Michelle Andrews, Kaiser Health News

The past decade has witnessed a rapid expansion of genetic tests, including new instruments to inform patients who have been diagnosed with breast cancer about the risk of recurrence and to guide their treatment.

But the clinical significance of many of the inherited mutations that can now be identified remains unclear, and experts are torn on when and how to deploy all the new tests available. Patients are sometimes left paying out-of-pocket for exams that are not yet the standard of care, and even the most up-to-date oncologists may be uncertain how to incorporate the flood of new information into what used to be standard treatment protocols.

A quarter-century ago, Myriad Genetics introduced the first breast cancer genetic test for BRCA mutations, two genes associated with a substantially elevated risk of getting breast cancer, opening the door to a new era in genetic testing. BRCA1 and BRCA2 mutations account for as many as half of all hereditary breast cancers, and people with a problematic mutation on one of those genes have a 45%-72% chance of developing breast cancer during their lifetimes. They may also be at higher risk for ovarian and other cancers than people without harmful BRCA mutations.

But the clinical significance is murkier for many other genetic tests.

Testing for BRCA1 and BRCA2 genes used to cost thousands of dollars. Now, for a fraction of that, doctors can order multigene test panels from commercial labs that look for mutations in dozens of genes. Some direct-to-consumer companies offer screening panels for a few hundred dollars, though their reliability varies.

When Jen Carbary was diagnosed with breast cancer in 2017 at age 44, genetic testing identified a mutation in a gene called PALB2 that significantly increases the risk of developing breast cancer. Guidelines suggest that breast cancer patients with a PALB2 mutation, much like those with BRCA1 and BRCA2 mutations, consider having a mastectomy to reduce the chance of a breast cancer recurrence.

“I wish genetic testing was the standard of care,” said Ms. Carbary, who owed nothing for the test because her insurer covered the cost.

Ms. Carbary, who lives in Sterling Heights, Mich., said the test results affirmed the decision she had already made to have a double mastectomy and provided important information for family members, including her 21-year-old daughter and 18-year-old son, who will likely be tested in their mid-20s or early 30s.

But some breast cancer experts are concerned that widespread testing may also identify genetic mutations whose impact is unclear, creating anxiety and leading to further testing and to treatment of questionable value that could raise costs for the health care system.

It can also confuse patients.

“It happens a lot, that patients find their way to us after getting confusing results elsewhere,” said Mark Robson, MD, chief of the breast medicine service at Memorial Sloan Kettering Cancer Center, New York. Robson said the cancer center has a clinical genetics service, staffed by doctors and genetic counselors, that helps people make decisions about how to manage genetic testing results.

For people diagnosed with breast cancer, many professional groups, including the influential National Comprehensive Cancer Network, recommend limiting testing to certain people, including those with high-risk factors, such as a family history of breast cancer; those who are 45 or younger when they’re diagnosed; and those with Ashkenazi Jewish ancestry.

But in 2019, the American Society of Breast Surgeons recommended a different approach: Offer genetic testing to all patients who are diagnosed with or have a personal history of breast cancer. The recommendation was controversial.

“The NCCN guidelines [cover] most of the women who needed testing, but we wanted to get them all,” said Eric Manahan, MD, a general surgeon in Dalton, Georgia, and a member of the surgeons group’s board of directors.

Mutations on other genes that are associated with breast cancer are much less common than BRCA1 and BRCA2 mutations and generally don’t increase the risk of developing breast cancer as much. The cancer-causing impact of these genes may be less clear than that of the BRCA genes, which have been tested for since the mid-1990s.

And the appropriate response to the less common mutations – whether to consider a risk-reducing mastectomy or stepped-up screening – is often unclear.

“Things get sloppier and sloppier when you look at other genes,” said Steven Katz, MD, MPH, a professor of medicine and health management and policy at the University of Michigan. “The risks tend to be lower for different cancers, and less certain and more variable. You might walk away wondering: ‘Why’d I have to know that?’ ”

After people are diagnosed with breast cancer, genetic testing can help inform their decisions about the types of surgery to pursue – for example, a high risk of recurrence or a new breast cancer might persuade some to opt for more extensive surgery, such as a double mastectomy. Testing can also provide important information to family members about their potential cancer risk.

(This type of “germline” genetic testing, as it’s called, looks at mutations in the genes that people inherit from their parents. It is different from genomic tumor tests that look at specific genes or proteins in the cancer cells and can help doctors understand the rate at which the cancer cells are dividing, for example, and the likelihood of a cancer recurrence.)

Increasingly, germline genetic testing can also help guide other treatment decisions. Some patients with metastatic breast cancer who have BRCA1 or BRCA2 mutations may be good candidates for poly (ADP-ribose) polymerase inhibitors, cancer drugs that target tumors with mutations in those genes.

But genetic testing that uncovers inherited mutations in many other genes yields less clearly actionable information, even though positive results may alarm people.

At Memorial Sloan Kettering, cancer specialists focus on “therapeutic actionability,” said Dr. Robson. Will testing help someone decide whether she should get a double mastectomy or provide other important guidance? “A policy of testing everyone will identify very few additional BRCA breast mutations but will cost a lot.”

As a result, doctors are debating how best to deploy and incorporate new genetic knowledge. Insurers are trying to figure out which to pay for.

There is both underuse of tests that science says are relevant and overuse of tests that experts say provide information that can’t be interpreted with any scientific certainty.

The result may be confusion for patients newly diagnosed with breast cancer as they confront the expense of genetic tests and sometimes little guidance on the proper treatment.

Some doctors say the first step is to make sure that the small group of people who would clearly benefit are getting the genetic tests whose meaning is clearly understood. Only 15% of breast cancer patients who met select NCCN testing guidelines for inherited cancer received genetic testing, according to a 2017 study that examined data from a national household health survey between 2005 and 2015.

“I would argue that our focus needs to be on the people who are at high risk for breast cancer that aren’t even identified yet,” said Tuya Pal, MD, associate director for cancer health disparities at Vanderbilt-Ingram Cancer Center and vice chair of the NCCN guidelines panel for genetic/familial high-risk assessment of breast, ovarian, and pancreatic cancers.

Patients may fall through the cracks because no one tells them they should be tested. In one analysis, 56% of high-risk breast cancer patients who didn’t get genetic testing said their doctors didn’t recommend it.

Even if doctors recommend genetic testing, they may lack the expertise to determine which tests people need and how to interpret the results. That’s the role of genetic counselors, but their ranks are stretched thin.

The consequences can be serious. In a study of 666 breast cancer patients who received genetic testing, half of those at average risk for inherited cancer got double mastectomies based on test results that found “variants of uncertain significance,” which aren’t clinically actionable. As many as half of surgeons reported managing such patients the same way as those with cancer-causing mutations.

“The bulk of our research would say that there is still room for improvement in terms of clinicians getting the understanding they need,” said Allison Kurian, MD, director of the women’s clinical cancer genetics program at Stanford (Calif.) University and a coauthor of the study.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

The past decade has witnessed a rapid expansion of genetic tests, including new instruments to inform patients who have been diagnosed with breast cancer about the risk of recurrence and to guide their treatment.

But the clinical significance of many of the inherited mutations that can now be identified remains unclear, and experts are torn on when and how to deploy all the new tests available. Patients are sometimes left paying out-of-pocket for exams that are not yet the standard of care, and even the most up-to-date oncologists may be uncertain how to incorporate the flood of new information into what used to be standard treatment protocols.

A quarter-century ago, Myriad Genetics introduced the first breast cancer genetic test for BRCA mutations, two genes associated with a substantially elevated risk of getting breast cancer, opening the door to a new era in genetic testing. BRCA1 and BRCA2 mutations account for as many as half of all hereditary breast cancers, and people with a problematic mutation on one of those genes have a 45%-72% chance of developing breast cancer during their lifetimes. They may also be at higher risk for ovarian and other cancers than people without harmful BRCA mutations.

But the clinical significance is murkier for many other genetic tests.

Testing for BRCA1 and BRCA2 genes used to cost thousands of dollars. Now, for a fraction of that, doctors can order multigene test panels from commercial labs that look for mutations in dozens of genes. Some direct-to-consumer companies offer screening panels for a few hundred dollars, though their reliability varies.

When Jen Carbary was diagnosed with breast cancer in 2017 at age 44, genetic testing identified a mutation in a gene called PALB2 that significantly increases the risk of developing breast cancer. Guidelines suggest that breast cancer patients with a PALB2 mutation, much like those with BRCA1 and BRCA2 mutations, consider having a mastectomy to reduce the chance of a breast cancer recurrence.

“I wish genetic testing was the standard of care,” said Ms. Carbary, who owed nothing for the test because her insurer covered the cost.

Ms. Carbary, who lives in Sterling Heights, Mich., said the test results affirmed the decision she had already made to have a double mastectomy and provided important information for family members, including her 21-year-old daughter and 18-year-old son, who will likely be tested in their mid-20s or early 30s.

But some breast cancer experts are concerned that widespread testing may also identify genetic mutations whose impact is unclear, creating anxiety and leading to further testing and to treatment of questionable value that could raise costs for the health care system.

It can also confuse patients.

“It happens a lot, that patients find their way to us after getting confusing results elsewhere,” said Mark Robson, MD, chief of the breast medicine service at Memorial Sloan Kettering Cancer Center, New York. Robson said the cancer center has a clinical genetics service, staffed by doctors and genetic counselors, that helps people make decisions about how to manage genetic testing results.

For people diagnosed with breast cancer, many professional groups, including the influential National Comprehensive Cancer Network, recommend limiting testing to certain people, including those with high-risk factors, such as a family history of breast cancer; those who are 45 or younger when they’re diagnosed; and those with Ashkenazi Jewish ancestry.

But in 2019, the American Society of Breast Surgeons recommended a different approach: Offer genetic testing to all patients who are diagnosed with or have a personal history of breast cancer. The recommendation was controversial.

“The NCCN guidelines [cover] most of the women who needed testing, but we wanted to get them all,” said Eric Manahan, MD, a general surgeon in Dalton, Georgia, and a member of the surgeons group’s board of directors.

Mutations on other genes that are associated with breast cancer are much less common than BRCA1 and BRCA2 mutations and generally don’t increase the risk of developing breast cancer as much. The cancer-causing impact of these genes may be less clear than that of the BRCA genes, which have been tested for since the mid-1990s.

And the appropriate response to the less common mutations – whether to consider a risk-reducing mastectomy or stepped-up screening – is often unclear.

“Things get sloppier and sloppier when you look at other genes,” said Steven Katz, MD, MPH, a professor of medicine and health management and policy at the University of Michigan. “The risks tend to be lower for different cancers, and less certain and more variable. You might walk away wondering: ‘Why’d I have to know that?’ ”

After people are diagnosed with breast cancer, genetic testing can help inform their decisions about the types of surgery to pursue – for example, a high risk of recurrence or a new breast cancer might persuade some to opt for more extensive surgery, such as a double mastectomy. Testing can also provide important information to family members about their potential cancer risk.

(This type of “germline” genetic testing, as it’s called, looks at mutations in the genes that people inherit from their parents. It is different from genomic tumor tests that look at specific genes or proteins in the cancer cells and can help doctors understand the rate at which the cancer cells are dividing, for example, and the likelihood of a cancer recurrence.)

Increasingly, germline genetic testing can also help guide other treatment decisions. Some patients with metastatic breast cancer who have BRCA1 or BRCA2 mutations may be good candidates for poly (ADP-ribose) polymerase inhibitors, cancer drugs that target tumors with mutations in those genes.

But genetic testing that uncovers inherited mutations in many other genes yields less clearly actionable information, even though positive results may alarm people.

At Memorial Sloan Kettering, cancer specialists focus on “therapeutic actionability,” said Dr. Robson. Will testing help someone decide whether she should get a double mastectomy or provide other important guidance? “A policy of testing everyone will identify very few additional BRCA breast mutations but will cost a lot.”

As a result, doctors are debating how best to deploy and incorporate new genetic knowledge. Insurers are trying to figure out which to pay for.

There is both underuse of tests that science says are relevant and overuse of tests that experts say provide information that can’t be interpreted with any scientific certainty.

The result may be confusion for patients newly diagnosed with breast cancer as they confront the expense of genetic tests and sometimes little guidance on the proper treatment.

Some doctors say the first step is to make sure that the small group of people who would clearly benefit are getting the genetic tests whose meaning is clearly understood. Only 15% of breast cancer patients who met select NCCN testing guidelines for inherited cancer received genetic testing, according to a 2017 study that examined data from a national household health survey between 2005 and 2015.

“I would argue that our focus needs to be on the people who are at high risk for breast cancer that aren’t even identified yet,” said Tuya Pal, MD, associate director for cancer health disparities at Vanderbilt-Ingram Cancer Center and vice chair of the NCCN guidelines panel for genetic/familial high-risk assessment of breast, ovarian, and pancreatic cancers.

Patients may fall through the cracks because no one tells them they should be tested. In one analysis, 56% of high-risk breast cancer patients who didn’t get genetic testing said their doctors didn’t recommend it.

Even if doctors recommend genetic testing, they may lack the expertise to determine which tests people need and how to interpret the results. That’s the role of genetic counselors, but their ranks are stretched thin.

The consequences can be serious. In a study of 666 breast cancer patients who received genetic testing, half of those at average risk for inherited cancer got double mastectomies based on test results that found “variants of uncertain significance,” which aren’t clinically actionable. As many as half of surgeons reported managing such patients the same way as those with cancer-causing mutations.

“The bulk of our research would say that there is still room for improvement in terms of clinicians getting the understanding they need,” said Allison Kurian, MD, director of the women’s clinical cancer genetics program at Stanford (Calif.) University and a coauthor of the study.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

The past decade has witnessed a rapid expansion of genetic tests, including new instruments to inform patients who have been diagnosed with breast cancer about the risk of recurrence and to guide their treatment.

But the clinical significance of many of the inherited mutations that can now be identified remains unclear, and experts are torn on when and how to deploy all the new tests available. Patients are sometimes left paying out-of-pocket for exams that are not yet the standard of care, and even the most up-to-date oncologists may be uncertain how to incorporate the flood of new information into what used to be standard treatment protocols.

A quarter-century ago, Myriad Genetics introduced the first breast cancer genetic test for BRCA mutations, two genes associated with a substantially elevated risk of getting breast cancer, opening the door to a new era in genetic testing. BRCA1 and BRCA2 mutations account for as many as half of all hereditary breast cancers, and people with a problematic mutation on one of those genes have a 45%-72% chance of developing breast cancer during their lifetimes. They may also be at higher risk for ovarian and other cancers than people without harmful BRCA mutations.

But the clinical significance is murkier for many other genetic tests.

Testing for BRCA1 and BRCA2 genes used to cost thousands of dollars. Now, for a fraction of that, doctors can order multigene test panels from commercial labs that look for mutations in dozens of genes. Some direct-to-consumer companies offer screening panels for a few hundred dollars, though their reliability varies.

When Jen Carbary was diagnosed with breast cancer in 2017 at age 44, genetic testing identified a mutation in a gene called PALB2 that significantly increases the risk of developing breast cancer. Guidelines suggest that breast cancer patients with a PALB2 mutation, much like those with BRCA1 and BRCA2 mutations, consider having a mastectomy to reduce the chance of a breast cancer recurrence.

“I wish genetic testing was the standard of care,” said Ms. Carbary, who owed nothing for the test because her insurer covered the cost.

Ms. Carbary, who lives in Sterling Heights, Mich., said the test results affirmed the decision she had already made to have a double mastectomy and provided important information for family members, including her 21-year-old daughter and 18-year-old son, who will likely be tested in their mid-20s or early 30s.

But some breast cancer experts are concerned that widespread testing may also identify genetic mutations whose impact is unclear, creating anxiety and leading to further testing and to treatment of questionable value that could raise costs for the health care system.

It can also confuse patients.

“It happens a lot, that patients find their way to us after getting confusing results elsewhere,” said Mark Robson, MD, chief of the breast medicine service at Memorial Sloan Kettering Cancer Center, New York. Robson said the cancer center has a clinical genetics service, staffed by doctors and genetic counselors, that helps people make decisions about how to manage genetic testing results.

For people diagnosed with breast cancer, many professional groups, including the influential National Comprehensive Cancer Network, recommend limiting testing to certain people, including those with high-risk factors, such as a family history of breast cancer; those who are 45 or younger when they’re diagnosed; and those with Ashkenazi Jewish ancestry.

But in 2019, the American Society of Breast Surgeons recommended a different approach: Offer genetic testing to all patients who are diagnosed with or have a personal history of breast cancer. The recommendation was controversial.

“The NCCN guidelines [cover] most of the women who needed testing, but we wanted to get them all,” said Eric Manahan, MD, a general surgeon in Dalton, Georgia, and a member of the surgeons group’s board of directors.

Mutations on other genes that are associated with breast cancer are much less common than BRCA1 and BRCA2 mutations and generally don’t increase the risk of developing breast cancer as much. The cancer-causing impact of these genes may be less clear than that of the BRCA genes, which have been tested for since the mid-1990s.

And the appropriate response to the less common mutations – whether to consider a risk-reducing mastectomy or stepped-up screening – is often unclear.

“Things get sloppier and sloppier when you look at other genes,” said Steven Katz, MD, MPH, a professor of medicine and health management and policy at the University of Michigan. “The risks tend to be lower for different cancers, and less certain and more variable. You might walk away wondering: ‘Why’d I have to know that?’ ”

After people are diagnosed with breast cancer, genetic testing can help inform their decisions about the types of surgery to pursue – for example, a high risk of recurrence or a new breast cancer might persuade some to opt for more extensive surgery, such as a double mastectomy. Testing can also provide important information to family members about their potential cancer risk.

(This type of “germline” genetic testing, as it’s called, looks at mutations in the genes that people inherit from their parents. It is different from genomic tumor tests that look at specific genes or proteins in the cancer cells and can help doctors understand the rate at which the cancer cells are dividing, for example, and the likelihood of a cancer recurrence.)

Increasingly, germline genetic testing can also help guide other treatment decisions. Some patients with metastatic breast cancer who have BRCA1 or BRCA2 mutations may be good candidates for poly (ADP-ribose) polymerase inhibitors, cancer drugs that target tumors with mutations in those genes.

But genetic testing that uncovers inherited mutations in many other genes yields less clearly actionable information, even though positive results may alarm people.

At Memorial Sloan Kettering, cancer specialists focus on “therapeutic actionability,” said Dr. Robson. Will testing help someone decide whether she should get a double mastectomy or provide other important guidance? “A policy of testing everyone will identify very few additional BRCA breast mutations but will cost a lot.”

As a result, doctors are debating how best to deploy and incorporate new genetic knowledge. Insurers are trying to figure out which to pay for.

There is both underuse of tests that science says are relevant and overuse of tests that experts say provide information that can’t be interpreted with any scientific certainty.

The result may be confusion for patients newly diagnosed with breast cancer as they confront the expense of genetic tests and sometimes little guidance on the proper treatment.

Some doctors say the first step is to make sure that the small group of people who would clearly benefit are getting the genetic tests whose meaning is clearly understood. Only 15% of breast cancer patients who met select NCCN testing guidelines for inherited cancer received genetic testing, according to a 2017 study that examined data from a national household health survey between 2005 and 2015.

“I would argue that our focus needs to be on the people who are at high risk for breast cancer that aren’t even identified yet,” said Tuya Pal, MD, associate director for cancer health disparities at Vanderbilt-Ingram Cancer Center and vice chair of the NCCN guidelines panel for genetic/familial high-risk assessment of breast, ovarian, and pancreatic cancers.

Patients may fall through the cracks because no one tells them they should be tested. In one analysis, 56% of high-risk breast cancer patients who didn’t get genetic testing said their doctors didn’t recommend it.

Even if doctors recommend genetic testing, they may lack the expertise to determine which tests people need and how to interpret the results. That’s the role of genetic counselors, but their ranks are stretched thin.

The consequences can be serious. In a study of 666 breast cancer patients who received genetic testing, half of those at average risk for inherited cancer got double mastectomies based on test results that found “variants of uncertain significance,” which aren’t clinically actionable. As many as half of surgeons reported managing such patients the same way as those with cancer-causing mutations.

“The bulk of our research would say that there is still room for improvement in terms of clinicians getting the understanding they need,” said Allison Kurian, MD, director of the women’s clinical cancer genetics program at Stanford (Calif.) University and a coauthor of the study.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Close to 4 million babies are born in the United States every year, and within their first 48 hours nearly all are pricked in the heel so their blood can be tested for dozens of life-threatening genetic and metabolic problems. The heel-stick test is considered such a crucial public health measure that states typically require it and parents aren’t asked for their permission before it’s done.

But the lab tests for newborn screenings generally don’t use all of the half-dozen or so drops of blood collected on filter paper cards. So states hold on to the leftover “dried blood spots,” as they’re called, often without parents’ knowledge or consent. In recent years, privacy-related concerns have grown about the sometimes decades-long storage and use of the material.

Some states allow the blood spots to be used in research studies, sometimes by third parties for a fee, or provided to law enforcement personnel investigating a crime. Permitting these or other uses without parents’ informed consent that they understand and agree to the use has prompted lawsuits from parents who want to make those decisions themselves and who seek to protect their children’s medical and genetic information.

In May, Michigan officials reportedly agreed to destroy more than 3 million blood spots as a partial settlement in a lawsuit brought by parents who said they didn’t receive enough clear information to provide informed consent for the blood to be used in research the state might conduct. The fate of millions of additional blood spots stored by the state will be determined at trial.

Philip L. Ellison, an attorney in Hemlock, Mich., who is spearheading the suit, said he became aware of the issue when his son was born 5 years ago. Mr. Ellison’s son, Patton, spent his first days in the neonatal intensive care unit after his blood sugar levels dropped precipitously after birth. The next morning, Mr. Ellison said, he was approached by a hospital staffer who asked whether he wanted to sign a consent form allowing the blood from Patton’s heel-stick test to be donated for research.

The unexpected request set off alarm bells for Mr. Ellison.

“We don’t know what the future will bring in terms of information that can be extracted from our blood,” he said. How the rules for using that blood might evolve over time is difficult to know. “A program that first starts out for one purpose, to test for disease, has now crept into medical research and then to law enforcement.”

Michigan is the rare state that asks parents for permission to use leftover newborn blood spots in research. Most do not, experts said. The state screens newborns for more than 50 diseases, such as cystic fibrosis and congenital hypothyroidism, because identifying and treating such illnesses early in a child’s life are crucial.

Afterward, whatever is left over is stored for up to 100 years and, if parents agree to it, may be used in research approved by the Michigan Department of Health and Human Services. Some recent studies have used deidentified blood spots to study the relationship between viral infection at birth and the development of autism later in life, as well as the impact of maternal exposure to manufactured chemicals known as PFAS on health outcomes.

Parents have also asked that their children’s blood spots be sent to researchers to help diagnose a disorder or to try to find a reason for a child’s death, said Chelsea Wuth, a spokesperson for the Michigan Department of Health and Human Services.

Michigan parents can request that the state destroy the leftover blood spots if they don’t want the state to hold on to them.

Since the 1960s, states have screened newborn blood for conditions that can lead to devastating physical or mental disabilities or death if they are not diagnosed and treated. The federal government recommends that roughly three dozen screening tests be performed, but some states conduct many more. Every year, an estimated 13,000 infants with serious medical conditions are identified through newborn screening programs, according to data published by the federal Centers for Disease Control and Prevention.

Many public health experts strongly support mandatory newborn screening as a critical component of infants’ clinical care. But some are receptive to giving parents a say in what happens to the blood after the screening.

“I have always believed that parents should be able to have the opportunity to say ‘yes’ or ‘no’ ” to having their newborns’ leftover blood used in research, said Beth Tarini, MD, a pediatrician and the associate director of the Center for Translational Research at Children’s National Research Institute in Washington, D.C. “Since it is not part of the clinical care, it is a different standard of engagement with the parents.”

In Michigan, 64% of parents consented to participate, according to court documents in Mr. Ellison’s case.

Encouraging people to participate is important, some public health experts say, because the blood spot repositories provide a rare opportunity for population-level research. People of European descent are often overrepresented in genetic databases, which can skew the results of studies. But the newborn screening program includes virtually everyone born in the United States.

“There’s strong evidence that research conducted on samples of white people creates disparities in the benefits of biomedical research for people who are not white,” said Kyle Brothers, MD, PhD, a pediatrician and bioethicist at Norton Children’s Research Institute in Louisville, Ky.

After privacy-related lawsuits were brought in 2009 and 2011 by parents in Texas and Minnesota, respectively, millions of blood spots were destroyed.

Brothers said an unwillingness to participate in research programs reflects larger trends, including more emphasis on the individual and less on contributing to the general good.

To those who might argue that parents’ privacy concerns are overblown, a recent lawsuit in New Jersey raises troubling questions.

In a public records lawsuit, the New Jersey Office of the Public Defender and the New Jersey Monitor, a nonprofit news site, charge that the state police used a subpoena to obtain an infant blood spot of a child who is now 9 years old from the state’s newborn screening laboratory. The lawsuit says a DNA analysis was conducted on the blood spot so evidence could be gathered against the child’s father, who was being represented by the public defender’s office, in connection with a sexual assault committed in 1996. The effort allowed police to get the DNA information without having to show a court probable cause, the suit alleges.

The lawsuit seeks to find out how often in the past 5 years New Jersey law enforcement agencies have used the newborn screening lab as a tool in investigations and subjected defendants to “warrantless searches and seizures.”

New Jersey keeps the records on file for 23 years, said CJ Griffin, a lawyer representing the public defender’s office and the New Jersey Monitor in the lawsuit.

Ms. Griffin said her clients aren’t challenging the program to test newborn blood for diseases. “It’s more the lack of transparency, and safeguards, and information about storage, and we don’t have any information about appropriate use.”

The New Jersey Department of Health doesn’t comment on pending litigation, spokesperson Nancy Kearney said. Ms. Kearney didn’t respond to a request for information about the state’s practices and policies related to the newborn screening program.

A recent Texas Law Review article found that more than a quarter of states lack policies on law enforcement access to newborn blood spot samples and related information and that nearly a third may allow access in certain circumstances.

In Michigan, the state gives law enforcement agencies dried blood spots only to identify the victim of a crime, Ms. Wuth said. “Typically, this means someone has been killed or gone missing,” she added.

Many clinicians and bioethicists say that standards for the use of blood spots need to be set.

“It’s nearly impossible for us to monitor the potential uses of our data,” said Andrew Crawford, senior policy counsel for the privacy and data project at the Center for Democracy and Technology. “That’s why need to put limitations on the use.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Close to 4 million babies are born in the United States every year, and within their first 48 hours nearly all are pricked in the heel so their blood can be tested for dozens of life-threatening genetic and metabolic problems. The heel-stick test is considered such a crucial public health measure that states typically require it and parents aren’t asked for their permission before it’s done.

But the lab tests for newborn screenings generally don’t use all of the half-dozen or so drops of blood collected on filter paper cards. So states hold on to the leftover “dried blood spots,” as they’re called, often without parents’ knowledge or consent. In recent years, privacy-related concerns have grown about the sometimes decades-long storage and use of the material.

Some states allow the blood spots to be used in research studies, sometimes by third parties for a fee, or provided to law enforcement personnel investigating a crime. Permitting these or other uses without parents’ informed consent that they understand and agree to the use has prompted lawsuits from parents who want to make those decisions themselves and who seek to protect their children’s medical and genetic information.

In May, Michigan officials reportedly agreed to destroy more than 3 million blood spots as a partial settlement in a lawsuit brought by parents who said they didn’t receive enough clear information to provide informed consent for the blood to be used in research the state might conduct. The fate of millions of additional blood spots stored by the state will be determined at trial.

Philip L. Ellison, an attorney in Hemlock, Mich., who is spearheading the suit, said he became aware of the issue when his son was born 5 years ago. Mr. Ellison’s son, Patton, spent his first days in the neonatal intensive care unit after his blood sugar levels dropped precipitously after birth. The next morning, Mr. Ellison said, he was approached by a hospital staffer who asked whether he wanted to sign a consent form allowing the blood from Patton’s heel-stick test to be donated for research.

The unexpected request set off alarm bells for Mr. Ellison.

“We don’t know what the future will bring in terms of information that can be extracted from our blood,” he said. How the rules for using that blood might evolve over time is difficult to know. “A program that first starts out for one purpose, to test for disease, has now crept into medical research and then to law enforcement.”

Michigan is the rare state that asks parents for permission to use leftover newborn blood spots in research. Most do not, experts said. The state screens newborns for more than 50 diseases, such as cystic fibrosis and congenital hypothyroidism, because identifying and treating such illnesses early in a child’s life are crucial.

Afterward, whatever is left over is stored for up to 100 years and, if parents agree to it, may be used in research approved by the Michigan Department of Health and Human Services. Some recent studies have used deidentified blood spots to study the relationship between viral infection at birth and the development of autism later in life, as well as the impact of maternal exposure to manufactured chemicals known as PFAS on health outcomes.

Parents have also asked that their children’s blood spots be sent to researchers to help diagnose a disorder or to try to find a reason for a child’s death, said Chelsea Wuth, a spokesperson for the Michigan Department of Health and Human Services.

Michigan parents can request that the state destroy the leftover blood spots if they don’t want the state to hold on to them.

Since the 1960s, states have screened newborn blood for conditions that can lead to devastating physical or mental disabilities or death if they are not diagnosed and treated. The federal government recommends that roughly three dozen screening tests be performed, but some states conduct many more. Every year, an estimated 13,000 infants with serious medical conditions are identified through newborn screening programs, according to data published by the federal Centers for Disease Control and Prevention.

Many public health experts strongly support mandatory newborn screening as a critical component of infants’ clinical care. But some are receptive to giving parents a say in what happens to the blood after the screening.

“I have always believed that parents should be able to have the opportunity to say ‘yes’ or ‘no’ ” to having their newborns’ leftover blood used in research, said Beth Tarini, MD, a pediatrician and the associate director of the Center for Translational Research at Children’s National Research Institute in Washington, D.C. “Since it is not part of the clinical care, it is a different standard of engagement with the parents.”

In Michigan, 64% of parents consented to participate, according to court documents in Mr. Ellison’s case.

Encouraging people to participate is important, some public health experts say, because the blood spot repositories provide a rare opportunity for population-level research. People of European descent are often overrepresented in genetic databases, which can skew the results of studies. But the newborn screening program includes virtually everyone born in the United States.

“There’s strong evidence that research conducted on samples of white people creates disparities in the benefits of biomedical research for people who are not white,” said Kyle Brothers, MD, PhD, a pediatrician and bioethicist at Norton Children’s Research Institute in Louisville, Ky.

After privacy-related lawsuits were brought in 2009 and 2011 by parents in Texas and Minnesota, respectively, millions of blood spots were destroyed.

Brothers said an unwillingness to participate in research programs reflects larger trends, including more emphasis on the individual and less on contributing to the general good.

To those who might argue that parents’ privacy concerns are overblown, a recent lawsuit in New Jersey raises troubling questions.

In a public records lawsuit, the New Jersey Office of the Public Defender and the New Jersey Monitor, a nonprofit news site, charge that the state police used a subpoena to obtain an infant blood spot of a child who is now 9 years old from the state’s newborn screening laboratory. The lawsuit says a DNA analysis was conducted on the blood spot so evidence could be gathered against the child’s father, who was being represented by the public defender’s office, in connection with a sexual assault committed in 1996. The effort allowed police to get the DNA information without having to show a court probable cause, the suit alleges.

The lawsuit seeks to find out how often in the past 5 years New Jersey law enforcement agencies have used the newborn screening lab as a tool in investigations and subjected defendants to “warrantless searches and seizures.”

New Jersey keeps the records on file for 23 years, said CJ Griffin, a lawyer representing the public defender’s office and the New Jersey Monitor in the lawsuit.

Ms. Griffin said her clients aren’t challenging the program to test newborn blood for diseases. “It’s more the lack of transparency, and safeguards, and information about storage, and we don’t have any information about appropriate use.”

The New Jersey Department of Health doesn’t comment on pending litigation, spokesperson Nancy Kearney said. Ms. Kearney didn’t respond to a request for information about the state’s practices and policies related to the newborn screening program.

A recent Texas Law Review article found that more than a quarter of states lack policies on law enforcement access to newborn blood spot samples and related information and that nearly a third may allow access in certain circumstances.

In Michigan, the state gives law enforcement agencies dried blood spots only to identify the victim of a crime, Ms. Wuth said. “Typically, this means someone has been killed or gone missing,” she added.

Many clinicians and bioethicists say that standards for the use of blood spots need to be set.

“It’s nearly impossible for us to monitor the potential uses of our data,” said Andrew Crawford, senior policy counsel for the privacy and data project at the Center for Democracy and Technology. “That’s why need to put limitations on the use.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Close to 4 million babies are born in the United States every year, and within their first 48 hours nearly all are pricked in the heel so their blood can be tested for dozens of life-threatening genetic and metabolic problems. The heel-stick test is considered such a crucial public health measure that states typically require it and parents aren’t asked for their permission before it’s done.

But the lab tests for newborn screenings generally don’t use all of the half-dozen or so drops of blood collected on filter paper cards. So states hold on to the leftover “dried blood spots,” as they’re called, often without parents’ knowledge or consent. In recent years, privacy-related concerns have grown about the sometimes decades-long storage and use of the material.

Some states allow the blood spots to be used in research studies, sometimes by third parties for a fee, or provided to law enforcement personnel investigating a crime. Permitting these or other uses without parents’ informed consent that they understand and agree to the use has prompted lawsuits from parents who want to make those decisions themselves and who seek to protect their children’s medical and genetic information.

In May, Michigan officials reportedly agreed to destroy more than 3 million blood spots as a partial settlement in a lawsuit brought by parents who said they didn’t receive enough clear information to provide informed consent for the blood to be used in research the state might conduct. The fate of millions of additional blood spots stored by the state will be determined at trial.

Philip L. Ellison, an attorney in Hemlock, Mich., who is spearheading the suit, said he became aware of the issue when his son was born 5 years ago. Mr. Ellison’s son, Patton, spent his first days in the neonatal intensive care unit after his blood sugar levels dropped precipitously after birth. The next morning, Mr. Ellison said, he was approached by a hospital staffer who asked whether he wanted to sign a consent form allowing the blood from Patton’s heel-stick test to be donated for research.

The unexpected request set off alarm bells for Mr. Ellison.

“We don’t know what the future will bring in terms of information that can be extracted from our blood,” he said. How the rules for using that blood might evolve over time is difficult to know. “A program that first starts out for one purpose, to test for disease, has now crept into medical research and then to law enforcement.”

Michigan is the rare state that asks parents for permission to use leftover newborn blood spots in research. Most do not, experts said. The state screens newborns for more than 50 diseases, such as cystic fibrosis and congenital hypothyroidism, because identifying and treating such illnesses early in a child’s life are crucial.

Afterward, whatever is left over is stored for up to 100 years and, if parents agree to it, may be used in research approved by the Michigan Department of Health and Human Services. Some recent studies have used deidentified blood spots to study the relationship between viral infection at birth and the development of autism later in life, as well as the impact of maternal exposure to manufactured chemicals known as PFAS on health outcomes.

Parents have also asked that their children’s blood spots be sent to researchers to help diagnose a disorder or to try to find a reason for a child’s death, said Chelsea Wuth, a spokesperson for the Michigan Department of Health and Human Services.

Michigan parents can request that the state destroy the leftover blood spots if they don’t want the state to hold on to them.

Since the 1960s, states have screened newborn blood for conditions that can lead to devastating physical or mental disabilities or death if they are not diagnosed and treated. The federal government recommends that roughly three dozen screening tests be performed, but some states conduct many more. Every year, an estimated 13,000 infants with serious medical conditions are identified through newborn screening programs, according to data published by the federal Centers for Disease Control and Prevention.

Many public health experts strongly support mandatory newborn screening as a critical component of infants’ clinical care. But some are receptive to giving parents a say in what happens to the blood after the screening.

“I have always believed that parents should be able to have the opportunity to say ‘yes’ or ‘no’ ” to having their newborns’ leftover blood used in research, said Beth Tarini, MD, a pediatrician and the associate director of the Center for Translational Research at Children’s National Research Institute in Washington, D.C. “Since it is not part of the clinical care, it is a different standard of engagement with the parents.”

In Michigan, 64% of parents consented to participate, according to court documents in Mr. Ellison’s case.

Encouraging people to participate is important, some public health experts say, because the blood spot repositories provide a rare opportunity for population-level research. People of European descent are often overrepresented in genetic databases, which can skew the results of studies. But the newborn screening program includes virtually everyone born in the United States.

“There’s strong evidence that research conducted on samples of white people creates disparities in the benefits of biomedical research for people who are not white,” said Kyle Brothers, MD, PhD, a pediatrician and bioethicist at Norton Children’s Research Institute in Louisville, Ky.

After privacy-related lawsuits were brought in 2009 and 2011 by parents in Texas and Minnesota, respectively, millions of blood spots were destroyed.

Brothers said an unwillingness to participate in research programs reflects larger trends, including more emphasis on the individual and less on contributing to the general good.

To those who might argue that parents’ privacy concerns are overblown, a recent lawsuit in New Jersey raises troubling questions.

In a public records lawsuit, the New Jersey Office of the Public Defender and the New Jersey Monitor, a nonprofit news site, charge that the state police used a subpoena to obtain an infant blood spot of a child who is now 9 years old from the state’s newborn screening laboratory. The lawsuit says a DNA analysis was conducted on the blood spot so evidence could be gathered against the child’s father, who was being represented by the public defender’s office, in connection with a sexual assault committed in 1996. The effort allowed police to get the DNA information without having to show a court probable cause, the suit alleges.

The lawsuit seeks to find out how often in the past 5 years New Jersey law enforcement agencies have used the newborn screening lab as a tool in investigations and subjected defendants to “warrantless searches and seizures.”

New Jersey keeps the records on file for 23 years, said CJ Griffin, a lawyer representing the public defender’s office and the New Jersey Monitor in the lawsuit.

Ms. Griffin said her clients aren’t challenging the program to test newborn blood for diseases. “It’s more the lack of transparency, and safeguards, and information about storage, and we don’t have any information about appropriate use.”

The New Jersey Department of Health doesn’t comment on pending litigation, spokesperson Nancy Kearney said. Ms. Kearney didn’t respond to a request for information about the state’s practices and policies related to the newborn screening program.

A recent Texas Law Review article found that more than a quarter of states lack policies on law enforcement access to newborn blood spot samples and related information and that nearly a third may allow access in certain circumstances.

In Michigan, the state gives law enforcement agencies dried blood spots only to identify the victim of a crime, Ms. Wuth said. “Typically, this means someone has been killed or gone missing,” she added.

Many clinicians and bioethicists say that standards for the use of blood spots need to be set.

“It’s nearly impossible for us to monitor the potential uses of our data,” said Andrew Crawford, senior policy counsel for the privacy and data project at the Center for Democracy and Technology. “That’s why need to put limitations on the use.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

It took years for Elle Moxley to get a diagnosis that explained her crippling gastrointestinal pain, digestion problems, fatigue, and hot, red rashes. And after learning in 2016 that she had Crohn’s disease, a chronic inflammation of the digestive tract, she spent more than 4 years trying medications before getting her disease under control with a biologic drug called Remicade.

So Ms. Moxley, 33, was dismayed to receive a notice from her insurer in January that Remicade would no longer be covered as a preferred drug on her plan. Another drug, Inflectra, which the Food and Drug Administration says has no meaningful clinical differences from Remicade, is now preferred. It is a “biosimilar” drug.

“I felt very powerless,” said Ms. Moxley, who recently started a job as a public relations coordinator for Kansas City (Mo.) Public Schools. “I have this decision being made for me and my doctor that’s not in my best interest, and it might knock me out of remission.”

After Ms. Moxley’s first Inflectra infusion in July, she developed a painful rash. It went away after a few days, but she said she continues to feel extremely fatigued and experiences gastrointestinal pain, constipation, diarrhea and nausea.

Many medical professionals look to biosimilar drugs as a way to increase competition and give consumers cheaper options, much as generic drugs do, and they point to the more robust use of these products in Europe to cut costs.

Yet the United States has been slower to adopt biosimilar drugs since the first such medicine was approved in 2015. That’s partly because of concerns raised by patients like Moxley and their doctors, but also because brand-name biologics have kept biosimilars from entering the market. The companies behind the brand-name drugs have used legal actions to extend the life of their patents and incentives that make offering the brand biologic more attractive than offering a biosimilar on a formulary, listing which drugs are covered on an insurance plan.

“It distorts the market and makes it so that patients can’t get access,” said Jinoos Yazdany, MD, MPH, a professor of medicine and chief of the rheumatology division at Zuckerberg San Francisco General Hospital.

The FDA has approved 31 biosimilar medications since 2015, but only about 60% have made it to market, according to an analysis by NORC, a research organization at the University of Chicago.

Remicade’s manufacturer, Johnson & Johnson, and Pfizer, which makes the Remicade biosimilar Inflectra, have been embroiled in a long-running lawsuit over Pfizer’s claims that Johnson & Johnson tried to choke off competition through exclusionary contracts with insurers and other anticompetitive actions. In July, the companies settled the case on undisclosed terms.

In a statement, Pfizer said it would continue to sell Inflectra in the United States but noted ongoing challenges: “Pfizer has begun to see progress in the overall biosimilars marketplace in the U.S. However, changes in policy at a government level and acceptance of biosimilars among key stakeholders are critical to deliver more meaningful uptake so patients and the health care system at large can benefit from the cost savings these medicines may deliver.”

Johnson & Johnson said it is committed to making Remicade available to patients who choose it, which “compels us to compete responsibly on both price and value.”

Biologic medicines, which are generally grown from living organisms such as animal cells or bacteria, are more complex and expensive to manufacture than drugs made from chemicals. In recent years, biologic drugs have become a mainstay of treatment for autoimmune conditions like Crohn’s disease and rheumatoid arthritis, as well as certain cancers and diabetes, among other conditions.

Other drugmakers can’t exactly reproduce these biologic drugs by following chemical recipes as they do for generic versions of conventional drugs.

Instead, biosimilar versions of biologic drugs are generally made from the same types of materials as the original biologics and must be “highly similar” to them to be approved by the FDA. They must have no clinically meaningful differences from the biologic drug, and be just as safe, pure and potent. More than a decade after Congress created an approval pathway for biosimilars, they are widely accepted as safe and effective alternatives to brand biologics.

Medical experts hope that as biosimilars become more widely used they will increasingly provide a brake on drug spending.

From 2015 to 2019, drug spending overall grew 6.1%, while spending on biologics grew more than twice as much – 14.6% – according to a report by IQVIA, a health care analytics company. In 2019, biologics accounted for 43% of drug spending in the United States

Biosimilars provide a roughly 30% discount over brand biologics in the United States but have the potential to reduce spending by more than $100 billion in the next 5 years, the IQVIA analysis found.

In a survey of 602 physicians who prescribe biologic medications, more than three-quarters said they believed biosimilars are just as safe and effective as their biologic counterparts, according to NORC.

But they were less comfortable with switching patients from a brand biologic to a biosimilar. While about half said they were very likely to prescribe a biosimilar to a patient just starting biologic therapy, only 31% said they were very likely to prescribe a biosimilar to a patient already doing well on a brand biologic.

It can be challenging to find a treatment regimen that works for patients with complicated chronic conditions, and physicians and patients often don’t want to rock the boat once that is achieved.

In Ms. Moxley’s case, for example, before her condition stabilized on Remicade, she tried a conventional pill called Lialda, the biologic drug Humira and a lower dose of Remicade.

Some doctors and patients raise concerns that switching between these drugs might cause patients to develop antibodies that cause the drugs to lose effectiveness. They want to see more research about the effects of such switches.

“We haven’t seen enough studies about patients going from the biologic to the biosimilar and bouncing back and forth,” said Marcus Snow, MD, chair of the American College of Rheumatology’s Committee on Rheumatologic Care. “We don’t want our patients to be guinea pigs.”

Manufacturers of biologic and biosimilar drugs have participated in advertising, exhibit or sponsorship opportunities with the American College of Rheumatology, according to ACR spokesperson Jocelyn Givens.

But studies show a one-time switch from Remicade to a biosimilar like Inflectra does not cause side effects or the development of antibodies, said Ross Maltz, MD, a pediatric gastroenterologist at Nationwide Children’s Hospital in Columbus, Ohio, and former member of the Crohn’s & Colitis Foundation’s National Scientific Advisory Committee. Studies may be conducted by researchers with extensive ties to the industry and funded by drugmakers.

Situations like Ms. Moxley’s are unusual, said Kristine Grow, senior vice president of communications at AHIP, an insurer trade group.

“For patients who have been taking a brand-name biologic for some time, health insurance providers do not typically encourage them to switch to a biosimilar because of a formulary change, and most plans exclude these patients from any changes in cost sharing due to formulary changes,” she said.

Drugmakers can seek approval from the FDA of their biosimilar as interchangeable with a biologic drug, allowing pharmacists, subject to state law, to switch a physician’s prescription from the brand drug, as they often do with generic drugs.

However, the FDA has approved only one biosimilar (Semglee, a form of insulin) as interchangeable with a biologic (Lantus).

Like Ms. Moxley, many other patients using biologics get copay assistance from drug companies, but the money often isn’t enough to cover the full cost. In her old job as a radio reporter, Ms. Moxley said, she hit the $7,000 maximum annual out-of-pocket spending limit for her plan by May.

In her new job, Ms. Moxley has an individual plan with a $4,000 maximum out-of-pocket limit, which she expects to blow past once again within months.

But she received good news recently: Her new plan will cover Remicade.

“I’m still concerned that I will have developed antibodies since my last dose,” she said. “But it feels like a step in the direction of good health again.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

It took years for Elle Moxley to get a diagnosis that explained her crippling gastrointestinal pain, digestion problems, fatigue, and hot, red rashes. And after learning in 2016 that she had Crohn’s disease, a chronic inflammation of the digestive tract, she spent more than 4 years trying medications before getting her disease under control with a biologic drug called Remicade.

So Ms. Moxley, 33, was dismayed to receive a notice from her insurer in January that Remicade would no longer be covered as a preferred drug on her plan. Another drug, Inflectra, which the Food and Drug Administration says has no meaningful clinical differences from Remicade, is now preferred. It is a “biosimilar” drug.

“I felt very powerless,” said Ms. Moxley, who recently started a job as a public relations coordinator for Kansas City (Mo.) Public Schools. “I have this decision being made for me and my doctor that’s not in my best interest, and it might knock me out of remission.”

After Ms. Moxley’s first Inflectra infusion in July, she developed a painful rash. It went away after a few days, but she said she continues to feel extremely fatigued and experiences gastrointestinal pain, constipation, diarrhea and nausea.

Many medical professionals look to biosimilar drugs as a way to increase competition and give consumers cheaper options, much as generic drugs do, and they point to the more robust use of these products in Europe to cut costs.

Yet the United States has been slower to adopt biosimilar drugs since the first such medicine was approved in 2015. That’s partly because of concerns raised by patients like Moxley and their doctors, but also because brand-name biologics have kept biosimilars from entering the market. The companies behind the brand-name drugs have used legal actions to extend the life of their patents and incentives that make offering the brand biologic more attractive than offering a biosimilar on a formulary, listing which drugs are covered on an insurance plan.

“It distorts the market and makes it so that patients can’t get access,” said Jinoos Yazdany, MD, MPH, a professor of medicine and chief of the rheumatology division at Zuckerberg San Francisco General Hospital.

The FDA has approved 31 biosimilar medications since 2015, but only about 60% have made it to market, according to an analysis by NORC, a research organization at the University of Chicago.

Remicade’s manufacturer, Johnson & Johnson, and Pfizer, which makes the Remicade biosimilar Inflectra, have been embroiled in a long-running lawsuit over Pfizer’s claims that Johnson & Johnson tried to choke off competition through exclusionary contracts with insurers and other anticompetitive actions. In July, the companies settled the case on undisclosed terms.

In a statement, Pfizer said it would continue to sell Inflectra in the United States but noted ongoing challenges: “Pfizer has begun to see progress in the overall biosimilars marketplace in the U.S. However, changes in policy at a government level and acceptance of biosimilars among key stakeholders are critical to deliver more meaningful uptake so patients and the health care system at large can benefit from the cost savings these medicines may deliver.”

Johnson & Johnson said it is committed to making Remicade available to patients who choose it, which “compels us to compete responsibly on both price and value.”

Biologic medicines, which are generally grown from living organisms such as animal cells or bacteria, are more complex and expensive to manufacture than drugs made from chemicals. In recent years, biologic drugs have become a mainstay of treatment for autoimmune conditions like Crohn’s disease and rheumatoid arthritis, as well as certain cancers and diabetes, among other conditions.

Other drugmakers can’t exactly reproduce these biologic drugs by following chemical recipes as they do for generic versions of conventional drugs.

Instead, biosimilar versions of biologic drugs are generally made from the same types of materials as the original biologics and must be “highly similar” to them to be approved by the FDA. They must have no clinically meaningful differences from the biologic drug, and be just as safe, pure and potent. More than a decade after Congress created an approval pathway for biosimilars, they are widely accepted as safe and effective alternatives to brand biologics.

Medical experts hope that as biosimilars become more widely used they will increasingly provide a brake on drug spending.

From 2015 to 2019, drug spending overall grew 6.1%, while spending on biologics grew more than twice as much – 14.6% – according to a report by IQVIA, a health care analytics company. In 2019, biologics accounted for 43% of drug spending in the United States

Biosimilars provide a roughly 30% discount over brand biologics in the United States but have the potential to reduce spending by more than $100 billion in the next 5 years, the IQVIA analysis found.

In a survey of 602 physicians who prescribe biologic medications, more than three-quarters said they believed biosimilars are just as safe and effective as their biologic counterparts, according to NORC.

But they were less comfortable with switching patients from a brand biologic to a biosimilar. While about half said they were very likely to prescribe a biosimilar to a patient just starting biologic therapy, only 31% said they were very likely to prescribe a biosimilar to a patient already doing well on a brand biologic.

It can be challenging to find a treatment regimen that works for patients with complicated chronic conditions, and physicians and patients often don’t want to rock the boat once that is achieved.

In Ms. Moxley’s case, for example, before her condition stabilized on Remicade, she tried a conventional pill called Lialda, the biologic drug Humira and a lower dose of Remicade.

Some doctors and patients raise concerns that switching between these drugs might cause patients to develop antibodies that cause the drugs to lose effectiveness. They want to see more research about the effects of such switches.

“We haven’t seen enough studies about patients going from the biologic to the biosimilar and bouncing back and forth,” said Marcus Snow, MD, chair of the American College of Rheumatology’s Committee on Rheumatologic Care. “We don’t want our patients to be guinea pigs.”

Manufacturers of biologic and biosimilar drugs have participated in advertising, exhibit or sponsorship opportunities with the American College of Rheumatology, according to ACR spokesperson Jocelyn Givens.

But studies show a one-time switch from Remicade to a biosimilar like Inflectra does not cause side effects or the development of antibodies, said Ross Maltz, MD, a pediatric gastroenterologist at Nationwide Children’s Hospital in Columbus, Ohio, and former member of the Crohn’s & Colitis Foundation’s National Scientific Advisory Committee. Studies may be conducted by researchers with extensive ties to the industry and funded by drugmakers.

Situations like Ms. Moxley’s are unusual, said Kristine Grow, senior vice president of communications at AHIP, an insurer trade group.

“For patients who have been taking a brand-name biologic for some time, health insurance providers do not typically encourage them to switch to a biosimilar because of a formulary change, and most plans exclude these patients from any changes in cost sharing due to formulary changes,” she said.

Drugmakers can seek approval from the FDA of their biosimilar as interchangeable with a biologic drug, allowing pharmacists, subject to state law, to switch a physician’s prescription from the brand drug, as they often do with generic drugs.

However, the FDA has approved only one biosimilar (Semglee, a form of insulin) as interchangeable with a biologic (Lantus).

Like Ms. Moxley, many other patients using biologics get copay assistance from drug companies, but the money often isn’t enough to cover the full cost. In her old job as a radio reporter, Ms. Moxley said, she hit the $7,000 maximum annual out-of-pocket spending limit for her plan by May.

In her new job, Ms. Moxley has an individual plan with a $4,000 maximum out-of-pocket limit, which she expects to blow past once again within months.

But she received good news recently: Her new plan will cover Remicade.

“I’m still concerned that I will have developed antibodies since my last dose,” she said. “But it feels like a step in the direction of good health again.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

It took years for Elle Moxley to get a diagnosis that explained her crippling gastrointestinal pain, digestion problems, fatigue, and hot, red rashes. And after learning in 2016 that she had Crohn’s disease, a chronic inflammation of the digestive tract, she spent more than 4 years trying medications before getting her disease under control with a biologic drug called Remicade.

So Ms. Moxley, 33, was dismayed to receive a notice from her insurer in January that Remicade would no longer be covered as a preferred drug on her plan. Another drug, Inflectra, which the Food and Drug Administration says has no meaningful clinical differences from Remicade, is now preferred. It is a “biosimilar” drug.

“I felt very powerless,” said Ms. Moxley, who recently started a job as a public relations coordinator for Kansas City (Mo.) Public Schools. “I have this decision being made for me and my doctor that’s not in my best interest, and it might knock me out of remission.”

After Ms. Moxley’s first Inflectra infusion in July, she developed a painful rash. It went away after a few days, but she said she continues to feel extremely fatigued and experiences gastrointestinal pain, constipation, diarrhea and nausea.

Many medical professionals look to biosimilar drugs as a way to increase competition and give consumers cheaper options, much as generic drugs do, and they point to the more robust use of these products in Europe to cut costs.

Yet the United States has been slower to adopt biosimilar drugs since the first such medicine was approved in 2015. That’s partly because of concerns raised by patients like Moxley and their doctors, but also because brand-name biologics have kept biosimilars from entering the market. The companies behind the brand-name drugs have used legal actions to extend the life of their patents and incentives that make offering the brand biologic more attractive than offering a biosimilar on a formulary, listing which drugs are covered on an insurance plan.

“It distorts the market and makes it so that patients can’t get access,” said Jinoos Yazdany, MD, MPH, a professor of medicine and chief of the rheumatology division at Zuckerberg San Francisco General Hospital.

The FDA has approved 31 biosimilar medications since 2015, but only about 60% have made it to market, according to an analysis by NORC, a research organization at the University of Chicago.

Remicade’s manufacturer, Johnson & Johnson, and Pfizer, which makes the Remicade biosimilar Inflectra, have been embroiled in a long-running lawsuit over Pfizer’s claims that Johnson & Johnson tried to choke off competition through exclusionary contracts with insurers and other anticompetitive actions. In July, the companies settled the case on undisclosed terms.

In a statement, Pfizer said it would continue to sell Inflectra in the United States but noted ongoing challenges: “Pfizer has begun to see progress in the overall biosimilars marketplace in the U.S. However, changes in policy at a government level and acceptance of biosimilars among key stakeholders are critical to deliver more meaningful uptake so patients and the health care system at large can benefit from the cost savings these medicines may deliver.”

Johnson & Johnson said it is committed to making Remicade available to patients who choose it, which “compels us to compete responsibly on both price and value.”

Biologic medicines, which are generally grown from living organisms such as animal cells or bacteria, are more complex and expensive to manufacture than drugs made from chemicals. In recent years, biologic drugs have become a mainstay of treatment for autoimmune conditions like Crohn’s disease and rheumatoid arthritis, as well as certain cancers and diabetes, among other conditions.

Other drugmakers can’t exactly reproduce these biologic drugs by following chemical recipes as they do for generic versions of conventional drugs.

Instead, biosimilar versions of biologic drugs are generally made from the same types of materials as the original biologics and must be “highly similar” to them to be approved by the FDA. They must have no clinically meaningful differences from the biologic drug, and be just as safe, pure and potent. More than a decade after Congress created an approval pathway for biosimilars, they are widely accepted as safe and effective alternatives to brand biologics.

Medical experts hope that as biosimilars become more widely used they will increasingly provide a brake on drug spending.

From 2015 to 2019, drug spending overall grew 6.1%, while spending on biologics grew more than twice as much – 14.6% – according to a report by IQVIA, a health care analytics company. In 2019, biologics accounted for 43% of drug spending in the United States

Biosimilars provide a roughly 30% discount over brand biologics in the United States but have the potential to reduce spending by more than $100 billion in the next 5 years, the IQVIA analysis found.

In a survey of 602 physicians who prescribe biologic medications, more than three-quarters said they believed biosimilars are just as safe and effective as their biologic counterparts, according to NORC.

But they were less comfortable with switching patients from a brand biologic to a biosimilar. While about half said they were very likely to prescribe a biosimilar to a patient just starting biologic therapy, only 31% said they were very likely to prescribe a biosimilar to a patient already doing well on a brand biologic.

It can be challenging to find a treatment regimen that works for patients with complicated chronic conditions, and physicians and patients often don’t want to rock the boat once that is achieved.

In Ms. Moxley’s case, for example, before her condition stabilized on Remicade, she tried a conventional pill called Lialda, the biologic drug Humira and a lower dose of Remicade.

Some doctors and patients raise concerns that switching between these drugs might cause patients to develop antibodies that cause the drugs to lose effectiveness. They want to see more research about the effects of such switches.

“We haven’t seen enough studies about patients going from the biologic to the biosimilar and bouncing back and forth,” said Marcus Snow, MD, chair of the American College of Rheumatology’s Committee on Rheumatologic Care. “We don’t want our patients to be guinea pigs.”

Manufacturers of biologic and biosimilar drugs have participated in advertising, exhibit or sponsorship opportunities with the American College of Rheumatology, according to ACR spokesperson Jocelyn Givens.

But studies show a one-time switch from Remicade to a biosimilar like Inflectra does not cause side effects or the development of antibodies, said Ross Maltz, MD, a pediatric gastroenterologist at Nationwide Children’s Hospital in Columbus, Ohio, and former member of the Crohn’s & Colitis Foundation’s National Scientific Advisory Committee. Studies may be conducted by researchers with extensive ties to the industry and funded by drugmakers.

Situations like Ms. Moxley’s are unusual, said Kristine Grow, senior vice president of communications at AHIP, an insurer trade group.

“For patients who have been taking a brand-name biologic for some time, health insurance providers do not typically encourage them to switch to a biosimilar because of a formulary change, and most plans exclude these patients from any changes in cost sharing due to formulary changes,” she said.

Drugmakers can seek approval from the FDA of their biosimilar as interchangeable with a biologic drug, allowing pharmacists, subject to state law, to switch a physician’s prescription from the brand drug, as they often do with generic drugs.

However, the FDA has approved only one biosimilar (Semglee, a form of insulin) as interchangeable with a biologic (Lantus).

Like Ms. Moxley, many other patients using biologics get copay assistance from drug companies, but the money often isn’t enough to cover the full cost. In her old job as a radio reporter, Ms. Moxley said, she hit the $7,000 maximum annual out-of-pocket spending limit for her plan by May.

In her new job, Ms. Moxley has an individual plan with a $4,000 maximum out-of-pocket limit, which she expects to blow past once again within months.

But she received good news recently: Her new plan will cover Remicade.

“I’m still concerned that I will have developed antibodies since my last dose,” she said. “But it feels like a step in the direction of good health again.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Ted Howard started taking Truvada a few years ago because he wanted to protect himself against HIV, the virus that causes AIDS. But the daily pill was so pricey he was seriously thinking about giving it up.

Under his insurance plan, the former flight attendant and customer service instructor owed $500 in copayments every month for the drug and an additional $250 every three months for lab work and clinic visits.

Luckily for Howard, his doctor at Las Vegas’ Huntridge Family Clinic, which specializes in LGBTQ care, enrolled him in a clinical trial that covered his medication and other costs in full.

“If I hadn’t been able to get into the trial, I wouldn’t have kept taking PrEP,” said Howard, 68, using the shorthand term for “preexposure prophylaxis.” Taken daily, these drugs — like Truvada — are more than 90% effective at preventing infection with HIV.

Starting in January of 2021, most people with private insurance will no longer have to decide whether they can afford to protect themselves against HIV. Most health plans must begin to cover the drugs then without charging consumers anything out-of-pocket (some plans already began doing so last year).

Drugs in this category — Truvada, Descovy and, newly available, a generic version of Truvada — received an “A” recommendation by the U.S. Preventive Services Task Force. Under the Affordable Care Act, preventive services that receive an “A” or “B” rating by the task force, a group of medical experts in prevention and primary care, must be covered by most private health plans without making members share the cost, usually through copayments or deductibles. Only plans that are grandfathered under the health law are exempt.

The task force recommended PrEP for people at high risk of HIV infection, including men who have sex with men and injection drug users.

In the United States, more than 1 million people live with HIV, and nearly 40,000 new HIV cases are diagnosed every year. Yet fewer than 10% of people who could benefit from PrEP are taking it. One key reason is that out-of-pocket costs can exceed $1,000 annually, according to a study published in the American Journal of Public Health last year. Required periodic blood tests and doctor visits can add hundreds of dollars to the cost of the drug, and it’s not clear if insurers are required to pick up all those costs.

“Cost sharing has been a problem,” said Michael Crews, policy director at One Colorado, an advocacy group for the LGBTQ community. “It’s not just getting on PrEP and taking a pill. It’s the lab and clinical services. That’s a huge barrier for folks.”

Whether you’re shopping for a new plan during open enrollment or want to check out what your current plan covers, here are answers to questions you may have about the new preventive coverage requirement.
 

Q: How can people find out whether their health plan covers PrEP medications without charge?

The plan’s list of covered drugs, called a formulary, should spell out which drugs are covered, along with details about which drug tier they fall into. Drugs placed in higher tiers generally have higher cost sharing. That list should be online with the plan documents that give coverage details.

Sorting out coverage and cost sharing can be tricky. Both Truvada and Descovy can also be used to treat HIV, and if they are taken for that purpose, a plan may require members to pay some of the cost. But if the drugs are taken to prevent HIV infection, patients shouldn’t owe anything out-of-pocket, no matter which tier they are on.

In a recent analysis of online formularies for plans sold on the ACA marketplaces, Carl Schmid, executive director of the HIV + Hepatitis Policy Institute, found that many plans seemed out of compliance with the requirement to cover PrEP without cost sharing this year.

But representatives for Oscar and Kaiser Permanente, two insurers that were called out in the analysis for lack of compliance, said the drugs are covered without cost sharing in plans nationwide if they are taken to prevent HIV. Schmid later revised his analysis to reflect Oscar’s coverage.

Coverage and cost-sharing information needs to be transparent and easy to find, Schmid said.

“I acted like a shopper of insurance, just like any person would do,” he said. “Even when the information is correct, [it’s so] difficult to find [and there’s] no uniformity.”

It may be necessary to call the insurer directly to confirm coverage details if information on the website is unclear.
 

Q: Are all three drugs covered without cost sharing?

Health plans have to cover at least one of the drugs in this category — Descovy and the brand and generic versions of Truvada — without cost sharing. People may have to jump through some hoops to get approval for a specific drug, however. For example, Oscar plans sold in 18 states cover the three PrEP options without cost sharing. The generic version of Truvada doesn’t require prior authorization by the insurer. But if someone wants to take the name-brand drug, that person has to go through an approval process. Descovy, a newer drug, is available without cost sharing only if people are unable to use Truvada or its generic version because of clinical intolerance or other issues.
 

Q: What about the lab work and clinical visits that are necessary while taking PrEP? Are those services also covered without cost sharing?

That is the thousand-dollar question. People who are taking drugs to prevent HIV infection need to meet with a clinician and have blood work every three months to test for HIV, hepatitis B and sexually transmitted infections, and to check their kidney function.

The task force recommendation doesn’t specify whether these services must also be covered without cost sharing, and advocates say federal guidance is necessary to ensure they are free.

“If you’ve got a high-deductible plan and you’ve got to meet it before those services are covered, that’s going to add up,” said Amy Killelea, senior director of health systems and policy at the National Alliance of State & Territorial AIDS Directors. “We’re trying to emphasize that it’s integral to the intervention itself.”

A handful of states have programs that help people cover their out-of-pocket costs for lab and clinical visits, generally based on income.

There is precedent for including free ancillary care as part of a recommended preventive service. After consumers and advocates complained, the Centers for Medicare & Medicaid Services (CMS) clarified that under the ACA removing a polyp during a screening colonoscopy is considered an integral part of the procedure and patients shouldn’t be charged for it.

CMS officials declined to clarify whether PrEP services such as lab work and clinical visits are to be covered without cost sharing as part of the preventive service and noted that states generally enforce such insurance requirements. “CMS intends to contact state regulators, as appropriate, to discuss issuer’s compliance with the federal requirements and whether issuers need further guidance on which services associated with PrEP must be covered without cost sharing,” the agency said in a statement.
 

Q: What if someone runs into roadblocks getting a plan to cover PrEP or related services without cost sharing?

If an insurer charges for the medication or a follow-up visit, people may have to go through an appeals process to fight it.

“They’d have to appeal to the insurance company and then to the state if they don’t succeed,” said Nadeen Israel, vice president of policy and advocacy at the AIDS Foundation of Chicago. “Most people don’t know to do that.”
 

Q: Are uninsured people also protected by this new cost-sharing change for PrEP?

Unfortunately, no. The ACA requirement to cover recommended preventive services without charging patients applies only to private insurance plans. People without insurance don’t benefit. Gilead, which makes both Truvada and Descovy, has a patient assistance program for the uninsured.
 

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of Kaiser Family Foundation, which is not affiliated with Kaiser Permanente.

Ted Howard started taking Truvada a few years ago because he wanted to protect himself against HIV, the virus that causes AIDS. But the daily pill was so pricey he was seriously thinking about giving it up.

Under his insurance plan, the former flight attendant and customer service instructor owed $500 in copayments every month for the drug and an additional $250 every three months for lab work and clinic visits.

Luckily for Howard, his doctor at Las Vegas’ Huntridge Family Clinic, which specializes in LGBTQ care, enrolled him in a clinical trial that covered his medication and other costs in full.

“If I hadn’t been able to get into the trial, I wouldn’t have kept taking PrEP,” said Howard, 68, using the shorthand term for “preexposure prophylaxis.” Taken daily, these drugs — like Truvada — are more than 90% effective at preventing infection with HIV.

Starting in January of 2021, most people with private insurance will no longer have to decide whether they can afford to protect themselves against HIV. Most health plans must begin to cover the drugs then without charging consumers anything out-of-pocket (some plans already began doing so last year).

Drugs in this category — Truvada, Descovy and, newly available, a generic version of Truvada — received an “A” recommendation by the U.S. Preventive Services Task Force. Under the Affordable Care Act, preventive services that receive an “A” or “B” rating by the task force, a group of medical experts in prevention and primary care, must be covered by most private health plans without making members share the cost, usually through copayments or deductibles. Only plans that are grandfathered under the health law are exempt.

The task force recommended PrEP for people at high risk of HIV infection, including men who have sex with men and injection drug users.

In the United States, more than 1 million people live with HIV, and nearly 40,000 new HIV cases are diagnosed every year. Yet fewer than 10% of people who could benefit from PrEP are taking it. One key reason is that out-of-pocket costs can exceed $1,000 annually, according to a study published in the American Journal of Public Health last year. Required periodic blood tests and doctor visits can add hundreds of dollars to the cost of the drug, and it’s not clear if insurers are required to pick up all those costs.

“Cost sharing has been a problem,” said Michael Crews, policy director at One Colorado, an advocacy group for the LGBTQ community. “It’s not just getting on PrEP and taking a pill. It’s the lab and clinical services. That’s a huge barrier for folks.”

Whether you’re shopping for a new plan during open enrollment or want to check out what your current plan covers, here are answers to questions you may have about the new preventive coverage requirement.
 

Q: How can people find out whether their health plan covers PrEP medications without charge?

The plan’s list of covered drugs, called a formulary, should spell out which drugs are covered, along with details about which drug tier they fall into. Drugs placed in higher tiers generally have higher cost sharing. That list should be online with the plan documents that give coverage details.

Sorting out coverage and cost sharing can be tricky. Both Truvada and Descovy can also be used to treat HIV, and if they are taken for that purpose, a plan may require members to pay some of the cost. But if the drugs are taken to prevent HIV infection, patients shouldn’t owe anything out-of-pocket, no matter which tier they are on.

In a recent analysis of online formularies for plans sold on the ACA marketplaces, Carl Schmid, executive director of the HIV + Hepatitis Policy Institute, found that many plans seemed out of compliance with the requirement to cover PrEP without cost sharing this year.

But representatives for Oscar and Kaiser Permanente, two insurers that were called out in the analysis for lack of compliance, said the drugs are covered without cost sharing in plans nationwide if they are taken to prevent HIV. Schmid later revised his analysis to reflect Oscar’s coverage.

Coverage and cost-sharing information needs to be transparent and easy to find, Schmid said.

“I acted like a shopper of insurance, just like any person would do,” he said. “Even when the information is correct, [it’s so] difficult to find [and there’s] no uniformity.”

It may be necessary to call the insurer directly to confirm coverage details if information on the website is unclear.
 

Q: Are all three drugs covered without cost sharing?

Health plans have to cover at least one of the drugs in this category — Descovy and the brand and generic versions of Truvada — without cost sharing. People may have to jump through some hoops to get approval for a specific drug, however. For example, Oscar plans sold in 18 states cover the three PrEP options without cost sharing. The generic version of Truvada doesn’t require prior authorization by the insurer. But if someone wants to take the name-brand drug, that person has to go through an approval process. Descovy, a newer drug, is available without cost sharing only if people are unable to use Truvada or its generic version because of clinical intolerance or other issues.
 

Q: What about the lab work and clinical visits that are necessary while taking PrEP? Are those services also covered without cost sharing?

That is the thousand-dollar question. People who are taking drugs to prevent HIV infection need to meet with a clinician and have blood work every three months to test for HIV, hepatitis B and sexually transmitted infections, and to check their kidney function.

The task force recommendation doesn’t specify whether these services must also be covered without cost sharing, and advocates say federal guidance is necessary to ensure they are free.

“If you’ve got a high-deductible plan and you’ve got to meet it before those services are covered, that’s going to add up,” said Amy Killelea, senior director of health systems and policy at the National Alliance of State & Territorial AIDS Directors. “We’re trying to emphasize that it’s integral to the intervention itself.”

A handful of states have programs that help people cover their out-of-pocket costs for lab and clinical visits, generally based on income.

There is precedent for including free ancillary care as part of a recommended preventive service. After consumers and advocates complained, the Centers for Medicare & Medicaid Services (CMS) clarified that under the ACA removing a polyp during a screening colonoscopy is considered an integral part of the procedure and patients shouldn’t be charged for it.

CMS officials declined to clarify whether PrEP services such as lab work and clinical visits are to be covered without cost sharing as part of the preventive service and noted that states generally enforce such insurance requirements. “CMS intends to contact state regulators, as appropriate, to discuss issuer’s compliance with the federal requirements and whether issuers need further guidance on which services associated with PrEP must be covered without cost sharing,” the agency said in a statement.
 

Q: What if someone runs into roadblocks getting a plan to cover PrEP or related services without cost sharing?

If an insurer charges for the medication or a follow-up visit, people may have to go through an appeals process to fight it.

“They’d have to appeal to the insurance company and then to the state if they don’t succeed,” said Nadeen Israel, vice president of policy and advocacy at the AIDS Foundation of Chicago. “Most people don’t know to do that.”
 

Q: Are uninsured people also protected by this new cost-sharing change for PrEP?

Unfortunately, no. The ACA requirement to cover recommended preventive services without charging patients applies only to private insurance plans. People without insurance don’t benefit. Gilead, which makes both Truvada and Descovy, has a patient assistance program for the uninsured.
 

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of Kaiser Family Foundation, which is not affiliated with Kaiser Permanente.

Ted Howard started taking Truvada a few years ago because he wanted to protect himself against HIV, the virus that causes AIDS. But the daily pill was so pricey he was seriously thinking about giving it up.

Under his insurance plan, the former flight attendant and customer service instructor owed $500 in copayments every month for the drug and an additional $250 every three months for lab work and clinic visits.

Luckily for Howard, his doctor at Las Vegas’ Huntridge Family Clinic, which specializes in LGBTQ care, enrolled him in a clinical trial that covered his medication and other costs in full.

“If I hadn’t been able to get into the trial, I wouldn’t have kept taking PrEP,” said Howard, 68, using the shorthand term for “preexposure prophylaxis.” Taken daily, these drugs — like Truvada — are more than 90% effective at preventing infection with HIV.

Starting in January of 2021, most people with private insurance will no longer have to decide whether they can afford to protect themselves against HIV. Most health plans must begin to cover the drugs then without charging consumers anything out-of-pocket (some plans already began doing so last year).

Drugs in this category — Truvada, Descovy and, newly available, a generic version of Truvada — received an “A” recommendation by the U.S. Preventive Services Task Force. Under the Affordable Care Act, preventive services that receive an “A” or “B” rating by the task force, a group of medical experts in prevention and primary care, must be covered by most private health plans without making members share the cost, usually through copayments or deductibles. Only plans that are grandfathered under the health law are exempt.

The task force recommended PrEP for people at high risk of HIV infection, including men who have sex with men and injection drug users.

In the United States, more than 1 million people live with HIV, and nearly 40,000 new HIV cases are diagnosed every year. Yet fewer than 10% of people who could benefit from PrEP are taking it. One key reason is that out-of-pocket costs can exceed $1,000 annually, according to a study published in the American Journal of Public Health last year. Required periodic blood tests and doctor visits can add hundreds of dollars to the cost of the drug, and it’s not clear if insurers are required to pick up all those costs.

“Cost sharing has been a problem,” said Michael Crews, policy director at One Colorado, an advocacy group for the LGBTQ community. “It’s not just getting on PrEP and taking a pill. It’s the lab and clinical services. That’s a huge barrier for folks.”

Whether you’re shopping for a new plan during open enrollment or want to check out what your current plan covers, here are answers to questions you may have about the new preventive coverage requirement.
 

Q: How can people find out whether their health plan covers PrEP medications without charge?

The plan’s list of covered drugs, called a formulary, should spell out which drugs are covered, along with details about which drug tier they fall into. Drugs placed in higher tiers generally have higher cost sharing. That list should be online with the plan documents that give coverage details.

Sorting out coverage and cost sharing can be tricky. Both Truvada and Descovy can also be used to treat HIV, and if they are taken for that purpose, a plan may require members to pay some of the cost. But if the drugs are taken to prevent HIV infection, patients shouldn’t owe anything out-of-pocket, no matter which tier they are on.

In a recent analysis of online formularies for plans sold on the ACA marketplaces, Carl Schmid, executive director of the HIV + Hepatitis Policy Institute, found that many plans seemed out of compliance with the requirement to cover PrEP without cost sharing this year.

But representatives for Oscar and Kaiser Permanente, two insurers that were called out in the analysis for lack of compliance, said the drugs are covered without cost sharing in plans nationwide if they are taken to prevent HIV. Schmid later revised his analysis to reflect Oscar’s coverage.

Coverage and cost-sharing information needs to be transparent and easy to find, Schmid said.

“I acted like a shopper of insurance, just like any person would do,” he said. “Even when the information is correct, [it’s so] difficult to find [and there’s] no uniformity.”

It may be necessary to call the insurer directly to confirm coverage details if information on the website is unclear.
 

Q: Are all three drugs covered without cost sharing?

Health plans have to cover at least one of the drugs in this category — Descovy and the brand and generic versions of Truvada — without cost sharing. People may have to jump through some hoops to get approval for a specific drug, however. For example, Oscar plans sold in 18 states cover the three PrEP options without cost sharing. The generic version of Truvada doesn’t require prior authorization by the insurer. But if someone wants to take the name-brand drug, that person has to go through an approval process. Descovy, a newer drug, is available without cost sharing only if people are unable to use Truvada or its generic version because of clinical intolerance or other issues.
 

Q: What about the lab work and clinical visits that are necessary while taking PrEP? Are those services also covered without cost sharing?

That is the thousand-dollar question. People who are taking drugs to prevent HIV infection need to meet with a clinician and have blood work every three months to test for HIV, hepatitis B and sexually transmitted infections, and to check their kidney function.

The task force recommendation doesn’t specify whether these services must also be covered without cost sharing, and advocates say federal guidance is necessary to ensure they are free.

“If you’ve got a high-deductible plan and you’ve got to meet it before those services are covered, that’s going to add up,” said Amy Killelea, senior director of health systems and policy at the National Alliance of State & Territorial AIDS Directors. “We’re trying to emphasize that it’s integral to the intervention itself.”

A handful of states have programs that help people cover their out-of-pocket costs for lab and clinical visits, generally based on income.

There is precedent for including free ancillary care as part of a recommended preventive service. After consumers and advocates complained, the Centers for Medicare & Medicaid Services (CMS) clarified that under the ACA removing a polyp during a screening colonoscopy is considered an integral part of the procedure and patients shouldn’t be charged for it.

CMS officials declined to clarify whether PrEP services such as lab work and clinical visits are to be covered without cost sharing as part of the preventive service and noted that states generally enforce such insurance requirements. “CMS intends to contact state regulators, as appropriate, to discuss issuer’s compliance with the federal requirements and whether issuers need further guidance on which services associated with PrEP must be covered without cost sharing,” the agency said in a statement.
 

Q: What if someone runs into roadblocks getting a plan to cover PrEP or related services without cost sharing?

If an insurer charges for the medication or a follow-up visit, people may have to go through an appeals process to fight it.

“They’d have to appeal to the insurance company and then to the state if they don’t succeed,” said Nadeen Israel, vice president of policy and advocacy at the AIDS Foundation of Chicago. “Most people don’t know to do that.”
 

Q: Are uninsured people also protected by this new cost-sharing change for PrEP?

Unfortunately, no. The ACA requirement to cover recommended preventive services without charging patients applies only to private insurance plans. People without insurance don’t benefit. Gilead, which makes both Truvada and Descovy, has a patient assistance program for the uninsured.
 

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of Kaiser Family Foundation, which is not affiliated with Kaiser Permanente.

When Katherine Frega was diagnosed with Hodgkin lymphoma 8 years ago at the age 17 years, she was so sick that all she could focus on was starting chemotherapy to treat her aggressive blood cancer. It was her dad who thought to ask the oncologist, “How is this treatment going to affect her ability to have children?”

The oncologist discussed the risks but stressed that Ms. Frega needed to start treatment right away.

The question of fertility is often overlooked when young cancer patients are battling a life-threatening illness. And since health insurance doesn’t typically cover fertility preservation care, patients and their families may be deterred by the cost.

But a growing number of states now require plans to cover such services when medically necessary treatment jeopardizes fertility.

Treatment for cancer and other serious conditions involves toxic chemotherapy drugs, radiation, and surgery that can cause infertility in women and men.

The cost to freeze patients’ healthy eggs, sperm, or embryos for future use can be a major barrier, said Eden Cardozo, MD, a reproductive endocrinologist and director of the fertility preservation program at the Women & Infants Fertility Center in Providence, R.I. Dr. Cardozo was instrumental in getting Rhode Island’s law passed last year.

“[Patients] have to move quickly,” she said. “They don’t have time to raise funds from family and friends. They don’t have time to petition their insurance company.”

Reproductive health advocates argue that fertility preservation should be viewed as a core component of cancer care in younger people, not as an optional infertility offering. Some compare this type of coverage with the federal Women’s Health and Cancer Rights Act, which requires plans that cover a patient’s mastectomy to also provide for breast reconstruction.

New laws in Delaware, Illinois, and Maryland require plans to include this benefit. The Delaware law applies to plans issued or renewed after June of this year; the requirement in the other two states starts in 2019. Connecticut and Rhode Island passed similar laws last year. New Jersey lawmakers are considering a bill and advocates in New York plan to make another attempt after both legislative chambers passed fertility preservation bills in the last session but failed to reconcile them.

The state measures don’t apply to companies that are self-funded, meaning they pay their employee claims directly rather than buying state-regulated insurance policies for that purpose. They also don’t apply to government-funded programs such as Medicaid or Tricare.

Although freezing sperm and embryos has been common medical practice for decades, egg freezing was considered experimental by professional groups until 2012. As the technology has improved, the need for insurance coverage has grown, said Joyce Reinecke, executive director of the Alliance for Fertility Preservation, an advocacy group for cancer patients.

When Ms. Frega’s cancer didn’t respond to chemotherapy, her doctors recommended a bone marrow transplant in January 2012. Even if her eggs hadn’t been damaged by the chemotherapy, the transplant would likely cause permanent infertility, she was told. So she took hormones to stimulate her ovaries to produce more eggs, among other things, and seven were retrieved during an outpatient procedure days before her transplant.

Ms. Frega’s parents paid $10,000 for the medications and egg retrieval, a significant amount but less than what many pay. They were aided by Livestrong Fertility, a nonprofit group that provides access to discounted fertility preservation services for cancer patients who meet income guidelines.

Ms. Frega has good insurance through her mother’s employer plan. “They covered everything else, except for this,” she said. “They considered it not medically necessary.”

Cancer-free following two bone marrow transplants, Ms. Frega, now 25 years old, is a third-year medical student at the Upstate Medical University in Syracuse, N.Y. She plans to specialize in oncology.

Between 20% and 70% of cancer patients experience some degree of fertility impairment, according to Dr. Cardozo in Rhode Island. Though they make up the largest at-risk group, the complication isn’t unique to cancer patients. People with other conditions such as lupus and rheumatoid arthritis who are treated with chemotherapy drugs may be affected, as may patients with conditions such as endometriosis who require surgery.

Despite the much-ballyhooed examples of tech companies like Facebook, Apple, and Google that offer egg freezing as an employee perk, cryopreservation, as it’s called, isn’t a typical employee benefit.

Only 6% of large companies with 500 or more workers offer egg freezing for employees or their spouses, according to the 2017 annual employer survey by benefits consultant Mercer. About a quarter cover in vitro fertilization (IVF). About 44% of large employers don’t offer any infertility services, the survey found.

Men face the same infertility risk when they need cancer treatment.

When Blake Hornbrook, an Army medic at Fort Campbell, Ky., had surgery to remove a cancerous testicle in the fall of 2015, he and his wife, Kelsey, were stationed in Germany. Mr. Hornbrook, then 26 years old, looked into fertility preservation while overseas, but the annual storage fee of 1,000 euros (about $1,150) deterred the couple.

He required a second surgery several months later to see if the cancer had spread to his lymph nodes. The couple returned to the United States and drove directly from the airport to a sperm bank in Fairfax, Va. It cost roughly $400 for the initial appointment to provide a sperm specimen and store it, Mr. Hornbrook said.

Tricare covered Mr. Hornbrook’s cancer treatment, but it didn’t pay for fertility preservation or for IVF, which he estimated cost the couple $6,500 in clinic fees. Tricare provided discounts on some of the fertility drugs.

Their daughter, Harper, was born 7 months ago, and Mr. Hornbrook’s cancer remains in remission.

For young cancer patients, the cost of storing the eggs or sperm that have been preserved can add up. Even if a state has a fertility preservation law, it typically doesn’t cover those costs, Ms. Reinecke said.

The Hornbrooks pay $480 annually to store his sperm and $375 to store their remaining embryos. Ms. Frega pays $1,000 annually to store her eggs.

Ms. Frega hopes to be able to conceive naturally and knowing she has frozen eggs available is “relieving, but also anxiety producing,” she said. If she can’t get pregnant later on, she may have to pay $10,000 or more for IVF as well. “That’s what lies ahead,” she said.

A total of 16 states require insurers to offer or cover infertility services to some extent, according to infertility advocacy organization Resolve. Requirements vary: Insurers may have to cover diagnosis or testing for infertility, for example, but not treatments like IVF or fertility medications, said Barbara Collura, president and CEO of Resolve.

Typically, state infertility coverage laws require couples to try to get pregnant for a year or two before they’re eligible for insurance coverage of IVF or other treatments.

That requirement makes little sense for patients trying to preserve their fertility before undergoing medically necessary cancer or other treatment.

“These people aren’t infertile,” said Ms. Collura. “They need to undergo some sort of intervention that is going to impair their future fertility, and what we say is that if it’s medically necessary, they should have a right to have it covered.”

KHN’s coverage of women’s health care issues is supported in part by The David and Lucile Packard Foundation. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

When Katherine Frega was diagnosed with Hodgkin lymphoma 8 years ago at the age 17 years, she was so sick that all she could focus on was starting chemotherapy to treat her aggressive blood cancer. It was her dad who thought to ask the oncologist, “How is this treatment going to affect her ability to have children?”

The oncologist discussed the risks but stressed that Ms. Frega needed to start treatment right away.

The question of fertility is often overlooked when young cancer patients are battling a life-threatening illness. And since health insurance doesn’t typically cover fertility preservation care, patients and their families may be deterred by the cost.

But a growing number of states now require plans to cover such services when medically necessary treatment jeopardizes fertility.

Treatment for cancer and other serious conditions involves toxic chemotherapy drugs, radiation, and surgery that can cause infertility in women and men.

The cost to freeze patients’ healthy eggs, sperm, or embryos for future use can be a major barrier, said Eden Cardozo, MD, a reproductive endocrinologist and director of the fertility preservation program at the Women & Infants Fertility Center in Providence, R.I. Dr. Cardozo was instrumental in getting Rhode Island’s law passed last year.

“[Patients] have to move quickly,” she said. “They don’t have time to raise funds from family and friends. They don’t have time to petition their insurance company.”

Reproductive health advocates argue that fertility preservation should be viewed as a core component of cancer care in younger people, not as an optional infertility offering. Some compare this type of coverage with the federal Women’s Health and Cancer Rights Act, which requires plans that cover a patient’s mastectomy to also provide for breast reconstruction.

New laws in Delaware, Illinois, and Maryland require plans to include this benefit. The Delaware law applies to plans issued or renewed after June of this year; the requirement in the other two states starts in 2019. Connecticut and Rhode Island passed similar laws last year. New Jersey lawmakers are considering a bill and advocates in New York plan to make another attempt after both legislative chambers passed fertility preservation bills in the last session but failed to reconcile them.

The state measures don’t apply to companies that are self-funded, meaning they pay their employee claims directly rather than buying state-regulated insurance policies for that purpose. They also don’t apply to government-funded programs such as Medicaid or Tricare.

Although freezing sperm and embryos has been common medical practice for decades, egg freezing was considered experimental by professional groups until 2012. As the technology has improved, the need for insurance coverage has grown, said Joyce Reinecke, executive director of the Alliance for Fertility Preservation, an advocacy group for cancer patients.

When Ms. Frega’s cancer didn’t respond to chemotherapy, her doctors recommended a bone marrow transplant in January 2012. Even if her eggs hadn’t been damaged by the chemotherapy, the transplant would likely cause permanent infertility, she was told. So she took hormones to stimulate her ovaries to produce more eggs, among other things, and seven were retrieved during an outpatient procedure days before her transplant.

Ms. Frega’s parents paid $10,000 for the medications and egg retrieval, a significant amount but less than what many pay. They were aided by Livestrong Fertility, a nonprofit group that provides access to discounted fertility preservation services for cancer patients who meet income guidelines.

Ms. Frega has good insurance through her mother’s employer plan. “They covered everything else, except for this,” she said. “They considered it not medically necessary.”

Cancer-free following two bone marrow transplants, Ms. Frega, now 25 years old, is a third-year medical student at the Upstate Medical University in Syracuse, N.Y. She plans to specialize in oncology.

Between 20% and 70% of cancer patients experience some degree of fertility impairment, according to Dr. Cardozo in Rhode Island. Though they make up the largest at-risk group, the complication isn’t unique to cancer patients. People with other conditions such as lupus and rheumatoid arthritis who are treated with chemotherapy drugs may be affected, as may patients with conditions such as endometriosis who require surgery.

Despite the much-ballyhooed examples of tech companies like Facebook, Apple, and Google that offer egg freezing as an employee perk, cryopreservation, as it’s called, isn’t a typical employee benefit.

Only 6% of large companies with 500 or more workers offer egg freezing for employees or their spouses, according to the 2017 annual employer survey by benefits consultant Mercer. About a quarter cover in vitro fertilization (IVF). About 44% of large employers don’t offer any infertility services, the survey found.

Men face the same infertility risk when they need cancer treatment.

When Blake Hornbrook, an Army medic at Fort Campbell, Ky., had surgery to remove a cancerous testicle in the fall of 2015, he and his wife, Kelsey, were stationed in Germany. Mr. Hornbrook, then 26 years old, looked into fertility preservation while overseas, but the annual storage fee of 1,000 euros (about $1,150) deterred the couple.

He required a second surgery several months later to see if the cancer had spread to his lymph nodes. The couple returned to the United States and drove directly from the airport to a sperm bank in Fairfax, Va. It cost roughly $400 for the initial appointment to provide a sperm specimen and store it, Mr. Hornbrook said.

Tricare covered Mr. Hornbrook’s cancer treatment, but it didn’t pay for fertility preservation or for IVF, which he estimated cost the couple $6,500 in clinic fees. Tricare provided discounts on some of the fertility drugs.

Their daughter, Harper, was born 7 months ago, and Mr. Hornbrook’s cancer remains in remission.

For young cancer patients, the cost of storing the eggs or sperm that have been preserved can add up. Even if a state has a fertility preservation law, it typically doesn’t cover those costs, Ms. Reinecke said.

The Hornbrooks pay $480 annually to store his sperm and $375 to store their remaining embryos. Ms. Frega pays $1,000 annually to store her eggs.

Ms. Frega hopes to be able to conceive naturally and knowing she has frozen eggs available is “relieving, but also anxiety producing,” she said. If she can’t get pregnant later on, she may have to pay $10,000 or more for IVF as well. “That’s what lies ahead,” she said.

A total of 16 states require insurers to offer or cover infertility services to some extent, according to infertility advocacy organization Resolve. Requirements vary: Insurers may have to cover diagnosis or testing for infertility, for example, but not treatments like IVF or fertility medications, said Barbara Collura, president and CEO of Resolve.

Typically, state infertility coverage laws require couples to try to get pregnant for a year or two before they’re eligible for insurance coverage of IVF or other treatments.

That requirement makes little sense for patients trying to preserve their fertility before undergoing medically necessary cancer or other treatment.

“These people aren’t infertile,” said Ms. Collura. “They need to undergo some sort of intervention that is going to impair their future fertility, and what we say is that if it’s medically necessary, they should have a right to have it covered.”

KHN’s coverage of women’s health care issues is supported in part by The David and Lucile Packard Foundation. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

When Katherine Frega was diagnosed with Hodgkin lymphoma 8 years ago at the age 17 years, she was so sick that all she could focus on was starting chemotherapy to treat her aggressive blood cancer. It was her dad who thought to ask the oncologist, “How is this treatment going to affect her ability to have children?”

The oncologist discussed the risks but stressed that Ms. Frega needed to start treatment right away.

The question of fertility is often overlooked when young cancer patients are battling a life-threatening illness. And since health insurance doesn’t typically cover fertility preservation care, patients and their families may be deterred by the cost.

But a growing number of states now require plans to cover such services when medically necessary treatment jeopardizes fertility.

Treatment for cancer and other serious conditions involves toxic chemotherapy drugs, radiation, and surgery that can cause infertility in women and men.

The cost to freeze patients’ healthy eggs, sperm, or embryos for future use can be a major barrier, said Eden Cardozo, MD, a reproductive endocrinologist and director of the fertility preservation program at the Women & Infants Fertility Center in Providence, R.I. Dr. Cardozo was instrumental in getting Rhode Island’s law passed last year.

“[Patients] have to move quickly,” she said. “They don’t have time to raise funds from family and friends. They don’t have time to petition their insurance company.”

Reproductive health advocates argue that fertility preservation should be viewed as a core component of cancer care in younger people, not as an optional infertility offering. Some compare this type of coverage with the federal Women’s Health and Cancer Rights Act, which requires plans that cover a patient’s mastectomy to also provide for breast reconstruction.

New laws in Delaware, Illinois, and Maryland require plans to include this benefit. The Delaware law applies to plans issued or renewed after June of this year; the requirement in the other two states starts in 2019. Connecticut and Rhode Island passed similar laws last year. New Jersey lawmakers are considering a bill and advocates in New York plan to make another attempt after both legislative chambers passed fertility preservation bills in the last session but failed to reconcile them.

The state measures don’t apply to companies that are self-funded, meaning they pay their employee claims directly rather than buying state-regulated insurance policies for that purpose. They also don’t apply to government-funded programs such as Medicaid or Tricare.

Although freezing sperm and embryos has been common medical practice for decades, egg freezing was considered experimental by professional groups until 2012. As the technology has improved, the need for insurance coverage has grown, said Joyce Reinecke, executive director of the Alliance for Fertility Preservation, an advocacy group for cancer patients.

When Ms. Frega’s cancer didn’t respond to chemotherapy, her doctors recommended a bone marrow transplant in January 2012. Even if her eggs hadn’t been damaged by the chemotherapy, the transplant would likely cause permanent infertility, she was told. So she took hormones to stimulate her ovaries to produce more eggs, among other things, and seven were retrieved during an outpatient procedure days before her transplant.

Ms. Frega’s parents paid $10,000 for the medications and egg retrieval, a significant amount but less than what many pay. They were aided by Livestrong Fertility, a nonprofit group that provides access to discounted fertility preservation services for cancer patients who meet income guidelines.

Ms. Frega has good insurance through her mother’s employer plan. “They covered everything else, except for this,” she said. “They considered it not medically necessary.”

Cancer-free following two bone marrow transplants, Ms. Frega, now 25 years old, is a third-year medical student at the Upstate Medical University in Syracuse, N.Y. She plans to specialize in oncology.

Between 20% and 70% of cancer patients experience some degree of fertility impairment, according to Dr. Cardozo in Rhode Island. Though they make up the largest at-risk group, the complication isn’t unique to cancer patients. People with other conditions such as lupus and rheumatoid arthritis who are treated with chemotherapy drugs may be affected, as may patients with conditions such as endometriosis who require surgery.

Despite the much-ballyhooed examples of tech companies like Facebook, Apple, and Google that offer egg freezing as an employee perk, cryopreservation, as it’s called, isn’t a typical employee benefit.

Only 6% of large companies with 500 or more workers offer egg freezing for employees or their spouses, according to the 2017 annual employer survey by benefits consultant Mercer. About a quarter cover in vitro fertilization (IVF). About 44% of large employers don’t offer any infertility services, the survey found.

Men face the same infertility risk when they need cancer treatment.

When Blake Hornbrook, an Army medic at Fort Campbell, Ky., had surgery to remove a cancerous testicle in the fall of 2015, he and his wife, Kelsey, were stationed in Germany. Mr. Hornbrook, then 26 years old, looked into fertility preservation while overseas, but the annual storage fee of 1,000 euros (about $1,150) deterred the couple.

He required a second surgery several months later to see if the cancer had spread to his lymph nodes. The couple returned to the United States and drove directly from the airport to a sperm bank in Fairfax, Va. It cost roughly $400 for the initial appointment to provide a sperm specimen and store it, Mr. Hornbrook said.

Tricare covered Mr. Hornbrook’s cancer treatment, but it didn’t pay for fertility preservation or for IVF, which he estimated cost the couple $6,500 in clinic fees. Tricare provided discounts on some of the fertility drugs.

Their daughter, Harper, was born 7 months ago, and Mr. Hornbrook’s cancer remains in remission.

For young cancer patients, the cost of storing the eggs or sperm that have been preserved can add up. Even if a state has a fertility preservation law, it typically doesn’t cover those costs, Ms. Reinecke said.

The Hornbrooks pay $480 annually to store his sperm and $375 to store their remaining embryos. Ms. Frega pays $1,000 annually to store her eggs.

Ms. Frega hopes to be able to conceive naturally and knowing she has frozen eggs available is “relieving, but also anxiety producing,” she said. If she can’t get pregnant later on, she may have to pay $10,000 or more for IVF as well. “That’s what lies ahead,” she said.

A total of 16 states require insurers to offer or cover infertility services to some extent, according to infertility advocacy organization Resolve. Requirements vary: Insurers may have to cover diagnosis or testing for infertility, for example, but not treatments like IVF or fertility medications, said Barbara Collura, president and CEO of Resolve.

Typically, state infertility coverage laws require couples to try to get pregnant for a year or two before they’re eligible for insurance coverage of IVF or other treatments.

That requirement makes little sense for patients trying to preserve their fertility before undergoing medically necessary cancer or other treatment.

“These people aren’t infertile,” said Ms. Collura. “They need to undergo some sort of intervention that is going to impair their future fertility, and what we say is that if it’s medically necessary, they should have a right to have it covered.”

KHN’s coverage of women’s health care issues is supported in part by The David and Lucile Packard Foundation. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

The woman arrived at the emergency department at Huntington Hospital on New York’s Long Island after she was hit by her boyfriend during an argument. Her situation raised concerns among the medical staff, which had recently been trained to be on the lookout for signs of sex trafficking.

VIPDesignUSA/Getty Images

An undocumented immigrant from El Salvador, she worked at a local “cantina” frequented by immigrants. Her job was to get patrons drinks and to dance with them, but many workers in those jobs are expected to offer sex, too. Her boyfriend didn’t want her to work there and that led to the fight, one doctor recalled.

As part of the intake process, the emergency staff asked the 36-year-old woman a series of questions about whether she’d ever had sex for money or whether she had to give someone else part of what she earned, among other things. The screening questions were part of a new program at Northwell Health, a 23-hospital system in the New York metro area that includes Huntington Hospital, to train staff and provide them with tools to identify and support victims of human trafficking.

There are no hard figures for how many people are involved in human trafficking, the term used when individuals are forced to work or have sex for someone else’s commercial benefit. Polaris, a Washington-based nonprofit that advocates for these people and runs help lines for them, said calls and texts to its national hotlines have steadily ticked up in recent years, increasing the number of cases 13% between 2016 and 2017, to 8,759.

But health care providers frequently fail to recognize these patients’ situation. According to a 2014 survey of about 100 survivors of sex trafficking, 88 percent said that while they were being trafficked they had contact with a health care provider, typically someone in an emergency department.

“When trafficking victims come through the health care system but we don’t identify them, it’s a big missed opportunity,” said Santhosh K. Paulus, MD, a family physician who is the site director of the Huntington Hospital’s family medicine residency program and who started the program at Northwell.

Northwell is one of a growing number of hospitals and health care systems that are putting such programs in place. They want to alert staff to be on the lookout for trafficking, much as they watch for signs of child abuse, domestic violence, and elder abuse.

Since last spring, nearly 300 staff members at Huntington Hospital and a family clinic have received training in how to spot trafficking victims and how to help them.

Training is given not only to doctors and nurses but also to registration and reception staff, social workers and security guards. Restore NYC, an organization that assists people caught up in sex trafficking, provided the initial training to key staff, and a hospital task force trains the others. During the next few years, similar efforts will be rolled out at all of Northwell’s 23 hospitals, Paulus said.

Identifying victims of trafficking is not unlike identifying victims of other forms of violence, said Wendy L. Macias-Konstantopoulos, MD, director of the human trafficking initiative at Massachusetts General Hospital in Boston.

One of the big red flags is when people delay coming in for medical care, such as waiting weeks to come in to get an injured ankle or sexually transmitted infection checked out, Dr. Macias-Konstantopoulos said. Or it may be a pattern of injuries that don’t make sense. Sometimes people are reluctant to explain their injury, or they come in with someone who seems overbearing.

“Having a high index of suspicion is the first step,” she said. “If we’re not asking about it, we’re just not going to see it.”

Starting in October, health care providers can also use new diagnosis codes in their records that differentiate trafficking from other types of abuse. This will help track the number of victims and provide appropriate treatment.

Asking may not be enough, however. Depending on what’s going on in their lives, these patients may not be willing or ready to acknowledge that they need help, said Holly Gibbs, human trafficking response program director for Dignity Health, a health care system with nearly 40 hospitals in California, Nevada and Arizona.

Ms. Gibbs knows the issue well. She was forced briefly into prostitution in Atlantic City, N.J., after meeting a man at a shopping mall as a 14-year-old and running away with him. The man persuaded Ms. Gibbs to go with him with promises of a new, glamorous life as a musician or model. At the time, Ms. Gibbs said, she thought that what happened to her was her own fault, a result of choices she made. No health care or law enforcement professional connected her to social services that could have helped her understand otherwise. She was reunited with her family by law enforcement personnel, who arrested the man. He was later convicted.

Dignity Health has implemented a human trafficking response program in the emergency departments and labor and delivery areas of each of its hospitals. Now it’s rolling out the program at clinics and physicians’ offices as well.

A key priority is to help clinicians know how to talk to patients about any violence they may be facing and to connect the patients with outside sources of help.

But in the end, if these patients don’t want assistance, “you respect their wishes,” Ms. Gibbs said. “They may not be ready to accept help now, but you may plant seeds so they’ll be able to accept it later on.”
 

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

The woman arrived at the emergency department at Huntington Hospital on New York’s Long Island after she was hit by her boyfriend during an argument. Her situation raised concerns among the medical staff, which had recently been trained to be on the lookout for signs of sex trafficking.

VIPDesignUSA/Getty Images

An undocumented immigrant from El Salvador, she worked at a local “cantina” frequented by immigrants. Her job was to get patrons drinks and to dance with them, but many workers in those jobs are expected to offer sex, too. Her boyfriend didn’t want her to work there and that led to the fight, one doctor recalled.

As part of the intake process, the emergency staff asked the 36-year-old woman a series of questions about whether she’d ever had sex for money or whether she had to give someone else part of what she earned, among other things. The screening questions were part of a new program at Northwell Health, a 23-hospital system in the New York metro area that includes Huntington Hospital, to train staff and provide them with tools to identify and support victims of human trafficking.

There are no hard figures for how many people are involved in human trafficking, the term used when individuals are forced to work or have sex for someone else’s commercial benefit. Polaris, a Washington-based nonprofit that advocates for these people and runs help lines for them, said calls and texts to its national hotlines have steadily ticked up in recent years, increasing the number of cases 13% between 2016 and 2017, to 8,759.

But health care providers frequently fail to recognize these patients’ situation. According to a 2014 survey of about 100 survivors of sex trafficking, 88 percent said that while they were being trafficked they had contact with a health care provider, typically someone in an emergency department.

“When trafficking victims come through the health care system but we don’t identify them, it’s a big missed opportunity,” said Santhosh K. Paulus, MD, a family physician who is the site director of the Huntington Hospital’s family medicine residency program and who started the program at Northwell.

Northwell is one of a growing number of hospitals and health care systems that are putting such programs in place. They want to alert staff to be on the lookout for trafficking, much as they watch for signs of child abuse, domestic violence, and elder abuse.

Since last spring, nearly 300 staff members at Huntington Hospital and a family clinic have received training in how to spot trafficking victims and how to help them.

Training is given not only to doctors and nurses but also to registration and reception staff, social workers and security guards. Restore NYC, an organization that assists people caught up in sex trafficking, provided the initial training to key staff, and a hospital task force trains the others. During the next few years, similar efforts will be rolled out at all of Northwell’s 23 hospitals, Paulus said.

Identifying victims of trafficking is not unlike identifying victims of other forms of violence, said Wendy L. Macias-Konstantopoulos, MD, director of the human trafficking initiative at Massachusetts General Hospital in Boston.

One of the big red flags is when people delay coming in for medical care, such as waiting weeks to come in to get an injured ankle or sexually transmitted infection checked out, Dr. Macias-Konstantopoulos said. Or it may be a pattern of injuries that don’t make sense. Sometimes people are reluctant to explain their injury, or they come in with someone who seems overbearing.

“Having a high index of suspicion is the first step,” she said. “If we’re not asking about it, we’re just not going to see it.”

Starting in October, health care providers can also use new diagnosis codes in their records that differentiate trafficking from other types of abuse. This will help track the number of victims and provide appropriate treatment.

Asking may not be enough, however. Depending on what’s going on in their lives, these patients may not be willing or ready to acknowledge that they need help, said Holly Gibbs, human trafficking response program director for Dignity Health, a health care system with nearly 40 hospitals in California, Nevada and Arizona.

Ms. Gibbs knows the issue well. She was forced briefly into prostitution in Atlantic City, N.J., after meeting a man at a shopping mall as a 14-year-old and running away with him. The man persuaded Ms. Gibbs to go with him with promises of a new, glamorous life as a musician or model. At the time, Ms. Gibbs said, she thought that what happened to her was her own fault, a result of choices she made. No health care or law enforcement professional connected her to social services that could have helped her understand otherwise. She was reunited with her family by law enforcement personnel, who arrested the man. He was later convicted.

Dignity Health has implemented a human trafficking response program in the emergency departments and labor and delivery areas of each of its hospitals. Now it’s rolling out the program at clinics and physicians’ offices as well.

A key priority is to help clinicians know how to talk to patients about any violence they may be facing and to connect the patients with outside sources of help.

But in the end, if these patients don’t want assistance, “you respect their wishes,” Ms. Gibbs said. “They may not be ready to accept help now, but you may plant seeds so they’ll be able to accept it later on.”
 

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

The woman arrived at the emergency department at Huntington Hospital on New York’s Long Island after she was hit by her boyfriend during an argument. Her situation raised concerns among the medical staff, which had recently been trained to be on the lookout for signs of sex trafficking.

VIPDesignUSA/Getty Images

An undocumented immigrant from El Salvador, she worked at a local “cantina” frequented by immigrants. Her job was to get patrons drinks and to dance with them, but many workers in those jobs are expected to offer sex, too. Her boyfriend didn’t want her to work there and that led to the fight, one doctor recalled.

As part of the intake process, the emergency staff asked the 36-year-old woman a series of questions about whether she’d ever had sex for money or whether she had to give someone else part of what she earned, among other things. The screening questions were part of a new program at Northwell Health, a 23-hospital system in the New York metro area that includes Huntington Hospital, to train staff and provide them with tools to identify and support victims of human trafficking.

There are no hard figures for how many people are involved in human trafficking, the term used when individuals are forced to work or have sex for someone else’s commercial benefit. Polaris, a Washington-based nonprofit that advocates for these people and runs help lines for them, said calls and texts to its national hotlines have steadily ticked up in recent years, increasing the number of cases 13% between 2016 and 2017, to 8,759.

But health care providers frequently fail to recognize these patients’ situation. According to a 2014 survey of about 100 survivors of sex trafficking, 88 percent said that while they were being trafficked they had contact with a health care provider, typically someone in an emergency department.

“When trafficking victims come through the health care system but we don’t identify them, it’s a big missed opportunity,” said Santhosh K. Paulus, MD, a family physician who is the site director of the Huntington Hospital’s family medicine residency program and who started the program at Northwell.

Northwell is one of a growing number of hospitals and health care systems that are putting such programs in place. They want to alert staff to be on the lookout for trafficking, much as they watch for signs of child abuse, domestic violence, and elder abuse.

Since last spring, nearly 300 staff members at Huntington Hospital and a family clinic have received training in how to spot trafficking victims and how to help them.

Training is given not only to doctors and nurses but also to registration and reception staff, social workers and security guards. Restore NYC, an organization that assists people caught up in sex trafficking, provided the initial training to key staff, and a hospital task force trains the others. During the next few years, similar efforts will be rolled out at all of Northwell’s 23 hospitals, Paulus said.

Identifying victims of trafficking is not unlike identifying victims of other forms of violence, said Wendy L. Macias-Konstantopoulos, MD, director of the human trafficking initiative at Massachusetts General Hospital in Boston.

One of the big red flags is when people delay coming in for medical care, such as waiting weeks to come in to get an injured ankle or sexually transmitted infection checked out, Dr. Macias-Konstantopoulos said. Or it may be a pattern of injuries that don’t make sense. Sometimes people are reluctant to explain their injury, or they come in with someone who seems overbearing.

“Having a high index of suspicion is the first step,” she said. “If we’re not asking about it, we’re just not going to see it.”

Starting in October, health care providers can also use new diagnosis codes in their records that differentiate trafficking from other types of abuse. This will help track the number of victims and provide appropriate treatment.

Asking may not be enough, however. Depending on what’s going on in their lives, these patients may not be willing or ready to acknowledge that they need help, said Holly Gibbs, human trafficking response program director for Dignity Health, a health care system with nearly 40 hospitals in California, Nevada and Arizona.

Ms. Gibbs knows the issue well. She was forced briefly into prostitution in Atlantic City, N.J., after meeting a man at a shopping mall as a 14-year-old and running away with him. The man persuaded Ms. Gibbs to go with him with promises of a new, glamorous life as a musician or model. At the time, Ms. Gibbs said, she thought that what happened to her was her own fault, a result of choices she made. No health care or law enforcement professional connected her to social services that could have helped her understand otherwise. She was reunited with her family by law enforcement personnel, who arrested the man. He was later convicted.

Dignity Health has implemented a human trafficking response program in the emergency departments and labor and delivery areas of each of its hospitals. Now it’s rolling out the program at clinics and physicians’ offices as well.

A key priority is to help clinicians know how to talk to patients about any violence they may be facing and to connect the patients with outside sources of help.

But in the end, if these patients don’t want assistance, “you respect their wishes,” Ms. Gibbs said. “They may not be ready to accept help now, but you may plant seeds so they’ll be able to accept it later on.”
 

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

On an afternoon a few weeks ago, Faithe Craig noticed that her temperature had spiked to just above 100 degrees. For most people, the change might not be cause for alarm, but Ms. Craig is being treated for stage III breast cancer, and any temperature change could signal a serious problem.

She called her nurse at the hospital clinic where she gets care at the University of Texas Southwestern Medical Center, Dallas, who told her to come in immediately for cancer urgent-care services at the hospital’s hematology-oncology clinic.

mgcatfish/Thinkstock

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

On an afternoon a few weeks ago, Faithe Craig noticed that her temperature had spiked to just above 100 degrees. For most people, the change might not be cause for alarm, but Ms. Craig is being treated for stage III breast cancer, and any temperature change could signal a serious problem.

She called her nurse at the hospital clinic where she gets care at the University of Texas Southwestern Medical Center, Dallas, who told her to come in immediately for cancer urgent-care services at the hospital’s hematology-oncology clinic.

mgcatfish/Thinkstock

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

On an afternoon a few weeks ago, Faithe Craig noticed that her temperature had spiked to just above 100 degrees. For most people, the change might not be cause for alarm, but Ms. Craig is being treated for stage III breast cancer, and any temperature change could signal a serious problem.

She called her nurse at the hospital clinic where she gets care at the University of Texas Southwestern Medical Center, Dallas, who told her to come in immediately for cancer urgent-care services at the hospital’s hematology-oncology clinic.

mgcatfish/Thinkstock

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

Limiting the number of foreign doctors who can get visas to practice in the United States could have a significant impact on certain hospitals and states that rely on them, according to a new study.

The research, published online in JAMA this week, found that more than 2,100 U.S. employers were certified to fill nearly 10,500 physician jobs nationwide, in 2016. That represents 1.4% of the physician workforce overall. There were wide variations by state and employer, however (JAMA. 2017 Apr 17. doi: 10.1001/jama.2017.4877).

Employers in New York, Michigan and Illinois accounted for the most H-1B visa applications for foreign physicians, nearly a third of the total. North Dakota, however, had the most applicants as a percentage of its physician workforce: 4.7%.

The top three employers that submitted applications for the most doctors through the visa program were William Beaumont Hospital in Royal Oak, Mich., with 470 physician applications, Bronx-Lebanon (N.Y.) Hospital Center, with 213, and Cleveland Clinic Foundation, with 180.

“People underestimate the fragility of certain hospitals and their reliance on certain physicians for their functioning,” said study coauthor Peter Kahn, who graduates from Albert Einstein College of Medicine, New York, this spring.

The H-1B visa program allows employers to hire highly skilled professionals from abroad to fill employment gaps in the United States, typically in high-tech, science, engineering, and math jobs. But hospitals use the program as well, often to recruit doctors to serve in rural or underserved urban areas. The number of visas is capped at 85,000 annually.

That could change. On Tuesday, President Donald Trump signed an executive order reiterating his administration’s priority to buy American goods and hire American workers. Among other things, it requires federal agencies to suggest reforms to the H-1B visa program to ensure the visas are awarded appropriately.
 

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

Limiting the number of foreign doctors who can get visas to practice in the United States could have a significant impact on certain hospitals and states that rely on them, according to a new study.

The research, published online in JAMA this week, found that more than 2,100 U.S. employers were certified to fill nearly 10,500 physician jobs nationwide, in 2016. That represents 1.4% of the physician workforce overall. There were wide variations by state and employer, however (JAMA. 2017 Apr 17. doi: 10.1001/jama.2017.4877).

Employers in New York, Michigan and Illinois accounted for the most H-1B visa applications for foreign physicians, nearly a third of the total. North Dakota, however, had the most applicants as a percentage of its physician workforce: 4.7%.

The top three employers that submitted applications for the most doctors through the visa program were William Beaumont Hospital in Royal Oak, Mich., with 470 physician applications, Bronx-Lebanon (N.Y.) Hospital Center, with 213, and Cleveland Clinic Foundation, with 180.

“People underestimate the fragility of certain hospitals and their reliance on certain physicians for their functioning,” said study coauthor Peter Kahn, who graduates from Albert Einstein College of Medicine, New York, this spring.

The H-1B visa program allows employers to hire highly skilled professionals from abroad to fill employment gaps in the United States, typically in high-tech, science, engineering, and math jobs. But hospitals use the program as well, often to recruit doctors to serve in rural or underserved urban areas. The number of visas is capped at 85,000 annually.

That could change. On Tuesday, President Donald Trump signed an executive order reiterating his administration’s priority to buy American goods and hire American workers. Among other things, it requires federal agencies to suggest reforms to the H-1B visa program to ensure the visas are awarded appropriately.
 

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

Limiting the number of foreign doctors who can get visas to practice in the United States could have a significant impact on certain hospitals and states that rely on them, according to a new study.

The research, published online in JAMA this week, found that more than 2,100 U.S. employers were certified to fill nearly 10,500 physician jobs nationwide, in 2016. That represents 1.4% of the physician workforce overall. There were wide variations by state and employer, however (JAMA. 2017 Apr 17. doi: 10.1001/jama.2017.4877).

Employers in New York, Michigan and Illinois accounted for the most H-1B visa applications for foreign physicians, nearly a third of the total. North Dakota, however, had the most applicants as a percentage of its physician workforce: 4.7%.

The top three employers that submitted applications for the most doctors through the visa program were William Beaumont Hospital in Royal Oak, Mich., with 470 physician applications, Bronx-Lebanon (N.Y.) Hospital Center, with 213, and Cleveland Clinic Foundation, with 180.

“People underestimate the fragility of certain hospitals and their reliance on certain physicians for their functioning,” said study coauthor Peter Kahn, who graduates from Albert Einstein College of Medicine, New York, this spring.

The H-1B visa program allows employers to hire highly skilled professionals from abroad to fill employment gaps in the United States, typically in high-tech, science, engineering, and math jobs. But hospitals use the program as well, often to recruit doctors to serve in rural or underserved urban areas. The number of visas is capped at 85,000 annually.

That could change. On Tuesday, President Donald Trump signed an executive order reiterating his administration’s priority to buy American goods and hire American workers. Among other things, it requires federal agencies to suggest reforms to the H-1B visa program to ensure the visas are awarded appropriately.
 

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