Last winter’s dreadful flu season may have had a silver lining: Flu vaccine uptake rose sharply this fall in both children and adults, according to newly released data.
The Centers for Disease Control and Prevention reported Friday that the number of children and teens vaccinated as of mid-November was up nearly 7 percentage points over last year at that time and coverage among adults was up 6.4 percentage points.
The data, which were drawn from three CDC-sponsored surveys, do not indicate whether more people will be vaccinated overall this winter — or that last year’s flu season is changing behavior this winter. The increase could mean that more people were inspired to get their flu shot sooner this year.
“It’s a good sign, but it’s too early to interpret,” said Michael Osterholm, director of the University of Minnesota’s Center for Infectious Diseases Research and Policy.
The increase in early vaccinations may be due to fresh memories of last winter. But Osterholm said other factors could also be at play.
“I don’t know if that’s what did it or if in fact there are more organized programs to get people vaccinated,” he said. The CDC acknowledges that it’s hard to say for sure what is driving the increase, but it’s working theory is that more people are getting vaccinated because last winter reminded them that influenza can be dangerous.
Last year’s flu season was one for the ages, with high-level activity stretching over several months. The CDC estimated that 80,000 Americans in total were killed by the flu; 185 children died. Last season’s flu activity was caused mainly by the influenza A virus H3N2, which is associated with more severe flu seasons.
Dr. Ram Koppaka, associate director for adult and influenza immunization, in the CDC’s immunization services division, noted that there was a rise in vaccination rates after the 2009 flu pandemic that was sustained over a number of seasons.
The rate hovered around 46 percent or 47 percent for several years, but dropped back to 42 percent last year.
Fewer than half of Americans have been vaccinated overall this year — 45.6 percent of children and 44.9 percent of adults had received flu vaccine.
Still, more young children are getting vaccinated this year over last year. There was an 8.2 percentage point increase in uptake among children aged 6 months (the earliest flu vaccine can be given) and 4 years and a 7 percentage point increase among children aged 5 to 12 years old.
But teens aged 13 to 17 were vaccinated at the same rates as last year, with only about 35 percent of children in this age group vaccinated.
The CDC report noted that experience from previous flu seasons shows that people continue to get vaccinated through the winter and even into spring, with end-of-season rates in children 19 percentage points higher than the early season rates, and 8 percentage points higher in adults.
Flu activity so far this season remains low, though there are signs that it is picking up steam. Six child flu deaths have been reported to the CDC.
Federal prosecutors have charged six Detroit-area physicians with fraudulently billing Medicare, Medicaid, and Blue Cross/Blue Shield of Michigan in connection with a scheme to hook patients on opioids and then require them to undergo unnecessary procedures to get more pills.
In a December 4 indictment filed in US District Court for the Eastern District of Michigan, the six doctors were charged with illegally billing $464.4 million “for services and equipment that was medically unnecessary, not eligible for reimbursement, and/or not provided as represented.” That sum includes allegedly fraudulent claims for $182.5 million to Medicare, $272.2 million to Medicaid, and $9.2 million to the Michigan Blues.
According to the indictment, the scheme began in January 2013 and continued through November 2018. During this period, the six physicians allegedly wrote prescriptions for more than 13 million dosage units of opioid drugs, including oxycodone, oxymorphone, hydrocodone, and hydromorphone. The indictment charges the defendants with “unlawful distribution of controlled substances outside the usual course of professional medical practice.”
The defendants allegedly prescribed opioids to induce patients to come in for office visits. Once there, if they wanted to get more pills, they were forced to undergo procedures such as painful joint and block injections, according to the indictment. In addition, the doctors allegedly referred some of these patients for medically unnecessary tests, including MRIs.
The lead defendant is Rajendra Bothra, MD, a surgeon who owns the Pain Center, which has clinics in Warren and Eastpointe, Michigan, and the Interventional Pain Center in Warren. The other defendants, all of whom are participating providers in these two entities, include Eric Backos, MD; Ganiu Edu, MD; David Lewis, MD; Christopher Russo, MD; and Ronald Kufner, MD.
According to the Detroit Free Press, Lewis, Edu, and Russo were released on bond. A judge refused to grant bond to Bothra because he was considered a flight risk. The newspaper didn’t mention the current status of Backos or Kufner.
It is unclear how much jail time the defendants are facing. However, the indictment stated that they were all subject to criminal forfeiture of the proceeds from their alleged offenses, including money and/or real property.
India Abroad, writing about Bothra’s indictment, noted that he was “one of the most high-profile American Republican Party activists and fundraisers in the 1980s and early 1990s, who even hosted major fundraisers for then President George H.W. Bush and other senior GOP lawmakers.”
In 1999, the article said, Bothra received the Padmashri Award, one of the highest civilian honors in India, for his work with the poor and the sick in that country. He left his US surgery practice every year to spend several weeks working with Indian organizations to increase awareness of HIV/AIDs and drug, tobacco, and alcohol addiction, the publication said.
This is not the only case of fraud involving Michigan pain clinics. Last June, the CEO of Tri-County Wellness, which owned numerous pain clinics in Michigan and Ohio, and four physicians were charged in connection with a $200 million healthcare fraud scheme involving unnecessary prescriptions of controlled substances and harmful injections.
Fast food gets a lot of blame for rising obesity rates, but meals at chain restaurants contain even more calories, two new international studies show.
The first study assessed the calories in 13,500 meals from six fast-food and 21 full-service restaurant chains in the United Kingdom. The researchers found an average of 751 calories in main meals at fast-food chains and 1,033 calories in those at full-service restaurant chains.
University of Liverpool researchers led by Eric Robinson said that 89 percent of the full-service restaurant meals and 83 percent of the fast-food meals exceeded England’s recommended limit of 600 calories for midday and evening meals.
In the second study, researchers measured calories in widely ordered meals in 116 full-service and fast-food restaurants in Brazil, China, Finland, Ghana and India, and compared them with calories in meals at popular U.S. restaurants.
Main meal dishes at fast-food chains had an average of 809 calories, compared with 1,317 calories in those served in full-service restaurant chains. Only restaurants in China served meals with significantly less calories than U.S. restaurants.
The recommended 600-calorie limit was exceeded by 94 percent of full-service restaurant meals and 72 percent of fast-food places, according to the study led by researchers at the Human Nutrition Research Center on Aging at Tufts University in Boston. The lead study author was Susan Roberts, who is director of the Energy Metabolism Laboratory at Tufts.
Both reports were published online Dec. 12 in the BMJ.
The researchers said their findings likely underestimate the number of calories consumed by restaurant customers because drinks, starters, desserts or side orders weren’t included in the studies.
Extremely high amounts of calories in full-service restaurant and fast-food meals are common in many countries and likely play a role in the global obesity epidemic, the researchers added.
They suggested tackling the problem through public health measures, such as: reducing the number of calories in meals; offering smaller portion sizes; and nutrition labeling of meals.
Health officials would be wise to consider how different types of solutions can be used together, Jean Adams, from the Centre for Diet and Activity Research, University of Cambridge, U.K., wrote in an accompanying editorial.
To achieve change, the public health community needs “to find ways to transcend ideological debates, appeal to all sides, and acknowledge the potential value of many different approaches,” Adams said in a journal news release.
In NP, PA, and physician treatment of diabetes patients, no significant difference is found in three clinical measures.
KEY TAKEAWAYS
Nurse practitioners and physician assistants have been proposed as a solution for the country’s physician shortage.
Researchers focused on diabetes care by NPs, PAs, and physicians because diabetes has characteristics similar to other chronic illnesses.
The researchers found NPs, PAs, and physicians achieved equivalent clinical results in three diabetes measures.
Nurse practitioners and physician assistants are as well equipped to treat patients with chronic illnesses as physicians, recent research indicates.
The finding is a boost for advocates of deploying nurse practitioners (NPs) and physician assistants (PAs) to ease the country’s physician shortage. The country is facing a projected shortfall as high as 104,000 physicians by 2030, according to a report by the Association of American Medical Colleges.
Research published last month in Annals of Internal Medicinefound no significant clinical variation in care for treatment of diabetes by nurse practitioners, physician assistants, and physicians.
“In our study, we did not identify any clinically meaningful differences in commonly measured intermediate diabetes outcomes among patients with NP, PA, or physician primary care providers,” the lead author of the research, George Jackson, PhD, MHA, of Durham VA Medical Center in Durham, North Carolina, told HealthLeaders this week.
The study featured 368,000 adult patients. The clinical measures examined were continuous and dichotomous control of hemoglobin A1c, systolic blood pressure, and low-density lipoprotein cholesterol.
“No clinically significant variation was found among the three primary care provider types with regard to diabetes outcomes, suggesting that similar chronic illness outcomes may be achieved by physicians, NPs, and PAs,” Jackson and his colleagues wrote.
Diabetes has key characteristics that are similar to many other chronic illnesses, Jackson said.
“Diabetes represents an important indicator of care quality because it involves both complex medication managementand helping patients learn to how to manage the illness themselves; for example, taking medicine as prescribed, changing diet, or getting more exercise,” he said.
In the primary care setting, it appears ill-advised to place limits on the conditions that NPs and PAs treat, Jackson said.
“I would not say there are specific conditions that per seshould or should not be cared for by specific types of primary care providers. Like all clinicians, primary care providers consider specific patient circumstances when deciding which other clinicians should be included as part of the care team or consulted when addressing patient needs,” he said.
An editorial accompanying the Jackson team’s research calls for giving NPs and PAs a higher degree of respect.
“It is time to stop calling NPs and PAs ‘midlevel’ providers, as is common in certain systems. Nurse practitioners and PAs are competent primary care providers in their own right and should be fully accepted as such,” the editorial says.
Health plans argue they are the best group to manage and receive funding from the CMS if it decides to pay for housing, transportation and other social determinants of health.
HHS Secretary Alex Azar shook up the industry when he remarked last month that the agency is putting together a pilot model that would allow healthcare organizations to bill the CMS for providing services such as assistance with food and housing.
And although details about the program are unknown at this time, it didn’t take long for health systems to speak out and say they would be smart benefactors of such a payment.
Payers beg to differ.
Health plans—particularly those caring for Medicaid beneficiaries— think they should be the ones getting paid by the CMS for managing social determinants of health, given their access to members no matter the care setting, their experience in taking on risk and the work they are already doing to address members’ social risk factors.
“We have the population. You should start with the health plan because they have all the members,” said Michael Schrader, CEO of CalOptima, a Medicaid and Medicare health plan based in Orange County, Calif. “You can go to a hospital, but all services don’t happen at the hospital. Hospitals are only going to touch a small number of our members in any given year.”
Hospital industry representatives, though, argue their connection to the community is one of the reasons why they should be a major part of managing social determinants. “America’s hospitals and health systems are leading the way in addressing the social determinants of health,” said Joanna Hiatt Kim, vice president of payment policy at the American Hospital Association. Kim said the AHA supports an enhanced version of the Center for Medicare & Medicaid Innovation’s Accountable Health Communities model, which involves providers working with community groups to address patient’s social risk factors. Health plans aren’t part of the model at this time.
“The AHA will continue to prioritize supporting hospitals, health systems and clinicians as they address social determinants of health, work to eliminate healthcare disparities and provide comprehensive care to every patient in every community,” Kim added.
HHS’ plans are unclear. Azar’s comments about the model were vague and didn’t directly address who would receive the payments. At one point in his remarks, however, he did refer to patients as beneficiaries. “What if we provide solutions for the whole person, including addressing housing, nutrition and other social needs?” Azar said. “What if we gave organizations more flexibility so they could pay a beneficiary’s rent if they were in unstable housing or make sure that a diabetic had access to, and could afford, nutritious food? If that sounds like an exciting idea … I want you to stay tuned to what CMMI is up to.”
More recently, a CMS spokesman said the agency didn’t have any additional details regarding who would receive the payments in such a model.
Insurers want in
Health plan officials are excited about the prospect of the CMS offering a payment mechanism to provide social services because they are already doing so with their own dollars.
THE BIGGEST BARRIER TO CMS PAYING FOR HOUSING? CONGRESSThe CMS has some big regulatory hoops to jump through to realize the agency’s vision of paying for housing and other social determinants of health.
Under current law, Medicare and Medicaid funds can’t be used to pay directly for housing. If the plan to do so moves ahead, the CMS would likely pilot the model through the Center for Medicare & Medicaid Innovation.
But if it wants to integrate the assistance as part of the Medicare or Medicaid programs, it would need Congress to change the Social Security Act.
And health policy experts said changing the law would be a tough sell on Capitol Hill. Dr. Anthony Shih, president of New York-based not-for-profit United Hospital Fund, called the statutory limitations, the “biggest barrier” to integrating payment for housing and other social needs in CMS programs.
But others were optimistic that Congress may get on board if it’s proven that the pilot model leads to reductions in costs and improvements in outcomes. “They will change the statute based on evidence,” said Len Nichols, professor of health policy at George Mason University.
There has been growth in published literature showing that addressing social risk factors can improve patients’ outcomes as well as decrease costs for health plans and providers through lower utilization of emergency departments and reduced readmission rates.
“There’s a lot of evidence out there that some of these social determinants of health interventions can pay for themselves,” Nichols said.
CalOptima has invested $11 million since 2015 to provide housing and other support services to 445 of its homeless Medicaid members. CEO Schrader said he felt it was CalOptima’s duty to try to address the growing homeless population in Orange County, a situation that has become contentious. A federal judge recently ordered a stay on an Orange County ordinance that would allow local authorities to prosecute homeless people for camping in public places.
Schrader said more than half of the county’s homeless population are CalOptima members. “Homelessness is an issue for our community and CalOptima is very much part of the community,” he said.
CalOptima partnered in 2015 with the not-for-profit Illumination Foundation to offer temporary housing for homeless individuals. The housing is staffed with support workers who help members stay on their medications, find employment and eat well.
Since 2015, roughly 20% of the individuals have graduated from the program to permanent housing while others were transferred to long-term care.
Schrader said the $11 million investment made sense for CalOptima. Under California’s Medicaid program, CalOptima is paid through capitation, or a fixed rate, to cover all the health costs for members.
It costs the health plan about $200 a day to provide housing for a member compared with an emergency room visit that can cost CalOptima at least $1,200.
Schrader said given the success CalOptima has experienced so far with this program, CMS’ potential model “is really appealing. These are things we are starting to pay for now, but we have no reimbursement from the Medicaid program.”
They have the data
Another capability that health plans have and providers don’t is extensive data about members, said Allen Karp, executive vice president of healthcare management and transformation at Horizon Blue Cross and Blue Shield of New Jersey.
As healthcare services are increasingly provided outside the walls of hospitals, in-depth patient information is hard for providers to gather. Health plans follow their members through all of their interactions with the healthcare system no matter the setting, insurance executives say.
Horizon has recently used its data capabilities to try to address its members’ social needs. Horizon has worked with RWJBarnabas Health since April 2017 to address the social risk factors affecting high-risk members across Newark, N.J.
Horizon helped RWJBarnabas identify the patients who would benefit most from the program through its data analytics and then together both organizations funded community health workers to help those patients “with whatever made sense for them,” said Mary Ann Christopher, Horizon’s vice president for community health. “The kind of intervention took the form of what the need for that member was.”
The intervention has led to reductions in ED visits, inpatient stays and an increase in behavioral health services because a lot of patients had undiagnosed behavioral health problems, Karp said. Horizon plans to expand the program in the first quarter of 2019 to more areas of New Jersey. Horizon is the largest Medicaid plan in the state with roughly 900,000 members.
Karp noted that the inherent mission of health plans makes them a better fit for the CMS model than hospitals. “We can improve outcomes and reduce the cost. That is one of the main things we do for a living, whereas hospitals are focused on getting people well once they are in the hospital,” he said.
Payers can also be the unifiers for the fragmented healthcare system that patients currently struggle to deal with, said Dr. Priya Batra, senior medical director for family and community health at Inland Empire Health Plan based in Rancho Cucamonga, Calif. Given the fact that health plans follow members throughout all their healthcare interactions and already work with health systems and the not-for-profit sector, health plans “are well-positioned to coordinate a lot of these types of programs.”
Inland has about 1.2 million members in California’s Medicaid program. It’s in the early stages of addressing members’ social determinants of health, Batra said.
Adding oversight
In terms of likely additional regulations that the CMS will require to prove that the model reduces cost and improves outcome, health plan executives said they aren’t too concerned.
“I think it’s to be expected. It’s par for the course,” CalOptima’s Schrader said.
“We have to evaluate these programs and I think doing that from a return-on-investment standpoint is reasonable,” Batra said. But she also added that “you have to be realistic about when you’ll see the benefits of these types of interventions and it might take longer” for the benefits to be fully realized.
Karp at Horizon also said he expects additional regulation, but “if it’s over-regulated, that stunts creativity; that would be our concern.” Although he added that given the Trump administration’s focus on reducing burdensome oversight, he expects “they don’t want to over-regulate” the model.
South Koreas Hanmi Pharmaceutical said Friday that Sanofi has signaled the start of two new phase 3 clinical studies of the Type 2 diabetes drug candidate efpeglenatide by officially listing the plans on ClinicalTrials.gov, a US-based clinical trials registry site.
By doing so, Sanofi has officially executed all five of its planned phase 3 clinical trial agenda for efpeglenatide, which Hanmi licensed out to Sanofi in 2015, according to the Korean drugmaker.
So far, Sanofi has been carrying out three phase 3 clinical studies — one to discern the effect of efpeglenatide on cardiovascular outcomes, another to compare the drugs efficacy to a placebo and another to compare efpeglenatide with Dulaglutide.
Now, two types of new clinical trials have begun. One study aims to compare efpeglenatides efficacy and safety in treating type 2 diabetes that is inadequately controlled with metformin alone or in combination with sulfonylurea.
The other study compares the diabetes drug candidates efficacy and safety in treating type 2 diabetes that is inadequately controlled with basal insulin alone or in combination with an oral antidiabetic drug.
Around 6,400 patients will participate in the five Sanofi-led efpeglenatide studies, which will conclude in the first half of 2021, according to the companies.
Developed by South Koreas Hanmi Pharmaceutical, efpeglenatide is a once-weekly GLP-1 receptor agonist for treating Type II diabetes. The drug candidate was licensed out to Sanofi in November 2015.
Efpeglenatide employs Hanmis Lapscovery — short for Long Acting Protein and Peptide Discovery — delivery technology, which extends the life of a peptide or protein in the body, extending efficacy and potency.
