Legalizing medical marijuana doesn’t curb opioid overdose deaths, study says

Lawmakers and marijuana advocates have argued that legalizing weed to manage chronic paid can help reduce opioid addiction, but researchers at Stanford University's School of Medicine say otherwise.
Health and Science

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FAQ: How Does New Trump Fetal Tissue Policy Impact Medical Research?

The announcement this week that the federal government is changing its policy on the use of human fetal tissue in medical research is designed to please anti-abortion groups that have strongly supported President Donald Trump.

But it could jeopardize promising medical research and set back attempts to make inroads in devastating diseases such as HIV, Parkinson’s and diabetes, U.S. scientists said.

Under the new policy, employees at the National Institutes of Health (NIH) will no longer conduct research with human fetal tissue obtained from elective abortions, after using up any material they have on hand. Officials also immediately stopped funding a multiyear contract at the University of California-San Francisco using human fetal tissue in mice to research HIV therapies.

Federally funded projects at other research institutions using fetal tissue can continue until their grants expire. But renewal for these projects and future proposals will have to go through a newly established ethics review process to receive funding. It’s not clear yet what standards that process will entail or whether such experiments will be able to proceed under government sponsorship.

The change was enthusiastically welcomed by abortion opponents, who have long had fetal tissue research in their sights. Many scientists had a very different view.

Here are a few answers to questions about the issue.

Q: What exactly does fetal tissue research refer to?

Fetal tissue is any tissue or organ obtained from a fetus that was fertilized at least eight weeks earlier. (Anything younger than that is called an embryo.)

The statement from the Department of Health and Human Services referred repeatedly to “human fetal tissue from elective abortions.”

Researchers generally use fetal tissue from elective abortions rather than miscarriages because miscarriages often result from chromosomal or other developmental abnormalities that could make the tissue unsuitable for research.

Q: What is fetal tissue research used for?

These cells are less specialized than adult tissue cells and can be grown readily, making them valuable in research. Fetal tissue has been used in many types of medical research, including the development of vaccines for polio, measles and other diseases, and therapies to treat Parkinson’s, diabetes, rheumatoid arthritis and to prevent the transmission of HIV.

Some researchers graft fetal tissue onto mice, creating “humanized mice” with human blood-forming and immune systems.

Fetal tissue helps researchers learn about birth defects and human tissue development. In recent years, it has been instrumental in understanding how the Zika virus crosses the placenta and affects the development of the human brain, according to a letter to HHS Secretary Alex Azar signed by 70 organizations in December in support of continued fetal tissue research.

Q: Are there rules about using fetal tissue? 

Strict federal rules govern the collection and use of human fetal tissue. It’s against the law for anyone to accept payment for human fetal tissue, except for reasonable amounts associated with acquisition, storage or other costs. There are also provisions that require women who are donating fetal tissue for research to provide informed consent and prohibit physicians from altering the timing or method of an abortion in order to obtain fetal tissue.

Q: Has it always been as controversial as it is today?

Not really. The level of controversy around fetal tissue research waxes and wanes. Human fetal tissue research has been done in the United States since the 1930s, and NIH has been funding this type of research since the 1950s. There was a ban on such funding, however, during part of the terms of Presidents Ronald Reagan and George H.W. Bush. Federal money was restored with bipartisan support in a 1993 bill for the NIH. Among the backers of that effort were some strong abortion opponents, such as Sen. Strom Thurmond (R-S.C.), who argued that the research could help people — like his daughter — with diabetes.

NIH spent $ 115 million on human fetal tissue research in 2018, a tiny fraction of the nearly $ 14 billion it spent on clinical research overall. NIH currently funds roughly 200 projects that use fetal tissue, according to HHS.

Fetal tissue once again became a hot-button issue in 2015 with the release of doctored videos, later discredited, purporting to show Planned Parenthood officials discussing tissue donation policies and reimbursement. Last fall, the Trump administration announced it was conducting a review of all research involving fetal tissue to ensure it was consistent with statutes and regulations governing it.

Q: Aren’t there effective alternatives?

It depends on whom you ask. Opponents of fetal tissue research point to a number of other possible options, including monkey or hamster cells for vaccines as well as blood collected after birth from umbilical cords that are rich in blood-forming stem cells. They also suggest the use of adult stem cells and “organoids” — artificially grown cells that somewhat mimic organs.

“Why do we keep focusing on these archaic models when newer, better alternatives are out there?” asked Tara Sander Lee, a senior fellow and director of life sciences at the Charlotte Lozier Institute, which opposes research using fetal tissue from elective abortion.

She suggested that using tissue from a miscarriage could be an acceptable alternative to using tissue from an aborted fetus because it’s from “a natural death, not an intentional killing of the child.”

The letter from researchers to Azar in December called the idea that other cells could replace fetal tissue “patently incorrect.”

“The study of human fetal tissue provides researchers with incomparable insights into how birth defects arise and how they can be prevented as well as an unparalleled window into the complexity of human tissue development,” the letter said.

Sally Temple, scientific director of the Neural Stem Cell Institute who is a past president of the International Society for Stem Cell Research, said that while these other types of cells hold promise, they aren’t ready for prime time.

“There’s a lot of excitement about using stem cells and talk about how we can use three-dimensional organoids,” said Temple. But organoids don’t have the same cellular arrangement or blood vessel network. “Organoids can’t mimic real tissue,” she said.

“If we’re going to understand how tissues are made in humans, you really have to have access to human tissue,” she added. “It makes you so nervous that scientists aren’t being heard.”

Kaiser Health News

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T.I.’s Sister Died from Cocaine and High Blood Pressure Says Medical Examiner

T.I.’s sister, Precious Harris, had enough cocaine in her system to trigger heart arrhythmia when she crashed her car and later died … according to the Medical Examiner’s report. The Fulton County M.E.’s report says Precious died from…

TMZ.com

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Supreme Court Declines To Hear Military Medical Malpractice Case

The family of a young Navy nurse who died after military doctors allegedly failed to halt massive bleeding following childbirth won’t get a hearing in the nation’s highest court.

The Supreme Court on Monday denied a petition that sought to change what’s known as the Feres doctrine, a long-standing rule that bars active-duty military members from suing the federal government for injuries, including medical malpractice.

The justices declined to discuss the case of Navy Lt. Rebekah “Moani” Daniel, who was 33 in 2014 when she died following a massive postpartum hemorrhage at the Naval Hospital Bremerton, within hours of the birth of her daughter, Victoria.

In court documents, Justice Ruth Bader Ginsburg said she would have granted the petition. Justice Clarence Thomas dissented from the decision, arguing that it was up to the court to reconsider the rule in the absence of a decision by Congress. He noted that the court in recent rulings “twisted traditional tort principles” to allow certain veterans to seek damages for negligence.

“Such unfortunate repercussions — denial of relief to military personnel and distortions of other areas of law to compensate — will continue to ripple through our jurisprudence as long as the Court refuses to reconsider Feres,” he wrote.

Through a lawyer, the nurse’s widower, Walter Daniel, and her daughter, Victoria, now 4, argued that the court should amend the 1950 ruling to allow service members to sue for medical malpractice the same way civilians can.

“Sadly, the justice system remains closed to our family, our colleagues and the families who commit their lives to military service,” Daniel, 39, said in a statement Monday. “Victoria and I won’t have the opportunity to learn what led to Moani’s death, and to ensure others don’t experience the same tragedy.”

Andrew Hoyal, Daniel’s lawyer, said he was “clearly disappointed” at the decision but heartened at the responses from Thomas and Ginsburg.

“We knew from the beginning that this would be a long journey with even longer odds,” he said.

Rebekah Daniel died on March 9, 2014, at the Washington state facility. In a 2015 wrongful death lawsuit, her husband claimed that she died from botched medical care that failed to halt hemorrhaging of nearly a third of the blood in her body.

Daniel, a former Coast Guard officer, disputed the findings of a Navy autopsy that concluded Rebekah Daniel died of “natural” causes possibly linked to a rare, hard-to-prove complication of childbirth.

But that lawsuit and subsequent appeals were dismissed not based on the facts of the case but because of the Feres doctrine, which holds that active-duty members of the military can’t sue under the Federal Tort Claims Act for harm that they incur “incident to service.”

The ruling was last challenged in the high court more than 30 years ago when the justices voted 5-4 to uphold it. That decision drew a scathing dissent from Justice Antonin Scalia, who declared the rule should be scrapped. More recently, Justice Thomas also argued it should be amended.

Since then, however, the court has refused to accept two previous petitions that would have allowed reconsideration. The Daniel request beat the odds. Of the 7,000 to 8,000 cases submitted to the Supreme Court each term, only about 80 are accepted.

Congress has considered amending the Feres rule in the past but stopped short of action. In April, Rep. Jackie Speier (D-Calif.) introduced H.R. 2422, which would allow active-duty service members to sue the government for damages caused by medical malpractice. The bill has been referred to the House judiciary committee.

Daniel said he would continue to work with lawmakers and advocates to change the rule.

“Our case and our fight is over — but it continues for other service members. Moani’s story has generated a groundswell of momentum to correct the injustice of Feres, and now this issue is going all the way to Capitol Hill,” the statement said.

Kaiser Health News

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President Donald Trump announced a new push Thursday for legislation designed to end surprise medical bills that leave Americans saddled with costs for care that they thought were covered by their insurance.
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Trump ‘conscience’ rule for medical providers facing legal challenge in California

Critics are assailing the Trump administration's so-called "conscience" rule that allows health-care providers to refuse medical treatment to people, even in emergencies.
Health and Science

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FDA To End Program That Hid Millions Of Reports On Faulty Medical Devices

The Food and Drug Administration announced it is shutting down its controversial “alternative summary reporting” program and ending its decades-long practice of allowing medical device makers to conceal millions of reports of harm and malfunctions from the general public.

The agency said it will open past records to the public within weeks.

A Kaiser Health News investigation in March revealed that the obscure program was vast, collecting 1.1 million reports since 2016. The program, which began about 20 years ago, was so little-known that forensic medical device experts and even a recent FDA commissioner were unaware of its existence.

Former FDA official Dr. S. Lori Brown said ending the program now is a “victory for patients and consumers.”

“The No. 1 job of the FDA — it shouldn’t be ‘buyer beware’ — is to have the information available to people so they can have information about the devices they are going to put in their body,” Brown said.

FDA principal deputy commissioner Dr. Amy Abernethy and its device center director, Dr. Jeff Shuren, announced the decision to terminate the program in a statement on increasing transparency about the safety of breast implants.

The agency has for years allowed makers of breast implants to report hundreds of thousands of injuries and malfunctions out of the public eye, federal records show.

“We believe these steps for more transparent medical device reports will contribute to greater public awareness of breast implant adverse events,” Abernethy and Shuren said in a Thursday statement. “This is part of a larger effort to end the alternative summary reporting program for all medical devices.”

FDA spokeswoman Angela Stark said the agency will also end “alternative summary reporting” exemptions still in place for makers of implantable cardiac defibrillators, pacemakers and tooth implants. The FDA has said the program was originally designed to allow for more efficient internal review of well-known risks.

The agency said it began winding down the program in mid-2017, revoking many reporting exemptions, including those for saline breast implants and for balloon pumps used inside patients’ blood vessels.

At that point, the agency required device makers with ongoing exemptions to file quarterly reports in its public device-harm database known as MAUDE, short for the Manufacturer and User Facility Device Experience.

Still, FDA data provided to KHN shows that during the first nine months of 2018 the FDA continued to accept more than 190,000 injury reports and 45,000 malfunction reports under the hidden “alternative summary reporting” program.

Ronni Solomon, vice president and chief policy officer of the ECRI Institute, which studies device safety, said the staff uses the FDA’s open data on a daily basis to look for signals that might show heightened risks with a particular device.

“We think it’s really vital for the sake of transparency, for the sake of policy, for sake of science,” she said. “We’re really glad to see this, the sooner the better.”

The agency said its forthcoming data release will be for the alternative summary reports filed before mid-2017. The FDA for years reached agreements with makers of about 100 devices, allowing them to cease public reports of certain types of problems. The agency previously said the agreements and resulting records were available only by filing a Freedom of Information Act request, a process that can take months or even years.

Going forward, device makers will be required to file individual reports describing each case of patient harm related to a medical device.

The FDA has not said it will stop allowing device makers to file other types of device-harm exemption reports that are withheld from the public, such as when there is mass litigation over a device or when a company is submitting reports from an independent device-tracking registry. Nor has a plan been announced to open those records, which contain reports of harm related to pelvic mesh and surgical robots and reports of deaths related to several cardiac devices.

The FDA had granted Covidien, now a division of Medtronic, a long-standing “alternative summary reporting” exemption for its surgical staplers, a device used to cut tissues and vessels and quickly seal them during a variety of surgeries.

In 2016, when just 84 reports of stapler-related harm were disclosed in the FDA’s MAUDE database, almost 10,000 more malfunction reports were sent directly to the FDA’s in-house database, the agency acknowledged.

The device has been subject to numerous lawsuits over patient deaths and grave harm.

Doris Levering alleged in court that a stapler malfunction during liver surgery caused profuse bleeding that left her husband, Mark, 62, with serious brain damage and unable to walk. She applauded the agency’s decision to open the database. “It’s just wonderful to know that this information is going to be out in the open and not covered up,” she said. “Now doctors who need to find the information will be able to find it.”

The surgeon, hospital and device maker have all denied wrongdoing in an ongoing legal case.

The FDA has announced a May 30 advisory board meeting to review the agency’s oversight of surgical staplers.

The FDA will leave in place a newer summary-reporting program that allows makers of more than 5,500 types of devices to send the agency spreadsheets logging device malfunctions. Unlike the “alternative summary reporting” program, device makers will not be allowed to report serious injuries using that approach.

Over the years, the FDA has had an uneven record of disclosing its “exemption” reports to advisers who review the safety of individual devices.

In February, FDA officials presented an advisory panel on gynecological devices with data showing 476 adverse events in 2017 related to a certain type of pelvic mesh. That panel was not briefed on nearly 12,000 reports filed by eight mesh makers in 2017, under a special exemption for lawsuit-related reports, according to an agency spokeswoman and a review of public records.

FDA spokeswoman Deborah Kotz said in an email that those “litigation” summary reports did not contain enough detail for the FDA to determine whether they shed any light on the safety question at hand.

The FDA ultimately took decisive action, though, ordering makers of the type of mesh under review to stop marketing those products, which were used to support sagging pelvic organs.

In late March, after KHN’s investigation landed, the FDA convened another panel to review breast implant-related injuries and a rare form of lymphoma. For that meeting, the agency did provide a full tally of previously unreported injury and malfunction reports related to breast implants.

As of Thursday, though, the agency said it would leave the textured breast implants linked to a rare lymphoma on the market.

Matt Baretich, a Denver-area biomedical engineer who advises health systems on device safety, is eager to examine the hidden reports as they’re released by the FDA.

“I’m really interested to see what information has been hidden so I can go back,” Baretich said. “I may have been looking for that information and not found anything and thought there was not a problem.”

Kaiser Health News

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NBC News

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4.25.19 Lower your overall housing costs; FCC is bad at collecting robocall fines; You don’t own your medical records

Housing is one of the biggest line items in your budget. But if you want to build wealth, keep that in check; The FCC has levied major fines against robocallers. But they haven’t collected much; Unless you live in New Hampshire, you don’t actually own your own medical records.

Learn more about your ad choices. Visit megaphone.fm/adchoices

Watch the video

The post 4.25.19 Lower your overall housing costs; FCC is bad at collecting robocall fines; You don’t own your medical records appeared first on Clark Howard.

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In 10 Years, Half Of Middle-Income Elders Won’t Be Able To Afford Housing, Medical Care

In 10 years, more than half of middle-income Americans age 75 or older will not be able to afford to pay for yearly assisted living rent or medical expenses, according to a study published Wednesday in Health Affairs.

The researchers used demographic and income data to project estimates of a portion of the senior population, those who will be 75 or older in 2029, with a focus on those in the middle-income range — currently $ 25,001 to $ 74,298 per year for those ages 75 to 84.

And it doesn’t look good for that group because of the rising costs of housing and health care. The researchers estimated that the number of middle-income elders in the U.S. will nearly double, growing from 7.9 million to 14.4 million by 2029. They will make up the biggest share of seniors, at 43%.

By 2029, more than half of the middle-income seniors will have annual financial resources of $ 60,000 or less, even if the equity in their homes is included. Projections put the average annual assisted living and medical expenses cost in 10 years at $ 62,000, meaning that a majority of the middle-income seniors then will not be able to afford an assisted living facility.

Middle-income seniors are a group that Beth Burnham Mace, one of the study’s authors, said has been often overlooked when policymakers and legislators think about housing and care for aging Americans.

“The low-income cohort has been taken care of by tax subsidies, while the high-income cohort is largely self-sufficient. But the middle-income seniors have been ignored,” said Mace, who is chief economist at the National Investment Center for Seniors Housing and Care, a nonprofit research group.

The study’s authors said they are probably underestimating the extent of the looming problem. They projected out-of-pocket medical costs of only $ 5,000 a year for seniors.

Deborah Carr, chairwoman of the department of sociology at Boston University who studies aging, noted that Americans “are able to live longer today than they have in the past because of medical technology.” The downside, said Carr, who was not affiliated with the study, is “if they’re living for years with dementia or mobility issues, then they have to pay longer for medical care for the additional years they live.”

Indeed, the researchers projected that 60% of the middle-income seniors will have mobility limitations, while 20% will be considered “high needs,” meaning they have three or more chronic conditions and one or more limitations in activities of daily living, such as bathing or dressing. Eight percent will have some form of cognitive impairment.

Seniors living with mobility limitations, chronic conditions or cognitive impairment are more likely to need care and support such as that offered by an assisted living facility.

But that’s not a reality for many.

In her written response to the Health Affairs study, Jennifer Molinsky, a senior research associate at the Joint Center for Housing Studies at Harvard University, addressed the needs of seniors who decide to stay at home as they age instead of going to an assisted living facility. She said these older Americans face a different set of challenges.

“One of the challenges is that most people don’t live in cities,” Molinsky said in an interview. “And most houses in these areas are single-family detached homes. The infrastructure is not set up for safe walking, so you have to drive. People often give up driving as they age. So these locations can be difficult to provide services to people.”

Molinsky said other issues to consider are making homes more accessible by adding ramps for wheelchairs or wall handles in the shower and the cost of these changes.

The other dire warning of the study: While spouses and middle-age daughters have historically provided the bulk of elder care, that is a less likely option in the future because of changing marriage patterns, lower birth rates and the increasing number of adult children who live far from their parents. Some seniors will need to seek paid care.

The study suggests that policymakers could expand Medicare benefits to include access to a wider range of supportive services, or create a new benefit, “Medicare Part E,” that funds long-term care. However, other attempts to set up such a program have run into resistance among lawmakers because of cost.

While Medicaid is the primary payer of long-term nursing home care, right now the program is available only to low-income seniors. Seniors may become eligible if they impoverish themselves. However, lawmakers could also broaden the Medicaid income eligibility requirements or expand options to include home-based care for those with higher-end incomes.

Some seniors are already turning to creative solutions to address their growing need for affordable housing.

Carr said one innovative option she has seen is the Village to Village Network, a community program that allows seniors to stay in their homes but have access to general support services, such as home repairs, transportation, health care and even social activities.

Co-housing, where seniors share a residence, like in the classic TV show, “Golden Girls,” is another solution, Carr said.

Mace said she hopes the study will spark more conversation between public and private sectors for creative ideas to address the issue of housing the growing number of Americans who will turn 75 or older in the next decade.

Her advice to both those seniors and their children is to openly discuss the issue.

“It is a good idea to sit down and talk about what your plan may be,” said Mace. “Talk about what the financial assets are and the housing options. It’s a worthy topic to talk about, though it can be hard, because it helps to avoid putting both children and parents in difficult situations in the future.”

Kaiser Health News

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RTT – Top Story

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Child Medical Consent Basics

There may come a time when you’re called away from
home—perhaps for work or a family emergency—and you must entrust your child to
a guardian in your absence.

In an event like this, it’s likely you’ll tell the guardian about your child’s medical history and of any precautions they’ll have to take or procedures they’ll have to follow if the child gets sick or injured.

Of course, parents are hardwired with the desire to protect
their children and can sometimes feel uneasy when surrendering their care to
someone else. So, how can you confidently prepare a guardian to manage your
child’s health and well-being when you’re away?

In this post, learn about the importance of a Child Medical
Consent form and the possible outcomes of a situation without one.  

When Should You Use a Child Medical Consent Form?

You should use a Child Medical Consent form when you know you’ll be away from your child for an extended period of time. This could include time you spend away on a business trip, vacation, or caring for a sick family member or time your child spends traveling for a sports tournament, a school field trip, or away at summer camp.

If you’re going to be separated for a full day or more, it’s
recommended you send a Child Medical Consent form to your child care provider
so they are prepared for an emergency medical situation. With this form, your
child care provider will be updated on all of your child’s medical information,
including:

  • The child’s medical history (including health insurance information, medications, allergies, or illnesses)
  • The family doctor’s contact information
  • Any medical treatments that the child care provider is allowed to consent to (e.g. transportation by ambulance during a medical emergency)

A Child Medical Consent is especially important for children
who have pre-existing medical conditions. For example, there are some illnesses
(like anemia, kidney disease, or severe infections) that hinder a person’s
ability to create healthy blood. As a result, this person might require blood
transfusions at some point or on a regular basis.

If your child has a condition that may require special
medical treatment, it’s imperative you grant your child care provider the power
to authorize such treatment in your absence.

What Happens If You Don’t Have a Child Medical Consent?

In many situations, a health care provider cannot provide
medical treatment to a child without the informed consent of a parent or
guardian. The exception is with medical emergencies, in which an emergency
responder will decide if treatment is necessary to prevent death or serious
injury. In this situation, it’s assumed that any reasonable person would also
consent to the treatment.

However, when it comes to non-emergency situations, consent
is generally considered to be an ongoing process. So, a person needs to be
fully aware of the procedures and consequences of a treatment before they
consent to it and they can withdraw that consent at any time if they choose.
That being said, a Child Medical Consent form can be used to inform a health
practitioner whether consent is or is not
given.

For instance, there may be a child diagnosed with Attention
Deficit Hyperactive Disorder (ADHD) who regularly attends behavior therapy and
takes prescribed medication. The child’s parents are going away for a week and
want the child to continue with his ADHD treatment, but they do not want the
child to take any different or new medications while they’re away.

With a Child Medical Consent form, the parents may give a temporary
guardian instruction on how to administer the child’s medication and permission
to bring the child to and from therapy (some establishments do not allow anyone
but the child’s legal guardian to take the child home, so in this case written
permission is necessary). However, the parents can add a clause to the form
that states the guardian is not allowed to pick up new prescriptions or
administer any other medications for the child’s ADHD in their absence.

Without a Child Medical Consent, your child may temporarily be
denied much needed medical treatments or possibly given a treatment that you
don’t agree with.

Conversations to Have with Your Child Care Provider

There are a few questions you may want to ask a potential guardian to ensure they are capable of caring for your child in your absence.

First, you’ll want to know if the person is of legal age to
provide consent (in many places, they’ll have to be at least 18 years old). It
will also help to know whether or not the person shares your moral beliefs and
is genuinely invested in your child’s well-being; this way, you’ll know you can
trust this person to make medical decisions for your child that respect your
wishes.

Once you’ve chosen a temporary guardian, you should explain
the extent of powers granted in the Child Medical Consent. Tell the guardian
exactly what’s expected of them (any treatments that must be administered) and
for how long (the date on which their authority ends).

Going through this information with your child care provider
gives them the opportunity to ask questions they might not have thought to ask.
It can also prepare them to act swiftly and confidently should medical
attention be required.

A Child Medical Consent benefits both the absent parents and
the temporary caregiver: parents can relax knowing their child is being
properly cared for, and caregivers have the information they need to deal with
any medical issues that might arise.

Uphold Your Health Care Standards with a Child Medical Consent

A Child Medical Consent form is an excellent way to
guarantee your child’s health will be properly cared for in your absence. It can
advise a temporary guardian not only of any illnesses, allergies, or medical
conditions your child might have, but also of any medical treatments your child
may need to be healthy. Without a medical consent, your child might not have
access to the health care they need or they might be given a treatment that
goes against your wishes. 

Parents work hard to ensure their kids grow up safe and strong,
whether it be something as simple as making sure their hands are washed or
something more complicated like finding the right medication to treat an
illness. Having a Child Medical Consent can reassure parents who have to be
separated from their children that their hard work will be respected and
carried on by another responsible adult.

The post Child Medical Consent Basics appeared first on LawDepot Blog.

LawDepot Blog

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Maternal Health Week: I Gave Stillbirth At 20 Weeks After Complaining For Weeks, Did I Receive Substandard Medical Care?

Source: Priska Neely / Priska Neely

Black Maternal Health week (April 11-17), founded and led by the Black Mamas Matter Alliance.

My stomach had been hurting all day but I could not possibly be going into labor — I was only at 20 weeks. My water had broken. I had explained these stomach pains to my doctor earlier that month, earlier that week, and even earlier that day. Each time I drove to Beverly Hills for my appointment, I was told I was fine. The bleeding? Just spotting, you’re fine. The cramps? They’re normal, you’re fine. My request to have tests done? “No need, you’re fine.”

Early in my pregnancy, I had begun to wonder if I was receiving substandard medical care. Could my doctor be dismissing me because I was an unmarried, pregnant Black women on Medi-Cal? I was convinced by medical staff that most of my concerns were just typical first-time mother over-worrying. I saw all the upper class Persian women get more attention and face-time with the doctor, while I was getting an average of 10 minutes each visit but I made justifications because I trusted my doctor and his expertise. If this was where many rich women were going for care, I figured I must be in good hands.

My water had definitely broken. When my now husband and I got to the nearest hospital, which was not where I was supposed to deliver, our parents were all there. We were told the baby’s lungs had not fully developed and he would not live outside of my womb. Still, I would have to push. I had to go through the labor and the delivery.

It was not until I delivered the baby, a boy who was stillborn, that I cried. I couldn’t stop screaming the words “no” and “please”. “No” was my disbelief. “Please” was my last appeal to God to change what just happened.

My nurse, an older Black woman, held my hand and treated me with so much care and compassion. My grief would not allow me to hold the baby but she held him for me and pressed him against my chest. I just put my hand on his very small body and held it there, unable to take him into my arms. Today, I wish I would have.

The loss of our first baby was devastating. Seven months later, we found out I was pregnant once again. This time, we switched medical providers.

By month five of my second pregnancy, I was having complications. My new medical staff was checking in with me so frequently that I almost got annoyed. They immediately put me on bedrest. Everyone made me feel like my pregnancy was their priority. It was one of the most difficult periods of my life but the level of care I received gave me hope. It also confirmed for me that although I had previously gone to one of the most coveted medical providers in one of the richest neighborhoods in Los Angeles for my care, I had received racially biased and subpar care.

Despite the excellent prenatal care I was receiving this time around, I spent two months in the hospital before having my son at 27 weeks — an experience that brought me back to the discrimination of my first delivery. I was ignored. I was overlooked. My life and the life of my child were both in danger.

This time, I was told that I couldn’t possibly be having contractions because they weren’t showing up on a monitor. I was feeling such extreme pain that I thought I was dying. After my nurse ignored several of my concerns, I physically grabbed her arms and pulled her down to me and demanded that she check between my legs because the baby was coming.

Alarms went off, nurses were running and a doctor jumped onto my bed and told me she had to stick her hand inside of me to keep my son’s umbilical cord inside. A nurse told me I needed to go under so they could get my baby out immediately. I had little time to think about any of this. I had to give consent although I was unsure and under informed. In seconds, I was unconscious.

I woke up an hour later with a scream. I was in so much pain. I opened my eyes to my mother who informed me that my son was born. “Is he perfect?” I asked. “So perfect.” she responded. Only two pounds and 12 ounces, but perfect.

Today, my son is a beautiful 6 year old who is becoming bilingual, loves dancing, sports and Black people. He has dressed as both Bobby Seale and Malcolm X for Halloween, and throws up the power fist for photos without prompt.

Now, after all of this drama, would you believe I went on to have another baby? Chile…But this time, I knew what my care should look like and that I wanted a full term, safe and happy pregnancy.

My mother had a friend named Rae Jones who ran an organization called Great Beginnings for Black Babies and it was from them that I received so much support and access to resources. I joined the Black Infant Health Program, a California statewide pregnancy education program for Black women, and learned more about my pregnancy and how to advocate for myself. I learned that Black women in America are 2 to 6 times more likely to die from complications of pregnancy and more than twice as likely to lose their babies than white women. My story was just one of many.

Though I did require another surgery to maintain my latest pregnancy, my daughter was born full term with no issues. I then devoted my life to ensuring that other Black women would never have to have three tries in order to get it right. We have so much work ahead of us but there are organizations around the country, most represented in an alliance called Black Mamas Matter, who are fighting to ensure that other Black women don’t experience what I did.

Black mamas, a safe and sacred pregnancy is your birthright and your legacy. Black women were successfully delivering babies back when hospitals wouldn’t even let us in. Connect to doulas and midwives who will assist in making sure your expectations and goals are met. There is a nationwide support system ready to love on you and the life you plan to bring forth. Despite the statistics, we can have the birth experiences that we deserve.

HEAD BACK TO THE BLACKAMERICAWEB.COM HOMEPAGE

Life & Style – Black America Web

BEST DEAL UPDATE:

Kelsey Grammer, Julia Stiles to Star in Medical Thriller ‘The God Committee’

Kelsey Grammer and Julia Stiles are starring in medical thriller “The God Committee.” Austin Stark is directing from his own script. Colman Domingo, Janeane Garofalo and Dan Hedaya are co-starring. “The God Committee” explores the U.S. organ transplant system. The movie follows a donor heart being flown to a New York hospital, where a transplant […]

Variety

FASHION DEAL UPDATE:

Kaiser Permanente Moanalua Medical Center Tops in Obstetrics

HONOLULU — Kaiser Permanente Moanalua Medical Center has been named one of America’s Best Hospitals for Obstetrics by the Women’s Choice Award®. Presented by WomenCertified Inc., this evidence-based designation scored Moanalua Medical Center in the top 17 percent of 2,778 U.S. hospitals offering obstetrics.

The America’s Best Hospitals for Obstetrics distinction is awarded based on the following criteria: low rates of early elective deliveries, high patient safety rankings for reducing infection and complication rates, and rankings above the national average for patient recommendation.

Moanalua Medical Center makes breastfeeding support and education a priority for new mothers. Additionally, the Family Birth Center at Moanalua Medical Center provides coordinated labor and delivery care in a safe and comfortable setting, facilitated by a team made up of the patient’s obstetrician-gynecologist, certified nurse-midwife, neonatologist and other care providers. New mothers and their families enjoy a personalized birth experience with private delivery suites, mother-baby rooms, room service, and labor aids such as a birthing ball and hydrotherapy tub.

“Prenatal and maternity care is essential to the health and well-being of mothers and their babies,” said Mabel Wong, MD, chief of obstetrics and gynecology at Kaiser Permanente Hawaii. “We’re grateful to be recognized by the Women’s Choice Award for promoting safe, patient-centered maternity care that revolves around mother and child.”

America’s Best Hospitals for Obstetrics combines national accreditations, Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey results and hospital outcome scores with primary research about women’s health care preferences. It is the only award recognizing excellence in obstetric services based on robust criteria that consider female patient satisfaction and clinical excellence.

About Kaiser Permanente

Kaiser Permanente is committed to helping shape the future of health care. We are recognized as one of America’s leading health care providers and not-for-profit health plans. Founded in 1945, Kaiser Permanente has a mission to provide high-quality, affordable health care services and to improve the health of our members and the communities we serve. We currently serve more than 12.2 million members in eight states and the District of Columbia. Care for members and patients is focused on their total health and guided by their personal Permanente Medical Group physicians, specialists and team of caregivers. Our expert and caring medical teams are empowered and supported by industry-leading technology advances and tools for health promotion, disease prevention, state-of-the-art care delivery and world-class chronic disease management. Kaiser Permanente is dedicated to care innovations, clinical research, health education and the support of community health. For more information, go to: kp.org/share.

About the Women’s Choice Award®

The Women’s Choice Award sets the standard for helping women to make smarter choices for themselves and their families. The company and its awards identify the brands, products and services that are most recommended and trusted by women. The Women’s Choice Award is the only evidence-based quality designation that drives consumer and patient appreciation through education, empowerment and validation. Additionally, they recognize those that deliver a recommendation-worthy customer experience. Visit www.WomensChoiceAward.com to learn more.

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NEW PARENT ESSENTIAL UPDATE:

Hidden FDA Reports Detail Harm Caused By Scores Of Medical Devices

Dr. Douglas Kwazneski was helping a Pittsburgh surgeon remove an appendix when something jarring happened. The surgical stapler meant to cut and seal the tissue around the appendix locked up.

Kwazneski later turned to the Food and Drug Administration’s public database that tracks medical device failures and “there was nothing,” he said. Yet when he surveyed leading surgeons on the matter, he discovered that more than two-thirds had experienced a stapler malfunction, or knew a peer who did. Such failures can have deadly consequences.

Kwazneski had no idea the FDA had quietly granted the makers of surgical staplers a special “exemption” allowing them to file reports of malfunctions in a database hidden from doctors and from public view.

“I don’t want to sound overdramatic here, but it seemed like a cover-up,” said Kwazneski, who practiced in Pasco County, Fla., from 2016 through earlier this year.

After Dr. Douglas Kwazneski witnessed a surgical stapler malfunction, he surveyed leading surgeons and discovered that more than two-thirds had experienced a stapler malfunction, or knew a peer who did.(Kendra Stanley-Mills for KHN)

The FDA has built and expanded a vast and hidden repository of reports on device-related injuries and malfunctions, a Kaiser Health News investigation shows. Since 2016, at least 1.1 million incidents have flowed into the internal “alternative summary reporting” repository, instead of being described individually in the widely scrutinized public database known as MAUDE, which medical experts trust to identify problems that could put patients in jeopardy.

Deaths must still be reported in MAUDE. But the hidden database has included serious injury and malfunction reports for about 100 medical devices, according to the FDA, many implanted in patients or used in countless surgeries. They have included surgical staplers, balloon pumps snaked into vessels to improve circulation and mechanical breathing machines.

An FDA official said that the program is for issues that are “well-known and well-documented with the FDA” and that it was reformed in 2017 as a new voluntary summary reporting program was put in place for up to 5,600 devices.

Yet the program, in all its iterations, has been so obscure that it is unknown to many of the doctors and engineers dedicated to improving device safety. Even a former FDA commissioner said he knew nothing of the program.

KHN pored over reams of public records for oblique references to reporting exemptions. After months of questions to the FDA, the agency confirmed the existence of reporting-exemption programs and thousands of never-before-acknowledged instances of malfunctions or harm.

Amid the blackout in information about device risks, patients have been injured, hundreds of times in some cases, lawsuits and FDA records show.

“The public has a right to know about this,” said Dr. S. Lori Brown, a former FDA official who accessed the data for her research. She said doctors relying just on the public reports — and unaware that many incidents may be omitted — can easily reach the wrong conclusion about the safety record of a particular device.

The FDA has also opened additional — and equally obscure — pathways for device makers to report thousands of injuries brought to light by lawsuits or even deaths that appear in private registries that medical societies use to track patients. Those exemptions apply to risky and controversial products, including pelvic mesh and devices implanted in the heart.

FDA spokeswoman Deborah Kotz confirmed that the “registry exemption” was created without any public notice or regulations. “Any device manufacturer can request an exemption from its reporting requirements,” she said in an email.

I don’t want to sound overdramatic here, but it seemed like a cover-up.

Dr. Douglas Kwazneski, surgeon

Agency records provided to KHN show that more than 480,000 injuries or malfunctions were reported through the alternative summary reporting program in 2017 alone.

Alison Hunt, another FDA spokeswoman, said the majority of device makers’ “exemptions” were revoked that year as a program took shape that requires a “placeholder” report to be filed publicly.

More than a million reports of malfunctions or harm spanning about 15 years remain in a database accessible only to the FDA. But with the agency’s new transparency push, the public may find a public report and submit a Freedom of Information Act request to get information about incidents. A response can take up to two years.

The long-standing exemption program “has allowed the FDA to more efficiently review adverse events … and take action when warranted without sacrificing the quality of our review or the information we receive,” Hunt said in an email.

Madris Tomes(Courtesy of Madris Tomes)

To those outside the agency, though, the exceptions to the reporting rules are troubling. They strike Madris Tomes, a former FDA manager, as the agency surrendering some of the strongest oversight and transparency powers it wields.

“The FDA is basically giving away its authority over device manufacturers,” said Tomes, who now runs Device Events, a website that makes FDA device data user-friendly. “If they’ve given that up, they’ve handed over their ability to oversee the safety and effectiveness of these devices.”

Doctors, like Kwazneski, who have turned to the public data to gauge the risks of surgical staplers have seen little. He wrote about the “unacknowledged” problem of stapler malfunctions in a 2013 article in the journal Surgical Endoscopy. In 2016, while reports of 84 stapler injuries or malfunctions were openly submitted, nearly 10,000 malfunction reports were included in the hidden database, according to the FDA.

Device maker Medtronic, which owns stapler maker Covidien, has been described as the market leader in surgical staplers. A company spokesman said that the firm has used reporting exemptions to file stapler-related reports through July 2017. Ethicon, the other major stapler maker, said it has not.

The public database shows that Medtronic has reported more than 250 deaths related to staplers or staples since 2001.

Mark Levering, 62, nearly lost his life after a stapler malfunction early last year, according to a lawsuit filed by his family. His surgeon has testified that a surgical stapler misfired during his liver surgery at ProMedica Toledo Hospital in Ohio.

Staff performed CPR for 22 minutes while surgeons rushed to suture the severed vein. He emerged from a coma unable to walk or consistently recognize his wife and son. The surgeon, hospital and device maker Covidien have denied allegations of wrongdoing in an ongoing legal case.

Told of the reporting “exemption” for surgical staplers, his wife, Doris Levering, was incredulous.

“Why would this information not be made available to doctors? The true information — I mean the actual numbers …” she said. “People’s lives are at stake. Mark’s life will never be the same.”

Doris Levering says her husband, Mark, underwent a procedure to remove an abscess from his liver and ended up in a coma for weeks.(Heidi de Marco/KHN)

Phil Levering (left) says his father, Mark Levering, used to have a calm demeanor but now exhibits signs of aggression due to a brain injury he suffered after a surgery gone wrong. (Heidi de Marco/KHN)

Doris Levering holds a photograph of her and her husband predating his surgery. Levering says it’s clear that the man who used to tend to stray cats and enjoy dinner out with his family is gone. “People’s lives are at stake. Mark’s life will never be the same,” she says.(Heidi de Marco/KHN)

The Stapler Problem

The sheer number of malfunctions made surgical staplers an easy pick for the new alternative summary reporting program at its inception nearly 20 years ago, according to Larry Kessler, a former FDA official and now a University of Washington health services professor.

Surgical staplers have a unique ability to help — or harm — patients. The device is designed to cut and seal tissues or vessels quickly, often during minimally invasive surgeries. When it fails to seal a major blood vessel, medical staff can quickly shift into “code blue” mode to rescue a patient from bleeding to death.

The severity of some of the injuries caught former FDA official Brown’s attention in the early years of its reporting exemption. Her 2004 article on stapler mishaps, published in the Journal of the American College of Surgeons, accounts for one of the few places in public records where an FDA authority mentions the “alternative summary” program. She found that in the first 28 months of filing to the hidden database, stapler makers filed more than 5,100 reports of malfunctions or injuries.

Mark Levering, now 62, was in a medically induced coma and had several surgeries after a surgical stapler malfunctioned during a Feb. 17, 2018, liver surgery. His wife, Doris Levering, said in a deposition that he did not open his eyes after the initial surgery until March 13.(Courtesy of Doris Levering)

She also noted that the publicly reported 112 stapler-related deaths in patients aged 22 to 91 from 1994 to 2001 were a “reason for concern.”

In the public data filed since, it would appear that the staplers rarely misfire. In 2011, only 18 injury or malfunction reports were filed publicly. Last year, the number was 79.

Lawsuits detail how quickly a stapler failure can turn a smooth surgery into a catastrophe.

In Michigan, Eugene Snook’s surgeon was in the process of removing part of his lung when he cut but couldn’t seal a major vessel due to a “stapler malfunction,” the surgeon said in sworn court testimony. Snook, then 59, had no detectable blood pressure for four minutes during the 2012 surgery.

The damage to Snook’s artery was so great, his surgeon decided to remove his lung completely, medical records filed in court say. Snook sued stapler maker Covidien, which in court records said there was no proof the stapler was unsafe when it left Covidien’s control and also that the surgeon used it improperly. The case reached a confidential settlement in 2017.

Another surgeon attempting to remove a benign liver growth from April Strange, 33, in 2013, testified that a stapler malfunction caused the woman to bleed to death. Strange, of central Illinois, left behind a husband and two daughters, then 6 and 8.

The stapler was thrown out after surgery, court records say. Covidien argued in court records that Ryan Strange couldn’t prove that the stapler had a specific defect.

Covidien reached an agreement to settle the family’s claims for $ 250,000, part of a larger settlement in the case.

Doctors initially thought Mark Levering had liver cancer. So when the diagnosis came back as an abscess that needed to be surgically removed last February, it came as a relief to his wife, Doris.

That relief turned to dread the day of surgery. The procedure was supposed to last two hours, she said. But the surgery hit a snag when the stapler “misfired,” according to the surgeon, causing so much bleeding that the minimally invasive procedure was converted to an open procedure so the doctor could suture the vein.

Levering underwent CPR for 22 minutes. A code blue was called, a nurse testified. Levering lost 3 quarts of blood — about half the blood in his body. He was put on life support and would remain in a coma for weeks.

After Levering reopened his eyes, it was clear that the man who used to tend to stray cats and enjoy dinner out with his family was gone. Levering could no longer walk, comb his hair or recognize the letters of the alphabet.

Doris and Mark Levering have sued the doctor, hospital and surgical stapler maker, alleging that the device caused Mark’s bleeding and brain injury. The surgeon has acknowledged in sworn testimony that the stapler malfunctioned, but denied other wrongdoing. The hospital said in a legal filing that its actions were “prudent, proper” and “lawful.”

Covidien denies any defect with the stapler or that it caused Levering’s injuries. A spokesman for parent company Medtronic declined to comment further on any lawsuit but said that “we always make patient safety our top priority” and that the company complies with FDA requirements.

The company’s reports of stapler problems in the public database remain relatively low. But in 2018, with the reporting exemption gone, a spike of reports emerged for Covidien’s staples — not to be confused with staplers. While Medtronic reported 1,000 staple malfunctions or injuries in 2015, the number soared to 11,000 for 2018.

Rolling Out The Program

The alternative summary reporting program started two decades ago with a simple goal: to cut down on redundant paperwork, according to officials who were at the FDA at the time.

Kessler, the former FDA official, said the program took shape after scandals over under-reporting of device problems spurred changes allowing criminal penalties against device companies.

Soon, thousands of injury and malfunction reports poured into the agency each month, with about 15 staff members dedicated to reviewing them, Kessler said. Many reports were so similar that reviewing them individually was “mind-numbing.” Kessler went to the FDA’s legal department and to device manufacturers to propose a solution.

Device makers would be able to seek a special “exemption” to avoid reporting certain complications to the public database. The manufacturers would instead send the FDA a spreadsheet of injury or malfunctions each quarter, half-year or year.

That way, Kessler said, reviewers could quickly look for new problems or spikes in known issues. When the program launched in 2000, the list of exempted devices was made public and only a few devices were involved, Kessler said.

“I don’t know why it’s not [made public] now,” he said. “I’m surprised about that.”

Starting in September, KHN filed Freedom of Information Act requests for “exemption” agreements and reports for several medical devices. Health and Human Services officials denied an appeal to provide some of the records quickly, concluding there was no “compelling need” for haste. For one request, the records were estimated to arrive in 22 months.

The FDA did provide some top-level data. It shows that from 2014 through 2017, the overall number of alternative summary reports filed by device makers rose from 431,000 to 481,000.

The FDA declined to provide a complete list of “about 100” devices that have been granted reporting exemptions over the years, but confirmed that exemptions have been used for mechanical breathing machines and balloon pumps, known as intra-aortic balloon pumps, inserted in the vessels of people with circulation problems.

An FDA spokeswoman said “alternative summary” exemptions remain in place for pacemaker electrodes and implantable defibrillators.

Matthew Baretich, a biomedical engineer in the Denver area, said he helps several area health systems analyze device-related patient injuries and make equipment-purchasing decisions.

He said he regularly scans the FDA’s public device-injury reports. Asked about “alternative summary” reports, he said, “I’ve got to tell you, that’s a new term to me.”

Bruce Barkalow, president of a Michigan-based biomedical engineering firm, said he’s the guy government officials, attorneys or device makers call if someone gets a pacemaker and dies in the shower three days later.

In an interview, he said he was not aware of the reports, either. He said they may appear to the FDA to be a “nothing burger,” but the data would be meaningful to his forensic investigations.

The ECRI Institute, a nonprofit leader in medical device safety, declined to provide an engineer for an interview. Educating hospital leaders and health providers, the institute issues an annual “Top 10” in medical technology hazards. Its tagline: “Separating fact from fiction in healthcare.”

Among the institute’s “top medical device subject matter experts,” spokeswoman Laurie Menyo said in an email, “none of them had any familiarity with FDA’s Alternative Summary Reporting Program.”

Even Dr. Robert Califf, former FDA deputy commissioner and commissioner from 2015 to 2017, said in an interview that he was unaware of the program. “Never heard anything about it,” he said. “It’s interesting.”

Companies that get the exemptions tend to be very “tight-lipped” about them, said Christine Posin, a former device firm manager and consultant to device companies.

The relative secrecy around the program can give them an advantage, she said. For instance, sales representatives can print out only the public reports of device problems, ignoring what’s buried elsewhere.

That creates a business opportunity to persuade a doctor to try a different device. “‘We have a good product that does the same thing,’” Posin said a sales representative might tell a physician.

Exemptions Multiply

The FDA has spent millions, convened experts and pledged to improve its work in device safety in recent years. All the while, it has quietly opened new avenues for the makers of controversial and risky devices to file injury and even death reports with little public review.

Pelvic mesh is one example. The fabric-like device has long been used to hold up pelvic organs in women experiencing organ prolapse. In 2011, the FDA issued a “safety communication” saying “serious complications” like pain or infection were “not rare.”

The agency soon reclassified the device, ordered safety studies and saw most mesh makers remove the device from the market.

Behind closed doors, though, the agency has since granted pelvic mesh makers a special exemption from reporting injuries to the public, according to the FDA and mesh makers who were asked about the practices.

Under what the FDA calls the “litigation complaint summary reporting” exemption, device makers can file a single placeholder “injury” report. Attached to the summary report, device makers have sent the FDA a spreadsheet with as many as 1,175 reports of patient injuries, based on allegations in lawsuits. 

To someone tallying the overall number of injuries related to pelvic mesh, the report would appear as a single injury. It would take a sharp eye to find the summary report and a special request — taking up to two years to be filled — to get the details on the 1,175 cases submitted directly to the FDA.

According to the FDA, in 2017 alone, eight mesh makers used their exemptions to send nearly 12,000 injury reports to the FDA.

The FDA is basically giving away its authority over device manufacturers. If they’ve given that up, they’ve handed over their ability to oversee the safety and effectiveness of these devices.

Madris Tomes, former FDA manager

Dr. M. Tom Margolis, a urogynecologist in the San Francisco Bay Area and an expert medical witness for those who are suing mesh makers, said a program that might hinder doctors relying on open FDA data to assess the risks of mesh is “horrible” and “unethical.”

“We need to know the good and the bad,” said Margolis, who treats patients in his urogynecology practice. “If you’re trying to hide complications from me, well that’s … wrong, my God, it’s heinous.”

The FDA issued the same kind of exemption to the makers of da Vinci surgical robots months after Johns Hopkins University School of Medicine researchers pointed out that the company was filing a notably small number of injury reports in the public database. Johns Hopkins professor Dr. Marty Makary noted in 2013 that the handful of reports sent to the FDA at the time were signs of a “haphazard” system that is “not independent and not transparent.”

Within months, the FDA allowed the makers of the robots to file a single report, noting that a spreadsheet sent straight to the FDA summarizes about 1,400 injuries alleged in lawsuits, with some injuries dating to 2004. Since then, the device maker has reported smaller batches of 99 and 130 injuries at a time.

Homa Alemzadeh(Courtesy of Homa Alemzadeh)

“This is very frustrating,” said Homa Alemzadeh, an assistant professor of computer engineering at the University of Virginia who is working with MAUDE data to create software to identify errors in real time or before they happen in surgeries performed by robots. She said she was not aware of the reporting exemption.

Under another reporting exemption, the FDA is allowing device makers to report hundreds of death cases in spreadsheets sent directly to the agency.

Under the “registry exemption,” device makers can summarize what they learn from registries that tend to be held by specialty medical societies, and track the use of a certain kind of device, according to FDA spokeswoman Kotz. 

Kotz said the data in registries often falls short of the level of detail that the FDA seeks for the more thorough death reports that device makers are required to file.

Device makers filing such reports include Edwards Lifesciences, which makes the Sapien 3 valve that’s snaked through a vessel and implanted in the heart. Some hail the device as a breakthrough for saving patients from the trauma of open-heart surgery to replace a valve. Others raise concerns over limited data showing how long the valve will last in the body.

The summary reports offer potential patients few answers. Such reports document as many as 297 deaths or 1,800 injuries in a single filing, with virtually no detail readily available to the public. In all, Edwards has filed more than 1,800 Sapien 3 valve patient deaths as summaries since 2016.

Edwards spokeswoman Sarah Huoh said in an email that the FDA mandated the tracking of every patient who has the valve in the registry to provide “comprehensive evidence for device safety.”

“The approval of alternative reporting protects against duplicate reports coming from multiple sources,” Huoh said.

Another device, the MitraClip, is used to attach two flaps in the heart that are allowing blood to flow backward. The device has been controversial, with some scientists saying it is crucial for a certain subset of patients, and others pointing to the harm it can cause to the heart.

The FDA has allowed Abbott Vascular, which makes the MitraClip, to report as many as 347 deaths or 1,000 injuries in a single filing, also shipping the details straight to the agency, FDA records show.

An Abbott spokesman said in an email that the company has done clinical trials with thousands of patients to establish the MitraClip’s safety. He said the exemption was granted because data in the registry was stripped of patient identifiers, making it hard to know whether the company would be filing redundant reports to the FDA.

We need to know the good and the bad. If you’re trying to hide complications from me, well that’s … wrong, my God, it’s heinous.

Dr. M. Tom Margolis, urogynecologist and expert medical witness

Last year, the FDA finalized regulations for yet another summary reporting program. Under the newest system, device makers do not have to seek an exemption or notify the FDA that they’ll be filing a public summary report in MAUDE.

The FDA has deemed the makers of more than 5,600 types of devices eligible to file “voluntary malfunction summary reports.” Among them are some of the riskiest devices the agency oversees, including cardiac stents, leadless pacemakers and mechanical heart valves.

The growing cadre of exceptions to the injury- and death-reporting rules strikes Dr. Michael Carome, director of the Public Citizen Health Research Group, as a retreat by the FDA from making crucial information available for researchers and patients.

“It’s just another example of a flawed oversight system,” he said, “bent toward making it easier for industry rather than making protection of public health the primary goal.”

California Healthline reporter and producer Heidi de Marco contributed to this report.

Kaiser Health News

BEST DEAL UPDATE:

Texas Lawmakers Take Aim At Surprise Medical Bills

A bipartisan group of lawmakers announced plans to address surprise medical bills in a way that would take the “burden” off Texans.

During a press conference Thursday, state Sen. Kelly Hancock, a Republican from suburban Fort Worth, announced he had filed a bill aimed at preventing medical providers from balance-billing patients, among other things. State Rep. Trey Martinez Fischer, a Democrat from San Antonio, is filing a similar bill in the House.

If passed, the legislation would force medical providers and health insurers to mediate payment disputes before they send bills to patients. Hancock said the point of SB 1264 is to take “the burden off of patients.”

“[It] takes it off of their plates completely,” Hancock said.

He highlighted the case of Drew Calver, a public school teacher in Austin whose six-figure hospital bill after a heart attack was featured in a “Bill of the Month” investigation by KHN, NPR member station KUT and CBS. Hancock noted Calver’s bill was reduced after the media attention, but it shouldn’t take such attention for a patient to get a reasonable bill.

Under this legislation, both sides of the payment dispute would settle their issues through an existing balance-bill mediation program. The Texas Department of Insurance program has been successful in lowering medical bills across the state.

The legislation would beef up the program, which addresses surprise balance bills greater than $ 500 from all emergency providers, including free-standing emergency departments and all out-of-network providers working at a network facility.

“This is designed to apply in situations where patients don’t have any choice which facility they go to or which physician is involved in their care,” Hancock said.

The insurance department’s mediation program, historically, had many loopholes and few consumers qualified for help. It was expanded in 2017, though, and more patients have been filing complaints.

For example, in 2014, the department was asked to mediate 686 medical bills. During the 2018 fiscal year, it received 4,445 bills.

Hancock said the program, so far, has saved Texas patients $ 30 million.

Consumer advocates argued the system works only when patients know mediation is an option, however.

Stacey Pogue, a senior policy analyst with the Center for Public Policy Priorities, said patients don’t always know help is available or they find the process intimidating.

“The instructions for how to do it are on your medical bill and your explanation of benefits — the most indecipherable documents you are going to get,” she told KUT earlier this year.

She and others have argued Texas should adopt a program similar to those in states like New York, California and Florida, whose systems are more consumer-friendly.

Martinez Fischer said it’s time Texas officials step in to help patients who are caught in the middle of disputes between medical providers and health insurers.

“It has been an industry issue for a few years — I grant you that,” he said, “the health plans and the providers fighting over their business interests, and I respect that. But 10 years later, it is a consumer issue.”

Among other things, Hancock’s bill would allow people with federally regulated self-funded health plans to opt into the state’s mediation program. According to Hancock, those plans make up about 40 percent of Texas’ insurance market, but those consumers are currently not able to take part in the program. Hancock said this should provide relief to consumers while federal lawmakers weigh their own efforts to address surprise medical bills.

“Texas will send a loud and clear signal to D.C. that similar consumer protections need to be passed at the federal level,” Hancock said. “Until then, Texas … [is] committed to doing something about it.”

U.S. Rep. Lloyd Doggett said he’s encouraged by Texas’ efforts, but called federal protections “essential.”

“Only approval in Congress of legislation like my End Surprise Billing Act can both protect those who work for large employers with self-funded, federally regulated ERISA plans and assure that patients across America are not forced to pay the price for conflicts between insurers and health care providers,” he said in a statement.

This story is part of a partnership that includes KUT, NPR and Kaiser Health News.

Kaiser Health News

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Texans Can Appeal Surprise Medical Bills, But The Process Can Be Draining

In Texas, a growing number of patients are turning to a little-known state mediation program to deal with unexpected hospital bills.

The bills in question often arrive in patients’ mailboxes with shocking balances that run into the tens or even hundreds of thousands of dollars.

When patients, through no fault of their own, are treated outside their insurers’ network of hospitals, the result can be a surprise bill. Other times, insurers won’t agree to pay what the hospital charges, and the patient is on the hook for the balance.

The Texas Department of Insurance’s mediation program can intervene when Texans complain about an unexpected bill — often after an emergency in which a patient is rushed for treatment at an out-of-network hospital.

Historically, the state program had many restrictions that left few consumers eligible for help. But the Texas Legislature expanded it in 2017.

Since then, more patients have been filing complaints. In 2014, the department was asked to mediate 686 medical bills. During the 2018 fiscal year, however, it received 4,445 bills, more than double the 2,063 bills received in 2017.

Even after the changes, the mediation program could be a lot more robust and is likely addressing only a fraction of these problematic bills, consumer advocates say.

The Road To A Surprise Medical Bill

Brad Buckingham had to deal with a surprise medical bill after a bicycle accident in 2016.

Buckingham sent his bill to Kaiser Health News and NPR’s “Bill of the Month” portal last year.

The Austin, Texas, dentist said he was on a ride with friends in December 2016 when he crossed train tracks at an angle to avoid a pileup. His wheel slipped out from under him, and he landed hard on his left hip.

“All I could do was scream,” he said. “I couldn’t even make words.”

His friends called an ambulance, and Buckingham was taken to the nearest hospital: St. David’s South Austin Medical Center.

“I specifically remember I gave them my health insurance information in the ambulance,” he said. “And they put me in the ER, and from the ER they took my insurance information again.”

Buckingham had insurance through Baylor Scott & White Health, which he bought through the Affordable Care Act marketplace. St. David’s was out of his plan’s network, but no one told him that — at first.

Buckingham had broken his hip, and doctors took him into surgery the same day.

“They held me in the hospital for three days just for recovery and never told me I was out of network until the time of my discharge,” he said.

A few weeks later, Buckingham got a bill that said he owed $ 71,543.

The total bill eventually came to $ 75,346. Baylor Scott & White, which left the ACA marketplace the following year, paid only $ 3,812.

Buckingham thought it was a mistake, he said. He called the hospital and the insurer to sort it out. But after weeks of inquiring about it, there was no resolution.

Both the hospital and insurer insisted payment was his responsibility.

“I’m sitting there thinking to myself that there is no way — there is no way — this is right,” he said.

Baylor Scott & White said it couldn’t discuss Buckingham’s bill “due to confidentiality requirements.”

After Buckingham gave St. David’s permission to discuss his case with the media, the hospital released a statement saying his bill was actually the amount he owed from his deductible and coinsurance — not a balance bill.

The hospital also said the bill was so large because of his “high deductible plan.”

Those plans “may be attractive to some people because they cost less, though they place more financial responsibility on the patient,” the statement from St. David’s said.

Buckingham said his policy had a deductible of $ 5,000 for in-network care and $ 10,000 for out-of-network care. He still doesn’t know how his bill got to be so high, he said.

Buckingham didn’t know about the state’s mediation program. But even if he had known, he wasn’t eligible for the program at the time. His bike accident and the billing dispute with the hospital happened months before the Texas Legislature decided to expand the pool of eligible patients. So he hired his own lawyer to help him negotiate with the hospital.

Buckingham now owes a couple of thousand dollars to St. David’s, he said, but he remains frustrated by the experience.

“You know, whenever I tell my story to anybody, they kind of agree — like, ‘Oh my gosh, this is ridiculous,’” he said. “But then when you talk to the people that have any control over it, it’s the exact opposite. It’s: ‘You owe it; we don’t.’”

‘A Total Roll Of The Dice’

A surprise bill can happen to anyone who makes an urgent trip to the nearest emergency room.

“It’s a total roll of the dice,” said Stacey Pogue, a senior policy analyst with the Center for Public Policy Priorities in Austin. She has been looking into balance billing for years. “The medical emergency that’s going to send you to the hospital where you could get a surprise bill — is that emergency room going to be in or out of network?”

Pogue said the Texas Department of Insurance’s mediation process forces an insurance company and the hospital or medical provider to negotiate a fair price for services. Ninety percent of the time those negotiations happen over the phone, she said.

There are two big reasons the number of bills sent for mediation more than doubled from 2017 to 2018, Pogue said.

“One is just increased awareness,” she said. “There is constant media attention now to surprise medical bills because the stories are so shocking, right? We see them covered more, so people are more aware that when they get one, they could do something about it.”

The second reason is that, in 2017, the Texas Legislature opened the mediation program up to more people, including teachers.

Stacey Shapiro got a $ 6,720 bill after being treated in the hospital for a hypoglycemic attack.(Gabriel C. Pérez/KUT)

Can’t Wish It Away

Stacey Shapiro, a first-grade teacher in Austin, also received a surprise bill from St. David’s South Austin Medical Center after she landed in the emergency room last March.

The marathon runner said she woke up one Saturday for an early run and wasn’t feeling well.

“All of a sudden the whole room started spinning. … I started sweating, sweating like buckets,” she said. “It was terrible, and then all I remember is that my ears started popping, my vision got blurred and then the next thing I knew, I had passed out.”

Shapiro’s boyfriend heard her hit the bathroom floor. He found her passed out, with her eyes open and hardly breathing. He took her to St. David’s because it was the closest hospital.

Shapiro was taken care of in a few hours, she said. Hospital staff gave her fluids and anti-nausea medication. Doctors found she had a dramatic change in her blood pressure that was likely due to a spell of hypoglycemia, or low blood sugar.

Two months later, a bill for $ 6,720 came in the mail.

Like many teachers in Austin, Shapiro gets her health insurance from Aetna.

In a statement, the insurer said Austin school district employees are supposed to use the Seton Accountable Care Organization network, comprising several Catholic hospitals in the area. The parent company for St. David’s, the for-profit hospital chain HCA, doesn’t participate in that network.

“Unfortunately, HCA is not currently accepting payments through Aetna’s [contracted payment] program, which provides set payment fees for non-participating providers. This has resulted in Ms. Shapiro being balance billed for her emergency room visit,” Aetna wrote in a statement.

Shapiro said she had heard of other Austin Independent School District employees dealing with high hospital bills. In fact, Shapiro reached out to radio station KUT after hearing the story of Drew Calver, an Austin high school teacher who was balance-billed for nearly $ 109,000 by St. David’s after a heart attack. Calver’s story was part of Kaiser Health News and NPR’s “Bill of the Month” series last year.

In her case, Shapiro said, Aetna told her not to pay what the hospital was charging her. She was told to pay only her deductible ($ 1,275), which she did right away, she said. But St. David’s kept sending her bills for the remaining balance, which was more than $ 5,000.

“I guess I just thought that it was going to go away,” Shapiro said.

But it didn’t. For a public school teacher, $ 5,000 would have been a huge blow to her budget, she said.

Shapiro applied for financial assistance, but St. David’s told her she didn’t qualify. She felt out of options, she said — until a friend told her about the state’s mediation program.

After she contacted the program, a state mediator set up a scheduled call with Aetna and St. David’s. But before it took place, a KUT reporter asked St. David’s for a comment on the situation. Shortly afterward, Shapiro said, St. David’s told her she no longer owed anything.

St. David’s later told KUT that Shapiro had “already satisfied her financial obligation.” It also denied that she was balance-billed to begin with.

Shapiro called the whole experience exhausting. “It’s just very frustrating because this has been very time-consuming,” she said.

More Work To Do

Pogue, of the Center for Public Policy Priorities, has been arguing that the state needs to find more ways to get involved. The current mediation process is pretty good, she said, but not enough people know it’s an option.

“Because first, the instructions for how to do it are on your medical bill and your explanation of benefits — the most indecipherable documents you are going to get,” she said.

And even if people understand they have a right to mediation, they might get scared off by the concept and think they need a lawyer, Pogue added.

When people do use the program, though, it tends to work by saving patients money.

In fiscal year 2018, the initial complaints amounted to $ 9.7 million worth of medical bills, according to the state insurance agency. After mediation, the final charges had been negotiated down to $ 1.3 million.

Mediation is helpful, Pogue said, but it still puts a big burden on the patient, who may be confused. “Why didn’t this happen in the first place?” she said. “How come I had to, while recovering from an emergency, decipher medical bills, fill out paperwork with the state department of insurance, jump through all these hoops, when all that needed to happen was a phone call?”

The ideal solution to surprise medical bills would remove consumers from this confusing web altogether, she said.

States like New York, California and Florida have systems that make things easier for consumers, Pogue said, and Texas should, too.

In 2015, New York became the first state to pass a law aimed at protecting patients from surprise medical bills from out-of-network hospitals. Its Emergency Medical Services and Surprise Bills Law holds consumers harmless if they are treated by an out-of-network doctor at a participating hospital, among other things.

In 2016, Florida lawmakers passed legislation protecting consumers from receiving surprise medical bills “from doctors and hospitals that don’t have a contract with the patient’s insurance plan,” the Miami Herald reported.

And in 2017, California passed a law shielding patients from balance billing. The law kicks in if someone visits an in-network provider, including a hospital, imaging center or lab. Under the law, patients would be responsible only for their in-network share of the cost, even if they’re seen by an out-of-network provider.

In the meantime, Pogue said, more Texans should take advantage of what’s already in place in the state.

The number of people who seek mediation is “tiny compared to the number of people who get surprise bills,” she said, “so there is a ton of work to be done.”

This story is part of a partnership that includes KUT, NPR and Kaiser Health News.

Kaiser Health News

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Kaiser Permanente Moanalua Medical Center Receives Women’s Choice Award for Excellence in Bariatric Surgery

HONOLULU — For the fourth straight year, Kaiser Permanente Moanalua Medical Center has been recognized as one of America’s Best Hospitals for Bariatric Surgery by the Women’s Choice Award®. Presented by WomenCertified Inc., this evidence-based designation scored Moanalua Medical Center in the top 8 percent of 4,797 U.S. hospitals reviewed.

The America’s Best Hospitals for Bariatric Surgery award is given to hospitals recognized by the American College of Surgeons and the American Society for Metabolic and Bariatric Surgery. To be eligible for consideration, hospitals must be accredited by the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program, which indicates the highest standards for patient safety and quality care in the treatment of severe obesity. The award also takes into account patient safety data from the Centers for Medicare and Medicaid Services, and patient recommendation ratings from the Hospital Consumer Assessment of Healthcare Providers and Systems survey.

“Nearly 24 percent of Hawaii’s adult population is obese, living with an increased risk of developing diabetes, hypertension, heart disease, arthritis and obesity-related cancer,” said Peggy Latare, MD, co-chief of the bariatric surgery department at Kaiser Permanente Hawaii. “Our bariatric team focuses on offering high-quality, integrated care and support that includes surgery, medication and meal replacements to treat obesity and its many associated risks, as well as education and resources that help patients improve their overall health and quality of life.” Kaiser Permanente Hawaii members who are interested in these services can call 808-432-7830.

America’s Best Hospitals for Bariatric Surgery combines national accreditations, HCAHPS survey results and hospital outcome scores with primary research about women’s health care preferences. It is the only award recognizing excellence in bariatric surgery based on robust criteria that consider female patient satisfaction and clinical excellence.


About the Women’s Choice Award®
The Women’s Choice Award sets the standard for helping women to make smarter choices for themselves and their families. The company and its awards identify the brands, products and services that are most recommended and trusted by women. The Women’s Choice Award is the only evidence-based quality designation that drives consumer and patient appreciation through education, empowerment and validation. Additionally, they recognize those that deliver a recommendation-worthy customer experience. Visit www.WomensChoiceAward.com to learn more.

About Kaiser Permanente
Kaiser Permanente is committed to helping shape the future of health care. We are recognized as one of America’s leading health care providers and not-for-profit health plans. Founded in 1945, Kaiser Permanente has a mission to provide high-quality, affordable health care services and to improve the health of our members and the communities we serve. We currently serve more than 12.2 million members in eight states and the District of Columbia. Care for members and patients is focused on their total health and guided by their personal Permanente Medical Group physicians, specialists and team of caregivers. Our expert and caring medical teams are empowered and supported by industry-leading technology advances and tools for health promotion, disease prevention, state-of-the-art care delivery and world-class chronic disease management. Kaiser Permanente is dedicated to care innovations, clinical research, health education and the support of community health. For more information, go to kp.org/share.

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http://www.acrx.org -As millions of Americans strive to deal with the economic downturn,loss of jobs,foreclosures,high cost of gas,and the rising cost of prescription drug cost. Charles Myrick ,the President of American Consultants Rx, announced the re-release of the American Consultants Rx community service project which consist of millions of free discount prescription cards being donated to thousands of not for profits,hospitals,schools,churches,etc. in an effort to assist the uninsured,under insured,and seniors deal with the high cost of prescription drugs.-American Consultants Rx -Pharmacy Discount Network News

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http://www.acrx.org -As millions of Americans strive to deal with the economic downturn,loss of jobs,foreclosures,high cost of gas,and the rising cost of prescription drug cost. Charles Myrick ,the President of American Consultants Rx, announced the re-release of the American Consultants Rx community service project which consist of millions of free discount prescription cards being donated to thousands of not for profits,hospitals,schools,churches,etc. in an effort to assist the uninsured,under insured,and seniors deal with the high cost of prescription drugs.-American Consultants Rx -Pharmacy Discount Network News

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CBS Blocked a Medical Marijuana Commercial From Playing During the Super Bowl

(Bloomberg) — The Super Bowl isn’t ready for medical marijuana.

Acreage Holdings, the multi-state cannabis company backed by John Boehner, says CBS rejected a television advertisement that calls for the legalization of medical marijuana. The network, which is airing the game on Feb. 3, nixed the proposed spot after seeing a rough outline, according to the company.

While medical marijuana is now legal in more than 30 states, the federal prohibition on cannabis has restricted research and made it difficult for some potential patients to get their hands on a drug that proponents say helps treat seizures, pain and other ailments.

The advertisement aimed to “create an advocacy campaign for constituents who are being lost in the dialogue,” Acreage President George Allen said. Super Bowl airtime would have been the best way to achieve this, he added.

“It’s hard to compete with the amount of attention something gets when it airs during the Super Bowl,” Allen said in a telephone interview.

CBS didn’t immediately reply to a request for comment on Monday, which was a federal holiday.

The Super Bowl is typically the most-watched television program of the year, and it’s an opportunity for brands to get in front of millions of Americans. Companies typically debut new publicity campaigns and air their most creative commercials during the event. Some viewers eagerly anticipate the advertisements that run during stoppages in play.

In past years, some advertisers have also grabbed the spotlight for offering up commercials that weren’t likely to be approved.

Injuries, Seizures

Acreage, one of the most valuable U.S. weed companies with a market value of more than $ 2.4 billion, had hoped to raise its profile and push for increased access to medical marijuana. The proposed ad features two subjects who have benefited from medicinal cannabis: a veteran with combat injuries and a child with seizures.

Super Bowl ads are expensive, reportedly costing more than $ 5 million for an average 30-second spot last year. Acreage, which went public in Canada last year, was prepared to pony up, and created the ad thinking it had a legitimate chance of getting onto the air. The company said it was careful to position the spot as a “call to political action” rather than a pitch for its brand, which now has cannabis operations in roughly 15 states.

“We certainly thought there was a chance,” Allen said. “You strike when the chance of your strike has the probability of success — this isn’t a doomed mission.”

Sports – TIME

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http://www.acrx.org -As millions of Americans strive to deal with the economic downturn,loss of jobs,foreclosures,high cost of gas,and the rising cost of prescription drug cost. Charles Myrick ,the President of American Consultants Rx, announced the re-release of the American Consultants Rx community service project which consist of millions of free discount prescription cards being donated to thousands of not for profits,hospitals,schools,churches,etc. in an effort to assist the uninsured,under insured,and seniors deal with the high cost of prescription drugs.-American Consultants Rx -Pharmacy Discount Network News

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Kaiser Permanente Moanalua Medical Center Receives Women’s Choice Award for Cancer Care

HONOLULU — For the second consecutive year, Kaiser Permanente Moanalua Medical Center has been named one of America’s Best Hospitals for Cancer Care by the Women’s Choice Award®. This evidence-based designation places Moanalua Medical Center in the top 9 percent of 4,797 U.S. hospitals offering cancer care services.

The America’s Best Hospitals for Cancer Care award is based on criteria such as the comprehensiveness of diagnostic and treatment services offered, low rates of infection compared to the national average, national accreditations, and female patient satisfaction and preference ratings on the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey.

Kaiser Permanente’s multidisciplinary, team-based approach focuses on all stages of cancer care, from prevention through treatment. The organization holds an annual Cancer Screening and Prevention Fair where medical specialists and counselors provide screening and lifestyle education to hundreds of attendees. Kaiser Permanente also recognizes that women have specialized health care needs. Moanalua Medical Center’s cancer care services include a breast care clinic, which provides cancer patients with a coordinated team made up of oncologists, geneticists, radiologists, surgeons and support staff who provide comprehensive care under one roof.

“Every year, thousands of people in Hawaii receive a cancer diagnosis,” said Jennifer Carney, MD, chief of oncology and hematology at Kaiser Permanente Hawaii. “Getting that news is never easy. We strive to provide coordinated care that takes into account our patients’ total picture of health so we can deliver safer, more effective care that is also more convenient for our members. We’re grateful to be able to make a difference in the lives of our many members, who survive cancer every year.”

In 2016, Kaiser Permanente Hawaii was ranked first in the state on breast and colorectal cancer screenings by the National Committee for Quality Assurance, a national quality assurance organization. In 2017, Moanalua Medical Center received a 3-year accreditation, the longest available, from the American College of Surgeons Commission on Cancer (ACS CoC) based on quality measures including early diagnosis, cancer staging, optimal treatment, rehabilitation and end-of-life care.


About the Women’s Choice Award®
The Women’s Choice Award sets the standard for helping women to make smarter choices for themselves and their families. The company and its awards identify the brands, products and services that are most recommended and trusted by women. The Women’s Choice Award is the only evidence-based quality designation that drives consumer and patient appreciation through education, empowerment and validation. Additionally, they recognize those that deliver a recommendation-worthy customer experience. Visit www.WomensChoiceAward.com to learn more.

About Kaiser Permanente
Kaiser Permanente is committed to helping shape the future of health care. We are recognized as one of America’s leading health care providers and not-for-profit health plans. Founded in 1945, Kaiser Permanente has a mission to provide high-quality, affordable health care services and to improve the health of our members and the communities we serve. We currently serve more than 12.2 million members in eight states and the District of Columbia. Care for members and patients is focused on their total health and guided by their personal Permanente Medical Group physicians, specialists and team of caregivers. Our expert and caring medical teams are empowered and supported by industry-leading technology advances and tools for health promotion, disease prevention, state-of-the-art care delivery and world-class chronic disease management. Kaiser Permanente is dedicated to care innovations, clinical research, health education and the support of community health. For more information, go to kp.org/share.

 

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Insured But Still In Debt: 5 Jobs Pulling In $100K A Year No Match For Medical Bills

Robert and Tiffany Cano of San Tan Valley, Ariz., have a new marriage, a new house and a 10-month-old son, Brody, who is delighted by his ability to blow raspberries.

They also have a stack of medical bills that threatens to undermine it all.

In the months since their sturdy, brown-eyed boy was born, the Canos have acquired more than $ 12,000 in medical debt — so much that they need a spreadsheet to track what they owe to hospitals and doctors.

“I’m on these payment arrangements that are killing us,” said Tiffany Cano, 37, who has spent her lunch hours on the phone negotiating payoff plans that now total $ 700 a month. “My husband is working four jobs. I work full time. We’re a hardworking family doing our best and not getting anywhere.”

The pair, who earn nearly $ 100,000 a year, are insured and have had no major illnesses or injuries. Still, the Canos are among the 1 in 4 Americans who report in multiple polls that the high cost of health care is the biggest concern facing their families. And they’re at risk of joining the 62 percent of people who file for bankruptcy tied to medical bills.

“Oh, yes, that worry is always in the back of my mind,” Tiffany said.

The family is part of a struggling group: middle-class folks who have followed the rules and paid for employer-based medical insurance, only to find that soaring health care costs — combined with high deductibles, high copayments and surprise medical bills — leave them vulnerable.

“I thought we’d be covered, and it’s just not enough coverage at all,” she said.

Robert Cano, also 37, had family health insurance for 2018 through his job as a manager at a large-chain retail store, for which he pays nearly $ 500 per month. The plan’s $ 3,000 annual deductible and 40 percent coinsurance fees have added up faster than the Canos anticipated.

First came the nearly $ 4,000 bill from the in-network hospital where Brody was born Jan. 2, followed by separate fees from the anesthesiologist and the doctor who performed the routine delivery. Then, at 2 months, Brody was hospitalized with breathing problems doctors said could be related to allergies or asthma. In May, Tiffany came down with a stomach virus that sent her to the emergency room for drugs to treat nausea and dehydration. In October, the baby developed a bad case of bacterial conjunctivitis, or pinkeye.

“It’s been, like, $ 300 here, $ 700 there,” said Tiffany. “We had a hospital bill for him being sick of, like, $ 1,800.” Unable initially to find a pediatrician she liked, Tiffany has agonized over whether to use the ER when Brody gets sick. When he had pinkeye, she debated whether to take him in, hoping it would get better on its own.

Then he got worse, she said, pulling up a photo on her phone of her son with half-moons of red, puffy flesh under his dark eyes.

“I let him suffer for a day like that,” she said.

The Canos lost their first child, a girl, midway through her pregnancy in 2016. Tiffany acknowledges that experience has left her more anxious than the average first-time mom.

“It gave me so much fear that something would happen to him,” she said.

As for their own health care needs, the couple put themselves lower on the priority list. Tiffany has used a prosthetic limb since childhood, when her lower left leg was amputated because of a birth defect.

She needs a new prosthesis because her body changed during pregnancy, but she can’t see how to afford it.

Tiffany Cano with her son, Brody. Cano was born with birth defects that left her with only three fingers on her right hand and a left leg that had to be amputated below the knee during childhood. Because of physical changes during pregnancy, her five-year-old prosthetic leg no longer fits, but she can’t afford her share of the cost of the new limb.

A model suitable for the busy life of a working mom would easily cost $ 10,000 to $ 15,000, according to Tom Fise, executive director of the American Orthotic & Prosthetic Association.

“I try to push through,” Tiffany said. “I put on that brave face of just walking, but it’s so painful to walk. I have bruises all over my leg. I get blisters all the time.” Lately, she’s been wearing an old prosthesis, one she used in high school, because it’s more comfortable.

The Canos don’t know how exactly they fell into such debt, since they tried hard to make responsible decisions. After meeting three years ago, they knew quickly that they wanted to marry and have a family.

“I waited until I found the right guy,” said Tiffany, who was thrilled when, in 2016, they were able to afford a 2,500-square-foot, two-story home in one of the stucco-and-tile neighborhoods an hour outside Phoenix.

But, taken together, the medical payment plans and premiums are almost as much as their $ 1,300 monthly mortgage. All told, the Canos spend about 15 percent of their annual income on health care, almost three times the average for non-Medicare households in the U.S.

That leaves too little for day care, car payments, gas, food and dozens of other domestic expenses, Tiffany said.

For 17 years, Robert Cano had comprehensive health insurance through his job as a soldier in the Army Reserve and paid little or nothing for medical care. He left the Army in 2017, however, after he learned he would be deployed for an extended time away from his wife and new son.

“I told them, ‘I have to be at home,’” he recalled. The Army insurance ended on Dec. 31, 2017, two days before Brody was born.

That meant moving to his employer’s insurance plan. Like more than 40 percent of 152 million Americans who get health insurance through work, the Canos are enrolled in a plan that demands thousands of dollars before any coverage kicks in.

The couple discovered that they earn too much to qualify for financial assistance from medical providers, or for subsidies if they shifted their insurance to a plan under the federal health insurance exchange. She is a full-time bank compliance officer. He is a full-time store manager.

Tiffany wrote to KHN after seeing stories about sky-high medical bills on TV. Dr. Merrit Quarum, the chief executive of WellRithms, a health care consulting firm, reviewed the family’s medical bills and the responses from their health care providers.

Though Quarum had questions about some of the fees in the itemized bills — $ 4 for a 600-milligram ibuprofen tablet? $ 3,125 to place an epidural? — he found the charges were legitimate under the terms of the contract between the hospital and the Canos’ insurer. Tiffany’s only recourse was to set up the five payment plans she navigates each month.

“I wish I could say it wasn’t so, but it is,” Quarum said.

Robert Cano plays with his 10-month-old son, Brody, before leaving for work on a recent Saturday morning.(Heidi de Marco/KHN)

Robert Cano of San Tan Valley, Ariz., gets ready for work on Oct. 20, 2018. He estimates he works up to 120 hours a week, mostly to cover the extra costs of his family’s health care. In addition to his retail job, he is a substitute teacher and a nighttime security guard, and delivers sandwiches for a fast-food chain.(Heidi de Marco/KHN)

Tiffany Cano feeds 10-month-old Brody on Oct. 20, 2018. She works 40 hours a week at a local bank as a compliance officer, commuting more than 90 minutes each way, while Brody attends a local day care center. Because her husband works so much, she says, she often feels as if she’s raising their son alone.(Heidi de Marco/KHN)

Mostly to pay off that health care debt, Robert has taken several part-time gigs this year — he works as a substitute teacher and a nighttime security guard and delivers sandwiches for a fast-food chain in Scottsdale, 40 miles away, where tips are better. He said he sometimes works up to 120 hours in a week.

“I’m not ashamed or embarrassed, even as old as I am, to deliver sandwiches,” he said, pulling on his retail chain polo shirt before rushing to a Saturday morning shift.

He continued: “I know people, they’d rather get food stamps and feel sorry for themselves. But I’m a fighter. I will not give up. … If I can bring in an extra $ 400 a week or $ 800 a month, she can get what she needs for the baby.”

Often getting home after midnight, he keeps shampoo and shaving cream in his car and naps in parking lots between jobs, relying on Red Bull and aspirin to stay alert.

That means on many nights, when Tiffany picks up Brody from day care after her 90-minute commute, she handles most of the chores at home.

“Sometimes I feel like a single mom because my husband is never around,” she said.

She carefully tracks the family’s medical expenses, trying to juggle them with ordinary outlays that can’t wait — like $ 500 for the brakes that went out on her car this month.

At the rate they’re going, the bills won’t be paid until Brody is 3, Tiffany said. The Canos are getting older and they’d like to have another baby before it’s too late, but, for now, that seems impossible.

For 2019, the couple have decided to switch to a different plan offered through the regional bank where Tiffany works. The premium is higher — $ 650 a month — but the deductible is $ 1,500 with just 10 percent coinsurance.

“It is going to be a lot more per paycheck, which is going to hurt us,” Tiffany said. “But after what just happened, I want to make sure we are prepared in case anything does occur.”

How to fix a health care system that burdens middle-class families so heavily is beyond her, she said.

“The only thing we can do is just keep working,” Tiffany said. “I always wonder: How does everybody else do it?”


KHN’s coverage of children’s health care issues is supported in part by the Heising-Simons Foundation.

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Charity buys and erases past-due medical debt

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Massachusetts Stroke Patient Receives ‘Outrageous’ $474,725 Medical Flight Bill

Kristina Cunningham was in stable condition on an evening in June, when EMTs lifted her gurney into a medical flight, bound for Boston.

The 34-year-old couldn’t use her right arm or speak clearly after a stroke six days earlier, and still had two blood clots at the base of her brain. Cunningham’s dad, Jim Royer, remembers doctors at the small hospital in Wichita, Kan., where Cunningham had attended a family wedding, saying she needed to see a neurosurgeon.

“There was discussion of flying her to St. Louis, there was discussion of flying her to Chicago, there was discussion of flying her to Dallas,” Royer recalled, but “we don’t have family in any of those locations.”

So the doctors arranged to transfer Cunningham, via an Angel MedFlight Learjet, to Massachusetts General Hospital, where she would be diagnosed with a rare blood vessel disease of the brain. MGH is about an hour from Cunningham’s home in Berlin, Mass. — and her 7-year-old son. Cunningham’s doctors and her insurer, CareFirst BlueCross BlueShield, based in Maryland, agreed the transfer was medically necessary.

“We assumed it would be [covered],” Royer said, “because it was supposedly preapproved by the insurer before any flight took place.”

Royer said he and Cunningham didn’t think about the Angel MedFlight piece of her health scare again until a letter arrived in August. It was a one-page “explanation of benefits” with a jaw-dropping total in a column labeled “other amounts not covered.”
“When I got the bill for $ 474,725, I’m thinking six or seven flights, and you can buy a whole new jet,” Royer said with a wry laugh.

That nearly half-million dollars is the total of four items, the largest of which is a per-mile charge. That figure, $ 389,125, breaks down to $ 275 a mile.

“It’s larger than any surprise medical bill I’ve personally seen,” said Chuck Bell, program director for the advocacy division at Consumer Reports. “It’s really outrageous.”

In a study last year, Consumer Reports detailed some of the reasons excessively high air ambulance bills have become more common. Use of air ambulances is rising as more rural hospitals close, baby boomers age and the use of telemedicine increases.

“The industry has really grown by leaps and bounds over the last 15 years and prices have doubled or tripled,” Bell said. “Most of the operators of air ambulances now are for-profit, Wall Street-type corporations reporting very large profits to investors.”

The Association of Air Medical Services (AAMS), a trade group, counters that it is not unique, that many hospitals and health insurers across the country are also for-profit and that some are owned by private equity firms.

AAMS said a key reason bills for patients with private insurance plans are often high is this: Companies have to make up for the money they lose transporting other patients.

“Medicare pays about 60 percent of the cost of the flight. Medicaid pays 35 percent or less. Self-paid patients pay a few cents on the dollar. And that has led to a crisis of being able to sustain the service,” Christopher Eastlee, AAMS vice president for government relations, said in a statement, stressing that he has cost data only for emergency helicopter transports, not jets like the one in which Cunningham traveled.

In 2018, Medicare paid $ 8.65 per mile for a fixed-wing aircraft like the Learjet that transported Cunningham. That’s a stark contrast to Angel MedFlight’s $ 275 charge per mile. There are no guidelines for determining reasonable charges in this case.

Cunningham’s insurer, CareFirst, initially paid $ 14,304.55, leaving about $ 460,420 unpaid. In Massachusetts, a ground-based ambulance could not demand that Cunningham pay the balance, as state law doesn’t allow so-called balance billing. But air ambulances are governed by federal aviation laws. There are numerous cases of companies demanding payments from patients. A few states have tried to intervene but been unsuccessful, with courts saying that federal law prevails.

Cunningham has been focused on recovering her speech and preparing for surgery. In January, she will meet with her doctors to decide which type of surgery they recommend for removing or bypassing the blood clots at the base of her brain.

But Cunningham and her father have another worry: what the mail may bring.
“I don’t know, we’ll see,” Cunningham said, with a shrug.

“It’s a big bill to be sitting out there wondering what’s going on,” said Royer, who contacted KHN-NPR’s Bill of the Month on his daughter’s behalf. “It would force her into bankruptcy.”

Angel MedFlight COO Andrew Bess told WBUR the company is negotiating with CareFirst and will not demand payment from Cunningham.

“We’re quite confident we’ll come to a clear resolution despite the insurer placing the patient in the middle of the dispute,” said Bess.

Royer said it was a letter from Angel MedFlight that sounded threatening. As he read it, the company told Cunningham she must sign over the rights for Angel MedFlight to negotiate with CareFirst or risk being held liable if the insurer did not pay. Cunningham signed the request.

Bell, with Consumer Reports, said agreeing to such terms can be risky. Some air ambulance companies ask for detailed information about the patient’s personal finances, information they then use to determine how much the patient can pay if the insurance reimbursement is deemed inadequate.

During inquiries for this story, CareFirst told WBUR it would increase the proposed payment to Angel MedFlight. The insurer said it had discovered an error in its initial reimbursement to Angel MedFlight. CareFirst is now proposing to pay $ 70,864.90, or about one-seventh of the original charge.

“Unfortunately, exorbitant charges like these by air ambulance providers are not uncommon,” said Scott Graham, a spokesman for CareFirst, in an email. “This is an issue because companies like Angel MedFlight typically do not contract with health insurers on negotiated rates.”

WBUR forwarded this update to Bess, who called it a “meaningful offer” in his emailed response.

“We provide a valuable service, and for that providers should be fairly compensated and reimbursed,” Bess said. “We strive to work with our patients and advocate on behalf of them to get coverage rightfully owed to them under their insurance plans.”

Royer, a retired Air Force air traffic control systems manager, knows something about the cost of operating jets. To him, it looks like Angel MedFlight inflated the bill, hoping the insurer would agree to a generous settlement.

“I guess that the way things work nowadays. You ask for the moon and if you only get a large island, that’s what you get,” Royer said.

Bess responded to Royer’s claim in a statement.

“Staffing what is essentially an Intensive Care Unit at 30,000 feet presents unique medical and aviation challenges that may not be apparent to those outside of the medical aviation industry,” Bess wrote. “The amount we receive per flight is a fraction of the billed charge.”

Patients caught up in an air ambulance billing dispute can file a complaint with the U.S. Department of Transportation.

A recent push for stricter federal billing regulations was stripped out of the Federal Aviation Reauthorization Act, passed in October. The legislation did establish a council of industry representatives, including air ambulance providers and insurance company representatives, among others, to write and re-evaluate consumer protections, including balance-billing practices. It did not add a requirement for more price and other data transparency called for in a Government Accountability Office report on the air ambulance industry.

The National Association of Insurance Commissioners says federal legislation is needed so that states can intervene to oppose unreasonable air ambulance charges. Lawmakers from rural states, including Sen. Jon Tester, a Montana Democrat, said they’ll reintroduce such legislation.

The air ambulance trade group says any such change would create “borders in the sky” that would interfere with lifesaving air rescues across state borders.

This story is part of a partnership that includes WBUR, NPR and Kaiser Health News.

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‘Widespread and dangerous’: Facing medical uncertainty, doctors tell patients it’s all in their heads

When 7-year-old Bailey Sheehan arrived at a hospital in Oregon partially paralyzed, a doctor said the girl was faking her symptoms to get her parents’ attention because she was jealous of her new baby sister.


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Gently stroking babies before medical procedures may reduce pain processing

Researchers found that gently stroking a baby seems to reduce activity in the infant brain associated with painful experiences. Their results suggest that lightly brushing an infant at a certain speed — of approximately 3 centimeters per second — could provide effective pain relief before clinically necessary medical procedures.
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Kaiser Permanente Opens New Beaverton Medical and Dental Office

PORTLAND, Ore. — Today, Kaiser Permanente opens its new Beaverton Medical and Dental Office. The new facility is our vision for the future of health care: person-centered care for body, mind and spirit, powered by innovation.

The three-floor, 90,000-square-foot facility replaces the current Beaverton facility that opened nearly 50 years ago, and is the first Kaiser Permanente facility outside of California that was built from the ground up to harness design, technology and workflow to create an intuitive and convenient experience for members and care teams.

This state-of-the-art care facility features a public square at its heart to educate, engage and inspire wellness, and appointment notification text alerts allowing patients to relax, enjoy something from the café, or take in the Northwest-created art displayed throughout the building. Larger exam rooms are designed to be less clinical and more conversational, and digital screens let providers share notes and display other medical information.

Medical and dental — together

One of the innovative ways that Kaiser Permanente is a national leader in care delivery is with medical and dental integration, which leads to improved health outcomes. For example, clinicians can look ahead at the dental patients on their schedule to see whether they’re due for any medical procedures, such as flu shots, immunizations or blood pressure checks, which can be taken care of during their visit. Because of Kaiser Permanente’s integrated medical record, a dental team provider can then, for example, send a message directly to the patient’s primary care doctor.

“Kaiser Permanente is unique in our movement toward integrated medical and dental care, and our new Beaverton office was built from the ground up to offer a convenient and highly personal total health experience,” said Curt Lemrick, DMD, the lead dentist at the new office. “Dental health can often give clues about a person’s overall health, and we strongly believe that the future state of medicine will be one where the two are integrated. We’re excited our Beaverton neighbors can now receive all of their medical and dental care in this state-of-the-art facility.”

Key Services

  • Primary care for adults and children
  • Dental care and dental hygiene services for adults and children
  • Imaging
  • Laboratory
  • Occupational Health
  • Nurse Treatment Center
  • Pharmacy
  • Urgent Care
  • Vision Essentials/Optometry

The new medical and dental office is adjacent to the old building at the corner of Western Avenue and Beaverton Hillsdale Highway. (The old building will be razed in 2019.)


About Kaiser Permanente
Kaiser Permanente is committed to helping shape the future of health care. We are recognized as one of America’s leading health care providers and not-for-profit health plans. Founded in 1945, Kaiser Permanente has a mission to provide high-quality, affordable health care services and to improve the health of our members and the communities we serve. We currently serve more than 12.2 million members in eight states and the District of Columbia. Care for members and patients is focused on their total health and guided by their personal Permanente Medical Group physicians, specialists and team of caregivers. Our expert and caring medical teams are empowered and supported by industry-leading technology advances and tools for health promotion, disease prevention, state-of-the-art care delivery and world-class chronic disease management. Kaiser Permanente is dedicated to care innovations, clinical research, health education and the support of community health. For more information, go to kp.org/share.

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This patient’s medical record said she’d given birth twice — in fact, she’d never been pregnant

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Kaiser Permanente Moanalua Medical Center Maintains “A” Grade for Patient Safety

HONOLULU — The Leapfrog Group, a nonprofit advocate for health care transparency, has awarded Kaiser Permanente Moanalua Medical Center its seventh straight “A” grade in the Fall 2018 Leapfrog Hospital Safety Grade. The Hospital Safety Grade, administered in the spring and fall every year, measures the overall performance of more than 2,500 hospitals nationwide in keeping patients safe from preventable medical errors. Moanalua Medical Center is 1 of 4 hospitals in Hawaii honored with the Straight A distinction of receiving five or more consecutive A grades.

The Hospital Safety Score uses hospital performance data collected by national health care organizations, including the Centers for Disease Control and Prevention and the U.S. Department of Health and Human Services. Scores are calculated based on 27 types of publicly available hospital data related to patient care, medication errors and infection prevention. It’s published as a free resource to help patients and their families make informed health care decisions. Only 32 percent of hospitals in the U.S. have received an A grade in the Fall 2018 report.

“Patient safety is a top priority at Kaiser Permanente, and we’re proud of our doctors, providers and staff who work together to create a healthy healing environment for patients,” said Linda Puu, RN, vice president of quality, safety and care experience at Kaiser Permanente in Hawaii. “Our integrated electronic health record system and coordinated care approach helps reduce errors and safety risks, which improves patient outcomes and ensures a higher quality of care.”


About Kaiser Permanente
Kaiser Permanente is committed to helping shape the future of health care. We are recognized as one of America’s leading health care providers and not-for-profit health plans. Founded in 1945, Kaiser Permanente has a mission to provide high-quality, affordable health care services and to improve the health of our members and the communities we serve. We currently serve 11.8 million members in eight states and the District of Columbia. Care for members and patients is focused on their total health and guided by their personal Permanente Medical Group physicians, specialists and team of caregivers. Our expert and caring medical teams are empowered and supported by industry-leading technology advances and tools for health promotion, disease prevention, state-of-the-art care delivery and world-class chronic disease management. Kaiser Permanente is dedicated to care innovations, clinical research, health education and the support of community health. For more information, go to kp.org/share.

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Flipped classroom enhances learning outcomes in medical certificate education

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Keiki Patients Enjoy Halloween Fun at Kaiser Permanente Moanalua Medical Center Trick-Or-Treat Event

HONOLULU — Kaiser Permanente Moanalua Medical Center held its annual trick-or-treat event for the hospital’s youngest patients today, celebrating Halloween with festive costumes, decorations and healthy treats. Eight pediatric patients ranging in age from toddlers to teens traveled through nearly every floor of the facility, showing off their costumes in exchange for stickers, coloring books and healthy snacks from physicians and staff.

Baby shark and friends enjoyed the healthy treats from staff.

Baby shark and friends enjoyed the healthy treats from staff.

Dressed as superheroes and movie characters, keiki visited General Surgery, Cardiology, Food & Nutrition and other departments to take in the hospital’s Halloween decorations and meet physicians and staff in costume. Five young patients who were unable to leave the pediatrics floor received a special delivery of Halloween treats delivered to their rooms by staff members.

“Our annual Halloween trick-or-treat event is a favorite for physicians, staff and parents, because it allows our young patients to celebrate the holidays without leaving the hospital,” said Kathryn Martin, RN, manager of pediatrics at Moanalua Medical Center. “We look forward to brightening the spirits of all our keiki with healthy treats and festive Halloween fun.”


About Kaiser Permanente
Kaiser Permanente is committed to helping shape the future of health care. We are recognized as one of America’s leading health care providers and not-for-profit health plans. Founded in 1945, Kaiser Permanente has a mission to provide high-quality, affordable health care services and to improve the health of our members and the communities we serve. We currently serve more than 12.2 million members in eight states and the District of Columbia. Care for members and patients is focused on their total health and guided by their personal Permanente Medical Group physicians, specialists and team of caregivers. Our expert and caring medical teams are empowered and supported by industry-leading technology advances and tools for health promotion, disease prevention, state-of-the-art care delivery and world-class chronic disease management. Kaiser Permanente is dedicated to care innovations, clinical research, health education and the support of community health. For more information, go to: kp.org/share.

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California’s Medi-Cal program paid $4B to recipients who may have been ineligible, audit shows

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‘Weed the People’ Explores Medical Marijuana for Kids With Cancer

Marijuana, both medicinal and recreational, is growing more mainstream. Medical marijuana is now legalized in a majority of states, and 62% of Americans support legalizing it outright — but in the political realm, the plant has long been controversial.

Now, a new documentary called Weed the People, which opens in some theaters in October, explores the potential of medical marijuana for childhood cancers and the regulatory hurdles facing people who want to use cannabis. The film, which was executive produced by former talk-show host Ricki Lake, follows five families using cannabis oils to treat pediatric cancers. Some of the children used cannabis alongside treatments like chemotherapy, while others turned to the drug after conventional treatments had failed.

Lake became interested in medical marijuana when her late ex-husband, Christian Evans, began researching cannabidiol (CBD) — a compound in marijuana that does not cause a high —for his own health issues, including chronic pain and ADHD. (Evans died by suicide last year.) The two met a young girl with a tumor disorder whose family was desperate to get her off chemotherapy, and they helped connect her with a doctor who specializes in medical marijuana. Lake and her production partner, director Abby Epstein, were inspired to find other families in similar situations and tell their stories on screen. They made Weed the People to explore the potential of medical marijuana, and the regulatory challenges families and researchers must overcome to use it.

“I want to get people seeing it as a medicine, seeing what it was able to do for these children, and fight for this medicine to be available to everyone who needs it,” Lake says. “It’s a human rights issue.”

The film paints a rosy, anecdotal picture of the effectiveness of cannabis oils; some of the children featured had their tumors shrink substantially or disappear entirely, even if they were using cannabis oils in place of chemotherapy and other conventional treatments. “You can’t say the ‘cure’ word,” Lake says, “but how else do you explain it?”

But the concept is far from proven and could even be dangerous. While there is some evidence that marijuana can ease chronic pain and chemotherapy side effects, the American Cancer Society (ACS) warns that “relying on marijuana alone as treatment while avoiding or delaying conventional medical care for cancer may have serious health consequences.” And while some studies have shown that compounds in marijuana can slow growth of or kill tumor cells in animals or lab dishes, evidence in humans — particularly around marijuana oils — is lacking, the ACS says. While conventional treatments like chemotherapy are still the standard, pediatric cancer providers are increasingly voicing their support for the use of medical marijuana, particularly in palliative or end-of-life care when other treatments may not be necessary.

More research is needed to learn about the potential effects and limitations of cannabis-derived medicines for both adult and pediatric cancers. As the families and experts in Weed the People see it, this lack of evidence is precisely the problem — and it’s exacerbated by current regulations around medical marijuana.

Marijuana, like heroin and LSD, is classified by the Drug Enforcement Administration (DEA) as a Schedule I drug, meaning it has “no currently accepted medical use and a high potential for abuse.” But in June, the FDA approved the first drug derived from marijuana, a purified version of CBD called Epidiolex, for kids and adults suffering from two rare forms of epilepsy; the DEA then rescheduled Epidiolex (but not CBD as a whole) to schedule V, the lowest restriction classification for controlled substances. Researchers who wish to study cannabis need a Schedule I drug license and must submit to background checks and site visits from the DEA.

The DEA also only permits one institution, the University of Mississippi, to grow marijuana for study, though DEA spokesperson Melvin Patterson says it is planning to grant additional licenses to other growers, which would “increase access to marijuana for researchers, potentially increase the number of available strains for research, and may foster additional research on marijuana.”

This means scientists are limited to studying only the products and formulations available from the University of Mississippi, which doesn’t include popular consumer products like vapes and edibles, says Dr. Jeff Chen, director of the University of California Los Angeles Cannabis Research Initiative. “At my office at UCLA, I look out my window and I can count two dispensaries that I can see,” Chen says. “We can’t touch that cannabis—not even to understand what’s in it.”

As a result of these challenges, many families who wish to use cannabis, including those in the documentary, are forced to buy it from sources outside the conventional medical system, and must trust that what they’re using is safe. “I just find it absolutely staggering to accept that in this day and age, with the billions of dollars that are spent on cancer research, the medicine we were relying on was made in somebody’s kitchen,” says Angela Smith in the film, whose son, Chico, uses cannabis oils to treat his soft tissue cancer.

Chen, who was not in the film but shares its frustration with current marijuana regulations, became swayed by the medical potential of cannabis compounds early in his career, when he encountered a young patient with epilepsy whose parents were treating her with CBD. Unfamiliar with CBD, Chen and his colleagues almost called Child Protective Services to intervene—until Chen looked into the compound further and saw how much he didn’t know.

“That’s when I realized that science had completely left cannabis in the dark,” Chen says. “It was time for science to step up and really to push on this issue. I felt a duty.” Today, Chen works to understand the health benefits and risks of marijuana and its many compounds, including CBD.

The film also touches on funding challenges associated with marijuana research, an impediment Chen has encountered with his own research. While the government does fund some marijuana research, Chen says the “vast majority” of federal dollars go toward understanding the harms of cannabis, not the potential benefits. Researchers who wish to study how marijuana may improve treatment for conditions ranging from cancer to chronic pain are largely left to find the money themselves, Chen says.

These roadblocks have led many researchers, including those quoted in the film, to call for looser marijuana scheduling, but the DEA denied two such petitions in 2016. Dr. Igor Grant, director of the Center for Medical Cannabis Research at the University of California San Diego, who was not in the film, agrees that current regulations have made research more difficult, and says marijuana probably doesn’t belong in schedule I. But he says he doesn’t believe that the government is actively trying to stifle cannabis research, as many people—including some in Weed the People—have alleged.

Grant says there’s some evidence that the barriers are becoming fewer. His lab recently made history by importing research-approved marijuana from Canada, a move that suggests U.S. researchers may soon have greater access to the plant. That access, combined with lighter regulations from the government, could open new doors, Grant says.

“You would have to both reschedule it and increase the availability of manufacturers,” he says. “This could be a joint effort between states, manufacturers, academia and federal [regulators].”

This type of collaboration is crucial, Lake says, and she hopes her documentary will garner public support for it. “I’m really hoping to reach the people who really have this idea that this drug is bad,” Lake says. “It’s a matter of just changing mindsets and having them fight to have access to this plant. I do believe change is coming.”


Entertainment – TIME

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