Brazil prosecutors hope to strike deal lifting Roundup injunction

Brazil federal prosecutors are negotiating with health authority Anvisa and the agriculture ministry to reach a deal that could lift an injunction against the popular weed-killer glyphosate, a prosecutor on the case told Reuters on Friday.

Prosecutors have requested a meeting next week to discuss a deal just as a ban on glyphosate products already on the market is expected to go into effect on Monday, Brasilia-based prosecutor Luciana Loureira Oliveira said by telephone.

The deal would lift injunctions on new and existing products provided that Anvisa issues a decision in the first quarter of 2019 on the chemical’s safety and the ministry agrees not to appeal the health regulator’s decision, she said.

Court documents say billions of dollars of agricultural trade could rest on whether glyphosate is ultimately allowed in Brazil, the world’s largest exporter of soy.

Brazilian farmers widely apply the herbicide to the oilseed and other crops with Monsanto SA, owned by Germany’s Bayer AG, being the largest supplier of glyphosate products in the country.

Monsanto is also facing legal backlash in the United States with hundreds of cases alleging glyphosate causes cancer.

The Brazilian federal prosecutors’ office has said that new evidence, including a study conducted in 2015 by an arm of the World Health Organization, indicates glyphosate could cause cancer and the country should reevaluate the chemical’s safety.

A Brazilian judge ruled earlier this month to halt the registration of new glyphosate-based products in the country and to suspend existing registrations after 30 days, to remain in effect until Anvisa issues a ruling on its safety.

That deadline is expected to lapse on Monday, Oliveira said, just as farmer’s are set to start planting the soy crop next month.

The Solicitor General’s office is appealing the decision with the backing of the agriculture ministry, but the court has yet to rule on the appeal.

A deal, subject to court approval, would shelve the injunction and allow glyphosate products to be used until Anvisa reaches a decision, Oliveira said.

Getting the ministry’s agreement to abide by the ruling would potentially avoid a long process of multiple layers of appeals within Brazil’s complex legal system, Oliveira said.

“We want to abbreviate this whole process that could still be very long,” she said.

Anvisa said it was taking necessary legal action in the case and could not comment on the prosecutor’s remarks. The ministry of agriculture’s press office declined to comment on the proposed deal.

A representative for Bayer and Monsanto said the companies maintain their previous statement that 40 years of use in practice and reviews by authorities around the world have shown that glyphosate is safe to use.

https://www.reuters.com/article/us-brazil-agriculture-chemicals-exclusiv/exclusive-brazil-prosecutors-hope-to-strike-deal-lifting-glyphosate-injunction-idUSKCN1LG2VP

Tennessee health system lawsuit alleges rigged Medicaid contracting by state

• Erlanger Health System filed a lawsuit last week against the state’s Medicaid program, TennCare. The Hamilton County, Tennessee-based nonprofit system alleges that TennCare is “purposefully siphoning money from hospitals who treat Tennessee’s neediest citizens” to the benefit of insurance companies where some TennCare employees work after they leave state government.
• Erlanger argues that state officials are ignoring a 2007 statute requiring TennCare to pay the average in-network contract rate to out-of-contract hospitals that provide emergency services to Medicaid beneficiaries. Instead, the suit claims, TennCare knowingly adopted a static rate approximating the lowest in-network contract rate in 2008 and in 2010, creating a windfall for profit-driven managed care organizations at the expense of out-of-network hospitals.
• The court filing is the latest in an ongoing lawsuit, TennCare representative Sarah Tanksley told Healthcare Dive via email. “The state clearly has an entirely different position on the issues being litigated and will provide a written response to the court disputing the allegations raised by the plaintiffs,” she said. Neither TennCare nor a legal representative for Erlanger had further comment on the active litigation.

Tennessee Medicaid contracts with managed care organizations by granting them a capitation payment for each enrollee. The insurer then assumes the risk and responsibility of paying for that patient’s covered medical expenses.

The potential for profits comes when the insurer’s price tag for a patient is less than the overall capitation payment it receives from the government. TennCare’s MCOs have earned billions of dollars in profits, according to the lawsuit, which calls out UnitedHealthcare Plan of the River Valley for earning more than $125 million in profit from 2017 alone.

Friday’s filing is the latest in litigation that stretches back to 2009, when Erlanger — the 10th largest public healthcare system in the U.S. — previously sued to recover rates from an MCO, with little luck. In 2015, the Tennessee Supreme Court held that Erlanger must exhaust all administrative remedies before further challenging TennCare rules in court.

In April 2017, Erlanger followed up on that ruling and sought to invalidate two rules that TennCare used to justify their rate coding, but the administrative proceeding didn’t bear fruit. Therefore, the multi-hospital health system, which treats more than 600,000 people a year, is now suing TennCare.

The two rules in question are referred to in the suit as the “74% SPA” and the “57% SPA,” both of which were submitted as state plan amendments to CMS in 2008 and 2010, respectively, and subsequently approved.

Both lowered the rate for out-of-network providers of covered outpatient emergency services, first to a static rate of 74% of 2006 Medicare rates, then to 57% of 2008 Medicare rates, approximating the lowest in-network rates paid by TennCare MCOs both times.

Erlanger requests the court to find both the 74% and 54% SPAs “invalid, unenforceable, unlawful, and unconstitutional,” given that those static rates are drastically lower than the lowest in-network rates applicable today.

The lawsuit also stresses that many former TennCare employees now work for “the very insurers they once regulated.”

TennCare offers health insurance to more than 1.4 million low-income citizens, and partners with four insurers in west, middle and east Tennessee: AmeriGroup, BlueCare, UnitedHealthcare and TennCare Select.

The litigation comes on the heels of a July OIG report finding that MCOs and states need to be doing a lot more to stop billions of dollars lost to waste, abuse and fraud, as program integrity in Medicaid hasn’t received the same attention as Medicaid fee-for-service.

https://www.healthcaredive.com/news/tennessee-health-system-lawsuit-alleges-rigged-medicaid-contracting-by-stat/531259/

Cleveland Clinic’s operating income plummets 80% in Q2

• Cleveland Clinic saw revenues inch up 2% to $2.21 billion in the second quarter of 2018, from $2.16 billion in the same period last year, but increased expenses sent operating income spiraling down by 80%.
• The nonprofit health system finished the quarter with operating income of $25.1 million versus $130.5 million in Q2 2017, according to recently released financial statements.
• After accounting for nonoperating gains, Cleveland Clinic reported net income of $80.7 million for the period, down 73% from $303.3 million the previous year.

The picture of strong revenues and declining operating income is one seen across the healthcare industry as hospitals and health systems juggle smaller inpatient volumes and lower reimbursement with rising labor and operating costs.

Earlier this week, Banner Health showed a 33% drop in net income for the first six months of 2018, despite a 5.9% jump in revenue. Rising expenses also offset revenue gains at Kaiser Permanente, which saw net income down 21% in the first half of this year.

Nonprofit hospitals continue to outspend their revenue growth, and that widening gap is among the difficult headwinds putting them “on an unsustainable path,” according to a Moody’s Investors Services report from this week.

At Cleveland Clinic, net patient revenue increased $106.6 million, or 5.7%, in the second quarter of this year, compared with the same period the prior year. However, the system saw a 1.2% decline in same-facility inpatient acute admissions and 2% drops each in same-facility surgical cases and emergency department visits.

Expenses grew 8% year over year from about $1.9 billion to $2.02 billion, fueled by increased costs of salaries, wages and benefits, supplies and pharmaceuticals.

To address the challenge of these rising expenses, the health system said it’s developing and implementing cost management and containment plans under its Care Affordability initiative, which launched in 2013 to promote more affordable patient care models.

The second quarter saw the completion of several capital projects, including a $34 million family health center in Lakewood, Ohio, and a $32 million family health center and surgery center in Coral Springs, Florida. Cleveland Clinic also completed and opened a $49 million emergency department at Akron General Medical Center in northeast Ohio.

https://www.healthcaredive.com/news/cleveland-clinics-operating-income-plummets-80-in-q2/531364/

Stepping Up Suicide Prevention

My name is Alex Crosby. I am a medical epidemiologist at the Centers for Disease Control and Prevention (CDC). I am pleased to join you as part of the CDC Expert Commentary Series on Medscape. I would like to talk today about suicide prevention. Nearly 45,000 lives are lost in the United States each year to suicide; that’s about one person every 12 minutes. More than 1 million people have attempted suicide in the past year. Over the past 15 years, suicide rates in the United States increased nearly 30%, while most other leading causes of death have declined. Suicide and suicide attempts cost more than $69 billion annually in direct medical and work-loss costs.^[1]

Suicidal behavior affects all segments of our society—all ages, from children to older adults, and all races and ethnicities. This means that clinicians in all specialties have a role to play in prevention.

Suicide is preventable. CDC’s Division of Violence Prevention developed a technical package to help healthcare providers understand effective approaches to prevent suicide. This package compiles the best available evidence on strategies that can increase factors that protect against suicide and decrease factors that put people at risk for suicide. I’ll talk about four approaches you can take that can make a difference in your practice.

Screening, assessment, and support. Ascertain whether systems are in place to screen, assess, and support people at risk for suicide. Make sure your staff members are trained in suicide care practices and protocols, including safety planning. Put evidence-based treatments into practice. In many cases, such as rural and underserved areas, primary care providers may be the only clinician a patient sees.^[2] Even in urban and suburban settings, primary care providers often see patients first before making referrals to a specialist. Below, you will find resources that outline important steps that different types of healthcare providers can take to asses and screen for suicide risk.^[3,4]

Limit access to lethal means. Another approach is to create protective environments that address risk factors where people live, work, and play. One way to do this is reducing access to lethal means for people at risk for suicide. For example, you can offer education and counseling to people who may be at risk, or who have made previous attempts, about how to keep medicines in a locked cabinet or how to store their firearms safely. The Community Guide and the Guide to Clinical Preventive Services provides proven strategies to adopt.

Risk for suicide. Another way to prevent suicide is to identify and support patients at risk. While no one tool or assessment will accurately screen everyone at risk for suicide, some patients are at higher risk than others. In particular, this includes people living with a mental illness; people who have previously attempted suicide; and veterans and active-duty military personnel. Specific approaches include referral agreements with mental health providers in your area, and making sure that there is continuity of care and ensuring the sharing of information among all of the patient’s different providers. Following up with at-risk patients by phone between visits can help prevent repeated suicide attempts.

Suicide prevention. Healthcare providers play a critical role in “postvention.” Interventions after a suicide may include debriefing sessions, counseling, and/or bereavement support groups for surviving friends, family members, or other close contacts.

Suicide is a serious public health problem. Rates of suicide have been on the rise for more than a decade. Suicide has a far-reaching ripple effect. Families of those who die of suicide often have higher rates of depression and anxiety. To prevent suicide, we must work to support people at high risk and their families. Clinicians have an important and influential role in preventing suicide in the first place and in lessening the immediate and long-term harms of suicidal behavior by helping those in times of crisis access the services and support they need. CDC has new information about suicide data at the state level in a recently released Vital Signs and other links and resources for healthcare providers. Visit the resources at the bottom of this page for more information. Thank you.

Web Resources

Centers for Disease Control and Prevention. Suicide Prevention

Suicide Prevention Resource Center

National Suicide Prevention Lifeline

National Action Alliance for Suicide Prevention. Recommended standard care for people with suicide risk: making health care suicide safe.

Agency for Healthcare Research and Quality. Guide to Clinical Preventive Services, 2014.

The Community Guide

https://www.medscape.com/viewarticle/900683

Diabetes Technology Advances: It’s a Whole New World for Kids

My name is Melissa Andrews Rearson. I am a pediatric nurse practitioner at the Children’s Hospital of Philadelphia (CHOP) in the Division of Diabetes and Endocrinology. Here at CHOP, we follow patients with type 1 diabetes, type 2 diabetes, and diabetes that is a result of other conditions, such as a pancreatectomy. We use developmental considerations as we help families and patients choose what types of technology might be appropriate for them.

As you know, over the past couple of years, technology in the diabetes field has advanced rapidly. Specifically, over the past year, there has been a huge increase in the number and types of devices that patients can use to manage diabetes.

Technology updates have allowed for improvements in all aspects of diabetes management, but the goal for overall control remains the same: a hemoglobin A1c of less than 7.5% for children and teens and less than 7% for adults. This goal is shared by the American Diabetes Association and the International Society for Pediatric and Adolescent Diabetes.

The phone has become a very important tool in diabetes management and can be used in many different ways by both parents and patients who have type 1 and type 2 diabetes. Parents and kids can use apps on the phone to determine carbohydrate content of different foods they are going to eat. There are also apps that allow families to input recipes so that they can determine the carbohydrate content of homemade foods to be able to dose insulin more correctly.

In addition, apps support record-keeping, including allowing Bluetooth input from blood glucose monitors so that patients have a record of blood sugars that could be shared from their phones through the Cloud with parents and other caregivers.

One of the insulin pens now available relays insulin-dosing information to a phone, which then can be used in an app in conjunction with a continuous glucose monitor (CGM) so that patients can look at blood glucose trends resulting from insulin pen injections.

One of the biggest advances in connectivity is with the CGM, a small monitor device worn by a person with diabetes that continually monitors glucose levels. Data from these devices can be read in a variety of ways, including on a pump, in a reader or a receiver device, or even on a phone. Some of the devices still require fingerstick testing for calibration, but the newest CGM devices no longer require any blood sugar testing with fingersticks.

Those using a device that connects with the phone can be connected through the Cloud to other phones so that parents or other caregivers or friends have 24-hour access to the glucose data on their own phone. You might imagine that this could be helpful for parents who can check on sleeping children without pricking fingers. Data can also be used by caregivers who are caring for the child and need input from a parent. And parents can follow older children and teens, assuring their safety while still allowing independence.

In addition to technology improvements in blood glucose monitoring, there have been many strides made in insulin pump technology. One company has developed a hybrid closed-loop pump that communicates with a CGM to be able to adjust insulin doses to keep blood sugars close to a target range. This system requires input from the user regarding carbohydrates, and blood sugars must still be tested with fingersticks for calibration. Other companies are working in this direction, using data from the CGMs to adjust insulin using complicated algorithms that adjust for daily insulin need.

Many other pumps on the market at this point can connect, or are close to releasing versions that can connect, to the CGM for data display.

As the future unfolds, we will be seeing more and more technological advances in diabetes that assist patients and families in daily management. Still, there is nothing that takes the place of responsibility for carbohydrate counting and paying attention to the resulting blood sugars. The human brain, when well trained, can do an excellent job of managing diabetes and taking into account the myriad of variables that affect diabetes management on a daily basis.

https://www.medscape.com/viewarticle/900685

‘Still affects our economic situation’: burden of breast cancer, lymphedema

Abstract

Purpose

Financial toxicity after breast cancer may be exacerbated by adverse treatment effects, like breast cancer-related lymphedema. As the first study of long-term out-of-pocket costs for breast cancer survivors in the USA with lymphedema, this mixed methods study compares out-of-pocket costs for breast cancer survivors with and without lymphedema.

Methods

In 2015, 129 breast cancer survivors from Pennsylvania and New Jersey completed surveys on demographics, economically burdensome events since cancer diagnosis, cancer treatment factors, insurance, and comorbidities; and prospective monthly out-of-pocket cost diaries over 12 months. Forty participants completed in-person semi-structured interviews. GLM regression predicted annual dollar amount estimates.

Results

46.5% of participants had lymphedema. Mean age was 63 years (SD = 8). Average time since cancer diagnosis was 12 years (SD = 5). Over 98% had insurance. Annual adjusted health-related out-of-pocket costs excluding productivity losses totaled $2306 compared to $1090 (p = 0.006) for those without lymphedema, or including productivity losses, $3325 compared to $2792 (p = 0.55). Interviews suggested that the cascading nature of economic burden on long-term savings and work opportunities, and insufficiency of insurance to cover lymphedema-related needs drove cost differences. Higher costs delayed retirement, reduced employment, and increased inability to access lymphedema care.

Conclusions

Long-term cancer survivors with lymphedema may face up to 112% higher out-of-pocket costs than those without lymphedema, which influences lymphedema management, and has lasting impact on savings and productivity. Findings reinforce the need for actions at policy, provider, and individual patient levels, to reduce lymphedema costs. Future work should explore patient-driven recommendations to reduce economic burden after cancer.

…

https://link.springer.com/article/10.1007/s00520-018-4418-4

What to Do About the Pre-Existing Conditions Argument

It’s a persistent Democratic talking point. It’s almost always mentioned by opponents of Brett Kavanaugh, Donald Trump’s choice to be on the Supreme Court. It’s the number one argument Democrats make for why they, rather than Republicans, should be trusted with the health care system.

Anyone with a pre-existing condition is at risk, they say. If Republicans have their way and you’re sick, you’ll face higher premiums, skimpier coverage and perhaps no insurance at all.

So, how did Republicans become vulnerable to these kinds of charges? Because they are partly true.

Obamacare is essentially private-sector socialism. Healthy people are forced to pay more than actuarially fair premiums so that sick people can pay less. And virtually every important change to Obamacare made by the Republican Congress and the Trump administration has been designed to give relief to the healthy.

Abolishing the individual mandate, allowing people to join association health plans, making it easier to buy short term insurance not bound by Obamacare regulations – all these measures allow the healthy to escape their unfair premiums. If another run at challenging the constitutionality of the entire Obamacare law is successful, that would also let healthy people escape.

All these changes are good. But if the healthy leave, what happens to the sick?

With fewer healthy people paying into the insurance pool, there is less money to subsidize those who remain. That gives Democrats the opportunity to stoke fear in the minds of anyone with a chronic health condition.

There is a very simple answer to this problem: Any reform of Obamacare – including its complete abolition – must protect the sick.

More on how to do that below. But first a quick review of the bidding – as they say in bridge.

The original aim of Obamacare was to insure the uninsured. It was to make health insurance affordable for almost everybody. But as Chuck Schumer later realized, the uninsured don’t vote. About 95% of people who did vote were already insured. So, commendable as the goal may have been, in creating Obamacare the Democrats were proposing to spend roughly $200 billion a year on people who didn’t plan to reward them at the polls.

Democrats learned this lesson early on. By the time Congress was ready to pass legislation, not a single one of them talked about insuring the uninsured. On the eve of the final vote every single proponent of Obamacare who went on TV to defend it had one and only one talking point: sick people were being abused by insurance companies.

Even today – with almost 30 million people uninsured – you rarely hear a Democratic candidate talk about that fact or propose to do anything about it. They have learned to focus on those who vote.

Now as it turns out, although Obamacare has been reasonably good for many of the uninsured, it has been terrible for most of the chronically ill. Bill Clinton was right. People are paying twice as much for half the coverage. If you earn more than $48,560, you get no subsidy. That means your premiums have doubled and maybe even tripled. Even if you get a subsidy, you face ridiculously high deductibles and unconscionably narrow networks of providers.

Half the counties in the country have only one (that is, a monopoly) insurer. More often than not that insurer is a Medicaid contractor who is offering a plan that looks like Medicaid with a high deductible. That means no access to the best doctors and the best hospitals.

Among people who get no subsidy, the vast majority would have been better off under the old system – before there was Obamacare. For the very few who were denied coverage because of a health condition, in most states there were risk pools. The plans looked like standard Blue Cross plans and Blue Cross was often the insurer. In some cases, the premium was 50% higher than the rates charged in the market, but that’s a whole lot better than premiums that are two or three times as high in the current environment.

There is one more bit of evidence that the chronically ill are worse off under Obamacare. In the first few years before the Obamacare exchanges opened up, there were federally subsidized risk pools in every state. Anyone who was denied coverage in the marketplace could obtain standard health insurance from the risk pool for the same premium healthy people were paying. The result? After several years of operation, enrollment was just over 107,000.

For all but a handful of people, the system was working tolerably well for everyone in the country with a chronic illness.

So how do we get out of the mess we are in while meeting the needs of people with serious health care problems?

Answer: Allow the states to ask for and receive a block grant of Obamacare funds and give them broad authority to reform their individual health insurance markets, provided that people with pre-existing conditions are protected.

Protection for people with health conditions means: Lower premiums, lower out-of-pocket costs and wider networks for chronic patients who are currently insured and paying premiums. It also means progress toward the ultimate goal of insuring that people who have been paying premiums to group plans and become too sick to work have access to individual insurance that is similar in price, quality and access to care – regardless of health condition.

As long as the states do this, they can be given the freedom to do almost anything else they want to do. And by giving them the opportunity, Republicans can have their cake and eat it too. They can solve the problems of Obamacare, without creating a new class of victims.

https://www.forbes.com/sites/johngoodman/2018/08/14/why-the-pre-existing-conditions-argument-is-killing-republican-candidates/#50b7f79d454f