FDA approves expanded label for Regeneron/Sanofi’s cholesterol drug

(Reuters) – The U.S. Food and Drug Administration on Friday approved Regeneron Pharmaceuticals Inc’s cholesterol drug Praluent as a treatment to cut the risk of heart attacks, stroke and other major cardiovascular events.

The FDA’s decision will allow the drug, developed along with Sanofi SA, to be prescribed to reduce the overall risk of major adverse cardiovascular events (MACE).

MACE includes heart attack, ischemic stroke, coronary heart disease and unstable chest pains requiring hospitalization.

Praluent belongs to a class of injectable biotech drugs called PCSK9 inhibitors that dramatically lower bad LDL cholesterol and reduce the risk of heart attacks and death.

The FDA also approved Praluent as an adjunct to diet, alone or in combination with other lipid-lowering therapies, for the treatment of adults with primary hyperlipidemia to reduce LDL-C.

In 2015, Praluent was approved in the United States for use as an add-on treatment to statin therapy in adults with heterozygous familial hypercholesterolemia, a condition that causes cholesterol levels in blood to shoot up. (bit.ly/1KM8WQf)

Sanofi and Regeneron in February cut the list price of Praluent by 60 percent to match the price of Amgen Inc’s Repatha, another treatment to cut the risk of heart attacks, as the drugmakers try to boost the sales of the drug.

The new list price for Praluent will be $5,850 a year, down from more than $14,000 a year, when it was first approved in 2015.

Sales of both Praluent and Repatha have been severely constrained by roadblocks put up by insurers looking to limit spending on the expensive drugs.

Praluent has been approved in more than 60 countries worldwide, including the U.S., Japan, Canada, Switzerland, Mexico and Brazil, as well as the European Union.

Reporting by Aakash Jagadeesh Babu, Akashdeep Baruah and Rishika Chatterjee in Bengaluru; Editing by Sandra Maler and Sonya Hepinstall

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Klobuchar wants to stop ‘pay-for-delay’ deals that keep drug prices high

Washington’s recent fixation with lowering drug costs has introduced Americans to once-insider terms like “pharmacy benefit managers” and “list prices.”

During an April 22 CNN town hall event for Democratic candidates, Sen. Amy Klobuchar (D-Minn.) described a drugmaker practice that sounds a lot like bribery — drawing attention to yet another secretive process that lawmakers and experts say prevents patients from obtaining affordable prescription drugs.

America, meet “pay-for-delay.”

“We can stop this horrible practice where big pharmaceuticals pay off, they literally pay off generics to keep the prices and the competition off the market,” Klobuchar said. “That’s bad, and we can fix it.”

Klobuchar’s comment was one of the fundamental changes she said she would make to the health care system if elected president.

She said ending the practice of pay-for-delay, as well as allowing Medicare to negotiate drug prices and importing less expensive drugs from countries like Canada, could help bring down pharmaceutical costs.

Nearly 8 in 10 Americans believe drug prices are unreasonable, according to a recent poll from the Kaiser Family Foundation. (KHN is an editorially independent program of the foundation.) So it is little surprise that not only Klobuchar but also many presidential candidates are talking about drug costs.

This practice of pay-for-delay sounds almost too shady to be real, so we decided to see if her claim checks out: Are pharmaceutical companies paying generic drugmakers to delay marketing their drugs, keeping prices high? Is that legal? And can it be stopped?

The Back Story On ‘Pay-For-Delay’ Deals

Yes, it is true that pharmaceutical companies compensate generic competitors to hold off on marketing their versions of brand-name drugs. It is also true that this practice results in delays before cheaper, generic drugs become available, leaving patients no choice but to pay for the pricier, brand-name drugs they have been prescribed.

Take Humira, a blockbuster anti-inflammatory medication that treats diseases such as rheumatoid arthritis and Crohn’s disease. AbbVie, the maker of Humira, has aggressively defended its claim on the top-selling drug, filing many patents and striking deals with would-be competitors to retain its exclusivity.

To be sure, the competitors’ versions of Humira are technically “biosimilars,” not generics. But as far as pay-for-delay deals go, they play the same role in this system.

As a result, cheaper versions of Humira will not be available in the United States until 2023 — despite already being on the market in Europe.

To understand this issue, it may help to know pay-for-delay deals by their wonkier name: “reverse payment agreements.”

Like many products, drugs are protected by patents. Before companies can sell a generic drug, they must certify they will not market it until any related patents have expired, or they can challenge the existing patents.

Faced with a challenge to its patent, a brand-name manufacturer may, in turn, choose to sue the generic for patent infringement. Often the companies decide to settle, with the generic manufacturer agreeing to hold off on marketing its drug until a certain date in exchange for some form of compensation from the brand-name company — a “reverse payment agreement” — because rather than seeking damages, they agree to compensate the company they sued.

The terms of these agreements, including the amount of money changing hands, are secret. Only the Federal Trade Commission knows how much they are worth — and the FTC says these deals result in Americans paying $3.5 billion in higher drug costs every year.

While drugmakers could argue the settlements help save on costly litigation, they effectively function as a payment to stay out of the marketplace, protecting the exclusivity and the bottom line of the brand-name drug and its manufacturer.

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In the past, that compensation usually came in the form of cash, said Dr. Aaron Kesselheim, an associate professor at Harvard Medical School who researches the effects of intellectual property laws on drug development.

But cash payments are no longer as common.

In 2013, the Supreme Court ruled that the FTC could scrutinize pay-for-delay agreements under antitrust laws as part of its mission to promote a competitive marketplace.

Since then, the FTC has made opposing what it calls these “anti-competitive deals” one of its top priorities, taking dozens of companies to court.

Thus, many drugmakers have changed strategies. Kesselheim said these deals have “evolved” since the Supreme Court’s decision, with fewer involving the transfer of cash.

With the FTC considering cash payments a red flag for anti-competitive behavior, drugmakers may offer compensation in other forms — say, by sharing knowledge or agreeing to market one another’s drugs to doctors.

That doesn’t help patients, Kesselheim said, as these agreements still delay lower-cost drugs from making their way to the pharmacy counter. “From a patient’s point of view, they’re both kind of not good,” he said.

Both brand-name and generic drug manufacturers have long opposed a ban on pay-for-delay deals. But it looks as if their days are numbered, said Rodney Whitlock, a consultant and former Republican congressional staffer who was deeply involved in health policy.

A handful of bills have been introduced in Congress to halt the practice, including one co-sponsored by Klobuchar and Sen. Chuck Grassley (R-Iowa), who is chairman of the Senate Finance Committee.

But while it looks likely that Congress will pass a law to stop pay-for-delay, that does not necessarily mean the problem will go away.

Passing legislation seems more likely than not, Whitlock said. But “after that, it will be implementation, and will manufacturers find new ways of attaining the same end that we haven’t contemplated yet?”

Our Ruling

Klobuchar said, “We can stop this horrible practice where big pharmaceuticals pay off — they literally pay off — generics to keep the prices and the competition off the market.”

“Pay-for-delay” is a pharmaceutical industry practice that involves brand-name drugmakers compensating their generic counterparts for holding off on marketing their versions of brand-name drugs, causing longer delays in getting cheaper, generic drugs to the pharmacy counter. There are currently no federal laws explicitly barring these sorts of deals.

Brand-name manufacturers do not in all cases “literally pay off” generic drugmakers. Since the Supreme Court ruled the FTC could challenge these agreements in court in 2013, cash payments have become less common, sometimes replaced by other forms of compensation.

Klobuchar is clearly aware of this distinction. The legislation she introduced with Grassley notes that an agreement violates their proposed ban if a drugmaker “receives anything of value,” not just cash.

We rate this statement True.

Kaiser Health NewsThis article was reprinted from khn.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.

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Trump tells Americans: Go get your measles vaccination

WASHINGTON (Reuters) – U.S. President Donald Trump on Friday urged Americans to protect themselves with the measles vaccination as the number of cases of the once-eradicated disease in the United States hit the highest levels since 2000.

U.S. President Donald Trump talks to reporters as he departs for travel to Indianapolis, Indiana from the White House in Washington, U.S., April 26, 2019. REUTERS/Jonathan Ernst

The growing outbreak in pockets across the country has triggered multiple public health efforts seeking to limit exposure to measles, including quarantines at two California universities.

“The vaccinations are so important. This is really going around now,” Trump told reporters at the White House. “They have to get their shots.”

Nearly 700 cases have been confirmed by federal health officials as of this week in a resurgence that has been concentrated in a handful of states — New York, Washington, Michigan, New Jersey and California — although 22 states in all are affected.

Measles can cause severe complications or death. So far, no U.S. fatalities have been reported.

U.S. public health officials have lamented the preventable outbreak and have blamed the nationwide outbreak, which comes alongside a global rise in measles cases, in part on the spread of misinformation about vaccine safety.

Some Americans have eschewed the vaccine for a variety of reasons from religious beliefs to doubts about modern medicine as well as lingering impacts from a debunked claim that vaccines cause autism. No link has been found between the measles vaccine and autism spectrum disorders.

Complacency is also an issue. With fewer cases of the infectious disease in recent decades, much of the public has not seen its impact firsthand.

Measles can cause pneumonia, brain swelling known as encephalitis, and severe ear infections that can lead to deafness, according the U.S. Centers for Disease Control and Prevention. It also can cause premature birth in pregnant women and, in rare cases, harm the central nervous system.

Up to 90 percent of those not immunized who have close contact with an infected person are likely to contract measles, the CDC has said.

On Thursday, county public health officials announced a quarantine at the University of California, Los Angeles and California State University, Los Angeles.

New York City officials have declared a public health emergency after an outbreak in parts of Brooklyn and have taken the unusual step of ordering unvaccinated people in affected neighborhoods to be immunized.

Trump, before winning the U.S. presidency, appeared to raise some doubts about vaccines, tweeting in 2014: “I believe in vaccinations but not massive, all at once, shots. Too much for small child to handle. Govt. should stop NOW!”

Days before Trump took office in the White House in January 2017, vaccine skeptic Robert F. Kennedy Jr. told reporters Trump was planning a vaccine safety review panel, a project Trump’s then-spokeswoman said was being explored but had not been decided.

Reporting by Jeff Mason and Makini Brice; Writing by Susan Heavey; Editing by Chizu Nomiyama and Jonathan Oatis

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Top Kansas court rules state constitution protects abortion rights

(Reuters) – The Kansas Supreme Court ruled on Friday that the state’s constitution protects a woman’s right to an abortion and upheld an injunction blocking a state law that would have banned a common second trimester abortion procedure.

FILE PHOTO: An exam room at the Planned Parenthood South Austin Health Center is seen in Austin, Texas, U.S. June 27, 2016. REUTERS/Ilana Panich-Linsman

The ruling would protect the right to abortion in Kansas even if the conservative-leaning U.S. Supreme Court overturns Roe v Wade, the 1973 ruling that recognized a right to abortion in the U.S. Constitution.

Rulings by state appeals courts on state constitutional issues are not normally subject to U.S. Supreme Court review.

The state’s constitution protects “the right to control one’s own body, to assert bodily integrity, and to exercise self-determination,” wrote the court.

“This right allows a woman to make her own decisions regarding her body, health, family formation, and family life — decisions that can include whether to continue a pregnancy.”

The case stems from challenges to 2015 law that generally banned the dilation and evacuation procedure, which was termed “dismemberment abortion” by the supporters of the law. Kansas became the first state to ban the practice.

The plaintiffs in the case, Dr. Herbert Hodes and Dr. Traci Nauser, a father and daughter, run a clinic in Overland Park, that provides abortions.

Political leaders in the state were quick to praise or condemn the ruling.

“While federal law has long guaranteed every woman the right to make their own medical decisions in consultation with their healthcare providers, I’m pleased that the Kansas Supreme Court’s decision now conclusively respects and recognizes that right under Kansas law as well,” said Kansas Governor Laura Kelly, a Democrat.

“Today the liberal, activist Supreme Court showed just how out of touch they are with Kansas values,” said Susan Wagle, the Republican president of the state senate.

The ruling ensures a right to an abortion in Kansas unless the state amends its constitution. It also comes as more states adopt restrictions on abortion procedures.

Activists on both sides say laws restricting abortions, which are commonly blocked by courts, are aimed at getting a case to the U.S. Supreme Court, where conservatives hold a 5-4 majority.

U.S. President Donald Trump used his annual State of the Union speech in February to push lawmakers to adopt more restrictions on abortion.

On Thursday, a federal judge in Washington state blocked a Trump administration rule that would prohibit taxpayer-funded family planning clinics from referring patients to abortion providers.

Additional reporting by Jonathan Stempel in New York, Karen Pierog in Chicago, Lawrence Hurley in Washington and Nate Raymond in Boston; Editing by David Gregorio

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Association Insurance Pushes On Despite Court Ruling

When the Trump administration in June issued rules making it easier for small employers to band together to buy health insurance, “we started looking immediately,” recalled Scott Lyon, a top executive at the Small Business Association of Michigan.

Although he offered traditional small-group health insurance to his association’s employees and members, Lyon liked adding a new option for both: potentially less expensive coverage through an association health plan, which doesn’t have to meet all the rules of the Affordable Care Act.

Now, a few months in, “we’ve got 400 companies and a couple of thousand workers signed up,” said Lyon last week.

Nationally, an estimated 30,000 people are in such association health plans, a type of health insurance seeing a nascent resurgence following an initial drop-off after the ACA took effect in 2014.

Most of the new enrollees joined through groups like Lyon’s or local chambers of commerce, farm bureaus or agriculture-based cooperatives. Such groups see the plans not only as a way to offer insurance, but also as an enticement to boost membership.

In the first legal test, however, U.S. District Judge John Bates at the end of March sided with 11 states and the District of Columbia challenging the law. He invalidated a large chunk of those June rules, saying the administration issued them as an “end-run around the Affordable Care Act.”

So what now?

Unless the government seeks — which it has yet to do — and is granted a stay of the judge’s order, “plans formed under the vacated sections of the rule are illegal,” said Timothy Jost, an emeritus health law professor from Washington and Lee University.

Still, that won’t mean anything for existing plans if the states or federal regulators choose not to enforce the ruling, Jost said.

And that could cause more confusion in the marketplace.

While the states that brought the challenge are expected to enforce the ruling, some other states support broader access to association health plans, said Christopher Condeluci, an attorney who represents several such plans, including the one formed by Lyon’s group.

“These plans are not an end run around the ACA,” said Condeluci.

Association health plans already established under the administration’s rules cover “virtually” all the federal law’s essential health benefits, he said, with the exception of dental and vision care for children.

Local chamber of commerce plans are mainly continuing business as usual while watching to see if the government will appeal, said Katie Mahoney, vice president of health policy at the U.S. Chamber of Commerce.

A few, including a plan offered through the Las Vegas chamber, may limit new enrollment for sole proprietors, she said, as the judge sharply questioned whether they qualified as “employers” under federal laws.

Sole proprietors are generally individuals who own and operate their own businesses without any employees.

Bates wrote that, in the regulation, the Department of Labor “stretches the definition of employer” beyond what federal law allows. The rule was designed to increase access to plans that “avoid the most stringent requirements” of the ACA.

The opinion by Bates, who was appointed by President George W. Bush, is widely expected to be appealed, although the government has not yet done so.

The decision affects one pillar of a broader effort by the Trump administration to expand access to less expensive health insurance. Association plans have long been a favorite of Republicans, existing before the ACA. Supporters say they are one way to pool groups of businesses together to get better premium rates.

Still, some plans faced problems in the past, including bankruptcy or complaints that they misled consumers by not fully informing them about what is covered.

After the ACA took effect, enrollment fell, partly because many small businesses were buying new ACA plans and many existing association plans had to comply with ACA rules for small-group coverage anyway. People who ran their own businesses and had no employees qualified only for coverage through the ACA’s individual market.

But the Trump administration in June broadened the definition of those eligible to buy insurance through employer-based associations to include sole proprietors and also made it easier to form associations to offer coverage.

In addition, the changes allowed more association plans to be classified as large-employer coverage, which exempts them from some of the ACA’s requirements. For example, association plans don’t have to include all 10 of the ACA’s “essential” health benefits, such as mental health care and prescription drug coverage.

Also, unlike ACA plans, association insurers can set premium rates based on an employer’s industry, as well as taking into account the age range and gender makeup of their workforce.

In other words, association plans can charge less for companies with workforces that are generally younger and male in occupations that involve mainly desk work than for firms with mostly older workers or companies doing riskier work, such as cutting down trees or roofing.

Still, such plans must abide by other ACA provisions, including accepting people with preexisting medical conditions.

Critics, including the states that sued, say the new rules and other administration-backed changes will weaken the market for ACA plans by drawing out younger and healthier people. The states also argued that the new rules would be costly for them to administer, alleging they would have to devote more resources to preventing consumer fraud.

In Michigan, Lyon said the association his group formed, called Transcend, offers coverage to small employers and sole proprietors that is just as generous as large-group plans. It is a fully insured plan through the state’s Blue Cross Blue Shield carrier that covers a broad array of benefits, except children’s dental and vision.

“One thing we don’t want to do is sell a bag of air to our members,” said Lyon.

While some new members have reported large savings by enrolling, Lyon said association plans are not necessarily less expensive than small-group coverage. It all depends on the demographic and occupational makeup of the small business, he said.

“Our best estimate was association health plans would be the right solution for 30 to 35% of the small-group world,” said Lyon. “It all has to come together. Age matters. Gender matters. It’s so specific to each company.”

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Bausch Health’s lotion for plaque psoriasis wins FDA approval

(Reuters) – The U.S. Food and Drug Administration on Thursday approved Bausch Health Companies Inc’s topical plaque psoriasis treatment, which is expected to be a key revenue driver for the company.

Duobrii, which is priced at $825 for a 100-gram tube, is 50 percent lower than other branded topical treatments, the company said. It is expected to be available in the United States in June.

U.S.-listed shares of the company, formerly known as Valeant Pharmaceuticals, rose 3.5 percent to $23.82.

In June, the FDA had declined to approve Duobrii, seeking details on its pharmacokinetic data, which shows how the body reacts to a treatment, including the duration and intensity of the drug’s effects.

Since taking over from former Chief Executive Officer Michael Pearson in 2016, when erstwhile Valeant was hit by a flurry of investigations into its accounting and pricing practices, CEO Joseph Papa has worked to regain investor confidence and has been building on the company’s product portfolio.

The treatment is part of Bausch’s “Significant Seven”, a suite of seven key products expected to generate more than $1 billion in sales over the next five years.

Market for global psoriasis drugs is expected to touch $21.11 billion by 2022, according to U.S. consultant Grand View Research.

Psoriasis is a chronic condition that causes an overproduction of skin cells, resulting in inflamed, red lesions or plaques, which can be itchy and painful. As many as 7.5 million Americans suffer from plaque psoriasis disease.

The green signal from FDA for Duobrii comes after a similar plaque psoriasis lotion, Bryhali, was granted a tentative approval by the health regulator in October.

Reporting by Manojna Maddipatla and Aakash Jagadeesh Babu in Bengaluru; Editing by James Emmanuel

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Burdened at home, some physician mothers consider career change

(Reuters Health) – Like many working mothers, female physicians with kids often handle most housework and childcare duties, and the high burden of domestic duties prompts some to consider a career change, a new study suggests.

Researchers examined data from an online survey of 1,712 female physicians with children who were working in U.S. hospitals in April and May of 2015. All of the women were members of the web-based Physician Moms Group.

Most participants were partnered or married, and most reported having sole responsibility for the majority of domestic tasks regardless of the type of medicine they practiced.

But the burden of domestic work weighed more heavily on women in surgery and other procedure-focused specialties, the study found.

Women in these “procedural” fields – all surgical specialties, as well as anesthesiologists, gastroenterologists and obstetricians-gynecologists – who reported primary responsibility for five or more domestic tasks were 50 percent more likely than colleagues with fewer household chores to report a desire to change careers.

In contrast, for doctors in non-procedural specialties like family medicine, the number of domestic duties they managed on their own didn’t appear to influence their desire for career change. About one in three women in these medical fields reported a desire to switch to a less demanding career or specialty no matter how many chores they had.

“As more women enter the surgical workforce, it is very important to discuss issues surrounding gender disparities and parenthood,” said senior study author Dr. Nelya Melnitchouk of Brigham and Women’s Hospital and Harvard Medical School in Boston.

“By ignoring this topic, there could be a loss of talented women and mothers in the medical and surgical workforces,” Melnitchouk said by email.

While half of medical school graduates in the U.S. are female, only about 14 percent of these women pursue careers in surgery, compared with 33 percent of men, the researchers note in JAMA Surgery. Many women choose instead to pursue “non-procedural” specialties like internal medicine, family medicine and pediatrics.

Both male and female physicians with kids tend to be less satisfied with their careers than their colleagues without children, previous research has found.

But unequal distribution of domestic labor has been documented as a driving force behind the scarcity of women in surgery and in leadership positions in medicine, the study team notes.

In the current study, 57 percent of women had sole responsibility for routine child care plans and 44 percent were responsible for solving backup child care options on their own.

Women, more often than their spouses, also had primary responsibility for domestic duties like cooking, grocery shopping, vacation planning, laundry and helping kids with homework.

For surgeons and women in other procedural specialties, the total burden added up. With sole responsibility for less than five domestic duties, about 43 percent of these doctors considered a career switch, compared with 57 percent of those bearing sole responsibility for five or more domestic tasks.

The survey wasn’t a random sample of all female physicians nationwide, and it’s possible the results don’t represent how all women in medicine feel about work-life balance.

Even so, the results do highlight a looming problem in the profession, particularly for women in surgery who may have a harder time controlling their schedules, said the author of an accompanying commentary, Dr. Julie Ann Freischlag, CEO of Wake Forest Baptist Medical Center and dean of the Wake Forest Baptist School of Medicine in Winston-Salem, North Carolina.

“It has to do with doing procedures, which sometimes get delayed or take longer and require your full attention,” Freischlag said by email. “The urgent and emergent nature of procedures plays into the stress as well.”

(This story has been refiled to correct typo in name spelling in paragraph 8)

SOURCE: bit.ly/2Iq0ygt and bit.ly/2ITaIGE JAMA Surgery, online April 10, 2019.

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Americans Overwhelmingly Want Federal Protections Against Surprise Medical Bills

Three-quarters of the public — including a majority of Republicans — want the federal government to protect patients from being stuck with surprise medical invoices after they are unwittingly treated by doctors or medical facilities that are out of their insurance network, a poll released Wednesday found.

These unexpected bills, which can be financially crippling, may arise when a patient is taken to the emergency room by an out-of-network ambulance; when the emergency room is not in their insurer’s network; or when their hospital is in their network, but a doctor or specialist within that facility who treats them is not.

Although insurers prohibit in-network doctors from billing more than the insurer agreed to, such bills occur because doctors and medical facilities that do not have such contracts are unconstrained from charging whatever they want. Often they charge list prices multiple times the amount insurers agree to pay.

In urgent medical circumstances, patients are rarely in a position to investigate the financial arrangements of their caregivers or make sure they are brought to a treatment center that works with their insurer. Often patients are not aware they were seen by an out-of-work provider until the bill arrives.

Four in 10 American adults under age 65 say that within the past two years they or a family member received an unexpectedly high invoice for a procedure, test or doctor’s visit they thought would be better covered by their insurer, according to the Kaiser Family Foundation poll. (KHN is an editorially independent program of the foundation.) Half of those people said the high bill occurred because the medical provider was not in their insurance network.

Some states have placed limits on what out-of-network doctors and facilities can charge or provided mechanisms for mediating the bills, but those protections do not apply to millions of Americans who receive their insurance through their employer. Policy forums and some members of Congress have discussed potential protections, such as limiting out-of-network payments in emergency care to a price that is a set amount above what Medicare pays.

The poll found between 76% and 78% of the public want the federal government to take action. Support among Democrats was between 88% and 91%, depending on the circumstance that led to the surprise bill, and Republican support ranged from 60% to 62%, the poll showed.

There is no consensus on who should eat the extra costs now borne by patients: 43% of the public said insurance companies should cover the extra costs from the bills, while 47% said doctors or providers should also be on the hook. Only 5% of the public said the provider alone should absorb all the cost, the poll found. Democrats were somewhat more likely than independents or Republicans to put the onus solely on insurers.

Half of the public categorized surprise billings as a top priority for Congress, but other health care issues draw even more support. The poll found 64% of the public said lawmakers should concentrate on protecting the Affordable Care Act’s guarantees that people with preexisting medical conditions can obtain insurance, and 68% gave precedence to lowering prescription drug costs.

Fewer than a third of respondents identified as a top priority either creating a “Medicare-for-all” insurance plan, repealing and replacing the health care law or increasing its financial assistance for people who buy policies on the marketplaces, the poll found.

The poll was conducted April 11-16 among 1,203 adults. The margin of error is +/-3 percentage points.

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In 10 Years, Half Of Middle-Income Elders Won’t Be Able To Afford Housing, Medical Care

In 10 years, more than half of middle-income Americans age 75 or older will not be able to afford to pay for yearly assisted living rent or medical expenses, according to a study published Wednesday in Health Affairs.

The researchers used demographic and income data to project estimates of a portion of the senior population, those who will be 75 or older in 2029, with a focus on those in the middle-income range — currently $25,001 to $74,298 per year for those ages 75 to 84.

And it doesn’t look good for that group because of the rising costs of housing and health care. The researchers estimated that the number of middle-income elders in the U.S. will nearly double, growing from 7.9 million to 14.4 million by 2029. They will make up the biggest share of seniors, at 43%.

By 2029, more than half of the middle-income seniors will have annual financial resources of $60,000 or less, even if the equity in their homes is included. Projections put the average annual assisted living and medical expenses cost in 10 years at $62,000, meaning that a majority of the middle-income seniors then will not be able to afford an assisted living facility.

Middle-income seniors are a group that Beth Burnham Mace, one of the study’s authors, said has been often overlooked when policymakers and legislators think about housing and care for aging Americans.

“The low-income cohort has been taken care of by tax subsidies, while the high-income cohort is largely self-sufficient. But the middle-income seniors have been ignored,” said Mace, who is chief economist at the National Investment Center for Seniors Housing and Care, a nonprofit research group.

The study’s authors said they are probably underestimating the extent of the looming problem. They projected out-of-pocket medical costs of only $5,000 a year for seniors.

Deborah Carr, chairwoman of the department of sociology at Boston University who studies aging, noted that Americans “are able to live longer today than they have in the past because of medical technology.” The downside, said Carr, who was not affiliated with the study, is “if they’re living for years with dementia or mobility issues, then they have to pay longer for medical care for the additional years they live.”

Indeed, the researchers projected that 60% of the middle-income seniors will have mobility limitations, while 20% will be considered “high needs,” meaning they have three or more chronic conditions and one or more limitations in activities of daily living, such as bathing or dressing. Eight percent will have some form of cognitive impairment.

Seniors living with mobility limitations, chronic conditions or cognitive impairment are more likely to need care and support such as that offered by an assisted living facility.

But that’s not a reality for many.

In her written response to the Health Affairs study, Jennifer Molinsky, a senior research associate at the Joint Center for Housing Studies at Harvard University, addressed the needs of seniors who decide to stay at home as they age instead of going to an assisted living facility. She said these older Americans face a different set of challenges.

“One of the challenges is that most people don’t live in cities,” Molinsky said in an interview. “And most houses in these areas are single-family detached homes. The infrastructure is not set up for safe walking, so you have to drive. People often give up driving as they age. So these locations can be difficult to provide services to people.”

Molinsky said other issues to consider are making homes more accessible by adding ramps for wheelchairs or wall handles in the shower and the cost of these changes.

The other dire warning of the study: While spouses and middle-age daughters have historically provided the bulk of elder care, that is a less likely option in the future because of changing marriage patterns, lower birth rates and the increasing number of adult children who live far from their parents. Some seniors will need to seek paid care.

The study suggests that policymakers could expand Medicare benefits to include access to a wider range of supportive services, or create a new benefit, “Medicare Part E,” that funds long-term care. However, other attempts to set up such a program have run into resistance among lawmakers because of cost.

While Medicaid is the primary payer of long-term nursing home care, right now the program is available only to low-income seniors. Seniors may become eligible if they impoverish themselves. However, lawmakers could also broaden the Medicaid income eligibility requirements or expand options to include home-based care for those with higher-end incomes.

Some seniors are already turning to creative solutions to address their growing need for affordable housing.

Carr said one innovative option she has seen is the Village to Village Network, a community program that allows seniors to stay in their homes but have access to general support services, such as home repairs, transportation, health care and even social activities.

Co-housing, where seniors share a residence, like in the classic TV show, “Golden Girls,” is another solution, Carr said.

Mace said she hopes the study will spark more conversation between public and private sectors for creative ideas to address the issue of housing the growing number of Americans who will turn 75 or older in the next decade.

Her advice to both those seniors and their children is to openly discuss the issue.

“It is a good idea to sit down and talk about what your plan may be,” said Mace. “Talk about what the financial assets are and the housing options. It’s a worthy topic to talk about, though it can be hard, because it helps to avoid putting both children and parents in difficult situations in the future.”

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Medically-tailored meal delivery tied to lower health spending

(Reuters Health) – Low-income people with chronic diseases who get free meals delivered that are tailored to their medical needs are less likely to be admitted to hospitals or nursing homes, a study in Massachusetts suggests.

Researchers followed 499 patients who had at least one year of weekly deliveries of 10 ready-to-eat meals customized to their specific health conditions. The study team also followed 521 individuals who had similar medical issues and other characteristics but didn’t receive the meals.

Overall, there were 1,242 inpatient hospital admissions and 1,213 skilled-nursing facility admissions during the study period.

The analysis found that if all the patients had received meal delivery, there would have been about half as many inpatient admissions and an even bigger reduction in skilled-nursing facility admissions.

Even after accounting for the cost of meals, researchers also calculated that average monthly health costs would have been about $753 lower per patient if everyone in the study received the meal deliveries.

“These results mean that if you have a serious medical illness that requires following a specific diet, and you would have trouble affording or otherwise following that diet, it would be worth looking into whether a medically-tailored meal program might be available to you, either through your health insurer or from a philanthropic organization in your area,” said lead study author Dr. Seth Berkowitz of the University of North Carolina at Chapel Hill.

Typically, medically-tailored meal plans are designed by a nutritionist for people with chronic health problems like cancer, AIDS or diabetes and may be covered by insurance for some low-income individuals who can’t afford their groceries, Berkowitz said by email.

Including the cost of meals and medical care, average annual health costs would have been $3,838 per person if everyone in the study received the free meal deliveries and $5,591 per person if nobody got these meals, researchers calculated.

The study wasn’t a controlled experiment designed to prove whether or how medically tailored meal delivery services might directly improve patients’ health.

But there are several ways meal delivery might help, Berkowitz said.

For one thing, people might follow dietary requirements like limiting salt, fat or sugar with meal delivery but not with foods they got on their own, Berkowitz said. This might lead to fewer disease flare-ups and help reduce the risk of hospital or skilled-nursing facility admissions.

Meal delivery may also free-up funds people would otherwise spend on food and allow them to instead devote more of their limited resources to other necessities like medicine or rent or heat, Berkowitz said.

For people who don’t have money or time to shop and cook, deliveries might also help to reduce stress and enable people to focus on other aspects of their health and self-care, Berkowitz added.

“Many patients are too ill to grocery shop or cook and may not have the means to hire someone to help,” said Samantha Heller, a nutritionist at New York University Langone Medical Center in New York City who wasn’t involved in the study.

“In other instances, patients may not have the knowledge or skills to make appropriate choices to help them manage their health and budget,” Heller said by email.

While the ease of having meals delivered that are customized to patients’ health needs can make it easier for them to eat the way doctors want them to, costs can be steep if it isn’t covered by insurance, Heller said.

Even without delivery, patients may still be able to get help planning meals from a registered dietician or another healthcare provider, Heller said. Too often, however, patients are not aware of these services and don’t seek help.

“Patients, families and caregivers should check with their local hospitals, social workers, health insurance company, registered dietitians and health care providers for resources available in the community to help them manage their meals, budgets and health,” Heller advised.

SOURCE: bit.ly/2IER8yM and bit.ly/2PrO1dU JAMA Internal Medicine, online April 22, 2019.

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