Pediatricians Stand By Meds For ADHD, But Some Say Therapy Should Come First

When children are diagnosed with attention deficit hyperactivity disorder, stimulant medications like Ritalin or Adderall are usually the first line of treatment.

The American Academy of Pediatrics issued new guidelines Monday upholding that central role of medications accompanied by behavioral therapy in ADHD treatment.

Some experts say, however, they are disappointed the new guidelines don’t recommend behavioral treatment first for more children, as that might lead to better outcomes, recent research suggests.

When 6-year-old Brody Knapp of Kansas City, Mo., was diagnosed with ADHD last year, his father, Brett, was skeptical. He didn’t want his son taking pills.

“You hear of losing your child’s personality, and they become a shell of themselves, and they’re not that sparking little kid that you love,” Brett Knapp said. “I didn’t want to lose that with Brody, ’cause he’s an amazing kid.”

Brody’s mother, Ashley, had other ideas. She’s a school principal with ADHD herself.

“I was all for stimulants at the very, very beginning just because I know what they can do to help a neurological issue such as ADHD,” Ashley Knapp said.

More and more families face the same dilemma. The prevalence of ADHD has shot up in the past two decades, and now, 1 in 10 children in the U.S. are diagnosed with it.

The new guidelines from the American Academy of Pediatrics recommend that children with ADHD be screened for mental illness and monitored closely, but the treatment recommendations regarding medication are essentially unchanged from previous guidelines published in 2011.

Anyone over age 5 should start taking medication and get behavioral therapy as soon as they are diagnosed. Children under 5 should start with behavioral treatment before taking any medications.

Still, many experts worry that the role of medication in treatment is too large.

“It’s certainly true that when you watch TV, you’re not going to see a lot of commercials about behavioral treatments, but you very well may see some new ones about medication,” said Dr. Carla Allan, an ADHD specialist at Children’s Mercy in Kansas City and a member of the ADHD Clinical Practice Guidelines Subcommittee. Allan is Brody’s doctor and had a role in drafting the latest guidelines. While she wants to see more ADHD patients receive behavioral treatment, she said, she agrees with the AAP’s decision to hold steady on its recommendations about medication.

Other experts say the guidelines should have done more to prioritize behavioral treatments.

“I think it’s a huge disservice to not just the children that we’re trying to treat but also to the parent who would prefer to have behavioral interventions,” said Erika Coles, a psychology researcher at Florida International University.

A behavioral intervention can range from cognitive therapy to school support. It can be as simple as parents setting up a system of expectations reinforced by rewards or punishments.

These interventions are designed to teach children strategies they can use on a daily basis to help stay focused and to reinforce social skills that may fail to develop when children struggle to concentrate.

After school, Ashley Knaap used behavioral techniques to keep son Brody on track with his chores. This is supposed to help him internalize the discipline and “grit” needed to complete difficult tasks, but it can feel to her like micromanaging, she said.

“I don’t like the idea that I have to tell my kids or anybody what to do,” she said. “I want them to be able to think for themselves and make those safe choices, but at this point, that’s just not possible yet for Brody.”

But the techniques — things like counting to keep him on the task of putting away his toys, and rewards like time playing legos after he finishes a chore — are helping him, she admitted.

While the AAP guidelines advise a combination of meds and behavioral treatment, the research backing this combination is problematic, according to Coles, because the two approaches weren’t evaluated separately.

“If you look at studies that did the combined treatment of both medication and behavioral interventions, you can’t disentangle what leads to the best outcome,” Coles said.

A study published in 2016 in the Journal of Clinical Child & Adolescent Psychology explored the sequencing of treatment methods and showed that kids with ADHD between ages 5 and 12 who were given behavioral treatment before starting pills had less behavioral problems than kids who started with pills right away.

A new study co-authored by Coles took it further. It found that children ages 5-13 with ADHD who received therapy first often needed less medication. And 37% of the children who got therapy first didn’t end up needing to take pills at all.

“Really, what it’s suggesting is that if we use behavioral intervention as the first line of treatment, we can reduce or eliminate the need for medication in children with ADHD,” Coles said.

Fewer meds also means fewer side effects. Some kids have trouble sleeping, lose their appetite or experience personality changes, and there’s not much research on what it means to stay on these drugs for years, especially when one is still growing.

The studies backing therapy first are promising and compelling, but they are small. Coles’ research looked at 127 children, while the 2016 study evaluated 146.

A spokesperson for the American Academy of Pediatrics ADHD Clinical Practice Guidelines Subcommittee said the group reviewed the recent behavioral-first research but didn’t find the evidence strong enough to warrant a change in the guidelines.

However, both the academy and its critics agree that not enough children are getting adequate behavioral treatment. Only about 60% of kids with ADHD in the U.S. ever got any behavioral interventions outside of school, while 90% had received medication, according to a 2018 study published in the Journal of Pediatrics.

Numerous advocates point out that there are not enough trained therapists, the interventions can be time-consuming for families, and many families can’t afford it.

Brody’s family started with behavioral treatments alone, but after four months he experienced a violent meltdown, which made the family decide to give Brody some medication too. He now takes Concerta.

Brody’s dad said he’s OK with that and that doing the therapy first gave him insight.

“It’s not necessarily for the child,” Brett Knapp said of the parental training he received. “It really is for the parent to realize what an ADHD kid looks like. And for the perspective, I think it helped out greatly to kind of realize how I need to interact and how I need to talk and how I need to work with my child.”

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

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Her Biopsy Report Was Benign. But The Bill Is A Spot Of Contention.

Brianna Snitchler was just figuring out the art of adulting when she scheduled a biopsy at Henry Ford Hospital in Detroit.

Snitchler was on top of her finances: Her student loan balance was down and her credit score was up.

“I had been working for the past three years trying to improve my credit and, you know, just become a functioning adult human being,” Snitchler, 27, said.

For the first time in her adult life, she had health insurance through her job and a primary care doctor she liked. Together they were working on Snitchler’s concerns about her mental and physical health.

One concern was a cyst on her abdomen. The growth was about the size of a quarter, and it didn’t hurt or particularly worry Snitchler. But it did make her self-conscious whenever she went for a swim.

“People would always call it out and be alarmed by it,” she recalled.

When the cyst on Snitchler’s abdomen was found to be benign, she thought her next step would be getting it removed. Then she received a $3,357.52 bill for her biopsy, ultrasound, physician charges and lab tests.(Callie Richmond for KHN)

Before having the cyst removed, Snitchler’s doctor wanted to check the growth for cancer. After a first round of screening tests, Snitchler had an ultrasound-guided needle biopsy at Henry Ford Health System’s main hospital.

The procedure was “uneventful,” with no complications reported, according to results faxed to her primary care doctor after the procedure. The growth was indeed benign, and Snitchler thought her next step would be getting the cyst removed.

Then the bill came.

The Patient: Brianna Snitchler, 26, a user-experience designer living in Detroit at the time. As a contractor for Ford Motor Co., she had a UnitedHealthcare insurance plan.

Total Bill: $3,357.52, including a $2,170 facility fee listed as “operating room services.” The balance included a biopsy, ultrasound, physician charges and lab tests.

Service Provider: Henry Ford Health System in Detroit.

Medical Procedure: Ultrasound-guided needle biopsy of a cyst.

What Gives: When Snitchler scheduled the biopsy, no one told her that Henry Ford Health System would also charge her a $2,170 facility fee.

Snitchler said the bill turned out to be far more than what she budgeted for. Her insurance plan from UnitedHealthcare had a high-deductible of $3,250, plus she would owe coinsurance. All told, her bills for the care she received related to the biopsy left her on the hook for $3,357.52, with her insurance paying $974.

“She shrugged it off,” Snitchler’s partner, Emi Aguilar, recalled. “But I could see that she was upset in her eyes.”

Snitchler panicked when she realized the bill threatened the couple’s financial security. Snitchler had already spent down her savings for a recent cross-country move to Austin, Texas.

In an email, Henry Ford spokesman David Olejarz said the “procedure was performed in the Interventional Radiology procedure room, where the imaging allows the biopsy to be much more precise.”

“We perform procedures in the most appropriate venue to ensure the highest standards of patient quality and safety,” Olejarz wrote.

The initial bill from Henry Ford referred to “operating room services.” The hospital later sent an itemized bill that referred to the charge for a treatment room in the radiology department. Both descriptions boil down to a facility fee, a common charge that has become controversial as hospitals search for additional streams of income, and as more patients complain they’ve been blindsided by these fees.

Hospital officials argue that medical centers need the boosted income to provide the expensive care sick patients require, 24 hours a day, 365 days a year.

But the way hospitals calculate facility fees is “a black box,” said Ted Doolittle, with the Office of the Healthcare Advocate for Connecticut, a state that has put a spotlight on the issue.

“It’s somewhat akin to a cover charge” at a club, said Doolittle, who previously served as deputy director of the federal Center for Program Integrity at the Centers for Medicare & Medicaid Services.

Hospitals in Connecticut billed more than $1 billion in facility fees in 2015 and 2016, according to state records. In 2015, Connecticut lawmakers approved a bill that forces all hospitals and medical providers to disclose facility fees upfront. Now patients in Connecticut “should never be charged a facility fee without being shown in burning scarlet letters that they are going to get charged this fee,” Doolittle said.

Snitchler plays with her dogs, Alas (left) and Luna.(Callie Richmond for KHN)

In Michigan, there’s no law requiring hospitals and other providers of health care services to inform patients of facility fees ahead of time.

Brianna Snitchler’s procedure took place on campus at Henry Ford’s main hospital site. When she got her bill, with its mention of “operating room services,” she was baffled. Snitchler said the room had “crazy medical equipment,” but she was still in her street clothes as a nurse numbed her cyst and she was sent home in a matter of minutes.

With Snitchler’s permission, Kaiser Health News shared her itemized bill, biopsy results and explanation of benefits with Dr. Mark Weiss, a radiologist who leads MediCrew, a company in Flint, Mich., that helps patients navigate the health system.

Weiss said it probably wasn’t medically necessary for Snitchler to go to the hospital to receive good care. “Not all surgical procedures have to be done at a surgical center,” he said, noting that biopsies often can be done in an office-based treatment center.

Resolution: Hoping for a reasonable explanation — or even the discovery of a mistake — Snitchler called her insurance company and the hospital.

A representative at Henry Ford told her on the phone that the hospital isn’t “legally required” to inform patients of fees ahead of time.

In an email, Henry Ford spokesman Olejarz apologized for that response: “We’ll use it as a teachable moment for our staff. We are committed to being transparent with our patients about what we charge.”

He pointed to an initiative launched in 2018 that helps patients anticipate out-of-pocket expenses. The program targets the most common elective radiology and gastroenterology tests that often have high price tags for patients.

Asked if Snitchler’s ultrasound-guided needle biopsy will be included in the price transparency initiative, Olejarz replied, “Can’t say at this point.”

The bill threatened the financial security of Snitchler and her partner. She had already spent down her savings for a recent cross-country move from Detroit to Austin, Texas.(Callie Richmond for KHN)

In addition to the pilot program to inform patients of fees, Olejarz said, the hospital also plans to roll out an online cost-estimator tool.

For now, Snitchler has decided not to get the cyst removed, and she plans to try to negotiate on her bill. She has not yet paid any portion of it.

“You should always negotiate; you should always try,” Doolittle said. “Doesn’t mean it’s going to work, but it can work. People should not be shy about it.”

“We are happy to work out a flexible payment plan that best meets her needs,” Olejarz wrote when Kaiser Health News first inquired about Snitchler’s bill.

The Takeaway: When your doctor recommends an outpatient test or procedure like a biopsy, be aware that the hospital may be the most expensive place you can have it done. Ask your physician for recommendations of where else you might have the procedure, and then call each facility to try to get an estimate of the costs you’d face.

Also, be wary of places that may look like independent doctor’s offices but are owned by a hospital. These practices also can tack hefty facility fees onto your bill.

If you get a bill that seems inflated, call your hospital and insurer and try to negotiate it down.

Bill of the Month is a crowdsourced investigation by Kaiser Health News and NPR that dissects and explains medical bills. Do you have an interesting medical bill you want to share with us? Tell us about it!

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Fruit fly trial unlocks clues for ‘polypill’ to beat aging

LONDON (Reuters) – 100 Scientists who gave fruit flies a triple drug combination treatment and found that it extended their lives by almost 50% say their work offers clues on how to fight aging in people.

FILE PHOTO: A fruit fly is seen in a laboratory at the Bar-Ilan University, in Ramat Gan, Israel, May 1, 2018. REUTERS/Amir Cohen

The researchers said their aim is not to find the secret of eternal life, but to figure out the mechanism of the aging process to find ways to help people stay healthy for longer.

“We are not trying to cheat death, but help people be healthy and disease-free in their final years,” said Linda Partridge, a professor at University College London’s Institute of Healthy Ageing and the Max Planck Institute for Biology of Aging who co-led the work.

The three drugs – the mood stabilizer lithium, a cancer treatment called trametinib and an immune regulator called rapamycin – target different cellular processes and had a “quite remarkable” impact on the flies’ lifespans, the scientists said.

And since the three drugs are all already in use as medical treatments, they are known to be safe to use in people, we have found that a combination drug treatment … may be an effective way to slow down the aging process,” said Jorge Castillo-Quan, who co-led the research.

Partridge said the findings add to growing evidence that so-called polypills – pills that combine low doses of multiple drugs – could one day help prevent age-related diseases.

“This may be possible by combining the drugs we’re investigating with other promising drugs, but there is a long way to go,” she said.

This research adds to previous studies finding that individually, lithium, trametinib and rapamycin can each extend lifespan in fruit flies. That evidence has also been supported by further studies in mice and worms, the scientists said.

In this study, published in Proceedings of the National Academy of Sciences journal, Castillo-Quan’s team gave fruit flies doses of the three drugs separately and in combination.

Each drug individually extended lifespan by an average of 11%, they found, and pairing two drugs extended lifespan by around 30%. But when all three were combined, the fruit flies lived 48% longer than flies that did not get the treatment.

“We found it was quite remarkable that this drug combination enabled them to live 48% longer,” said Castillo-Quan, who now works at Harvard Medical School in the United States.

The researchers said they plan to conduct more studies to try to decipher exactly how the drugs work in combination with each other. They hope to move on to experiments in more complex animals, such as mice, to gauge the effects on the entire body before eventually progressing to human trials.

Reporting by Kate Kelland, editing by Louise Heavens

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Occupational pesticide exposure may raise heart risk

(Reuters Health) – On-the-job exposure to high levels of pesticides might raise the risk of developing heart disease or having a stroke, according to a long-term study in Hawaii.

Farm and agricultural workers need to wear personal protective equipment and, even after they retire should continue to have their health monitored for cardiovascular complications, the authors conclude in the Journal of the American Heart Association.

“Pesticides have a long half-life and exist in the body for a long time, so side effects may appear even 10-20 years later,” said lead author Zara Berg of Fort Peck Community College in Peck, Montana.

“Many workers may not think that exposure during their younger or middle years is crucial, but it actually is,” said Berg, who worked on the study as part of her doctoral research at the University of Hawaii at Manoa in Honolulu.

For the analysis, Berg’s team used data from the Kuakini Honolulu Heart Program, established in 1965 to study heart disease in middle-aged Japanese-American men living on the island of Oahu. Participants were born between 1900 and 1919 in Japan or Hawaii and were between ages 45 and 68 at the beginning of the study. Data was updated through 1999, which allowed for up to 34 years of follow-up with surviving participants.

Berg and colleagues focused on 7,557 men who had provided information on their work history and had no heart disease at the beginning of the study period.

To gauge pesticide exposures, the research team used the Occupational Safety Health Administration exposure scale, which estimates typical pesticide amounts encountered during an eight-hour workday and 40-hour workweek based on a participant’s job, age and years worked in that industry, particularly for industrial, factory and agricultural workers.

Berg’s team then looked at medical records to assess who developed cardiovascular disease, which they defined as coronary heart disease or a cerebrovascular incident such as a stroke.

Overall, just 451 men had high exposure to pesticides and 410 men had low-moderate exposure, while the rest had none.

After adjusting for other cardiovascular risk factors like age, weight, physical activity, alcohol and smoking, researchers found that the men with high pesticide exposure were 42% more likely than those with none to develop cardiovascular disease during the first 10 years of follow-up.

“High exposure during middle age led to cardiovascular disease sooner,” Berg noted. “Pesticides can also affect cholesterol and the concentration of heavy metals in the body.”

Heart disease wasn’t associated with low or moderate levels of exposure to pesticides, and the link to high exposure was not seen in the longer term up to 34 years.

One limitation of the study is that only a small proportion of men had high or low-moderate pesticide exposure, the authors note. The fact that the men were all from a single ethnic group is a strength of the analysis because it removes some potential confounding differences, they add, but also means the results might not be generalizable to other populations.

“Most importantly, workers should save their medical records and document potential exposure, especially if their employers don’t,” Berg said. “Wear proper protective equipment and clothing, and request some if it’s not provided.”

Research studies are still trying to unpack how pesticides contribute to heart disease and death, whether through inflammation or oxidative stress, as well as how often or how much exposure is most harmful.

“Research on human exposure to environmental pollutants is highly complex and difficult,” said Juan Pedro Arrebola of the University of Granada in Spain, who wasn’t involved in the study.

“In my opinion, the main advice should be to use the ‘precautionary principle,’ or in plain words, ‘better safe than sorry,’” he told Reuters Health by email. “It’s not a matter of going into panic because we’re surrounded by chemicals, and many of them have considerably helped us, but to avoid as much exposure as possible.”

SOURCE: Journal of the American Heart Association, online September 25, 2019.

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Deer can pass tuberculosis to humans, CDC warns

Tuberculosis or TB is a highly contagious infection that usually affects the lungs, but it can spread to other parts of the body, such as the spine and brain. Commonly caused by Mycobacterium tuberculosis, which can spread through the air from person to person. A person doesn’t know he or she is sick, as the bacteria can live in the host for years, without causing symptoms.

3D illustration of bacterium Mycobacterium tuberculosis.  Image Credit: Kateryna Kon / Shutterstock

3D illustration of bacterium Mycobacterium tuberculosis. Image Credit: Kateryna Kon / Shutterstock

But, when the human’s immune system deteriorates, the bacteria can activate and cause serious signs and symptoms, including chronic cough, sometimes with blood, weight loss, fatigue, night sweats, and chills. Recently, the Centers for Disease Control and Prevention (CDC) has found that humans can acquire tuberculosis from hunting deer.

In a report published by the CDC, it says that in 2017, a 77-year-old Michigan hunter was diagnosed with pulmonary tuberculosis, caused by the agent Mycobacterium bovis. The hunter acquired the infection from an infected deer.

“The patient had rheumatoid arthritis and was taking 5 mg prednisone daily; he had no history of travel to countries with endemic tuberculosis, no known exposure to persons with tuberculosis, and no history of consumption of unpasteurized milk,” the CDC said.

The patient had hunted deer in the same location where two other hunters had acquired the infection more than 15 years earlier. The patient might have inhaled the infectious bacteria causing bovine tuberculosis while he removed the dead deer’s internal organs.

The National Veterinary Services Laboratories in Iowa performed whole-genome sequencing on the patient’s respiratory isolate, which was compared with M. bovis library, including about 900 wildlife and cattle isolates acquired since 1993. The agency found that the hunter had been exposed to a circulating strain of M. bovis, at some point through his hunting activities.

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It is also possible that the hunter acquired the infection in the past and only had reactivation of infection as pulmonary disease in 2017. In the state, there had been reports of cases of the same type of TB strain in humans. In 2004, one infection occurred when a hunter injured a finder while field-dressing a deer. Another case occurred in 2002 when experts believe a hunter had inhaled the bacteria while he field-dressed a carcass.

The CDC concludes that exposure to the pathogen puts the hunters at risk for both active and latent infections. Latent infections mean that bacteria stays in the body until it becomes reactivated. This usually happens in people with a diminished immune response or those with compromised immune systems.

“To prevent exposure to M. bovis and other diseases, hunters are encouraged to use personal protective equipment while field-dressing deer. Besides, hunters in Michigan who submit deer heads that test positive for M. bovis might be at higher risk for infection, and targeted screening for tuberculosis could be performed,” the CDC warned.

“Close collaboration between human and animal health sectors is essential for containing this zoonotic infection,” it added.

What is bovine tuberculosis?

Bovine tuberculosis is a contagious disease caused by Mycobacterium bovis, which is commonly found in cattle and other animals such as elk, deer, and bison. It accounts for less than 2 percent of total tuberculosis cases in the United States.

The CDC reports that the illness has been eradicated from commercial cattle, but the bacteria may still linger in wild animals. Bovine tuberculosis, when present in humans, can affect the lungs, lymph nodes, and other parts of the body.

Though not all bovine infections progress to TB disease, those who develop TB may experience signs and symptoms like those infected with M. tuberculosis, including fever, cough, weight loss, and night sweats.

To prevent infection with the bovine tuberculosis pathogen, CDC suggests that people should avoid consuming unpasteurized dairy products, such as cheese and milk. For hunters, who are at risk of contact with body fluids and tissue of wild animals, like deer and bison, they are advised to protect themselves. If they suspect that they have been exposed to the bacteria, prompt medical attention is essential.

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Bangladesh bans heartburn drug ranitidine over cancer fears

DHAKA (Reuters) – Bangladesh’s drug regulatory authority on Sunday issued a ban on sales of popular heartburn drug ranitidine while it investigates a potential cancer-causing substance in the drug.

The move comes after the U.S. Food and Drug Administration (FDA) warned that some of the pills contained small amounts N-nitrosodimethylamine (NDMA), which the regulator says is a “probable human carcinogen”.

“We have banned the import of raw materials, production and sale of ranitidine until further notice,” said Khandaker Sagir Ahmed, a director of Bangladesh’s drug regulatory authority, adding that the decision was taken a precautionary measure.

Drug manufacturers across the world have begun recalling the widely taken heartburn drug, which is sold under the trade name Zantac among others, while the FDA and European drug regulators review whether low levels of NDMA in ranitidine pose a health risk to patients.

Domestic companies affected include Beximco Pharmaceuticals and Square Pharmaceuticals, which produce ranitidine under the Neoceptin R and Neotack brands respectively.

The Bangladesh drug regulatory authority will test drug samples but has also asked domestic manufacturers to test their drugs in accredited labs and send reports to the watchdog, Ahmed said.

Reporting by Ruma Paul; Editing by David Goodman

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Novartis says Kisqali boosts survival in breast cancer patients

FILE PHOTO: Logo of Swiss drugmaker Novartis is seen at its branch in Schweizerhalle near Basel, Switzerland, March 29, 2018. REUTERS/Arnd Wiegmann/File Photo

ZURICH (Reuters) – Novartis said on Sunday that Kisqali helped women with advanced breast cancer after menopause live longer, adding to data the Swiss company hopes will help convince doctors to choose its drug over Pfizer’s blockbuster Ibrance.

Kisqali plus the hormone therapy fulvestrant, when compared to fulvestrant alone, demonstrated a significant improvement in survival with a 28% reduction in risk of death, Novartis said at the European Society for Medical Oncology meeting in Barcelona.

Novartis said Kisqali is now the only drug of its kind to show positive overall survival in two pivotal studies.

The Basel-based firm said this year that Kisqali also boosted survival for women before menopause with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.

“These results arm oncologists with more evidence to make a confident treatment choice for their hormone receptor-positive metastatic breast cancer patients,” Dennis Slamon, a doctor at the University of California, Los Angeles Jonsson Comprehensive Cancer Center involved with the study, said in a statement.

Kisqali had $235 million in sales in 2018, well behind $4.1 billion for Ibrance, as Pfizer’s first-to-market drug captured the lion’s share of women with metastatic HR+/HER2- cancer.

However, a Refinitiv poll found analysts expect Kisqali, priced at about $130,000 per year, to have sales of about $1.2 billion annually by 2024.

Reporting by John Miller; Editing by Alexander Smith

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KHN Files Lawsuit To Force Feds To Disclose Medicare Advantage Audits

Kaiser Health News is suing the U.S. Centers for Medicare & Medicaid Services to release dozens of audits that the agency says reveal hundreds of millions of dollars in overcharges by Medicare Advantage health plans.

The suit, filed late Thursday in U.S. District Court in San Francisco under the Freedom of Information Act, seeks copies of 90 government audits of Medicare Advantage health plans conducted for 2011, 2012 and 2013 but never made public. CMS officials have said they expect to collect $650 million in overpayments from the audits. Although the agency has disclosed the names of the health plans under scrutiny, it has not released any other details.

“This action is about accountability for hundreds of millions of public dollars misspent,” said Elisabeth Rosenthal, KHN’s editor-in-chief. “The public deserves details about the overpayments, since many of these private companies are presumably still providing services to patients and we need to make sure it can’t happen again.”

Medicare Advantage, mostly run by private insurance companies, has enrolled more than 22 million seniors and people with disabilities, more than 1 in 3 people on Medicare.

On July 3, KHN reporters filed a FOIA requesting copies of the CMS audits, which are known as Risk Adjustment Data Validation, or RADV, and include the audit spreadsheets, payment error calculations and other records. CMS has yet to respond to that request, according to the suit.

“By this FOIA action, KHN seeks to shine a public light on CMS’s activities on behalf of millions of Americans and their families,” the suit states. The suit asks the court to find that CMS violated the FOIA law and order the agency to “immediately disclose the requested records.”

While Medicare publicly discloses audits of other medical businesses, Medicare Advantage insurers “are being treated differently,” according to the suit. “These audits are improperly being withheld by CMS, even though CMS estimates that these audits have identified some $650 million in improper charges,” the suit alleges.

While proving popular with seniors, the Medicare Advantage industry has long faced criticism that it overcharges the government by billions of dollars every year.

Medicare pays the health plans higher rates for sicker patients and less for those in good health. However, the RADV audits have shown that health plans often cannot document whether many patients actually had the medical conditions the government paid them to treat, generating overpayments. The secretive RADV audits are the primary means for CMS to hold the industry accountable and claw back overcharges for the U.S. Treasury.

In July, KHN reported that Medicare Advantage plans have overcharged the government by nearly $30 billion in the past three years alone, money federal officials have struggled to recoup.

This month, U.S. Sen. Sherrod Brown, an Ohio Democrat, and five other senators sent a letter to CMS Administrator Seema Verma asking her to investigate Medicare Advantage overbilling. “In many cases, CMS has known for years about the tendency for some MA plans to overbill the government yet, despite this, CMS has taken little to no action to course correct. It is critical that CMS act immediately to recoup these overpayments and prevent future overbilling by MA plans,” Brown wrote.

The insurance industry is fighting a proposal by CMS to expand the impact of RADV by extrapolating error rates found in a random sample of patients to the plan’s full membership — a technique expected to trigger many multimillion-dollar penalties.

America’s Health Insurance Plans, the industry’s trade association, said in an Aug. 28 statement that the CMS proposals “violate numerous statutory requirements and are fundamentally unfair and ill-conceived.”

Stepping up RADV penalties “could lead to higher costs, reduced benefits, and fewer MA plan options for seniors,” the group argued.

The FOIA lawsuit is the second by a media organization to compel CMS to disclose RADV audit findings. In 2014, the Center for Public Integrity sued CMS and won a court order forcing the release of RADV audits for the first time. The audits showed that 35 of 37 plans had been overpaid, in some cases by as much as $10,000 per patient in a year.

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Results of GSK and AstraZeneca trials may widen ovarian cancer drug use

BARCELONA (Reuters) – GlaxoSmithKline and AstraZeneca both reported trial results that will likely make their competing drugs available to a wider group of ovarian cancer patients, possibly helping GSK catch its rival in a highly contested drug class.

FILE PHOTO: The GlaxoSmithKline (GSK) logo is seen on top of GSK Asia House in Singapore, March 21, 2018. REUTERS/Loriene Perera/File Photo

The two said separately on Saturday their drug candidates – in a class known as PARP inhibitors – staved off the return of metastasized ovarian cancer in women who had responded to initial standard treatment, reducing the risk of a relapse.

AstraZeneca and its U.S. development partner Merck & Co said their Lynparza drug cut the risk of the cancer progressing again by 41%. The figure was 38% for GSK’s drug.

The companies said they would discuss the results with healthcare regulators with a view to a wider label.

Analysts have seen AstraZeneca and Merck’s Lynparza in the lead with an average sales estimate of $3.1 billion for 2023. GSK’s Zejula is seen achieving about 870 million pounds ($1.1 billion) in revenue that year.

But different trial settings will make it difficult to predict how physicians will weigh up the two drugs.

While the Lynparza trial worked on the assumption that patients get an initial treatment of chemotherapy plus Roche’s Avastin, the trial with GSK’s Zejula included only patients who had initially gone through chemotherapy only.

AstraZeneca argues that more than half of advanced ovarian cancer patients in developed countries already get Avastin, with the rate increasing, while GSK says concerns about side effects may speak against the Roche drug.

Both companies, which are competing to burnish their oncology credentials, showed that not just the small group of women with mutated BRCA genes can benefit as the results also covered the full variety of ovarian cancer.

Many cancer cells have a limited ability to make DNA repairs during cell division, as healthy cells would. This feature makes tumors genetically volatile and helps them develop resistance to treatment over time.


Drugmakers try to use that to their advantage with PARP inhibitors, which block what is left of the DNA repair mechanism so cancer cells fail to replicate. Mutated BRCA genes make the DNA repair particularly weak, which is why PARP inhibitors have been approved already for that subgroup.

Both trials showed benefit in using Zejula or Lynparza also in tumors with a wider range of genetic mutations that hamper DNA repairs, grouped together under the term homologous recombination deficiency (HRD).

But in a patient subgroup with tumors where the DNA repair was still intact, GSK appears to make headway over its rivals.

That group, which according to GSK accounts for about half of ovarian cancer cases, showed a reduction in the cancer relapse risk by 32%, when given Zejula.

In the Lynparza trial, however, there was no meaningful benefit in that cohort. But reliable tests on HRD have yet to become widely available.

“We know now we can use PARP inhibitors in the first-line setting beyond women with BRCA mutations,” said Susana Banerjee, an oncologist at the Royal Marsden NHS Foundation Trust in London, who discussed the results at an ESMO press conference.

FILE PHOTO: The company logo for pharmaceutical company AstraZeneca is displayed on a screen on the floor at the New York Stock Exchange (NYSE) in New York, U.S., April 8, 2019. REUTERS/Brendan McDermid/File Photo

“I think the key question really is, what about patients that don’t have HR deficiency?” Banerjee added.

Zejula was the lead compound of U.S. cancer specialist Tesaro, which GSK acquired for $5.1 billion in December.

Other approved PARP inhibitors, Pfizer’s Talzenna and Clovis Oncology’s Rubraca, are seen as further behind in terms of future revenue prospects. Abbvie is testing an experimental compound called veliparib.

Reporting by Ludwig Burger; Editing by David Holmes

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Targeted Amgen drug has low response rate in colon cancer in study

(Reuters) – An experimental Amgen Inc drug that targets a specific genetic mutation shrank tumors in just one of 12 patients with advanced colorectal cancer who were given the highest dose in a small, early-stage trial, the company said on Saturday.

The cancer stopped growing in 10 of the patients taking 960 milligrams of AMG510 daily, while one patient had tumor progression, according to Phase I trial data presented in Barcelona at a meeting of the European Society of Medical Oncology (ESMO).

In addition, one of the 10 patients whose colon cancer had initially stabilized later left the trial after the disease worsened.

Amgen had previously reported a much higher response rate for AMG510 in lung cancer. The trial tested the drug against multiple tumor types.

AMG510 could become the first approved medicine targeting a mutated form of a gene known as KRAS. The mutation, KRASG12C, occurs in around 13% of non-small cell lung cancers, 3% to 5% of colorectal cancers and up to 2% of other solid tumor cancers.

Guggenheim analyst Michael Schmidt recently estimated that drugs targeting KRASG12C could reach annual U.S. sales of $3 billion and $6.4 billion worldwide.

Rivals, such as Mirati Therapeutics Inc, are also developing drugs that target KRAS mutations.

Amgen said it has not decided whether to move AMG510 into a larger Phase II colon cancer study as a monotherapy. The U.S. biotech does plan to begin a colon cancer trial this year testing the pill in combination with drugs known as MEK inhibitors that block a protein associated with tumor growth.

“The fact that we saw one response is encouraging,” Greg Friberg, head of oncology development at Amgen, told Reuters, adding that “additional work in understanding mutational drivers is ongoing.”

AMG510 is part of a growing trend of precision medicines that target specific gene mutations driving cancer regardless of the organ in which the disease originated.

Earlier this month, the company said AMG510 shrank tumors in about half of advanced non-small cell lung cancer patients in the trial. The U.S. Food and Drug Administration has granted “fast track” status to the drug for lung cancer, which could hasten an eventual approval decision.

Early results appear to indicate that the drug is safe, with six out of 76 patients reporting diarrhea or anemia.

Amgen is also studying AMG510 in combination with Keytruda, Merck & Co’s blockbuster immunotherapy, for treating lung cancer.

Reporting By Deena Beasley; Editing by Bill Berkrot

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