Doctors just Used a Brand New Gene Therapy to Try to Save a Child’s Vision

The Potential Is Enormous

Jack Hogan has never been able to play baseball because of his poor eyesight. Now 13, Jack was born with a rare genetic disorder that has eaten away at his vision. At night, he’s fully blind, so before dark, he has to leave his friends behind and return to his family’s home in Fair Haven, New Jersey.

Jack’s parents had been told that he could be legally blind by his 20s unless a treatment became available. That day, astonishingly, has arrived.

On Tuesday, Jack became the first patient in the US to get a new gene therapy for adults and children with inherited forms of vision loss. It’s called Luxturna and was approved by the Food and Drug Administration last year as the first treatment available to treat these genetic disorders.

The treatment delivered into Jack’s left eye a synthetic version of a gene that’s important for vision — and one that Jack was missing. In a week, he’ll get the same surgery on his right eye. After he recovers from the surgeries, his peripheral vision might improve and he should be able to see more clearly at night.

“I won’t have to go in at like 8 or 7 [at night], and I can sit and watch my friends play a game or something,” he told Vox, a day after his operation at Massachusetts Eye and Ear in Boston. He may also finally be able to play baseball too — something he’s looking forward to.

Jack is now one in a small club of patients to receive the first-ever gene therapies approved by the FDA — including Luxturna, which was developed at the University of Pennsylvania and now owned by Spark Therapeutics.

“Twenty years from now, when gene therapy or gene editing drugs are widespread, we’ll look back on today and think of this as truly momentous,” said Fyodor Urnov, associate director at the Altius Institute for Biomedical Sciences.

But there’s a catch. With a price tag of $850,000 — or $425,000 per eye — Luxturna is the costliest drug ever approved for sale in the US. That means it’s completely out of reach for the vast majority of Americans who, like Jack, have genetic disorders that impair their vision.

“This is a fantastic story of tremendous innovation,” said Dr. Steve Pearson, the president of ICER, an independent research organization that evaluates the cost of drugs.

But he’s also very worried. “As a system, it feels sometimes like we’re headed 100 miles per hour at a brick wall in terms of how we are going to pay for these drugs, and how the prices can reflect what we know about their benefits for patients.”

Luxturna works by delivering patients a synthetic copy of a missing gene

About 1 in 4,000 people in the United States are born with inherited retinal diseases called retinitis pigmentosa or leber congenital amaurosis, which can be caused by dozens of genetic mutations. In a very small subset of patients, about 1,000, mutations in the RPE65 gene specifically bring on their vision problems.

RPE65 is essential for the health of the retina, the layer at the back of the eye that’s sensitive to light. “Vitamin A is the chemical that changes shape when light hits the retina,” said Jason Comander, Jack’s doctor at Massachusetts Eye and Ear. RPE65 carries the instructions needed to make the vitamin A chemical processing machinery work. People with RPE65 mutations can begin to experience losses of vision in their infancy, including the loss of peripheral vision and night vision. Most are legally blind by their 20s.

Defect of RPE genetic mutation 

 Appearance of Retina in Patient (adult) with Leber's Disease

Luxturna was designed to address the RPE65 genetic mutation — in the best cases, permanently — for patients who have RPE65-associated retinitis pigmentosa or leber congenital amaurosis. To perform the therapy, doctors take a synthetic copy of RPE65 and put it in a virus whose sole function is to deliver the new gene to the cells that support the retina. The virus is injected — in three drops of liquid — into the space underneath the retina.

“Once you put [RPE65] back in, the eye is ready to see,” Comander told Vox. “It’s potentially a one-time treatment.”

There isn’t a ton of data on the treatment. But the results from the biggest and most robust clinical trial to date are why Jack’s doctors are optimistic it will work for him.

The phase 3 clinical trial of Luxturna was conducted in 2012 and 2013 and found that 27 of the 29 patients who received the treatment gained vision over a follow-up period of at least one year, according to a test that measured their ability to see dim light. In a test of their ability to navigate independently in varying degrees of darkness, 21 of the 29 could function at the lowest light level evaluated. (The trial was small, but not unusually small in the world of rare diseases, which have few patients eligible to participate.)

There was, however, some variation in individuals’ responses. Some people had complete turnarounds. “One kid got kicked out of School for Blind because [their] vision got better,” Comander said. But another person in the trial lost visual acuity as a result of the therapy.

Researchers only have four years of follow-up data, so the very long-term outcomes of Luxturna are unknown. For now, doctors do know that the surgery also promotes cataracts, which would require additional surgery later.

“There are risks with any surgery,” Comander said. “Jack will probably have to have cataract surgery earlier than he would otherwise. But overall the ratio of potential benefits to potential risks is amazing for this. It works — it’s not even a close call as to whether people should do it or not.”

“We were very happy and grateful our son was able to receive this surgery — the first one in the US,” Jack’s mom, Jeanette Hogan, told Vox. “Everyone deserves to be able to see”

Reckoning with the cost

But not everyone who is eligible will be able to afford Luxturna. The treatment costs $850,000 — a price tag that reflects the fact that the market of patients who need the drug is small, and that the investment could have a huge potential payoff: permanently fixed vision. But it also reflects the fact that, in the US, pharmaceutical companies can essentially charge whatever they want for drugs.

In a great story, published in Stat, journalist Eric Boodman details a moment that nearly derailed Jack’s surgery — and it had nothing to do with the medicine of science. Instead, it involved Jack’s insurance company.

A few days before surgery, Comander got a call from Jack’s family insurer, asking for proof that the cause of Jack’s vision problems is indeed the RPE65 genetic mutation. They’d only cover the surgery with that evidence. Comander had to scramble to muster it — one of the many administrative challenges that came with performing the operation, he told Vox. (In the end, it’s not clear exactly how much of the cost Jack’s family’s insurance covered and his mother declined to discuss the details.)

This is just one example of the hurdles patients may face in trying to access Luxturna, even when they have health insurance.

“There’s always an annual cap on out of pocket spending, so there could be a substantial payment that eats up a family’s deductible or hits their out-of-pocket maximum,” said Pearson of ICER. And patients who have no insurance, or whose insurance companies don’t cover — or adequately — Luxturna, may be out of luck.

To address these access issues, Spark, the company that makes the drug, is exploring rebate programs for patients who don’t fully respond to the therapy. It’s also working with insurers to allow patients to pay for the drug in installments.

But these are patchwork fixes for a drug pricing system that is fundamentally broken. “If we don’t get our act together, we may hit an affordability crunch that’ll be bad for patients, it’ll be bad for manufacturers, it’ll be bad for everybody,” Pearson said. “We have a new science, and we need a new policy — in terms of looking at the pricing and payment [system] — that will be consistent [with these] innovations.”

 This application of gene therapy is just the beginning of a potential paradigm shift for the treatment of genetic diseases. How will our health financing system accomodate these treatments.  Time will tell. Will these treatments still be effective after 5, 10, ot 20 years post-treatment

Read full article

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The Myth That Refuses to Die: All Health Care is Local | THCB

You go to your physician's office, and you step into a world of chaos. This article explains the 'Black Hole' of health care.

In 1980, industry healthcare planners imagined a system where the centerpiece was a hospital in every community and a complement of physicians. Demand forecasting was fairly straightforward: based on the population’s growth and age, the need was 4 beds per thousand and 140 docs per 100,000, give or take a few.

For almost 40 years, we’ve operated the U.S. health system based on an underlying assumption that all healthcare is local. We’ve presumed that except in rare circumstances, patients stayed home for the care they need. But that’s changing.

Three trends are converging that are changing how we think of the markets we serve:

Virtual care: Goldman Sachs forecasts virtual care will be a $20 billion industry by 2020 as employers and insurers adopt lower cost options to local medicine. Investor-funded companies (American Well, Teladoc, 2nd.MD, Carena, Health Integrated, MD Live, et al) offer distance medicine that is convenient and less costly. 78% of consumers say they would be receptive to receiving care virtually (Carenet Healthcare Services) though only 14% of hospitals offer digital tools and only 23% offer telemedicine (Kaufman Hall). And funding for digital health is robust: per RockHealth, start-ups have attracted $18 billion in the last four years, with most applications targeting mechanisms whereby consumers can make better choices about the care they receive, where, from whom and at what cost.

Destination Hubs: Historically, individuals left their community when facing a complex diagnosis based on a referral from a trusted local clinician. For cancer, Hutchinson, Dana Farber, Memorial Sloan Kettering, Mayo, MD Anderson, Moffit and others were prominent. For hearts, Cleveland Clinic, New York Presbyterian, Mayo, Mass General, Duke, Northwestern, Brigham and Women’s and others attracted referrals. Most of these set-up referral management programs to accommodate out of town patients, offering lodging and other forms of assistance. But destination hubs have expanded beyond those that cater to physician referrals. Each of these is a business model that makes a big bet that consumers will leave their community for care elsewhere:

Founded in 1988, Cancer Treatment Centers of America (CTSA) operates inpatient and outpatient facilities in 5 markets. Its national ads promote its integrative clinical model and patient-friendly approach to diagnosing and treating the full continuum of cancers. On its website, patient satisfaction scores for each patient cohort are reported with scores averaging above 95%.

Founded in 2005, Laser Spine Institute operates surgery centers in 7 markets and advertises nationally. It offers a free MRI and requires candidates for their minimally invasive procedures to stay within 15 miles of their surgery center one day after the procedure for post-op follow-up. Per its website, the company has performed 75,000 procedures: 60% for patients who live outside its markets.

Large employers like Boeing, Wal-Mart, Lowe’s, Whole Foods are contracting directly with hospitals out of their local markets. Though only 3% of employers contract directly today, the National Business Group on Health estimates activity will increase as health costs escalate in coming years.

And medical tourism remains a factor: According to Patients beyond Borders, 1.4 million U.S. adults traveled outside the U.S. for medical care last year. The Joint Commission International accredits 458 hospitals off-shore that perform elective surgical procedures as 30% of the

So, destination hubs are no longer limited to tertiary care providers in urban settings.

Affordability: One in five Americans under the age of 65 say they are having problems paying their medical bills and 2 million will declare bankruptcy due to medical debt this year (Nerd Wallet). As prices charged by U.S. providers. Reported by the Federal Reserve last November, household debt hit an all-time high last year increasing 16% since the summer of 2013. Student loan, medical and mortgage debt are the culprits. As households face higher deductibles, affordable options will be on their radar. Out-of-market healthcare services offered at a lower price by a reputable provider will be attractive. And the entry of Amazon-JPMorgan-Berkshire Hathaway into the fray of employer benefits and health cost containment promises to spark increased consideration of new models and strategies.

The bottom line is this: healthcare is no longer about competition between insurers, physicians and hospitals operating in a relatively confined hospital referral region. 

The Myth That Refuses to Die: All Health Care is Local | THCB

Alere pays $33M to settle claim it knowingly sold unreliable devices

Alere is paying the U.S. $33.2 million to settle claims it knowingly sold unreliable point-of-care testing devices to emergency departments. The government alleges Alere continued to sell Triage devices in the years running up to a 2012 recall despite receiving reports of erroneous results.

Waltham, Massachusetts-based Alere recalled five products in its Triage range in 2012 in response to the reports of erroneous results. But the government sees that as a tardy response brought about by the findings of an FDA inspection. Alere is accused of failing to take corrective actions in response to reports of false results and of continuing to sell the Triage devices.

The false negatives and positives may have led patients with suspected heart failure, drug overdose, and other serious conditions to receive inappropriate clinical management. 

“Physicians who work to treat patients with suspected myocardial infarctions rely upon devices such as Alere’s Triage Cardiac products for quick and accurate readings," Stephen Schenning, acting U.S. attorney for the District of Maryland, said in a statement. “When manufacturers such as Alere make changes to the specifications that affect the product’s reliability without informing physicians or the FDA, patient care is put at substantial risk.”

That is what got the FDA involved in 2012. The financial settlement relates to the business side of Alere’s actions. The government alleges Alere’s Triage sales to Medicare, Medicaid, and other federal healthcare programs from January 2006 to March 2012 amount to false claims as it was “knowingly selling materially unreliable point-of-care diagnostic testing devices.”

To settle the allegations, Alere has agreed to pay $33.2 million. Around $28 million of the settlement will go to the federal government, with the remainder returning to individual U.S. states that jointly funded Medicaid Triage claims. Amanda Wu, an Alere senior quality analyst turned whistleblower, is receiving $5.6 million. Alere settled without admitting liability.

As reported by FierceMedTech 

https://tinyurl.com/yc9dtljg

Trump Signs 2018 Budget, With Some Big Wins for Healthcare

The Department of Health and Human Services (HHS) is set to receive $78 billion, a $10 billion increase. The Centers for Medicare & Medicaid Services(CMS) would receive $4 billion for administrative expenses, which congressional appropriators said  is the same as in 2017, and "sufficient to maintain all core operations and services.

The bill does not provide new funding for the Affordable Care Act (ACA) and continues to block the federal government from funding the risk corridor program, which seeks to protect insurance companies from higher than expected costs on the state insurance exchanges.

The bill would also require CMS to notify congressional committees 2 days before any ACA-related data or grant opportunities are released to the public; require the administration to publish ACA-related spending by category since its inception; and require the administration to publish information on the number of employees, contractors, and activities related to the ACA.

Opioid Crisis, Mental Health Big Winners

Funding to address the opioid crisis was given a $2.55 billion, or 244%, increase, to $3.6 billion. Still, that is far less than the $10 billion annually that many healthcare and substance use providers and public health officials have said is necessary.

After first suggesting he may veto the new budget bill passed by Congress yesterday, President Donald J. Trump signed the huge $1.3 trillion budget bill today that will fund the federal government through the rest of its fiscal 2018 year, including some big increases for health programs and money to fight the opioid crisis, flouting cuts that had been called for by the president.

Trump had threatened to veto the bill because it did not include money for some of his signature requests, including a wall on the border with Mexico and a fix to the Deferred Action for Childhood Arrivals (DACA) program that has allowed some children who were brought to the United States illegally to stay in the country.

The House of Representatives approved the bill by a 256-167 vote yesterday and the Senate approved it 65-32 late last night,  after Sen. Rand Paul (R-KY) relented on his apparent threat to withhold his vote over what he called excessive spending.






Trump Signs 2018 Budget, With Some Big Wins for Healthcare

Big Data and Machine Learning in Health Care | Clinical Decision Support | JAMA | JAMA Network

Nearly all aspects of modern life are in some way being changed by big data and machine learning. Netflix knows what movies people like to watch and Google knows what people want to know based on their search histories. Indeed, Google has recently begun to replace much of its existing non–machine learning technology with machine learning algorithms, and there is great optimism that these techniques can provide similar improvements across many sectors.

It is perhaps more useful to imagine an algorithm as existing along a continuum between fully human-guided vs fully machine-guided data analysis. To understand the degree to which a predictive or diagnostic algorithm can said to be an instance of machine learning requires understanding how much of its structure or parameters were predetermined by humans. The trade-off between the human specification of a predictive algorithm’s properties vs learning those properties from data is what is known as the machine learning spectrum. Returning to the Framingham study, to create the original risk score statisticians and clinical experts worked together to make many important decisions, such as which variables to include in the model, the relationship between the dependent and independent variables, and variable transformations and interactions. Since considerable human effort was used to define these properties, it would place low on the machine learning spectrum (#19 in the Figure and Supplement). Many evidence-based clinical practices are based on a statistical model of this sort, and so many clinical decisions in fact exist on the machine learning spectrum (middle left of Figure). On the extreme low end of the machine, learning spectrum would be heuristics and rules of thumb that do not directly involve the use of any rules or models explicitly derived from data (bottom left of Figure).

It is no surprise then that medicine is awash with claims of revolution from the application of machine learning to big healthcare data. Recent examples have demonstrated that big data and machine learning can create algorithms that perform on par with human physicians.¹ Though machine learning and big data may seem mysterious at first, they are in fact deeply related to traditional statistical models that are recognizable to most clinicians. It is our hope that elucidating these connections will demystify these techniques and provide a set of reasonable expectations for the role of machine learning and big data in healthcare.

Machine learning was originally described as a program that learns to perform a task or make a decision automatically from data, rather than having the behavior explicitly programmed. However, this definition is very broad and could cover nearly any form of data-driven approach. For instance, consider the Framingham cardiovascular risk score, which assigns points to various factors and produces a number that predicts 10-year cardiovascular risk. Should this be considered an example of machine learning? The answer might obviously seem to be no. Closer inspection of the Framingham risk score reveals that the answer might not be as obvious as it first seems. The score was originally created² by fitting a proportional hazards model to data from more than 5300 patients, and so the “rule” was in fact learned entirely from data. Designating a risk score as a machine learning algorithm might seem a strange notion, but this example reveals the uncertain nature of the original definition of machine learning.

There is no doubt that  'machine learning', artificial intelligence will gradually intrude upon our routines almost unnoticed, just as chatbots already have done so.





Big Data and Machine Learning in Health Care | Clinical Decision Support | JAMA | JAMA Network

What Happens When Doctors Only Take Cash | Time.com

Coming very soon to your city..Direct pay...

When Art Villa found out, after one too many boating accidents, that he needed a total knee replacement, he began asking around to see how much it would cost. The hospital near his home in Helena, Mont., would charge $40,000 for the procedure, he says. But that didn't include the anesthesiologist's fee, physical therapy or a stay at a rehabilitation center afterward. A 2015 Blue Cross Blue Shield study found that one hospital in Dallas billed $16,772 for a knee replacement while another in the same area charged $61,585.

It was in the midst of this confounding research that Villa, who's 68, heard about the Surgery Center of Oklahoma, whose business model is different from that of most hospitals. There, the all-inclusive price for every operation is listed on the website. A rotator-cuff repair for the shoulder costs $8,260. A surgical procedure for carpal tunnel syndrome is $2,750. Setting and casting a basic broken leg: $1,925.

What Happens When Doctors Only Take Cash | Time.com

Uber launches healthcare platform | Healthcare Dive

"Every year an estimated 3.6 million Americans miss their appointments due to a lack of reliable transportation1. At Uber, we recognize that the path to health may not be easy, but we know the road to care can be."

“Within days of using Uber Health to arrange trips for our patients, we stopped using traditional transportation services. Coordination is seamless for us and rides are easy for patients.”

• The ride-sharing company Uber is officially launching a new platform for providers to use the app to get patients to their facilities.
• The dashboard, Uber Health, allows a healthcare worker to book a ride on demand or schedule a future ride for a patient. The passenger is alerted by text or phone call with trip details.
• The product has been tested by about 100 hospitals and doctor's offices so far, according to The Atlantic.
• The news may not come as a shock, but it does draw a line in the sand for competitors.
  Lindsay Elin, director of federal and community affairs at Uber, told Connected Health Conference in 2016 that the company was investing in a team to work solely on healthcare. 
  "I'd say there are two major things driving Uber's interest," Naveen Rao, health innovation analyst and founder of Patchwise Labs told Healthcare Dive.
  "First, they see how much Lyft has rolled up their sleeves in healthcare, so the official trigger was a simple reaction to their main competitor. Second, is they've been involved as an enabling partner in the non-emergency medical transport space for a couple of years now and seen the demand." 
  Companies like Veyo are targeting Medicaid and Medicare patients and Circulation is offering a platform connecting ride-share services like Uber and Lyft for NEMT.Ralph Decaro, Manhattan Centers for Women's Health

One study found when Uber enters a city, ambulance use decreases by at least 7%. However, using Uber as an ambulance can put a driver in an awkward position for suddenly taking on a job they weren't trained for.

Earlier this year, Uber and MedStar Health announced a partnership aimed to help alleviate patient no-shows for the Columbia, MD-based health system while presenting it as a forward-thinking, digital-savvy operation. With about a year's worth of experience under the partnership's belt, representatives from both Uber and MedStar shared their insights into the partnership and where such collaborations are going at the Connected Health Conference on Monday in the Washington, DC area.

Getting there for care

"Half our battle is getting the patient to the appointment," Pete Celano, director of consumer health initiatives at MedStar Institute for Innovation, said at a panel discussion on cities that promote health. Missed appointments are a costly problem for health plans and physician offices, with some estimates as high as $150 billion a year in the U.S., according to a Washington Business Journal report from earlier this year, a stat Lindsay Elin, director of federal and community affairs at Uber, also shared during the panel. An estimated 3.6 million people in the U.S. miss or delay medical care each year because of issues related to transportation.

For years, MedStar used taxis in effort to reduce no-shows. However, according to Celano, taxis came with three issues: They were expensive, clunky from an operations perspective and drivers historically wouldn't go the extra mile for patients.

MedStar was the first healthcare provider to partner with Uber but Elin said there has been increased interest from other healthcare providers. In fact, Uber is investing in the creation of a small team at the company that will do nothing but work with healthcare providers, Elin stated. Currently, Uber is doing over 5 million rides a day, she shared, adding 75% of the U.S. population lives in a county that has access to Uber. "We firmly believe with partnerships with healthcare providers, senior centers [and] transit agencies that we can do even more and reach more people," Elin said.

How it's working

While the partnership started in January beginning with UberX services, Uber created a a dashboard tool called UberCENTRAL with MedStar. The product allows healthcare providers to request and manage a ride on behalf of their patient who doesn't need to own a smartphone, an important fact to consider when dealing with low-income patients. MedStar moved to the UberCENTRAL platform two months ago.

Celano stated the system is already seeing returns on the partnership. With UberX, for example, the cost to the system is about 60% of the cost of a cab in DC, Northern Virginia or Maryland, according to Celano. In addition, using an UberX means having the ability to hail a car inside an hour which reduces the chance of an appointment going unfilled.

"For patients who can afford it, we say 'Please Uber if and as you want to,'" Celano said. "It could be less expensive to go to Georgetown University Hospital for example on an Uber from most places than to park there, if we even have parking spots available."

For patients with a medical and financial need (about 30% of the patients in the U.S. health system), MedStar can cover the Uber transportation fee. About half of indigent patients are able to get a ride to the facility, Celano shared. "People ask me how it's going and I say it's all about the power of going door-to-door," he said. The average roundtrip cost is $18 which can move an appointment that does not occur to one that does occur, whereby a given healthcare system can recognize new revenue or cost savings. These face-to-face visits can help result in better health outcomes for patients, Celano indicated.

We can expect more innovation cross-over from consumer oriented technology into the health space.

Uber launches healthcare platform | Healthcare Dive

Measuring What Matters and Capturing the Patient Voice.

Incorporating the patient voice into health care delivery has proved challenging—particularly when there is little agreement about how to define and discuss the concept nor about how to measure its impact. NEJM Catalyst convened an in-person roundtable to address these issues in depth. The roundtable and an accompanying survey of our Insights Council point the way toward a framework for defining the patient voice and integrating it into care delivery.  Some have called this Patient-Centered Medicine.



At the same time  it assumes the physician ear is tuned to the same frequency. In the background, and at times many other voices are present. Some are wanted, most are extraneous, disruptive and irrelevant to physicians. After all physicians spend most of their time listening.

While communication is a good thing we must all master becoming better physicians, most of these interactions are distracting at the least. During out daily routine we manage to synthesize or eliminate these Voices



During a Roundtable sponsored by the NEJM Catalyst this article attempts to organize the cacaphony of voices.

Measuring What Matters and Capturing the Patient Voice


Measuring What Matters and Capturing the Patient Voice.pdf

Anthem Calls On Eye Surgeons To Monitor Anesthesia During Cataract Surgery | California Healthline

Cost Containment overrides Safety

If you need cataract surgery, your eye surgeon may have to do double duty as your anesthetist under a new policy by health insurer Anthem. In a clinical guideline released this month, the company says it's not medically necessary to have an anesthesiologist or nurse anesthetist on hand to administer and monitor sedation in most cases.

Some ophthalmologists and anesthesiologists say the policy jeopardizes patient safety, and they are calling on Anthem to rescind it.

"The presence of anesthesia personnel is one of the key ingredients in the patient safety and effectiveness of cataract surgery today," says Dr. David Glasser, an ophthalmologist in Columbia, Md., who is secretary for federal affairs at the American Academy of Ophthalmology, a professional group for eye physicians and surgeons. "An ophthalmologist cannot administer conscious sedation and monitor the patient and do cataract surgery at the same time."

Anthem, which offers commercial insurance plans in 14 states, says anesthesia needs vary and so should coverage. According to a statement from the company:

"Anthem's Medical Policy and Technology Assessment Committee, a majority of whom are external physicians, reviewed the available evidence addressing the use of general anesthesia and monitored anesthesia care for cataract surgery. According to the literature reviewed, there is no one definitive approach regarding the use of anesthesia for cataract surgery and patient-specific needs should be taken into consideration as well as potential risk of harm to individuals who are sedated during surgical procedures."

Medicare, the health care program for people age 65 and older, covers cataract surgery, including anesthesia services.

A cataract, typically related to aging, is caused by clumps of protein that cloud the lens of the eye and can distort vision. During a cataract operation, the surgeon makes an incision in the surface of the eye with a laser or blade and then uses a tool to break up the clouded lens, pull it out and replace it with an artificial one.

Cataract surgery is common. More than half of Americans have either had a cataract or had cataract surgery by the time they reach age 80, according to the National Eye Institute.

Surgery is typically performed on an outpatient basis and takes less than an hour. Though drowsy while sedated, patients are generally conscious during the procedure and can hear what's said to them and speak if necessary.

Eye surgeons often have an anesthesiologist or a nurse anesthetist present to administer intravenous drugs to help keep the patient relaxed and ensure they don't move during the operation as well as monitor their vital signs and adjust medication as necessary.

Anthem's new policy states that this type of monitored anesthesia care is medically necessary only if the patient is under 18 years old, or is unable to cooperate or communicate because of dementia or other medical conditions, can't lie flat, has known problems with anesthesia, or if a complex surgery is anticipated.

But some ophthalmologists and anesthesiologists disagree.

"I wouldn't even consider doing a cataract surgery without an anesthesiologist or nurse anesthetist in the room," says Dr. David Aizuss, an eye surgeon who is president-elect of the California Medical Association. "If you're working inside the eye it's a very confined space, and if the patient gets agitated and starts moving around you have to get the equipment out of the eye very quickly."

Although Anthem posted the new policy online, providers are seeking clarification from the company about the timing of its implementation in their states, physicians said.

Until then, some practices are taking no chances. At the Freedom Vision Surgery Center in Encino, Calif., where Aizuss practices, Anthem patients who come in for cataract surgery are asked to pay $400 out-of-pocket upfront for anesthesia services.

Professional groups representing California eye physicians and anesthesiologists have written to Anthem requesting the policy be rescinded. In addition, the California Medical Association has lodged complaints with state regulators.

This isn't the first time Anthem has come under scrutiny for changes to its clinical guidelines that some have charged help the company's bottom line at patients' expense. Last year, the company said it would no longer pay for emergency department visits it later determined were not emergencies. Then in September it said it would no longer pay for imaging tests like MRIs in many cases if patients got them at hospital-owned centers rather than independent imaging centers.

Last week, Modern Healthcare reported that the company says it was modifying its ER rule so that certain types of visits would always be paid for, including those by patients who are directed to the emergency department by their provider or have recently had surgery.

Some safety experts say they were concerned about Anthem's new policy, even for routine cataract surgeries.

"If you're putting a knife in my eye, that's not routine for me," says Leah Binder, president and CEO of the Leapfrog Group, a nonprofit organization that advocates for improved safety and quality at hospitals. Noting that anesthesiologists and nurse anesthetists were pioneers in the patient safety movement, she says there are better ways for Anthem to save money than shutting them out of the operating room.

"How about identifying the surgeons who have the highest complication rates, and letting patients know about them?" she suggested.

Original Article   

Anthem Calls On Eye Surgeons To Monitor Anesthesia During Cataract Surgery | California Healthline

For Natives Americans, In Indian Health Service And Outside It : Shots - Health News : NPR

The life expectancy of Native Americans in some states is 20 years shorter than the national average.

There are many reasons why.

Among them, health programs for American Indians are chronically underfunded by Congress. And, about a quarter of Native Americans reported experiencing discrimination when going to a doctor or health clinic, according to findings of a poll by NPR, the Robert Wood Johnson Foundation and Harvard T.H. Chan School of Public Health.

Margaret Moss, a member of the Hidatsa tribe, has worked as a nurse for the Indian Health Service and in other systems. She now teaches nursing at the University of Buffalo.

She says she has seen racism toward Native Americans in health care facilities where she's worked, and as a mom trying to get proper care for her son.

Once, when she was on a health policy fellowship with a U.S. Senate committee, Moss' son had a broken arm improperly set at a non-IHS health facility in Washington, D.C.

She asked the physician about options to correct it, but he told her it was fine, she said. "Even when I, as an educated person using the right words, was saying what needed to happen, [he] didn't want to do anything for us, even though we had a [health insurance] card."

HEALTH

For Native Americans, Health Care Is A Long, Hard Road Away

Moss then reluctantly pulled out a business card with the Senate logo, she recalled, and was instantly transformed in the doctor's eyes from "this American Indian woman with my obviously minority son" to someone he could not afford to dismiss.

"It wasn't until the person ... felt they could get in trouble for this ... then the person did something," said Moss. "I felt like it was racism. Not everybody has a card they can just whip out."

She says she feels discrimination is more overt, "in areas where American Indians are known about," like the Dakotas and parts of the American Southwest, but also exists in places without big tribal populations.

In the NPR poll, Native Americans who live in areas where they are in the majority reported experiencing prejudice at rates far higher than in areas where they constituted a minority.

In places where there are few American Indians, Moss says, "people don't expect to see American Indians; they think they are from days gone by, and so you are misidentified. And that's another form of discrimination."

Health care systems outside the Indian Health Service generally see very few Native American patients, because it's so hard for American Indians to access care in the private sector. A lot of that has to do with high poverty and uninsured rates among American Indians, who also often live in rural areas with few health care providers.

"The strikes against people trying to get care are huge: geographic, transportation, monetary," Moss says.

A persistent myth inside and outside Indian Country is that Native Americans get free health care from the federal government.

A persistent myth inside and outside Indian Country is that Native Americans get free health care from the federal government.

Anna Whiting Sorrell, a health care administrator for her tribes, says she is optimistic that the Affordable Care Act will make a big difference for Native Americans. It gives lower-income people access to affordable insurance coverage outside the IHS. Many Natives Americans who weren't eligible for Medicaid before the ACA now are, too.

Moss is more skeptical that the ACA will make a big difference, in part because of entrenched institutional discrimination toward Native Americans in healthcare.

"Until attitudes change," Moss says, "we're still going to be in a sad situation."

For Natives Americans, In Indian Health Service And Outside It : Shots - Health News : NPR