With sexually transmitted infections off the charts, California pushes at-home tests

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Changed
Mon, 01/10/2022 - 10:26

 



SACRAMENTO, CALIF. – California has become the first state to require health insurance plans to cover at-home tests for sexually transmitted infections such as HIV, chlamydia, and syphilis – which could help quell the STI epidemic that has raged nearly unchecked as public health departments have focused on COVID-19.

The rule, part of a broader law addressing the STI epidemic, took effect Jan. 1 for people with state-regulated private insurance plans and will kick in sometime later for the millions of low-income Californians enrolled in the state’s Medicaid program.

By making it easier and cheaper for Californians to self-administer tests in the privacy of their homes, the provision could bring better disease monitoring to rural and underserved parts of the state, reduce the stigma patients experience when seeking care, and give them more control over their health, say experts on infectious diseases.

“This is the first law of its kind, and I’d say it’s kind of cutting-edge,” said Stephanie Arnold Pang, senior director of policy and government relations for the National Coalition of STD Directors. “We want to bring down every single barrier for someone to get STI testing, and out-of-pocket cost is a huge factor.”

But being first has its downsides. Because the concept of insurance coverage for home STI tests is so new, the state’s Medicaid program, Medi-Cal, could not establish by Jan. 1 the billing codes it needs to start paying for tests. Federal regulators also haven’t approved the tests for home use, which could make labs reluctant to process them. And a state analysis predicts most in-network health care providers won’t start prescribing home tests for at least a year until they adjust their billing and other practices.

Nevertheless, the situation is urgent and requires action, said state Sen. Richard Pan (D-Sacramento), a pediatrician who wrote the law.

“We have children born in California with syphilis,” Dr. Pan said. “You’d think that went away in the Victorian era.”

Even before COVID, sexually transmitted infections hit all-time highs in the United States and California for 6 years in a row, according to 2019 data from the Centers for Disease Control and Prevention. Rates of congenital syphilis, which babies contract from their mothers, illustrate the severity of the STI epidemic: Cases were up 279% from 2015 to 2019 nationally and 232% in California. Of the 445 cases of congenital syphilis in California in 2019, 37 were stillbirths.

The pandemic only worsened the problem because health departments were overwhelmed responding to the COVID emergency, and stay-at-home orders kept people away from clinics.

In surveys of public health programs across the country since May 2020, the National Coalition of STD Directors found that most respondents – up to 78% in one survey – have diverted some of their STI workforces to test and monitor COVID. A report that accompanied the most recent survey found that some STIs were “completely unchecked” because of reductions in clinic hours, diversion of resources, shortages of testing kits and staff burnout.

Some at-home STI tests screen for a single disease but other kits can collect and send samples to check for a variety of infections. Depending on the test, patients collect a drop of blood with a lancet, or swab their mouth, vagina, anus, or penis.

Some tests require patients to send samples to a lab for analysis, while some oral HIV tests give results at home in a few minutes.

Ivan Beas, a 25-year-old graduate student at University of California, Los Angeles, was getting tested frequently as part of a 2-year research study. When clinics closed during the pandemic, researchers sent him a home kit.

The kit, which tests for HIV, hepatitis C, herpes, syphilis, chlamydia, gonorrhea, and trichomoniasis, was packaged discreetly and came with easy instructions. It took Mr. Beas about 10 minutes to prick his finger, swab his mouth and send the samples to the lab.

Mr. Beas wanted to continue screening himself every few months after the study ended, he said, but the kit he used retails for $289, which is out of reach for him.

The last time he went to a clinic in person, “I spent 2 hours waiting to even be seen by a doctor because of how busy they are,” he said. Until Medi-Cal begins covering home tests, he said, he will have to find time to get tested for free at a Planned Parenthood clinic.

“If insurance were to cover it, I’d definitely do it more,” he said.

Under California’s new law, plans regulated by the state must cover home STI tests when ordered by a health care provider.  

Privately insured Californians can take advantage of the coverage immediately. How much they will owe out-of-pocket for the tests – if anything – depends on the type of plan they have, whether their provider is in-network, and whether they fall into a category the federal government has designated for free screening.

Medi-Cal patients almost never face out-of-pocket expenses, but they will have to wait for coverage because the Department of Health Care Services, which administers Medi-Cal, is working with the American Medical Association and the federal government to create billing codes. The reimbursement rates for those codes will then need federal approval.

The state doesn’t know how long that process will take, according to department spokesperson Anthony Cava.

The rule does not apply to the millions of Californians whose job-based health insurance plans are regulated by the federal government.

Other states and organizations have experimented with at-home STI tests. The public health departments in Alabama and the District of Columbia send free kits to residents who request them, but neither jurisdiction requires insurance coverage for them. The National Coalition of STD Directors is sending free kits to people through health departments in Philadelphia; Iowa; Virginia; Indiana; Puerto Rico; and Navajo County, Arizona. The list of recipients is expected to grow this month.

Iwantthekit.org, a project of Johns Hopkins University, has been sending free kits to Maryland residents since 2004, and to Alaskans since 2011. The program is funded by grants and works with local health departments.

Charlotte Gaydos, cofounder of the project, said that requests for test kits during the pandemic nearly tripled – and that she would expand to every state if she could bill insurance the way the California law mandates.

The tests fall into a murky regulatory area. While they have been approved by the Food and Drug Administration, none have been cleared for use at home. Patients are supposed to collect their own samples within the walls of a health facility, and some labs may not analyze samples collected at home.

Public health officials cited other potential challenges: Patients may not have the same access to counseling, treatment, or referrals to other services such as food banks that they would receive at clinics. And although patients are supposed to self-report the results of their tests to public health authorities, some people won’t follow through.

Vlad Carrillo, 31, experienced such trade-offs recently. Mr. Carrillo used to get tested at a San Francisco clinic, where they could get counseling and other services. But Carrillo lost their apartment during the pandemic and moved about 7 hours away to Bishop, the only incorporated city in rural Inyo County.

“Being away from the city, it took me a whole year to find a way to get tested,” Carrillo said.

Carrillo eventually got the kit through the mail, avoiding the stigma of going to the clinic in Bishop, which is “more focused on straight stuff,” like preventing pregnancy. Without the test, Carrillo couldn’t get PrEP, a medication to prevent HIV.

“Going without it for so long was really hard on me,” Carrillo said.

This story was produced by Kaiser Health News (KHN), which publishes California Healthline, an editorially independent service of the California Health Care Foundation. KHN 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.

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SACRAMENTO, CALIF. – California has become the first state to require health insurance plans to cover at-home tests for sexually transmitted infections such as HIV, chlamydia, and syphilis – which could help quell the STI epidemic that has raged nearly unchecked as public health departments have focused on COVID-19.

The rule, part of a broader law addressing the STI epidemic, took effect Jan. 1 for people with state-regulated private insurance plans and will kick in sometime later for the millions of low-income Californians enrolled in the state’s Medicaid program.

By making it easier and cheaper for Californians to self-administer tests in the privacy of their homes, the provision could bring better disease monitoring to rural and underserved parts of the state, reduce the stigma patients experience when seeking care, and give them more control over their health, say experts on infectious diseases.

“This is the first law of its kind, and I’d say it’s kind of cutting-edge,” said Stephanie Arnold Pang, senior director of policy and government relations for the National Coalition of STD Directors. “We want to bring down every single barrier for someone to get STI testing, and out-of-pocket cost is a huge factor.”

But being first has its downsides. Because the concept of insurance coverage for home STI tests is so new, the state’s Medicaid program, Medi-Cal, could not establish by Jan. 1 the billing codes it needs to start paying for tests. Federal regulators also haven’t approved the tests for home use, which could make labs reluctant to process them. And a state analysis predicts most in-network health care providers won’t start prescribing home tests for at least a year until they adjust their billing and other practices.

Nevertheless, the situation is urgent and requires action, said state Sen. Richard Pan (D-Sacramento), a pediatrician who wrote the law.

“We have children born in California with syphilis,” Dr. Pan said. “You’d think that went away in the Victorian era.”

Even before COVID, sexually transmitted infections hit all-time highs in the United States and California for 6 years in a row, according to 2019 data from the Centers for Disease Control and Prevention. Rates of congenital syphilis, which babies contract from their mothers, illustrate the severity of the STI epidemic: Cases were up 279% from 2015 to 2019 nationally and 232% in California. Of the 445 cases of congenital syphilis in California in 2019, 37 were stillbirths.

The pandemic only worsened the problem because health departments were overwhelmed responding to the COVID emergency, and stay-at-home orders kept people away from clinics.

In surveys of public health programs across the country since May 2020, the National Coalition of STD Directors found that most respondents – up to 78% in one survey – have diverted some of their STI workforces to test and monitor COVID. A report that accompanied the most recent survey found that some STIs were “completely unchecked” because of reductions in clinic hours, diversion of resources, shortages of testing kits and staff burnout.

Some at-home STI tests screen for a single disease but other kits can collect and send samples to check for a variety of infections. Depending on the test, patients collect a drop of blood with a lancet, or swab their mouth, vagina, anus, or penis.

Some tests require patients to send samples to a lab for analysis, while some oral HIV tests give results at home in a few minutes.

Ivan Beas, a 25-year-old graduate student at University of California, Los Angeles, was getting tested frequently as part of a 2-year research study. When clinics closed during the pandemic, researchers sent him a home kit.

The kit, which tests for HIV, hepatitis C, herpes, syphilis, chlamydia, gonorrhea, and trichomoniasis, was packaged discreetly and came with easy instructions. It took Mr. Beas about 10 minutes to prick his finger, swab his mouth and send the samples to the lab.

Mr. Beas wanted to continue screening himself every few months after the study ended, he said, but the kit he used retails for $289, which is out of reach for him.

The last time he went to a clinic in person, “I spent 2 hours waiting to even be seen by a doctor because of how busy they are,” he said. Until Medi-Cal begins covering home tests, he said, he will have to find time to get tested for free at a Planned Parenthood clinic.

“If insurance were to cover it, I’d definitely do it more,” he said.

Under California’s new law, plans regulated by the state must cover home STI tests when ordered by a health care provider.  

Privately insured Californians can take advantage of the coverage immediately. How much they will owe out-of-pocket for the tests – if anything – depends on the type of plan they have, whether their provider is in-network, and whether they fall into a category the federal government has designated for free screening.

Medi-Cal patients almost never face out-of-pocket expenses, but they will have to wait for coverage because the Department of Health Care Services, which administers Medi-Cal, is working with the American Medical Association and the federal government to create billing codes. The reimbursement rates for those codes will then need federal approval.

The state doesn’t know how long that process will take, according to department spokesperson Anthony Cava.

The rule does not apply to the millions of Californians whose job-based health insurance plans are regulated by the federal government.

Other states and organizations have experimented with at-home STI tests. The public health departments in Alabama and the District of Columbia send free kits to residents who request them, but neither jurisdiction requires insurance coverage for them. The National Coalition of STD Directors is sending free kits to people through health departments in Philadelphia; Iowa; Virginia; Indiana; Puerto Rico; and Navajo County, Arizona. The list of recipients is expected to grow this month.

Iwantthekit.org, a project of Johns Hopkins University, has been sending free kits to Maryland residents since 2004, and to Alaskans since 2011. The program is funded by grants and works with local health departments.

Charlotte Gaydos, cofounder of the project, said that requests for test kits during the pandemic nearly tripled – and that she would expand to every state if she could bill insurance the way the California law mandates.

The tests fall into a murky regulatory area. While they have been approved by the Food and Drug Administration, none have been cleared for use at home. Patients are supposed to collect their own samples within the walls of a health facility, and some labs may not analyze samples collected at home.

Public health officials cited other potential challenges: Patients may not have the same access to counseling, treatment, or referrals to other services such as food banks that they would receive at clinics. And although patients are supposed to self-report the results of their tests to public health authorities, some people won’t follow through.

Vlad Carrillo, 31, experienced such trade-offs recently. Mr. Carrillo used to get tested at a San Francisco clinic, where they could get counseling and other services. But Carrillo lost their apartment during the pandemic and moved about 7 hours away to Bishop, the only incorporated city in rural Inyo County.

“Being away from the city, it took me a whole year to find a way to get tested,” Carrillo said.

Carrillo eventually got the kit through the mail, avoiding the stigma of going to the clinic in Bishop, which is “more focused on straight stuff,” like preventing pregnancy. Without the test, Carrillo couldn’t get PrEP, a medication to prevent HIV.

“Going without it for so long was really hard on me,” Carrillo said.

This story was produced by Kaiser Health News (KHN), which publishes California Healthline, an editorially independent service of the California Health Care Foundation. KHN 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.

 



SACRAMENTO, CALIF. – California has become the first state to require health insurance plans to cover at-home tests for sexually transmitted infections such as HIV, chlamydia, and syphilis – which could help quell the STI epidemic that has raged nearly unchecked as public health departments have focused on COVID-19.

The rule, part of a broader law addressing the STI epidemic, took effect Jan. 1 for people with state-regulated private insurance plans and will kick in sometime later for the millions of low-income Californians enrolled in the state’s Medicaid program.

By making it easier and cheaper for Californians to self-administer tests in the privacy of their homes, the provision could bring better disease monitoring to rural and underserved parts of the state, reduce the stigma patients experience when seeking care, and give them more control over their health, say experts on infectious diseases.

“This is the first law of its kind, and I’d say it’s kind of cutting-edge,” said Stephanie Arnold Pang, senior director of policy and government relations for the National Coalition of STD Directors. “We want to bring down every single barrier for someone to get STI testing, and out-of-pocket cost is a huge factor.”

But being first has its downsides. Because the concept of insurance coverage for home STI tests is so new, the state’s Medicaid program, Medi-Cal, could not establish by Jan. 1 the billing codes it needs to start paying for tests. Federal regulators also haven’t approved the tests for home use, which could make labs reluctant to process them. And a state analysis predicts most in-network health care providers won’t start prescribing home tests for at least a year until they adjust their billing and other practices.

Nevertheless, the situation is urgent and requires action, said state Sen. Richard Pan (D-Sacramento), a pediatrician who wrote the law.

“We have children born in California with syphilis,” Dr. Pan said. “You’d think that went away in the Victorian era.”

Even before COVID, sexually transmitted infections hit all-time highs in the United States and California for 6 years in a row, according to 2019 data from the Centers for Disease Control and Prevention. Rates of congenital syphilis, which babies contract from their mothers, illustrate the severity of the STI epidemic: Cases were up 279% from 2015 to 2019 nationally and 232% in California. Of the 445 cases of congenital syphilis in California in 2019, 37 were stillbirths.

The pandemic only worsened the problem because health departments were overwhelmed responding to the COVID emergency, and stay-at-home orders kept people away from clinics.

In surveys of public health programs across the country since May 2020, the National Coalition of STD Directors found that most respondents – up to 78% in one survey – have diverted some of their STI workforces to test and monitor COVID. A report that accompanied the most recent survey found that some STIs were “completely unchecked” because of reductions in clinic hours, diversion of resources, shortages of testing kits and staff burnout.

Some at-home STI tests screen for a single disease but other kits can collect and send samples to check for a variety of infections. Depending on the test, patients collect a drop of blood with a lancet, or swab their mouth, vagina, anus, or penis.

Some tests require patients to send samples to a lab for analysis, while some oral HIV tests give results at home in a few minutes.

Ivan Beas, a 25-year-old graduate student at University of California, Los Angeles, was getting tested frequently as part of a 2-year research study. When clinics closed during the pandemic, researchers sent him a home kit.

The kit, which tests for HIV, hepatitis C, herpes, syphilis, chlamydia, gonorrhea, and trichomoniasis, was packaged discreetly and came with easy instructions. It took Mr. Beas about 10 minutes to prick his finger, swab his mouth and send the samples to the lab.

Mr. Beas wanted to continue screening himself every few months after the study ended, he said, but the kit he used retails for $289, which is out of reach for him.

The last time he went to a clinic in person, “I spent 2 hours waiting to even be seen by a doctor because of how busy they are,” he said. Until Medi-Cal begins covering home tests, he said, he will have to find time to get tested for free at a Planned Parenthood clinic.

“If insurance were to cover it, I’d definitely do it more,” he said.

Under California’s new law, plans regulated by the state must cover home STI tests when ordered by a health care provider.  

Privately insured Californians can take advantage of the coverage immediately. How much they will owe out-of-pocket for the tests – if anything – depends on the type of plan they have, whether their provider is in-network, and whether they fall into a category the federal government has designated for free screening.

Medi-Cal patients almost never face out-of-pocket expenses, but they will have to wait for coverage because the Department of Health Care Services, which administers Medi-Cal, is working with the American Medical Association and the federal government to create billing codes. The reimbursement rates for those codes will then need federal approval.

The state doesn’t know how long that process will take, according to department spokesperson Anthony Cava.

The rule does not apply to the millions of Californians whose job-based health insurance plans are regulated by the federal government.

Other states and organizations have experimented with at-home STI tests. The public health departments in Alabama and the District of Columbia send free kits to residents who request them, but neither jurisdiction requires insurance coverage for them. The National Coalition of STD Directors is sending free kits to people through health departments in Philadelphia; Iowa; Virginia; Indiana; Puerto Rico; and Navajo County, Arizona. The list of recipients is expected to grow this month.

Iwantthekit.org, a project of Johns Hopkins University, has been sending free kits to Maryland residents since 2004, and to Alaskans since 2011. The program is funded by grants and works with local health departments.

Charlotte Gaydos, cofounder of the project, said that requests for test kits during the pandemic nearly tripled – and that she would expand to every state if she could bill insurance the way the California law mandates.

The tests fall into a murky regulatory area. While they have been approved by the Food and Drug Administration, none have been cleared for use at home. Patients are supposed to collect their own samples within the walls of a health facility, and some labs may not analyze samples collected at home.

Public health officials cited other potential challenges: Patients may not have the same access to counseling, treatment, or referrals to other services such as food banks that they would receive at clinics. And although patients are supposed to self-report the results of their tests to public health authorities, some people won’t follow through.

Vlad Carrillo, 31, experienced such trade-offs recently. Mr. Carrillo used to get tested at a San Francisco clinic, where they could get counseling and other services. But Carrillo lost their apartment during the pandemic and moved about 7 hours away to Bishop, the only incorporated city in rural Inyo County.

“Being away from the city, it took me a whole year to find a way to get tested,” Carrillo said.

Carrillo eventually got the kit through the mail, avoiding the stigma of going to the clinic in Bishop, which is “more focused on straight stuff,” like preventing pregnancy. Without the test, Carrillo couldn’t get PrEP, a medication to prevent HIV.

“Going without it for so long was really hard on me,” Carrillo said.

This story was produced by Kaiser Health News (KHN), which publishes California Healthline, an editorially independent service of the California Health Care Foundation. KHN 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.

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Capitol Hill Dems, HHS Secretary Price trade jabs on HHS budget

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Thu, 03/28/2019 - 14:51

 

In back-to-back appearances on Capitol Hill Wednesday, Health and Human Services Secretary Tom Price sparred with Democrats over the Trump administration’s budget cuts for his department and the coming troubles in the individual health insurance market.

“President Trump’s budget does not confuse government spending with government success,” Price said, defending a spending plan that calls for substantial funding reductions to Medicaid, the Centers for Disease Control and Prevention, the National Institutes of Health, and other HHS agencies.

The problem with many federal programs “is not that they are too expensive or too underfunded. The real problem is that they do not work – they fail the very people they are meant to help,” Price said in testimony before the Senate Finance Committee and the House Ways and Means Committee.

He cited Medicaid, the federal-state insurance program for low-income people, as an example of an area in which rising costs require reforms. The administration’s budget would reduce federal Medicaid funds to states by $610 billion over a decade. Under its proposal, states would gain latitude over how to spend those funds, which Price said would lead to innovations and efficiencies.

Sen. Sherrod Brown (D-Ohio) questioned whether HHS is budgeting enough money under Medicaid to fight the opioid-abuse epidemic. Of the $939 million that Ohio spent on opioid treatment in 2016, 70% came from federal Medicaid dollars, he said.

“You would never propose we fight cancer with a $50 million increase to a grant program,” Brown said. “How does this possibly work if you’re going to cut the biggest revenue stream to treat people?”

Price pushed back, pointing out that more than 52,000 Americans died of overdose deaths in 2015.

“We continue to tolerate a system that allows for overdose deaths, and I simply won’t allow it,” Price said.

Trump’s budget has come under heavy attack in Congress since its release last month and is expected to undergo much rewriting. The budget would take effect for the fiscal year starting Oct. 1.

Democratic senators and representatives on the committees repeatedly challenged Price on his testimony and the administration’s health care policies, sometimes using strong words and loud voices.

“It’s mean-spirited. It’s not good for America. We can do much better,” thundered Rep. John Lewis (D-Ga.).

With insurers facing looming deadlines to decide whether to participate in the Affordable Care Act’s online marketplaces next year, lawmakers also pressed Price on whether the Trump administration will pay insurers about $7 billion in “cost-sharing subsidies” for 2018. The White House has sent mixed signals, but many insurers’ decisions about next year’s premiums and where they will offer health plans hinge on the verdict.

Sen. Debbie Stabenow (D-Mich.) repeatedly asked Price if he would commit to making subsidy payments, but Price refused to answer beyond reiterating that the budget includes payments through 2018. Price said he could not elaborate because he is the defendant in a lawsuit regarding these subsidies – a still-pending case brought by the Republican-led House of Representatives during the Obama administration.

Democrats accused Price of doing little to stabilize the individual insurance marketplace as insurers have announced withdrawal plans. But, Sen. Pat Roberts (R-Kan.) said the market was failing and it wasn’t Price’s fault.

“We are in the Obama car and it’s like being in the same car as Thelma and Louise going into the canyon,” he said. “We need to get out of the car.”

Price was also asked about a draft rule from HHS that would scale back the ACA’s mandate requiring nearly all employers to offer health insurance covering birth control. The HHS proposal would allow more types of employers to claim moral or religious exemptions to the mandate. “I think that, for women who desire birth control, it should be available,” Price said.

When Sen. Maria Cantwell (D-Wash.) pressed him to answer whether birth control should be available to women through their employers, Price reiterated that it should be available to women who want it.

“This is a very big problem,” she said. ”Women cannot be discriminated against by their employers who want to cherry-pick women’s health.”

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

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In back-to-back appearances on Capitol Hill Wednesday, Health and Human Services Secretary Tom Price sparred with Democrats over the Trump administration’s budget cuts for his department and the coming troubles in the individual health insurance market.

“President Trump’s budget does not confuse government spending with government success,” Price said, defending a spending plan that calls for substantial funding reductions to Medicaid, the Centers for Disease Control and Prevention, the National Institutes of Health, and other HHS agencies.

The problem with many federal programs “is not that they are too expensive or too underfunded. The real problem is that they do not work – they fail the very people they are meant to help,” Price said in testimony before the Senate Finance Committee and the House Ways and Means Committee.

He cited Medicaid, the federal-state insurance program for low-income people, as an example of an area in which rising costs require reforms. The administration’s budget would reduce federal Medicaid funds to states by $610 billion over a decade. Under its proposal, states would gain latitude over how to spend those funds, which Price said would lead to innovations and efficiencies.

Sen. Sherrod Brown (D-Ohio) questioned whether HHS is budgeting enough money under Medicaid to fight the opioid-abuse epidemic. Of the $939 million that Ohio spent on opioid treatment in 2016, 70% came from federal Medicaid dollars, he said.

“You would never propose we fight cancer with a $50 million increase to a grant program,” Brown said. “How does this possibly work if you’re going to cut the biggest revenue stream to treat people?”

Price pushed back, pointing out that more than 52,000 Americans died of overdose deaths in 2015.

“We continue to tolerate a system that allows for overdose deaths, and I simply won’t allow it,” Price said.

Trump’s budget has come under heavy attack in Congress since its release last month and is expected to undergo much rewriting. The budget would take effect for the fiscal year starting Oct. 1.

Democratic senators and representatives on the committees repeatedly challenged Price on his testimony and the administration’s health care policies, sometimes using strong words and loud voices.

“It’s mean-spirited. It’s not good for America. We can do much better,” thundered Rep. John Lewis (D-Ga.).

With insurers facing looming deadlines to decide whether to participate in the Affordable Care Act’s online marketplaces next year, lawmakers also pressed Price on whether the Trump administration will pay insurers about $7 billion in “cost-sharing subsidies” for 2018. The White House has sent mixed signals, but many insurers’ decisions about next year’s premiums and where they will offer health plans hinge on the verdict.

Sen. Debbie Stabenow (D-Mich.) repeatedly asked Price if he would commit to making subsidy payments, but Price refused to answer beyond reiterating that the budget includes payments through 2018. Price said he could not elaborate because he is the defendant in a lawsuit regarding these subsidies – a still-pending case brought by the Republican-led House of Representatives during the Obama administration.

Democrats accused Price of doing little to stabilize the individual insurance marketplace as insurers have announced withdrawal plans. But, Sen. Pat Roberts (R-Kan.) said the market was failing and it wasn’t Price’s fault.

“We are in the Obama car and it’s like being in the same car as Thelma and Louise going into the canyon,” he said. “We need to get out of the car.”

Price was also asked about a draft rule from HHS that would scale back the ACA’s mandate requiring nearly all employers to offer health insurance covering birth control. The HHS proposal would allow more types of employers to claim moral or religious exemptions to the mandate. “I think that, for women who desire birth control, it should be available,” Price said.

When Sen. Maria Cantwell (D-Wash.) pressed him to answer whether birth control should be available to women through their employers, Price reiterated that it should be available to women who want it.

“This is a very big problem,” she said. ”Women cannot be discriminated against by their employers who want to cherry-pick women’s health.”

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

 

In back-to-back appearances on Capitol Hill Wednesday, Health and Human Services Secretary Tom Price sparred with Democrats over the Trump administration’s budget cuts for his department and the coming troubles in the individual health insurance market.

“President Trump’s budget does not confuse government spending with government success,” Price said, defending a spending plan that calls for substantial funding reductions to Medicaid, the Centers for Disease Control and Prevention, the National Institutes of Health, and other HHS agencies.

The problem with many federal programs “is not that they are too expensive or too underfunded. The real problem is that they do not work – they fail the very people they are meant to help,” Price said in testimony before the Senate Finance Committee and the House Ways and Means Committee.

He cited Medicaid, the federal-state insurance program for low-income people, as an example of an area in which rising costs require reforms. The administration’s budget would reduce federal Medicaid funds to states by $610 billion over a decade. Under its proposal, states would gain latitude over how to spend those funds, which Price said would lead to innovations and efficiencies.

Sen. Sherrod Brown (D-Ohio) questioned whether HHS is budgeting enough money under Medicaid to fight the opioid-abuse epidemic. Of the $939 million that Ohio spent on opioid treatment in 2016, 70% came from federal Medicaid dollars, he said.

“You would never propose we fight cancer with a $50 million increase to a grant program,” Brown said. “How does this possibly work if you’re going to cut the biggest revenue stream to treat people?”

Price pushed back, pointing out that more than 52,000 Americans died of overdose deaths in 2015.

“We continue to tolerate a system that allows for overdose deaths, and I simply won’t allow it,” Price said.

Trump’s budget has come under heavy attack in Congress since its release last month and is expected to undergo much rewriting. The budget would take effect for the fiscal year starting Oct. 1.

Democratic senators and representatives on the committees repeatedly challenged Price on his testimony and the administration’s health care policies, sometimes using strong words and loud voices.

“It’s mean-spirited. It’s not good for America. We can do much better,” thundered Rep. John Lewis (D-Ga.).

With insurers facing looming deadlines to decide whether to participate in the Affordable Care Act’s online marketplaces next year, lawmakers also pressed Price on whether the Trump administration will pay insurers about $7 billion in “cost-sharing subsidies” for 2018. The White House has sent mixed signals, but many insurers’ decisions about next year’s premiums and where they will offer health plans hinge on the verdict.

Sen. Debbie Stabenow (D-Mich.) repeatedly asked Price if he would commit to making subsidy payments, but Price refused to answer beyond reiterating that the budget includes payments through 2018. Price said he could not elaborate because he is the defendant in a lawsuit regarding these subsidies – a still-pending case brought by the Republican-led House of Representatives during the Obama administration.

Democrats accused Price of doing little to stabilize the individual insurance marketplace as insurers have announced withdrawal plans. But, Sen. Pat Roberts (R-Kan.) said the market was failing and it wasn’t Price’s fault.

“We are in the Obama car and it’s like being in the same car as Thelma and Louise going into the canyon,” he said. “We need to get out of the car.”

Price was also asked about a draft rule from HHS that would scale back the ACA’s mandate requiring nearly all employers to offer health insurance covering birth control. The HHS proposal would allow more types of employers to claim moral or religious exemptions to the mandate. “I think that, for women who desire birth control, it should be available,” Price said.

When Sen. Maria Cantwell (D-Wash.) pressed him to answer whether birth control should be available to women through their employers, Price reiterated that it should be available to women who want it.

“This is a very big problem,” she said. ”Women cannot be discriminated against by their employers who want to cherry-pick women’s health.”

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

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Trump’s promise to rein in drug prices could open floodgate to importation laws

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Thu, 03/28/2019 - 14:54

 

With prescription drug prices soaring and President Donald Trump vowing to take action, an old idea is gaining fresh traction: allowing Americans to buy medicines from foreign pharmacies at far lower prices. A new bill in Congress to allow the practice would modify previous safety standards and remove a barrier that proved insurmountable in past attempts to enable progress.

Congress came close to allowing importation through the Medicare Modernization Act in 2003 but added one firm precondition that has proved a nonstarter. The secretary of Health & Human Services had to guarantee that imported medications posed no additional risk to public safety and would save money.

“That is a fairly absolute standard and a high bar to cross,” said Elizabeth Jungman, director of public health at the Pew Charitable Trusts. Such an exacting standard – guaranteeing that no imported prescriptions posed a threat – has kept any secretary of HHS from condoning it.

In an open letter to Congress, four former commissioners of the Food and Drug Administration argue consumer drug importation remains too risky to permit. “It could lead to a host of unintended consequences and undesirable effects, including serious harm stemming from the use of adulterated, substandard, or counterfeit drugs,” they said in the letter distributed to media organizations. It was signed by Robert Califf, Margaret Hamburg, Mark McClellan, and Andrew von Eschenbach, who each headed the FDA at various times during 2002 through 2016.

The recent proposal, from senators Bernie Sanders (I-Vt.) and Cory Booker (D-N.J.) and Bob Casey (D-Pa.) drops that requirement. Instead, it sets up a regulatory system in which Canadian pharmacies that purchase supplies from manufacturers inspected by the FDA would be licensed to sell to customers across the border. The bill allows not only individuals but also drug wholesalers and pharmacies to buy from Canada.

After 2 years, HHS could allow importation from other countries that meet standards comparable to those of the United States.

Another bill in Congress, proposed in January by senators John McCain (R-Ariz.) and Amy Klobuchar (D-Minn.), focuses solely on allowing individuals to purchase drugs from such pharmacies.

President Trump has promised that “pricing for the American people will come way down.” Last week, he had a high-profile meeting at the White House with congressmen Elijah Cummings (D-Md.) and Peter Welch (D-Vt.) and the president of Johns Hopkins Hospital, Baltimore, Redonda Miller, MD, to discuss allowing Medicare to negotiate prices on outpatient medicines. Cong. Cummings told reporters later that President Trump said he supports Medicare price negotiation as well as the Sanders bill.

PhRMA, the drug industry’s trade group, has denounced Sanders’ proposal as it has others that enabled imports in the past.

“The bill lacks sufficient safety controls [and] would exacerbate threats to public health from counterfeit, adulterated, or diverted medicines, and increase the burden on law enforcement to prevent unregulated medicines and other dangerous products from harming consumers,” said PhRMA spokeswoman Nicole Longo.

Surveys indicate that up to 8% of Americans have bought medicines outside the United States, even though the practice is technically illegal and imported pills are subject to confiscation.

Around 45 million Americans – 18% of the adult population – said last year that they did not fill a prescription because of cost, according to an analysis of data from the Commonwealth Fund by Gabe Levitt, president of pharmacychecker.com, whose company helps Americans buy medications online by vetting overseas pharmacies and comparing prices for different drugs. Data compiled by the company compare Canadian prescription prices with those offered in New York and show drugs that frequently are three or more times as expensive in the United States as across the border.

For example, a simple Proventil asthma inhaler costs $73.19 in the United States vs. $21.66 in Canada. Crestor, the cholesterol-lowering drug, is $6.82 per pill in U.S. pharmacies but $2.58 in Canada. Abilify, a psychiatric medicine, is $29.88 vs. $7.58, according to pharmacychecker.com.

Many previous bills that permitted importation or that allowed Medicare to negotiate prices for its beneficiaries have failed in the face of $1.9 billion in congressional lobbying by the pharmaceutical industry since 2003, according to Open Secrets. But Americans may be reaching a tipping point of intolerance. In polling just before the election by the Kaiser Family Foundation, 77% of Americans called drug prices “unreasonable” and well over half favored a variety of proposals to address them.

To address safety concerns, the Sanders bill institutes several new strategies. Canadian pharmacies that want to be registered to sell to Americans would have to pay a fee to pay for additional FDA monitoring. A Government Accountability Office study would be required within 18 months of the final rule to address outcomes related to importation processes, drug safety, consumer savings, and regulatory expenses.

Allowing people to legally import medications would not completely solve the problem of high prescription drugs prices, advocates say, but would be a step in the right direction. Said Mr. Levitt, “the best way for Americans to afford their meds is to enact policies here to bring the prices down here.”
 

 

 

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation. KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

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With prescription drug prices soaring and President Donald Trump vowing to take action, an old idea is gaining fresh traction: allowing Americans to buy medicines from foreign pharmacies at far lower prices. A new bill in Congress to allow the practice would modify previous safety standards and remove a barrier that proved insurmountable in past attempts to enable progress.

Congress came close to allowing importation through the Medicare Modernization Act in 2003 but added one firm precondition that has proved a nonstarter. The secretary of Health & Human Services had to guarantee that imported medications posed no additional risk to public safety and would save money.

“That is a fairly absolute standard and a high bar to cross,” said Elizabeth Jungman, director of public health at the Pew Charitable Trusts. Such an exacting standard – guaranteeing that no imported prescriptions posed a threat – has kept any secretary of HHS from condoning it.

In an open letter to Congress, four former commissioners of the Food and Drug Administration argue consumer drug importation remains too risky to permit. “It could lead to a host of unintended consequences and undesirable effects, including serious harm stemming from the use of adulterated, substandard, or counterfeit drugs,” they said in the letter distributed to media organizations. It was signed by Robert Califf, Margaret Hamburg, Mark McClellan, and Andrew von Eschenbach, who each headed the FDA at various times during 2002 through 2016.

The recent proposal, from senators Bernie Sanders (I-Vt.) and Cory Booker (D-N.J.) and Bob Casey (D-Pa.) drops that requirement. Instead, it sets up a regulatory system in which Canadian pharmacies that purchase supplies from manufacturers inspected by the FDA would be licensed to sell to customers across the border. The bill allows not only individuals but also drug wholesalers and pharmacies to buy from Canada.

After 2 years, HHS could allow importation from other countries that meet standards comparable to those of the United States.

Another bill in Congress, proposed in January by senators John McCain (R-Ariz.) and Amy Klobuchar (D-Minn.), focuses solely on allowing individuals to purchase drugs from such pharmacies.

President Trump has promised that “pricing for the American people will come way down.” Last week, he had a high-profile meeting at the White House with congressmen Elijah Cummings (D-Md.) and Peter Welch (D-Vt.) and the president of Johns Hopkins Hospital, Baltimore, Redonda Miller, MD, to discuss allowing Medicare to negotiate prices on outpatient medicines. Cong. Cummings told reporters later that President Trump said he supports Medicare price negotiation as well as the Sanders bill.

PhRMA, the drug industry’s trade group, has denounced Sanders’ proposal as it has others that enabled imports in the past.

“The bill lacks sufficient safety controls [and] would exacerbate threats to public health from counterfeit, adulterated, or diverted medicines, and increase the burden on law enforcement to prevent unregulated medicines and other dangerous products from harming consumers,” said PhRMA spokeswoman Nicole Longo.

Surveys indicate that up to 8% of Americans have bought medicines outside the United States, even though the practice is technically illegal and imported pills are subject to confiscation.

Around 45 million Americans – 18% of the adult population – said last year that they did not fill a prescription because of cost, according to an analysis of data from the Commonwealth Fund by Gabe Levitt, president of pharmacychecker.com, whose company helps Americans buy medications online by vetting overseas pharmacies and comparing prices for different drugs. Data compiled by the company compare Canadian prescription prices with those offered in New York and show drugs that frequently are three or more times as expensive in the United States as across the border.

For example, a simple Proventil asthma inhaler costs $73.19 in the United States vs. $21.66 in Canada. Crestor, the cholesterol-lowering drug, is $6.82 per pill in U.S. pharmacies but $2.58 in Canada. Abilify, a psychiatric medicine, is $29.88 vs. $7.58, according to pharmacychecker.com.

Many previous bills that permitted importation or that allowed Medicare to negotiate prices for its beneficiaries have failed in the face of $1.9 billion in congressional lobbying by the pharmaceutical industry since 2003, according to Open Secrets. But Americans may be reaching a tipping point of intolerance. In polling just before the election by the Kaiser Family Foundation, 77% of Americans called drug prices “unreasonable” and well over half favored a variety of proposals to address them.

To address safety concerns, the Sanders bill institutes several new strategies. Canadian pharmacies that want to be registered to sell to Americans would have to pay a fee to pay for additional FDA monitoring. A Government Accountability Office study would be required within 18 months of the final rule to address outcomes related to importation processes, drug safety, consumer savings, and regulatory expenses.

Allowing people to legally import medications would not completely solve the problem of high prescription drugs prices, advocates say, but would be a step in the right direction. Said Mr. Levitt, “the best way for Americans to afford their meds is to enact policies here to bring the prices down here.”
 

 

 

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation. KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

 

With prescription drug prices soaring and President Donald Trump vowing to take action, an old idea is gaining fresh traction: allowing Americans to buy medicines from foreign pharmacies at far lower prices. A new bill in Congress to allow the practice would modify previous safety standards and remove a barrier that proved insurmountable in past attempts to enable progress.

Congress came close to allowing importation through the Medicare Modernization Act in 2003 but added one firm precondition that has proved a nonstarter. The secretary of Health & Human Services had to guarantee that imported medications posed no additional risk to public safety and would save money.

“That is a fairly absolute standard and a high bar to cross,” said Elizabeth Jungman, director of public health at the Pew Charitable Trusts. Such an exacting standard – guaranteeing that no imported prescriptions posed a threat – has kept any secretary of HHS from condoning it.

In an open letter to Congress, four former commissioners of the Food and Drug Administration argue consumer drug importation remains too risky to permit. “It could lead to a host of unintended consequences and undesirable effects, including serious harm stemming from the use of adulterated, substandard, or counterfeit drugs,” they said in the letter distributed to media organizations. It was signed by Robert Califf, Margaret Hamburg, Mark McClellan, and Andrew von Eschenbach, who each headed the FDA at various times during 2002 through 2016.

The recent proposal, from senators Bernie Sanders (I-Vt.) and Cory Booker (D-N.J.) and Bob Casey (D-Pa.) drops that requirement. Instead, it sets up a regulatory system in which Canadian pharmacies that purchase supplies from manufacturers inspected by the FDA would be licensed to sell to customers across the border. The bill allows not only individuals but also drug wholesalers and pharmacies to buy from Canada.

After 2 years, HHS could allow importation from other countries that meet standards comparable to those of the United States.

Another bill in Congress, proposed in January by senators John McCain (R-Ariz.) and Amy Klobuchar (D-Minn.), focuses solely on allowing individuals to purchase drugs from such pharmacies.

President Trump has promised that “pricing for the American people will come way down.” Last week, he had a high-profile meeting at the White House with congressmen Elijah Cummings (D-Md.) and Peter Welch (D-Vt.) and the president of Johns Hopkins Hospital, Baltimore, Redonda Miller, MD, to discuss allowing Medicare to negotiate prices on outpatient medicines. Cong. Cummings told reporters later that President Trump said he supports Medicare price negotiation as well as the Sanders bill.

PhRMA, the drug industry’s trade group, has denounced Sanders’ proposal as it has others that enabled imports in the past.

“The bill lacks sufficient safety controls [and] would exacerbate threats to public health from counterfeit, adulterated, or diverted medicines, and increase the burden on law enforcement to prevent unregulated medicines and other dangerous products from harming consumers,” said PhRMA spokeswoman Nicole Longo.

Surveys indicate that up to 8% of Americans have bought medicines outside the United States, even though the practice is technically illegal and imported pills are subject to confiscation.

Around 45 million Americans – 18% of the adult population – said last year that they did not fill a prescription because of cost, according to an analysis of data from the Commonwealth Fund by Gabe Levitt, president of pharmacychecker.com, whose company helps Americans buy medications online by vetting overseas pharmacies and comparing prices for different drugs. Data compiled by the company compare Canadian prescription prices with those offered in New York and show drugs that frequently are three or more times as expensive in the United States as across the border.

For example, a simple Proventil asthma inhaler costs $73.19 in the United States vs. $21.66 in Canada. Crestor, the cholesterol-lowering drug, is $6.82 per pill in U.S. pharmacies but $2.58 in Canada. Abilify, a psychiatric medicine, is $29.88 vs. $7.58, according to pharmacychecker.com.

Many previous bills that permitted importation or that allowed Medicare to negotiate prices for its beneficiaries have failed in the face of $1.9 billion in congressional lobbying by the pharmaceutical industry since 2003, according to Open Secrets. But Americans may be reaching a tipping point of intolerance. In polling just before the election by the Kaiser Family Foundation, 77% of Americans called drug prices “unreasonable” and well over half favored a variety of proposals to address them.

To address safety concerns, the Sanders bill institutes several new strategies. Canadian pharmacies that want to be registered to sell to Americans would have to pay a fee to pay for additional FDA monitoring. A Government Accountability Office study would be required within 18 months of the final rule to address outcomes related to importation processes, drug safety, consumer savings, and regulatory expenses.

Allowing people to legally import medications would not completely solve the problem of high prescription drugs prices, advocates say, but would be a step in the right direction. Said Mr. Levitt, “the best way for Americans to afford their meds is to enact policies here to bring the prices down here.”
 

 

 

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation. KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

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