the medical cures and treatments they deserve,” Trump said on his social media platform, Truth Social, and in a press release.

While Los Angeles Times owner and physician-entrepreneur Patrick Soon-Shiong, MBBCh, MSc, praised the nomination of Makary (and the two other nominees) as “inspired,” other physicians criticized Makary for his anti-COVID mandate views and “fear-mongering” over COVID vaccine side effects.

 

Janette Nesheiwat

As surgeon general, Nesheiwat would serve as the top “health communicator in chief” and oversee the 6000 member US Public Health Service Commissioned Corps.

She is a frequent medical contributor to Fox News and serves as a medical director for a group of urgent care clinics in New York. She received her medical degree from the American University of the Caribbean School of Medicine and completed a family medicine residency at the University of Arkansas for Medical Sciences. She is board-certified in family medicine.

Nesheiwat sells vitamin supplements on her website and in December will publish a book on “miracles in medicine” and her Christian faith. 

Trump said in a statement that Nesheiwat “is a fierce advocate and strong communicator for preventive medicine and public health. She is committed to ensuring that Americans have access to affordable, quality healthcare, and believes in empowering individuals to take charge of their health to live longer, healthier lives.”

While Nesheiwat was critical of COVID mandates, she voiced more support for COVID vaccines and mask-wearing during the pandemic than her fellow nominees, leading some Trump supporters to criticize her nomination. 

“A good appointment, happy about this: I got to know @DoctorJanette during the pandemic, exchanging information. She is very smart, thoughtful, interested in learning, and a compassionate doctor, and…a truly nice person,” noted vaccine researcher Peter Hotez, MD, PhD, said on X.

 

David J. Weldon

If confirmed, former congressman Weldon would oversee the sprawling CDC, an agency with a roughly $17 billion budget, 15,000 employees or contractors, and numerous centers covering everything from health statistics to vaccines to epidemiology.

After earning his medical degree from the University at Buffalo School of Medicine, Weldon served in the US Army and US Army reserve. The Republican later served for 14 years in Congress representing Florida’s 15th district, which covers the Tampa region.

He now practices as an internist in Brevard County, Florida.

In Congress, Weldon raised concerns about the safety of some vaccines and promoted the false narrative that a former vaccine ingredient, thimerosal, caused autism, the Washington Post reported. Thimerosal has not been used in child vaccines for more than two decades. He also introduced a bill to move vaccine safety oversight from the CDC to an independent agency within HHS.

Trump said in a statement that Weldon “will proudly restore the CDC to its true purpose, and will work to end the Chronic Disease Epidemic.” 

But some physicians criticized Weldon for what they called his anti-vaccine views.

A version of this article first appeared on Medscape.com.

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New Federal Rule for Prior Authorizations a ‘Major Win’ for Patients, Doctors

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Fri, 01/19/2024 - 14:27

Physicians groups on January 17 hailed a new federal rule requiring health insurers to streamline and disclose more information about their prior authorization processes, saying it will improve patient care and reduce doctors’ administrative burden.

Health insurers participating in federal programs, including Medicare Advantage and Medicaid, must now respond to expedited prior authorization requests within 72 hours and other requests within 7 days under the long-awaited final rule, released on January 17 by the Centers for Medicare & Medicaid Services (CMS). 

Insurers also must include their reasons for denying a prior authorization request and will be required to publicly release data on denial and approval rates for medical treatment. They’ll also need to give patients more information about their decisions to deny care. Insurers must comply with some of the rule’s provisions by January 2026 and others by January 2027. 

The final rule “is an important step forward” toward the Medical Group Management Association’s goal of reducing the overall volume of prior authorization requests, said Anders Gilberg, the group’s senior vice president for government affairs, in a statement. 

“Only then will medical groups find meaningful reprieve from these onerous, ill-intentioned administrative requirements that dangerously impede patient care,” Mr. Gilberg said.

Health insurers have long lobbied against increased regulation of prior authorization, arguing that it’s needed to rein in healthcare costs and prevent unnecessary treatment. 

“We appreciate CMS’s announcement of enforcement discretion that will permit plans to use one standard, rather than mixing and matching, to reduce costs and speed implementation,” said America’s Health Insurance Plans, an insurers’ lobbying group, in an unsigned statement. “However, we must remember that the CMS rule is only half the picture; the Office of the Coordinator for Health Information Technology (ONC) should swiftly require vendors to build electronic prior authorization capabilities into the electronic health record so that providers can do their part, or plans will build a bridge to nowhere.” 

The rule comes as health insurers have increasingly been criticized for onerous and time-consuming prior authorization procedures that physicians say unfairly delay or deny the medical treatment that their patients need. With federal legislation to rein in prior authorization overuse at a standstill, 30 states have introduced their own bills to address the problem. Regulators and lawsuits also have called attention to insurers’ increasing use of artificial intelligence and algorithms to deny claims without human review.

“Family physicians know firsthand how prior authorizations divert valuable time and resources away from direct patient care. We also know that these types of administrative requirements are driving physicians away from the workforce and worsening physician shortages,” said Steven P. Furr, MD, president of the American Academy of Family Physicians, in a statement praising the new rule. 

Jesse M. Ehrenfeld, MD, MPH, president of the American Medical Association, called the final rule “ a major win” for patients and physicians, adding that its requirements for health insurers to integrate their prior authorization procedures into physicians’ electronic health records systems will also help make “the current time-consuming, manual workflow” more efficient.

A version of this article first appeared on Medscape.com.

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Physicians groups on January 17 hailed a new federal rule requiring health insurers to streamline and disclose more information about their prior authorization processes, saying it will improve patient care and reduce doctors’ administrative burden.

Health insurers participating in federal programs, including Medicare Advantage and Medicaid, must now respond to expedited prior authorization requests within 72 hours and other requests within 7 days under the long-awaited final rule, released on January 17 by the Centers for Medicare & Medicaid Services (CMS). 

Insurers also must include their reasons for denying a prior authorization request and will be required to publicly release data on denial and approval rates for medical treatment. They’ll also need to give patients more information about their decisions to deny care. Insurers must comply with some of the rule’s provisions by January 2026 and others by January 2027. 

The final rule “is an important step forward” toward the Medical Group Management Association’s goal of reducing the overall volume of prior authorization requests, said Anders Gilberg, the group’s senior vice president for government affairs, in a statement. 

“Only then will medical groups find meaningful reprieve from these onerous, ill-intentioned administrative requirements that dangerously impede patient care,” Mr. Gilberg said.

Health insurers have long lobbied against increased regulation of prior authorization, arguing that it’s needed to rein in healthcare costs and prevent unnecessary treatment. 

“We appreciate CMS’s announcement of enforcement discretion that will permit plans to use one standard, rather than mixing and matching, to reduce costs and speed implementation,” said America’s Health Insurance Plans, an insurers’ lobbying group, in an unsigned statement. “However, we must remember that the CMS rule is only half the picture; the Office of the Coordinator for Health Information Technology (ONC) should swiftly require vendors to build electronic prior authorization capabilities into the electronic health record so that providers can do their part, or plans will build a bridge to nowhere.” 

The rule comes as health insurers have increasingly been criticized for onerous and time-consuming prior authorization procedures that physicians say unfairly delay or deny the medical treatment that their patients need. With federal legislation to rein in prior authorization overuse at a standstill, 30 states have introduced their own bills to address the problem. Regulators and lawsuits also have called attention to insurers’ increasing use of artificial intelligence and algorithms to deny claims without human review.

“Family physicians know firsthand how prior authorizations divert valuable time and resources away from direct patient care. We also know that these types of administrative requirements are driving physicians away from the workforce and worsening physician shortages,” said Steven P. Furr, MD, president of the American Academy of Family Physicians, in a statement praising the new rule. 

Jesse M. Ehrenfeld, MD, MPH, president of the American Medical Association, called the final rule “ a major win” for patients and physicians, adding that its requirements for health insurers to integrate their prior authorization procedures into physicians’ electronic health records systems will also help make “the current time-consuming, manual workflow” more efficient.

A version of this article first appeared on Medscape.com.

Physicians groups on January 17 hailed a new federal rule requiring health insurers to streamline and disclose more information about their prior authorization processes, saying it will improve patient care and reduce doctors’ administrative burden.

Health insurers participating in federal programs, including Medicare Advantage and Medicaid, must now respond to expedited prior authorization requests within 72 hours and other requests within 7 days under the long-awaited final rule, released on January 17 by the Centers for Medicare & Medicaid Services (CMS). 

Insurers also must include their reasons for denying a prior authorization request and will be required to publicly release data on denial and approval rates for medical treatment. They’ll also need to give patients more information about their decisions to deny care. Insurers must comply with some of the rule’s provisions by January 2026 and others by January 2027. 

The final rule “is an important step forward” toward the Medical Group Management Association’s goal of reducing the overall volume of prior authorization requests, said Anders Gilberg, the group’s senior vice president for government affairs, in a statement. 

“Only then will medical groups find meaningful reprieve from these onerous, ill-intentioned administrative requirements that dangerously impede patient care,” Mr. Gilberg said.

Health insurers have long lobbied against increased regulation of prior authorization, arguing that it’s needed to rein in healthcare costs and prevent unnecessary treatment. 

“We appreciate CMS’s announcement of enforcement discretion that will permit plans to use one standard, rather than mixing and matching, to reduce costs and speed implementation,” said America’s Health Insurance Plans, an insurers’ lobbying group, in an unsigned statement. “However, we must remember that the CMS rule is only half the picture; the Office of the Coordinator for Health Information Technology (ONC) should swiftly require vendors to build electronic prior authorization capabilities into the electronic health record so that providers can do their part, or plans will build a bridge to nowhere.” 

The rule comes as health insurers have increasingly been criticized for onerous and time-consuming prior authorization procedures that physicians say unfairly delay or deny the medical treatment that their patients need. With federal legislation to rein in prior authorization overuse at a standstill, 30 states have introduced their own bills to address the problem. Regulators and lawsuits also have called attention to insurers’ increasing use of artificial intelligence and algorithms to deny claims without human review.

“Family physicians know firsthand how prior authorizations divert valuable time and resources away from direct patient care. We also know that these types of administrative requirements are driving physicians away from the workforce and worsening physician shortages,” said Steven P. Furr, MD, president of the American Academy of Family Physicians, in a statement praising the new rule. 

Jesse M. Ehrenfeld, MD, MPH, president of the American Medical Association, called the final rule “ a major win” for patients and physicians, adding that its requirements for health insurers to integrate their prior authorization procedures into physicians’ electronic health records systems will also help make “the current time-consuming, manual workflow” more efficient.

A version of this article first appeared on Medscape.com.

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Proposed Medicare bill would raise docs’ pay with inflation

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Mon, 04/24/2023 - 13:48

Doctors’ groups are lining up to support new federal legislation to permanently tie Medicare physician payment updates to inflation.

Introduced by four physician U.S. House representatives, HR 2474 would link Medicare fee schedule updates to the Medicare Economic Index, a measure of inflation related to physicians’ practice costs and wages.

That’s a long-sought goal of the American Medical Association, which is leading 120 state medical societies and medical specialty groups in championing the bill.

The legislation is essential to enabling physician practices to better absorb payment distributions triggered by budget neutrality rules, performance adjustments, and periods of high inflation, the groups wrote in a joint letter sent to the bill’s sponsors. The sponsors say they hope the legislation will improve access to care, as low reimbursements cause some physicians to limit their number of Medicare patients.

Physicians groups for years have urged federal lawmakers to scrap short-term fixes staving off Medicare pay cuts in favor of permanent reforms. Unlike nearly all other Medicare clinicians including hospitals, physicians’ Medicare payment updates aren’t currently tied to inflation.

Adjusted for inflation, Medicare payments to physicians have declined 26% between 2001 and 2023, including a 2% payment reduction in 2023, according to the AMA. Small and rural physician practices have been disproportionately affected by these reductions, as have doctors treating low-income or uninsured patients, the AMA said.

Last month, an influential federal advisory panel recommended permanently tying Medicare physician pay increases to inflation. Clinicians’ cost of providing services, measured by the Medicare Economic Index, rose by 2.6% in 2021 and are estimated to have risen 4.7% in 2022, significantly more than in recent years, the Medicare Payment Advisory Commission said.

A version of this article originally appeared on Medscape.com.

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Doctors’ groups are lining up to support new federal legislation to permanently tie Medicare physician payment updates to inflation.

Introduced by four physician U.S. House representatives, HR 2474 would link Medicare fee schedule updates to the Medicare Economic Index, a measure of inflation related to physicians’ practice costs and wages.

That’s a long-sought goal of the American Medical Association, which is leading 120 state medical societies and medical specialty groups in championing the bill.

The legislation is essential to enabling physician practices to better absorb payment distributions triggered by budget neutrality rules, performance adjustments, and periods of high inflation, the groups wrote in a joint letter sent to the bill’s sponsors. The sponsors say they hope the legislation will improve access to care, as low reimbursements cause some physicians to limit their number of Medicare patients.

Physicians groups for years have urged federal lawmakers to scrap short-term fixes staving off Medicare pay cuts in favor of permanent reforms. Unlike nearly all other Medicare clinicians including hospitals, physicians’ Medicare payment updates aren’t currently tied to inflation.

Adjusted for inflation, Medicare payments to physicians have declined 26% between 2001 and 2023, including a 2% payment reduction in 2023, according to the AMA. Small and rural physician practices have been disproportionately affected by these reductions, as have doctors treating low-income or uninsured patients, the AMA said.

Last month, an influential federal advisory panel recommended permanently tying Medicare physician pay increases to inflation. Clinicians’ cost of providing services, measured by the Medicare Economic Index, rose by 2.6% in 2021 and are estimated to have risen 4.7% in 2022, significantly more than in recent years, the Medicare Payment Advisory Commission said.

A version of this article originally appeared on Medscape.com.

Doctors’ groups are lining up to support new federal legislation to permanently tie Medicare physician payment updates to inflation.

Introduced by four physician U.S. House representatives, HR 2474 would link Medicare fee schedule updates to the Medicare Economic Index, a measure of inflation related to physicians’ practice costs and wages.

That’s a long-sought goal of the American Medical Association, which is leading 120 state medical societies and medical specialty groups in championing the bill.

The legislation is essential to enabling physician practices to better absorb payment distributions triggered by budget neutrality rules, performance adjustments, and periods of high inflation, the groups wrote in a joint letter sent to the bill’s sponsors. The sponsors say they hope the legislation will improve access to care, as low reimbursements cause some physicians to limit their number of Medicare patients.

Physicians groups for years have urged federal lawmakers to scrap short-term fixes staving off Medicare pay cuts in favor of permanent reforms. Unlike nearly all other Medicare clinicians including hospitals, physicians’ Medicare payment updates aren’t currently tied to inflation.

Adjusted for inflation, Medicare payments to physicians have declined 26% between 2001 and 2023, including a 2% payment reduction in 2023, according to the AMA. Small and rural physician practices have been disproportionately affected by these reductions, as have doctors treating low-income or uninsured patients, the AMA said.

Last month, an influential federal advisory panel recommended permanently tying Medicare physician pay increases to inflation. Clinicians’ cost of providing services, measured by the Medicare Economic Index, rose by 2.6% in 2021 and are estimated to have risen 4.7% in 2022, significantly more than in recent years, the Medicare Payment Advisory Commission said.

A version of this article originally appeared on Medscape.com.

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New state bill could protect docs prescribing abortion pills to out-of-state patients

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Wed, 04/05/2023 - 14:28

California lawmakers are considering legislation to protect California physicians and pharmacists who prescribe abortion pills to out-of-state patients. The proposed law would shield health care providers who are legally performing their jobs in California from facing prosecution in another state or being extradited.

State Sen. Nancy Skinner, who introduced the bill, said the legislation is necessary in a fractured, post-Roe legal landscape where doctors in some states can face felony charges or civil penalties for providing reproductive health care. It’s part of a package of 17 new bills aiming to “strengthen California’s standing as a safe haven for abortion, contraception, and pregnancy care,” according to a press release.

“I’m trying to protect our healthcare practitioners so they can do their jobs, without fear,” Ms. Skinner said in a statement on March 24.

Most abortions are banned in 14 states after the Supreme Court overturned Roe v. Wade. Lawmakers in those states have established a variety of penalties for doctors, pharmacists, and other clinicians to provide abortion care or assist patients in obtaining abortions, including jail time, fines, and loss of professional licenses.

As a result, doctors in restrictive states have anguished over having to delay treatment for patients experiencing miscarriages, ectopic pregnancies, and other conditions until their lives are enough at risk to satisfy exceptions to state abortion laws.

“As a physician, I believe everyone deserves the care they need, regardless of where they live,” said Daniel Grossman, MD, a University of California, San Francisco, ob.gyn. professor who directs the university’s Advancing New Standards in Reproductive Health program.

“Since the fall of Roe v. Wade, patients are being forced to travel long distances – often over 500 miles – to access abortion care in a clinic. People should be able to access this essential care closer to home, including by telemedicine, which has been shown to be safe and effective. I am hopeful that SB 345 will provide additional legal protections that would allow California clinicians to help patients in other states,” he stated.

Other states, including New York, Vermont, New Jersey, Massachusetts, and Connecticut, have passed or are considering similar legislation to protect doctors using telemedicine to prescribe abortion medication to out-of-state patients. These laws come amid a growing push by some states and anti-abortion groups to severely restrict access to abortion pills.

Wyoming is the first state to explicitly ban the pills, although a judge on March 22 blocked that ban. And, in a closely watched case, a conservative federal judge could soon rule to ban sales of mifepristone, one of the medications in a two-pill regimen approved for abortions early in pregnancy.

California’s legislation protects clinicians from losing their California professional licenses if an out-of-state medical board takes action against them. It also allows clinicians to sue anyone who tries to legally interfere with the care they are providing.

It also covers California physicians prescribing contraceptives or gender-affirming care to out-of-state patients. At least 21 states are considering restrictions on gender-affirming care for minors and another 9 states have passed them, according to the advocacy group Human Rights Campaign. Courts have blocked the restrictions in some states.

“It’s understandable that states like California want to reassure their doctors ... that, if one of their patients is caught in one of those states and can’t get help locally, they can step up to help and feel safe in doing so,” said Matthew Wynia, MD, MPH, FACP, director of the Center for Bioethics and Humanities at the University of Colorado at Denver, Aurora.

“This is also a crazy development in terms of the law. It’s just one part of the legal mayhem that was predicted when the Supreme Court overturned Roe,” Dr. Wynia said of the growing number of bills protecting in-state doctors. These bills “will almost certainly end up being litigated over issues of interstate commerce, cross-state licensure and practice compacts, FDA regulations and authorities, and maybe more. It’s a huge mess, in which both doctors and patients are being hurt.”

A version of this article first appeared on Medscape.com.

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California lawmakers are considering legislation to protect California physicians and pharmacists who prescribe abortion pills to out-of-state patients. The proposed law would shield health care providers who are legally performing their jobs in California from facing prosecution in another state or being extradited.

State Sen. Nancy Skinner, who introduced the bill, said the legislation is necessary in a fractured, post-Roe legal landscape where doctors in some states can face felony charges or civil penalties for providing reproductive health care. It’s part of a package of 17 new bills aiming to “strengthen California’s standing as a safe haven for abortion, contraception, and pregnancy care,” according to a press release.

“I’m trying to protect our healthcare practitioners so they can do their jobs, without fear,” Ms. Skinner said in a statement on March 24.

Most abortions are banned in 14 states after the Supreme Court overturned Roe v. Wade. Lawmakers in those states have established a variety of penalties for doctors, pharmacists, and other clinicians to provide abortion care or assist patients in obtaining abortions, including jail time, fines, and loss of professional licenses.

As a result, doctors in restrictive states have anguished over having to delay treatment for patients experiencing miscarriages, ectopic pregnancies, and other conditions until their lives are enough at risk to satisfy exceptions to state abortion laws.

“As a physician, I believe everyone deserves the care they need, regardless of where they live,” said Daniel Grossman, MD, a University of California, San Francisco, ob.gyn. professor who directs the university’s Advancing New Standards in Reproductive Health program.

“Since the fall of Roe v. Wade, patients are being forced to travel long distances – often over 500 miles – to access abortion care in a clinic. People should be able to access this essential care closer to home, including by telemedicine, which has been shown to be safe and effective. I am hopeful that SB 345 will provide additional legal protections that would allow California clinicians to help patients in other states,” he stated.

Other states, including New York, Vermont, New Jersey, Massachusetts, and Connecticut, have passed or are considering similar legislation to protect doctors using telemedicine to prescribe abortion medication to out-of-state patients. These laws come amid a growing push by some states and anti-abortion groups to severely restrict access to abortion pills.

Wyoming is the first state to explicitly ban the pills, although a judge on March 22 blocked that ban. And, in a closely watched case, a conservative federal judge could soon rule to ban sales of mifepristone, one of the medications in a two-pill regimen approved for abortions early in pregnancy.

California’s legislation protects clinicians from losing their California professional licenses if an out-of-state medical board takes action against them. It also allows clinicians to sue anyone who tries to legally interfere with the care they are providing.

It also covers California physicians prescribing contraceptives or gender-affirming care to out-of-state patients. At least 21 states are considering restrictions on gender-affirming care for minors and another 9 states have passed them, according to the advocacy group Human Rights Campaign. Courts have blocked the restrictions in some states.

“It’s understandable that states like California want to reassure their doctors ... that, if one of their patients is caught in one of those states and can’t get help locally, they can step up to help and feel safe in doing so,” said Matthew Wynia, MD, MPH, FACP, director of the Center for Bioethics and Humanities at the University of Colorado at Denver, Aurora.

“This is also a crazy development in terms of the law. It’s just one part of the legal mayhem that was predicted when the Supreme Court overturned Roe,” Dr. Wynia said of the growing number of bills protecting in-state doctors. These bills “will almost certainly end up being litigated over issues of interstate commerce, cross-state licensure and practice compacts, FDA regulations and authorities, and maybe more. It’s a huge mess, in which both doctors and patients are being hurt.”

A version of this article first appeared on Medscape.com.

California lawmakers are considering legislation to protect California physicians and pharmacists who prescribe abortion pills to out-of-state patients. The proposed law would shield health care providers who are legally performing their jobs in California from facing prosecution in another state or being extradited.

State Sen. Nancy Skinner, who introduced the bill, said the legislation is necessary in a fractured, post-Roe legal landscape where doctors in some states can face felony charges or civil penalties for providing reproductive health care. It’s part of a package of 17 new bills aiming to “strengthen California’s standing as a safe haven for abortion, contraception, and pregnancy care,” according to a press release.

“I’m trying to protect our healthcare practitioners so they can do their jobs, without fear,” Ms. Skinner said in a statement on March 24.

Most abortions are banned in 14 states after the Supreme Court overturned Roe v. Wade. Lawmakers in those states have established a variety of penalties for doctors, pharmacists, and other clinicians to provide abortion care or assist patients in obtaining abortions, including jail time, fines, and loss of professional licenses.

As a result, doctors in restrictive states have anguished over having to delay treatment for patients experiencing miscarriages, ectopic pregnancies, and other conditions until their lives are enough at risk to satisfy exceptions to state abortion laws.

“As a physician, I believe everyone deserves the care they need, regardless of where they live,” said Daniel Grossman, MD, a University of California, San Francisco, ob.gyn. professor who directs the university’s Advancing New Standards in Reproductive Health program.

“Since the fall of Roe v. Wade, patients are being forced to travel long distances – often over 500 miles – to access abortion care in a clinic. People should be able to access this essential care closer to home, including by telemedicine, which has been shown to be safe and effective. I am hopeful that SB 345 will provide additional legal protections that would allow California clinicians to help patients in other states,” he stated.

Other states, including New York, Vermont, New Jersey, Massachusetts, and Connecticut, have passed or are considering similar legislation to protect doctors using telemedicine to prescribe abortion medication to out-of-state patients. These laws come amid a growing push by some states and anti-abortion groups to severely restrict access to abortion pills.

Wyoming is the first state to explicitly ban the pills, although a judge on March 22 blocked that ban. And, in a closely watched case, a conservative federal judge could soon rule to ban sales of mifepristone, one of the medications in a two-pill regimen approved for abortions early in pregnancy.

California’s legislation protects clinicians from losing their California professional licenses if an out-of-state medical board takes action against them. It also allows clinicians to sue anyone who tries to legally interfere with the care they are providing.

It also covers California physicians prescribing contraceptives or gender-affirming care to out-of-state patients. At least 21 states are considering restrictions on gender-affirming care for minors and another 9 states have passed them, according to the advocacy group Human Rights Campaign. Courts have blocked the restrictions in some states.

“It’s understandable that states like California want to reassure their doctors ... that, if one of their patients is caught in one of those states and can’t get help locally, they can step up to help and feel safe in doing so,” said Matthew Wynia, MD, MPH, FACP, director of the Center for Bioethics and Humanities at the University of Colorado at Denver, Aurora.

“This is also a crazy development in terms of the law. It’s just one part of the legal mayhem that was predicted when the Supreme Court overturned Roe,” Dr. Wynia said of the growing number of bills protecting in-state doctors. These bills “will almost certainly end up being litigated over issues of interstate commerce, cross-state licensure and practice compacts, FDA regulations and authorities, and maybe more. It’s a huge mess, in which both doctors and patients are being hurt.”

A version of this article first appeared on Medscape.com.

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States strive to curb costs for a crucial – but exorbitant – hemophilia treatment

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Fri, 01/18/2019 - 17:27

 

The child is well-known in the halls in which state bureaucrats oversee health care for millions of Californians – not by name, but by a number: $21 million.

His medications alone cost state taxpayers that much in a single year, not including other health care. The boy, whose identity has not been released, was California’s most expensive Medicaid patient in recent years. His case was singled out in a tweet last year by the state’s top health care official to highlight the public insurance program’s extraordinary obligations as a backstop for low-income patients.

How on earth can a single child’s treatment cost that much? The answer: He has hemophilia and needs large quantities of a pricey drug – known as clotting factor – that makes blood coagulate.

Hemophilia drugs are among the most costly drugs in the nation, and taxpayers are footing the bill for many patients on Medicaid who could never afford them on their own. Officials in California and other states are doing what they can to manage the costs, but it’s a daunting task that highlights the complexity and secrecy of prescription drug pricing.

 

 

Kaiser Health News is examining how America has become a “Medicaid Nation” – where tens of millions of poor and disabled people now rely on the support of the federal and state insurance program. Hemophilia is one those diseases that helps explain its burgeoning cost.

Medications for hemophilia are crucial to patients – overwhelmingly male – with the rare genetic condition that prevents clotting and puts them at great risk of bleeding to death, even from a minor injury. There is no question the drugs prolong and save lives, and state officials are not arguing that they should be withheld.

“It’s a highly vulnerable population,” said Ken Kizer, a veteran federal and state health administrator who formerly oversaw Medi-Cal, California’s version of Medicaid. “If anyone has seen a hemophiliac in crisis, you’re not going to say no.”

But drugmakers profit handsomely, competing vigorously for the limited number of patients.

The U.S. hemophilia market, which serves about 20,000 patients, is worth $4.6 billion a year, according to AllianceBernstein, a research and investment firm.
 

 

“There are millions being made out there on these kids – it’s a huge business,” said Doris Quon, MD, medical director of the Orthopaedic Hemophilia Treatment Center at the University of California, Los Angeles.

Contributing to the costs is the fact that there is no cure for hemophilia and no cheaper substitute for blood factor. Factor may be prescribed at high doses for a lifetime, even more so when a patient has an injury or complications.

Nationwide, a third of adults and children living with hemophilia are covered by Medicaid. And the Medicaid program’s three most expensive drugs per prescription are for hemophilia, according to an analysis by the Kaiser Family Foundation. (California Healthline is produced by Kaiser Health News, an editorially independent publication of the foundation.)

In 2015 alone, Medicaid paid about $353 million for prescriptions of Advate, the most commonly prescribed blood-clotting medication for hemophilia – a 273% increase from 2011.

Generally speaking, the price of hemophilia drugs rise as rival drugs hit the market. But, in addition, doctors are prescribing ever more clotting factor for prevention of joint-damaging bleeds and for improved long-term health. The increase in the cost of Advate, for example, was nearly all attributed to increased use.

Tab for 145 kids: $195 million

The California boy whose drugs cost $21 million in a single year was an extreme case, and the circumstances of his care have not been disclosed because of confidentiality protections. Still, medications to treat hemophilia on average annual cost more than $270,000 per patient, according to a 2015 Express Scripts report, and they can easily soar past $1 million annually.

In contrast to more common diseases like hepatitis C, hemophilia treatment is not a state “budget buster” per se: about 4,000 patients live in California. About 1,100 of them are covered by Medi-Cal or two other government-funded programs for chronically ill children in California, according to Jennifer Kent, director of the state Department of Health Care Services and author of last year’s tweet. But the amount of money spent per person dwarfs that spent on people with other serious diseases.

One Stanford University study of 34,000 California kids with severe chronic diseases found that the tiny portion of children who needed blood factor accounted for 41% of the state’s outpatient drug spending on this entire patient population. About $195 million was spent on just 145 kids over a 3-year period, although some of that money came back to the state in rebates from drug companies – a portion of the cost that Medicaid can recoup after purchase.

Caitlin Carroll, director of public affairs for PhRMA, the pharmaceutical industry lobbying group, said high development costs and the complicated and lengthy manufacturing process play a role in how hemophilia drugs are priced. She added that federally mandated rebates significantly reduce the cost of blood factor. They amount to 17% of the average manufacturer price per unit.

Manufacturers also note that some newer and more expensive hemophilia drugs last longer and do not need to be administered as frequently, so they can prove less costly to payers overall.

Even so, some patients require a monumental investment to survive.
 

 

 

‘Extremely fortunate’

Colleen Tuite’s son Kevin, a 7-year-old, has severe hemophilia with a complication known as an inhibitor – an antibody that makes his regular blood-factor infusions less effective. Inhibitors can dramatically increase the cost of care, because massive doses of blood factor or expensive, specialized blood products known as bypassing agents may be needed.

Ms. Tuite and her husband initially were Kevin’s foster parents, then adopted the boy as a toddler. Because he has been a foster child, Kevin qualifies for Medi-Cal until he is 26.

The Monrovia, Calif., family also has private health insurance, which pays for about half of Kevin’s medical bills. These can run upward of $200,000 per month, Ms. Tuite said.

“We definitely would not have been able to adopt him without the help of Medi-Cal,” Ms. Tuite said. “We’ve been extremely fortunate.”

With the support of drug manufacturers and hemophilia advocacy groups, patients and their families have significant political clout. Some experts say they also have a moral claim on public resources: In the early days of the AIDS epidemic, thousands of the nation’s hemophilia patients died after they contracted HIV through transfusions before the virus was eliminated from the blood supply.

State health officials say the costs of hemophilia are hard to anticipate and control, even with rebates.

“We do a really aggressive job of collecting rebates on our pharmacy costs,” said Ms. Kent, California’s top Medicaid official. “But there’s just not any way around blood factor. It is just a very, very expensive product. It’s nonnegotiable for people that require it.”

In 2016, California’s Medicaid program paid at least $205 million for medications used to treat hemophilia, according to a Kaiser Health News analysis of federal Medicaid data. That figure doesn’t account for the federal rebates.

States can negotiate “supplemental” rebates with drugmakers for individual medications – but those must be kept secret under federal and some state laws. Such secrecy is becoming increasingly controversial as states continue to confront spiraling drug prices.

 

 

Limited options for states

In 2016, Pfizer sued Texas’ state health agency for giving data on the drug company’s supplemental Medicaid rebates to state lawmakers who requested it. The drugmaker alleged that releasing the confidential information would undermine the company’s competitiveness and give away trade secrets, and warned that the discounts it gave Texas could disappear.

In early October, a judge ruled that lawmakers should be able to obtain some of that data, noting dryly that “in Pfizer’s view, legislators are not necessary to carry out the state’s Medicaid program.”

Instead of seeking additional rebates from manufacturers for blood factor, some states, including Washington and Oregon, have chosen to require patients to get their blood factor from federally designated Hemophilia Treatment Centers only. That allows state Medicaid programs to take advantage of a federal drug-discount program known as “340B.”

However, officials in California said they studied that option and determined it wouldn’t save them any more money than the rebates they negotiate with drugmakers.

Whatever their approach, state health officials say they are struggling against forces they are nearly powerless to change.

“There aren’t a lot of options available to Medicaid programs in terms of controlling costs, because we don’t set the initial costs,” said Deborah Weston, pharmacy program manager for Oregon’s Medicaid program.
 

Kaiser Health News data correspondent Sydney Lupkin contributed to this report. KHN’s coverage of these topics is supported by Laura and John Arnold Foundation and Heising-Simons Foundation. This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation. Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

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The child is well-known in the halls in which state bureaucrats oversee health care for millions of Californians – not by name, but by a number: $21 million.

His medications alone cost state taxpayers that much in a single year, not including other health care. The boy, whose identity has not been released, was California’s most expensive Medicaid patient in recent years. His case was singled out in a tweet last year by the state’s top health care official to highlight the public insurance program’s extraordinary obligations as a backstop for low-income patients.

How on earth can a single child’s treatment cost that much? The answer: He has hemophilia and needs large quantities of a pricey drug – known as clotting factor – that makes blood coagulate.

Hemophilia drugs are among the most costly drugs in the nation, and taxpayers are footing the bill for many patients on Medicaid who could never afford them on their own. Officials in California and other states are doing what they can to manage the costs, but it’s a daunting task that highlights the complexity and secrecy of prescription drug pricing.

 

 

Kaiser Health News is examining how America has become a “Medicaid Nation” – where tens of millions of poor and disabled people now rely on the support of the federal and state insurance program. Hemophilia is one those diseases that helps explain its burgeoning cost.

Medications for hemophilia are crucial to patients – overwhelmingly male – with the rare genetic condition that prevents clotting and puts them at great risk of bleeding to death, even from a minor injury. There is no question the drugs prolong and save lives, and state officials are not arguing that they should be withheld.

“It’s a highly vulnerable population,” said Ken Kizer, a veteran federal and state health administrator who formerly oversaw Medi-Cal, California’s version of Medicaid. “If anyone has seen a hemophiliac in crisis, you’re not going to say no.”

But drugmakers profit handsomely, competing vigorously for the limited number of patients.

The U.S. hemophilia market, which serves about 20,000 patients, is worth $4.6 billion a year, according to AllianceBernstein, a research and investment firm.
 

 

“There are millions being made out there on these kids – it’s a huge business,” said Doris Quon, MD, medical director of the Orthopaedic Hemophilia Treatment Center at the University of California, Los Angeles.

Contributing to the costs is the fact that there is no cure for hemophilia and no cheaper substitute for blood factor. Factor may be prescribed at high doses for a lifetime, even more so when a patient has an injury or complications.

Nationwide, a third of adults and children living with hemophilia are covered by Medicaid. And the Medicaid program’s three most expensive drugs per prescription are for hemophilia, according to an analysis by the Kaiser Family Foundation. (California Healthline is produced by Kaiser Health News, an editorially independent publication of the foundation.)

In 2015 alone, Medicaid paid about $353 million for prescriptions of Advate, the most commonly prescribed blood-clotting medication for hemophilia – a 273% increase from 2011.

Generally speaking, the price of hemophilia drugs rise as rival drugs hit the market. But, in addition, doctors are prescribing ever more clotting factor for prevention of joint-damaging bleeds and for improved long-term health. The increase in the cost of Advate, for example, was nearly all attributed to increased use.

Tab for 145 kids: $195 million

The California boy whose drugs cost $21 million in a single year was an extreme case, and the circumstances of his care have not been disclosed because of confidentiality protections. Still, medications to treat hemophilia on average annual cost more than $270,000 per patient, according to a 2015 Express Scripts report, and they can easily soar past $1 million annually.

In contrast to more common diseases like hepatitis C, hemophilia treatment is not a state “budget buster” per se: about 4,000 patients live in California. About 1,100 of them are covered by Medi-Cal or two other government-funded programs for chronically ill children in California, according to Jennifer Kent, director of the state Department of Health Care Services and author of last year’s tweet. But the amount of money spent per person dwarfs that spent on people with other serious diseases.

One Stanford University study of 34,000 California kids with severe chronic diseases found that the tiny portion of children who needed blood factor accounted for 41% of the state’s outpatient drug spending on this entire patient population. About $195 million was spent on just 145 kids over a 3-year period, although some of that money came back to the state in rebates from drug companies – a portion of the cost that Medicaid can recoup after purchase.

Caitlin Carroll, director of public affairs for PhRMA, the pharmaceutical industry lobbying group, said high development costs and the complicated and lengthy manufacturing process play a role in how hemophilia drugs are priced. She added that federally mandated rebates significantly reduce the cost of blood factor. They amount to 17% of the average manufacturer price per unit.

Manufacturers also note that some newer and more expensive hemophilia drugs last longer and do not need to be administered as frequently, so they can prove less costly to payers overall.

Even so, some patients require a monumental investment to survive.
 

 

 

‘Extremely fortunate’

Colleen Tuite’s son Kevin, a 7-year-old, has severe hemophilia with a complication known as an inhibitor – an antibody that makes his regular blood-factor infusions less effective. Inhibitors can dramatically increase the cost of care, because massive doses of blood factor or expensive, specialized blood products known as bypassing agents may be needed.

Ms. Tuite and her husband initially were Kevin’s foster parents, then adopted the boy as a toddler. Because he has been a foster child, Kevin qualifies for Medi-Cal until he is 26.

The Monrovia, Calif., family also has private health insurance, which pays for about half of Kevin’s medical bills. These can run upward of $200,000 per month, Ms. Tuite said.

“We definitely would not have been able to adopt him without the help of Medi-Cal,” Ms. Tuite said. “We’ve been extremely fortunate.”

With the support of drug manufacturers and hemophilia advocacy groups, patients and their families have significant political clout. Some experts say they also have a moral claim on public resources: In the early days of the AIDS epidemic, thousands of the nation’s hemophilia patients died after they contracted HIV through transfusions before the virus was eliminated from the blood supply.

State health officials say the costs of hemophilia are hard to anticipate and control, even with rebates.

“We do a really aggressive job of collecting rebates on our pharmacy costs,” said Ms. Kent, California’s top Medicaid official. “But there’s just not any way around blood factor. It is just a very, very expensive product. It’s nonnegotiable for people that require it.”

In 2016, California’s Medicaid program paid at least $205 million for medications used to treat hemophilia, according to a Kaiser Health News analysis of federal Medicaid data. That figure doesn’t account for the federal rebates.

States can negotiate “supplemental” rebates with drugmakers for individual medications – but those must be kept secret under federal and some state laws. Such secrecy is becoming increasingly controversial as states continue to confront spiraling drug prices.

 

 

Limited options for states

In 2016, Pfizer sued Texas’ state health agency for giving data on the drug company’s supplemental Medicaid rebates to state lawmakers who requested it. The drugmaker alleged that releasing the confidential information would undermine the company’s competitiveness and give away trade secrets, and warned that the discounts it gave Texas could disappear.

In early October, a judge ruled that lawmakers should be able to obtain some of that data, noting dryly that “in Pfizer’s view, legislators are not necessary to carry out the state’s Medicaid program.”

Instead of seeking additional rebates from manufacturers for blood factor, some states, including Washington and Oregon, have chosen to require patients to get their blood factor from federally designated Hemophilia Treatment Centers only. That allows state Medicaid programs to take advantage of a federal drug-discount program known as “340B.”

However, officials in California said they studied that option and determined it wouldn’t save them any more money than the rebates they negotiate with drugmakers.

Whatever their approach, state health officials say they are struggling against forces they are nearly powerless to change.

“There aren’t a lot of options available to Medicaid programs in terms of controlling costs, because we don’t set the initial costs,” said Deborah Weston, pharmacy program manager for Oregon’s Medicaid program.
 

Kaiser Health News data correspondent Sydney Lupkin contributed to this report. KHN’s coverage of these topics is supported by Laura and John Arnold Foundation and Heising-Simons Foundation. This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation. Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

 

The child is well-known in the halls in which state bureaucrats oversee health care for millions of Californians – not by name, but by a number: $21 million.

His medications alone cost state taxpayers that much in a single year, not including other health care. The boy, whose identity has not been released, was California’s most expensive Medicaid patient in recent years. His case was singled out in a tweet last year by the state’s top health care official to highlight the public insurance program’s extraordinary obligations as a backstop for low-income patients.

How on earth can a single child’s treatment cost that much? The answer: He has hemophilia and needs large quantities of a pricey drug – known as clotting factor – that makes blood coagulate.

Hemophilia drugs are among the most costly drugs in the nation, and taxpayers are footing the bill for many patients on Medicaid who could never afford them on their own. Officials in California and other states are doing what they can to manage the costs, but it’s a daunting task that highlights the complexity and secrecy of prescription drug pricing.

 

 

Kaiser Health News is examining how America has become a “Medicaid Nation” – where tens of millions of poor and disabled people now rely on the support of the federal and state insurance program. Hemophilia is one those diseases that helps explain its burgeoning cost.

Medications for hemophilia are crucial to patients – overwhelmingly male – with the rare genetic condition that prevents clotting and puts them at great risk of bleeding to death, even from a minor injury. There is no question the drugs prolong and save lives, and state officials are not arguing that they should be withheld.

“It’s a highly vulnerable population,” said Ken Kizer, a veteran federal and state health administrator who formerly oversaw Medi-Cal, California’s version of Medicaid. “If anyone has seen a hemophiliac in crisis, you’re not going to say no.”

But drugmakers profit handsomely, competing vigorously for the limited number of patients.

The U.S. hemophilia market, which serves about 20,000 patients, is worth $4.6 billion a year, according to AllianceBernstein, a research and investment firm.
 

 

“There are millions being made out there on these kids – it’s a huge business,” said Doris Quon, MD, medical director of the Orthopaedic Hemophilia Treatment Center at the University of California, Los Angeles.

Contributing to the costs is the fact that there is no cure for hemophilia and no cheaper substitute for blood factor. Factor may be prescribed at high doses for a lifetime, even more so when a patient has an injury or complications.

Nationwide, a third of adults and children living with hemophilia are covered by Medicaid. And the Medicaid program’s three most expensive drugs per prescription are for hemophilia, according to an analysis by the Kaiser Family Foundation. (California Healthline is produced by Kaiser Health News, an editorially independent publication of the foundation.)

In 2015 alone, Medicaid paid about $353 million for prescriptions of Advate, the most commonly prescribed blood-clotting medication for hemophilia – a 273% increase from 2011.

Generally speaking, the price of hemophilia drugs rise as rival drugs hit the market. But, in addition, doctors are prescribing ever more clotting factor for prevention of joint-damaging bleeds and for improved long-term health. The increase in the cost of Advate, for example, was nearly all attributed to increased use.

Tab for 145 kids: $195 million

The California boy whose drugs cost $21 million in a single year was an extreme case, and the circumstances of his care have not been disclosed because of confidentiality protections. Still, medications to treat hemophilia on average annual cost more than $270,000 per patient, according to a 2015 Express Scripts report, and they can easily soar past $1 million annually.

In contrast to more common diseases like hepatitis C, hemophilia treatment is not a state “budget buster” per se: about 4,000 patients live in California. About 1,100 of them are covered by Medi-Cal or two other government-funded programs for chronically ill children in California, according to Jennifer Kent, director of the state Department of Health Care Services and author of last year’s tweet. But the amount of money spent per person dwarfs that spent on people with other serious diseases.

One Stanford University study of 34,000 California kids with severe chronic diseases found that the tiny portion of children who needed blood factor accounted for 41% of the state’s outpatient drug spending on this entire patient population. About $195 million was spent on just 145 kids over a 3-year period, although some of that money came back to the state in rebates from drug companies – a portion of the cost that Medicaid can recoup after purchase.

Caitlin Carroll, director of public affairs for PhRMA, the pharmaceutical industry lobbying group, said high development costs and the complicated and lengthy manufacturing process play a role in how hemophilia drugs are priced. She added that federally mandated rebates significantly reduce the cost of blood factor. They amount to 17% of the average manufacturer price per unit.

Manufacturers also note that some newer and more expensive hemophilia drugs last longer and do not need to be administered as frequently, so they can prove less costly to payers overall.

Even so, some patients require a monumental investment to survive.
 

 

 

‘Extremely fortunate’

Colleen Tuite’s son Kevin, a 7-year-old, has severe hemophilia with a complication known as an inhibitor – an antibody that makes his regular blood-factor infusions less effective. Inhibitors can dramatically increase the cost of care, because massive doses of blood factor or expensive, specialized blood products known as bypassing agents may be needed.

Ms. Tuite and her husband initially were Kevin’s foster parents, then adopted the boy as a toddler. Because he has been a foster child, Kevin qualifies for Medi-Cal until he is 26.

The Monrovia, Calif., family also has private health insurance, which pays for about half of Kevin’s medical bills. These can run upward of $200,000 per month, Ms. Tuite said.

“We definitely would not have been able to adopt him without the help of Medi-Cal,” Ms. Tuite said. “We’ve been extremely fortunate.”

With the support of drug manufacturers and hemophilia advocacy groups, patients and their families have significant political clout. Some experts say they also have a moral claim on public resources: In the early days of the AIDS epidemic, thousands of the nation’s hemophilia patients died after they contracted HIV through transfusions before the virus was eliminated from the blood supply.

State health officials say the costs of hemophilia are hard to anticipate and control, even with rebates.

“We do a really aggressive job of collecting rebates on our pharmacy costs,” said Ms. Kent, California’s top Medicaid official. “But there’s just not any way around blood factor. It is just a very, very expensive product. It’s nonnegotiable for people that require it.”

In 2016, California’s Medicaid program paid at least $205 million for medications used to treat hemophilia, according to a Kaiser Health News analysis of federal Medicaid data. That figure doesn’t account for the federal rebates.

States can negotiate “supplemental” rebates with drugmakers for individual medications – but those must be kept secret under federal and some state laws. Such secrecy is becoming increasingly controversial as states continue to confront spiraling drug prices.

 

 

Limited options for states

In 2016, Pfizer sued Texas’ state health agency for giving data on the drug company’s supplemental Medicaid rebates to state lawmakers who requested it. The drugmaker alleged that releasing the confidential information would undermine the company’s competitiveness and give away trade secrets, and warned that the discounts it gave Texas could disappear.

In early October, a judge ruled that lawmakers should be able to obtain some of that data, noting dryly that “in Pfizer’s view, legislators are not necessary to carry out the state’s Medicaid program.”

Instead of seeking additional rebates from manufacturers for blood factor, some states, including Washington and Oregon, have chosen to require patients to get their blood factor from federally designated Hemophilia Treatment Centers only. That allows state Medicaid programs to take advantage of a federal drug-discount program known as “340B.”

However, officials in California said they studied that option and determined it wouldn’t save them any more money than the rebates they negotiate with drugmakers.

Whatever their approach, state health officials say they are struggling against forces they are nearly powerless to change.

“There aren’t a lot of options available to Medicaid programs in terms of controlling costs, because we don’t set the initial costs,” said Deborah Weston, pharmacy program manager for Oregon’s Medicaid program.
 

Kaiser Health News data correspondent Sydney Lupkin contributed to this report. KHN’s coverage of these topics is supported by Laura and John Arnold Foundation and Heising-Simons Foundation. This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation. Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

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CVS MinuteClinics: A Cure for Long Wait Times at Veterans Affairs?

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CVS MinuteClinics: A Cure for Long Wait Times at Veterans Affairs?

Struggling with long wait times, the Veterans Affairs Health Care System is trying something new: a partnership with the CVS Pharmacy chain to offer urgent care services to more than 65,000 veterans.

The experiment begins today at the VA’s operations in Palo Alto, California.

Veterans can visit 14 “MinuteClinics” operated by CVS in the San Francisco Bay area and Sacramento, where staff will treat them for conditions such as respiratory infections, order lab tests and prescribe medications, which can be filled at CVS pharmacies.

The care will be free for veterans, and the VA will reimburse CVS for the treatment and medications. Whether the partnership will spread to other VA locales isn’t yet clear.

The collaboration comes amid renewed scrutiny of the nation’s troubled VA health system, which has tried without much success to improve long wait times for veterans needing health care.

Despite a $10 billion “Veterans Choice” program allowing veterans to receive care outside the closed VA system, vets nationwide wait for an appointment even longer than they did before the program started in 2014, according to a federal audit.

The MinuteClinic partnership is not part of the Veterans Choice program.

“The concern has always been, how do we make sure veterans get the care they need in a timely way and in a way that works for the veteran?” said Dr. Stephen Ezeji-Okoye, the Palo Alto VA’s deputy chief of staff. The deal indicates that the VA is willing to try outside partnerships to meet veterans’ needs, he said. “We want to have not just timely access but geographic access to care.”

Sarah Russell, the Palo Alto VA’s chief medical informatics officer, came up with the idea, said Ezeji-Okoye.

The VA will integrate MinuteClinics’ patient records with its own electronic health records to provide consistency of care, Ezeji-Okoye said.

The Palo Alto VA fares better than some other facilities nationwide in providing timely care to veterans, according to VA data, and Ezeji-Okoye said most patients with urgent care needs are seen quickly.

But the system was so busy in the past year that about 11 percent of appointments at its network of hospitals and clinics — which stretch south from Sonora to Monterey — could not be scheduled within 30 or fewer days, which is considered an acceptable timeframe, VA data show. That includes appointments that would require urgent care.

More than 5,000 appointments system-wide were scheduled more than 30 days out, but each hospital and clinic’s performance varied widely. At a Fremont clinic, less than 2 percent of appointment requests could not be scheduled within 30 days. At the VA’s rural Modesto clinic, by contrast, more than 17 percent of requests were not be scheduled within 30 days.

Once the MinuteClinic operation is well underway, Ezeji-Okoye anticipates that between 10 and 15 veterans — from among the estimated 150 who call the Palo Alto VA’s advice nurse hotline daily — will be treated at the retail clinics on any given day.

About 95,000 veterans are eligible to use the Palo Alto system, one of the VA’s largest in the Western United States. About 65,000 use it every year.

The $330,000 pilot project will be evaluated after one year. CVS’ MinuteClinic president, Dr. Andrew Sussman, hopes it can be rolled out nationally if it succeeds. CVS is by far the biggest player in retail pharmacy clinics, operating 1,135 of them in 35 states.

“We’d love to have that opportunity to expand after we go through this phase,” Sussman said. “We’re well suited to help because of our large footprint and ability to see people on a quick basis.”

It is unclear, however, what the VA’s nationwide plans are. The Veterans Health Administration office did not respond to Kaiser Health News’ request for comment.

Blake Schindler, a retired Army major who lives in Santa Clara near one of the participating MinuteClinics, was intrigued, but cautious about the MinuteClinics. He counts himself lucky because unlike some other veterans, he has access to the U.S. military’s TRICARE health insurance program for active and some retired service members.

“It could make a big difference, but how much access are the veterans going to have? That was the big problem with the Veterans Choice program; it didn’t end up the way it was supposed to,” said Schindler, 58.

“I’m always hopeful when I hear about these things; I keep an open mind until I have experience with it,” he added.

Interested veterans served by the VA Palo Alto can call its advice nurse line at 800-455-0057.

 

 

This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.

This story also ran on NPR.

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Struggling with long wait times, the Veterans Affairs Health Care System is trying something new: a partnership with the CVS Pharmacy chain to offer urgent care services to more than 65,000 veterans.

The experiment begins today at the VA’s operations in Palo Alto, California.

Veterans can visit 14 “MinuteClinics” operated by CVS in the San Francisco Bay area and Sacramento, where staff will treat them for conditions such as respiratory infections, order lab tests and prescribe medications, which can be filled at CVS pharmacies.

The care will be free for veterans, and the VA will reimburse CVS for the treatment and medications. Whether the partnership will spread to other VA locales isn’t yet clear.

The collaboration comes amid renewed scrutiny of the nation’s troubled VA health system, which has tried without much success to improve long wait times for veterans needing health care.

Despite a $10 billion “Veterans Choice” program allowing veterans to receive care outside the closed VA system, vets nationwide wait for an appointment even longer than they did before the program started in 2014, according to a federal audit.

The MinuteClinic partnership is not part of the Veterans Choice program.

“The concern has always been, how do we make sure veterans get the care they need in a timely way and in a way that works for the veteran?” said Dr. Stephen Ezeji-Okoye, the Palo Alto VA’s deputy chief of staff. The deal indicates that the VA is willing to try outside partnerships to meet veterans’ needs, he said. “We want to have not just timely access but geographic access to care.”

Sarah Russell, the Palo Alto VA’s chief medical informatics officer, came up with the idea, said Ezeji-Okoye.

The VA will integrate MinuteClinics’ patient records with its own electronic health records to provide consistency of care, Ezeji-Okoye said.

The Palo Alto VA fares better than some other facilities nationwide in providing timely care to veterans, according to VA data, and Ezeji-Okoye said most patients with urgent care needs are seen quickly.

But the system was so busy in the past year that about 11 percent of appointments at its network of hospitals and clinics — which stretch south from Sonora to Monterey — could not be scheduled within 30 or fewer days, which is considered an acceptable timeframe, VA data show. That includes appointments that would require urgent care.

More than 5,000 appointments system-wide were scheduled more than 30 days out, but each hospital and clinic’s performance varied widely. At a Fremont clinic, less than 2 percent of appointment requests could not be scheduled within 30 days. At the VA’s rural Modesto clinic, by contrast, more than 17 percent of requests were not be scheduled within 30 days.

Once the MinuteClinic operation is well underway, Ezeji-Okoye anticipates that between 10 and 15 veterans — from among the estimated 150 who call the Palo Alto VA’s advice nurse hotline daily — will be treated at the retail clinics on any given day.

About 95,000 veterans are eligible to use the Palo Alto system, one of the VA’s largest in the Western United States. About 65,000 use it every year.

The $330,000 pilot project will be evaluated after one year. CVS’ MinuteClinic president, Dr. Andrew Sussman, hopes it can be rolled out nationally if it succeeds. CVS is by far the biggest player in retail pharmacy clinics, operating 1,135 of them in 35 states.

“We’d love to have that opportunity to expand after we go through this phase,” Sussman said. “We’re well suited to help because of our large footprint and ability to see people on a quick basis.”

It is unclear, however, what the VA’s nationwide plans are. The Veterans Health Administration office did not respond to Kaiser Health News’ request for comment.

Blake Schindler, a retired Army major who lives in Santa Clara near one of the participating MinuteClinics, was intrigued, but cautious about the MinuteClinics. He counts himself lucky because unlike some other veterans, he has access to the U.S. military’s TRICARE health insurance program for active and some retired service members.

“It could make a big difference, but how much access are the veterans going to have? That was the big problem with the Veterans Choice program; it didn’t end up the way it was supposed to,” said Schindler, 58.

“I’m always hopeful when I hear about these things; I keep an open mind until I have experience with it,” he added.

Interested veterans served by the VA Palo Alto can call its advice nurse line at 800-455-0057.

 

 

This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.

This story also ran on NPR.

Struggling with long wait times, the Veterans Affairs Health Care System is trying something new: a partnership with the CVS Pharmacy chain to offer urgent care services to more than 65,000 veterans.

The experiment begins today at the VA’s operations in Palo Alto, California.

Veterans can visit 14 “MinuteClinics” operated by CVS in the San Francisco Bay area and Sacramento, where staff will treat them for conditions such as respiratory infections, order lab tests and prescribe medications, which can be filled at CVS pharmacies.

The care will be free for veterans, and the VA will reimburse CVS for the treatment and medications. Whether the partnership will spread to other VA locales isn’t yet clear.

The collaboration comes amid renewed scrutiny of the nation’s troubled VA health system, which has tried without much success to improve long wait times for veterans needing health care.

Despite a $10 billion “Veterans Choice” program allowing veterans to receive care outside the closed VA system, vets nationwide wait for an appointment even longer than they did before the program started in 2014, according to a federal audit.

The MinuteClinic partnership is not part of the Veterans Choice program.

“The concern has always been, how do we make sure veterans get the care they need in a timely way and in a way that works for the veteran?” said Dr. Stephen Ezeji-Okoye, the Palo Alto VA’s deputy chief of staff. The deal indicates that the VA is willing to try outside partnerships to meet veterans’ needs, he said. “We want to have not just timely access but geographic access to care.”

Sarah Russell, the Palo Alto VA’s chief medical informatics officer, came up with the idea, said Ezeji-Okoye.

The VA will integrate MinuteClinics’ patient records with its own electronic health records to provide consistency of care, Ezeji-Okoye said.

The Palo Alto VA fares better than some other facilities nationwide in providing timely care to veterans, according to VA data, and Ezeji-Okoye said most patients with urgent care needs are seen quickly.

But the system was so busy in the past year that about 11 percent of appointments at its network of hospitals and clinics — which stretch south from Sonora to Monterey — could not be scheduled within 30 or fewer days, which is considered an acceptable timeframe, VA data show. That includes appointments that would require urgent care.

More than 5,000 appointments system-wide were scheduled more than 30 days out, but each hospital and clinic’s performance varied widely. At a Fremont clinic, less than 2 percent of appointment requests could not be scheduled within 30 days. At the VA’s rural Modesto clinic, by contrast, more than 17 percent of requests were not be scheduled within 30 days.

Once the MinuteClinic operation is well underway, Ezeji-Okoye anticipates that between 10 and 15 veterans — from among the estimated 150 who call the Palo Alto VA’s advice nurse hotline daily — will be treated at the retail clinics on any given day.

About 95,000 veterans are eligible to use the Palo Alto system, one of the VA’s largest in the Western United States. About 65,000 use it every year.

The $330,000 pilot project will be evaluated after one year. CVS’ MinuteClinic president, Dr. Andrew Sussman, hopes it can be rolled out nationally if it succeeds. CVS is by far the biggest player in retail pharmacy clinics, operating 1,135 of them in 35 states.

“We’d love to have that opportunity to expand after we go through this phase,” Sussman said. “We’re well suited to help because of our large footprint and ability to see people on a quick basis.”

It is unclear, however, what the VA’s nationwide plans are. The Veterans Health Administration office did not respond to Kaiser Health News’ request for comment.

Blake Schindler, a retired Army major who lives in Santa Clara near one of the participating MinuteClinics, was intrigued, but cautious about the MinuteClinics. He counts himself lucky because unlike some other veterans, he has access to the U.S. military’s TRICARE health insurance program for active and some retired service members.

“It could make a big difference, but how much access are the veterans going to have? That was the big problem with the Veterans Choice program; it didn’t end up the way it was supposed to,” said Schindler, 58.

“I’m always hopeful when I hear about these things; I keep an open mind until I have experience with it,” he added.

Interested veterans served by the VA Palo Alto can call its advice nurse line at 800-455-0057.

 

 

This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.

This story also ran on NPR.

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Cutting-edge DNA technology could boost cystic fibrosis screening for newborns

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Cutting-edge DNA technology could boost cystic fibrosis screening for newborns

Stanford University scientists say they’ve devised a more accurate and comprehensive DNA test to screen newborns for cystic fibrosis.

Every state screens newborns for cystic fibrosis, but the current sequence of tests can miss cases. The new method, presented in a study published Feb. 1 in the Journal of Molecular Diagnostics, promises to be more efficient and cost effective, researchers said. It may also improve screening for nonwhite babies, for whom cystic fibrosis is rarer and harder to diagnose.

The test “offers the promise of potentially eliminating the false negative results that lead to miss ed cases,” said Dr. Philip Farrell, a former dean of the University of Wisconsin School of Medicine and Public Health, Madison.

Cystic fibrosis is caused by a defect in the CFTR gene. Current genetic screens look for 40 of the most common mutations of the CFTR gene in newborns. Yet, any of the more than 2,000 known mutations in that gene could play a role in the disease, and there are likely others that have not yet been discovered.

The new test uses “next generation” DNA sequencing that can quickly and more cheaply look at the entire CFTR gene, not just selected mutations. It does not require an extra blood sample. Rather, it uses the tiny amount of blood drawn from the common newborn heel stick test that’s already used to screen for a number of diseases, including cystic fibrosis.

The researchers say this advance can enable testing labs to review many newborn samples at a time and reduce costs, allowing a technology previously used to diagnose only individual cases to be applied to a large population.

“Next generation” DNA sequencing has been used in recent years to diagnose disease, but is only now becoming cheap and fast enough to even be considered for large-scale population screening. Scientists from Stanford, the California Department of Public Health, and the University of Texas at Austin conducted the research. Other U.S. scientists have been working on similar newborn screening approaches using next-generation DNA sequencing.

The test is not only quicker and cheaper, but also “very accurate,” said Dr. Iris Schrijver, a Stanford University Medical School pathology professor who is one of the study’s authors. “We can look at the entire gene and assess … all kinds of mutations in this single test,” possibly in half the time of a current DNA test.

A spokesman for the California Department of Public Health, which oversees newborn screenings, said the current cost, including DNA testing, is approximately $113 per newborn, which is typically covered by insurers.

The department declined to make one of its scientists, a coauthor of the study, available for an interview. It also declined to respond directly to questions about the cost of these new tests or whether it might adopt them.

In general, the spokesman noted, the agency’s newborn screening program evaluates potential new testing methods for effectiveness and cost.

“Historically, changes to existing testing methods have been rare, so the department cannot speculate on a timeline for this process,” the spokesman wrote in an email.

However, a Stanford spokeswoman said its laboratory is currently running side-by-side comparisons of the new test and the current one, and its lab physicians expect to meet with public state health officials within the year to discuss next steps.

This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.

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Stanford University scientists say they’ve devised a more accurate and comprehensive DNA test to screen newborns for cystic fibrosis.

Every state screens newborns for cystic fibrosis, but the current sequence of tests can miss cases. The new method, presented in a study published Feb. 1 in the Journal of Molecular Diagnostics, promises to be more efficient and cost effective, researchers said. It may also improve screening for nonwhite babies, for whom cystic fibrosis is rarer and harder to diagnose.

The test “offers the promise of potentially eliminating the false negative results that lead to miss ed cases,” said Dr. Philip Farrell, a former dean of the University of Wisconsin School of Medicine and Public Health, Madison.

Cystic fibrosis is caused by a defect in the CFTR gene. Current genetic screens look for 40 of the most common mutations of the CFTR gene in newborns. Yet, any of the more than 2,000 known mutations in that gene could play a role in the disease, and there are likely others that have not yet been discovered.

The new test uses “next generation” DNA sequencing that can quickly and more cheaply look at the entire CFTR gene, not just selected mutations. It does not require an extra blood sample. Rather, it uses the tiny amount of blood drawn from the common newborn heel stick test that’s already used to screen for a number of diseases, including cystic fibrosis.

The researchers say this advance can enable testing labs to review many newborn samples at a time and reduce costs, allowing a technology previously used to diagnose only individual cases to be applied to a large population.

“Next generation” DNA sequencing has been used in recent years to diagnose disease, but is only now becoming cheap and fast enough to even be considered for large-scale population screening. Scientists from Stanford, the California Department of Public Health, and the University of Texas at Austin conducted the research. Other U.S. scientists have been working on similar newborn screening approaches using next-generation DNA sequencing.

The test is not only quicker and cheaper, but also “very accurate,” said Dr. Iris Schrijver, a Stanford University Medical School pathology professor who is one of the study’s authors. “We can look at the entire gene and assess … all kinds of mutations in this single test,” possibly in half the time of a current DNA test.

A spokesman for the California Department of Public Health, which oversees newborn screenings, said the current cost, including DNA testing, is approximately $113 per newborn, which is typically covered by insurers.

The department declined to make one of its scientists, a coauthor of the study, available for an interview. It also declined to respond directly to questions about the cost of these new tests or whether it might adopt them.

In general, the spokesman noted, the agency’s newborn screening program evaluates potential new testing methods for effectiveness and cost.

“Historically, changes to existing testing methods have been rare, so the department cannot speculate on a timeline for this process,” the spokesman wrote in an email.

However, a Stanford spokeswoman said its laboratory is currently running side-by-side comparisons of the new test and the current one, and its lab physicians expect to meet with public state health officials within the year to discuss next steps.

This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.

Stanford University scientists say they’ve devised a more accurate and comprehensive DNA test to screen newborns for cystic fibrosis.

Every state screens newborns for cystic fibrosis, but the current sequence of tests can miss cases. The new method, presented in a study published Feb. 1 in the Journal of Molecular Diagnostics, promises to be more efficient and cost effective, researchers said. It may also improve screening for nonwhite babies, for whom cystic fibrosis is rarer and harder to diagnose.

The test “offers the promise of potentially eliminating the false negative results that lead to miss ed cases,” said Dr. Philip Farrell, a former dean of the University of Wisconsin School of Medicine and Public Health, Madison.

Cystic fibrosis is caused by a defect in the CFTR gene. Current genetic screens look for 40 of the most common mutations of the CFTR gene in newborns. Yet, any of the more than 2,000 known mutations in that gene could play a role in the disease, and there are likely others that have not yet been discovered.

The new test uses “next generation” DNA sequencing that can quickly and more cheaply look at the entire CFTR gene, not just selected mutations. It does not require an extra blood sample. Rather, it uses the tiny amount of blood drawn from the common newborn heel stick test that’s already used to screen for a number of diseases, including cystic fibrosis.

The researchers say this advance can enable testing labs to review many newborn samples at a time and reduce costs, allowing a technology previously used to diagnose only individual cases to be applied to a large population.

“Next generation” DNA sequencing has been used in recent years to diagnose disease, but is only now becoming cheap and fast enough to even be considered for large-scale population screening. Scientists from Stanford, the California Department of Public Health, and the University of Texas at Austin conducted the research. Other U.S. scientists have been working on similar newborn screening approaches using next-generation DNA sequencing.

The test is not only quicker and cheaper, but also “very accurate,” said Dr. Iris Schrijver, a Stanford University Medical School pathology professor who is one of the study’s authors. “We can look at the entire gene and assess … all kinds of mutations in this single test,” possibly in half the time of a current DNA test.

A spokesman for the California Department of Public Health, which oversees newborn screenings, said the current cost, including DNA testing, is approximately $113 per newborn, which is typically covered by insurers.

The department declined to make one of its scientists, a coauthor of the study, available for an interview. It also declined to respond directly to questions about the cost of these new tests or whether it might adopt them.

In general, the spokesman noted, the agency’s newborn screening program evaluates potential new testing methods for effectiveness and cost.

“Historically, changes to existing testing methods have been rare, so the department cannot speculate on a timeline for this process,” the spokesman wrote in an email.

However, a Stanford spokeswoman said its laboratory is currently running side-by-side comparisons of the new test and the current one, and its lab physicians expect to meet with public state health officials within the year to discuss next steps.

This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.

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ICD-10 launches nationally, changing medical billing

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If you’re struck by an orca, sucked into a jet engine, or having relationship problems with your in-laws, fear not: Your doctor now has a medical diagnosis code for that.

Today, U.S. doctors, hospitals, and health insurers must start using the ICD-10, a vast new set of alphanumeric codes for describing diseases and injuries in unprecedented detail.

©Brian Jackson/iStockphoto.com

The transition, mandated by the federal government, has been called American health care’s Y2K moment because the codes haven’t been updated in 36 years. Doctors and hospitals are on high alert since the arcane letters and digits are key to how health care providers get paid. If they don’t use the right codes, down to the decimal, they may not be paid sufficiently – or at all.

For months, health care insiders have been venting their frustrations with the changeover, posting Halloween-themed ICD-10 office decor on social media and mocking some of the wackier codes. Among the targets: W61.33 (pecked by a chicken), Y08.01 (assault by hockey stick), and R46.1 (bizarre personal appearance).

Not to mention W56.22xA – “struck by orca” – which became the title of an illustrated book of infamous ICD-10 codes that’s sold nearly 10,000 copies, said its editor, Niko Skievaski of Madison, Wis.

“Basically everyone who works in health care interacts with this code system – it’s really the language that’s used to communicate from the clinical side to insurers,” said Skievaski, whose experience at a health information technology company helped him and colleagues come up with the book idea. “These codes, they affect everybody.”

Behind the gallows humor lies a major change in how health providers do business, albeit one that’s nearly invisible to patients.

The codes doctors now must use to diagnose patients have multiplied from about 14,000 to nearly 70,000. Hospitals use a related set of medical procedure codes, which has grown even more – from 4,000 to about 72,000.

The reason for the change? The previous set of codes, ICD-9, which were in use since 1979, didn’t reflect the complexity of modern medicine. And some of the information was wrong or obsolete.

The ICD-10 codes set a new bar for comprehensiveness. Did you break your shinbone? Your physician will need to figure out which among dozens of codes for a fractured tibia correctly identify your injury. And if you’ve eaten toxic mushrooms, there are 18 potential codes to cover you.

Government and private insurers can reject claims that aren’t specific enough, use the wrong codes, or have a mismatch between a diagnosis and procedure code.

The ICD-10 changeover will be even more complicated in four states – California, Louisiana, Maryland, and Montana – because of their antiquated billing systems. They have permission from the federal government to temporarily use the old codes, at least for their Medicaid billing, until their systems can be upgraded. California’s upgrade is expected to be completed by 2017.

In Kaiser Permanente’s 4-million member health care region in Southern California, the transition involved revamping up to 30 computer systems and training about 10,000 employees, at an estimated cost of $15 million to $25 million.

“We’re about as prepared as any region can be,” senior manager Larry Sharfstein, who has been leading the process.

A Pasadena “command center” – a term generally applied in crisis situations – has been up and running since Monday.

So how does he feel now that the big day is here?

Sharfstein laughed. “I feel older,” he said.

The ICD-10 codes used by doctors are based on the International Classification of Diseases, 10th edition, a list of medical classifications maintained by the World Health Organization. It contains codes for injuries and diseases and their causes and symptoms, along with patient complaints and socioeconomic circumstances. While health organizations have long been preparing for the transition from ICD-9, the actual changeover date was delayed several times after some physicians and provider lobbying groups said they weren’t ready.

Even with the additional time, some recent tests of the codes among early adopters nationwide resulted in about a fifth of the claims being denied because they weren’t accurate or weren’t correctly submitted, said Dr. Richard Thorp, the immediate past president of the California Medical Association.

In the small town of Paradise, Calif., 85 miles north of Sacramento, Thorp said his 18-person medical group is hoping for the best. It invested late last year in a new electronic health records system that should help with the transition. Even so, he remains skeptical that things will go smoothly.

“It’s not going to be clear for 3-6 weeks whether there are going to be payment issues,” he said.

 

 

If everything goes well, he said, “we’ll just breathe a sigh of relief and go on doing what we really want to do – which is take care of patients.”

Kaiser Health News is a nonprofit national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

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If you’re struck by an orca, sucked into a jet engine, or having relationship problems with your in-laws, fear not: Your doctor now has a medical diagnosis code for that.

Today, U.S. doctors, hospitals, and health insurers must start using the ICD-10, a vast new set of alphanumeric codes for describing diseases and injuries in unprecedented detail.

©Brian Jackson/iStockphoto.com

The transition, mandated by the federal government, has been called American health care’s Y2K moment because the codes haven’t been updated in 36 years. Doctors and hospitals are on high alert since the arcane letters and digits are key to how health care providers get paid. If they don’t use the right codes, down to the decimal, they may not be paid sufficiently – or at all.

For months, health care insiders have been venting their frustrations with the changeover, posting Halloween-themed ICD-10 office decor on social media and mocking some of the wackier codes. Among the targets: W61.33 (pecked by a chicken), Y08.01 (assault by hockey stick), and R46.1 (bizarre personal appearance).

Not to mention W56.22xA – “struck by orca” – which became the title of an illustrated book of infamous ICD-10 codes that’s sold nearly 10,000 copies, said its editor, Niko Skievaski of Madison, Wis.

“Basically everyone who works in health care interacts with this code system – it’s really the language that’s used to communicate from the clinical side to insurers,” said Skievaski, whose experience at a health information technology company helped him and colleagues come up with the book idea. “These codes, they affect everybody.”

Behind the gallows humor lies a major change in how health providers do business, albeit one that’s nearly invisible to patients.

The codes doctors now must use to diagnose patients have multiplied from about 14,000 to nearly 70,000. Hospitals use a related set of medical procedure codes, which has grown even more – from 4,000 to about 72,000.

The reason for the change? The previous set of codes, ICD-9, which were in use since 1979, didn’t reflect the complexity of modern medicine. And some of the information was wrong or obsolete.

The ICD-10 codes set a new bar for comprehensiveness. Did you break your shinbone? Your physician will need to figure out which among dozens of codes for a fractured tibia correctly identify your injury. And if you’ve eaten toxic mushrooms, there are 18 potential codes to cover you.

Government and private insurers can reject claims that aren’t specific enough, use the wrong codes, or have a mismatch between a diagnosis and procedure code.

The ICD-10 changeover will be even more complicated in four states – California, Louisiana, Maryland, and Montana – because of their antiquated billing systems. They have permission from the federal government to temporarily use the old codes, at least for their Medicaid billing, until their systems can be upgraded. California’s upgrade is expected to be completed by 2017.

In Kaiser Permanente’s 4-million member health care region in Southern California, the transition involved revamping up to 30 computer systems and training about 10,000 employees, at an estimated cost of $15 million to $25 million.

“We’re about as prepared as any region can be,” senior manager Larry Sharfstein, who has been leading the process.

A Pasadena “command center” – a term generally applied in crisis situations – has been up and running since Monday.

So how does he feel now that the big day is here?

Sharfstein laughed. “I feel older,” he said.

The ICD-10 codes used by doctors are based on the International Classification of Diseases, 10th edition, a list of medical classifications maintained by the World Health Organization. It contains codes for injuries and diseases and their causes and symptoms, along with patient complaints and socioeconomic circumstances. While health organizations have long been preparing for the transition from ICD-9, the actual changeover date was delayed several times after some physicians and provider lobbying groups said they weren’t ready.

Even with the additional time, some recent tests of the codes among early adopters nationwide resulted in about a fifth of the claims being denied because they weren’t accurate or weren’t correctly submitted, said Dr. Richard Thorp, the immediate past president of the California Medical Association.

In the small town of Paradise, Calif., 85 miles north of Sacramento, Thorp said his 18-person medical group is hoping for the best. It invested late last year in a new electronic health records system that should help with the transition. Even so, he remains skeptical that things will go smoothly.

“It’s not going to be clear for 3-6 weeks whether there are going to be payment issues,” he said.

 

 

If everything goes well, he said, “we’ll just breathe a sigh of relief and go on doing what we really want to do – which is take care of patients.”

Kaiser Health News is a nonprofit national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

If you’re struck by an orca, sucked into a jet engine, or having relationship problems with your in-laws, fear not: Your doctor now has a medical diagnosis code for that.

Today, U.S. doctors, hospitals, and health insurers must start using the ICD-10, a vast new set of alphanumeric codes for describing diseases and injuries in unprecedented detail.

©Brian Jackson/iStockphoto.com

The transition, mandated by the federal government, has been called American health care’s Y2K moment because the codes haven’t been updated in 36 years. Doctors and hospitals are on high alert since the arcane letters and digits are key to how health care providers get paid. If they don’t use the right codes, down to the decimal, they may not be paid sufficiently – or at all.

For months, health care insiders have been venting their frustrations with the changeover, posting Halloween-themed ICD-10 office decor on social media and mocking some of the wackier codes. Among the targets: W61.33 (pecked by a chicken), Y08.01 (assault by hockey stick), and R46.1 (bizarre personal appearance).

Not to mention W56.22xA – “struck by orca” – which became the title of an illustrated book of infamous ICD-10 codes that’s sold nearly 10,000 copies, said its editor, Niko Skievaski of Madison, Wis.

“Basically everyone who works in health care interacts with this code system – it’s really the language that’s used to communicate from the clinical side to insurers,” said Skievaski, whose experience at a health information technology company helped him and colleagues come up with the book idea. “These codes, they affect everybody.”

Behind the gallows humor lies a major change in how health providers do business, albeit one that’s nearly invisible to patients.

The codes doctors now must use to diagnose patients have multiplied from about 14,000 to nearly 70,000. Hospitals use a related set of medical procedure codes, which has grown even more – from 4,000 to about 72,000.

The reason for the change? The previous set of codes, ICD-9, which were in use since 1979, didn’t reflect the complexity of modern medicine. And some of the information was wrong or obsolete.

The ICD-10 codes set a new bar for comprehensiveness. Did you break your shinbone? Your physician will need to figure out which among dozens of codes for a fractured tibia correctly identify your injury. And if you’ve eaten toxic mushrooms, there are 18 potential codes to cover you.

Government and private insurers can reject claims that aren’t specific enough, use the wrong codes, or have a mismatch between a diagnosis and procedure code.

The ICD-10 changeover will be even more complicated in four states – California, Louisiana, Maryland, and Montana – because of their antiquated billing systems. They have permission from the federal government to temporarily use the old codes, at least for their Medicaid billing, until their systems can be upgraded. California’s upgrade is expected to be completed by 2017.

In Kaiser Permanente’s 4-million member health care region in Southern California, the transition involved revamping up to 30 computer systems and training about 10,000 employees, at an estimated cost of $15 million to $25 million.

“We’re about as prepared as any region can be,” senior manager Larry Sharfstein, who has been leading the process.

A Pasadena “command center” – a term generally applied in crisis situations – has been up and running since Monday.

So how does he feel now that the big day is here?

Sharfstein laughed. “I feel older,” he said.

The ICD-10 codes used by doctors are based on the International Classification of Diseases, 10th edition, a list of medical classifications maintained by the World Health Organization. It contains codes for injuries and diseases and their causes and symptoms, along with patient complaints and socioeconomic circumstances. While health organizations have long been preparing for the transition from ICD-9, the actual changeover date was delayed several times after some physicians and provider lobbying groups said they weren’t ready.

Even with the additional time, some recent tests of the codes among early adopters nationwide resulted in about a fifth of the claims being denied because they weren’t accurate or weren’t correctly submitted, said Dr. Richard Thorp, the immediate past president of the California Medical Association.

In the small town of Paradise, Calif., 85 miles north of Sacramento, Thorp said his 18-person medical group is hoping for the best. It invested late last year in a new electronic health records system that should help with the transition. Even so, he remains skeptical that things will go smoothly.

“It’s not going to be clear for 3-6 weeks whether there are going to be payment issues,” he said.

 

 

If everything goes well, he said, “we’ll just breathe a sigh of relief and go on doing what we really want to do – which is take care of patients.”

Kaiser Health News is a nonprofit national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

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Heart attack patients more likely to die after ambulances are diverted

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Heart attack patients more likely to die after ambulances are diverted

Heart attack patients whose ambulances were diverted from crowded emergency departments to hospitals farther away were more likely to be dead a year later than patients who weren’t diverted, according to a recent study published in the journal Health Affairs.

The study, conducted by researchers at the University of California, San Francisco, and the National Bureau of Economic Research, looked at ambulance diversions affecting nearly 30,000 Medicare patients in 26 California counties from 2001 to 2011.

©Aaron Kohr/Thinkstock.com

The study adds to a growing body of research nationally showing that temporary diversions of ambulances from the nearest hospital can harm patients with life-threatening conditions, including heart attack and stroke. One smaller study in New York City also linked diversions to higher heart attack death rates, while others have found that diversions can lead to delays in administering drug therapy to heart attack patients.

Some hospitals see diversion as a necessary safety valve for full-up emergency departments. But emergency care experts say they push the crowding problem to nearby hospitals and can compromise patient care, especially in life-threatening cases.

“This setup is absolutely a disaster for these kinds of patients,” said Mike Williams, president of the Abaris Group, a Martinez, Calif.–based health care consulting firm that specializes in emergency medical services. Mr. Williams was not involved in the study.

The researchers found that heart attack patients whose ambulances had been diverted to an emergency department farther away were nearly 10% more likely to be dead 1 year later than those whose ambulances were not diverted. They were also slightly less likely to get the treatment they needed to restore blood flow to major organs, such as an angioplasty or coronary artery bypass graft.

That’s primarily because diverted patients were taken to EDs with less advanced cardiac care technology.

“This study is telling us that as we continue to saturate our emergency care system, [diversions] affect everybody,” said University of California, San Francisco, researcher Dr. Renee Hsia, one of the study’s authors. “We tend to think that it’s only people who aren’t that sick who don’t get treated quickly in emergency departments. Diversions affect patients who are really sick, too.”

The study found, however, that patients of color were more likely to be diverted. Statewide, about half of heart attack patients were diverted to other hospitals on the day of admission between 2001 and 2011.

Diversion policies varied from one county emergency medical services (EMS) agency to another, and some places were far more affected than others. In Los Angeles County, as many as three-quarters of heart attack patients were diverted in some years, the study showed.

Experts said that the higher mortality rate is particularly troubling because it is only the most extreme indicator of how patients fare. Other possible outcomes include nonfatal strokes, bleeding complications, or heart arrhythmias, all of which can require rehospitalization later on.

“Those are hidden behind the higher mortality rate,” said Dr. James Augustine, director of clinical operations for Emergency Medicine Physicians, a national network of emergency doctors based in Ohio. “You’re only looking at the worst outcomes when you do these studies.”

The good news is that ambulance diversions declined statewide during the decade. Records show one of the county’s busiest EDs, at LAC+USC (Los Angeles County + University of Southern California) Medical Center, went from diverting ambulance patients an average of 62% of the time in 2011 to 32% in 2014. Los Angeles County officials in 2006 created policies to ensure hospitals cannot automatically remain on diversion for hours on end.

Overall, average diversion rates for the county’s 71 hospitals with emergency departments dropped from 10.5% of the time in 2011 to 7.8% in 2014, county data show.

Nationwide, hospital and EMS staff have significantly speeded up treatment for heart attacks, when minutes can mean the difference between life and death. But not enough has been done to expand emergency department capacity, critics say.

“Diversion is essentially a crutch that allows hospitals to understaff and not make efficient use of all the resources they have,” said Ross Elliott of the California Ambulance Association, an industry group that primarily represents private ambulance contractors.

On the other hand, diversions can reduce “wall time” in which paramedics wait at the hospital’s emergency department until their patients can be admitted, he said.

“It still boils down to lack of resources to meet the demand,” Mr. Elliott said.

B.J. Bartleson, vice president of nursing and clinical services for the California Hospital Association, said the state’s hospitals are working with local EMS agencies to make sure patients get to the right hospital at the right time.

 

 

One large-scale effort began in the mid-2000s, about midway through the UCSF study. It involves dispatching patients with a particularly deadly type of heart attack, known by the acronym STEMI (ST-segment elevation myocardial infarction), to 136 hospitals around the state specifically certified to receive and rapidly treat them.

These “STEMI receiving centers,” as they’re known, have advanced cardiac technology and may not refuse STEMI patients even when their emergency departments are otherwise diverting ambulances.

And while other kinds of heart attack patients still may be diverted to a nonspecialized hospital, there’s a process to quickly get them to a receiving center if their symptoms worsen, said Dr. Marianne Gausche-Hill, medical director of Los Angeles County’s EMS agency.

Dr. Marc Futernick, president of the California chapter of the American College of Emergency Physicians and medical director of the emergency department at a downtown Los Angeles hospital, favors a more radical solution. He believes hospitals should agree to stop diverting ambulances altogether, except in extreme cases. He recently asked several emergency department directors in his area to commit to a no-diversion policy.

“They didn’t agree,” he said.

Kaiser Health News (KHN) is a nonprofit national health policy news service.

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Heart attack patients whose ambulances were diverted from crowded emergency departments to hospitals farther away were more likely to be dead a year later than patients who weren’t diverted, according to a recent study published in the journal Health Affairs.

The study, conducted by researchers at the University of California, San Francisco, and the National Bureau of Economic Research, looked at ambulance diversions affecting nearly 30,000 Medicare patients in 26 California counties from 2001 to 2011.

©Aaron Kohr/Thinkstock.com

The study adds to a growing body of research nationally showing that temporary diversions of ambulances from the nearest hospital can harm patients with life-threatening conditions, including heart attack and stroke. One smaller study in New York City also linked diversions to higher heart attack death rates, while others have found that diversions can lead to delays in administering drug therapy to heart attack patients.

Some hospitals see diversion as a necessary safety valve for full-up emergency departments. But emergency care experts say they push the crowding problem to nearby hospitals and can compromise patient care, especially in life-threatening cases.

“This setup is absolutely a disaster for these kinds of patients,” said Mike Williams, president of the Abaris Group, a Martinez, Calif.–based health care consulting firm that specializes in emergency medical services. Mr. Williams was not involved in the study.

The researchers found that heart attack patients whose ambulances had been diverted to an emergency department farther away were nearly 10% more likely to be dead 1 year later than those whose ambulances were not diverted. They were also slightly less likely to get the treatment they needed to restore blood flow to major organs, such as an angioplasty or coronary artery bypass graft.

That’s primarily because diverted patients were taken to EDs with less advanced cardiac care technology.

“This study is telling us that as we continue to saturate our emergency care system, [diversions] affect everybody,” said University of California, San Francisco, researcher Dr. Renee Hsia, one of the study’s authors. “We tend to think that it’s only people who aren’t that sick who don’t get treated quickly in emergency departments. Diversions affect patients who are really sick, too.”

The study found, however, that patients of color were more likely to be diverted. Statewide, about half of heart attack patients were diverted to other hospitals on the day of admission between 2001 and 2011.

Diversion policies varied from one county emergency medical services (EMS) agency to another, and some places were far more affected than others. In Los Angeles County, as many as three-quarters of heart attack patients were diverted in some years, the study showed.

Experts said that the higher mortality rate is particularly troubling because it is only the most extreme indicator of how patients fare. Other possible outcomes include nonfatal strokes, bleeding complications, or heart arrhythmias, all of which can require rehospitalization later on.

“Those are hidden behind the higher mortality rate,” said Dr. James Augustine, director of clinical operations for Emergency Medicine Physicians, a national network of emergency doctors based in Ohio. “You’re only looking at the worst outcomes when you do these studies.”

The good news is that ambulance diversions declined statewide during the decade. Records show one of the county’s busiest EDs, at LAC+USC (Los Angeles County + University of Southern California) Medical Center, went from diverting ambulance patients an average of 62% of the time in 2011 to 32% in 2014. Los Angeles County officials in 2006 created policies to ensure hospitals cannot automatically remain on diversion for hours on end.

Overall, average diversion rates for the county’s 71 hospitals with emergency departments dropped from 10.5% of the time in 2011 to 7.8% in 2014, county data show.

Nationwide, hospital and EMS staff have significantly speeded up treatment for heart attacks, when minutes can mean the difference between life and death. But not enough has been done to expand emergency department capacity, critics say.

“Diversion is essentially a crutch that allows hospitals to understaff and not make efficient use of all the resources they have,” said Ross Elliott of the California Ambulance Association, an industry group that primarily represents private ambulance contractors.

On the other hand, diversions can reduce “wall time” in which paramedics wait at the hospital’s emergency department until their patients can be admitted, he said.

“It still boils down to lack of resources to meet the demand,” Mr. Elliott said.

B.J. Bartleson, vice president of nursing and clinical services for the California Hospital Association, said the state’s hospitals are working with local EMS agencies to make sure patients get to the right hospital at the right time.

 

 

One large-scale effort began in the mid-2000s, about midway through the UCSF study. It involves dispatching patients with a particularly deadly type of heart attack, known by the acronym STEMI (ST-segment elevation myocardial infarction), to 136 hospitals around the state specifically certified to receive and rapidly treat them.

These “STEMI receiving centers,” as they’re known, have advanced cardiac technology and may not refuse STEMI patients even when their emergency departments are otherwise diverting ambulances.

And while other kinds of heart attack patients still may be diverted to a nonspecialized hospital, there’s a process to quickly get them to a receiving center if their symptoms worsen, said Dr. Marianne Gausche-Hill, medical director of Los Angeles County’s EMS agency.

Dr. Marc Futernick, president of the California chapter of the American College of Emergency Physicians and medical director of the emergency department at a downtown Los Angeles hospital, favors a more radical solution. He believes hospitals should agree to stop diverting ambulances altogether, except in extreme cases. He recently asked several emergency department directors in his area to commit to a no-diversion policy.

“They didn’t agree,” he said.

Kaiser Health News (KHN) is a nonprofit national health policy news service.

Heart attack patients whose ambulances were diverted from crowded emergency departments to hospitals farther away were more likely to be dead a year later than patients who weren’t diverted, according to a recent study published in the journal Health Affairs.

The study, conducted by researchers at the University of California, San Francisco, and the National Bureau of Economic Research, looked at ambulance diversions affecting nearly 30,000 Medicare patients in 26 California counties from 2001 to 2011.

©Aaron Kohr/Thinkstock.com

The study adds to a growing body of research nationally showing that temporary diversions of ambulances from the nearest hospital can harm patients with life-threatening conditions, including heart attack and stroke. One smaller study in New York City also linked diversions to higher heart attack death rates, while others have found that diversions can lead to delays in administering drug therapy to heart attack patients.

Some hospitals see diversion as a necessary safety valve for full-up emergency departments. But emergency care experts say they push the crowding problem to nearby hospitals and can compromise patient care, especially in life-threatening cases.

“This setup is absolutely a disaster for these kinds of patients,” said Mike Williams, president of the Abaris Group, a Martinez, Calif.–based health care consulting firm that specializes in emergency medical services. Mr. Williams was not involved in the study.

The researchers found that heart attack patients whose ambulances had been diverted to an emergency department farther away were nearly 10% more likely to be dead 1 year later than those whose ambulances were not diverted. They were also slightly less likely to get the treatment they needed to restore blood flow to major organs, such as an angioplasty or coronary artery bypass graft.

That’s primarily because diverted patients were taken to EDs with less advanced cardiac care technology.

“This study is telling us that as we continue to saturate our emergency care system, [diversions] affect everybody,” said University of California, San Francisco, researcher Dr. Renee Hsia, one of the study’s authors. “We tend to think that it’s only people who aren’t that sick who don’t get treated quickly in emergency departments. Diversions affect patients who are really sick, too.”

The study found, however, that patients of color were more likely to be diverted. Statewide, about half of heart attack patients were diverted to other hospitals on the day of admission between 2001 and 2011.

Diversion policies varied from one county emergency medical services (EMS) agency to another, and some places were far more affected than others. In Los Angeles County, as many as three-quarters of heart attack patients were diverted in some years, the study showed.

Experts said that the higher mortality rate is particularly troubling because it is only the most extreme indicator of how patients fare. Other possible outcomes include nonfatal strokes, bleeding complications, or heart arrhythmias, all of which can require rehospitalization later on.

“Those are hidden behind the higher mortality rate,” said Dr. James Augustine, director of clinical operations for Emergency Medicine Physicians, a national network of emergency doctors based in Ohio. “You’re only looking at the worst outcomes when you do these studies.”

The good news is that ambulance diversions declined statewide during the decade. Records show one of the county’s busiest EDs, at LAC+USC (Los Angeles County + University of Southern California) Medical Center, went from diverting ambulance patients an average of 62% of the time in 2011 to 32% in 2014. Los Angeles County officials in 2006 created policies to ensure hospitals cannot automatically remain on diversion for hours on end.

Overall, average diversion rates for the county’s 71 hospitals with emergency departments dropped from 10.5% of the time in 2011 to 7.8% in 2014, county data show.

Nationwide, hospital and EMS staff have significantly speeded up treatment for heart attacks, when minutes can mean the difference between life and death. But not enough has been done to expand emergency department capacity, critics say.

“Diversion is essentially a crutch that allows hospitals to understaff and not make efficient use of all the resources they have,” said Ross Elliott of the California Ambulance Association, an industry group that primarily represents private ambulance contractors.

On the other hand, diversions can reduce “wall time” in which paramedics wait at the hospital’s emergency department until their patients can be admitted, he said.

“It still boils down to lack of resources to meet the demand,” Mr. Elliott said.

B.J. Bartleson, vice president of nursing and clinical services for the California Hospital Association, said the state’s hospitals are working with local EMS agencies to make sure patients get to the right hospital at the right time.

 

 

One large-scale effort began in the mid-2000s, about midway through the UCSF study. It involves dispatching patients with a particularly deadly type of heart attack, known by the acronym STEMI (ST-segment elevation myocardial infarction), to 136 hospitals around the state specifically certified to receive and rapidly treat them.

These “STEMI receiving centers,” as they’re known, have advanced cardiac technology and may not refuse STEMI patients even when their emergency departments are otherwise diverting ambulances.

And while other kinds of heart attack patients still may be diverted to a nonspecialized hospital, there’s a process to quickly get them to a receiving center if their symptoms worsen, said Dr. Marianne Gausche-Hill, medical director of Los Angeles County’s EMS agency.

Dr. Marc Futernick, president of the California chapter of the American College of Emergency Physicians and medical director of the emergency department at a downtown Los Angeles hospital, favors a more radical solution. He believes hospitals should agree to stop diverting ambulances altogether, except in extreme cases. He recently asked several emergency department directors in his area to commit to a no-diversion policy.

“They didn’t agree,” he said.

Kaiser Health News (KHN) is a nonprofit national health policy news service.

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