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Friday, July 13, 2018

More insurers using outcomes-based deals with drug, device companies


  • Health plans are increasingly working with drug and medical device companies to tie reimbursement to clinical, quality, utilization or financial outcomes, a new Avalere survey finds.
  • Of 50 health plans and pharmacy benefit managers that participated in the survey, 25% reported having an outcomes-based contract in place and 85% of those said they were considering more such contracts. One-third of respondents said they were looking into such an arrangement.
  • Plans are also having more conversations about the deals within their organizations. More than a third said they talk about outcomes contracts “a great deal,” up from 25% a year ago, and 49% said there was “some” discussion of the pacts. The rest acknowledged some interest in the topic, but “not very much.”

The report highlights the rising popularity of the contracts to tie payment to patient outcomes rather than volume of services among both private and public insurers.
“Outcomes-based contracts are becoming more of a mainstream topic within health plans,” Avalere President Matt Brow said in a statement. ‘While most remain in an exploratory stage, plans that have accrued some experience with outcomes-based contracts are interested in pursuing more.”
The three most common therapeutic areas targeted by the contracts are cardiovascular disease, infectious diseases and cancers. Avalere notes that heart disease and infectious diseases, particularly hepatitis C, already have well-defined outcomes, making them prime candidates.
Other areas where payers are using the agreements are orthopedics, diabetes and other endocrine disorders, immune/inflammatory diseases, rare/orphan diseases and respiratory illnesses like asthma and COPD.
One such contract between UnitedHealthcare and Medtronic targets patient with diabetes. In one-year results released this week, use of Medtronic insulin pumps led to 27% fewer preventable hospital admissions compared with patients who injected themselves throughout the day. The companies did not disclose an amount, but said the program lowered costs in the first year.
Medtronic has promoted the deals, signing close to a thousand contracts with hospitals for specific costs if its Tyrx antibacterial sleeve fails to prevent infection in patients with cardiac implants.
GE Healthcare and Philips have also signed contracts tying payments to outcomes. Such deals can range from pricing arrangements, where there is one price for hitting a metric and a different price if it is missed, to warranties on outcomes.
For example, GE is looking at macro-level outcomes and aligning with clients to help them reduce their costs of care. That includes the performance of GE’s imaging products in providing care, but also product maintenance and location of devices to optimize use.
The company currently has nine partnerships with a combined $2 billion in committed outcomes over the past six to nine years, Helen Stewart, managing principal of GE Healthcare Partners, told Healthcare Dive in a March interview.
For GE, the decision to embrace value-based care was strategic. “We stepped into this strategy because we needed a way to inform our product roadmap [and] investments, aligned not just to what is the most clinically relevant piece of equipment … but also around how those pieces of equipment deliver efficient quality care,” Stewart said.
If plans and providers can see real savings, it is likely to compel more to seek out value-based contracts with their suppliers.

Siga smallpox treatment OKd by FDA


SIGA Technologies announced that the U.S. Food and Drug Administration has approved oral TPOXX for the treatment of smallpox to mitigate the impact of a potential outbreak. TPOXX, a small-molecule antiviral treatment for smallpox, is the first therapy specifically approved for this indication. On May 1, 2018, the FDA’s Antimicrobial Drugs Advisory Committee voted unanimously, 17 to 0, that the benefits of TPOXX outweigh its risks. Concurrent with the approval, FDA granted SIGA’s request for a Priority Review Voucher. A PRV is a voucher that may be used to obtain an accelerated FDA review of a future SIGA product, or sold to a third party, and this is the first PRV awarded under the Material Threat Countermeasure PRV program enacted by the 2016 21st Century Cures Act. In addition, FDA approved a seven-year expiry for TPOXX. Under SIGA’s existing contract with the Biomedical Advanced Research and Development Authority (BARDA), the company will ask BARDA to exercise an option for a $50 million payment to the company based on this extended shelf-life determination. The exercise of this option is at the sole discretion of BARDA. With the approval, SIGA is entitled to a $41 million hold back payment under the existing contract with BARDA, provided that BARDA confirms that there is no difference between the approved product and the courses of TPOXX that have already been delivered to the Strategic National Stockpile. FDA approval is based on data from 12 clinical trials of oral TPOXX in over 700 healthy human volunteers, which showed no drug-related serious adverse events. Four pivotal trials in non-human primates (NHPs) and two pivotal trials in rabbits demonstrated that TPOXX significantly reduced both mortality and viral load in NHP infected with monkeypox virus (MPXV) and in rabbits infected with rabbitpox virus. The results of these studies were published in the July 5, 2018 issue of the New England Journal of Medicine.

Novel therapy delays muscle atrophy in Lou Gehrig’s disease model


Supplementing a single protein found in the spinal cord could help prevent symptoms of Lou Gehrig’s disease, according to a new study out of Case Western Reserve University School of Medicine. Researchers found high levels of the protein — called mitofusion 2 or Mfn2 — prevented nerve degeneration, muscle atrophy, and paralysis in a mouse model of the disease. Since Mfn2 is often depleted during Lou Gehrig’s, the new study suggests supplementing it could be a novel therapeutic approach for the disease.
Lou Gehrig’s disease, or amyloid lateral sclerosis (ALS), is a progressive disorder that devastates motor nerve cells. People with ALS slowly lose the ability to control muscle movement, and are ultimately unable to speak, eat, move, or breathe. The cellular mechanisms behind ALS are also found in certain types of dementia. For the estimated 15,000 Americans living with ALS, the findings offer new hope for ways to delay symptoms.
“We found a way to alleviate age and ALS-related muscular atrophy in our mouse models,” said Xinglong Wang, PhD, associate professor of pathology at Case Western Reserve University School of Medicine. “Amazingly, we could delay ALS symptom onset by 67 days.”
Wang led the study, published today in Cell Metabolism, in which researchers successfully staved off muscle atrophy and paralysis simply by increasing Mfn2 levels in mouse spinal cords.
Wang and colleagues tested the most widely used ALS mouse model. They genetically engineered the diseased mice to have increased Mfn2 levels — but only in nerve cells that extend from the spinal cord and connect to muscle fibers. In late stages of the disease, mice with high Mfn2 levels in these nerves were a healthy weight, and did not have any of the muscle atrophy, gait abnormalities, or reduced grip strength that mice in control groups developed. Even mice who underwent heavy sciatic nerve damage benefited from elevated Mfn2 levels.
Said Wang, “Upregulation of Mfn2 specifically in nerve cells is sufficient to abolish skeletal muscle loss in ALS and aged mice, despite ALS-causing protein being found in all organs and tissues.”
By studying nerve cells collected from the mice, Wang’s team uncovered how Mfn2 offers its protective effects. The researchers found Mfn2 coexists with nutrients in cell structures called mitochondria. Their experiments showed mitochondria travel along nerve cell extensions — axons — and deliver the nutrients to the point where nerve cells and muscle fibers meet. This preserves sensitive connections — synapses — between nerve and muscle cells and prevents muscle atrophy. “We found mitochondria function as miniature ‘trucks’ to transport protein along axons to prevent synaptic degeneration,” explained Wang.
Cellular transport is not typically in the job description for mitochondria. The ancient cellular structures are well-known to be “powerhouses of the cell” — producing energy that keeps cells running. According to Wang, “this is a novel, previously unrecognized role for mitochondria.”
Specifically, Wang’s team found mitochondria use Mfn2 on their surfaces to carry a nutrient called calpstatin. Calpstatin inhibits harmful enzymes that break down nerves and muscle fibers. With the help of Mfn2, mitochondria carry calpstatin along nerve cells axons to meet muscle cells. There, calpstatin prevents enzymes from destroying delicate synapse connections. But without Mfn2, mitochondria can’t carry the nutrient.
According to Wang, the findings have broad implications. “Mfn2 deficiency or mutations are commonly observed in patients with ALS, peripheral neuropathy, Alzheimer’s disease, and other neurodegenerative diseases in which synaptic loss has long been recognized as a prominent early feature,” he says. “Supplementing Mfn2 may be a common and effective therapeutic approach to treat a wide range of diseases including but not limited muscular disorders, patients with nerve injury and various major neurodegenerative diseases associated with synaptic loss.”
Story Source:
Materials provided by Case Western Reserve UniversityNote: Content may be edited for style and length.

Wearable device can predict older adults’ risk of falling


Every year, more than one in three individuals aged 65 and older will experience a fall.
Falls are the most common cause of injury in older adults, and can create ongoing health problems. But treatment and awareness of falling usually happens after a fall has already occurred.
As a part of the NIH’s Women’s Health Initiative, researchers wanted to see if they could predict an individual’s risk of falling so that preventative measures could be taken to reduce this risk.
New analysis has now made this prediction a reality.
The study involved 67 women, all over the age of 60, who were tested on their walking ability and asked about the number of falls they had experienced in the past year. Participants also wore a small device with motion sensors that measured their walking patterns for one week.
Bruce Schatz, head of the Department of Medical Information Science in the University of Illinois College of Medicine at Urbana-Champaign and faculty member of the IGB’s Computing Genomes for Reproductive Health research theme, was asked to analyze the data from the study. He worked with colleagues from the Women’s Health Initiative, including David Buchner from the Department of Kinesiology & Community Health, while supervising Illinois graduate students Andrew Hua and Zachary Quicksall, associated with the University of Illinois College of Medicine.
They found that data extracted automatically from the devices could accurately predict the participants’ risk of falling, as measured by physical examinations of unsteadiness in standing and walking. Their findings were published in Nature Digital Medicine.
“Our prediction showed that we could very accurately tell the difference between people that were really stable and people that were unstable in some way,” Schatz said.
Studies have shown that older individuals fall differently than younger individuals. Younger people fall if they misjudge something, such as a slippery surface. But older adults fall because their bodies are unstable, causing them to lose balance when walking or become unsteady when standing up and sitting down.
This difference gave researchers the idea that they might be able to measure this instability. The device they used, called an accelerometer, was able to measure the user’s walking patterns and how unsteady they were. They combined this measurement with the individual’s fall history to determine the risk of falling in the future.
Being able to predict the fall risk is significant because many older adults often don’t pay attention to the fact that they are unstable until after they fall. But if they know they’re at risk, they can do rehabilitation exercises to increase their strength and reduce their chance of falling.
Schatz sees the successful outcome of this research as a sign that, in the future, more wearable devices, or even smartphone apps, will be able to measure walking patterns and warn users of their fall risk.
Most cellphones today already have an accelerometer, the same sensor that was used in this study. Schatz envisions a future where everyone over 60 would have a phone app that constantly records their motion, requiring no input from the user. If the user’s walking becomes unstable, the app could notify the user or their doctor, and they could begin preventative exercises.
“I work a lot with primary care physicians, and they love this (idea), because they only see people after they start falling,” Schatz said. “At that point, it’s already sort of too late.”
This research relates to the larger idea of preventative medicine — health care that can warn patients about health problems so they can take action and better manage the problem.
Predictions like these are difficult to make, but research experiments like this one make Schatz hopeful that progress is being made. More federally funded studies monitoring larger populations are being conducted more often, so predictive models developed for existing studies, such as the Women’s Health Initiative, are important for future research. Additionally, wearable devices like those used in this study are becoming cheaper and more widely available.
These developments give Schatz hope that a future with successful predictive medicine is coming.
“The question is: is it known how to take the signal, how to take whatever comes out of (a device), and predict something that’s useful?” he said. “I believe strongly the answer is yes.”
Schatz sees value in doing fundamental research that could solve major health problems, like falls in older adults. Most people are aware that it’s a common problem, but Schatz said there is a sense of hopelessness about this issue — if it happens to so many older adults, then what can be done?
“There is a solution which is completely workable and isn’t very expensive, but requires different behavior,” Schatz said. “That message is not getting out.”

CMS aims to ‘restore the doctor-patient relationship’ with 2019 proposed rule


The Centers for Medicare & Medicaid Services (CMS) issued a proposed rule on Thursday making what officials called “historic changes” to the Medicare program aimed at restoring the doctor-patient relationship.
The federal agency issued the 1,473 page proposed rule (PDF) to update the Medicare physician fee schedule and outline changes for year three of the physician payment program implemented under MACRA.
In a press call, CMS Administrator Seema Verma said officials had listened to physicians and made changes to give them more time with patients.
“Today’s proposals deliver on the pledge to put patients over paperwork by enabling doctors to spend more time with their patients. Physicians tell us they continue to struggle with excessive regulatory requirements and unnecessary paperwork that steal time from patient care,” she said in an announcement.
The major changes of the proposed rule include streamlining documentation requirements for so-called evaluation and management office visits to save doctors time; paying clinicians for more virtual care provided via technology; lowering costs for new drugs that come on the market; and giving doctors in small practices who don’t meet existing thresholds for participation in MIPS the choice to opt into the program.
The changes would take effect in 2019, but Verma noted that the proposals are subject to change based on public comments, which are due by September 10.
Removing paperwork requirements through the physician fee schedule would save individual clinicians an estimated 51 hours per year if 40% of their patients are in Medicare, according to CMS. Changes to the MACRA program would collectively save clinicians an estimated 29,305 hours and approximately $2.6 million in reduced administrative costs in 2019.
Image of a dr with a patient and text: Leverage technology and restore time with doctors. #ReducingBurden
Administrator Seema Verma
✔@SeemaCMS
.@CMSgov proposes changes to @MedicareGov Physician Fee Schedule and Quality Payment Program () that would leverage technology and restore patients’ time with doctors by  on physicians.   https://go.cms.gov/2miCpwh 
In the press call, Verma described the following changes:
Streamlining documentation: The agency would reduce documentation requirements for physician services known as “evaluation and management” or E&M office visits, that make up about 20% of allowed charges under the physician fee schedule and consume much of clinicians’ time. The requirements were put in place in 1997 and have not changed in 21 years, Verma said. They require doctors to put information into the patient record strictly for Medicare billing purposes, reflecting little about the patient’s actual medical care. The plan is to cut four different sets of documentation down to just one.
Donald Rucker@donrucker
Real burden reduction for docs may be coming! @CMSGov and @SeemaCMS are proposing changes to the physician fee schedule so that doctors get paid to see patients, not write meaningless billing documentation associated with E&M.   
Leveraging technology: Changes in the fee schedule would pay clinicians for virtual check-ins, or brief, non-face-to-face appointments using telecommunications technology (e.g., audio or video applications); pay for the evaluation of patient-submitted photos such as a skin condition; and expand Medicare-covered telehealth services to include prolonged preventive services.
While not meant to replace regular office visits, the change will allow patients, particularly the elderly and disabled who may struggle to get to the doctor’s office, the ability to check in with a clinician, Verma said.
However, the proposed rule would also require physicians to upgrade to 2015 Edition Certified Electronic Health Record Technology beginning in 2019. The rule said the 2014 edition certification criteria—currently allowed for 2018—is out of date and insufficient to meet clinician needs in the evolving health IT industry.

Changing the MIPS program, one of two payment tracks under MACRA: CMS proposed eliminating MIPS process-based quality measures that clinicians said are low value or low priority. The agency will also overhaul the MIPS “Promoting Interoperability” performance category to support greater EHR interoperability and patient access to their health information, and align the program with the proposed new program for hospitals.
In addition, doctors in small practices who don’t meet the existing threshold to participate in MIPS can do so, allowing them to be eligible for bonus incentives. The 2018 threshold will remain in place for 2019. The agency also plans to move forward with its Medicare Advantage Qualifying Payment Arrangement Incentive (MAQI) demonstration. Under the project, CMS will move ahead with intent to test whether certain Medicare Advantage plans should qualify as an advanced alternative payment model and exempt doctors from MIPS.

Lowering prescription drug costs: The changes would affect payment under Medicare Part B, which covers medicines that patients receive in a doctor’s office, such as infusions. CMS is proposing a change in the payment amount for new drugs under Part B, so that the payment amount would more closely match the actual cost of the drug.
This change would be effective January 1, 2019, and would reduce the amount that seniors would have to pay out-of-pocket, especially for drugs with high launch prices, Verma said. CMS proposes reducing the add-on for these Part B drugs that are new to the market from 6% to 3% beyond the wholesale acquisition cost (WAC), an estimate of the manufacturer’s list price for the drug.
Currently, Medicare pays the physicians that WAC plus the add-on to cover office overhead and the cost of administration. Under the proposal, for the first two quarters that a new drug is on the market, Medicare would pay the reduced 3%. Thereafter, reimbursement would revert to the current system, which pays doctors the average sales price of the drug plus an additional 6%.

The proposed rule already drew reaction from both supporters and critics. In a blog post, Don Rucker, M.D., of the Office of the National Coordinator for Health Information Technology supported what it called a “historic shift” in the documentation requirements for E/M visits.
“This effort, if finalized, will help shift the nation’s electronic documentation away from overly long, form-driven, hard-to-read documents written primarily to satisfy billing requirements to what it was originally intended for—providing high-quality care to patients,” he wrote.
But in a statement, the Medical Group Management Association (MGMA) said it was disappointed that CMS decided to continue its policy requiring physicians document a full 365-days of quality measures, rather than 90 consecutive days.
“Reducing the reporting burden would allow more physicians to participate in MIPS and focus the program on rewarding quality care rather than quality reporting,” said Anders Gilberg, senior vice president of government affairs.
Forty-nine physician groups sent a letter to CMS earlier this year asking the government to reduce the reporting period for MIPS this year.
The MGMA was also unhappy the rule would require physicians to make costly upgrades to their electronic health records for 2019 and take further steps toward implementing burdensome appropriate use criteria.
“At first glance, the rule doesn’t meet MGMA’s definition of administrative simplification,” Gilberg said.
In an emailed statement, the AMGA said it was disappointed CMS maintained a high MIPS exclusion threshold and said the agency missed the opportunity to move Medicare provider payments forward to value-based care.
To help physicians understand all the changes, CMS released a series of fact sheets on the physician fee schedule proposed rule regarding the changes to the quality payment program under MACRA and for the MAQI demonstration.

New Guidelines Mean Almost 800,000 More U.S. Kids Have High Blood Pressure


There’s good news and bad news from a new report when it comes to high blood pressure among America’s children.
The good news: perhaps because of better diets and use of antihypertensive medications, the percentage of kids with high blood pressure declined between 2001 and 2016, according to a research team from the U.S. Centers for Disease Control and Prevention.
The bad news: New hypertension guidelines issued by the American Academy of Pediatrics (AAP) in 2017 lowered the threshold for a diagnosis of high blood pressure in those under 19 years of age, and that means 795,000 more children are now classified as having the condition than before.
But is that really bad news? One heart specialist thinks not.
“The new hypertension guidelines have reclassified those young patients who previously were considered to have ‘normal’ blood pressure to now fall under the category of high blood pressure,” said Dr. Rachel Bond, who helps direct women’s heart health at Lenox Hill Hospital in New York City.
The new guidelines are “a positive step towards screening and risk-stratifying younger patients, who are often neglected from the health system,” she said.
Bond wasn’t involved in the new report, but said that “by diagnosing these patients earlier in life, we can implement aggressive lifestyle modifications through diet and exercise with the hope of completely changing their future cardiovascular disease risk.”
The new study was led by Sandra Jackson, a heart researcher at the CDC’s National Center for Chronic Disease Prevention and Health Promotion.
Before the AAP changed the threshold for hypertension, kids aged 12 to 17 who either were already taking a high blood pressure medication, or who placed within the top 5 percent of pediatric blood pressure readings, were deemed to be hypertensive. For those aged 18 to 19, hypertension was defined as readings of 140/90 mmHg or above, and/or the current use of any antihypertensive drug.
In 2017, the AAP lowered those thresholds: Now, kids under 18 were deemed to have high blood pressure if they fell into the two categories from the prior guidelines or they had blood pressure readings of 130/80 mmHg or above. For those aged 18 to 19, the threshold for hypertension was lowered to 130/80 mmHg and/or any use of antihypertensive drugs.
So what effect did all this have on the overall number of U.S. kids deemed to have hypertension?
Looking at national health data from 2001 through 2016, the researchers found that, even using the new guidelines, the overall percentage of kids aged 12 to 19 who had hypertension fell from 7.7 percent to 4.2 percent. That was true even though the percentage of kids who were obese rose from about 18 percent in 2001 to nearly 22 percent in 2016. Obesity is a big risk factor for high blood pressure.
Jackson’s team theorized that the percentage drop in high blood pressure cases “might be related to improved diet quality or improved [blood pressure] screening, and earlier lifestyle or pharmacological interventions.” For example, many U.S. schools have recently worked to reduce salt and fatty foods from cafeteria menus, and the researchers said there’s also been a rise in the use of antihypertensive medications in kids.
However, despite these improvements, and because of the changes in the AAP’s definition of pediatric hypertension, there was a “net increase” of an estimated 795,000 kids aged 12 to 19 who met the new threshold for hypertension, the CDC team explained.
The study authors believe those numbers can be lowered through nationwide interventions, such as “sodium reduction in the food supply and promotion of physical activity.”
Dr. David Friedman directs heart failure services at Northwell Health’s Long Island Jewish Valley Stream Hospital, N.Y. He agreed that heart health can’t begin too early.
“Screening and intervening on risk factors for heart disease earlier in life can make a big difference in trying to reduce future risk,” he said.
Bond seconded that notion.
“Although children don’t usually suffer the consequences of high blood pressure in the pediatric years, if left untreated, high blood pressure, also known as the ‘silent killer,’ can result in multiple complications later on in life,” Bond said.
The new findings were published in the July 13 issue of the CDC’s Morbidity and Mortality Weekly Report.
More information
Find out more about high blood pressure in kids at the American Heart Association.
SOURCES: Rachel Bond, M.D., associate director, Women’s Heart Health, Lenox Hill Hospital, New York City; David Friedman, M.D., chief, Heart Failure Services, Northwell Health’s Long Island Jewish Valley Stream Hospital, Valley Stream, N.Y.; July 13, 2018, Morbidity and Mortality Weekly Report

Eat your way to better asthma control?


Need another reason to eat healthy? New evidence bolsters the notion that nutritionally rich foods might help prevent or minimize asthma.
While the study couldn’t prove cause and effect, one asthma specialist said there’s certainly no downside to eating better.
“The health benefits of a diet rich in plant foods and unprocessed foods are already well-known,” said Dr. Ann Tilley, a pulmonologist at Lenox Hill Hospital in New York City.
She wasn’t involved in the new study, but said it “should provide additional motivation for lung doctors to discuss diet choices with their patients, and for asthma patients to choose more fruits and vegetables and fewer processed foods.”
The new French research was led by Roland Andrianasolo, part of the Nutritional Epidemiology Research Team at Inserm-Inra in Paris.
He and his colleagues surveyed nearly 35,000 French adults on the number of asthma symptoms they had experienced over the past year. About a quarter of the participants had experienced at least one symptom.
The participants were also asked about their eating habits. Diets high in fruits, vegetables and whole grain cereals were rated the healthiest, while those high in meat, salt and sugar were deemed the least healthy.
After adjusting for other factors linked with asthma such as smoking and exercise, the researchers found that healthier diets were tied to a 30 percent lower risk of developing asthma symptoms for men, and a 20 percent lower risk for women.
Among participants who already had asthma, healthy eating was associated with 60 percent lower risk for “poorly controlled” symptoms in men, and a 27 percent lower risk in women, the study found.
The study was published July 12 in the European Respiratory Journal.
“Our results strongly encourage the promotion of healthy diets for preventing asthma symptoms and managing the disease,” Andrianasolo said in a journal news release.
How could food influence asthma? According to Andrianasolo, dietary components such as fruit, vegetables and fiber “have antioxidant and anti-inflammatory properties and are elements in a healthy diet that potentially lower symptoms.”
On the other hand, sugar, meat and salt “are elements with pro-inflammatory capacities that may potentially worsen symptoms of asthma,” he explained.
Pulmonologist Dr. Alan Mensch helps direct medical affairs at Plainview and Syosset Hospitals in Long Island, N.Y. Regarding the study, “we should not be surprised by these results,” he said.
“It is known that healthy eating plans such as the Mediterranean diet improve the health of patients with cardiovascular disease and hypertension,” Mensch said.
“Foods ingested are broken down in the digestive tract, and some components are bioactive. In some ways this is no different than medications we ingest,” he said.
Another potential link tying healthy diets to better asthma resistance may lie in the makeup of an individual’s “microbiome,” Mensch said.
“This refers to the many bacteria which normally inhabit the gut,” he explained. “It is felt that the microbiome associated with healthy diets has anti-inflammatory properties.”
More information
The U.S. National Heart, Lung, and Blood Institute has more on asthma.
SOURCES: Ann Tilley, M.D., pulmonologist, Lenox Hill Hospital, New York City; Alan Mensch, M.D., senior vice president, medical affairs, Plainview and Syosset Hospitals, Long Island, N.Y.; European Respiratory Journal, news release, July 11, 2018