Kentucky Becomes First State to Adopt New Medicaid Work Requirement

(THIS ARTICLE IS COURTESY OF TIME NEWS)

 

Kentucky Gov. Matt Bevin announces federal approval of Kentucky's Medicaid waiver in Frankfort, Ky on Jan. 12, 2018
Kentucky Gov. Matt Bevin announces federal approval of Kentucky’s Medicaid waiver in Frankfort, Ky on Jan. 12, 2018
Alex Slitz—Lexington Herald-Leader/AP

By ALANA ABRAMSON

10:50 AM EST

The state of Kentucky has become the first to adopt the Trump administration’s new policy of imposing work requirements as a precondition of receiving Medicaid benefits.

Consequently, residents of Kentucky who are on Medicaid and considered healthy enough to work, must now comply with certain requirements to receive the health care provided by the government program.

The Trump administration announced on January 11 that states could impose work requirements on Medicaid recipients. One day later, the Center for Medicare and Medicaid Services approved a waiver for Kentucky adopting that new policy for the next five years. Under the program, which officially starts in July, Medicaid beneficiaries between the ages of 19 and 64 who do not meet exemption requirements must complete at least 80 hours per month of “community engagement,” which includes work, school, job skills training, or community service. If they do not complete the requirements, Medicaid eligibility will be suspended. The program exempts several categories of recipients, including pregnant women, those diagnosed as “medically frail,” primary caregivers, and former foster care youth.

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“It will be transformational,” Kentucky Governor Matt Bevin said in an announcement Friday. “Transformational in all the right ways, in good ways, in powerful ways.”

More than 2 million people are on Medicaid in Kentucky, according to the Kaiser Family Foundation, which is nearly one quarter of the state’s population. Kentucky was among the 33 states to adopt the Medicaid expansion program that is a cornerstone of the Affordable Care Act enacted under the Obama administration, but Bevin has been seeking to implement these changes since he was elected in 2015.

Bevin also defended the program from criticism that it was essentially punishing lower income people, and insisted that the program will only impact those who are physically able to work. The recipients of the program who are unable to comply with the new regulations, he said, will remain unaffected.

“This idea that somehow we are punishing people, that this will be a detriment to people I think is a huge huge misunderstanding of what people need,” he said, noting that he himself came from a low-income family. “There is dignity associated with owning the value of something you receive.”

 

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Stop Charging Rape Victims for Post-Assault Medical Care

(THIS ARTICLE IS COURTESY OF ‘CARE2’)

 

Stop Charging Rape Victims for Post-Assault Medical Care

34,075 SUPPORTERS
35,000 GOAL

According to current law, you can be billed for medical treatment you received after a rape. Let’s take a moment to let that sink in. Right now, the government allows hospitals to charge rape victims and their private insurers for additional costs after a rape. Thus one’s emotional trauma can often come with a high financial burden.

Currently, the Violence Against Women Act (VAWA), requires states to pay for rape kits. But there are often extra costs that are passed on to the victim. Pain medication, antibiotics, HIV prevention drugs, emergency contraceptives and other treatments aren’t guaranteed by the VAWA and they are not cheap. In fact, in 2013, women victims of rape paid out nearly 1.26 million dollars to cover extra medical costs. That’s nearly $1000 per person.

In no other instance are victims of violent crimes responsible for footing the bill for injuries the incurred. Rape victims shouldn’t be charged either.

The VAWA is up for reauthorization next year and it is time that Congress put an end to this practice by updating VAWA’s language to ensure all rape-related medical expenses are covered by the state.

Please sign this petition to voice your support for an updated VAWA that covers all rape-related medical expenses are covered by the states.

Dear Congress:

The Violence Against Women Act provides victims of sexual assault, rape and violence with the rights they deserve after such a harrowing experience. Yet, I recently learned that rape victims can actually be billed for the medical treatment they require after an assault. This is not the case for other violent crime victims and it shouldn’t be the case with rape victims. Please rectify this by updating the VAWA to ensure the state covers all rape-related medical expenses a victim may incur.

[Your comments here]

Sincerely,

[your name]

Texas House Passes Bill To Make Women Buy ‘Rape Insurance’

(THIS ARTICLE IS COURTESY OF ‘NEWS.GROUPSPEAK’)

 

The most populous Republican state in the country, the good ole’ state of Texas, has passed a bill in the House of Representatives that will essentially force women to buy rape insurance if they seek to have an abortion.

Critics of the bill are calling it especially cruel and a detriment to women’s health in general. If put into law, the bill will take effect as soon as Dec. 1 and force women to buy supplemental plans if they wish to have abortions, even if induced by rape.

Considering the Senate has already passed a very similar measure, and Governor Greg Abbott has already come out publicly showing his support, it’s only a matter of time before the bill gets signed.

“Women and parents will be faced with the horrific decision of having to purchase ‘rape insurance’ to cover them if they are victimized,” Democratic Representative Chris Turner said in a statement. “This is not only ridiculous, but it is cruel.”

“No woman plans to be raped. No parent plans for their child to be a victim of incest.” The idea that a woman would be forced to consider purchasing for herself – or a parent would be forced to purchase for their child – essentially a rape insurance policy should be abhorrent.”

The bill’s sponsor, Republican John Smithee, says it’s not that simple, though.

“It’s a question of economic freedom and freedom in general. This isn’t about who can get an abortion. It is about who is forced to pay for an abortion.”

By that, he means, he doesn’t want opponents of abortion being forced to subsidize it.

But, looking at it a different way, it will force women to completely absorb the costs of abortion. Every male in Texas with an insurance plan won’t have to pay into the pool of funds helping to support its costs. That will cost women more, which is another way for Texas Republicans to make women’s health care more expensive.

Also – if women don’t buy the supplemental insurance, which many lawmakers are betting that they won’t – it will make getting an abortion that much more unlikely.

“This bill takes us backwards,” said Rep. Ina Minjarez, D-San Antonio. “This bill is about denying Texas women their right to a safe abortion.”

Currently, 10 other states ban private insurance plans from covering abortions. Texas is about to be added to that list.

 

Autism Rates Have Stabilized in U.S. Children

(THIS ARTICLE IS COURTESY OF TIME NEWS)

 

Getty Images

By AMANDA MACMILLAN

January 2, 2018
TIME Health
For more, visit TIME Health.

Rates of autism spectrum disorder among children in the U.S. remained stable from 2014 to 2016, according to new research—a change from previous studies that found steady increases over the past two decades.

The new research letter, published in JAMA, looked at survey responses from a nationally representative sample of more than 30,000 children, ages 3 to 17, and their families. From 2014 to 2016, adults in each household were asked if a doctor had ever told them that their child had autism, Asperger’s disorder, pervasive developmental disorder or autism spectrum disorder. Data from the study was then adjusted to account for differences in people’s age, gender and ethnicity.

The researchers found that in 2014, 2.24% of participating children were reported to have an autism spectrum disorder. That number rose only slightly in 2015 and 2016, to 2.41% and 2.58%, respectively—an increase that was not statistically significant.

Autism rates did vary by sub-group. Over the three-year period, 3.54% of boys were reported to have an autism spectrum disorder, compared to 1.22% of girls. Prevalence was 1.78% in Hispanic children, 2.36% in black children and 2.71% in white children.

The overall estimate for autism prevalence among children in the analysis—2.4%—is higher than another recent estimate, from the Autism and Developmental Disabilities Monitoring (ADDM) Network, of 1.46%. The discrepancy may be explained by differences in study design, the authors note in their report. For example, the new study asked parents if their child has received a diagnosis, while the previous study looked at education and health-care evaluations.

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The current study did not gather information about possible causes for autism and how those factors may (or may not) have changed over time. And, although the survey the researchers used has been going on since the 1960s, the question about autism was changed in 2014—so it cannot be used to estimate change in autism prevalence rates during earlier years.

Several large studies have suggested that autism rates have risen steadily in the last 20 years, but this new report suggests that rates may be leveling off. The ADDM Network’s estimated rates also plateaued between 2010 and 2012 (after increasing roughly 123% between 2002 and 2010), but then jumped 30% from 2012 to 2014.

Changes in diagnostic criteria, an increase in public awareness and more children being referred to physicians have all been suggested as possible causes for the previously documented rise in autism rates, the authors wrote in their report. So have potential changes in genetic and environmental risk factors. “Continued monitoring of the prevalence and investigation of changes in risk factors are warranted,” they concluded.

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North Korea soldier who defected had immunity to anthrax

(THIS ARTICLE IS COURTESY OF THE NEW YORK POST)

 

North Korea soldier who defected had immunity to anthrax

A North Korean soldier who defected to the Southwas found to have antibodies to anthrax — triggering concerns that the rogue regime has weaponized the deadly bacteria, according to reports Tuesday.

The man, who was either exposed to or vaccinated for anthrax, had developed immunity to the deadly disease before defecting, UPI reported, citing local Channel A.

A South Korean intelligence official who spoke on condition of anonymity did not say which of the four soldiers who fled the hermit kingdom this year had the antibodies in his system.

The discovery is causing concern in Seoul because the disease can kill at least 80 percent of those who are exposed to the bacterium in 24 hours — unless antibiotics are taken or vaccination is available.

But South Korea’s military has yet to procure an anthrax vaccine.

Defense Ministry spokeswoman Choi Hyun-soo has said an anthrax “vaccine is expected to be developed by the end of 2019,” but not sooner, UPI reported.

The North Korean rogue regime has been suspected of developing biological weapons after in 2015 publicizing the works of the Pyongyang Biological Technology Research Institute, which is run by the Korean People’s Army Unit 810.

Pyongyang claimed the facility specializes in pesticide research, but analysts have said its dual-use equipment suggests biological weapons are being manufactured in North Korea.

North Korea’s neighbors fear Pyongyang is conducting illegal biological weapons tests to see if anthrax-laden warheads can be loaded onto its missiles, the Sun of the UK reported.

Japan’s Asahi paper recently reported that North Korea — which has demonstrated the theoretical capacity of striking the US mainland with its missiles — had begun to test loading anthrax onto them, the International Business Times reported.

The report said the US is aware of the tests, which are meant to ascertain whether the anthrax bacteria could survive the sizzling re-entry from space.

Seoul believes North Korea has a chemical weapons stockpile of up to 5,000 tons and can produce biological warfare agents such as anthrax and smallpox, according to Bloomberg.

Last week, the White House pointed to the dangers posed by North Korea in the National Security Strategy released by President Trump.

“North Korea — a country that starves its own people — has spent hundreds of millions of dollars on nuclear, chemical and biological weapons that could threaten our homeland,” read the report.

“[North Korea is] pursuing chemical and biological weapons which could also be delivered by missile.”

Pyongyang denied the Asahi report through the state media Korean Central News Agency.

“As a state party to the Biological Weapons Convention (BWC), [North Korea] maintains its consistent stand to oppose development, manufacture, stockpiling and possession of biological weapons,” the KCNA reported.

A North Korean soldier defected to South Korea last week — the second known defection from the North in about five weeks. Another North Korean soldier suffered critical gunshot wounds during a defection dash across the border Nov. 13.

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2-day-old Syrian refugee baby airlifted to Israel for emergency heart surgery

(THIS ARTICLE IS COURTESY OF THE TIMES OF ISRAEL)

 

2-day-old Syrian refugee baby airlifted to Israel for emergency heart surgery

Interior Minister Deri grants entry permits to father and child after Cyprus appeals to Israeli for assistance in treating the 2-day-old

Aviation Bridge officials pose for a photo with a Syrian infant being airlifted to Israel from Cyprus for emergency heart surgery on December 23, 2017. (Courtesy: Aviation Bridge)

Aviation Bridge officials pose for a photo with a Syrian infant being airlifted to Israel from Cyprus for emergency heart surgery on December 23, 2017. (Courtesy: Aviation Bridge)

A 2-day-old baby boy born in Cyprus to a pair of Syrian refugees was airlifted to Israel early Saturday for emergency surgery to repair a life-threatening heart defect.

The baby was born in a refugee camp in Cyprus where his parents had fled to escape the ongoing Syrian civil war. He was diagnosed with a heart defect that the Cypriots were unable to treat.

On Friday, the Cyprus Health Ministry sent an urgent request to Israel’s Ambassador to Nicosia Shmuel Rabel for assistance in saving the infant.

The Foreign Ministry appealed to Interior Minister Aryeh Deri for entry permits for the baby and his father, which were subsequently granted.

A day-old baby with a heart defect was flown overnight from the Cypriot Syrian refugee camp where he was born to Israel for emergency surgery.  (Pictures: Air Bridge)

The Syrian father and son arrived at the Sheba Medical Center in Tel Hashomer early Saturday morning and doctors began prepping the infant for surgery.

“In Cyprus, there is no ability to provide any kind of complex treatment — including heart surgery — for children,” said Sheba children’s hospital deputy director Dr. Itai Pesach in a statement. “The baby is currently in pediatric intensive care and diagnosed with a congenital heart defect.”

The infant is expected to undergo heart surgery on either Sunday or Monday. He will remain in the hospital for “a period of time” to recover, Pesach said.

Pesach added that the Syrian father and son are accompanied by a medical team that speaks Arabic.

Officially, Israel has maintained a policy of non-intervention in the Syrian war and has not taken in any refugees. But the Jewish state has still managed to offer some help to its northern neighbors.

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משרד הבריאות של קפריסין פנה אתמול בדחיפות לשגריר ישראל ,סמי רבאל, וביקש סיועו להטיס בדחיפות ארצה, תינוק בן יומו אשר נולד  בקפריסין עם פגם חמור בליבו.
במשה”ח ציינו בסיפוק את שתה”פ המהיר של כל הגורמים שאיפשרו להציל את התינוק הסורי.
קרדיט- חברת גשר אווירי .

Since early 2013, the Israeli army has taken in some 3,000 wounded Syrians and ill children for treatment. Generally working at night, soldiers have provided initial medical care and then evacuated them to nearby hospitals.

While the numbers are a tiny fraction of the hundreds of thousands of dead and wounded in the six-year Syrian war, both doctors and patients say the program has changed perceptions and helped ease tensions across the hostile border.

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The embryo is just a year younger than the mother who birthed her

(THIS ARTICLE IS COURTESY OF CNN)

 

The embryo is just a year younger than the mother who birthed her

Story highlights

  • Emma Wren Gibson, conceived within a year of her mother, was delivered November 25
  • A “snowbaby” is an embryo frozen and left in storage for possible later birth

(CNN)The longest known frozen human embryo to result in a successful birth was born last month in Tennessee.

Emma Wren Gibson, delivered November 25 by Dr. Jeffrey Keenan, medical director of the National Embryo Donation Center, is the result of an embryo originally frozen on October 14, 1992.
Emma’s parents, Tina and Benjamin Gibson of eastern Tennessee, admit feeling surprised when they were told the exact age of the embryo thawed March 13 by Carol Sommerfelt, embryology lab director at the National Embryo Donation Center.
“Do you realize I’m only 25? This embryo and I could have been best friends,” Tina Gibson said.
Today, Tina, now 26, explained to CNN, “I just wanted a baby. I don’t care if it’s a world record or not.”

Emma Wren Gibson was born November 25.

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Sommerfelt said the birth is “pretty exciting considering how long the embryos had been frozen.” Previously, the oldest known frozen embryo that came to successful birth was 20 years old.
Weighing 6 pounds 8 ounces and measuring 20 inches long, Emma is a healthy baby girl, and that’s the only thought on her parents’ minds.
“We’re just so thankful and blessed. She’s a precious Christmas gift from the Lord,” Tina said. “We’re just so grateful.”
Despite not sharing genes, Benjamin, 33, said that Emma feels completely like his own child. “As soon as she came out, I fell in love with her,” he said.
Emma’s story begins long before the Gibsons “adopted” her (and four sibling embryos from the same egg donor). Created for in vitro fertilization by another, anonymous couple, the embryos had been left in storage so they could be used by someone unable or unwilling to conceive a child naturally.
These are “snowbabies,” lingering in icy suspension, potential human lives waiting to be born.

Infertility and fostering

Seven years ago, the Gibsons married, refusing to allow a dark cloud to shadow their love. “My husband has cystic fibrosis, so infertility is common,” Tina said, adding that they had found peace with it. “We had decided that we were more than likely going to adopt, and we were fine with that.”
Before trying to implant an embryo, they fostered several children and enjoyed doing so.
During a break between fosters, they decided to take a week-long vacation. As they were dropping off their dog at her parents’ house, Tina’s father stopped them.

Benjamin and Tina Gibson with daughter Emma.

“I saw something on the news today. It’s called embryo adoption, and they would implant an embryo in you, and you could carry a baby,” he told his daughter.
“I was like, ‘Well, that’s nice, Dad, but we’re not interested. We’re knee-deep in foster care right now,’ ” Tina recalled with a laugh. “I kind of blew it off. I had no interest in it.”
But during the eight-hour car trip, Tina could not stop thinking about her father’s words. “It was playing in my mind over and over and over,” she said. Hours into her journey, she turned to Benjamin and asked what he thought about “this embryo adoption.” He too had been thinking about it “the whole time.”
Tina started researching on her phone, sharing information with Benjamin as he drove. “I knew everything about it before I got off that vacation,” she said. She knew, for instance, that the National Embryo Donation Center was based in Knoxville, Tennessee, and could facilitate a frozen embryo transfer.
Still, she was not immediately ready. Weeks passed.
“During August of last year, I just came home one day; I looked at Benjamin, and I said, ‘I think we need to submit an application for embryo adoption,’ ” she explained. “On a whim, we filled out an application and submitted that night.”

”It’s a world record!’

By December, she was on medication to do a “mock transfer”: essentially a series of medical examinations to see whether her uterus would be physically capable of receiving an implanted embryo. In January, the tests were complete, and though Tina required a small procedure to remove a polyp from her uterus, she was eligible for implantation.
Next, a home study was performed, said Mark Mellinger, marketing and development director for the National Embryo Donation Center. This part of the process, conducted by a partner organization run by a social worker, is “just the standard home study that mimics any home study that anybody would go through in a traditional adoption process.”
Families who have been approved by the state generally pass the requirements set by the donation center. “Very rarely does a review find a red flag,” Mellinger said.
Finally, the Gibsons were ready for the implantation procedure in March. But they had to choose an embryo, which required viewing donor “profiles” listing the basic genetic information about the genetic parents. “We literally had two weeks to go through 300 profiles,” Benjamin said.
“It was overwhelming,” Tina said. “There was so many, and it’s like, how do you pick?”
The couple started with one small detail just to “narrow it down in an easy way,” she said. Since she and Benjamin are physically small, they began by looking at profiles based on height and weight. “Then we started looking at some of the bigger things, like medical history.
“Long story short, we picked our profile,” Tina said, but that embryo was not viable, so their second choice was used.
Only when they “were fixing to go for the transfer” did her doctor and Sommerfelt explain “It’s a world record!”
“I didn’t sign up for this,” Tina said, laughing.
In fact, no one knows that it’s definitely a record.
“Identifying the oldest known embryo is simply an impossibility,” said Dr. Zaher Merhi, director of IVF research and development at New Hope Fertility Center, which is not involved to the Gibson case. American companies are not required to report to the government the age of an embryo used, only the outcome of the pregnancy, so “nobody has these records.”
Other experts, though, cited the study on a 20-year-old frozen embryo that came to successful birth.
Sommerfelt said she had unthawed three “snowbabies,” all of them adopted from the same anonymous donor. Surprisingly, all three survived. Normally, there’s about a 75% survival rate when unthawing frozen embryos.
Though Keenan transferred all three to Tina, only one implanted. This is normal, since successful implantation rate “normally runs about 25% to 30%,” she said.
The transfer “worked out perfect,” Tina said. “It’s a miracle. First time.”
Problems encountered during pregnancy were due to Tina having a short cervix, which could have prevented her from successfully carrying her baby. That did not happen, and just after Thanksgiving, Tina began 20 hours of labor. All the while, Emma’s heart beat normally.
“So it all just fell into place,” said Tina. “It’s our new normal; it’s crazy to think about it.”

Odds of success

Dr. Jason Barritt, laboratory director and research scientist at the Southern California Reproductive Center, said that only about “15% to 20% of the time there are additional embryos” not used in IVF. Due to the high success rates of the IVF process, which has been scientifically explored in animals for more than half a century, fewer embryos are now created. Louise Brown, the first human resulting from an IVF procedure, was born in July 1978.
“Usually, couples have leftover embryos because they have completed their families and no longer need additional embryos,” Barritt said. His center was not involved in the Gibson case. “They remain frozen until the patient asks for some other disposition.”
Disposition options — what is done with the additional embryos — include simply leaving them cryopreserved in liquid nitrogen storage tanks, disposing of them in an appropriate way, donating them to research or training for the advancement of the field of reproductive medicine, or donating them to another couple.
The final option is rare, Barritt said, “due to a variety of additional steps and guidelines that must be met,” such as infectious disease screening and meeting US Food and Drug Administration donor eligibility regulations, “and significant legal documentation that must be met.”
Mellinger said the National Embryo Donation Center is a faith-based organization founded in 2003. “We say that our reason for existence is to protect the sanctity and dignity of the human embryo,” he said. “We are big advocates of embryo donation and embryo adoption.”
If you want to donate an embryo, it will handle the details for free.
“We will contact the fertility clinic where the embryos are stored, and they are happy to work with us,” Mellinger said. A special storage container is shipped, the fertility center places the embryos inside and sends it to the the donation center, and then the embryos are stored in the lab in Knoxville.
“We will adopt out an embryo whenever,” he said. “Sometimes, embryos have been in storage for a few weeks, maybe a few months. Sometimes, it’s literally been decades.”
The adopting couple pays all the fees, amounting to less than about $12,500 for a first try, according to Mellinger.

Weighing 6 pounds 8 ounces and measuring 20 inches long, Emma is a healthy baby girl.

Recalling the birth of her special daughter, Tina’s voice dissolves into tears.
“We wanted to adopt, and I don’t know that that isn’t going to be in our future. We may still adopt,” she said. “This just ended up being the route that we took. I think that we would have been equally elated if were able to adopt. “
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Asked whether they might try again with the remaining two embryos — Emma’s sisters or brothers — Tina said she absolutely would have said “yes” two months ago.
“But after having natural childbirth, I’m like, ‘I’m never doing that again!’ ” she said. “But I’m sure in like a year, I’ll be like, ‘I want to try for another baby.’ “

Experts Tell Congress How To Cut Drug Prices

(THIS ARTICLE IS COURTESY OF KAISER HEALTH NEWS)

 

Experts Tell Congress How To Cut Drug Prices


(Kaiser Health News)
 December 12 at 5:15 AM
This Kaiser Health News story can be republished for free (details).The nation’s most influential science advisory group will tell Congress today that the U.S. pharmaceutical market is not sustainable and needs to change.

“Drugs that are not affordable are of little value and drugs that do not exist are of no value,” said Norman Augustine, chair of the National Academies of Sciences, Engineering and Medicine’s committee on drug pricing and former CEO of Lockheed Martin Corp.

The report, “Making Medicines Affordable: A National Imperative,” identifies eight steps to cut drug prices. It also provides a list of specific “implementation actions” for various federal agencies, including Congress, the Federal Trade Commission and the U.S. Departments of Justice and Health and Human Services.

Today’s hearing, which is the third in a series by the Senate Health, Education, Labor and Pensions committee, comes as Americans across the political spectrum say lowering the price of prescription drugs is a top priority. Yet, while individual states have passed laws for more transparency and price controls and President Donald Trump has publicly called for lower drug prices, Congress has stalled.

So, will the committee’s recommendations spur action? Kaiser Health News takes the political temperature, talks to experts and rates their chances:

Recommendation No. 1: Allow the federal government to negotiate drug prices

Current law prohibits the U.S. Health and Human Services Secretary from directly negotiating drug prices and the committee says that’s ridiculous.

The committee recommends Medicare and other agencies negotiate which drugs are placed on a list of covered drugs and, when necessary, exclude some drugs. This is not a new idea.

Some states are already restricting high-priced drugs in Medicaid, the state-federal insurance program for low-income Americans. But federal efforts to change Medicare are more complicated.

Just two months ago, top House Democrats introduced another Medicare negotiation bill. But don’t hold your breath, Trump hasn’t responded to multiple letters sent from Rep. Elijah Cummings (D-Md.) — including one after the most recent bill was introduced in late October. That bill hasn’t moved past the health subcommittee.

Subscribe to KHN’s free Morning Briefing.

Recommendation No. 2: Speed approvals of safe and effective generics and biosimilars

This recommendation has a strong ally at the Food and Drug Administration.

Commissioner Scott Gottlieb announced a “drug competition action plan” in June and followed it up two months ago with a new set of policies aimed at speeding the drug approval process for complex generics. More changes are expected too, as Gottlieb wrote in his blog post “if consumers are priced out of the drugs they need, that’s a public health concern that FDA should address.”

But the pharmaceutical world knows which games to play to keep competition at bay. The committee specifically recommends the U.S. Department of Justice and the Federal Trade Commission should watch for anti-competitive tactics, such as pay-for-delay and extending exclusivity protections. The U.S. Supreme Court weighed in on pay-for-delay, saying settlements between brand-name drug makers and generic rivals warranted antitrust review, The total number of these deals has fallen in recent years.

To further encourage generic approvals, Congress could include several proposed bills, such as the so-called CREATES Act, in a final year-end package, said Chip Davis, president of the generics and biosimilars lobby Association for Accessible Medicines.

“People are starting to pay more attention” to anticompetitive patent tactics, Davis said.

Recommendation No. 3: Transparency

The committee takes direct aim at drug prices by saying that Congress should make manufacturers and insurers disclose drug prices, as well as the rebates and discounts they negotiate. It also asks that HHS curate and publicly report the information.

States have taken the lead on price transparency with Vermont the first to pass a law, which requires an annual report on up to 15 drugs that cost the state a lot of money and have seen price spikes. In Congress, Sen. Ron Wyden (D-Ore.), introduced a bill in June that would impose price-reporting requirements on some drugs. It now sits in the Senate finance committee. The pharmaceutical industry has fended off most price disclosure efforts in the past.

Notably, the committee also recommends that nonprofits in the pharmaceutical sector — such as patient groups — disclose all sources of income in their tax filings. That’s a move that would reveal exactly how much the pharmaceutical companies are supporting advocacy groups.

Recommendation No. 4:  Discourage the pharmaceuticual industry’s direct-to-consumer advertising

The U.S. is only one of two developed countries in the world to allow direct-to-consumer pharmaceutical advertising (the other is New Zealand and doctors there have called for a ban). And U.S. taxpayers support the tax breaks with a deduction that politicians have tried to eliminate in the past.

Now, the committee recommends Congress eliminate the tax deduction pharmaceutical companies are allowed to take on direct-to-consumer advertising.

This is an idea that should have wide support. Polls show that most Americans favor banning the ads and federal lawmakers have tried to change the rules on so-called DTC for years. The American Medical Association called for a ban on pharmaceutical advertising directly to patients in 2015, saying there were concerns that the ads were driving up demand for expensive drugs. The FDA provides guidance for the advertising and, in August, FDA Commissioner Gottlieb said he may reduce the number of risks manufacturers must reveal when advertising a medicine.

In a sign of just how entrenched the tax break is in D.C. politics, Sen. Dick Durbin (D- Ill.) introduced a bill last month that doesn’t eliminate the break but takes a step to rein in the advertising. Durbin’s bill would require manufacturers to provide the wholesale price of a drug in their advertisements.

Recommendation No. 5: Limit what Medicare enrollees pay for drugs

The committee ticks off a to-do list for Congress when it comes to what older Americans and those with disabilities are paying for drugs.

Their recommendations include asking Congress to establish limits on total annual out-of-pocket costs for Medicare Part D enrollees and telling Congress to make sure the Centers for Medicare and Medicaid Services efforts to guarantee enrollee cost-sharing is based on the real price of the drug as well as how well the drug works.

Turns out, there is already some limited movement on this one.

Medicare allows negotiations between the corporate insurers and pharmacy benefit managers who help administer the Part D program. CMS announced last month that it is exploring how to pass on the behind-the-scenes manufacturer rebates to patients, though it warns premiums may rise if they make this move.

Recommendation No. 6: Increasing oversight of a very specific federal drug discount program

The committee is stepping into a hot-button political issue by recommending increased transparency and oversight of a program that Congress created in 1992.

The program, known as 340B, requires pharmaceutical companies to sell drugs at steep discounts to hospitals and clinics that serve high volumes of low-income patients. Congress held two hearings this year, questioning who is benefiting from the discounts and the Centers for Medicare and Medicaid Services recently announced it was slashing Medicare reimbursement to some hospitals enrolled in the program.

Hospitals are fighting back, filing a lawsuit over the reimbursement cut. The committee, echoing concerns from House Republicans, recommends making sure the program helps “aid vulnerable populations.”

Recommendation No. 7: Revise the Orphan Drug Act

The committee wants to make sure the 1983 Orphan Drug Act helps patients with rare diseases.

The law, intended to spur development of medicines for rare diseases, provides financial incentives for drugmakers such as seven years of market exclusivity for drugs that treat a specific condition that affects fewer than 200,000 people.

The program has been under fire this year after Kaiser Health News, whose investigation is cited by the committee, reported that approved drugs often gamed this system and won won blockbuster sales for more common diseases. The Government Accountability Office has begun an investigation into the program after receiving a request from top Republican senators and FDA’s announced a “modernization” plan for the agency this summer.

The committee’s requests include limiting the number of exclusivity periods a drug can receive and making sure drugs that win the financial incentives really do treat rare disease. Finally, the committee says HHS should “obtain favorable concessions on launch prices, annual price increases,” and more.

Recommendation No. 8: Make sure doctors prescribe drugs for the right reasons

Medical practices, hospitals and doctors should “substantially” tighten restrictions on office visits by pharma employees, and the acceptance of free samples, the committee recommends.

This isn’t the first time the national group has recommended controlling drug samples and visits. In 2009, the then Institute of Medicine said doctors and medical schools should stop taking free drug samples. It may have worked — to some extent. A study this year found that academic medical centers that limited visits saw changes in prescribing patterns.

Now, the National Academies committee says doctors in private practice should also stop taking free samples and welcoming pharmaceutical visits. The AMA, which is nation’s largest membership group doctors, supports physicians using samples on a voluntary basis, particularly for uninsured patients.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

India parents: ‘Our baby died after doctors put him in a (Plastic) bag’

(THIS ARTICLE IS COURTESY OF THE BBC)

 

India parents: ‘Our baby died after doctors put him in a bag’

The babies were given to the parents in these plastic bagsImage copyrightASHISH
Image captionThe babies were given to the parents in these plastic bags

A shocking case of doctors in the Indian capital, Delhi, mistakenly declaring a newborn dead sparked outrage and led to the cancellation of the hospital’s licence. BBC Hindi’s Bhumika Rai met the parents at the centre of the ordeal.

Ashish Kumar remembers the morning of 30 November when he was told that his twins were stillborn in vivid detail.

Doctors at the privately run Max Hospital handed him his son and daughter in plastic bags.

“It was heartbreaking but I couldn’t cry because I had to stay strong for my wife,” he told BBC Hindi.

Instead he poured himself into arranging for the funeral of the babies, who had been born prematurely at 23 weeks.

But then came a massive shock.

“We were on our way for the funeral, when my father-in-law realised that one of the babies was moving inside the plastic bag,” he said.

Shock turned to elation as they rushed the infant to another hospital and doctors confirmed he was indeed alive. But then the horror of what had happened to his family started sinking in.

“Max Hospital declared my little boy dead while he was struggling to survive,” he said fighting back tears.

“He was wrapped in five layers of plastic. Nobody can survive without oxygen for that long.” The baby died after a five-day battle to survive.

The babies' grandfather, Kailash (left), says he will never forgive the doctorsImage copyrightASHISH KUMAR
Image captionThe babies’ grandfather, Kailash (left), says he will never forgive the doctors

Mr Kumar’s father Kailash who saw the baby move, said he was struggling to cope with the experience.

“They had put the twins together in one basket. They were not even cleaned. I can’t stop thinking that my grandson who was alive, was kept for hours with my granddaughter, who was stillborn.

“He looked so beautiful – exactly like my daughter. I had a faint hope that he would survive. We were planning the traditional ceremonies to celebrate his birth. But he is gone and all I can now see is a void that will never be filled,” Mr Kumar’s mother Meena said.

‘They never came home’

Mr Kumar said his family had been very excited about the impending arrival of the babies.

“We had no clue that there were any medical complications until 30 November. We took good care of my wife, Varsha, during her pregnancy,” he said.

He added that doctors at Max Hospital did an ultrasound on 29 November and told him that everything was fine.

Mr Kumar says his wife, Varsha, had no medical complications until 30 NovemberImage copyrightASHISH
Image captionMr Kumar says his wife, Varsha, had no medical complications until 30 November

“The hospital said that the babies would need to be kept in a special unit for four days and it would cost 100,000 rupees per day,” he adds.

Mr Kumar did not have enough money to pay the hospital but decided to borrow money from friends.

“Any parent would do that to save their babies. But I am heartbroken and Varsha has been completely inconsolable. My entire family was so excited to welcome the children.

“But they never came home. We never heard their cries. I have come to hate the silence in my house.”

Fight for justice

Delhi’s health minister, Satyendra Jain, announced on Friday that the hospital’s licence had been cancelled.

The organisation had last week fired the two doctors involved in the case.

But Mr Kumar insists that “it’s not enough”.

“The doctors need to be tried in a court. I won’t stop protesting until that happens,” he said.

The BBC’s request for an interview with a representative of the hospital was turned down.

Ashish Kumar says he is struggling to cope with the lossImage copyrightASHISH KUMAR
Image captionAshish Kumar says he is struggling to cope with the loss

Mr Kumar said he is fighting a separate “battle of emotions” at home.

“We had bought toys for them and had decorated the house. I am not sure what to do. I tried to throw the toys away but couldn’t even muster the courage to do that,” he added.

“I will have to live with this pain all my life. I worry if my family will ever be complete.”

Related Topics

Israeli ‘fat-melting’ injection claims to help battle obesity

(THIS ARTICLE IS COURTESY OF THE TIMES OF ISRAEL)

 

Israeli ‘fat-melting’ injection claims to help battle obesity

Jerusalem-based startup Raziel Therapeutics says it has developed an injectable molecule that melts away fat cells

Israel's Raziel Therapeutics says it has developed fat melting chemical molecule (Delpixart, iStock by Getty Images)

Israel’s Raziel Therapeutics says it has developed fat melting chemical molecule (Delpixart, iStock by Getty Images)

The key to fighting obesity is through diet and lifestyle, experts agree. But a new “fat-melting” injection developed by an Israeli startup may help us lose the bulge as we scramble to get our exercise and food schedules in order.

Jerusalem-based startup Raziel Therapeutics says it has developed a medical treatment that melts away fat cells upon delivery of a new synthetic small chemical molecule via subcutaneous injection. Similar medical treatments already exist, but Raziel Therapeutics claims that recent studies show a marked advantage to its product.

The injection is heat-producing, burning fat cells and delaying their regeneration for up to nine months, when another injection is needed. The treatment is safer than surgery, the creators say, but will only be effective long-term if it is part of a broader lifestyle change.

“We feel that we should repeat [the injection] every 9 to 12 months… in order to sustain the effect of the fat reduction,” said Alon Bloomenfeld, the CEO of Raziel in a phone interview. “Of course, it depends on each person.”

The story behind Raziel Therapeutics is a combination of medical research, startup entrepreneurship — and pure accident.

Jerusalem-based Raziel Therapeutics says its fat-busting injection delays fat regeneration for up to 9 months (Pixfly, iStock by Getty Images)

Professor Shmuel Ben-Sasson of Hebrew University was conducting research unrelated to obesity when he realized that a particular treatment was causing test mice to lose weight, their fat cells disappearing. Together with Bloomenfeld, who has a 20-year track record in biomed and high-tech companies, in 2012 he launched a new venture that set up the corporate infrastructure to test and hopefully eventually market the treatment.

The seven-person team is funded by the Israel Innovation Authority, the Van Leer Technology Incubator and Pontifax, a VC firm focused on healthcare-related investments. They are based out of Hebrew University’s Hadassah Medical Center, where Ben-Sasson was working when he made his discovery.

The product — a molecule referred to in their research as a New Chemical Entity — is currently undergoing Phase 2a clinical testing in the US, with 32 patients. Early tests on pigs found that the injection could remove around 40-60 percent of the fat tissue in the area that received the injections, Bloomenfeld said.

“The company is in a position to capture a significant share of a multi-billion-dollar market for clinical and aesthetic applications,” the firm said in a presentation. The first aesthetic application of the drug could be in cutting back on breast fat in men, and the first medical application of the injection could be for lipedema, a potentially painful condition that is often triggered at puberty, pregnancy or menopause in which legs become enlarged due to irregular deposits of fat, the fir said.

Clinical trials conducted on 24 patients in the US showed a 30 to 50 percent reduction in fat around the site of a single, subcutaneous injection.

Jerusalem-based Raziel Therapeutics hopes to capture slice of multi-billion-dollar fat-busting market (iStock by Getty Images)

A New England journal of medicine study released in June showed that in 2015 over ten percent of the world’s population was obese, causing millions of deaths every year. The overall figures represent a doubling of the problem over the past 37 years, with a surge in childhood obesity, with China and India most affected, and a massive increase in body mass index-related diseases.

In Israel, roughly 25 percent of women and 17 percent of men were found to be obese, a 5.4 and 6.2 percent increase from 1980, respectively. Obesity-related medical expenses are estimated to reach $190.2 billionyearly in the US, accounting for roughly 21% of annual medical spending for the whole country, including $14 billion in childhood obesity-related costs alone.

Raziel assumes it has the ability to capture 10% of the markets share in the US for gynecomastia, the benign proliferation of the breast tissue in males, and make a profit of $1,000 per treatment, with a projected annual income of $2 billion in the US and a similar income in the EU. It expects to capture a similar market share for lipedema treatments, with a projected annual income of $1.3 billion in the US and a similar income in the EU, the presentation said.

Bloomenfeld said it is too early to determine the final price of the injections for users. However, the cost of an injection treatment made by Allergan Inc. for double chins is around $1,000-$1,500 per treatment, and an average of 4-5 shots are needed. So to get rid of a double chin, patients today dish out as much as $7,500.

As promising as Raziel’s test results have been, the injection is not by itself a remedy for obesity.

Raziel Therapeutics’s CEO Alon Bloomenfeld (Courtesy)

“It will not work if you don’t change your lifestyle,” said Bloomenfeld. “Of course, you can come and get the treatment every year. But don’t think that this is the best solution for people.”

“They have to cooperate and to… change their life.”

Doctor and endocrinologist Daniela Jakubowicz — who teaches at Tel Aviv University and Virginia Commonwealth University — agrees with Bloomenfeld, and supports injections like these, so long as they work “with diet together.” She said that working in tandem with diet and lifestyle changes, injections like these can help people better fight obesity.

Jakubowicz’s research has focused on key areas connected to obesity, including addiction to carbohydrates and the timing of meals outside of our bodies’ natural rhythms. She said that people who suffer from obesity often have poor breakfast habits, but will consume large amounts of carbohydrates and sugar in the evening, the worst possible time for our bodies to then metabolize them. It’s habits like these, she said, which are “the center of the problem” and need to be changed.

“You can add any drug, but if you don’t do the appropriate diet, no drug, no injection will work.”

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