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States Face Costly Conundrum: How To Treat Inmates With Hepatitis C

Kaiser Health News:States - 15 hours 7 min ago

In a corner of Jymie Jimerson’s house in the town of Sparta, in southwestern Missouri, she has set up a kind of shrine. It has Native American art representing her Cherokee heritage alongside Willie Nelson albums, books and photos in remembrance of her late husband.

There’s a copy of Nelson’s mid-’70s LP “Red Headed Stranger.”

“When Steve was young, he had red hair and a red beard, so he always really identified with Willie’s ‘Red Headed Stranger,'” Jimerson said. “I try to keep it up there as a reminder of better days.”

Her husband, Steve Jimerson, was sentenced to life in prison in 1996 for his role in the shooting deaths of two men. Jimerson said her husband’s life had been ravaged by drug abuse. But after he entered prison, he got off drugs and become a mentor for other inmates.

“Once he got inside, recovery became his life,” Jimerson said. “And that was his passion until the day he died.”

Steve Jimerson died on Jan. 6, 2017, of complications from hepatitis C, a liver infection that’s especially widespread among prison inmates. He was 59.

While the disease is common among the incarcerated, treatment with the latest hepatitis drugs isn’t.

Civil liberties groups in Missouri and at least seven other states are now suing to get more inmates treated with new-generation hepatitis C drugs that are highly effective but also costly.

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After Steve Jimerson was diagnosed with hepatitis C in prison, his widow said, he was on the lookout for news of treatment advances.

In 2013, Gilead Sciences introduced Sovaldi, the first of a new generation of drugs called direct-acting antivirals that can cure hepatitis C and with fewer side effects than the previous treatments. But the excitement was dampened by the drug’s price. A full course of treatment carried an $84,000 price tag.

In 2016, around 5,000 inmates in Missouri’s prisons had hepatitis C, and no more than 14 of them received the drugs, according to internal state data obtained by the Roderick & Solange MacArthur Justice Center in St. Louis. That’s about 15 percent of the 32,000 people incarcerated in Missouri’s prisons.

Jimerson said that her husband wasn’t given direct-acting antivirals. By the fall of 2016, his health was deteriorating rapidly, and he grew pessimistic about the prospects for a cure.

“He told me that if someone had to die to get the DOC [Department of Corrections] to change their policy, he was OK with it being him,” she said.

As recently as 2012, scores of Missouri inmates were being treated with older hepatitis C drugs, including one called interferon that is notorious for its debilitating side effects. But in 2013, the Federal Bureau of Prisons started changing treatment guidelines to replace the old hepatitis C drugs with new ones.

Many states follow those guidelines, including Missouri, according to a spokesperson from Corizon Health, the private company that provides health care for Missouri’s inmates.

But the updated guidelines gave prisons more leeway to decide when it’s appropriate to provide treatment. And as Missouri phased out the old drugs, it hasn’t used the new drugs nearly as often. That has left only a handful of inmates getting any hepatitis C drug treatment at all.

In December 2016, the American Civil Liberties Union and MacArthur Justice Center sued to get the Missouri Department of Corrections to provide direct-acting antiviral drugs to inmates with hepatitis C who qualify for treatment.

ACLU lawyer Tony Rothert said the state’s current treatment practices violate the U.S. Constitution’s Cruel and Unusual Punishments Clause, part of the Eighth Amendment.

“The Supreme Court has said that in the context of medical care, that means that prisons cannot be deliberately indifferent to serious medical needs,” Rothert said. “Hepatitis C fairly easily satisfies this test, because if left untreated, there’s a fair chance that you will die.”

Advocates making this argument got a big boost for their case in November 2017, when a federal judge in Florida ordered that state’s prisons start providing direct-acting drugs to its inmates at least until that state’s case goes to trial in August.

“It was a great victory for people who are incarcerated and have hepatitis C because now we have a federal judge who said, ‘Look, this is just unconscionable,’ and the state is going to have to do something about it,” said Elizabeth Paukstis, public policy director of the National Viral Hepatitis Roundtable.

In July 2017, the Missouri lawsuit took a leap forward when the judge overseeing the case certified it as a class action on behalf of state inmates with hepatitis C. The Missouri Department of Corrections and Corizon, which are defendants in the lawsuit, have appealed that ruling.

Both the Missouri Department of Corrections and Corizon declined to comment on the suit or answer questions about their hepatitis C treatment protocols beyond saying they are following federal guidelines.

But if Missouri and other states are required to offer the new drugs, they would face a huge problem, said Gregg Gonsalves, an assistant professor of epidemiology at the Yale School of Public Health. “Even if they wanted to treat patients, they would break the bank. They would run out of money to treat every other medical condition,” he said.

For example, if Missouri gave the 2,500 inmates that the ACLU says are candidates for Harvoni, the direct-acting antiviral drug it now uses, the cost would exceed $236 million, based on its list price. That far exceeds the Department of Corrections’ entire budget for inmate health.

Gonsalves said the emergence of newer, cheaper drugs could help, and some state prison systems have managed to negotiate discounts.

Even at a lower cost, though, providing these drugs on a large scale could still cost states a fortune. But advocates insist it’s worth it to stop the disease from spreading. And a 2015 study showed that as many as 12,000 lives would be saved if inmates across the country were screened and treated; preventing liver transplants and liver disease would save money in the long run.

“The impetus for treating infectious disease in the prison system is that it’s a population you can reach, it’s a population you can cure, and it’s a population you can help prevent onward infections from,” Gonsalves said.

Jymie Jimerson understands that many people might be skeptical about providing expensive health care for prison inmates. But she hopes they can see them as more than people convicted of crimes, she said.

“I’m not condoning what they did. I’m not condoning criminals,” Jimerson said. “What I’m saying is, they’re human beings. And there are hundreds, hundreds of first-time offenders that this medication would cure them. So that when they went home, they could actually spend time and enjoy a little bit of life with their families.”

This story is part of a partnership that includes KCUR, NPR and Kaiser Health News.

Tax Bill Provision Designed To Spur Paid Family Leave To Lower-Wage Workers

Kaiser Health News:Insurance - 15 hours 8 min ago

Tucked into the new tax law is a provision that offers companies a tax credit if they provide paid family and medical leave for lower-wage workers.

Many people support a national strategy for paid parental and family leave, especially for workers who are not in management and are less likely to get that benefit on the job. But consultants, scholars and consumer advocates alike say the new tax credit will encourage few companies to take the plunge.

The tax credit, proposed by Sen. Deb Fischer (R-Neb.), is available to companies that offer at least two weeks of paid family or medical leave annually to workers, but two key criteria must be met. The workers must earn less than $72,000 a year and the leave must cover at least 50 percent of their wages.

If contributing at the half-wage level, a company receives a tax credit equal to 12.5 percent of the amount it pays to the worker. The tax credit will increase on a sliding scale if the company pays more than 50 percent of wages. It could go up to a maximum credit of 25 percent of the amount the employer paid for up to 12 weeks of leave.

Payments to full- and part-time workers taking family leave who’ve been employed for at least a year would be eligible for the employer’s tax break. But the program, which is designed to test whether this approach works well, is set to last just two years, ending after 2019.

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Aparna Mathur, a resident scholar in economic policy studies at the American Enterprise Institute, says the new tax credit sidesteps a pitfall for Republicans. They are wary of any legislation mandating that employers provide paid leave. The tax credit also is appropriately aimed at lower-wage workers who are most likely to lack access to paid leave, said Mathur, who co-authored a recent report on paid family leave.

But it’s not a big enticement.

“Providing this benefit is a huge cost for employers,” Mathur said. “It’s unlikely that any new companies will jump on board just because they have a 12.5 to 25 percent offset.”

That view is shared by Vicki Shabo, vice president for workplace policies and strategies at the National Partnership for Women & Families, an advocacy group, who said it will primarily benefit workers at companies already offering paid family leave. The new tax credit “just perpetuates the boss lottery,” she added.

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Heather Whaling said her 22-person public relations company probably qualifies for the new tax credit, but she doesn’t think it’s the right approach. Whaling, the president of Geben Communication in Columbus, Ohio, already offers paid leave. The company provides up to 10 weeks of paid leave at full pay for new parents. Four employees have taken leave, and by divvying up their work to other team members and hiring freelancers they’ve been able to get by.

“It is an expense, but if you plan and budget carefully it’s not cost-prohibitive,” she said.

The tax credit isn’t big enough to provide a strong incentive to provide paid leave, said Whaling, 37. Besides, “having access to paid family leave shouldn’t be luck of the draw, it should be available to every employee in the country.”

Still, the tax credit may be appealing to companies that have been considering adding a paid family and medical leave benefit, said Rich Fuerstenberg, a senior partner at benefits consultant Mercer.

By defraying some of the cost, the tax credit could help “tip them over” into offering paid leave, he said. But  “I’m not even sure I’d call it the icing on the cake,” Fuerstenberg said. “It’s like the cherry on the icing.”

Only 15 percent of private-sector and state and local government workers had access to paid family and medical leave in 2017, according to the Bureau of Labor Statistics’ National Compensation Survey. Eighty-eight percent had access to unpaid leave, however.

Under the federal Family and Medical Leave Act, employers with 50 or more workers generally must allow eligible employees to take unpaid leave for up to 12 weeks annually for specified reasons. These include the birth or adoption of a child, caring for your own or a family member’s serious health condition, or leave for military caregiving or deployment. An individual’s job is protected during such leaves.

A tax credit that can be claimed at the end of the year is unlikely to encourage small businesses to offer paid family and medical leave, said Erik Rettig, an expert on family leave policies at the Small Business Majority, which advocates for those firms on national policy.

“It isn’t going to help the family business that has to absorb the costs of this employee while they’re gone,” Rettig said.

A better solution, according to Shabo and others, is to provide a paid family leave benefit that’s funded by employer and/or employee payroll contributions. Sen. Kirsten Gillibrand (D-N.Y.) and Rep. Rosa DeLauro (D-Conn.) last year reintroduced such legislation. Their bill would guarantee workers, including those who are self-employed, up to 12 weeks of family and medical leave with as much as two-thirds of their pay.

A handful of mostly Democratic states — including California, New Jersey, Rhode Island and New York — have similar laws in place, and a program in the District of Columbia and Washington state will begin in 2020.

“We know from states that this approach works for both employees and their bosses,” Shabo said.

CHIP Renewed For Six Years As Congress Votes To Reopen Federal Government

Kaiser Health News:Insurance - January 22, 2018
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A brief, partial shutdown of the federal government ended Monday, as the Senate and House approved legislation that would keep federal dollars flowing until Feb. 8, as well as fund the Children’s Health Insurance Program for the next six years.

President Donald Trump signed the bill Monday evening.

The CHIP program, which provides coverage to children in families who earn too much to qualify for Medicaid but not enough to afford private insurance, has been bipartisan since its inception in 1997. But its renewal became a partisan bargaining chip over the past several months.

Funding for CHIP technically expired Oct. 1, although a temporary spending bill in December gave the program $2.85 billion. That was supposed to carry states through March to maintain coverage for an estimated 9 million children, but some states began to run short almost as soon as that bill passed.

The Georgetown University Center for Children and Families estimated that 24 states could face CHIP funding shortfalls by the end of January, putting an estimated 1.7 million children’s coverage at risk in 21 of those states.

Meanwhile, both houses of Congress had been at loggerheads over how to put the program on firmer financial footing.

In October, just days after the program’s funding expired, the Senate Finance Committee approved a bipartisan five-year extension of funding by voice vote. But that bill did not include a way to pay the cost, then estimated at $8.2 billion.

In November, the House passed its own five-year funding bill for the program, but it was largely opposed by Democrats because it would have offset the CHIP funding by making cuts to Medicare and the Affordable Care Act (ACA).

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Prospects for a CHIP deal brightened earlier this month when the Congressional Budget Office re-estimated how much the extension of funding for the program would cost. In a letter to Senate Finance Committee Chairman Orrin Hatch (R-Utah) on Jan. 5, CBO said changes to health care made in the tax bill would result in lowering the five-year cost of the program from $8.2 billion to $800 million — effectively a reduction of 90 percent.

The reason, explained CBO, is that the landmark tax bill passed in December eliminated the ACA’s individual mandate, which would likely drive up premiums in the individual market. Those higher premiums, in turn, would increase the federal premium subsidies for those with qualifying incomes. As a result, if kids were to lose their CHIP coverage and go onto the individual exchanges instead, the federal premium subsidies would cost more than their CHIP coverage.

Driving that point home, on Jan. 11, CBO Director Keith Hall wrote to Rep. Frank Pallone (D-N.J.) that renewing CHIP funding for 10 years rather than five would save the federal government money. “The agencies estimate that enacting such legislation would decrease the deficit by $6.0 billion over the 2018-2027 period,” the letter said.

That made it easier for Republicans to include the CHIP funding in the latest spending bill. But it infuriated Democrats, who had vowed not to vote for another short-term spending bill until Congress dealt with the issue of immigrant children brought to the country illegally by their parents.

Republicans, said Senate Minority Leader Chuck Schumer (D-N.Y.) on Sunday, “were using the 10 million kids on CHIP, holding them as hostage for the 800,000 kids who were Dreamers. Kids against kids. Innocent kids against innocent kids. That’s no way to operate in this country.”

Republicans, however, said it was the opposite — that Democrats were holding CHIP hostage by not voting for the spending bill. “There is no reason for my colleagues to pit their righteous crusade on immigration against their righteous crusade for CHIP,” said Hatch. “This is simply a matter of priorities.”

The CHIP renewal was not the only health-related change in the temporary spending bill. The measure also delays the collection of several unpopular taxes that raise revenues to pay for the ACA’s benefits. The taxes being delayed include ones on medical device makers, health insurers and high-benefit “Cadillac” health plans.

The bill does not, however, extend funding for Community Health Centers, another bipartisan program whose funding is running out. That will have to wait for another bill.

Update: This story was updated at 9:15 p.m. on Jan. 22 to report that President Donald Trump signed the bill.

HHS Takes Major Actions to Protect Conscience Rights and Life

HHS Gov News - January 20, 2018

On Friday, January 19, 2018, the Department of Health and Human Services (HHS) announced two major actions to protect life and the conscience rights of Americans.

HHS’ Centers for Medicare & Medicaid Services (CMS) is issuing new guidance to state Medicaid directors restoring state flexibility to decide program standards. The letter issued today rescinds 2016 guidance that specifically restricted states’ ability to take certain actions against family-planning providers that offer abortion services.

Additionally, HHS’ Office for Civil Rights (OCR) is announcing a new proposed rule to enforce 25 existing statutory conscience protections for Americans involved in HHS-funded programs, which protect people from being coerced into participating in activities that violate their consciences, such as abortion, sterilization, or assisted suicide.

“Today’s actions represent promises kept by President Trump and a rollback of policies that had prevented many Americans from practicing their profession and following their conscience at the same time,” said Acting HHS Secretary Eric D. Hargan. “Americans of faith should feel at home in our health system, not discriminated against, and states should have the right to take reasonable steps in overseeing their Medicaid programs and being good stewards of public funds.”

“America’s doctors and nurses are dedicated to saving lives and should not be bullied out of the practice of medicine simply because they object to performing abortions against their conscience,” said OCR Director Roger Severino. “Conscience protection is a civil right guaranteed by laws that too often haven’t been enforced.  Today’s proposed rule will provide our new Conscience and Religious Freedom Division with enforcement tools that will make sure our conscience laws are not empty words on paper, but guarantees of justice to victims of unlawful discrimination.”

Background

New Draft Conscience Regulation

  • The proposed rule provides practical protections for Americans’ conscience rights and is modelled on existing regulations for other civil rights laws.
  • The laws undergirding the proposed regulation include the Coats-Snowe, Weldon, and Church Amendments, as well as parts of Medicare, Medicaid, the Affordable Care Act, and others (25 statutes in total).
  • The proposed rule applies to entities that receive funds through programs funded or administered in whole or in part through HHS.
  • The proposed rule requires, for instance, that entities applying for federal grants certify that they are complying with the above-mentioned conscience-protection statutes.
  • Since President Trump took office, OCR has stepped up enforcement of these conscience statutes, many of which saw little to no enforcement activity under the previous administration.
  • The proposed rule includes a public comment period of 60 days.
  • Friday’s proposed rule follows the announcement on Thursday of a new Conscience and Religious Freedom Division in OCR, charged with implementing the proposed regulation as finalized and enforcing statutes that protect individuals and organizations from being compelled to participate in procedures such as abortion, sterilization, and assisted suicide when it would violate their religious beliefs or moral convictions.

New Medicaid Guidance Restoring State Flexibility

  • On Friday, January 19, 2018, CMS issued a State Medicaid Director Letter restoring state flexibility to establish reasonable standards for their Medicaid programs.
  • The letter rescinded an April 2016 guidance (State Medicaid Directors Letter #16-005), which limited states’ long-standing authority to regulate providers operating within their states.
  • The 2016 letter had said that states that attempted to protect the integrity of their program standards by disqualifying abortion providers from their Medicaid programs would come under CMS scrutiny, and would be required to present to CMS evidence of criminal action or unfitness to perform healthcare services.
  • As stated in the Friday letter to state Medicaid directors, CMS is concerned that the 2016 letter may have gone beyond merely interpreting what the statute and current regulations require.
  • This decision returns CMS policy to what it was prior to the issuance of the 2016 letter.
  • States will still be required to comply with all applicable statutory and regulatory requirements, including the requirement that provider qualification standards be reasonable.

The new State Medicaid Directors Letter is here: https://www.medicaid.gov/federal-policy-guidance/downloads/smd18003.pdf

The conscience regulation can be found in the Federal Register here: https://www.federalregister.gov/public-inspection/2018/01/19

How The Shutdown Might Affect Your Health

Kaiser Health News:Madicaid - January 19, 2018
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A government shutdown will have far-reaching effects for public health, including the nation’s response to the current, difficult flu season. It will also disrupt some federally supported health services, experts said Friday.

In all, the Department of Health and Human Services will send home — or furlough — about half of its employees, or nearly 41,000 people, according to an HHS shutdown contingency plan released Friday.

Here are some federal services and programs consumers might be wondering about:

CENTERS FOR DISEASE CONTROL AND PREVENTION

According to the HHS plan, the CDC will suspend its flu-tracking program. That’s bad timing, given the country is at the height of a particularly bad flu season, said Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston. Without the CDC’s updates, doctors could have a harder time diagnosing and treating patients quickly, he said.

Although states will still track flu cases, “they won’t be able to call CDC to verify samples or seek their expertise,” said Dr. Thomas Frieden, who was the director of the agency during the 2013 government shutdown.

A government shutdown will also affect the CDC’s involvement in key decisions about next year’s flu vaccine, which are scheduled to be made in coming weeks, said Dr. Arnold Monto, a professor of global public health at the University of Michigan.

Beyond the flu, the CDC will provide only “minimal support” to programs that investigate infectious-disease outbreaks. The Atlanta-based agency’s ability to test suspicious pathogens and maintain its 24-hour emergency operations center will be “significantly reduced,” according to the plan.

That could prevent the CDC from identifying clusters of symptoms and disease “that are the earliest indicators of outbreaks,” Frieden said.

NATIONAL INSTITUTES OF HEALTH

Although the NIH will continue to treat patients at its clinical center in Bethesda, Md., the agency will not enroll new patients in clinical trials — which many people with life-threatening illnesses see as their last hope.

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MEDICARE

Beneficiaries will be largely unaffected by a shutdown, especially if it is short. Patients will continue to receive their insurance coverage, and Medicare will continue to process reimbursement payments to medical providers. But those checks could be delayed if the shutdown is prolonged.

MEDICAID

States already have their funding for Medicaid through the second quarter, so no shortfall in coverage for enrollees or payments to providers is expected. Enrolling new Medicaid applicants is a state function, so that process should not be affected.

States also handle much of the Children’s Health Insurance Program (CHIP), which provides coverage for lower-income children whose families earn too much to qualify for Medicaid. But federal funding for CHIP is running dry — its regular authorization expired on Oct. 1, and Congress has not agreed on a long-term funding solution. Federal officials announced Friday that the staff necessary to make payments to states running low on funds will continue to work during a shutdown.

COMMUNITY HEALTH CENTERS

According to the HHS plan, the Health Resources and Services Administration will continue to operate the nation’s 1,400 community health centers — clinics that serve about 27 million low-income people, providing preventive care, dentistry and other basic services. It will also continue the Maternal, Infant and Early Childhood Home Visiting Program, which targets low-income and at-risk families with house calls and lessons for healthy parenting. That program served about 160,000 families in fiscal year 2016.

But even those programs may not be at full speed. Funding for community health centers and the home visiting program was not renewed last fall — a casualty of Congress’ fight over the CHIP reauthorization — so, they are operating on left-over funds.

ACA PREMIUM SUBSIDIES

The shutdown will not affect some of the most politically charged health care programs, including ones created by the Affordable Care Act. Subsidies for people who get their health insurance through healthcare.gov or state marketplaces will not be affected, according to HHS.

VETERANS AFFAIRS

Staffing for the Department of Veterans Affairs will remain largely intact. “Even in the event that there is a shutdown, 95.5 percent of VA employees would come to work, and most aspects of VA’s operations would not be impacted,” said department press secretary Curtis Cashour in an email.

More than 99 percent of employees of the Veterans Health Administration, which runs the health care system, will continue working, according to the department’s contingency plan.

However, the Veterans Benefits Administration, responsible for overseeing benefits such as life insurance and disability checks, will face larger cutbacks. Over a third of its employees face furlough under a government shutdown.

FOOD AND DRUG ADMINISTRATION

In the short term, the crucial activities that protect consumers will get done, said Jill Hartzler Warner, who was the associate commissioner for special medical programs at the FDA during the 2013 shutdown.

Programs that are critical for the public safety will continue, as will positions paid for by user fees, including work under the Center for Tobacco Products, according to the HHS plan.

The hundreds of staff members who conduct sample analysis and review entry of products into the U.S. will continue to work. However, routine inspections and laboratory research will cease.

Warner, who left the agency in March 2017 and now works as an industry consultant, said grants for rare-disease drug development were determined in 2013 to not be necessary and were postponed.

NUTRITION SERVICES FOR SENIORS

The Administration for Community Living will not be able to fund federal senior nutrition programs during any shutdown, according to HHS officials. But it was not immediately clear how quickly clients would be affected.

A shutdown could delay federal reimbursements to independent Meals on Wheels programs, which serve more than 2.4 million seniors nationwide, according to Colleen Psomas, a spokeswoman for Meals on Wheels America. That could force programs to expand waiting lists for meals, reduce meals or delivery days, or suspend service, she said.

The magnitude of the effect could vary by the length of the shutdown and any final allocation. Some programs, however, could weather a shutdown, staffers said. In Portland, Ore., Meals on Wheel People spokeswoman Julie Piper Finley said meal delivery there will not be suspended. That agency receives about 35 percent of its funding through the Older Americans Act, but raises the rest of the money, ensuring that services are not disrupted.

Meanwhile, services connected to food and nutrition services for other needy populations are likely to keep operating with state partners who have funding through February and, in some cases, March, according to a Department of Agriculture spokesperson. Those programs include the Supplemental Nutrition Assistance Program, the Child Nutrition Programs and the Special Supplemental Nutrition Program for Women, Infants and Children.

FOOD SAFETY

The FDA’s food safety programs will cease, according to the HHS plan, but inspections conducted by Agriculture’s Food Safety and Inspection Service (FSIS) will continue.

Meat and poultry inspections are “such a critical, essential task, and the meat and poultry inspection acts require that inspectors be present continuously,” otherwise processing plants would have to close, said Brian Ronholm, former head of FSIS who now works for the law firm Arent Fox.

Ronholm added that many FSIS employees are “career folks” who have worked there through previous government shutdowns. “There was a lot of built-in knowledge of how to function during the [2013] shutdown,” he said, adding that this expertise would help the agency if there is another shutdown.

Staff writers JoNel Aleccia, Julie Appleby, Carmen Heredia Rodriguez, Shefali Luthra,  Jordan Rau, Stephanie Stapleton, Liz Szabo, Sarah Jane Tribble and Lydia Zuraw contributed to this report.

This article was updated on Jan. 20 to reflect that the deadline for government funding had passed without an agreement in Congress.

In The Event Of A Shutdown … How It Might Affect Your Health

Kaiser Health News:HealthReform - January 19, 2018
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A government shutdown would have far-reaching effects for public health, including the nation’s response to the current, difficult flu season. It could also disrupt some federally supported health services, experts said Friday.

In all, the Department of Health and Human Services would send home — or furlough — about half of its employees, or nearly 41,000 people, according to an HHS shutdown contingency plan released Friday.

Here are some federal services and programs consumers might be wondering about:

CENTERS FOR DISEASE CONTROL AND PREVENTION

According to the HHS plan, the CDC would suspend its flu-tracking program. That’s bad timing, given the country is at the height of a particularly bad flu season, said Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston. Without the CDC’s updates, doctors could have a harder time diagnosing and treating patients quickly, he said.

Although states would still track flu cases, “they won’t be able to call CDC to verify samples or seek their expertise,” said Dr. Thomas Frieden, who was the director of the agency during the 2013 government shutdown.

A government shutdown could also affect the CDC’s involvement in key decisions about next year’s flu vaccine, which are scheduled to be made in coming weeks, said Dr. Arnold Monto, a professor of global public health at the University of Michigan.

Beyond the flu, the CDC would provide only “minimal support” to programs that investigate infectious-disease outbreaks. The Atlanta-based agency’s ability to test suspicious pathogens and maintain its 24-hour emergency operations center would be “significantly reduced,” according to the plan.

That could prevent the CDC from identifying clusters of symptoms and disease “that are the earliest indicators of outbreaks,” Frieden said.

NATIONAL INSTITUTES OF HEALTH

Although the NIH would continue to treat patients at its clinical center in Bethesda, Md., the agency would not enroll new patients in clinical trials — which many people with life-threatening illnesses see as their last hope. The only exception would be an admission deemed medically necessary by the NIH director.

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MEDICARE

Beneficiaries would be largely unaffected by a shutdown, especially if it is short. Patients would continue to receive their insurance coverage, and Medicare would continue to process reimbursement payments to medical providers. But those checks could be delayed if the shutdown were prolonged.

MEDICAID

States already have their funding for Medicaid through the second quarter, so no shortfall in coverage for enrollees or payments to providers is expected. Enrolling new Medicaid applicants is a state function, so that process should not be affected.

States also handle much of the Children’s Health Insurance Program (CHIP), which provides coverage for lower-income children whose families earn too much to qualify for Medicaid. But federal funding for CHIP is running dry — its regular authorization expired on Oct. 1, and Congress has not agreed on a long-term funding solution. Federal officials announced Friday that the staff necessary to make payments to states running low on funds would continue to work during a shutdown.

COMMUNITY HEALTH CENTERS

According to the HHS plan, the Health Resources and Services Administration would continue to operate the nation’s 1,400 community health centers — clinics that serve about 27 million low-income people, providing preventive care, dentistry and other basic services. It would also continue the Maternal, Infant and Early Childhood Home Visiting Program, which targets low-income and at-risk families with house calls and lessons for healthy parenting. That program served about 160,000 families in fiscal year 2016.

But even those programs may not be at full speed. Funding for community health centers and the home visiting program was not renewed last fall — a casualty of Congress’ fight over the CHIP reauthorization — so, they are operating on left-over funds.

ACA PREMIUM SUBSIDIES

The shutdown would not affect some of the most politically charged health care programs, including ones created by the Affordable Care Act. Subsidies for people who get their health insurance through healthcare.gov or state marketplaces would not be affected, according to HHS.

VETERANS AFFAIRS

Staffing for the Department of Veterans Affairs will remain largely intact. “Even in the event that there is a shutdown, 95.5 percent of VA employees would come to work, and most aspects of VA’s operations would not be impacted,” said department press secretary Curtis Cashour in an email.

More than 99 percent of employees of the Veterans Health Administration, which runs the health care system, would continue working, according to the department’s contingency plan.

However, the Veterans Benefits Administration, responsible for overseeing benefits such as life insurance and disability checks, will face larger cutbacks. Over a third of its employees face furlough under a government shutdown.

FOOD AND DRUG ADMINISTRATION

In the short term, the crucial activities that protect consumers would get done, said Jill Hartzler Warner, who was the associate commissioner for special medical programs at the FDA during the 2013 shutdown.

Programs that are critical for the public safety would continue, as would positions paid for by user fees, including work under the Center for Tobacco Products, according to the HHS plan.

The hundreds of staff members who conduct sample analysis and review entry of products into the U.S. would continue to work. However, routine inspections and laboratory research would cease.

Warner, who left the agency in March 2017 and now works as an industry consultant, said grants for rare-disease drug development were determined in 2013 to not be necessary and were postponed.

NUTRITION SERVICES FOR SENIORS

The Administration for Community Living would not be able to fund federal senior nutrition programs during any shutdown, according to HHS officials. But it was not immediately clear how quickly clients would be affected.

A shutdown could delay federal reimbursements to independent Meals on Wheels programs, which serve more than 2.4 million seniors nationwide, according to Colleen Psomas, a spokeswoman for Meals on Wheels America. That could force programs to expand waiting lists for meals, reduce meals or delivery days, or suspend service, she said.

The magnitude of the effect could vary by the length of the shutdown and any final allocation. Some programs, however, could weather a shutdown, staffers said. In Portland, Ore., Meals on Wheel People spokeswoman Julie Piper Finley said meal delivery there would not be suspended. That agency receives about 35 percent of its funding through the Older Americans Act, but raises the rest of the money, ensuring that services are not disrupted.

Meanwhile, services connected to food and nutrition services for other needy populations are likely to keep operating with state partners who have funding through February and, in some cases, March, according to a Department of Agriculture spokesperson. Those programs include the Supplemental Nutrition Assistance Program, the Child Nutrition Programs and the Special Supplemental Nutrition Program for Women, Infants and Children.

FOOD SAFETY

The FDA’s food safety programs would cease, according to the HHS plan, but inspections conducted by Agriculture’s Food Safety and Inspection Service (FSIS) would continue.

Meat and poultry inspections are “such a critical, essential task, and the meat and poultry inspection acts require that inspectors be present continuously,” otherwise processing plants would have to close, said Brian Ronholm, former head of FSIS who now works for the law firm Arent Fox.

Ronholm added that many FSIS employees are “career folks” who have worked there through previous government shutdowns. “There was a lot of built-in knowledge of how to function during the [2013] shutdown,” he said, adding that this expertise would help the agency if there is another shutdown.

Staff writers JoNel Aleccia, Julie Appleby, Carmen Heredia Rodriguez, Shefali Luthra, Liz Szabo, Jordan Rau, Stephanie Stapleton, Sarah Jane Tribble and Lydia Zuraw contributed to this report.

HHS Announces New Conscience and Religious Freedom Division

HHS Gov News - January 19, 2018

Today, the U.S. Department of Health and Human Services (HHS) is pleased to announce the formation of a new Conscience and Religious Freedom Division in the HHS Office for Civil Rights (OCR).  The announcement will take place at an event at HHS headquarters from 10:30 a.m. to noon.  It will be livestreamed here. Speakers will include Acting Secretary Eric D. Hargan, House Majority Leader Kevin McCarthy, Representative Vicky Hartzler, Senator James Lankford, OCR Director Roger Severino, and special guests.

The Conscience and Religious Freedom Division has been established to restore federal enforcement of our nation’s laws that protect the fundamental and unalienable rights of conscience and religious freedom.  OCR is the law enforcement agency within HHS that enforces federal laws protecting civil rights and conscience in health and human services, and the security and privacy of people’s health information.  The creation of the new division will provide HHS with the focus it needs to more vigorously and effectively enforce existing laws protecting the rights of conscience and religious freedom, the first freedom protected in the Bill of Rights.

OCR already has enforcement authority over federal conscience protection statutes, such as the Church, Coats-Snowe, and Weldon Amendments; Section 1553 of the Affordable Care Act (on assisted suicide); and certain federal nondiscrimination laws that prohibit discrimination on the basis of religion in a variety of HHS programs. 

OCR Director Severino said, “Laws protecting religious freedom and conscience rights are just empty words on paper if they aren’t enforced. No one should be forced to choose between helping sick people and living by one’s deepest moral or religious convictions, and the new division will help guarantee that victims of unlawful discrimination find justice. For too long, governments big and small have treated conscience claims with hostility instead of protection, but change is coming and it begins here and now.”

Acting HHS Secretary Hargan said, “President Trump promised the American people that his administration would vigorously uphold the rights of conscience and religious freedom.  That promise is being kept today. The Founding Fathers knew that a nation that respects conscience rights is more diverse and more free, and OCR’s new division will help make that vision a reality.”

To learn more about the new Conscience and Religious Freedom Division, visit us at www.hhs.gov/conscience.

To file a complaint with OCR based on a violation of civil rights, conscience or religious freedom, or health information privacy, visit us at https://www.hhs.gov/ocr/complaints.

OCR Announces New Conscience and Religious Freedom Division. It will restore federal enforcement of our nation’s laws that protect the fundamental rights of conscience and religious freedom. https://go.usa.gov/xnvfJ

 

Judge Orders New Olympus Trial Over Superbug Death

Kaiser Health News:Marketplace - January 18, 2018

A Seattle judge said Olympus Corp. failed to properly disclose internal emails that raised safety concerns about a redesigned medical scope as early as 2008, several years before the device was publicly tied to deadly superbug outbreaks.

Citing those “willful discovery violations” by the Japanese device giant, King County Superior Court Judge Steve Rosen ordered a new trial Tuesday in a wrongful death case brought by Theresa Bigler. The Seattle-area widow, whose case was the first to go to trial in the nationwide outbreaks, claimed that a tainted Olympus scope caused the infection that led to her husband’s death in 2013. The jury returned a mixed verdict, finding that the device’s design was not unsafe.

The emails from 2008 — which Olympus shared with the plaintiffs but were not translated from Japanese, as required — suggest that the company was aware of a potential design problem at least four years earlier than had been disclosed, even before the scope hit the market in 2010. The newly discovered emails could lend support to plaintiffs’ claims that it put sales ahead of patient safety.

More than 25 lawsuits against the scope maker have been filed nationally, most of them in Los Angeles and at least four in Washington state.

Richard Bigler, a 57-year-old who was receiving treatment for pancreatic cancer, was one of at least 35 patients in American hospitals to have died since 2013 after developing infections tied to Olympus duodenoscopes, which are snake-like tubes threaded down a patient’s throat to diagnose and treat problems in the digestive tract. About 700,000 such procedures are performed annually in the U.S.

At the initial Bigler trial last year, jurors rejected claims that the design of the company’s top-selling gastrointestinal scope hampered cleaning and declined to award punitive damages to the family. Instead, the jury ordered Olympus to pay the Seattle hospital involved $6.6 million in damages. In turn, the hospital, Virginia Mason Medical Center, had to pay the family $1 million.

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“Olympus robbed the Bigler family of a full and fair trial. They hid the documents and hid the witnesses,” said plaintiff’s attorney David Beninger, whose team found the emails after an Olympus executive  mentioned hospital tests during the first trial. “The family is grateful they will get another chance to hold Olympus accountable.

Olympus said it intends to appeal the judge’s ruling.

“We believe we were compliant with the Washington discovery rules,” the Tokyo-based company said in a statement. “The jury rightly found the Olympus TJF-Q180V duodenoscope design was not defective. This device remains the preferred choice of physicians and hospitals around the world.”

The judge’s order is a setback for the Japanese manufacturer, which has tried for years to win back public trust after a $1.7 billion accounting scandal marred the company’s reputation in 2012. The scope-related outbreaks have sparked renewed scrutiny of the company’s conduct.

In 2016, Olympus recalled its TJF-Q180V duodenoscopes and made repairs to reduce the risk of contamination.

Until now, federal investigations and patient lawsuits into the scope outbreaks have focused more on a warning issued in 2012 by an independent expert who concluded that the scope’s design could allow blood and tissue to become trapped, spreading bacteria from one patient to the next. Olympus emails from 2013, in which executives rejected the idea of a broad warning to U.S. hospitals about possible infections, played a prominent role at last year’s Bigler trial. The company issued a safety alert in Europe in 2013.

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Follow California Healthline’s continuing coverage of the tainted scopes issue from Senior Correspondent Chad Terhune:

Although Olympus had turned over the documents in question to the plaintiffs as part of thousands of pages of pretrial discovery, the judge said the company failed to translate the documents — and flag the hospital test results in response to specific queries from the plaintiffs.

“The rules require that when you produce something under [court rules for interrogatories], it has to be in English,” Rosen said at a Nov. 2 hearing on potential discovery sanctions. “Otherwise, it becomes a very easy way, as a policy matter and a practical matter, to hide things.”

At that same hearing, the judge said “there was massive impropriety on Olympus’s part with regard to verification of discovery.”

Rosen ordered Olympus to pay the Bigler family $250,000 as a sanction as well as cover the plaintiff’s legal expenses for the new trial.

The new documents reveal for the first time that Olympus gave a scope prototype to several hospitals and doctors in Europe and the U.S. for a trial run before putting it on the market in 2010. Olympus controls about 85 percent of the U.S. market for gastrointestinal scopes, which can cost up to $40,000 apiece.

At one of those facilities, Oslo University Hospital in Norway, an unidentified nurse expressed concerns about being able to clean inside the tip of the reusable scope, Olympus internal emails show.

The nurse told the scope maker it would need to certify that the device could be easily cleaned and added: “‘You do want to sell these, right?’” according to an April 15, 2008, email by Masakazu Higashimoto, an Olympus research and development liaison in Germany.

This feedback sparked more messages among Olympus employees who worried that adding a cleaning brush would diminish the company’s upcoming sales pitch and delay the product launch. In 2010, in marketing brochures, Olympus touted its new scope as easier to clean because a crucial section of the device was sealed to keep bacteria out.

“I don’t want to actively market [the brush] since it makes it harder to make [a marketing] appeal based on the high level of cleanliness and ease of cleaning,” Olympus executive Naoya Shimada wrote in an April 18, 2008, email to Higashimoto and three other colleagues, which was filed in court. “I don’t want to have the risk of delaying the scope due to problems with the brush or a need to revise the specs,” Shimada added.

The brush wasn’t included at the product’s launch. Only after superbug outbreaks in the Netherlands, Seattle, Pittsburgh and Los Angeles did Olympus issue a 2015 safety alert advising U.S. customers to use a similar brush.

Lars Aabakken, chief of gastrointestinal endoscopy at Oslo University Hospital, said he doesn’t recall testing the Olympus prototype. But “it does not sound implausible that our nurses may have raised this question, given the quite substantial change” from the previous Olympus model in Europe, which had a removable cap that offered better access for cleaning areas that could harbor dangerous bacteria, he said.

Several U.S. medical centers are listed in translated company documents as participating in the evaluation of the scope prototype around 2008, according to the plaintiffs’ ongoing review and translation of Olympus documents. They include the Cleveland Clinic, Beth Israel Deaconess Medical Center in Boston, Indiana University, the University of Virginia and Thomas Jefferson University Hospital in Philadelphia. It’s unclear what feedback, if any, those hospitals gave Olympus as company documents continue to undergo translation.

In 2013, Thomas Jefferson had eight patient infections tied to contaminated Olympus duodenoscopes, according to a U.S. Senate investigation released in 2016. A hospital spokeswoman, Gail Benner, said, “We have not identified any records indicating that Jefferson conducted formal testing of the Olympus TJF-Q180V duodenoscope.”

Cleveland Clinic declined to comment, citing the ongoing litigation. The other hospitals didn’t respond to requests for comment.

The Seattle judge also found that Virginia Mason committed a discovery violation by not providing a spreadsheet containing scope test results to Olympus. An attorney for the hospital said the material had been provided as required.

It’s In The Mail: Aetna Agrees To $17M Payout In HIV Privacy Breach

Kaiser Health News:Marketplace - January 18, 2018

Aetna settled a lawsuit for $17 million Wednesday over a data breach that happened in the summer of 2017. The privacy of as many as 12,000 people insured by Aetna was compromised in a very low-tech way: The fact that they had been taking HIV drugs was revealed through the clear window of the envelope.

“I was shocked,” said Sam, who distinctly recalls the day he received the notice in August. (Kaiser Health News and NPR agreed not to use his full name because he worries about how going public with his HIV status might affect his work.) The letter came to his mailbox in an apartment complex in New Jersey. He wasn’t directly involved in the lawsuit but says the letter hit a level of vulnerability he had never felt before.

“I haven’t disclosed my HIV status to my parents,” said Sam, 36, who is a civil rights attorney. “Let’s say that letter had gotten forwarded to their house and someone happened to open the mail. Those were the types of things going through my mind.”

In a statement, Aetna wrote: “Through our outreach efforts, immediate relief program and this settlement we have worked to address the potential impact to members following this unfortunate incident.”

The insurer also said it is “implementing measures designed to ensure something like this does not happen again as part of our commitment to best practices in protecting sensitive health information.”

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In an ironic twist, the letters were sent in response to a settlement over previous privacy violation concerns. Aetna had required members to obtain HIV medications through mail-order pharmacies. The affected people had taken medication to treat HIV or to lower the risk of becoming infected with the virus, an approach called PrEP, or pre-exposure prophylaxis.

Lawsuits filed in 2014 and 2015 alleged that policy was discriminatory, that it prevented patients taking HIV medicine from receiving in-person counseling from a pharmacist and that it jeopardized members’ privacy.

Aetna settled with the individual plaintiffs, changed its policy to allow members to fill HIV prescriptions in person at retail pharmacies, and, in turn, sent out notification letters to anyone who had filled prescriptions for HIV medications.

It was those notification letters that contained a large envelope window that exposed sensitive HIV information.

While the stigma surrounding HIV may be less severe than it used to be and treatments have improved greatly, Ronda Goldfein, director of the AIDS Law Project of Pennsylvania, said the reality is that serious discrimination still exists. That means protecting patient confidentiality is critical to ensuring people feel safe getting care.

As hundreds of calls from people who received the Aetna letter started coming into Goldfein’s office and others around the country, she learned of more harrowing and devastating experiences. She said she heard from one man who had homophobic slurs painted on his door when neighbors saw the letter. Other letter recipients felt the need to move out of their neighborhoods. For one woman, whose status became known in her tight-knit immigrant community, “she stopped being able to function, she stopped being able to go to work, and she lost her job,” Goldfein said.

Adrian Lowe (left), staff attorney with the AIDS Law Project of Pennsylvania, and Ronda Goldfein, an attorney and executive director of the AIDS Law Project, filed a class-action suit against Aetna over privacy breaches. (Elana Gordon/WHYY)

The AIDS Law Project of Pennsylvania and the Legal Action Center initially issued a demand letter in late August that the insurer stop the mailings. The company responded, setting up a relief fund for affected people and apologizing. “This type of mistake is unacceptable, and we are undertaking a full review of our processes to ensure something like this never happens again,” the health insurer said.

Goldfein and others soon discovered that the mailing was more widespread than first thought: Up to 12,000 people had received it. Her agency, the Legal Action Center and Berger & Montague PC filed a lawsuit and sought class-action status.

The privacy breach as outlined in the proposed settlement was twofold: Aetna released the names of 13,480 people to its legal counsel and a vendor without proper authorization. Of those, 11,875 got the letter that revealed they were taking HIV medication.

The proposed settlement is awaiting approval in federal court, but in it Aetna has agreed to pay $17 million and set up new “best practices” to prevent something like this from happening again.

As part of the payout, the law firms are setting aside at least $12 million for payments of at least $500 to the estimated 11,875 people who may have received a letter exposing that information, acknowledging that “the harm was in the status being disclosed,” Goldfein said. Plus, people won’t have to file additional paperwork and go through more mailings pertaining to their HIV medications.

A fund will be set up for those who experienced additional financial or emotional distress. Individuals will be able to claim up to $20,000. The rest of the money will go toward legal fees and costs.

“It’s a much bigger settlement than ordinary identity theft scenarios, where an online database has been breached and the main injury people are claiming is that they might be victims of identity theft and maybe have their financial information compromised,” said William McGeveran, a specialist in privacy law and data breaches at the University of Minnesota.

The amount may be unusual, but McGeveran also said low-level breaches like this aren’t. Companies may be so focused on IT security that they overlook other ways that privacy can be breached.

“They’re more common than people realize,” McGeveran said. “There’s so much attention to cybersecurity, and rightly so, but a lot of medical privacy concerns are much more analog than that. They’re about things being overheard, they’re about paper records and in this case it’s about a paper mailing.”

Beyond the payout itself, she hopes the suit helps change the culture of companies when it comes to the attention paid to medical privacy, and the rights of people with HIV in particular. To highlight that, lawyers used “Andrew Beckett” as the pseudonym for the original plaintiff in the case, a Pennsylvania man from Bucks County.

It’s a nod to the Tom Hanks character in the 1993 film “Philadelphia,” who was fired after his law firm found out he had HIV. This “Beckett” is taking PrEP.

“HIV still has a negative stigma associated with it, and I am pleased that this encouraging agreement with Aetna shows that HIV-related information warrants special care,” the man known as Beckett said in statement.

This story is part of a partnership that includes WHYY, NPR and Kaiser Health News.

Podcast: What The Health? Our First Live Show: What The Health Will Happen In 2018?

Kaiser Health News:HealthReform - January 18, 2018

Congress is at the precipice of shutting down the government, unless lawmakers can quickly agree on another short-term spending bill. And this time, the Children’s Health Insurance Program is caught in the crosshairs. Republicans are offering six years of funding for CHIP as an enticement for Democratic votes on the spending bill, but Democrats are still balking because they want the bill to include protections for undocumented individuals brought to the U.S. by their parents when they were children.

Meanwhile, with the help of the Trump administration, states are looking at other ways to change the Medicaid program besides work requirements.

And Tom Scully, former head of the Centers for Medicare & Medicaid Services under President George W. Bush, offers his predictions for what might happen this year in health policy. His short answer: not much.

Julie Rovner of Kaiser Health News (left), Sarah Kliff of Vox.com, Paige Winfield Cunningham of The Washington Post and Alice Ollstein of Talking Points Memo speak at a live taping of this week’s “What The Health?” podcast. (Lynne Shallcross/KHN)

This week’s “What The Health?” panelists are Julie Rovner of Kaiser Health News, Stephanie Armour of The Wall Street Journal, Joanne Kenen of Politico, Sarah Kliff of Vox.com, Alice Ollstein of Talking Points Memo, Margot Sanger-Katz of The New York Times and Paige Winfield Cunningham of The Washington Post.

In the podcast’s first live taping before an audience, the panelists discuss these topics as well as whether states will pass their own individual insurance requirements now that the penalty for the federal “individual mandate” has been repealed, how the loss of that penalty will change the individual marketplaces and whether anyone will address the high cost of prescription drugs.

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Among the takeaways from this week’s podcast:

  • Although CHIP has long enjoyed a reputation as having bipartisan support, it appears that House Republicans are less committed to the program than in past years.
  • The addition of a work requirement gained many of the headlines in the Trump administration’s Medicaid waiver for Kentucky, but other important changes were given a green light, too. They include jettisoning the long-standing practice of giving enrollees retroactive coverage if they were eligible for it at that time, charging premiums, and locking people out of coverage if they fail to provide required premiums or paperwork.
  • Maryland officials are weighing the option of setting up a state-based requirement that people get insurance since the federal government has repealed the Affordable Care Act’s penalties for not having insurance. If it passes, other states could follow suit.
  • Scully says one of the biggest issues facing policymakers is trying to fix the gross inequities in Medicaid as different states use it for different populations and programs.

To hear all our podcasts, click here.

And subscribe to What the Health? on iTunesStitcher or Google Play.

Home Care Agencies Often Wrongly Deny Medicare Help To The Chronically Ill

Kaiser Health News:Marketplace - January 18, 2018

Colin Campbell needs help dressing, bathing and moving between his bed and his wheelchair. He has a feeding tube because his partially paralyzed tongue makes swallowing “almost impossible,” he said.

Campbell, 58, spends $4,000 a month on home health care services so he can continue to live in his home just outside Los Angeles. Eight years ago, he was diagnosed with amyotrophic lateral sclerosis, or “Lou Gehrig’s disease,” which relentlessly attacks the nerve cells in his brain and spinal cord and has no cure.

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The former computer systems manager has Medicare coverage because of his disability, but no fewer than 14 home health care providers have told him he can’t use it to pay for their services.

That’s an incorrect but common belief. Medicare does cover home care services for patients who qualify, but incentives intended to combat fraud and reward high quality care are driving some home health agencies to avoid taking on long-term patients such as Campbell, who have debilitating conditions that won’t get better, according to advocates for seniors and the home care industry. Rule changes that took effect this month could make the problem worse.

“We feel Medicare coverage laws are not being enforced and people are not getting the care that they need in order to stay in their homes,” said Kathleen Holt, an attorney and associate director of the Center for Medicare Advocacy, a nonprofit, nonpartisan law firm. The group is considering legal action against the government.

Campbell has ALS, which attacks the nerve cells in the brain and the spinal cord. The former computer systems manager uses a walker, wheelchair and built-in fixtures to help him get around. (Heidi de Marco/KHN)

Campbell developed drop foot due to his ALS and needs to wear a brace. He relies on help from a home health worker to get dressed and bathed every day. (Heidi de Marco/KHN)

Federal law requires Medicare to pay indefinitely for home care — with no copayments or deductibles — if a doctor ordered it and patients can leave home only with great difficulty. They must need intermittent nursing, physical therapy or other skilled care that only a trained professional can provide. They do not need to show improvement. Those who qualify can also receive an aide’s help with dressing, bathing and other daily activities. The combined services are limited to 35 hours a week.

Medicare affirmed this policy in 2013 when it settled a key lawsuit brought by the Center for Medicare Advocacy and Vermont Legal Aid. In that case, the government agreed that Medicare covers skilled nursing and therapy services — including those delivered at home —to maintain a patient’s abilities or to prevent or slow decline. It also agreed to inform providers, bill auditors and others that a patient’s improvement is not a condition for coverage.

Campbell said some home health care agencies told him Medicare would pay only for rehabilitation, “with the idea of getting you better and then leaving,” he said. They told him that Medicare would not pay them if he didn’t improve, he said. Other agencies told him Medicare simply did not cover home health care.

Medicaid, the federal-state program for low-income adults and families, also covers home health care and other home services, but Campbell doesn’t qualify for it.

Securing Medicare coverage for home health services requires persistence, said John Gillespie, whose mother has gone through five home care agencies since she was diagnosed with ALS in 2014. He successfully appealed Medicare’s decision denying coverage, and afterward Medicare paid for his mother’s visiting nurse as well as speech and physical therapy.

“You have to have a good doctor and people who will help fight for you to get the right company,” said Gillespie, of Orlando, Fla. “Do not take no for an answer.”

Yet a Medicare official did not acknowledge any access problems. “A patient can continue to receive Medicare home health services as long as he/she remains eligible for the benefit,” said spokesman Johnathan Monroe.

But a leading industry group contends that Medicare’s home health care policies are often misconstrued. “One of the myths in Medicare is that chronically ill individuals are not qualified for coverage,” said William Dombi, president of the National Association for Home Care and Hospice, which represents nearly half of the nation’s 12,000 home care providers.

Part of the problem is that some agencies fear they won’t be paid if they take on patients who need their services for a long time, Dombi said. Such cases can attract the attention of Medicare auditors who can deny payments if they believe the patient is not eligible or they suspect billing fraud. Rather than risk not getting paid, some home health agencies “stay under the radar” by taking on fewer Medicare patients who need long-term care, Dombi said.

And they may have a good reason to be concerned. Medicare officials have found that about a third of the agency’s payments to home health companies in the fiscal year ending last September were improper. 

Campbell’s adjustable wheelchair allows him to recline, which makes breathing easier. (Heidi de Marco/KHN)

Shortages of home health aides in some areas might also lead an overburdened agency to focus on those who need care for only a short time, Dombi said.

Another factor that may have a negative effect on chronically ill patients is Medicare’s Home Health Compare ratings website. It includes grades on patient improvement, such as whether a client got better at walking with an agency’s help. That effectively tells agencies who want top ratings “to go to patients who are susceptible to improvement,” Dombi said.

This year, some home care agencies will earn more than just ratings. Under a Medicare pilot program, home health firms in nine states will start receiving payment bonuses for providing good care and those who don’t will pay penalties. Some criteria used to measure performance depend on patient improvement, Holt said.

Another new rule, which took effect last Saturday, prohibits agencies from discontinuing services for Medicare and Medicaid patients without a doctor’s order. But that, too, could backfire. 

“This is good,” Holt said. “But our concern is that some agencies might hesitate to take patients if they don’t think they can easily discharge them.”

This article was written with the support of a journalism fellowship from New America Media, the Gerontological Society of America and the Silver Century Foundation.

If Poor Neighborhood = Poor Health, Relocation Is One Solution

Kaiser Health News:States - January 17, 2018

When low-income Americans are concentrated in substandard homes in struggling or violent neighborhoods, it has tangible consequences for well-being. Research confirms that moving families into less segregated neighborhoods improves overall health, and some communities are giving families vouchers to relocate. Kaiser Health News correspondent Sarah Varney and PBS Newshour producer Jason Kane filed this story that begins in St. Louis.

Readout of Acting HHS Secretary Hargan’s visit to Baltimore

HHS Gov News - January 16, 2018

Acting Health and Human Services Secretary Eric D. Hargan, Surgeon General Jerome Adams, and Deputy Assistant Secretary for Minority Health Matthew Lin traveled to Baltimore on Friday to meet with city officials and community leaders to learn firsthand how the Department can better empower those on the front lines of America’s pressing public health challenges.

While in Baltimore, Acting Secretary Hargan and HHS officials were able to tour local facilities and participate in roundtables with leaders from the Baltimore City Health Department; Health Care for the Homeless, a federally qualified community health center; and Bon Secours Hospital. At these three locations, they engaged in dialogue and exchanged ideas with medical experts, local leaders and individuals receiving treatment or recovering from various conditions, including opioid addiction, on a variety of issues such as reducing health disparities, treatment of serious mental illness, and the opioid epidemic.

The visits were a part of an ongoing effort by HHS to reaffirm the Trump administration’s commitment to combating the opioid epidemic and engaging with local communities on efforts to address the nation’s healthcare challenges.

Inside The Global Race To Deliver A Vital Radioactive Isotope Used To Detect Cancer

Kaiser Health News:Marketplace - January 16, 2018

JANESVILLE, Wis. — In a cornfield here, past the shuttered General Motors plant and the Janesville Terrace trailer home park, a facility not seen in the United States in three decades could soon rise: a manufacturing plant that will make a vital radioactive isotope used to detect cancer and other potentially fatal maladies in millions of people every year.

Nuclear medicine imaging, a staple of American health care since the 1970s, runs almost entirely on molybdenum-99, a radioisotope produced by nuclear fission of enriched uranium that decays so rapidly it becomes worthless within days. But moly-99, as it’s called, is created in just six government-owned nuclear research reactors — none in North America — raising concerns about the reliability of the supply and even prompting federal scientists to warn of the possibility of severe shortages.

Some 50,000 Americans each day depend on a strange and precarious supply chain easily disrupted by a variety of menaces: shipments grounded by fog in Dubai, skittish commercial airline pilots who refuse to carry radioactive material and unplanned nuclear reactor shutdowns, including one in South Africa when a mischievous baboon sneaked into a reactor hall.

Delays that pose an inconvenience for other commercial goods are existential threats in the daily global relay race of medical isotopes that disappear hour by hour. “It’s like running through the desert with an ice cream cone,” said Ira Goldman, senior director of global strategic supply at Lantheus Medical Imaging in North Billerica, Mass.

But that race may soon be shortened. Propelled by persistent supply problems and fears that terrorists could seize American uranium en route to foreign facilities, President Barack Obama signed legislation in 2013 prodding American companies into the medical-isotope business.

The $100 million Janesville plant, in the hometown of Rep. Paul Ryan, speaker of the House, is the first construction project to pass through the labyrinthine nuclear regulatory approval process since 1985 and is being built by SHINE Medical Technologies with $25 million in federal funds.

Greg Piefer, the company’s founder and a nuclear engineer (he drives a Tesla with the license plate “NEUTRON”), has big plans for the cornfield: a plant that could manufacture up to 50,000 doses of imaging agent a week. “Ryan called me out of the blue and he said, ‘We really want you here,’” Piefer said.

Still, it could be years before moly-99 is manufactured in the United States. SHINE still needs more money to complete its manufacturing plant, and investors are wary of the many problems that can arise during construction. Already, construction deadlines promised by SHINE have come and gone. Other competitors, meanwhile, that received tens of millions of dollars in federal grants to build their own moly-99 manufacturing plants have been thwarted by protracted drug approvals and nuclear regulatory hurdles, and some have given up.

European rivals have also cautioned the American upstarts. At industry presentations, Goldman said, the producers have warned, “This is more difficult than it looks. You can’t come up with a fancy slide that says, ‘I’m going to be producing moly-99 in a couple of years.’”

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Birth Of An Isotope

The radioactive isotope injected into the veins of potential heart attack victims or bone cancer patients begins its journey in the heavily guarded American nuclear stockpile.

The Department of Energy’s National Nuclear Security Administration ships Cold War-era uranium overseas, where the containers — sought by terrorists for dirty bombs — are secretively trucked to government-owned nuclear research reactors in the Netherlands, Belgium, Czech Republic and Poland. (South Africa and Australia also use American uranium to produce moly-99 in research reactors.)

Private companies rent time in the reactors to irradiate enriched uranium targets, producing an atomic alphabet soup. Nearby processing facilities fish out the moly-99, and the radioactive material is loaded onto commercial airline flights bound for the United States in protective containers.

Three companies dominate the American market for moly-99 — Lantheus, Curium and GE Healthcare. They distribute the material to specialized pharmacies around the country, where technicians process it into a diagnostic imaging agent called technetium-99. The companies work against a ticking clock: Because of its short half-life, just 66 hours for moly-99 and six hours for the imaging agent, the material must be quickly delivered to hospitals and administered to patients.

“The whole industry is like a duck going on a fast-flowing river,” said Kevin Charlton, an analyst at the Organization for Economic Cooperation and Development’s Nuclear Energy Agency in Paris. “On the surface, it looks like things are going very smoothly, but under the water, their legs are going really fast.”

Countless things can go wrong, starting with the first step.

The worldwide supply of moly-99 relies on a fleet of government-subsidized nuclear research reactors built mostly during the Khrushchev-Eisenhower era.

Regular maintenance and major repairs can shutter the reactors, sometimes for months, and so-called scrams — caused by anything from a hiccup in a reactor’s cooling system to an errant lightning strike — frequently halt production. “It’s a nuclear reactor,” Charlton said. “The only thing you can do is shut it off.”

Even the Mayo Clinic in Rochester, Minn., a prestigious cancer treatment center, can be left waiting for shipments of the generators that contain the imaging agent. “We’ve had days when no generator comes in at all, or it’s been cut in half,” said Andrew Paulsen, supervisor of the clinic’s radiopharmaceutical laboratory.

And the ephemeral nature of moly-99 always looms. On a recent afternoon, inside a locked laboratory at Stanford Hospital’s nuclear medicine department in Palo Alto, Calif., a technician held a lead-lined, plastic cylinder containing a syringe of fragile atoms that had traveled around the globe.

Once the imaging agent is injected into a patient’s body, it emits gamma rays that can be detected by gamma cameras that look like X-ray machines. The radioactive tracer lights up on a computer monitor wherever the heart’s blood vessels are blocked or bones are riddled with potentially cancerous tumors. The imaging agent was first used in medical applications in the 1960s because its short half-life meant that patients were getting less exposure to radioactivity than from other diagnostic tracers.

But at Stanford’s nuclear medicine department that day, a patient had missed his appointment. This meant the dose — which cost the hospital an irretrievable $500 — had decayed and was now useless. The technician threw the syringe in the trash.

The supply chain’s vulnerability, acutely felt during a severe worldwide shortage in 2009 and 2010 when two reactors shut down unexpectedly, has led some doctors to shift to more dependable, but more toxic, imaging agents. “For cardiac imaging, we had to shift to a more expensive agent and expose patients to more radiation,” said Dr. Andrei Iagaru, chief of the division of nuclear medicine at Stanford Health Care.

After the worldwide shortage, the volume of nuclear medicine tests went down, and stayed down. “It definitely had an impact on the way many practices run their cardiac stress tests,” Iagaru said.

Depending On Other Countries

American patients consume nearly half of the world’s supply of moly-99. And despite plans to ramp up production in Australia, reactor construction is notoriously tricky. In addition, reactors that are converting for security reasons to low-enriched uranium have lower yields and more waste, according to nuclear scientists.

Concerns about moly-99 shortages heightened in October 2016, when the Canadian government mothballed a reactor in Chalk River, Ontario, that supplied about 40 percent of the American market. The government’s decision to shutter the plant was, in part, due to frustration that Canada had had to spend $70 million in 2009 to repair the facility — in effect, subsidizing the American health care industry. That is a complaint of European governments as well.

William Magwood, director of the Nuclear Energy Agency in Paris, said that moly-99 production at Chalk River “went from being incidental to being the only reason to operate the reactor.”

“Canadians didn’t want to continue to operate a high-cost reactor to sell isotopes to the U.S.,” he said.

Some European governments have begun charging moly-99 producers higher rates to rent reactor time, and prices are expected to rise sharply when governments strip for-profit companies of subsidies originally meant to support academic research.

“How much will get passed on to the health care providers?” said Leah Gannon, senior portfolio executive of radiopharmaceutical distribution sourcing for Vizient, a company that negotiates contracts for hospitals. “Probably almost all of it.”

With no source of moly-99 anywhere in North America, American nuclear medicine specialists appointed by the National Academies of Sciences, Engineering and Medicine warned in a 2016 report commissioned by Congress of a more than 50 percent likelihood of another severe shortage in the coming years.

Moly-99 suppliers refute the report’s findings, a position echoed by the Nuclear Energy Agency, which has fostered closer ties among producing nations. Reactor operators, the suppliers say, work closely to stagger maintenance shutdowns to minimize shortages and respond to disruptions in production, and producers have increased the number of uranium targets.

“We’re describing a glass that is half-full,” Charlton said, “whereas the National Academy of Sciences sees the glass looking half empty.”

Still, nuclear medicine physicians and nuclear pharmacists charged with filling patient orders each day say the supply remains fragile, especially for smaller pharmacies where the moly-99 imaging agent can account for 95 percent of their business. “It is inconceivable to believe that an outage will never occur on any of these old reactors in the future,” said Dr. Joseph Hung, director of radiopharmaceutical operations at the Mayo Clinic and a member of the government committee.

Wendy Galbraith, a clinical associate professor at the University of Oklahoma College of Pharmacy in Oklahoma City who runs the university’s pharmacy, said she frequently doesn’t know if moly-99 is going to be available until the wee hours of the morning. Even when there are no major outages, she said, “it’s a scramble.”

That uncertainty means delays and on-the-fly triage for patients. “If we have a patient who can wait two days for their cardiac stress test, we’ll put them off,” Galbraith said.

Suppliers want to tamp down fears about reliability, physicians and pharmacists say, to dissuade them from seeking alternative imaging methods when possible, like positron emission tomography, a costly and complex type of medical scan.

“It’s hard to stay relevant in an environment when things are not available every now and then,” said Iagaru at Stanford.

Even more troubling, critics say, is the lack of redundancy in the supply chain. Of the four global suppliers, two rely on a single reactor. “If anything goes wrong with the reactors in South Africa and Australia,” Dr. Hung said, “it will be déjà vu again like in 2009.”

The Wisconsin Project

If the United States is to grow a domestic moly-99 supply, it will probably rise from the corn and soybean fields in America’s Dairyland.

Rock County, Wis., has become the unexpected home to two of the three companies vying for control: NorthStar Medical Radioisotopes in Beloit, which has been awarded $50 million in federal grants, and SHINE, or Subcritical Hybrid Intense Neutron Emitter, in Janesville.

Backed by $25 million in federal support, Piefer, SHINE’s chief executive, has promised to build a nuclear accelerator and produce moly-99 by 2020. (The previous deadline was 2015.) In early 2017, the company opened its headquarters in Janesville above the Time Out Pub & Eatery and down the street from a fishing tackle shop and Speaker Ryan’s district office.

Nuclear engineers have moved en masse to Janesville in recent months, decorating their cubicles with hand-painted signs with sayings like, “Think like a proton, stay positive.”

Piefer zips along Highway 90 in his Model S Tesla between Janesville and Monona, a Madison suburb where his research lab, Phoenix Nuclear Labs is located. There, engineers have built a ghostly particle beam that looks like a giant, purple lightsaber.

Eight particle accelerators have been designed for the Janesville plant, which the Nuclear Regulatory Agency approved for construction in 2016. Piefer still needs to raise considerable private capital, a challenge with eager entrants like NorthStar and Nordion, an Ottawa-based company also with aggressive plans to enter the Moly-99 market.

“If we don’t have significant production soon, we will continue to export highly enriched uranium,” Piefer said. “And the National Nuclear Security Administration will have failed their mission.”

The city of Janesville is banking on Piefer. Its economy reeling from the closing of the General Motors plant in 2008, the City Council aggressively pursued SHINE with a generous economic development package, besting two other Wisconsin cities.

In 2011, over the objections of some residents opposed to a nuclear facility in the town, the council authorized $1.53 million to buy 84 acres of farmland, which it has agreed to turn over to SHINE for $1. The city has also agreed to pay $345,000 to extend utilities to the site, provide $2 million in forgivable loans and co-sign a bank loan with SHINE for up to $4 million that it would have to pay should the company fail, a first for the city.

Gale Price, economic development director for the city of Janesville, said that although it was unusual to put public money into a startup, the city expected to recoup its investment within 10 years. “That’s how we measure whether we’re giving away the farm,” he said.

Ryan has championed the project and spoke at a celebration marking nuclear regulatory approval. But Piefer said, except for the initial phone call urging him to come to Janesville, Ryan has played no part in the federal grant and construction approvals.

SHINE jumped at the chance at federal money for the private plant. But Piefer isn’t solely focused on the need in American hospitals. The company has already announced lucrative deals to ship moly-99 to Chinese hospitals.

But first, it needs to start producing.

“You cannot just open a shop down the street and start nuclear medicine,” said Iaragu, of Stanford. “The public comes with an expectation that if my oncologist wants me to get a bone scan, it’s not big deal. But the truth is, it’s a big deal.”

When You Need A Breast Screening, Should You Get A 3-D Mammogram?

Kaiser Health News:Insurance - January 16, 2018

When I went to the imaging center for my regular mammogram last year, the woman behind the desk asked me if I’d like to get a “3-D” mammogram instead of the standard test I’d had in the past.

“It’s more accurate,” she said.

What do you say to that? “No, thanks, I’d rather have the test that gets it wrong?” Of course, I agreed.

A growing number of women are likely to face a similar choice in coming years as imaging centers across the country add three-dimensional (3-D) mammography, also called digital breast tomosynthesis, to the two-dimensional (2-D) screening women customarily receive.

What’s not yet clear is whether this newer, more expensive technology is better at catching cancers that are likely to kill. So should it be widely recommended? And who should pick up the extra cost involved?

According to the Food and Drug Administration, there were 3,915 certified mammography imaging facilities that offered digital breast tomosynthesis in January. That’s a sharp increase over the previous January, when the total was 3,011.

Some facilities have switched over entirely to 3-D imaging, but many practices have both, experts said.

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“There’s a lot of marketing pressure to offer these new machines,” said Robert Smith, vice president of cancer screening at the American Cancer Society.

Both types of tests use X-ray technology to create images of the breast. The 2-D digital mammograms that most women receive typically provide front and side images, while for the 3-D test the X-ray arcs across the breast, creating multiple images of breast tissue. The experience is the same for women, though, because both scans involve compressing the breast between two plates extending from the machine.

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Studies have generally shown that the 3-D test is slightly better at detecting cancers than the 2-D test, and women typically have to return less often to have additional images taken. But the jury is still out on whether the newer technology is any better at identifying the advanced cancers that will become lethal.

“Cancers don’t always progress and kill people,” said Dr. Etta Pisano, chief science officer at the American College of Radiology’s Center for Research and Innovation and a faculty member at Harvard Medical School. Pisano is leading a five-year clinical trial of 165,000 women that will compare the two types of screening tests to evaluate whether the new technology reduces the risk that women will develop life-threatening cancers.

“If tomosynthesis is improving the likelihood of women to survive their breast cancers, they should have fewer cancers that are more likely to kill women over the 4.5 years of screening. Since tomosynthesis caught them early, they’ll never grow up to be bad cancers,” Pisano said.

Overdiagnosis is one of the potential downsides of this technology, said Dr. David Grossman, chair of the U.S. Preventive Services Task Force. The more sensitive test picks up more breast lesions for which the clinical significance is unclear, potentially resulting in women receiving more testing and treatment they don’t need. Some research suggests the biopsy rate is slightly higher with 3-D mammograms.

In addition, some of the mammography systems require both 2-D and 3-D X-rays, which can expose women to twice as much radiation. Other systems are able to generate a 2-D image from the 3-D version with software, eliminating the extra exposure. The 2-D image is important because clusters of calcifications, which may signal breast cancer, might be easier to see on the 2-D image, said Pisano.

Under the Affordable Care Act, most health plans are required to cover preventive services that are recommended by the task force without charging patients anything out-of-pocket. The task force recommends biennial mammograms for women ages 50 to 74, but it says that there’s not enough evidence to recommend 3-D mammograms at this time.

Insurance coverage of 3-D testing has improved in recent years, but it’s not assured. The 3-D test typically costs about $50 more than a 2-D test, according to a 2015 study by Truven Health Analytics that was funded by Hologic, a manufacturer of 3-D mammography systems. Medicare also covers 3-D tests.

A growing number of states require commercial insurers to cover 3-D mammograms, including Arkansas, Texas, Connecticut, Maryland, Illinois and Pennsylvania.

My state of New York also requires coverage, without any out-of-pocket payments. Though I didn’t have to pay it, the explanation of benefits form I got from my insurer said the 3-D portion of the test added $51 to the $157 cost of the mammogram.

“Costs are high for new technologies,” Pisano said. “Maybe they are better, but we need to have evidence before we recommend it for the entire population.”

So if you’re offered a 3-D test, should you get it?

“If the examination is available at no extra cost, the data we have now tells us it has some advantages,” said Smith. On the other hand, “any woman who’s feeling stressed about the extra cost … should feel comfortable getting a regular mammogram,” he said.

Trump’s Work-For-Medicaid Rule Puts Work On States’ Shoulders

Kaiser Health News:Insurance - January 12, 2018
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The Trump administration’s watershed decision Thursday to allow states to test a work requirement for adult Medicaid enrollees sparked widespread criticism from doctors, advocates for the poor, and minority and disability rights groups.

Conservatives, however, hailed the change to the federal-state program for low-income people. Stephen Miller, the Medicaid commissioner for Kentucky, which received authority Friday to implement a work requirement, said the new policy will “allow states the flexibility to pursue innovative approaches to improve the health and well-being of Medicaid beneficiaries.”

Yet states considering whether to enact the controversial strategy face major hurdles. They will have to figure out how to define the work requirement and alternative options, such as going to school or volunteering in some organizations; how to enforce the new rules; how to pay for new administrative costs; and how to handle the millions of enrollees likely to seek exemptions.

Take Arizona, one of the 10 states that have applied for federal approval for a work requirement. The state must settle basic questions, including whether people would have to meet the new conditions at the time of enrollment, at the annual renewal of their Medicaid coverage or at another time.

Jami Snyder, deputy director of the Arizona Medicaid program, said a key goal for the state is to help people find jobs — not to reduce its Medicaid enrollment, which stands at 1.9 million.

“Infusing the requirement into our eligibility requirements acts as a nice incentive for enrollees in their effort to seek out employment and job training,” she said.

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But the state today doesn’t know how many of its enrollees are already employed, said Snyder.

“We are still working through all the operational details,” she explained.

Seema Verma, administrator for the Centers for Medicare & Medicaid Services, said she hopes the new work requirement will improve enrollees’ health while reducing Medicaid rolls. The policy change should help people find jobs that offer health coverage or make enough money to afford private plans, she said.

Critics expressed skepticism. They say the work requirement proposal — which was repeatedly rejected by the Obama administration on the argument it would interfere with providing health coverage — is a more subtle way to reduce the number of non-disabled adults added to Medicaid under the Affordable Care Act. That Medicaid expansion was sharply criticized by conservatives, and Republicans in Congress tried to add work requirements in their unsuccessful bid last year to overturn the health law.

“This is an effort to walk back the Medicaid expansion,” said Judith Solomon, vice president of the Center on Budget and Policy Priorities, a Washington-based research organization. CMS said states would have to test whether the work requirement improves enrollees’ health — a point Solomon ridiculed. “What health outcome will be improved if we take away health care from those not able to work?” she asked.

Dr. Richard Pan, a California state senator and pediatrician in Sacramento who sees Medicaid patients, said the idea just “doesn’t make sense.” By making it harder for people to have health insurance, “you’re going to make it less likely for them to work,” he said.

Pan, a Democrat, said the proposal would create more bureaucracy and “feeds into a fiction” that Medicaid enrollees don’t work — or don’t want to work.

More than 4 in 10 non-disabled adults with Medicaid coverage already work full time.

Despite their concerns about the change in Medicaid policy, critics of the plan acknowledge that it will touch only a fraction of the nation’s total enrollment. Solomon estimates that fewer than 2 percent of the 74 million people covered would be directly affected by a work requirement.

In addition to the large group of enrollees already working, the federal guidelines excluded children — who make up nearly half of Medicaid enrollees. Also off the hook are the more than 10 million enrollees who have a disability. Many of those left either to go to school or take care of a relative or are too sick to work.

The CMS guidelines give states wide latitude in enacting work requirements, and state rules may differ on who gets exempted from the mandate. Arizona’s proposal has one of the longest lists of exemptions, including people 55 and over, victims of domestic violence, American Indians and individuals who have experienced a death of a family member living in the same household.

It is unclear how enrollees will prove they meet such criteria or if states will use the honor system.

In comparison, Kentucky seeks to exempt children; pregnant women; primary caregivers for children or a disabled relative; people who are medically frail; and full-time students.

Emily Beauregard, executive director for Kentucky Voices for Health, an advocacy group, said one of the key exemption issues states must work out is defining who is “medically frail”— a designation that CMS said would exempt enrollees from the requirement. The federal government, however, leaves the qualifying characteristics up to states.

Before coming to Washington last year, Verma was a health consultant who worked with Indiana and Kentucky to expand Medicaid under the ACA. But in a speech to the nation’s Medicaid directors in November, Verma said adding non-disabled adults to Medicaid was a mistake for a program designed to help children, the disabled and pregnant women.

“The thought that a program designed for our most vulnerable citizens should be used as a vehicle to serve working-age, able-bodied adults does not make sense,” she said at the time.

Some Democratic-leaning states are not expected to make the change. California health care leaders dismissed the idea of imposing a work requirement on the state’s Medicaid enrollees, saying it would never come to pass.

Kevin de León, a Democrat and the leader of California’s Senate, wouldn’t comment on the proposal because he said it’s a non-starter.

“This is not an option we are considering,” said Jennifer Kent, director of the state Department of Health Care Services, which administers Medi-Cal, the state’s Medicaid program that covers about 13.5 million Californians.

Most states contract with private health insurers to run much of their Medicaid operations. Those insurers said they remain concerned that as the work mandate unfolds, their jobs might become harder because of increased churn in enrollment and administrative work. About 52 million of the 74 million Medicaid enrollees rely on managed-care companies for their coverage.

“With this guidance from CMS, it will be essential for states and stakeholders in the states — including insurance providers — to understand the details of who will be impacted by work requirements, how these requirements will be defined and administered, and how people who are impacted will be directed to new pathways for coverage and care,” said Kristine Grow, a spokeswoman for America’s Health Insurance Plans, a national trade group.

Jeff Myers, president and CEO of the Medicaid Health Plans of America, another trade group, noted that most people on Medicaid already work. He said his group is concerned work requirements could affect how the health plans operate. They will need to “see all of details from states,” he said.

Kentucky Is First State Granted Approval For Medicaid Work Requirements

Kaiser Health News:States - January 12, 2018
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[UPDATE: This story was updated at 3:50 p.m. ET with comments from Kentucky’s governor and details on who would be exempted from the state’s new rule.]

Thousands of poor adults in Kentucky will have to find jobs and pay monthly premiums to retain their Medicaid coverage as a result of drastic changes to the state’s health insurance program approved Friday by the Trump administration.

With the long-expected decision, Kentucky becomes the first state to win federal approval to test a new work requirement in Medicaid, a controversial policy shift likely to result in a court battle over whether the administration overstepped its legal authority.

“I was raised by a father who said, ‘Don’t take something that is not earned,’” said Republican Gov. Matt Bevin in announcing the approval of Kentucky’s Medicaid waiver. “The vast majority of able-bodied men and women, able-bodied Kentuckians, they want the dignity associated with being able to earn and have engagement in the very things they are receiving, and an opportunity not to be put in a dead-end entitlement trap but given a path forward and upward.”

Conservatives say the work requirement can help lead people to employment and off the state-federal health program. Democrats, health providers and patient groups say the measure adds another stumbling block for people to keep their coverage.

“By lessening dependence on government assistance and promoting individual self-sufficiency, Kentucky’s efforts should also help to promote the fiscal sustainability of the program to better protect services for the Commonwealth’s most vulnerable,” Demetrios Kouzoukas, principal deputy administrator of the Centers for Medicare & Medicaid Services, wrote in his Kentucky approval letter. “Overall, CMS believes that Kentucky HEALTH [Helping to Engage and Achieve Long Term Health] has been designed to empower individuals to improve their health and well-being.”

Radio story by Jake Harper, Side Effects Public Media, a news collaborative covering public health.

The approval comes one day after the Trump administration released guidance to states on how to design and test programs that require work as a condition of receiving Medicaid.

A study by the Kaiser Family Foundation found that 6 in 10 non-disabled adults on Medicaid already work at least part time, although they often aren’t offered health benefits through those jobs or can’t afford them. (Kaiser Health News is an editorially independent program of the foundation.)

Surveys show that many Medicaid enrollees who don’t work are in job training, go to school or are taking care of a child or an elderly relative, conditions that would make them exempt from the new mandate, according to the CMS guidelines.

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Kentucky’s program would require non-disabled adults  each month to participate in 80 hours of work, job training, education  or other qualified “community engagement.”

Those who are exempted include children and former foster care kids, pregnant women, senior citizens, people who are the primary caretakers for a child or a disabled adult, those who are deemed medically frail or diagnosed with an acute medical condition that would prevent them from working, and full-time students.

Officials acknowledge that the work requirement — coupled with other changes in its waiver request — would lead to about 95,000 fewer people enrolled after five years. But many of those would drop out not because of finding work but because they can’t overcome the new bureaucratic hurdles, say advocates for the poor.

“We expect that fewer people will be able to stay enrolled in coverage due to all of the red tape and penalties they’ll encounter,” said Emily Beauregard, executive director for Kentucky Voices for Health, an advocacy group. “Keeping up with the reporting requirements alone will be enough of a burden on people who have two or three part-time jobs that they’ll either lose coverage at some point or may decide it’s not worth enrolling to begin with.”

The Kentucky approval brings other major changes to the state’s Medicaid program, which has doubled in enrollment to 1.2 million people since the state expanded eligibility in 2014 under the federal Affordable Care Act.

The revisions would cut dental and vision coverage for many adults, although they can regain it by completing health-related activities, such as taking a disease management class or volunteering.

Individuals with income above the poverty level ($12,060) who do not pay their premiums in 60 days will be kicked out of coverage for six months. Enrollees can return to the program earlier if they pay two months of missed premiums and make one new premium payment. They also must complete a financial or health literacy course.

The state also eliminates its non-emergency transportation benefit for some adults in the program.

Under Kentucky HEALTH, enrollees will make a monthly payment ranging from $1 to $15 depending on income. Pregnant women and children will be exempt from that cost sharing.

The Kentucky Medicaid changes generally mimic those of neighboring Indiana, which altered its program in 2015 under then-Gov. Mike Pence.

CMS Administrator Seema Verma recused herself from the Kentucky decision because she had worked with state officials on the waiver request when she was a consultant before joining the Trump administration.

Kentucky is one of 10 states that have applied to CMS to enact a work requirement.

The work requirement is one of the biggest changes in the history of Medicaid, which covers more than 74 million people, or about 1 in 5 Americans. It is the nation’s largest health insurance program.

The majority of enrollees in Medicaid are children, pregnant women and elderly nursing home residents. But the expansion under President Barack Obama led to millions of non-disabled low income adults added to the program.

Update: This story was updated on Jan. 12 to add information from the governor and more details on the Kentucky waiver once they were released. 

Podcast: ‘What The Health?’ Should You Work For Your Medicaid Coverage?

Kaiser Health News:Insurance - January 12, 2018
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THE EVENT: A live taping of KHN’s “What The Health?” podcast.

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The Trump administration this week told states they will be allowed to require some beneficiaries of the Medicaid program to work or perform community service in order to keep their health insurance — a break with long-standing policies of both Democratic and Republican administrations.

Meanwhile, the Congressional Budget Office said that renewing the Children’s Health Insurance Program (CHIP) for 10 years would actually save the federal government money, because alternative arrangements for the 9 million children now covered would be more expensive.

Plus, Paul Starr, Princeton professor and co-editor of The American Prospect, talks about his about ideas for expanding the Medicare program, if and when the political winds shift in that direction.

This week’s “What The Health?” panelist are Julie Rovner of Kaiser Health News, Joanne Kenen of Politico, Sarah Kliff of Vox.com and Margot Sanger-Katz of The New York Times.

They discuss these topics as well as the prospects for quick confirmation of former Health and Human Services Deputy Secretary Alex Azar to head the department. And Rovner interviews Paul Starr.

Among the takeaways from this week’s podcast:

  • The new work policy follows efforts to add a work requirement to Medicaid eligibility. But that change came through congressional action. The Trump administration’s decision to shift policy through the executive branch could complicate its legal arguments when advocates file their promised lawsuits.
  • Despite concerns about the historic nature of the change in Medicaid requirements, many people — including many Medicaid enrollees — say they support a work mandate.
  • The Congressional Budget Office’s revisions to estimates about the cost of the Children’s Health Insurance Program appear to be breaking the logjam on funding on Capitol Hill.
  • Alex Azar, the nominee to be secretary of the Department of Health and Human Services, appears on the glide path for confirmation, with at least two Democratic senators, Heidi Heitkamp of North Dakota and Joe Manchin of West Virginia, having already announced they will vote for him.
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Plus, for “extra credit,” the panelists recommend their favorite health stories of the week they think you should read, too.

Julie Rovner:  Mother Jones’ “Go Fund Yourself,” by Stephen Marche

ALSO: The New York Times’ “You’re Sick. Whose Fault Is That?” by Dhruv Khullar.

Joanne Kenen: The New York Times’ “Baltimore Hospital Patient Discharged at Bus Stop, Stumbling and Cold,” by Jacey Fortin

Sarah Kliff: Marketplace’s “The Uncertain Hour, Episode 1: The Magic Bureaucrat,” by Krissy Clark

Margot Sanger-Katz: The Wall Street Journal’s “Trump Nominee to Lead Indian Health Services Faces Claims of Misrepresentation,” by Christopher Weaver and Dan Frosch.

To hear all our podcasts, click here.

And subscribe to What the Health? on iTunesStitcher or Google Play.

With CHIP Funds Running Low, Doctors And Parents Scramble To Cover Kids’ Needs

Kaiser Health News:Insurance - January 12, 2018

Dr. Mahendra Patel, a pediatric cancer doctor, has begun giving away medications to some of his patients, determined not to disrupt their treatments for serious illnesses like leukemia, should Congress fail to come up with renewed funding for a key children’s health program now hostage to partisan politics.

In his 35 years of practice, Patel, of San Antonio, has seen the lengths to which parents will go to care for their critically ill children. He has seen couples divorce just to qualify for Medicaid coverage, something he fears will happen if the Children’s Health Insurance Program (CHIP) is axed. He said: “They are looking at you and begging for their child’s life.”

The months-long failure on Capitol Hill to pass a long-term extension to CHIP that provides health coverage to 9 million lower-income children portends serious health consequences, with disruption in ongoing treatments.

While funding promises and estimates of dates for it disappearing vary from week to week and state to state, treatment plans for serious diseases span months into the future, leaving some doctors, like Patel, to jury-rig solutions. The challenges are particularly great for kids with chronic or ongoing illnesses such as asthma or cancer.

Dr. Joanne Hilden, a pediatric cancer physician in Aurora, Colo., and past president of the American Society of Pediatric Hematology-Oncology, said cancer patients who are worried their CHIP funding will run out can’t schedule care ahead of time.

A San Antonio pediatrician, Dr. Carmen Garza, is advising parents to be sure to keep their children’s asthma medications and other prescriptions current and fill any refills that they can so they don’t get left without vital medicines if CHIP expires.

Federal funding for CHIP originally ran out Oct. 1. In December, Congress provided $2.85 billion to temporarily fund the program. That was supposed to help states get through at least March, but it is coming up well short. The Centers for Medicare & Medicaid Services (CMS) last week said it couldn’t guarantee funding to all states past Jan. 19.

About 1.7 million children in 20 states and the District of Columbia could be at risk of losing their CHIP coverage in February because of the shortfall, according to a report Wednesday by the Georgetown University Center for Children and Families.

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A few states, including Louisiana and Colorado, plan to use state funds to make up for the lack of federal funding. But that is a drastic step, since the federal government pays on average nearly 90 percent of CHIP costs. Most states cannot afford to make up the difference and will have to freeze enrollment or terminate coverage when their federal funding runs out.

Virginia and Connecticut can promise to keep their CHIP program running only through February, officials said.

The largest states seem to be in the best shape, though even that guarantees only a few months of care. Florida, California and Texas officials said they have enough CHIP funding to last through March. New York officials said they have enough money to last at least into mid-March.

Before the short-term funding was passed in late December, CHIP programs survived on the states’ unspent funds and a $3 billion redistribution pool of CHIP dollars controlled by CMS.

Republicans and Democrats on Capitol Hill say they want to continue CHIP, but they have been unable to agree on how to continue funding it. The House plan includes a controversial funding provision — opposed by Democrats — that takes millions of dollars from the Affordable Care Act’s Prevention and Public Health Fund and increases Medicare premiums for some higher-earning beneficiaries.

The Senate Finance Committee reached an agreement to extend the program for five years but did not unite around a plan on funding.

But two key Republican lawmakers — Sen. John Cornyn of Texas, who is part of the Senate leadership, and Rep. Greg Walden of Oregon, who chairs the House Energy and Commerce Committee — told reporters Wednesday that they think an agreement is close.

Alabama and Utah are among several states unsure how long their federal CHIP funding will last, according to interviews with state officials. Part of the problem is they have not been told by CMS how it will be disbursing money from the redistribution pool. Under the pool restrictions, states with excess dollars would have to give money to states running low.

Although health care provider groups and child health advocates have for months been sounding the alarm about CHIP, the Trump administration has kept quiet, saying it’s up to Congress to renew the program.

When Marina Natali’s younger son broke his arm ice-skating last year, she did not have to worry about paying: CHIP footed all of his medical bills.

Had that accident happened this year, though, Natali, 50, of Aliquippa, Pa., might be scrambling. She cannot afford private coverage for her two children on her dental hygienist pay.

“It’s creating a lot of anxiety about not having insurance and the kids getting sick,” she said.

Without CHIP, dental hygienist Marina Natali says she couldn’t afford health coverage for her sons, 12-year-old Ciro (right) and 15-year-old Marcus. When Ciro broke his arm ice-skating last year, CHIP covered his medical bills. (Courtesy of Marina Natali)

Dr. Todd Wolynn, a Pittsburgh pediatrician, said families are reacting with “fear and disbelief” to CHIP’s uncertain future. The group practice hasn’t changed any scheduling for CHIP patients, but he said “families are terrified” about the program having to be terminated.

Pennsylvania officials sent a notice to CHIP providers in late December — who then sent it to enrollees — saying it would have to end the program in March unless Congress acts.

“These families don’t know if the rug is being pulled out from them at any time,” he said.

Dr. Dipesh Navsaria, a Madison, Wis., pediatrician and vice president of the state’s chapter of the American Academy of Pediatrics, said many parents and doctors have been told for months that Congress would firm up long-term funding for CHIP, but those promises have been dashed.

“If CHIP coverage disappears, we run the risk of kids going without care or emergency room visits going up,” he said.

Navsaria also worries that many parents will be surprised if their children are suddenly without coverage. They may not know the state-branded programs they use, such as BadgerCare Plus in Wisconsin, Healthy Kids in Florida and All Kids in Alabama, are part of the CHIP program.

Ariel Haughton of Pittsburgh said she’s upset her federal lawmakers have left CHIP in flux for her two children and millions of kids around the country. “They seem so cavalier about it,” she said.

If CHIP gets canceled by the state, she likely won’t bring Javier, 2, for his two-year checkup if nothing seems wrong. “We will have to decide between their health and spending the money on something else,” she said.

Correction: This story was updated on Jan. 12 to correct the name of an organization. Dr. Joanne Hilden is the past president of the American Society of Pediatric Hematology-Oncology, not the American Society of  Hematology-Oncology.

J.P. Morgan Health Conference All About The Deals Amid Uncertainty For Millions

Kaiser Health News:Marketplace - January 11, 2018

SAN FRANCISCO — There’s so much money floating around here this week, you can almost see it wafting through the air.

About 10,000 attendees, mostly confident men in well-cut suits and even nicer watches, are packing the elegant Westin St. Francis Hotel for the invite-only J.P. Morgan Healthcare Conference, which ends Thursday.

For many of these investors, health providers, insurers and entrepreneurs at the nation’s largest and most prestigious health investment conference, it’s all about the deal — and the after-hours parties.

In the first few days of what’s become known as J.P. Morgan Week, New Jersey-based Celgene announced it would spend up to $7 billion to acquire Impact Biomedicines. And Novo Nordisk, the world’s biggest insulin maker, bid $3.1 billion for a Belgian biotech firm.

For those who didn’t land a coveted invite, satellite conferences on digital health and biotechnology dot the city, offering lesser mortals an opportunity to network and make their own deals. Former Vice President Joe Biden even popped into town to keynote the StartUp Health Festival satellite conference, speaking about cancer treatment costs and electronic health records.

The J.P. Morgan gathering comes at a jarring time when you consider that the other world of health care is flooded with uncertainty for the millions of ordinary Americans who inhabit it. They face a precarious political landscape in which the future of the Affordable Care Act remains uncertain and Republican leaders in Congress mull dramatic cuts to Medicaid and Medicare.

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John Baackes, CEO of the nation’s largest public health plan, L.A. Care, which insures 2.1 million low-income patients, said if his enrollees wandered into the conference, “they’d think they were in a foreign land and that this has nothing to do with them.”

Much of U.S. health care is underwritten by public dollars, but people here didn’t come to talk about that or rising costs, particularly for prescription drugs. Only a few presentations at this year’s conference have touched on prices, including a J.P. Morgan study released Monday that found many Americans put off medical care until they get their tax refund — a clear sign that that they don’t have enough saved up to pay for care when they need it.

“It’s just so striking how much maneuvering and desire there is at this meeting for a piece of the 18 percent of GDP spent on health care,” mused Dr. Vivian Lee, the former leader of the University of Utah Health Care system, who made a point of tracking costs with pinpoint precision. “Is anyone here trying to decrease their share?”

Baackes, who comes to the conference to network and monitor the latest developments in health care, said he’s always skeptical of the well-heeled company officials who attend promising better health outcomes and cost savings. “In a way, there’s too much money walking around here,” he said. “Investors are thinking, ‘Health care is a $3 trillion sector of the economy; surely it will benefit from my genius.’”

Many attendees view the conference with a less critical eye.

“It’s a useful place for us to be,” said Amanda Cowley, strategy director of the quasi-governmental organization that produces the U.S. Pharmacopeia, a compendium of information and standards for producing medicines and food ingredients. Cowley said she and her colleagues need to learn about emerging health technologies so they can anticipate their future work products.

Cowley stood in a line of hundreds of attendees waiting to dine on tri-tip, vegetables and macarons while listening to Microsoft founder Bill Gates talk about how his foundation is helping improve the health of subsistence farmers and children in the developing world.

But there was little talk of America’s subsistence patients, who often cannot afford the expensive drugs and medical devices that are bought and sold in deals brokered at conferences like these, in private rooms guarded by phalanxes of staffers at tony hotels.

Those patients, however, were the focus of a Medicaid panel held Tuesday at Glide Memorial Church in San Francisco’s troubled Tenderloin district, a few blocks and a world away from the Westin St. Francis. That event, which drew about 70 people, was sponsored by ConsejoSano, a Southern California-based startup that has raised $7.2 million to help Spanish speakers better navigate the health system.

Rallying the troops at Glide was former Medicare and Medicaid chief Andy Slavitt, a fierce critic of Republican efforts to repeal and replace the ACA. Slavitt recently invested in Cityblock Health, a public health startup focusing on Medicaid and other low-income patients.

The good thing about J.P. Morgan Week, Slavitt told Kaiser Health News, is that it draws innovative people who want to invest. “The question is, should health care capital be focused on solving big problems and getting rewarded for them, or just focused on the status quo?”

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