California Sues Sutter Health, Alleging Excessive Pricing

California’s attorney general announced a lawsuit Friday against Sutter Health, alleging the hospital giant engaged in anticompetitive conduct that drove up prices for patients and employers in the state.

The lawsuit marked a bold move by state Attorney General Xavier Becerra against the dominant health care system in Northern California as concerns mount nationally about consolidation among hospitals, insurers and other industry middlemen.

“It’s time to hold health care corporations accountable,” Becerra said at a news conference Friday. “We seek to stop Sutter from continuing this illegal conduct.”

Sutter, which owns 24 hospitals, reported net income of $893 million last year on $12.4 billion in revenue.

In a statement Friday, Sutter said it had not yet seen the state’s complaint and couldn’t comment on specific claims.

Overall, Sutter said, “healthy competition and choice exists across Northern California” for consumers seeking medical care, and that its charges for an inpatient stay are lower than what other nearby hospitals charge.

“Sutter Health is proud to save patients, government payers and health plans hundreds of millions of dollars each year by providing more efficient and integrated care,” the statement said.

This high-profile legal fight will attract attention from employers and policymakers across the country amid growing alarm about the financial implications of industry consolidation. Large health systems are gaining market clout and the ability to raise prices by acquiring more hospitals, outpatient surgery centers and physicians’ offices.

Martin Gaynor, a health care economist at Carnegie Mellon University, said California’s lawsuit may portend more litigation at the state level.

“There are a number of markets in the U.S. that are dominated by one very large, powerful health system,” Gaynor said. “It could be that we’re going to see a new level of activity by state antitrust enforcers looking at competition in their own backyards.”

The complaints about Sutter’s high prices and market power have persisted for years.

A 2016 study found that hospital prices at Sutter and Dignity Health, the two biggest hospital chains in California, were 25 percent higher than at other hospitals around the state. Researchers at the University of Southern California said the giant health systems used their market power to drive up prices — making the average patient admission at both chains nearly $4,000 more expensive.

This week, researchers at University of California-Berkeley issued a report that examined the consolidation of the hospital, physician and health insurance markets in California from 2010 to 2016. The authors said 44 of California’s 58 counties had “highly concentrated” hospital markets.

The problem is worse in Northern California, and the report said prices for medical procedures are often up to 30 percent higher there than in Southern California, which has more competition.

“Consumers are paying more for health care as a result of market consolidation. It is now time for regulators and legislators to take action,” according to the report by the Petris Center on Health Care Markets and Consumer Welfare at UC-Berkeley.

After the report was issued Monday, Becerra said his office would be reviewing those findings and pledged to apply more scrutiny to health care mergers and anticompetitive practices across the state.

Sutter Health has gobbled up doctor practices across the Bay Area, gaining market muscle that has pushed costs upward. Obstetricians employed by Sutter Health, for example, are reimbursed about three times more for the same service than independent doctors, according to a KHN review of OB-GYN charges on several insurers’ online cost estimators. It’s a key reason why Northern California is the most expensive place in the country to have a baby.

Becerra’s lawsuit could build off a similar civil case filed in 2014 by a grocery workers’ health plan.

“It’s time to hold health care corporations accountable,” California Attorney General Xavier Becerra said at a news conference Friday. (Ana B. Ibarra/KHN)

The plaintiffs in that case, scheduled for trial next year, allege Sutter is violating antitrust and fair competition laws. The plaintiffs have been requesting documents related to contracting practices, such as “gag clauses” that prevent patients from seeking negotiated rates and choosing a cheaper provider. They also are challenging “all-or-nothing” terms that require every facility in a health system to be included in insurance networks.

In November, the state judge handling the grocery workers’ case said Sutter was “grossly reckless” when it intentionally destroyed 192 boxes of documents that employers and labor unions were seeking in the lawsuit. San Francisco County Superior Court Judge Curtis E.A. Karnow said Sutter destroyed documents “knowing that the evidence was relevant to antitrust issues. … There is no good explanation for the specific and unusual destruction here.”

The lead plaintiffs, the United Food and Commercial Workers and its Employers Benefit Trust, are a joint employer-union health plan that represents more than 60,000 employees, dependents and retirees. The court certified its case as a class action in August, allowing hundreds of other employers and self-funded health plans to potentially benefit from the litigation.

In addition to its 24 hospitals, Sutter’s nonprofit health system has 35 surgery centers, 32 urgent-care clinics and more than 5,000 physicians in its network.

KHN senior correspondent Jenny Gold and reporter Ana Ibarra contributed reporting.

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

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Come for your drugs, leave with more shopping: Walmart’s new growth strategy?

(Reuters) – Walmart Inc’s (WMT.N) efforts to develop closer ties with health insurer Humana Inc (HUM.N), which came to light on Thursday, point to a brave new world of retail where superstores become healthcare centers offering basic medical care.

FILE PHOTO: The logo of Walmart is seen on shopping trolleys at their store in Sao Paulo, Brazil February 14, 2018. REUTERS/Paulo Whitaker/File photo

They are also aimed at boosting Walmart’s slowing growth in brick-and-mortar store sales as it faces increasing pressure online from Inc (AMZN.O). Deepening its existing partnership with Humana, or even acquiring the company outright, could be a step toward turning its 4,700 or so U.S. stores into healthcare centers that aim to attract more shoppers over 65.

“The end goal here is to get more people in their stores, get them to buy drugs and make an additional purchase while they are in the store,” said Charles Sizemore, founder of Sizemore Capital Management LLC, who owns shares of Walmart.

If Walmart can offer “competitive rates” on primary care and other health services, he said, it “can grow traffic and push store visits.”

Walmart approached Humana this month, and the companies began to discuss closer ties focused on new partnerships, two people familiar with the matter told Reuters on Thursday. An acquisition of Humana by Walmart is also being discussed, the sources said.

Walmart declined comment Friday. Humana could not immediately be reached for comment.

Closer ties between the two could enable the retailer to tap into Humana’s patient roster and possibly put some of its physician clinics in stores to offer medical care to customers.

Slideshow (3 Images)

Walmart is the largest retailer to hit upon the combination of retail and health insurance, but it is not the first.

CVS Health Corp (CVS.N) has struck a $69 billion deal to acquire Aetna Inc (AET.N). Separately, insurer Cigna Corp (CI.N) has a $54 billion deal to buy pharmacy benefits company Express Scripts Holding Co (ESRX.O). The two deals, if approved, will put pressure on the entire health care supply chain.


Humana could provide Walmart with “one more way to checkmate Amazon and equal and eclipse the CVS/Target partnership and equal and eclipse the CVS/Aetna partnership,” said Burt Flickinger at marketing consulting firm Strategic Resource Group.

“It allows them to get ahead of everybody from warehouse club operators like Costco, Target and other retailers who run chain drugstores as well as food and drug combo operators like Kroger and Wegmans.”

Bentonville, Arkansas-based Walmart already has pharmacies at many store locations and has a co-branded drug plan with Humana that caters to patients using Medicare, the federal health insurance program for people over 65. That plan steers patients to Walmart stores for their pharmacy needs, offering customers an opportunity to save up to 20 percent on drug costs, analysts said.

Louisville, Kentucky-based Humana is one of the country’s largest providers of Medicare Advantage plans – a type of coverage offered by a private company that contracts with Medicare.

Humana has 5.1 million seniors on prescription drug benefits and another 3.5 million on full medical benefits, according to Ana Gupte, senior health care analyst with Leerink Partners in New York.

Walmart superstores “could be a one-stop shop for seniors,” said Gupte, adding that Humana already has about 50 pharmacies sharing locations with doctors’ clinics, and could expand that model using Walmart’s real estate and pharmacies.


There is also a potential for Walmart and Humana to benefit from their mass of customer data, said Neil Saunders, managing director of GlobalData Retail.

“One thing retailers have is a very good understanding of customers. They know their eating habits and other consumption patterns and that is quite useful in forming insurance decisions,” he said. “That is certainly something that Walmart would be able to leverage.”

Humana patients are most likely already heavy shoppers at Walmart, according to David Friend at the BDO Center for Healthcare Excellence and Innovation.

“If you know that somebody is on a certain medicine you can sell them other products and services and that will help keep customer loyalty,” he said.

Reporting by Nandita Bose and Chris Prentice; Additional reporting by Carl O’Donnell and Emma Thomasson; Writing by Vanessa O’Connell; Editing by Susan Thomas and Bill Rigby

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Time’s Running Out: The Frail In Puerto Rico Face End Of Hurricane Relief Programs

SAN JUAN, Puerto Rico — Straddled across Ausberto Maldonado’s backyard in Bayamon, a suburb of San Juan, is a nagging reminder of Hurricane Maria’s destructive power.

“See, that tree broke off that branch, which is as thick as a tree — and now it’s in my yard,” said Maldonado, a 65-year-old retiree.

The downed tree — and the rats attracted to it —prevent Maldonado from hanging his laundry. To get the tree removed, he must show up at a local government office. But the diabetic ulcers on his feet make it painful for him to walk.

After a lifetime of work on the U.S. mainland, picking corn and asparagus and processing chickens in poultry plants, Maldonado returned to Puerto Rico a decade ago to help care for his ailing mother, who has since died. Today the retiree finds himself living day to day on the island. He receives $280 a month in Social Security and $89 a month in food stamps — which alone covers about $3 a day for food.

Six months after Hurricane Maria devastated Puerto Rico and its economy — and killing by some estimates at least 1,052 people — the daily indignities are piling up, especially for people who are frail or elderly. Many are finding their current economic straits nearly as threatening as the storm.

The storm also crippled the island’s power grid, and as of Sunday 86,000 utility customers still had no electricity in their homes and businesses, affecting hundreds of thousands of people.

In the island’s central mountain region, entire towns and neighborhoods continue to rely on finicky and expensive gas-fueled generators, putting the elderly and chronically ill who depend on ventilators and sleep apnea machines at risk. Many homes along the island’s mountainous roads remain entirely in the dark and do not have clean water.

The emergency government support that helped pay for some health care services and medically related transportation needs of Puerto Ricans after Hurricane Maria is running out. Private donations of water and food have slowed. And it’s not clear who, if anyone, will carry on with that work.

Maldonado opened the cupboards in his tidy kitchen. There are a few cans of corned beef, SpaghettiOs and beans. He sounds wistful about what he likes to cook.

“When I have enough food, when I do my groceries,” he said, “I have eggs and bread and coffee and juice for breakfast. I would make spaghetti or some sort of salad and maybe a little dessert” for dinner.

But the oven is unplugged, and there is no juice or eggs or lettuce. It has been months, Maldonado said, since he has had fresh vegetables in the house.

“When there’s very little, then I kinda go on a diet,” he said.

It was hard enough for the retiree to fill his cupboards before the storm, but now, as many aid groups are winding down their donations, Maldonado needs to find money to buy clean, bottled water and to replace his refrigerator, which was ruined during the hurricane.

To buy groceries, he must wait two weeks for his next Social Security check.

“I’m waiting until the 10th so I can go do my grocery shopping again — if I can find a way to get there,” Maldonado said. “That’s when I would have food again, enough to make three meals — lunch, breakfast and dinner.”

Though the light in Maldonado’s refrigerator still works, power outages during Hurricane Maria broke the mechanism that chills the food — and the insulin he depends on. (Sarah Varney/KHN)

Maintaining a decent diet isn’t simply about staving off hunger; diabetes is consuming Maldonado’s foot, and unless he eats healthy food and takes his insulin, doctors have warned him, his foot will need to be amputated.

Maldonado opens the door to his broken refrigerator and points to a vial that holds a few drops of insulin — the last of his supplies until he can afford the $3 copay for refills and find a ride to the pharmacy.

“The pharmacist said it could be stored in a dark place [without refrigeration] for a couple of weeks,” he said.

Ideally, insulin should be kept cool, but broken refrigerators and a lack of power in many homes in Puerto Rico pose grim hazards for the island’s expanding population of people with diabetes.

A visiting nurse, Leslie Robles, who checks on Maldonado monthly, examined the 3-inch-long, gaping wound on his foot. They sat at the kitchen table under a print of Leonardo da Vinci’s “The Last Supper” and sifted through piles of paperwork for Maldonado’s upcoming cataract surgery.

Robles told him that the free medical transportation service the government made available to large numbers of people after the storm is expiring soon, and he’ll no longer qualify for free rides.

But she doesn’t tell him the visiting nurse program she works for, operated by VarMed, a health care management company whose services had been paid for by the government, is shutting down, too.

VarMed has been helping coordinate medical care, social services and housing for thousands of Puerto Ricans for four years. The company, in recent weeks, laid off more than 100 nurses and social workers across the island, as the local government seeks to overhaul its Medicaid contract with insurance companies.

It is unclear how much longer Robles will be able to help Maldonado, and other patients like him, who are on Medicaid and have complex medical needs — the “high cost, high need” patients on the island.

The government wants Medicaid-contracted insurers to develop their own programs for these patients, but the earliest that would happen is this fall.

In the meantime, Maldonado said he has no one to help him shop for groceries, fill prescriptions and get to doctor’s appointments; the volunteers who helped him survive Hurricane Maria are returning to their own lives.

In many ways, he, too, is returning to the same spartan life he had before the storm. But with a weakened island safety net that continues to unravel, and with his own health increasingly tenuous, Maldonado said he feels alone.

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Starbucks coffee in California must have cancer warning, judge says

(Reuters) – Starbucks Corp (SBUX.O) and other coffee sellers must put a cancer warning on coffee sold in California, a Los Angeles judge has ruled, possibly exposing the companies to millions of dollars in fines.

A little-known not-for-profit group sued some 90 coffee retailers, including Starbucks, on grounds they were violating a California law requiring companies to warn consumers of chemicals in their products that could cause cancer.

One of those chemicals is acrylamide, a byproduct of roasting coffee beans that is present in high levels in brewed coffee.

Los Angeles Superior Court Judge Elihu Berle said in a decision dated Wednesday that Starbucks and other companies had failed to show there was no significant risk from a carcinogen produced in the coffee roasting process, court documents showed.

Starbucks and other defendants have until April 10 to file objections to the decision.

Starbucks declined to comment, referring reporters to a statement by the National Coffee Association (NCA) that said the industry was considering an appeal and further legal actions.

“Cancer warning labels on coffee would be misleading. The U.S. government’s own Dietary Guidelines state that coffee can be part of a healthy lifestyle,” the NCA statement said.

FILE PHOTO – A woman holds a Frappuccino at a Starbucks store inside the Tom Bradley terminal at LAX airport in Los Angeles, California, United States, October 27, 2015. REUTERS/Lucy Nicholson

In his decision, Berle said: “Defendants failed to satisfy their burden of proving by a preponderance of evidence that consumption of coffee confers a benefit to human health.”

Officials from Dunkin’ Donuts (DNKN.O), McDonald’s Corp (MCD.N), Peet’s and other big coffee sellers did not immediately respond to requests for comment.

The lawsuit was filed in 2010 by the Council for Education and Research on Toxics (CERT). It calls for fines as large as $2,500 per person for every exposure to the chemical since 2002 at the defendants’ shops in California. Any civil penalties, which will be decided in a third phase of the trial, could be huge in California, which has a population of nearly 40 million.

CERT’s lawyer Raphael Metzger did not immediately respond to a request for comment.

Starbucks lost the first phase of the trial in which it failed to show the level of acrylamide in coffee was below that which would pose a significant risk of cancer. In the second phase of the trial, defendants failed to prove there was an acceptable “alternative” risk level for the carcinogen, court documents showed.

Several defendants in the case settled before Wednesday’s decision, agreeing to post signage about the cancer-linked chemical and pay millions in fines, according to published reports.

Reporting by Nate Raymond; Additional reporting by Lisa Baertlein; Writing by Andrew Hay; Editing by Richard Chang and Leslie Adler

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Pfizer’s rare heart disease drug succeeds in late-stage study

(Reuters) – Pfizer Inc’s experimental drug to treat a rare and fatal disease linked to heart failure reduced deaths and need for hospitalizations in a late-stage study.

FILE PHOTO: A company logo is seen at a Pfizer office in Dublin, Ireland November 24, 2015. REUTERS/Cathal McNaughton

The company’s clinical study investigated the efficacy, safety and tolerability of an oral dose of tafamidis capsules compared with a placebo in 441 patients.

Pfizer said tafamidis met the main goal of statistically significant reduction in deaths and frequency of cardiovascular-related hospitalizations compared with a placebo at 30 months. The data also showed that tafamidis was generally well tolerated by the enrolled patients.

Tafamidis was being tested for the treatment of transthyretin cardiomyopathy, a condition that results from deposits of transthyretin protein in the heart, which leads to eventual heart failure.

Brokerage SunTrust Robinson Humphrey said it expects tafamidis global sales of $130 million in 2022.

The U.S. Food and Drug Administration granted tafamidis a ‘fast track’ designation in June last year. The designation aims to facilitate the development and expedite the review process for certain drugs and vaccines for serious conditions.

Currently, there are no approved medications in the United States for the treatment of transthyretin cardiomyopathy.

However, Stifel analyst Stephen Wiley noted that the data could be a negative for Alnylam Pharmaceuticals and Ionis Pharma, whose shares were down in regular trading.

Alnylam and Ionis are developing drugs for the treatment of hereditary TTR amyloidosis, also caused by a buildup of transthyretin protein in the body.

Some investors could look at Pfizer’s data as providing validation for both the companies’ drugs, Wiley said, adding that he believed the data could potentially complicate product labeling for both the drugs.

Alnylam closed down 8.3 percent at $119.1, while Ionis closed at $44.08, down 4 percent.

Reporting by Anuron Kumar Mitra, Akankshita Mukhopadhyay and Manas Mishra in Bengaluru; Editing by Shounak Dasgupta

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Podcast: KHN’s ‘What The Health?’ VA Secretary Out, Privatization In?

David Shulkin, the secretary of Veterans Affairs, was fired Wednesday night by President Donald Trump. To replace him, Trump will nominate his White House physician, naval Rear Adm. Ronny Jackson. Shulkin, however, is not going quietly. He took to The New York Times op-ed page to claim he was pushed out by those who want to privatize VA health services for profit.

Meanwhile, two more states, Iowa and Utah, passed legislation that would sidestep some of the requirements of the Affordable Care Act. Iowa wants to allow the sale of health plans that cover fewer benefits — or restrict coverage for people with preexisting health conditions. Utah wants to expand Medicaid to those higher up the income scale — but not as high as prescribed by the ACA.

This week’s panelists for KHN’s “What the Health?” are Julie Rovner of Kaiser Health News, Anna Edney of Bloomberg News, Sarah Kliff of and Alice Ollstein of Talking Points Memo.

Among the takeaways from this week’s podcast:

  • If Shulkin is right that the administration is keen on privatizing the VA, would it move to something akin to the Medicaid managed-care systems that many states have set up?
  • Veterans groups haven’t yet shown their cards on whether they think Jackson is a suitable choice to replace Shulkin.
  • Iowa is poised to allow farmers groups to offer health plans that could sidestep some of the consumer protections in the federal Affordable Care Act, such as requiring that preexisting conditions be covered. Tennessee has a program similar to what Iowa is implementing, and some consumer groups have complained it pulls healthy individuals out of the ACA marketplace and drives up premiums for those who remain.
  • Utah’s request for a federal waiver so that it can offer a Medicaid expansion program to people earning up to 100 percent of the federal poverty level — and not the 138 percent included in the ACA — will show whether the Trump administration has a different standard than the Obama administration. Obama officials rejected partial Medicaid expansion requests.
  • Sen. Elizabeth Warren (D-Mass.) introduced a bill that offers provisions to help middle-income customers buying insurance on the ACA marketplace. But it suggests Democrats are still not sure what is the best health care strategy heading into the midterm elections.

New Segment: ‘Bill Of The Month’

This month, Shefali Luthra talks about the case of the $1,500 tube of toenail fungus cream and how patients can never be too careful in asking how much a prescription will cost.

If you want to submit a bill for the “Bill of the Month” series, here is the form.

Several other news outlets are reaching out to patients to crowdsource some health stories. If you’re uninsured and you want to share your story with Bloomberg News, here’s where you can do that.

And if you have an emergency room bill you’d like to share for this project, here’s the form.

Plus, for “extra credit,” the panelists recommend their favorite health stories of the week they think you should read, too.

Julie Rovner: Bloomberg News’ “Why Some Americans Are Risking It and Skipping Health Insurance,” by John Tozzi.

Anna Edney: Kaiser Health News’ “As Trump Targets Immigrants, Elderly Brace To Lose Caregivers,” by Melissa Bailey.

Alice Ollstein: The Brookings Institution and the University of Southern California’s “Do States Regret Expanding Medicaid?” by Mark Hall.

Sarah Kliff: Kaiser Health News’ “Reporter’s Notebook: The Tale Of Theranos And The Mysterious Fire Alarm,” by Jenny Gold.

To hear all our podcasts, click here.

And subscribe to What the Health? on iTunes, Stitcher or Google Play.

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Scrutinizing Medicare Coverage For Physical, Occupational and Speech Therapy

For years, confusion has surrounded the conditions under which older adults can receive physical, occupational and speech therapy covered by Medicare.

Services have been terminated for some seniors, such as those with severe cases of multiple sclerosis or Parkinson’s disease, because therapists said they weren’t making sufficient progress. Others, including individuals recovering from strokes or traumatic brain injuries, have been told that they reached an annual limit on services and didn’t qualify for further care.

Neither explanation stands up to scrutiny. Medicare does not require that older adults demonstrate improvement in order to receive ongoing therapy. Nor does it limit the amount of medically necessary therapy, for the most part.

The February congressional budget deal eases long-standing concerns by lifting a threat that some types of therapy might be restricted. But potential barriers to accessing this type of care remain. Here’s a look at how Medicare now covers such services.

Medical necessity. All therapy covered by Medicare must be deemed “reasonable and necessary to treat the individual’s illness or injury,” require the services of skilled professionals and be subject to medical oversight.

What isn’t a precondition for receiving services is ongoing improvement — getting measurably better. While this can be a goal for therapy, other goals can include maintaining a person’s current abilities or preventing deterioration, according to a groundbreaking legal settlement in 2013.

The implication for older adults: If your therapist claims that she can’t help you any longer because you aren’t making substantial progress, you may well have grounds for an appeal. At the very least, a discussion with your physician about reasonable goals for therapy is advisable.

Part A therapy services. Often, older adults require therapy after an untoward event brings them to the hospital — for instance, a stroke or a bad fall. If a senior has an inpatient stay in the hospital of at least three days, he or she becomes eligible for up to 100 days of rehabilitation, including therapy, in a skilled nursing facility under Medicare Part A.

Therapy services covered by Medicare Part A also can be obtained in an inpatient, hospital-based rehabilitation facility. In this setting, requirements call for therapy to be “intensive” — at least three hours a day, five days a week. Stays are covered by Medicare up to a maximum 90 days.

If a senior returns home after being in the hospital, he or she may receive therapy from a home health agency under Medicare Part A. To qualify for home health care, an older adult must need intermittent skilled services, such as those provided by a registered nurse or physical therapist, and be substantially homebound. Each episode of home health care can last up to 60 days and be renewed with a physician’s authorization.

“A lot of home health agencies believe, wrongly, that the home health benefit, including therapy services, is limited in duration to a couple of 60-day episodes,” said David Lipschutz, senior policy attorney at the Center for Medicare Advocacy. The bottom line for beneficiaries: You may have to advocate aggressively for the care you think you need and enlist your physician to intervene on your behalf.

Part B services. Physical, speech and occupational therapy are also covered by Medicare Part B in private practices, hospital outpatient clinics, skilled nursing facilities (when a patient’s Part A benefits have run out) and, less frequently, in people’s homes (when individuals no longer qualify for Part A home health services but still need assistance).

More than 5 million older adults and people with disabilities covered by Medicare receive “outpatient” therapy services of this kind each year. Care can last up to 90 days, with the potential for renewal if a physician certifies that ongoing services are necessary.

Questions about coverage for Part B therapy services have surfaced repeatedly since Congress authorized annual limits on the care that Medicare would cover in 1997 — a cost-saving move.

Faced with criticism, Congress delayed implementation of these “caps” for several years. Then, in 2006, it created an “exceptions” process that allowed caps to be exceeded, so long as therapy was judged to be medically necessary.

The exceptions process had two steps. First, a therapist had to request that services be extended when a patient reached an initial “cap” — set this year at $2,010. Then, another request had to be made when a patient reached another, higher threshold — initially set at $3,700 this year, but reduced to $3,000 in the budget legislation.

Both steps called for therapists to justify additional services by providing extra documentation. At the second, higher threshold, therapists also faced the prospect of intensive medical review of their practices and, potentially, audits.

At that point, therapists were often hesitant to pursue exceptions, which has made it difficult for patients with complex medical conditions to access care. Also, sometimes requests for exceptions have been denied, posing another barrier.

“We use the exceptions process, but we’ve tried to be very vigilant in who we used it for,” said Sarah Gallagher, a physical therapist at South Valley Physical Therapy in Denver, which specializes in treating people with complicated neurological conditions. “The risk is putting your clinic at risk for an audit if you ask for exceptions too often.”

With February’s budget deal, Medicare has gotten rid of the “caps” but retained the notion of “thresholds.” After billing for $2,010 in services (about 20 therapy sessions at $100 per visit) this year, a provider has to add an extra code to a bill. After billing $3,000, targeted medical reviews and the potential for audits can again be prompted.

Eliminating the caps should make things easier for older adults who need a time-limited course of therapy.  But whether therapists will be wary about approaching the $3,000 threshold, with its extra administrative burdens and potential risks, remains to be seen. If so, patients recovering from strokes or brain injuries and those with complicated chronic conditions, who need intensive therapy for an extended period, could be affected.

“We fear that there still might be barriers to accessing care,” said Lipschutz, of the Center for Medicare Advocacy. “We suspect some providers will say I don’t want to deal with this process, and if I’m getting anywhere near that $3,000 threshold, I’m just going to give it up.”

“Theoretically, all the uncertainty we’ve been living with, related to the therapy caps and acceptable goals of therapy, has been resolved,” said Kimberly Calder, senior director of health policy at the National Multiple Sclerosis Society. “But only time will tell.”

KHN’s coverage related to aging and improving care of older adults is supported in part by The John A. Hartford Foundation.

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Listeria class action filed against South Africa’s Tiger Brands

JOHANNESBURG (Reuters) – A class action lawsuit was filed on Thursday against South Africa’s Tiger Brands, after one of its food factories was linked to a listeria outbreak that has killed 180 people since early 2017, the lawyer running the case said.

FILE PHOTO: A couple leaves Tiger Brands factory shop in Germiston, Johannesburg, South Africa, March 5, 2018. REUTERS/Siphiwe Sibeko/File Photo

Richard Spoor, a human rights advocate who previously masterminded a massive class action on behalf of gold miners with silicosis, filed the lawsuit on behalf of families affected by the listeria outbreak. The case against Tiger Brands was clear, Spoor said.

“Their fingerprints are all over this outbreak,” he told Reuters.

A spokeswoman for Tiger Brands confirmed the company had received the filing, the first lawsuit against the company following the outbreak, and was reviewing its contents.

Tiger Brands said this month it had received notice of two class action suits against the firm, with the total amount claimed against the company estimated at 425 million rand ($36 million).

Tiger Brands’ Chief Financial Officer Noel Doyle said at the time in an interview on Radio 702 that the company had yet to calculate the total financial impact of the suits.

The food producer has suspended production at its Polokwane, Germiston, Pretoria and Clayville sites in South Africa, which produce polony, and other cold meats.

Separately, the World Health Organization said in a statement that it was ready to provide support in cases where countries do not have well-established surveillance systems and laboratory diagnostic services in place to detect listeria, and “has reached out to 16 African nations.”

Kenya, Zimbabwe and Zambia have banned imports of South African processed meat, dairy products, vegetables and fruit since the listeria outbreak. Mozambique and Namibia halted imports of processed meat products and Botswana said it was recalling them. Malawi has stepped up screening of South African food imports.

Reporting by Ed Cropley and Nqobile Dludla; Editing by Alexander Winning and Susan Fenton

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FDA expands use of Amgen leukemia drug Blincyto to patients with relapse risk

(Reuters) – The U.S. Food and Drug Administration on Thursday expanded the use of Amgen Inc’s leukemia drug Blincyto to include patients who are in remission but still have residual signs of the disease.

FILE PHOTO: A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed/File Photo

The drug, part of a class known as bispecific antibodies, is already approved for patients with acute lymphoblastic leukemia (ALL) whose cancer has returned after treatment or did not respond to previous treatment, such as chemotherapy.

The expanded approval is for patients with “minimal residual disease,” meaning the presence of cancer cells below a level that can be seen under a microscope. Such patients, who can now be identified with new molecular testing, still have an increased risk of relapse. 

The FDA approval marks the first time molecular tests are being used to identify patients for early intervention in order to prevent cancer from reappearing, said Gregory Friberg, head of oncology global development at Amgen.

In studies, four out of five patients with residual ALL showed no signs of the disease after a single cycle of Blincyto, he said. The drug can cause serious side effects including a potentially life-threatening inflammatory condition called cytokine release syndrome.

An estimated 5,960 Americans will be diagnosed with ALL this year, and around 1,470 will die from the disease, according to the National Cancer Institute.

Amgen’s sales of Blincyto, which has an average wholesale price near $173,000, totaled $175 million last year.

Reporting by Deena Beasley; editing by Bernadette Baum and Susan Thomas

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Alzheimer’s Stigma a Barrier to Prevention, Care: Survey

News Picture: Alzheimer's Stigma a Barrier to Prevention, Care: Survey

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WEDNESDAY, March 28, 2018 (HealthDay News) — Stigma surrounding Alzheimer’s disease may discourage Americans from learning about their risk and from joining clinical trials for potential new treatments, a small survey reveals.

“We found that concerns about discrimination and overly harsh judgments about the severity of symptoms were most prevalent,” lead researcher Shana Stites said in an Alzheimer’s Association news release.

“By understanding what the biggest concerns are about the disease, we can help develop programs and policies to reduce the stigma,” Stites added.

She is senior research investigator with the University of Pennsylvania Perelman School of Medicine’s Division of Medical Ethics.

Researchers gave a random sample of 317 adults a fictional description of a patient with mild cognitive impairment or dementia due to Alzheimer’s. Respondents were told the patient’s condition would worsen, improve or stay the same.

Fifty-five percent expected the patient would be discriminated against by employers and be excluded from medical decision-making. Forty-seven percent thought data in the patient’s medical records, such as a brain image (46 percent) or genetic test result (45 percent), would lead to limits on his or her health insurance.

Those percentages rose when respondents were told that the patient’s condition would worsen over time.

When they were told the patient would improve, 24 percent to 41 percent fewer respondents said they expected that discrimination or exclusion from medical decisions would result.

That suggests advances in therapies to improve the prognosis of Alzheimer’s patients could help reduce stigma, according to the study authors.

“The unfortunate stigma associated with Alzheimer’s may prevent people from getting the diagnosis they need or the opportunity for early intervention that could improve their quality of life,” said Maria Carrillo, the association’s chief science officer.

“We need to reduce the stigma to encourage persons with mild or even no symptoms of Alzheimer’s disease to enroll in prevention trials to find effective treatments. These survey findings could also have implications on the national goal of developing an effective therapy by 2025,” Carrillo said.

The findings were published online March 27 in Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association.

— Robert Preidt

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SOURCE: Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association, news release, March 27, 2018

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