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Thursday, July 5, 2018

HHS faces tight deadline to reunite migrant kids with parents


HHS will send about 100 immigrant children, ages 4 and under, to stay with their immigrant parents in detention next week to meet the first deadline to reunify families separated under the Trump administration’s “zero tolerance” policy for people accused of entering the U.S. illegally, according to HHS Secretary Alex Azar.
Azar on Thursday criticized last week’s court order mandating the tight timeline, telling reporters in a news briefing that the arbitrary deadline fails to account for the complicated processes in place.
HHS has faced increasing strain over the last month as part of the sprawling network of state and federal agencies involved in the current immigration issues.
To try to speed up the process of unification while adequately vetting parent-child relationships, HHS is using DNA swabs to verify children’s parents, Azar said. The department so far has not sent any kids to their parents in detention. Per the California federal court’s injunction, HHS’ Office of Refugee Resettlement (ORR) has until Tuesday to reunite kids age 4 and under with their parents or guardians. Many of those children are detained in Immigration and Customs Enforcement facilities, Azar said. The department has until July 26 to release the rest, ages 5 to 17.
Meanwhile, the Department of Homeland Security, which has jurisdiction over ICE, is also moving parents of children 4 and under to detention centers close to the ORR facilities where their kids are being kept, Azar explained, “in order to speed the process.” HHS has contracts with permanent facilities in at least 15 states.
Fewer than 3,000 kids fall under the court’s injunction, according to the secretary, although he characterized the estimate as a moving target because HHS officials are counting all unaccompanied minors who said that they were separated from their parents at some point on their journey to the U.S., but not necessarily at the point of entry. The grantee facilities who contract with HHS to care for immigrant minors currently have custody of about 11,800 kids under 18.
The costs of the system, in the meantime, are more nebulous.
Of the $1.86 billion appropriated by Congress in fiscal 2018 for refugee and entrant assistance, $1.3 billion was earmarked for unaccompanied minors. Congress designated $320 million for medical and transitional services, and $155 million for social services.
The congressional appropriation limits transfers among HHS accounts to not more than 3%, but the refugee and entrant assistant account lifts this cap to 10%.
The Administration for Children and Families—which has jurisdiction over the unaccompanied minor program—allocates about 15% of its funding for medical care, background checks and family reunifications, according to its budget justification for fiscal 2019. As of deadline, HHS had not clarified whether this includes expenses such as the DNA testing.
According to the Administration for Children and Families document, 80% of its funding goes to “bed capacity care,” and 5% goes to administrative costs.
The budget justification goes on to note that since HHS assumed responsibility for migrant minors through fiscal 2011, fewer than 8,000 children fell to its care each year. The document chronicles only one spike, in fiscal 2016, when the agency got referrals for 59,000 children that left the Obama administration’s HHS struggling to care for them all with temporary shelters. There was a similar spike in 2014, but the document doesn’t mention it.
From fiscal 2014 through fiscal 2016, the federal funding for the unaccompanied minor program stayed relatively flat, between $912 million to $948 million.
In the first quarter of 2017, when President Donald Trump assumed office, 23,000 unaccompanied minors came into HHS custody, “the highest first-quarter referrals in the history of the program,” according to the budget justification. But the numbers flattened and overall just under 41,000 kids in total entered HHS custody although Congress had boosted funding for fiscal 2017 to $1.4 billion.
Still, as numbers of kids in the program waned, temporary shelters were shuttered and the permanent bed capacity reduced until the number of incoming kids started to pick up again in the last six months of 2017.
Even in years when the congressional funding for the unaccompanied minor program stayed flat, contracts for facilities with custody of the kids increased sharply.
Southwest Key, a not-for-profit with facilities in Texas, California and Arizona, saw their revenue rise from $95 million in fiscal 2013 to $242.8 million, with almost 99% of that coming from grants and contracts. As previously reported by Modern Healthcare, by fiscal 2016 the organization was netting $16.6 million in profit, nearly double the profit from the previous year, and CEO Juan Sanchez’s salary had spiked from $269,000 in 2010 to $1.5 million in 2016, according to tax records.
The company’s contracts for fiscal 2018 will climb to nearly $450 million.
Since 2015, an Indiana-based carrier called Point Comfort Underwriters has processed payment claims for community care for these kids, paying Medicare fee-for-service rates. The company took over from the Veterans Affairs Department, which still processes payment for independent providers of care for migrant adults in DHS and ICE detention.
Point Comfort could not disclose how many claims they process each year for the unaccompanied minor program or their annual spending. The company also could not specify the funding stream. As of deadline, HHS did not clarify those numbers.
The complications could mount once HHS transfers the kids to their parents’ detention centers and as the furor and litigation rage in the fallout of the Trump administration policy.
In addition to the lawsuit that led to the recent court order—originally filed in February by the American Civil Liberties Union on behalf of a Congolese immigrant family—17 Democratic attorneys general have lodged a separate lawsuit that names Azar, HHS, ORR and other departments and administration officials as defendants.
Legal allegations, in addition to citing trauma inflicted by separation of children from parents, include a story from an El Salvadoran women who lost her son in the early days of the separation policy for 85 days.
“When I took off his clothes he was full of dirt and lice. It seemed like they had not bathed him the 85 days he was away from us,” the mother, Olivia Caceres, said in the court filings.
Azar declined to comment on pending litigation.
“I will say it’s important to remember: not every picture you see is a picture of a child in an ORR facility,” Azar said. “Not every reunification is of a child from an ORR facility.”

Melinta started at buy by Cantor


Cantor Fitzgerald analyst Louise Chen initiated coverage with a Buy rating on Melinta Therapeutics Inc (NASDAQ: MLNT) last week and set a price target of $15. The company’s shares previously closed at $6.35, close to its 52-week low of $5.20.
Chen noted:
“. We are initiating coverage of Melinta’s stock with an Overweight rating and $15 PT. Upward earnings revisions and multiple expansion will drive the shares higher, in our view. We think a greater appreciation for the company’s four commercial, antibiotic drugs (Baxdela, and its growing pipeline (new drugs, international expansion, additional indications) will increase earnings estimates to levels not yet reflected in consensus expectations. Also, MLNT is considering adjacent opportunities, which means it could become a diversified hospital company. This should improve its trading multiple, in our view.”

Eisai, Biogen: positive results of final analysis for early Alzheimer’s med


Eisai (ESALY) and Biogen (BIIB) announced positive topline results from the Phase II study with BAN2401, an anti-amyloid beta protofibril antibody, in 856 patients with early Alzheimer’s disease. The study achieved statistical significance on key predefined endpoints evaluating efficacy at 18 months on slowing progression in Alzheimer’s Disease Composite Score and on reduction of amyloid accumulated in the brain as measured using amyloid-PET. Topline results of the final analysis of the study demonstrated a statistically significant slowing of disease progression on the key clinical endpoint after 18 months of treatment in patients receiving the highest treatment dose as compared to placebo. Results of amyloid PET analyses at 18 months, including reduction in amyloid PET standardized uptake value ratio and amyloid PET image visual read of subjects converting from positive to negative for amyloid in the brain, were also statistically significant at this dose. Dose-dependent changes from baseline were observed across the PET results and the clinical endpoints. Further, the highest treatment dose of BAN2401 began to show statistically significant clinical benefit as measured by ADCOMS as early as 6 months including at 12 months. BAN2401 demonstrated an acceptable tolerability profile through 18 months of study drug administration. The most common treatment emergent adverse events were infusion-related reactions and Amyloid Related Imaging Abnormalities. Infusion related reactions were mostly mild to moderate in severity. Incidence of ARIA-E was not more than 10% in any of the treatment arms, and less than 15% in patients with APOE4 at the highest dose per the study protocol safety and reporting procedures.

Moms can put an end to childhood obesity


Hey, mamas, here’s yet another reason to commit to a healthy lifestyle.
Mothers who model healthy choices — eating a good diet, getting regular exercise, keeping your weight down, drinking sparingly and saying no to nicotine — are 75 percent less likely to have obese kids, according to a new study published in the British Medical Journal on Wednesday.
That number shoots up to 82 percent when a mom encourages her children to do the same.
Although that might sound like common sense, the study’s authors at the Harvard T.H. Chan School of Public Health are the first to prove that a mother’s healthy habits can have a direct, measurable impact on her little ones’ weight.
“An overall healthy lifestyle really outweighs any individual healthy lifestyle factors followed by mothers when it comes to lowering the risk of obesity in their children,” study author Qi Sun says.
While the data show that adhering to all five factors is really best, there’s also good news for those who aren’t quite so high-achieving — moms who eat well but can’t bring themselves to go to the gym, for instance.
Just maintaining a healthy body weight alone makes a woman’s children 56 percent less likely to be obese.

What tech giants really do with your data


Tracking your phone’s gyroscope, scanning your messages and giving your data to third-party companies.
These are just three of the things you agree to when signing up to some tech companies’ apps and sites.
BBC research has found some of the language used in privacy policies and terms requires a university education to be understood.
But dig down beneath the jargon, and there are some surprising realities about how your data is used.

1. Your location is tracked – even if you don’t allow it

Many apps ask permission to track your precise location through your phone’s Global Positioning System (GPS), which users can refuse.
But even if you refuse the app permission, they can still see where you are.
Facebook, for example, collects location-related information aside from your phone’s GPS. It still tracks where you are through IP addresses, “check-ins or events you attend”.
Twitter also “requires” information about your current location, “which we get from signals such as your IP address or device settings”. This is so it can “securely and reliably set up and maintain your account”.

2. Companies pass your data to affiliates…

When you agree to terms and conditions, you often don’t just give your data to that specific app – there’s a lot of intra-group data sharing.
For example, the data that dating app Tinder collects is shared with other members of the Match Group, which includes other dating sites OkCupid, Plenty of Fish, and Match.com.
Tinder says it does so for “maintenance, customer care, marketing and targeted advertising”, and to remove users who violate their terms of use.
Elsewhere, LinkedIn was bought by Microsoft in 2016, and according to its privacy policy, receives data “about you when you use some of the other services provided by us or our affiliates, including Microsoft.”

3. …and you’re also bound by third-party terms

If having to read the tech giant’s terms itself wasn’t enough, you might also have to read those of other companies that deal with your data.
Amazon says they may share your information with third parties: as well as their own terms, users should “carefully review their privacy statements and other conditions of use”.
Or, if you use Apple products, your personal data is shared with companies “who provide services such as information processing, extending credit […] and assessing your interest in our products and services”.
The EU’s General Data Protection Regulation (GDPR), which came into force in May, does not order companies to list these third parties in their terms.
However, Ailidh Callander, legal officer at Privacy International, a charity, says this has worrying implications: “It means that companies like data brokers are able to use your location, your interests, your contacts and much more to profile you.
“Privacy policies can be overwhelming, but it is really important to take the time to look not only at what data is being collected and why, but also who it is being shared with (and for what purposes)”, she adds.
Wikipedia, on the other hand, does not share your personal information with third parties for marketing purposes. Their terms also make a point of saying how they “don’t allow tracking by third-party websites you have not visited”.

4. Tinder collects gyroscope data

Sometimes data collection goes beyond name, age and location.
Tinder says that the app collects data from your phone’s accelerometers (for measuring movement), gyroscopes (which measure the angle you’re holding your phone at), and compasses.
It doesn’t, however, say exactly what that data is used for.

5. Facebook keeps your deleted searches…

Facebook offers the option to delete searches from their history, giving the user the impression that records of their searches are wiped clean.
The problem, however, is that they aren’t.
Their data policy states that while search history can be deleted at any time, “the log of that search is deleted after 6 months”.

6. …and tracks you even if you’re off the app

Facebook even tracks what you do when you’re not signed in to it – or when you don’t have an account.
According to its data policy, it works with “advertisers, app developers and publishers”, who can send them information “about your activities off Facebook”, through something called Facebook Business Tools.
These partners “provide information about your activities off Facebook – including information about your device, websites you visit, purchases you make, [and] the ads you see”.
This happens “whether or not you have a Facebook account or are logged into Facebook”.

7. LinkedIn scans your private messages

If you thought private messages were private, think again.
LinkedIn uses “automatic scanning technology on messages”, according to its privacy policy.
Twitter, meanwhile, stores and processes your messages.
It uses data about “whom you have communicated with and when (but not the content of those communications) to better understand the use of our services, to protect the safety and integrity of our platform.”

8. And if you’re under 18, your parents should have read this with you

Apple’s terms say that “children under the age of majority should review this Agreement with their parent or guardian to ensure that the child and parent or legal guardian understand it.”
Yet as BBC research found, to sit through and read their privacy policy and terms would take the average adult more than 40 minutes – let alone the average 13-year-old.
And if reading the privacy policy once wasn’t enough, Amazon invites you back to check again: “Our business changes constantly and our Privacy Notice will change also. You should check our website frequently to see recent changes.”

9. Don’t use your iPhone to make nuclear weapons

Finally, Apple has a line in its UK terms of use telling customers not to use their products “for any purposes prohibited by United States law”.
According to their definition, that includes “without limitation, the development, design, manufacture or production of nuclear, missile or chemical or biological weapons”.

ASCO Updates Clinical Guidelines for HER2+ Breast Cancer


The American Society of Clinical Oncology (ASCO) has updated its clinical practice guidelines on systemic therapy for patients with human epidermal growth factor receptor 2 (HER2)–positive advanced breast cancer.
In 2014, ASCO published evidence-based clinical practice guidelines (J Clin Oncol2014;32:2078-2099) on the optimal management of this population of patients with breast cancer. The goal of this update is to provide oncologists and other clinicians with current recommendations regarding treatment of these patients.
However, after an expert panel identified and reviewed 622 publications, they concluded that no results would change the 2014 guideline recommendations.
The updated guidelines are therefore almost unchanged and were published online June 25 in the Journal of Clinical Oncology.

Key Recommendations

The current recommendations for optimal medical therapy for patients with advanced HER2-positive breast cancer include the following:
  • HER2-targeted therapy–based combinations for first-line treatment should be recommended except for highly selected patients with estrogen receptor–positive or progesterone receptor–positive and HER2-positive disease. In those cases, endocrine therapy may be used alone (type: evidence based; evidence quality: high; strength of recommendation: strong).
  • If disease progresses during or after first-line HER2-targeted therapy, second-line HER2-targeted therapy–based treatment is recommended (type: evidence based; evidence quality: high; strength of recommendation: strong).
  • If disease progresses during or after second-line or greater HER2-targeted treatment, third-line or greater HER2-targeted therapy–based treatment is recommended (type: evidence based; evidence quality: intermediate; strength of recommendation: moderate).
  • Combination treatment with trastuzumab, pertuzumab, and a taxane is recommended for first-line treatment, unless taxanes are contraindicated (type: evidence based; evidence quality: high; strength of recommendation: strong).
  • If disease progresses during or after first-line HER2-targeted therapy, trastuzumab emtansine (T-DM1) is recommended as second-line treatment (type: evidence based; evidence quality: high; strength of recommendation: strong).
  • If disease progresses during or after second-line or greater HER2-targeted therapy but the patient has not received T-DM1, clinicians should offer T-DM1 (type: evidence based; evidence quality: high; strength of recommendation: strong).
  • For those already receiving HER2-targeted therapy and chemotherapy combinations, chemotherapy should continue for approximately 4 to 6 months (or longer) and/or to the time of maximal response, depending on toxicity and in the absence of progression. HER2-targeted therapy should continue after chemotherapy is stopped, and no further change in the regimen is needed until progression or unacceptable toxicities (type: evidence based; evidence quality: intermediate; strength of recommendation: moderate).
  • If a patient finished trastuzumab-based adjuvant treatment 12 months or less before recurrence, the second-line HER2-targeted therapy–based treatment recommendations should be followed (type: evidence based; evidence quality: intermediate; strength of recommendation: moderate).
  • If trastuzumab-based adjuvant treatment is completed more than 12 months before recurrence, first-line HER2-targeted therapy–based treatment recommendations should be followed (type: evidence based; evidence quality: high; strength of recommendation: strong).
  • For hormone receptor–positive and HER2-positive disease, the following may be recommended:
    • HER2-targeted therapy plus chemotherapy (type: evidence based; evidence quality: high; strength of recommendation: strong).
    • Endocrine therapy plus trastuzumab or lapatinib (in selected cases; type: evidence based; evidence quality: high; strength of recommendation: moderate).
    • Endocrine therapy alone (in selected cases; type: evidence based; evidence quality: intermediate; strength of recommendation: weak).
ASCO has also added a qualifying statement: Although clinicians may discuss using endocrine therapy with or without HER2-targeted therapy, most patients will still receive chemotherapy plus HER2-targeted therapy.

Treatment for Brain Metastases

At the same time, ASCO has also updated its 2014 consensus-based guideline recommendations (J Clin Oncol. 2014;32:2100-2108) for the management of brain metastases in patients with HER-2 positive advanced breast cancer.
Once again, after a review of 622 articles, the expert panel found no additional evidence that would warrant a change to the previous recommendations.
The key recommendations include the following:
  • Options for patients with a favorable prognosis and a single brain metastasis include surgery with postoperative radiation, stereotactic radiosurgery (SRS), whole-brain radiotherapy (WBRT with or without SRS), fractionated stereotactic radiotherapy (FSRT), and SRS (with or without WBRT); serial imaging every 2 to 4 months may be used to continue to monitor for local and distant brain failure.
  • Options for patients with a favorable prognosis for survival and limited (two to four) metastases include resection for large symptomatic lesion(s) plus postoperative radiotherapy, SRS for additional smaller lesions, WBRT (with or without  SRS), SRS (with or without  WBRT), and FSRT for metastases greater than 3 to 4 cm. For metastases less than 3 to 4 cm, options include resection with postoperative radiotherapy.
  • WBRT may be offered for patients with diffuse disease/extensive metastases and a more favorable prognosis or symptomatic leptomeningeal metastasis in the brain.
  • Options for patients with a poor prognosis include WBRT, best supportive care, and/or palliative care.
  • For patients with progressive intracranial metastases despite initial radiation therapy, options include SRS, surgery, WBRT, a trial of systemic therapy, or enrollment in a clinical trial.
  • For patients whose systemic disease is progressive at the time of brain metastasis diagnosis, HER2-targeted therapy is recommended.
  • Patients without a known history or symptoms of brain metastases should not undergo routine surveillance with brain MRI.
Several of the authors for both guidelines have disclosed relationships with industry.

HCA to open 24/7 ER in east Houston as Harvey-shut hospital preps for demo


HCA Healthcare’s Gulf Coast Division will open a freestanding emergency services site on July 17, according to a press release.
HCA Houston ER 24/7 will be at 6191 E. Sam Houston Parkway North in the New Forest Crossing shopping center off Beltway 8 near Highway 90. It will occupy a 5,625-square-foot space that used to house a CHI St. Luke’s Health-Baylor St. Luke’s Emergency Center location, HCA Gulf Coast spokeswoman Debra Burbridge confirmed.
A ribbon cutting ceremony will be held July 16 from noon to 2 p.m. In addition to emergency physicians, the new center will offer access to on-call specialists, on-site testing and imaging, and direct admission to a hospital if necessary, per the release.
HCA is opening the new ER to help fill a gap left when East Houston Regional Medical Center closed.
“The Gulf Coast Division is committed to providing emergency services in the east Houston area and has been for more than 40 years,” Gulf Coast Division President Troy Villarreal said in the release. “Unfortunately, Hurricane Harvey destroyed East Houston Regional Medical Center, leaving many people in the area without a nearby, easily accessible place to seek medical attention in case of an emergency.”
The hospital, at 13111 East Freeway on the Bayshore Medical Center campus, was evacuated on Aug. 25 in preparation for Harvey and was flooded with nearly 6 feet of water during the storm, according to a letter to the Texas Workforce Commission and a press release. The hospital never reopened, and HCA announced in November that it would close for good. Floodwaters from Tropical Storm Allison in 2001 and Hurricane Ike in 2008 also had significantly damaged the hospital, which factored into the decision to close.
Now, demolition of the facility is scheduled to begin in late July, Burbridge told the Houston Business Journal. An exact timeline for the entire process has not been determined. Houston-based Cherry Cos. is working on the demolition.
Pre-demolition work currently is underway and includes removing usable equipment and materials from the hospital, Burbridge said.
HCA Healthcare’s Gulf Coast Division owns the East Houston Regional Medical Center building and its land, but the company is still considering several options for the property’s future, Burbridge said.
According to Harris County Appraisal District records, the hospital’s 6.7-acre property includes 212,117 square feet of buildings, most of which were remodeled in 2016. In 2017, the property was appraised at nearly $27.68 million, but the 2018 appraisal dropped to less than $9.26 million, per HCAD.
HCAD records show two smaller tracts of land also listed at 13111 East Freeway, at least one of which is also owned by HCA. That 1.25-acre tract doesn’t have any buildings listed on it and was appraised at $334,316 for 2018. The third tract has a 31,054-square-foot building on nearly 0.27 acres, and its appraised value dropped from $1.4 million in 2017 to $307,509 in 2018.
HCA Healthcare Inc. (NYSE: HCA) is based in Nashville, Tennessee. A little over a year ago, HCA announced it would buy three Houston hospitals from Dallas-based Tenet Healthcare Corp. and one from Franklin, Tennessee-based Community Health Systems Inc. Those deals made HCA Gulf Coast the largestHouston-area health care system, based on its 4,110 local licensed beds as of September 2017.
HCA Healthcare Inc. reported $43.6 billion in revenue for 2017, up about 5 percent from 2016, according to a filing with the U.S. Securities and Exchange Commission. As of Dec. 31, the company had about 253,000 employees nationwide.