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Friday, August 31, 2018

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.

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.

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

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.

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



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.


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.


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.


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.

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.

Zydus Cadila gets US FDA nod to market 2 products

Drug firm Zydus Cadila today said it has received final approval from the US health regulator to market Gemfibrozil tablets and Aripiprazole orally disintegrating tablets in the US.
The company has received the US FDAs final clearance to market Gemfibrozil tablets in strengths of 600 mg and the other product in strengths of 10 mg, 15 mg, 20 mg, and 30 mg, Zydus Cadila said in a statement. Both the drugs will be manufactured at the groups formulations manufacturing facility at Moraiya, Ahmedabad, it added.
Gemfibrozil tablets are used together with the diet to treat high cholesterol and triglyceride levels in people with pancreatitis, Zydus Cadila said. The drug is also used to lower the risk of stroke, heart attack or other heart complications in people with high cholesterol and triglycerides, who have not benefited from other treatments, it added.
Aripiprazole is an atypical anti-psychotic. The drug is used to treat certain mental/ mood disorders, such as bipolar disorder, schizophrenia, Tourettes disorder, and irritability associated with autistic disorder, Zydus Cadila said.
It may also be used in combination with other medication to treat depression, it added. The group now has 215 approvals and has so far filed over 330 abbreviated new drug applications (ANDAs), Zydus Cadila said.

Abbott Laboratories 401(k) program to help employees who have student debt

A new perk at Abbott Laboratories that helps employees save for retirement even as they pay down student debt has caught the attention of a national employer group that is asking the government to clear the way for more companies to offer a similar benefit.
Abbott had sought and received the blessing of the Internal Revenue Service for a program that would allow workers who direct a certain amount of their paycheck toward student loan repayments to still get an employer contribution in their 401(k) retirement accounts, even if the workers don’t contribute themselves.
On Wednesday, the ERISA Industry Committee, which advocates on behalf of large employers regarding benefit plans governed by the Employee Retirement Income Security Act, sent a letter to the IRS commending the agency for its ruling. The IRS did not name the company when it publicly released its ruling in August, but Abbott confirmed it was the employer that had requested and received the ruling.
Because the IRS ruling applied only to Abbott, the ERISA group wants the agency to issue a broader ruling that would make the guidance generally applicable, a move that could encourage more employers to implement similar programs.
“Many employers recognize the burden that student loan debt can have on their workers’ ability to save for retirement and would like to help these workers,” Will Hansen, senior vice president of retirement policy for the group, wrote in the letter. “However, while we believe that current law allows employers to make contributions to their retirement plans on behalf of workers who repay student loan debt, the IRS has yet to clearly articulate that such contributions will not affect the tax-qualified status of an employer’s retirement plan.”
The IRS declined to comment on whether it was considering issuing broader guidance.
Student loan help has become a hot issue in employee benefits, but many employers who wish to offer it don’t know the best way to go about it, said Jeffrey Holdvogt, a partner in the employee benefits practice at McDermott Will and Emery. Most employers with a student loan perk make monthly cash payments against an employee’s debt to the loan holder, typically about $100 per month, but those payments are taxed.
Abbott’s program is unique because the employer makes a tax-free contribution to an employee’s 401(k) on the condition that the employee make student loan payments. Holdvogt said it was the first time he has heard of the IRS approving of contributions being conditioned on an employee doing something independent of the retirement plan.
The benefit doesn’t generally cost the employer any more, because the company would expect to match an employee’s 401(k) contributions anyway, he said.
The thumbs-up the IRS gave the program “is quite likely to kick-start a lot of interest from other employers and potentially be something that really causes a change in the way employers provide these types of benefits,” Holdvogt said.
The rising cost of college, as well as rising admissions, has caused student debt to triple nationally since 2005. In Illinois, more than 60 percent of students who graduate college have student debt, with an average bill of nearly $30,000, and those struggling to pay it off forgo critical years of saving. College graduates with student loans have retirement assets that are 50 percent lower than their peers without debt by age 30, and it can be difficult to catch up, according to a June report from the Center for Retirement Researchat Boston College.
At Abbott, which started enrolling employees in the voluntary program this month, any U.S. employee who devotes at least 2 percent of his or her paycheck to paying off student loans can get a 5 percent 401(k) contribution from Abbott. That’s the same percentage match given to employees who contribute 2 percent to their 401(k)s. The program will allow people to accumulate savings in their retirement accounts without committing any of their own money.
The medical device manufacturer, which is based in the north suburbs, said a couple of hundred people have signed up for the program so far and it anticipates several thousand will eventually take advantage of it.
“Student loan debt is one of the biggest financial concerns in the U.S. today and we’re thrilled we’ve been able to address this issue for our employees in an innovative, meaningful way,” Steve Fussell, executive vice president of human resources, said in an emailed statement. “We’re proud to be pioneers in this space and hopeful we may have paved a pathway for more companies to help employees with this crushing problem.”
While other companies wishing to offer the same benefit could also request an individual ruling from the IRS to protect them from questions down the road, having broader guidance affirming the legality of the practice would open the door wider, said Holdvogt. The letter from the ERISA industry group is a first step toward pushing the agency in that direction.
“The more interest there is, the more groups submit requests, the more likely it is the IRS will issue guidance,” Holdvogt said. “They want to be helpful.”

Glaxo researcher admits plot to steal secrets to sell in China

A cancer researcher has pleaded guilty to conspiring to steal biopharmaceutical trade secrets from GlaxoSmithKline in what prosecutors said was a scheme to set up companies in China to market them.
Yu Xue entered a guilty plea in federal court Friday to a single conspiracy count.
Prosecutors have described the 48-year-old U.S. citizen as one of the top protein biochemists in the world. She had worked at GlaxoSmithKline’s research facility in suburban Philadelphia for about a decade until charges were brought against her in early 2016.
Prosecutors had accused her of downloading and emailing confidential information and working with four others, including two people in China, charged in connection with the scheme.
During the hearing, Xue said she thought she held a patent for the information and did not understand it was a trade secret.

FDA Warns of Dangers of Liquid Nitrogen in Food, Drinks

You risk serious injury if you consume or handle food and drink products where liquid nitrogen is added just before consumption, the U.S. Food and Drug Administration warned Friday.
These products — which have names such as “Dragon’s Breath,” “Heaven’s Breath” and “nitro puff” — are available in food courts, kiosks, state or local fairs, and other places where food and drinks are sold.
Examples of such products include liquid nitrogen-infused colorful cereal or cheese puffs that emit a misty or smoke-like vapor, and alcoholic and nonalcoholic drinks prepared with liquid nitrogen that emit a fog.
Liquid nitrogen isn’t toxic, but its extremely low temperature can cause severe damage to skin and internal organs if mishandled or consumed, the FDA said in a news release. Inhaling the vapor released by liquid nitrogen in food or drinks can also cause breathing problems, especially among people with asthma, according to the agency.
“The main issue is that liquid nitrogen must be fully evaporated from food or beverage before it is served,” explained Dr. Robert Glatter, an emergency room physician at Lenox Hill Hospital in New York City.
“In liquid form, it can cause burns to the mouth, esophagus and upper airway, leading to perforation or rupture of the organs — which could be deadly,” Glatter said. “It may also cause burns of the fingers or hands when it is handled in the liquid state.”
And people with asthma or lung disease who inhale the vapors might experience constriction of their airways, triggering an asthma attack or worsening of their lung disease, he added.
“Beyond this, it may also lead to inflammation in the lungs and aspiration, which can reduce the ability to breathe, as well as trigger infections such as pneumonia,” Glatter said.
In fact, the FDA said it has received reports of severe and life-threatening injuries caused by liquid nitrogen in food and drinks, and also reports of breathing problems.
“With state fairs upon us, parents and teens need to understand the potential risks of foods such as nitro popcorn and nitrogen-infused cereals, which promise excitement and thrill but may end with a trip to the emergency department,” Glatter noted.
People who’ve suffered an injury after handling or consuming food or drinks prepared with liquid nitrogen should consult a health care provider, and also consider reporting their injury to MedWatch, the FDA’s safety reporting program, the agency said.
More information
The U.S. Food and Drug Administration has more on food safety.
SOURCES: Robert Glatter, M.D., emergency room physician, Lenox Hill Hospital, New York City; U.S. Food and Drug Administration, news release, Aug. 30, 2018

Attention Biotech Investors: September FDA Dates

August was a pretty steady month for biotechs. In terms of new molecular entity or NME approvals, the month was productive, with the FDA giving the go-ahead for seven of these products containing active moieties that haven’t been previously approved by the agency.
Several drug approvals came through this month and the second-quarter reporting season panned out to be a better one for biotechs, with large-caps reporting both earnings and revenue beats.
Now, here are the PDUFA catalysts that could trigger moves in the biotech space in September.
PDUFA dates are deadlines for the FDA to review new drugs. The FDA is normally given 10 months to review new drugs. If a drug is selected for priority review, the FDA is allotted 6 months to review the drug. These time frames begin on the date that an NDA is accepted by the FDA as complete.

Roche Seeks Expanded Use For its Lung Cancer Drug

  • Company: Roche Holdings AG Basel ADR RHHBY 0.55%
  • Type of Application: sBLA
  • Candidate: Tecentriq in combination with Avastin, paclitaxel and carboplatin, or chemotherapy
  • Indication: first-line treatment of non-squamous non-small cell lung cancer, or NSCLC
  • Date: Sept. 5
The application was submitted based on the Phase 3 IMpower150 study, which met the its co-primary endpoints of overall survival and progression-free survival. Tecentriq is currently approved to treat people with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumour has ALK and EGFR mutations.

Will FDA Go Against Panel Verdict And Back GlaxoSmithKline’s COPD Drug?

  • Company: GlaxoSmithKline plc (ADR) GSK 1.78%
  • Type of Application: sBLA
  • Candidate: Mepolizumab
  • Indication: Chronic obstructive pulmonary disease, or COPD, with an eosinophilic phenotype
  • Date: Sept. 7
Mepolizumab is GlaxoSmithKline’s add-on treatment to inhaled corticosteroid-based maintenance treatment for the reduction of exacerbations in patients with COPD, guided by blood eosinophil counts.
FDA’s Pulmonary Allergy Drugs Advisory Committee, which met in late July to discuss the sBLA for the drug, voted against its approval by a 16-3 margin.
Mepolizumab has already been approved by the FDA for treating patients with severe eosinophilic asthma.

No Headaches For Teva’s Migraine Drug?

  • Company: Teva Pharmaceutical Industries Ltd (ADR) TEVA 0.91%
  • Type of Application: BLA
  • Candidate: Fremanezumab
  • Indication: Migraine
  • Date: Sept. 16
The original PDUFA date for Fremanezumab was extended in May by three months. At that time, the company said there was no additional data request from the FDA.
Fremanezumab is a quarterly or monthly injection for the preventive treatment of migraine in adults.

Adamis Seeks Approval For Expanded Use Of Allergy Drug

  • Company: Adamis Pharmaceuticals Corp ADMP 1.79%
  • Type of Application: sNDA
  • Candidate: Low dose Symjepi (epinephrine) injection
  • Indication: Anaphylaxis
  • Date: Sept. 27
Adamis communicated FDA acceptance of its application Feb. 12, 2018.
Symjepi 0.3 mg dosage is already approved for treating Type 1 allergic reactions, including anaphylaxis, in patients weighing 66 pounds or greater. The low dose version, the review of which is pending before the FDA, is of 0.15 mg in strength and is intended to potentially treat patients weighing 33-65 pounds.
Anaphylaxis is a serious life-threatening allergic reaction.

Insmed Awaits Word On Lung Disease Drug After Mixed Panel Vote

  • Company: Insmed Incorporated INSM 8.62%
  • Type of Application: NDA
  • Candidate: Amikacin Liposome Inhalation Suspension, or ALIS
  • Indication: Nontuberculous mycobacterial, or NTM, lung disease caused by Mycobacterium avium complex, or MAC
  • Date: Sept. 28
NTM lung disease is a rare, progressive and potentially fatal disease. FDA’s Antimicrobial Drugs Advisory Committee, which met on Aug. 7 to discuss the safety and efficacy of ALIS, voted 12 to 2 in favor of the therapy.
The committee also voted in favor of the surrogate endpoint of sputum culture conversion used in the Phase 3 COVERT study reasonably predicting clinical benefit.
However, the committee voted against the safety and effectiveness of ALIS in the broadest population of adult patients with NTM lung disease caused by MAC.

Can Second Time Be Charm For Antares?

  • Company: Antares Pharma Inc ATRS
  • Type of Application: NDA
  • Candidate: XYOSTED (testosterone enanthate)
  • Indication: Testosterone deficiency
  • Date: Sept. 29
Following the issue of a complete response letter in October 2017, Antares made a resubmission, which was deemed by the FDA as a complete, class 2 response on March 29, 2018.

Eli Lily Seeks Approval For Migraine Drug

  • Company: Eli Lilly And Co LLY 0.11%
  • Type of Application: BLA
  • Candidate: Galcanezumab
  • Indication: Migraine in adults
  • Date: September (no date provided)
Galcanezumab is a monoclonal antibody that binds to calcitonin gene-related peptide, CGRP, produced in the neurons that plays a key role in the transmission of pain. The candidate is being evaluated as a once-monthly, self-administered injection via auto-injector pen or prefilled syringe.
The BLA submission was based on three studies, namely EVOLVE-1, EVOLVE-2 and REGAIN.

Pfizer’s Lung Cancer Drug Awaits FDA Nod

  • Company: Pfizer Inc. PFE
  • Type of Application: NDA
  • Candidate: Dacomitinib
  • Indication: Non-small cell lung cancer, or NSCLC
  • Date: Sep. (no date provided)
The FDA accepted the NDA for Dacomitinib in April, with the candidate, a pan-human epidermal growth factor receptor tyrosine kinase inhibitor, being evaluated as a first-line treatment for patients with locally advanced o metastatic NSCLC.
Pfizer also said the European Medicines Agency has also accepted the Marketing Authorization Application for dacomitinib for the same indication.

California set to serve healthy, ‘ethical’ food in institutions

California lawmakers on Thursday passed a bill requiring hospitals, healthcare facilities and prisons to offer plant-based meals, saying that even inmates deserve to have healthy and “ethical” meal choices.
The legislation, SB 1138, which passed overwhelmingly, allows patients and prisoners to choose a non-meat option at every meal, regardless of whether they are doing so for health, environmental or personal reasons.

The measure, sponsored by state Senator Nancy Skinner, a Democrat from Berkeley, still requires approval from Governor Jerry Brown to become law. Brown has not said whether he will sign the bill.
The bill would result in “minor costs to California Department of Corrections and Rehabilitation to prepare a plan to implement the provision of plant-base meals on an overall cost-neutral basis,” according to the Assembly Appropriations Committee.
“By guaranteeing access to plant-based food, SB 1138 respects the health, ethical and diet choices of those in hospitals or other institutions who don’t have the option to prepare their own meals,” Skinner said in a written statement.
The lawmaker said serving plant-based meals was also good for the environment, citing a 2014 study in the journal Climatic Change that vegetarian diets were associated with a reduction in food-related greenhouse gas emissions.

Curae, 3 affiliate hospitals in Miss. file for bankruptcy

Curae vows to keep hospitals open while new owner is found.
The health system has accumulated $96 million in liabilities.
Unanticipated EHR costs cited as a one of ‘several factors.’

Curae Health and three affiliated hospitals in Mississippi have filed for bankruptcy protection after claiming more than $96 million in liabilities, the Clinton, Tennessee-based hospital chain announced this week.
The affiliated Mississippi hospitals are: Gilmore Memorial Hospital, in Amory; Panola Medical Center, in Batesville; and Northwest Mississippi Medical Center in Clarksdale, which Curae leases.
Four Mississippi hospitals filed for Chapter 11 in the past week, including unaffiliated Magee General Hospital, which filed last Friday.
Curae said in a media release that the goal of the bankruptcy filing was “to ensure that the communities where these hospitals are located will continue to have access to local healthcare services.”
The not-for-profit health system blamed insolvency on “several factors.”
“Many rural hospitals across the country have faced year-over-year financial challenges due to government funding cuts, unfunded care mandates and other pressures,” Curae said.
“Our hospitals were not immune to these issues and after exhausting other possibilities, the decision was clear that the hospitals could not continue to operate under mounting debt and tightening financial resources,” the statement read.
Those pressures included unexpected expenses related to electronic medical records and a cash crunch that came as vendors demanded payment for outstanding debts.
Curae said the bankruptcy became the only viable course because cost-savings measures were outstripped by “a dramatic decline” in net revenues that came immediately after the hospitals were acquired from Community Health Systems in 2016.
Local media reported that bankruptcy filings made in Nashville showed that Curae Health and the three hospitals have $3.4 million in cash and cash equivalents and $96 million in liabilities. It owes lender ServisFirst $18.8 million. It owes Community Health Systems, which previously owned the three hospitals, $28.6 million.
“The conversion to a not-for-profit system combined with a lower cost structure was unable to keep pace with the dramatic decline in revenue,” Curae said.
Ownership of Curae’s Lakeland Community Hospital in Haleyville, Alabama, was transferred to a local authority this spring and it’s now managed by Java Medical Group. Curae’s fourth hospital, Russellville Hospital in northwest Alabama, has not filed for bankruptcy.


Curae says its 1,245 employees will be paid through the bankruptcy proceedings.
The health system’s Mississippi hospitals “will be sold as going concerns to arms-length third parties who are able to keep them in operation so that they can continue to serve the community.”
“All potential acquirers of the hospitals will have the opportunity to express their interest in acquiring one or all of the hospitals and to bid for them in a fair and open process,” Curae said.
“We have been working with various interested parties to assist them in their review of the hospital(s) and anticipate filing a motion with the bankruptcy court to authorize the sale of the hospitals in the near term. Once the legal process is completed we hope the hospitals will emerge in a stronger financial and market position,” Curae said.
The North Carolina Rural Health Research Program says 87 rural hospitals have closed nationwide since 2010, including five rural Mississippi hospitals since 2013.