US health official reveals fentanyl almost killed his son

“The head of the nation’s top public health agency says the opioid epidemic will be one of his priorities, and he revealed a personal reason for it: His son almost died from taking cocaine contaminated with the powerful painkiller fentanyl.
“For me, it’s personal. I almost lost one of my children from it,” Dr. Robert Redfield Jr. told the annual conference of the National Association of County and City Health Officials.
The AP viewed a video of his speech, which he delivered Thursday in New Orleans. Redfield declined to speak about it Monday, except to say in a statement: “It’s important for society to embrace and support families who are fighting to win the battle of addiction — because stigma is the enemy of public health.”
Redfield mentioned his younger son while talking about his priorities for the U.S. Centers for Disease Control and Prevention, where he started as director in March. He listed the opioid crisis first, calling it “the public health crisis of our time.”
Public records show that the son, a 37-year-old musician, was charged with drug possession in 2016 in Maryland. The outcome of the case is not available in public records.” (A)

“Sen. Elizabeth Warren (D-MA) wants to know what, exactly, President Donald Trump is doing in response to the opioid epidemic.
Experts and observers have concluded that your efforts to address the opioid crisis are ‘pathetic’ and ‘ambiguous promises’ that are ‘falling far short of what is needed’ and are ‘not … addressing the epidemic with the urgency it demands,’” Warren wrote in a new letter to Trump. “I agree, and I urge you to move quickly to address these problems.”
The letter points out that Trump, on the campaign trail and as president, has repeatedly promised to take serious action on the crisis, vowing to “liberate our communities from this scourge of drug addiction” and declaring the opioid epidemic a national public health emergency in October.
Since then, the administration has renewed the declaration twice — in January and April. And the declaration will require another renewal next week. But experts have complained that the administration has taken little action to actually leverage the declaration and take serious action on the opioid epidemic, with Stanford drug policy expert Keith Humphreys previously describing the administration’s actions as “pathetic.”
“Six months after you first declared the opioid crisis a public health emergency, you pledged that ‘we will be spending the most money ever on the opioid crisis,’” Warren wrote. “Yet your claim appears to have no basis in reality. While the U.S. Senate reached a budget agreement earlier this year to spend an additional $6 billion over two years to address the opioid crisis, your Administration’s own proposals to address the opioid crisis, including your most recent opioid initiative policies released on March 19th, lack commitments of federal funds.”
The letter asks Trump to clarify what actions his administration is taking, as well as whether he will extend the public health emergency declaration next week and what other steps he will take if so. (Read the full letter.)” (B)

“A Senate report released Thursday lays out systematic failures in the reporting system for suspicious opioid orders, faulting some drug distributors and manufacturers for their roles and criticizing the Drug Enforcement Administration for a years-long lull in enforcement actions.
The findings, the latest in a series of reports from Sen. Claire McCaskill (D-Mo.), the top Democrat on the Senate’s leading oversight committee, pointed in particular to disparities between two leading drug distributors: McKesson and AmerisourceBergen.
The two distributors shipped nearly identical volumes of opioids to Missouri between 2012 and 2017: roughly 650 million doses each.
But the number of orders each company flagged to authorities as suspicious were nowhere close: 224 from AmerisourceBergen and 16,714 from McKesson.
Taken together, the “Big Three” group of distributors, including Cardinal Health, sent 52 dosage units for each of the state’s citizens in 2015.
“It’s staggering. Over six years we averaged 260 pills for every man, woman, and child in Missouri,” McCaskill said in a statement. “The opioid crisis these pills have fueled is a failure of policy and oversight by the government and a failure of basic human morality on the part of many pharmaceutical companies and distributors — a failure that has destroyed families and communities all over our state.” (C)

“Last month, Democratic Sen. Claire McCaskill of Missouri introduced a bill going after, of all things, nonprofits. The word “nonprofit” tends to conjure images of idealistic charities committed to saving vanishing forests, teaching underprivileged kids or counseling the victims of sexual assault. The reality can be far different.
McCaskill’s proposed legislation follows from a scorching report she released in February detailing how opioid manufacturers funneled almost $9 million over five years to various advocacy groups that amplified messages and policies favorable to their industry. Many of these nonprofits had lobbied against laws to decrease opioid use and tried to downplay charges against physicians and pharmaceutical industry officials responsible for over-prescribing. As years of evidence began to confirm we were facing an epidemic, the Centers for Disease Control and Prevention issued the first national standards to limit opioid prescriptions for chronic pain in 2016. Many of these corporate-funded groups immediately began to criticize the new rules.
McCaskill’s bill, the Patient Advocacy Transparency Act, would require pharmaceutical manufacturers to disclose their payments to patient advocacy groups, professional societies and other nonprofit organizations….” (D)

“The Justice Department is expanding its efforts to combat the opioid abuse epidemic to drugmakers, it announced Wednesday.
In the finalization of an April proposal, the Drug Enforcement Agency (DEA) may cut back the amount of a drug allowed to be produced in a given year if it believes a particular company’s opioids are being diverted for misuse.
The goal is to encourage opioid manufacturers to become more vigilant about how their drugs are being used, they said. It will also help the DEA respond to changing drug threats and reduce the availability of potentially addictive drugs outside legitimate uses while ensuring its availability for genuine medical, scientific, research and industrial needs…
“DEA must make sure that we prevent diversion and abuse of prescription opioids,” Attorney General Jeff Sessions said in a statement. “By taking diversion of these opioids into account, will allow the DEA to be more responsive to the facts on the ground. More importantly, it will help us stop and even prevent diversion from taking place.” (E)

“Beyond good medical management, the FDA recognized it too has a part to play in ameliorating the opioid crisis, citing its revised blueprint for drug manufacturer training to be finalized later this year and its innovation challenge to foster development of novel, pain-treating medical devices. At the same time, payers like Aetna, Anthem and Cigna are making their own efforts to combat overprescribing.
Gottlieb also said the FDA will work to encourage medical professional societies to develop evidence-based guidelines on correct opioid prescribing practices to reduce careless or superfluous dispensing. “Unfortunately,” Gottlieb writes, “the fact remains that there are still too many prescriptions being written for opioids.”..
And despite limited progress, costs in dollars and deaths are still rising.
Opioid addiction and overdose treatment costs in large employer-based health plans increased by a factor of nine between 2004 and 2016, even though opioid prescriptions have steadily fallen since their peak in 2009.
The rate of drug overdose deaths involving synthetic opioids such as fentanyl doubled between 2015 and 2016. In 2016 alone, there were more than 63,600 drug overdose deaths in the U.S.
Experts agree that a multifaceted and comprehensive approach is needed to slow the cresting opioid epidemic. Bipartisan legislation is currently being workshopped in Congress, with measures ranging from restructuring grants to help states boost addiction treatment in hard-hit areas to removing barriers to non-addictive medication research.
It’s a “difficult challenge both for the FDA and for providers,” Gottlieb admitted in the statement. “We don’t want to act in ways that are poorly targeted.” (F)

“A lawsuit filed on behalf of Tennessee taxpayers against Oxycontin-maker Purdue Pharma reveals how they fueled the opioid epidemic to snare profits. Michael Schwab/USA TODAY NEWTWORK – TENNESSEE
The marching orders for Purdue Pharma’s 87 Tennessee opioid marketers from their bosses each day were simple: “Sell hope in a bottle” and “always be closing,” newly revealed internal records show.
A lawsuit unsealed this week in Knox County Circuit Court filed on behalf of Tennessee taxpayers accuses Purdue Pharma — a family-owned firm that has turned OxyContin into a Forbes-rating fortune — of intentionally fueling the opioid epidemic that has claimed thousands of lives.
The lawsuit, filed by Tennessee Attorney General Herbert H. Slatery III, uses Purdue’s own company records and its staffers’ own words to show the firm’s founders and executives pushed medical providers to prescribe increasingly high doses of OxyContin for longer periods — even after Purdue promised the state it would stop.” (G)

“The Massachusetts attorney-general opened up a new front in the legal fight last month when she sued Purdue’s current and former executives and directors — including several Sacklers and a board member at GlaxoSmithKline, for their alleged role in fuelling the US opioid addiction epidemic. ..
This crisis is killing people, too — 42,200 died from overdoses in 2016 — but many of the 2.6m Americans with opioid abuse disorders will cycle in and out of addiction for decades, which will put long-term strain on public services.
Already, the cracks are starting to show. Addiction treatment in the US is provided mainly by a patchwork of thousands of independent operators more used to dealing with alcoholism than opioid abuse. Their inability to handle the epidemic means that police are fighting more drug-related crime, emergency rooms are at breaking point, and child protection offers are scrambling to find homes for displaced kids. A recent report estimated that the crisis is costing Ohio up to $8.8bn a year — more than its annual budget for primary and secondary education combined.
But if the financial case for restitution is clear-cut, the legal one is less so. While there was a direct link between the sale of cigarettes and lung cancer deaths, many people suffering from opioid addiction have since progressed from prescription painkillers to heroin. Dealers’ tendency to cut the street drug with fentanyl, a dangerous synthetic opioid imported from China, is responsible for a rise in overdoses.
Other actors also share some blame, from the US Food and Drug Administration, which approved the painkillers, to the doctors who prescribed pills so liberally and the wholesalers that did not report suspiciously large orders. Then there are the academics who authored studies — paid for by pharma companies — concluding there is hardly any risk of addiction. The many links in the chain will make it more difficult for lawyers to show the companies are the prime suspects — the “proximate cause” of the epidemic.” (H)

(A) US health official reveals fentanyl almost killed his son, by Mike Stobbe, US health official reveals fentanyl almost killed his son, https://www.apnews.com/8cc276150f7e4860bc05bdd4ac04d5e0
(B) Elizabeth Warren wants answers about Trump’s “pathetic” response to the opioid epidemic, by German Lopez, https://www.vox.com/policy-and-politics/2018/7/19/17590434/elizabeth-warren-trump-opioid-epidemic
(C) System for reporting suspicious opioid orders repeatedly failed, report finds, by LEV FACHER, https://www.statnews.com/2018/07/12/senate-report-opioids-distribution/
(D) Big Pharma is quietly using nonprofits to push opioids, by PAUL D. THACKER, http://www.latimes.com/opinion/op-ed/la-oe-thacker-funders-opioid-misinformation-20180719-story.html#
(E) DOJ expands focus to drugmakers in efforts to curb opioid epidemic, https://www.fiercehealthcare.com/hospitals-health-systems/doj-finalizes-rule-opioid-production-limits?mkt_tok=eyJpIjoiWXpCaE4yRXdaVEprWkRjdyIsInQiOiJvVFhGQ2VcL3lBRnNiZ1JUV3AydjZnZDdtSWE4XC9YRW1tVHhuMTRvVE5WZGFJYWRQQ1NMY2xLZkRucW9Id25YNTRnSDRLS0lyWXBzZ2R0TnAxMjZ4QmZZbFwvVnJ4UGMwRWFISE5Zb1kxUGQ3Vm9lcjJPeEh4QTZUVjdxNUp3YnhYeiJ9&mrkid=654508
(F) Gottlieb: FDA seeking ‘right balance’ in regulating opioid prescriptions, by Rebecca Pifer, https://www.healthcaredive.com/news/gottlieb-fda-seeking-right-balance-in-regulating-opioid-prescriptions/527370/
(G) Purdue Pharma pushed opioids as ‘hope in a bottle,’ records show, by Jamie Satterfield, https://www.knoxnews.com/story/news/crime/2018/07/06/purdue-pharma-lawsuit-oxycontin-tennessee-opioids/762143002/
(H) Ending America’s opioid crisis requires more than a moral crusade, by David Crowe, https://www.ft.com/content/cb112920-8079-11e8-bc55-50daf11b720d

Share on LinkedInShare on Google+Share on FacebookTweet about this on Twitter

The new health care Gold Standard” GawandeCare”.

“Jeff Bezos, Warren Buffett and Jamie Dimon did not hire a big-thinking industry outsider to set up a conventional insurance system or haggle with doctors and hospitals over prices. Dr. Gawande was selected to fundamentally change how healthcare is structured, paid for and provided. He was hired to disrupt the industry, to make traditional health plans obsolete, and to create a bold new future for American healthcare…
So, what will the future of Dr. Gawande’s high-profile healthcare venture look like?..
Taking out the trash. It’s estimated that 25 percent of all U.S. healthcare spending (about $765 billion each year) is wasted…
Creating a checklist. Gawande earned national acclaim with his 2009 bestseller, The Checklist Manifesto, inspiring an entire industry to double down on evidence-based medicine…
Being human. In Being Mortal, Dr. Gawande shines an unflattering light on end-of-life care in America, revealing that treatment for our nation’s elderly is often expensive, ineffective and inhumane.
I predict the Bezos-Buffett-Dimon cooperative will become a for-profit company that sells its expertise to dozens, possibly hundreds, of large corporations, each of them eager to offer their employees better healthcare at a lower cost. And once smaller companies see 30 percent improvements in both quality and cost, they too will prefer the new model to the old. And when that happens, the traditional health insurers, hospitals and independent physicians who refuse to change will become obsolete. If you have any doubt, just ask the former CEOs of Kodak or Borders, or the current executives at Yellow Cab, or anyone who has faced the business end of disruptive innovation.
The good news for healthcare’s incumbents is that the change process will likely take five to 10 years to solidify. The bad news is that the clock just started ticking.” (A)

“Dr. Atul Gawande is best known as a surgeon and a writer, but it’s his experience running a Boston-based health research program that may be most relevant to his new role as chief executive of the health care venture spun out of Amazon, Berkshire Hathaway, and JPMorgan Chase.
Ariadne Labs, a partnership between a major Boston hospital and Harvard University, has since 2012 served as a testing ground for projects to improve the quality of health care around the world. The project’s track record, and how Gawande has run it, may be indicative of what’s in store for the company he’ll be heading up starting July 9.
A STAT examination of Ariadne’s work shows that Gawande and his team are willing to push ahead with bold ideas that have the potential to save patients’ lives but don’t always end up working as well as intended in the complex world of health care. It paints a picture of Gawande as a big thinker, ready to empower others and reluctant to micromanage.
“Our tools do work to improve the quality of care, but, in some cases, don’t achieve the result hoped for,” said Deborah O’Neil, director of communications for Ariadne. “We recognize there is more to do.”..
Many of Ariadne’s projects focus on checklists — chief among them, the “safe surgery” checklist, which has its roots in research that Gawande began before Ariadne’s official founding. He developed the checklist along with Berry, and in 2007 and 2008 they tested it in eight hospitals around the world.
The goals of the checklist are twofold, Berry said. “[It was] a conscious attempt to combine both process checks and prompts for team communication.”
At Aspen, Gawande said that checklists are a first step in moving health care from an individual to a team exercise.
Added Tsai, “You need to learn from both the successes and the failures … [and] I think it’s that level of nuance and transparency, which, I think, makes him unique.” (B)

“After interviews with leaders across the world of health care, STAT has identified five challenges Gawande will take on in his new role. Each one carries substantial risks and complications that range from the political, to the personal, to the professional and ethical:
1. Challenge: Controlling costs while improving quality
How: Leverage technology to inform patients, demand lower prices
Risk: Coming off as a corporate stooge, rather than a steward of better health
2. Challenge: Lowering hospital prices
How: Shift care to lower-cost settings, get more employers to join the effort
Risk: Alienating academic centers that dominate some markets
3. Challenge: Cutting out the middlemen
How: Create innovative business solutions that streamline health care’s supply chain
Risk: Alienating key stakeholders needed to access or serve customers
4. Challenge: Attacking chronic disease; and variations in care
How: Leverage technology to improve patient knowledge, contract with select providers
Risk: Changing patient behavior is the hardest thing to do in health care, and may prove costly
5. Challenge: Writing for the New Yorker while leading a national effort to reform health care
How: Carefully selecting subjects and avoiding conflicts
Risk: Compromising the progress of the new venture, or undermining his credibility as a journalist” (C)

“These accomplishments, while esteemed, are merely scratching the surface. Here are nine lesser known things about Dr. Gawande.
6. He tried (and failed) as a rock & roller. Dr. Gawande had a rock band that had many names, one of which was “Thousands of Breaded Shrimp,” he told Boston Magazine. Despite the “terrible” songs he wrote, his girlfriend Kathleen Hobson stayed with him. The two met at Stanford and married in 1992. Dr.
8. He is a recognized genius. Dr. Gawande was named a MacArthur genius in 2006, receiving a “no-strings attached” grant from the John D. and Catherine T. MacArthur Foundation for “extraordinary originality and dedication in their creative pursuits and a marked capacity for self-direction.”” (D)

“In one of his first actions as a CEO, Gawande is planning to travel across the country to meet with the employees he will serve through the health care venture being formed by Amazon, JPMorgan Chase, and Berkshire Hathaway.
Gawande intends to hold one-on-one meetings with a variety of employees who work for the sprawling companies, with the goal of understanding the breadth of their needs and the challenges they face in getting care, according to a person familiar with the plan. The expedition is set to take place in coming weeks and will be done without the involvement of the high-profile leaders of the three companies: Jeff Bezos, Jamie Dimon, and Warren Buffett.
The listening tour will put Gawande face to face with the enormity of his task: lowering costs and improving care for 1.2 million people whose incomes and health struggles are as diverse as their geography. The group includes fulfillment center workers and bank tellers, software engineers and store clerks. Berkshire Hathaway owns companies ranging from Duracell to GEICO to Acme Brick, with a workforce spread through factories, office towers, and shopping malls in rural and urban areas nationwide.” (E)

(A) Why Atul Gawande Will Soon Be The Most Feared CEO In Healthcare, by Robert Pearl, https://www.forbes.com/sites/robertpearl/2018/06/25/atul-gawande-ceo/#3a68e210369b
(B) Ariadne Labs: Atul Gawande’s testing ground for new ideas in health care, by Ike Swetlitz, https://www.statnews.com/2018/06/27/inside-ariadne-labs-atul-gawande-testing-ground/?utm_source=Sailthru&utm_medium=email&utm_campaign=Newsletter%20Weekly%20Roundup:%20Healthcare%20Dive%2006-30-2018&utm_term=Healthcare%20Dive%20Weekender
(C) As Atul Gawande steps into a risky health CEO role, here are five challenges he faces, by CASEY ROSS, https://www.statnews.com/2018/07/09/atul-gawande-health-ceo-risks/
(D) 9 lesser known things about Dr. Atul Gawande, by Emily Rappleye, https://www.beckershospitalreview.com/hospital-management-administration/9-lesser-known-things-about-atul-gawande.html
(E) CEO Gawande’s first task: a road trip to hear firsthand about workers’ health challenges, By CASEY ROSS, https://www.statnews.com/2018/07/19/atul-gawande-ceo-listening-tour/

Share on LinkedInShare on Google+Share on FacebookTweet about this on Twitter

Can Kavanaugh Be Trusted on Obamacare?

“In 2011, Judge Brett Kavanaugh was selected at random to rule on whether President Barack Obama’s signature legislative achievement, the Affordable Care Act, was constitutional.
It was a career-defining moment for the aspiring Supreme Court justice, who was 46 at the time. The case promised to be a political bomb splitting two powerful forces. On one side was the Republican Party, which made Kavanaugh a judge and wanted to see the law invalidated under a limited vision of federal authority to regulate interstate commerce. On the other were millions of Americans poised to gain access to health insurance — in some cases for the first time ever — backed by scholars who said axing the law would be a grave error of judicial activism and taint the courts.
While the other two judges on the D.C. Circuit Court of Appeals panel ruled to uphold the law, Kavanaugh dissented and said the lawsuit should be dismissed for lack of standing until after a tax penalty at the heart of the challenge took effect. He cited an 1867 statute known as the Tax Anti-Injunction Act. In doing so, he managed to avoid touching the case on its merits.” (A)

“In two Affordable Care Act (ACA) cases, Kavanaugh dissented from the majority opinion that had rejected a challenge to the ACA. In both, however, he objected only to the reasoning of the court; he agreed with the majority that the complaint against the ACA should have been rejected…
In neither case did Kavanaugh evidence strong opposition to the ACA. After a long discussion of the Tax Anti-Injunction Act in Seven-Sky, Kavanaugh concluded his opinion by musing about the possible invalidity of the mandate under Congress’s commerce power. On the one hand, he entertained arguments that the mandate encroached on state authority and individual rights, but on the other, he suggested that it was a novel approach to providing safety-net services through the private sector. Seeing both sides of the argument, he concluded that the court should avoid a constitutional ruling until the case was properly before it.” (B)

“The heated debate over how Supreme Court nominee Brett Kavanaugh would vote on the Affordable Care Act might not matter. As long as five past defenders of the health care law remain on the nation’s highest court, the odds tilt in favor of it being allowed to stand.
Some Democrats are warning that President Donald Trump’s designee could spell doom for the statute, even as some conservatives are portraying Kavanaugh as sympathetic to former President Barack Obama’s landmark legislation.
But where Kavanaugh would vote if he joins the Supreme Court is less clear than both sides suggest, according to an Associated Press review of the appeals court judge’s decisions, other writings and speeches.
Kavanaugh could get to weigh in on the health care statute if the high court takes up a lawsuit brought by Texas and 19 other states. Those states are seeking to strike down the entire law because the Republican-backed tax overhaul removed fines for not having health insurance.
The Trump administration recently said in that case that it will no longer defend the ACA’s protections for people with pre-existing medical conditions, nor its limits on how much insurers can charge older customers.
But if Chief Justice John Roberts joins the four Democratic appointees in upholding the law — as he did in the two previous challenges — Kavanaugh wouldn’t be the deciding factor. Retiring Justice Anthony Kennedy joined the majority on the second decision, in 2015, for a 6-3 majority.” (C)

“If Kavanaugh is confirmed, he and the court may have to consider a lawsuit by Texas and other states that challenges the Affordable Care Act (ACA)’s health insurance protections for patients with preexisting conditions such as cancer, diabetes, and Parkinson disease.
Supporters of the ACA: Some people have voiced concern that Kavanaugh has publicly discussed fears about how broad the ACA can be and have also noted that he may be the deciding vote on whether Americans with preexisting conditions will continue to receive healthcare.
Critics of the ACA: In 2011, Kavanaugh wrote a narrowly focused dissent from the appeals court’s decision that upheld the law. He did not dissent because he thought the law was unconstitutional; rather, he thought the court lacked the jurisdiction to consider the question according to the Anti-Injunction Act. In the dissent, he wrote that the ACA is “unprecedented” in US history and warned that upholding it would “usher in a significant expansion of congressional authority with no obvious principled limit.”” (D)

“All of which brings us back to the question: Can Brett Kavanaugh be trusted on Obamacare? The answer is an easy, “Yes,” if one reads the above excerpt from his opinion in Seven-Sky. The last sentence tells you all you need to know: “It follows from those two provisions, taken together, that these Affordable Care Act penalties must be assessed and collected ‘in the same manner as taxes.’” Everything discussed in this passage has been rendered moot by Congress, a possibility Kavanaugh discussed in the same opinion. After December 31, 2018, those two provisions can no longer be “taken together” because there will be no tax penalty.
Consequently, the only question left for SCOTUS to decide, when Texas v. United States arrives on its doorstep, is what possible rationale can be used to uphold the individual mandate? The Court has already rejected the Commerce Clause argument. The Republican Congress eliminated the tax effective January 1. Thus, because Judge Kavanaugh is an originalist, he will look to the Constitution for some other legitimate reason to uphold the mandate. He will, of course, come up dry. And that’s why Brett Kavanaugh can be trusted on Obamacare.” (E)

(A) The Artful Dodge That Saved Kavanaugh From Supreme Court Doom, by Sahil Kapur, https://www.bloomberg.com/news/articles/2018-07-16/the-artful-dodge-that-saved-kavanaugh-from-supreme-court-doom
(B) (B) Examining Supreme Court Nominee Kavanaugh’s Health Care Opinions, by Timothy S. Jost, http://www.commonwealthfund.org/blog/2018/supreme-court-nominee-health-care-opinions
(C) Dems see Kavanaugh as Obamacare threat, but law likely safe, by alanna durkin richer and dan sewell, https://abcnews.go.com/Health/wireStory/dems-kavanaugh-obamacare-threat-law-safe-56643576
(D) 5 Things to Know About SCOTUS Nominee Brett Kavanaugh’s Healthcare Views, https://www.ajmc.com/
(E) Can Kavanaugh Be Trusted on Obamacare?, https://spectator.org/can-kavanagh-be-trusted-on-obamacare/

Share on LinkedInShare on Google+Share on FacebookTweet about this on Twitter

Apple, Amazon, Google and Microsoft trajectories for healthcare

PREQUEL
March 18, 2018
Case Study on Disruption/Disintermediation in health care (10 posts)

“After months of speculation about when Amazon would officially enter the drug distribution market, the online retail giant offered a definitive answer on Thursday, announcing the acquisition of the online pharmacy PillPack.
The full-service pharmacy offers presorted packaging and home delivery and provides Amazon with a nationwide distribution network. PillPack holds mail order pharmacy licenses in all 50 states.” (A)

“It seems only natural for the Everything Store to be doing, well, everything. It is also a necessity.
Amazon.com AMZN 0.82% just gave the world a strong reminder of its ambitions. On Thursday, the company announced a new effort to beef up its own package-delivery network by recruiting small-business owners to operate fleets of Amazon-branded vehicles. On the same day, Amazon also announced its acquisition of online pharmacy PillPack for a reported $1 billion.
The latter move inserts Amazon squarely into the $400 billion U.S. prescription drug market. That is likely only part of the company’s health-care ambitions. Amazon is also working with Berkshire Hathaway and JPMorgan Chase on a new venture aiming to reimagine health-care delivery for their own employees, now collectively numbering close to 1.2 million.” (B)

“In the last 24 hours, Amazon announced a program that all but franchises its last-mile deliveries and bought the popular online pharmacy PillPack. At first glance, these may seem like utterly unrelated deals — another case of Jeff Bezos digging into his very deep pockets to reach even further into your life.
Step back, though, and you can see these two developments coming together to make dealing with a pharmacy as easy as thumbing your phone: Place your order and an Amazon-branded truck delivers your amoxicillin, along with tissues, all-natural cough drops and organic chicken noodle soup from Whole Foods.
Right now, going to the pharmacy can be a tough pill to swallow. Get your prescription, schlep to the drug store, wait in line. It’s even worse when you’re fevered and sneezing and generally feeling lousy. Bezos is betting you’d rather have those meds delivered to your door, along with everything else Amazon sells, in almost no time at all.
“This is going to have serious implications for the brick-and-mortar retail pharmacies,” said Arielle Trzcinski, a senior analyst at Forrester who covers health care and technology.” (C)

“E-commerce retail giant Amazon (Nasdaq: AMZN) is making waves into the health care space, but the company has also been building a means to service providers in a more traditional way.
Amazon Business, the retailer’s B2B service line, is shaping the supply chain process for health care providers by enabling them to order in a familiar way online. After launching Amazon Business three years ago, the platform has more than 1 million business customers that use it to order everything from office supplies to certain medical equipment.
While Amazon doesn’t break out its customer base by provider type, the business platform services home health care providers, doctors, nursing homes, skilled nursing facilities, ambulatory surgery centers and more.
“[We] offer [the service] to businesses of all sizes—single doctors and offices with five employees or a 10,000-employee system, and everything in between,” Chris Holt, global health care leader at Amazon Business, told Home Health Care News. “[We have] home health customers and nursing homes, that’s right in our mid-size sweet spot, where it’s a company that maybe doesn’t have huge purchasing power, a lot of employees and a consumes a lot of products.”” (D)

“Deep inside Amazon, a secretive group called Grand Challenge, led by the creator of Google Glass, is working on a series of bold projects involving cancer research, medical records and last-mile delivery, according to people familiar with the matter.
Similar to Alphabet’s experimental research lab, X (formerly Google X), Grand Challenge is a research team set up to explore ambitious new ventures that can eventually expand Amazon’s already wide footprint, said the people, who asked not to be named because the work is confidential.
The group, which also operates under the monikers 1492 and Amazon X, has added over 50 people since 2014, when Babak Parviz left Google X to head up the effort. The makeup of Parviz’s team illustrates how far out Amazon is going to pursue innovative projects, beyond its primary businesses of e-commerce, consumer devices and Amazon Web Services, while still using resources from those divisions for some of its initiatives…
One person with knowledge of Grand Challenge said the group gets to take a longer time horizon than teams that focus on commercial products. An internal job listing for Grand Challenge quotes astronomer Carl Sagan in the post: “Somewhere, something incredible is waiting to be known.” (E)

“Microsoft has been playing in the healthcare waters for some time now. Since wading into the wearables market in 2014, the company has teamed up with Twist BioScience on the capabilities of DNA digital data storage, partnered with UPMC to create innovative AI-enabled care delivery products and collaborated with Cigna to leverage Microsoft’s HoloLens technology for interactive game-based health screenings.
As healthcare’s digital transformation continues, many organizations are looking to the cloud to modernize their IT infrastructures, EHRs and data analytics capabilities to foster value-based care. Microsoft Healthcare stated it will draw on the company’s AI and the cloud expertise to create products that tackle those goals…
“We are taking concrete steps with an initial ‘blueprint’ intended to standardize the process for the compliant, privacy-preserving movement of a patient’s personal health information to the cloud and the automated tracking of its exposure to machine learning and data science, for example to support external audit,” Lee wrote.”” (F)

“Many eyes are watching the likes of Amazon, Apple, Google, Microsoft and other tech stalwarts for some kind of signal about their healthcare intentions. While some moves are already out in the open, such as Apple Health Records and Amazon Web Services expressing interest in longitudinal health records and analytics, the companies also have patents that potentially foretell the future.
As of Jan. 23, Amazon-owned 7,096 U.S. patents, according to the United States Patent and Trademark Office.
In addition, Amazon Technologies, Inc., had filed and published 870 patent applications in the U.S. as of Jan. 23, and Amazon.com, Inc., had filed and published 16 patent applications.
Amazon has been granted patents for thousands of inventions spanning one-click buying, drones, virtual-reality mirrors and Alexa, the company’s AI–powered voice assistant.
Google, for instance, – with 186 patents – focused mostly on investments for DeepMind, its artificial intelligence technology, and also on Verily, its healthcare and disease research entity among its 186 patents, according to the new Kalorama report.
Apple filed 54 patents to turn its iPhone into a medical device that can monitor biometric data such as blood pressure and body fat levels and to develop algorithms to predict abnormal heart rates. Microsoft filed 73 patents based on expanding its AI capabilities and developing monitoring devices for chronic diseases.
Microsoft, meanwhile, has a number of projects that are impacting – or will impact – the digital health arena including: Microsoft Genomics, Microsoft Azure Security and Compliance Blueprint. The tech giant is also expanding Microsoft’s Intelligent Network and plans to create an AI-focused network in cardiology.” (G)

“Apple has filed over 50 patents that will allow the iPhone to be used as a medical device to track patient health. Microsoft’s patents include expanding on its AI technology to help monitor chronic disease.
Microsoft also has other healthcare projects in the works including:
• Microsoft Genomics – Microsoft’s Azure provides researchers and clinicians with highly accelerated, cloud-powered genomic processing services
• Microsoft Azure Security and Compliance Blueprint: HIPAA/HITRUST – Health Data & AI – Microsoft’s availability of an end-to-end application development foundation to help health organizations move to the cloud efficiently and safely.
• Microsoft’s Intelligent Network – Microsoft is expanding its Microsoft Intelligent Network for Eyecare, now AI Network for Healthcare, to create an AI-focused network in cardiology.
• Microsoft 365 Huddle Solution Templates- Microsoft’s solution so that health teams can benefit from collaboration tools to drive quality and care outcomes.
• Project InnerEye – This will feature new integration with TeraRecon and Intuitive Surgical
• Project Empower MD – This is a research collaboration that will create a system that listens and learns what doctors say and do in situations.” (H)

“Amazon Business, the B2B purchasing arm of the e-commerce behemoth, is looking to disrupt the healthcare supply chain amid accelerating hospital operating expenses, flattening admissions and an increasing need to cut costs.
Under pressure to pare down unnecessary spending, supply chain professionals are increasingly rethinking traditional distribution and supplier models to gain a competitive advantage.
Some have turned to Amazon, whose shadow looms ever larger in the healthcare space. Much has been discussed concerning the Amazon-BerkshireHathaway-JPMorgan employee health cost endeavor (along with Amazon’s recent acquisition of PillPack) but one can’t ignore Amazon’s subtle foray into the supply chain sector.
Amazon Business provides a marketplace for medical supplies in a format very similar to its popular Amazon Prime service. The B2B purchasing venture has generated more than a billion dollars in sales its first year alone and introduced three business verticals last year — education, government and healthcare. Already, hundreds of thousands of medical products are available on Amazon Business, from hand sanitizer to biopsy forceps.
“The shopping experience feels the same, but in the background we’ve configured that organization’s procurement practices and policies,” Chris Holt, global healthcare leader at Amazon, told Healthcare Dive in an interview. “So, if they want to service particular suppliers in a given category or focus on diversity suppliers, women-owned businesses, quality-certified suppliers, they can search for things based on their own company-specific credentials, and that drives the algorithms that feed our search results.” (I)

“Here are five major inroads Microsoft has made in the healthcare industry during the past year:
Artificial intelligence
Microsoft’s flagship healthcare initiative is Healthcare NExT, an effort the company launched in early 2017. The initiative serves as an umbrella program for various AI and cloud computing projects related to healthcare, such as an AI-chatbot the company rolled out at Milwaukee-based Aurora Health Care and Pittsburgh-based UPMC in December 2017…
Cloud computing..
A range of healthcare companies already use Microsoft’s cloud services. New Orleans-based Ochsner Health System is developing an AI platform to predict adverse patient outcomes using Epic’s machine learning capabilities and Azure, Microsoft’s cloud computing service. Health IT vendors like Allscripts and SnapMD also offer customers the option to purchase select platforms on Azure.
Cybersecurity..
WannaCry hit healthcare organizations across the world, with the U.K. National Health Service canceling almost 20,000 appointments as a result of the ransomware attack. One year after the attack, the U.K. Department of Health and Social Care, which oversees the NHS, announced it had entered into a deal with Microsoft to improve the health service’s cybersecurity resilience.
Genomics and precision medicine..
In February, Microsoft launched a set of cloud-based processing tools for clinicians and scientists pursuing genomics research in the U.S., Western Europe and Southeast Asia. Microsoft developed the service, dubbed Microsoft Genomics, in partnership with Memphis, Tenn.-based St. Jude Children’s Research Hospital and DNAnexus, a genomic data management platform Microsoft has helped finance.
Telehealth
Microsoft on July 2 unveiled a project to expand broadband coverage in rural areas. For the project, Microsoft partnered with broadband wireless solutions provider Radwin to introduce internet solutions that leverage TV white spaces, or the unused spectrum between TV stations, to deliver internet connectivity to underserved communities. The partnership with Radwin is part of Microsoft’s Airband Initiative…” (J)

(A) Amazon’s acquisition of online pharmacy PillPack spooks retail drugstores, by Evan Sweeney, https://www.fiercehealthcare.com/tech/amazon-pillpack-drug-distribution-pharmaceuticals-walgreens-cvs
(B) Why Amazon Needs to Do Everything, by Dan Gallagher, https://www.wsj.com/articles/why-amazon-needs-to-do-everything-1530369827
(C) Amazon could radically change how you get prescriptions, by Kaya Yurieff, http://money.cnn.com/2018/06/28/technology/amazon-health-care/index.html
(D) Amazon Business Streamlines Supply Chain for Home Health, by Amy Baxter, https://homehealthcarenews.com/2018/06/amazon-business-streamlines-supply-chain-for-home-health/
(E) Inside Amazon’s Grand Challenge — a secretive lab working on cancer research and other ventures, by Michael S. Williamson, https://www.cnbc.com/2018/06/05/amazon-grand-challenge-moonshot-lab-google-glass-creator-babak-parviz.html
(F) Microsoft doubles down on healthcare with formal unit, new hires, by https://www.healthcaredive.com/news/microsoft-doubles-down-on-healthcare-with-formal-unit-new-hires/526719/
(G) Patents hold clues about Apple, Amazon, Google and Microsoft plans for healthcare, by Bernie Monegain, http://www.healthcareitnews.com/news/patents-hold-clues-about-apple-amazon-google-and-microsoft-plans-healthcare
(H) Microsoft, Apple, Google Secure HIT Infrastructure Patents, https://hitinfrastructure.com/news/microsoft-apple-google-secure-hit-infrastructure-patents
(I) Amazon Business’ medical supply chain ambitions: 4 things to know, by Rebecca Pifer, https://www.healthcaredive.com/news/amazon-business-medical-supply-chain-ambitions-4-things-to-know/526985/
(J) How Microsoft is shaking up healthcare, by Jessica Kim Cohen, https://www.beckershospitalreview.com/healthcare-information-technology/how-microsoft-is-shaking-up-healthcare.html
(K)

Share on LinkedInShare on Google+Share on FacebookTweet about this on Twitter

“Right-to-try should not be right-to-die-poorer”

“The newly enacted right-to-try law allows drug makers to earn a profit by selling unproven therapies to desperate and dying patients. The FDA is powerless to stop it.
You’d think no drug maker would be dumb enough to actually try to make money this way, given prevailing public opinion that already views the drug industry as greedy, price-gouging profiteers.
But you’d be wrong. Enter BrainStorm Cell Therapeutics, which intends to start a “semi-commercial enterprise with modest profits” that would sell its experimental stem cell therapy to patients with amyotrophic lateral sclerosis, or ALS, according to a story from Bloomberg…
But the precedent that BrainStorm will set by turning what should be an altruistic act into a money-making venture is extremely dangerous and potentially exploitive. Unscrupulous drug companies will be incentivized to skip the traditional clinical trial and FDA review process altogether. Drugs no better than snake oil — but deemed safe — could be sold to desperate patients at a profit. The FDA would have no power to stop it from happening…
There’s little evidence that ALS patients, especially those with advanced disease, will benefit from NurOwn. In BrainStorm’s Phase 2 study, NurOwn was unable to slow the progression of ALS compared with a placebo. The company turned to a responder analysis to eke out a signal of efficacy, which it’s now trying to confirm in the Phase 3 study.
The idea that BrainStorm could make a profit from NurOwn before the treatment is proven effective and approved by the FDA is a bad look for the company and the entire pharmaceutical industry. It reeks of opportunism, even when couched in compassionate rhetoric.
Right-to-try should not be right-to-die-poorer, but that’s what the law will end up being for patients if profit motive takes hold.” (A)

The balance between investigational new drug access and protection of patients from therapies without established safety the FDA built during the past 20 years could be compromised by the new Right to Try law, a new study in JAMA Network Open suggests.
“To our knowledge, no studies have examined the timing and duration of drugs made available through expanded access programs to determine whether the program was serving its original purpose,” Jeremy Puthumana, MS, of the division of medical ethics at Yale School of Medicine, and colleagues wrote.
Researchers used ClinicalTrials.gov to locate investigational medicines made obtainable through expanded access and compassionate use programs prior to FDA approval and ascertained the start date of each program and several “key regulatory dates” — investigational new drug application activation, initial NDA submission and FDA approval — and timing and duration of expanded access availability in regard to NDA submission and FDA approval…
“For medicines that ultimately receive FDA approval, these findings suggest that the FDA and pharmaceutical industry have established a balance between investigational new drug access and protection of patients from therapies without established safety,” Puthumana and colleagues wrote.
“This balance may be compromised by policymakers seeking to speed access to investigational medicines through the Right to Try Act,” they added.
Despite more than 100 advocacy groups, including the American Lung Association and American Society of Clinical Oncology sending a letter to Congress strongly opposing the law, the bill passed both chambers. President Donald J. Trump signed Right to Try into law on May 30. An expert who spoke to Healio before the bill signing indicated the effect of the law on patients remained unclear.” (B)

“In essence,” says Klein, “patients and their doctors have had the ‘right to try’ investigational agents when all else fails and the company is willing to make the product available, for decades.”
For more than 30 years, people with serious diseases have had access to investigational drugs, vaccines, devices and biologics via the FDA’s expanded access pathway. Under the current program, which is also referred to as compassionate use, once a company agrees to provide an investigational product, the FDA and an institutional review board (IRB) must approve the product before it is administered to the patient. And the FDA retains the right to deny certain requests for drugs that it has not yet approved for safe use within the general population.
“Expanded access is really a ‘pathway,’ a regulatory process that permits companies to provide unapproved therapeutic agents to a patient if the company decides to do so. There are many reasons companies might say no. But the FDA allows more than 99 percent of requests to go forward. The small number of situations where the FDA doesn’t allow the expanded access use of the drug to proceed involves situations where there is a known risk that outweighs the potential benefit for the patient,” says Klein.
The expanded access program began in 1987 during the HIV/AIDS epidemic, when sick patients demanded that protocols be established for those not enrolled in a clinical trial who wanted to try potentially life-saving medications when nothing else was available.”..
Klein offers this scenario of how it works: “Suppose a patient came into the hospital late at night and had a stroke and the doctor thought a particular investigational drug was an appropriate option for this particular patient. The physician could contact the emergency call center, which would contact the medical officer on duty. They would review the case, ask a few pointed questions as necessary and provide an IND number by email or possibly over the phone. The IND allows the investigational product to be administered.” (C)

“Anyone with a smidgen of knowledge about healthcare understood that the right-to-try legislation signed by President Trump on Wednesday was a scam, perpetrated by the Koch brothers and their henchmen.
Masquerading as a “compassionate” measure aimed at providing victims of terminal diseases with a last bit of hope that an experimental treatment might save them, it really was aimed at undermining the authority of the Food and Drug Administration to make sure our drugs are safe and effective.
Among those who bought into this pretense out of sheer ignorance was Trump, who claimed the measure would save “hundreds of thousands” lives, which was just fantasy.
This law intends to diminish the FDA’s power over people’s lives, not increase it.
Now, the measure’s chief sponsor has pulled open the curtain, so that even laypeople can understand how horrible this law is. He’s Sen. Ron Johnson, R-Wisc. In a letter Thursday to FDA Commissioner Scott Gottlieb, who was critical of the law, Johnson wrote:
“This law intends to diminish the FDA’s power over people’s lives, not increase it.”
Apparently under the misbegotten impression that he was doing the public a favor, Johnson proceeded to underscore some of the more egregious provisions of his own bill. Among them is a prohibition against the FDA’s using clinical results from these last-chance treatments as the drugs continue through its regulatory process.
Put simply, if a drug is found not to work or even to be harmful in right-to-try cases — findings the FDA normally considers of paramount importance in judging a drug’s fitness for approval — the FDA can’t use those findings in the approval process.”
FDA Commissioner Gottlieb drew Johnson’s ire by suggesting, just prior to the bill’s passage, that his agency would have to promulgate guidance and regulations to balance the measure’s broadening of access to experimental drugs with “appropriate patient protections.”
Johnson made clear that he has no use for any additional patient protections. His bill, he wrote, “is not meant to grant FDA more power or enable the FDA to write new guidance, rules, or regulations.” (D)

“So what’s the catch? Did something just happen that everyone loves, and will save hundreds of thousands of lives?
If that were the case, of course, the bill would’ve passed long ago. In fact, many ethicists and doctors and patient advocates quite emphatically oppose it, as do former FDA commissioners. The American Society of Clinical Oncology is among nearly 40 health organizations that have publicly dragged the bill, saying it “could do more harm than good to seriously ill patients.” In a February letter to Congress, the groups reminded legislators that the current regulatory system for medical products was created as a result of serious harm and exploitation that occurred early in the 20th century: “Birth defects resulting from Thalidomide are an example of what happens when drugs are given to humans without proper safety review and approval.”
The legislation is a product of the conservative advocacy organization the Goldwater Institute, and backed by the Koch Brothers’ Americans for Prosperity. The name is cynical but effective. As Trump said on Wednesday, “‘Right to Try.’ It’s such a great name. Some bills, they don’t have a good name. Okay? They really don’t. But this is such a great name, from the first day I heard it. It’s so perfect.”
The name is certainly catchier than the existing name for the program that already does almost exactly the same thing—allowing people with serious diseases to obtain experimental medicines. It is known as expanded access, or more commonly, “compassionate use.”
The difference is that the current program operates through the Food and Drug Administration, which retains the ability to deny some requests for drugs it has not yet approved for use in the general population. The FDA reports that it already authorizes more than 99 percent of requests—so the upcoming change could be minimal. But the potential to exploit this lack of oversight is a risk. In the rare cases when access to unapproved drugs is denied, it can be because of serious concerns about risks on behalf of the pharmaceutical company, or because a physician has overlooked an obviously better alternative.
Under “right to try” this safeguard will be gone, and drugs can be usable after just phase one of clinical trials. As David Gorski, a cancer surgeon and professor at Wayne State University, wrote on Twitter this week, “Claiming phase I testing is enough to show that a drug is ‘safe’ enough for #RightToTry … is utterly insane, as anyone who’s ever had anything to do with clinical trials knows.” …
The goal should not be a right to try, but a right to have safe, effective, affordable drugs that do not drive people to medical bankruptcy. When we remain so far from that, there is no celebration in offering people untested substances and crossing our fingers and then claiming that we have improved the health-care system, much less that we have saved even one life.” (E)

(A) Here come the right-to-try profiteers. The FDA is powerless to stop them, Adam Feuerstein, https://www.statnews.com/2018/06/20/right-to-try-opportunism/?utm_source=STAT+Newsletters&utm_campaign=daf8644f20-DC_Diagnosis&utm_medium=email&utm_term=0_8cab1d7961-daf8644f20-149527969
(B) New study suggests ‘Right to Try’ may undo efforts on patient safety, by Janel Miller, https://www.healio.com/family-medicine/practice-management/news/online/%7B106cd5cf-fa34-4c42-93dc-441ac64d9461%7D/new-study-suggests-right-to-try-may-undo-efforts-on-patient-safety
(C) FDA’s Expanded Access Pre-dates Right to Try by Decades, https://health.howstuffworks.com/medicine/healthcare/fdas-pathway-to-experimental-drugs-pre-dates-right-to-try-by-decades.htm
(D) GOP senator reveals the truth: Right-to-try bill was a scam tailored to harm public health, by Michael Hiltzik, http://www.latimes.com/business/hiltzik/la-fi-hiltzik-right-to-try-20180604-story.html
(E) The Disingenuousness of ‘Right to Try’, by James Hamblin, https://www.theatlantic.com/health/archive/2018/06/right-to-try/561770/

Share on LinkedInShare on Google+Share on FacebookTweet about this on Twitter

CONSULTANTS are the one big winner of the Obamacare wars

“After failing to get a comprehensive Affordable Care Act repeal through Congress — you know, the place where laws are supposed to be made — and then winning a repeal of one of the law’s provisions in last year’s massive tax cut, the Trump administration now asks a judge to undo the rest of the law through the courts.
This is a brazen act of executive overreach. If it succeeds, it will endanger the coverage of thousands of sick Americans.
In federal court in Texas Thursday, where 20 states are suing to undo pieces of Obamacare, the Justice Department jumped in on the states’ side with a stunning argument…
It is one thing for states to claim in court that these interwoven pieces of the federal legislation should be invalidated. It is another and far more dangerous step for this administration to abandon, on the flimsiest rationale, a law duly passed by a previous Congress and signed by a previous President…
If the President gets his way, that’s just the early stage of a disease that’s about to get a whole lot deadlier.” (A)

“The Affordable Care Act, by contrast, has withstood numerous legal challenges in the eight years since it became law, including two at the Supreme Court. The current lawsuit against it hinges not on big questions of equality and justice, but on a technicality.
If that technicality were to carry the day, insurance companies could once again deny coverage, or charge much more for it, to people who have battled cancer, or are pregnant, or who have diabetes, or a heart condition, or arthritis. There’s no clear-cut definition of “pre-existing condition,” so this list goes on and on, affecting Americans of all political stripes. And even if the current law prevails in court, at least some damage will already have been done; uncertainty created by the Justice Department’s stance will almost certainly lead to higher premiums for Americans.
Add this latest move to a growing list of similar efforts — eliminating the mandate tax penalty to begin with, allowing more short-term plans on the market — and it becomes clear where the administration’s priorities lie: not in helping more Americans get good health care, not even in supporting the will of the people, but in dismantling what some political opponents built, just for the sake of doing so.” (B)

“In April, a group of conservatives put together guidance for another bid to overhaul the Affordable Care Act. The effort was and is being spearheaded by the Heritage Foundation and entails meetings with health-policy analysts to generate a consensus plan that would make it to the president’s desk. Those involved acknowledge the heavy lift, but the hope is that activists might pressure lawmakers to move before they potentially suffer losses in the midterm elections…
But for some directly involved with the plan, it’s vitally important to at least try to get something accomplished, precisely because, as it stands, Democrats are using Republican inaction on health care as an electoral cudgel.
“We need to have a plan that we can talk about as we go through the elections,” one source working on the initiative, requesting to speak on background, told The Daily Beast. “What it’s going to take is a political imperative to act. Republicans thought it was an existential crisis if they didn’t get tax reform done.”..
“‘Blame John McCain, then pivot to how great it is that the [individual mandate] is taken care of,’ is the president’s messaging strategy for this. Shift blame, show a win,” a senior Trump aide told The Daily Beast.” (C)

“For the first time since it became law in 2010, Obamacare is a political asset for Democrats heading into an election—a striking turn after several cycles in which the law’s unpopularity helped Republicans sweep into power in legislative races across the country. Still, Democrats face a challenge: President Trump’s attacks on Obamacare prompted a broad reassessment of its merits and hurt his party’s political standing. To successfully exploit the issue, Democrats have to find a way to cut through the din of Trump news and scandal coverage and convince voters they’ll defend the health-care law from ongoing GOP sabotage and repeal efforts…
Democratic strategists are convinced voters aren’t ignoring the assaults on Obamacare, even if press coverage has been dwarfed by Trump. “It’s the biggest disparity I’ve ever seen between what’s being covered on cable news and what candidates are actually running on in their home states: Medicare, Medicaid, the ACA, opioids,” Priorities USA’s Cecil says. That could change soon. Insurers have begun notifying states of their plans to increase premiums—some by double digits. Those rate hikes, set to take effect in October, could deliver voters a shock. “There’s a land mine waiting,” candidate Harder says. “That’s going to be an area where we’re going to have a pretty strong closing argument.”..
BOTTOM LINE – Democrats finally have something to sell with health care, which is the top issue for voters, according to a poll. The trick will be cutting through the noise to get voters’ attention.” (D)

“Conservative health care think tank scholars have published a new proposal to repeal and replace Obamacare, hoping that they can persuade Congress to take up the issue one more time before November. Can it succeed where prior efforts have failed?…
The Consensus Group proposal improves upon Graham-Cassidy by requiring that “at least 50% of the block grant goes toward supporting people’s purchase of private health coverage” in the individual insurance market. Under the new program, states would be required to offer Medicaid enrollees the opportunity to purchase “commercially available coverage” with their Medicaid dollars, and plans sold under the block grants would be exempted from costly Obamacare rules, like 3:1 age bands that double or triple the cost of insurance for young people…
It comes down to a tension among conservatives between those who most highly value individual rights, and those who most highly value states’ rights.
The states’ rights wing believes that the best policy outcomes can be achieved by consolidating control of taxpayer funds in the hands of state governments…
On the other hand, the individual-rights wing believes that central planning by state governments often leads to the same results as central planning by federal governments, and that true free-market reform involves helping individuals directly purchase the health insurance and health care services that best suit their needs…” (E)

“The first Sunday after his inauguration, New Jersey Gov. Phil Murphy signed an executive order directing state agencies to report everything they could do to ramp up the visibility of the Affordable Care Act and persuade more people to buy health coverage under the law.
Four months later, the Democratic governor signed into law a requirement that makes New Jersey the first state in a dozen years to compel most residents to carry insurance….
Several states are erecting barriers against rules the Trump administration is writing to promote short-term health plans that are comparatively inexpensive because they lack benefits and consumer protections guaranteed by the ACA. And some states, led by Democrats and Republicans alike, are trying to slow insurance rate increases through methods that Congress considered but did not pass.
“There are all these federal changes that are­ happening, and some states are pushing back on them and some states are taking advantage of them,” said Jason Levitis, a consultant who led the development of the ACA’s tax components at the Treasury Department during the Obama administration. “The most important and interesting health policy action is in states.” (F)

“Associate Justice Anthony Kennedy’s retirement from the Supreme Court may lead to big changes in constitutional law, some court-watchers say, but others are not so sure…
“This suit has a greater likelihood of attracting a majority,” he wrote in an email. “With a more reliable conservative, and Roberts having dug his own hole after basing the constitutionality of the ACA on the mandate being a tax — and the tax now having been repealed, that leaves the door open to a different decision in the Supreme Court.”
Indeed, “several of the recent decisions have been 5-4,” said Gail Wilensky, PhD, senior fellow at Project HOPE, in Bethesda, Maryland, in an email. “With a second Trump appointee, the conservative wing of the court will be clearly strengthened. However, as became clear in the [NFIB v. Sebelius] decision regarding the constitutionally of the ACA, predicting Supreme Court decisions is not always straightforward.” (G)

“The Trump administration’s decision to join a conservative lawsuit challenging some of the most popular parts of the Affordable Care Act continues to be the gift that keeps on giving, at least politically, for Democrats ― first in the midterms and now in the upcoming Supreme Court fight…
Democrats immediately went to town on the suit, blasting out ads and fundraising emails warning that the Trump administration wants to take away coverage for people with pre-existing conditions.
And now, Democrats say they plan to use the suit to their advantage when Trump picks his Supreme Court nominee, expected to be announced July 9.
The lawsuit, brought by 20 states led by Republicans, argues that the law’s protections were supposed to work in tandem with the mandate that individuals have health insurance. Because Congress is no longer enforcing the mandate, they say, insurers no longer have to sell policies to everyone regardless of medical status.
Democratic senators are assuredly going to question the nominee as to whether he or she supports Trump’s position on the lawsuit. Normally, nominees punt on these sorts of questions, arguing that the issue could come before them if they are confirmed to the court.” (H)

“Forget the Affordable Care Act: The future of our health care system will be shaped by a much bigger and broader fight — one that will likely culminate with a 2020 choice between private markets and an authentic government-run program in the form of a Bernie Sanders-style Medicare for All…
This is one of America’s great unsolved problems: We have the world’s best care, talent and innovation. But before it gets to patients, the magic goes through a hodgepodge of inexplicable, expensive and unnecessary hurdles.” (I)

“Trump administration highlights customers being ‘priced out’ of Obamacare. The health law is “increasingly failing” to cover people who don’t get the government to pay for premiums, according to the Trump administration. Twenty percent of people who don’t receive subsidies dropped their Obamacare coverage in 2017 due to increasing costs, show data from the Centers for Medicare and Medicaid Services, highlighting a trend that has been occurring since 2015. Between 2015 and 2016, unsubsidized enrollment fell in 23 states, with 10 states seeing double-digit declines. “As the Trump administration took office, there were warning signs that we were dealing with a crisis in the individual health insurance market and Obamacare was failing its consumers,” Seema Verma, CMS administrator, said in a statement. “These reports show that the high price plans on the individual market are unaffordable and forcing unsubsidized middle class consumers to drop coverage.”” (J)

“As health insurers across the country begin filing their proposed rates for 2019, one thing is clear: The market created by the Affordable Care Act shows no signs of imminent collapse in spite of the continuing threats by Republicans to destroy it.
In fact, while President Trump may insist that the law has been “essentially gutted,” the A.C.A. market appears to be more robust than ever, according to insurance executives and analysts. A few states are likely to see a steep spike in prices next year, but many are reporting much more modest increases. Insurers don’t appear to be abandoning markets altogether. In contrast to last year, regulators are not grappling with the prospect of so-called “bare” counties, where no carrier is willing to sell A.C.A. policies in a given area.
“The market is in a better position now than it has ever been since the exchanges have opened,” said Deep Banerjee, who follows insurers for S & P Global Ratings. The companies first began selling policies in the state exchanges, or marketplaces, five years ago. After years of losses, the insurers are now generally making money.” (K)

“Republicans could still repeal and replace ObamaCare if they are able to keep the House majority and gain seats in the Senate, Republican National Committee (RNC) spokeswoman Kayleigh McEnany told Hill TV’s “Rising” on Thursday.
McEnany specifically noted legislation proposed by GOP Sens. Lindsey Graham (S.C.) and Bill Cassidy (La.), which was defeated last fall.
“We were a big proponent of Graham-Cassidy. That, of course, was the Senate bill that gave the states the power and allowed each state to select what the best way forward was for them on health care,” McEnany told Hill TV’s Krystal Ball and Buck Sexton on “Rising.”
“That was one vote short, and if we maintain the House as we expect we will, pick up a few Senate seats, Graham-Cassidy can become a reality,” she said.” (L)

“The Trump administration on Saturday halted billions of dollars in payments to health insurers under the Obamacare healthcare law, saying that a recent federal court ruling prevents the money from being disbursed.
The Centers for Medicare and Medicaid Services, which administers programs under the Affordable Care Act, said the action affects $10.4 billion in risk adjustment payments.
President Donald Trump’s administration has used its regulatory powers to undermine Obamacare after the Republican-controlled Congress last year failed to repeal and replace the law. About 20 million Americans have received health insurance coverage through the program.
The payments are intended to help stabilize health insurance markets by compensating insurers that had sicker, more expensive enrollees in 2017. The government collects the money from health insurers with relatively healthy enrollees, who cost less to insure.
CMS, which is overseen by the U.S. Department of Health and Human Services, said the move was necessary because of a February ruling by a federal court in New Mexico, which found that the federal government was using an inaccurate formula for allocating the payments.” (M)

“Republicans could still repeal and replace ObamaCare if they are able to keep the House majority and gain seats in the Senate, Republican National Committee (RNC) spokeswoman Kayleigh McEnany told Hill TV’s “Rising” on Thursday.
McEnany specifically noted legislation proposed by GOP Sens. Lindsey Graham (S.C.) and Bill Cassidy (La.), which was defeated last fall.
“We were a big proponent of Graham-Cassidy. That, of course, was the Senate bill that gave the states the power and allowed each state to select what the best way forward was for them on health care,” McEnany told Hill TV’s Krystal Ball and Buck Sexton on “Rising.”
“That was one vote short, and if we maintain the House as we expect we will, pick up a few Senate seats, Graham-Cassidy can become a reality,” she said.” (N)

“The Trump-era attack on the Affordable Care Act has left the nation’s health system plagued with uncertainties: Will “Obamacare” insurance survive? Can independent hospitals make it? What’s next for doctors? And will patients ever really get “affordable” care?
But one certainty is prevailing: No matter what the outcome, it will be a bonanza for health-care consultants.
These fixers—the visionaries, the mercenaries and everyone in between—have been dramatically increasing their role in the economy since the Affordable Care Act was passed in 2010. A Modern Health Care Magazine survey of just 25 prominent national consultant firms found that revenue rose from $2.3 billion in 2008—the year before Obama took office—to $6.6 billion in 2014, the start of the ACA coverage expansion. Deloitte, for instance, which topped the list in 2014, saw its health-related revenue rise from $725 million to $2.2 billion in that time…
The reasons for the health care fixing frenzy are varied: Digitization forced doctors to abandon their bulging file folders in favor of computerized records. Obamacare expanded insurance coverage at a pace not seen since the creation of Medicare in 1965—and Trumpcare has begun to contract it. And doctors, hospitals, government and the private sector are all grappling with how to pay for medical care in ways that reward the quality, not quantity, in a system that may not really be the “best in the world,” but is certainly the most expensive…
THE ONLY THING that can compare to the rapid change of the Obama years is whatever’s next under Donald Trump’s administration—and that changes tweet by tweet. Repeal fervor has dissipated, and a more concrete anti-ACA framework is taking shape: repeal of the Obamacare mandate as part of the tax law, the emergence of skimpy health plans that will cost less than Obamacare but lack its comprehensive protections, and vast but still ill-defined “state flexibility” that has already generated a rash of lawsuits.” (O)

(A) Unhealthy and unwise: Trump undermines Obamacare, and the American people will suffer, http://www.nydailynews.com/opinion/ny-edit-unhealthy-and-unwise-20180608-story.html
(B) The Health Care Stalkers, https://www.nytimes.com/2018/06/11/opinion/the-health-care-stalkers.html
(C) A ‘Suicide’ Mission: White House and GOP Leadership Fear New Obamacare Repeal Push, https://www.thedailybeast.com/a-suicide-mission-white-house-and-gop-leadership-fear-new-obamacare-repeal-push
(D) The Dems Take Obamacare on the Road, by Joshua Green and SahilKapur, https://www.bloomberg.com/news/articles/2018-06-25/democrats-see-health-care-as-boon-not-burden-as-midterms-near
(E) Once More Into The Breach: Conservative Think Tankers Publish A New Obamacare Replacement,by Avok Roy, https://www.forbes.com/sites/theapothecary/2018/06/20/once-more-into-the-breach-conservative-think-tankers-publish-a-new-obamacare-replacement/#4492f4422c32
(F) States act on their own to fill holes Washington is knocking in Affordable Care Act, by Amy Goldstein, https://www.washingtonpost.com/national/health-science/states-act-on-their-own-to-fill-holes-washington-is-knocking-in-affordable-care-act/2018/07/01/15374aae-73f8-11e8-9780-b1dd6a09b549_story.html?noredirect=on&utm_term=.cdc891785d12
(G) How Will SCOTUS Roll on Healthcare Without Kennedy?, by Joyce Frieden, https://www.washingtonpost.com/national/health-science/states-act-on-their-own-to-fill-holes-washington-is-knocking-in-affordable-care-act/2018/07/01/15374aae-73f8-11e8-9780-b1dd6a09b549_story.html?noredirect=on&utm_term=.cdc891785d12
(H) Obamacare To Be Central To Democrats’ Fight Against Trump’s Supreme Court Pick, by Amanda Terkel, https://www.huffingtonpost.com/entry/obamacare-trump-supreme-court_us_5b3a7ab4e4b09e4a8b262965
(I) What’s next: The health care debate is no longer a linear fight over a straight repeal of President Obama’s health care law. Instead, it has metastasized into a multi-front war, Special report: The next health care wars, by David Nather, https://www.axios.com/health-care-wars-medicare-for-all-insurance-bernie-d91da849-6c0e-4cd0-8662-091cc51676a9.html
(J) Daily on Healthcare: Trump administration highlights customers being ‘priced out’ of Obamacare, by Philip Klein, by Kimberly Leonard, & Robert King, https://www.washingtonexaminer.com/daily-on-healthcare-trump-administration-highlights-customers-being-priced-out-of-obamacare
(K) Obamacare Is Proving Hard to Kill, by Reed Abelson, https://www.nytimes.com/2018/07/03/health/obamacare-insurance-rates.html
(L) RNC spokeswoman: ObamaCare repeal possible if GOP keeps House, by Julia Manchester, http://thehill.com/hilltv/rising/395574-rnc-obamacare-repeal-possible-if-gop-keeps-house
(M) Trump administration halts billions in insurance payments under Obamacare, https://www.cnbc.com/2018/07/07/reuters-america-trump-administration-halts-billions-in-insurance-payments-under-obamacare.html
(N) RNC spokeswoman: ObamaCare repeal possible if GOP keeps House, by Julia Manchester, http://thehill.com/hilltv/rising/395574-rnc-obamacare-repeal-possible-if-gop-keeps-house
(O) The one big winner of the Obamacare wars, by JOANNE KENEN, https://www.politico.com/agenda/story/2018/07/07/affordable-care-act-health-consulting-000680

Prequels
From REPEAL & REPLACE to WRECK & REJOICE (from Obamacare to Trumpcare) (April 25th)

“This would appear to be Republicans’ last-ditch attempt (well, their latest last-ditch attempt) to repeal Obamacare.” (June 7th)

Share on LinkedInShare on Google+Share on FacebookTweet about this on Twitter

..The HHS needs to review thousands of case files by hand for clues to which children were taken from their parents…

“A migrant mother said her 14-month-old son was “full of dirt and lice” after being separated from his family for months by the Trump administration.
Olivia Caceras’s claims are included in a lawsuit against the Trump administration’s immigration policy separating families that was filed by 17 states and the District of Columbia, PBS News Hour reported Thursday.
Caceras’s testimony is one of many in the nearly 1,000-page court filing.
Caceras said she was separated from her son for roughly 12 weeks before they were reunited.
“He continued to cry when we got home and would hold on to my leg and would not let me go,” Caceras said in her testimony, as reported by PBS. “When I took off his clothes, he was full of dirt and lice.”
“It seems like they had not bathed him the 85 days he was away from us,” she added.” (A)

“The Trump administration asked a judge Friday for more time to reunite families who were separated at the border under its “zero-tolerance” policy to prosecute every person who enters the country illegally.
Hours before a hearing in San Diego, the Justice Department filed papers seeking an extension of the deadline, which is July 10 for all parents with children under 5 and July 26 to reunite everyone else.
The administration says federal law requires it to ensure that children are safe and that requires more time. Administration officials also say that they won’t be able to confirm a child’s parentage by the deadline if DNA testing is inconclusive. They will need more time to collect DNA samples or other evidence from parents who have been released from government custody.” (B)

“Government lawyers said Friday that they cannot locate the parents of 38 migrant children under the age of 5, as a federal judge indicated he is open to extending the deadline for reuniting nearly 3,000 children separated from their mothers and fathers while crossing the US-Mexico border.
In a status hearing with U.S. District Judge Dana Sabraw of the Southern District of California, who ordered the reunification, government lawyers said the Health and Human Services Department would only be able to reunify about half of approximately 100 children under the age of 5 by the court-ordered deadline of July 10.
For 19 children, their parents have been released from custody into the U.S. and their whereabouts are unknown. The parents of another 19 children have been deported.
“The way [a family separation] is put in the system is not in some aggregable form, so we can’t just run it all,” said Sarah Fabian, the Justice Department attorney representing the government before Sabraw.
Sabraw said he would agree to delay the deadline for reunifying the youngest children if the government could provide a master list of all children and the status of their parents. Sabraw ordered the administration to share a list of 101 children with the American Civil Liberties Union by Saturday afternoon.” (C)

“Records of the separated children are embarrassingly spotty, a Health and Human Services (HHS) spokesperson admitted on a July 5 call with press. HHS is charged with reuniting the children, who were originally separated and processed by agents from another federal agency, the Department of Homeland Security. Its own records must therefore be cross-checked with data from other sources, including records from Immigrations and Customs Enforcement (which reports to DHS) and the Office of Refugee Resettlement (ORR).
Cross-referencing may not be enough, said the spokesperson. As the New York Times reported, hundreds of files have already been deleted by border patrol staff. HHS secretary Alex Azar has additionally “ordered a hand audit of the records of every single child in our care,” but that’s more than 12,000 children, only some of which came to the border with their families.
That’s right: The HHS needs to review thousands of case files by hand for clues to which children were taken from their parents—just the beginning of a process that would also require talking with case managers to verify information and then trying to locate their families. The task is so massive that the agency is asking staff to work overtime reviewing the records, according to the Times, which obtained an internal email stating that “[e]veryone here is now participating in this process, including the Secretary who personally stayed until past midnight to assist.” (D)

“How is President Donald Trump dealing with that crisis? By tweeting, of course.
Trump unleashed a trio of tweets Thursday morning — all dealing with immigration.
“Congress must pass smart, fast and reasonable Immigration Laws now,” he tweeted. “Law Enforcement at the Border is doing a great job, but the laws they are forced to work with are insane. When people, with or without children, enter our Country, they must be told to leave without our Country being forced to endure a long and costly trial. Tell the people ‘OUT,’ and they must leave, just as they would if they were standing on your front lawn. Hiring thousands of ‘judges’ does not work and is not acceptable – only Country in the World that does this!”
For good measure, Trump added: “Congress – FIX OUR INSANE IMMIGRATION LAWS NOW!”
What you may have noticed in Trump’s tweets is that there is a) no mention of the children already separated from their parents due to the Trump administration’s “zero-tolerance” policy and b) no clear directive to Congress about any sort of comprehensive immigration reform proposal aside from “FIX OUR INSANE IMMIGRATION LAWS NOW,” which is, um, sort of non-specific…
By July 26, all children separated from their parents at the border have to be reunited.” (E)

“Felicia Baez teaches English as a second language at a shelter in South Florida where anywhere from 30 to 100 migrant children in federal custody live at one time. Most stay about two months, but some leave after only a few days.
“It’s always like the first day of school,” Ms. Baez said of the turnover at the shelter, His House Children’s Home, in the suburb of Miami Gardens. And the wide range of academic ability among her students — some haven’t been in a classroom in years, while others graduated from high school in their home countries — means she is constantly making adjustments.
These are just some of the challenges of educating the thousands of migrant children now housed in youth shelters and family detention centers across the country.
Federal law requires that all children on American soil receive a free public education, regardless of their immigration status. As the Trump administration expands the number of people detained at the border, shelters and detention facilities are ramping up their roles as makeshift schools, teaching English and civics classes, offering cooking lessons and setting up field trips to art museums.
But according to lawyers and educators with firsthand knowledge of the child detention system, the education offered inside the facilities is uneven and, for some children, starkly inadequate.
Teachers at the schools are sometimes not state-certified as teachers, according to these accounts. Some shelter instructors cannot communicate effectively in Spanish, and in other cases the curriculum is so limited and classes are so wide-ranging in age groups that students seem bored and disengaged.” (F)

(A) Lawsuit: Migrant child returned to parent with lice after 85 day separation, by Morgan Gstalter, http://thehill.com/latino/395752-lawsuit-trump-dhs-returned-lice-ridden-migrant-child-after-85-days
(B) Trump Administration Wants More Time to Reunite Families Separated at the Border, http://time.com/5332091/trump-reunify-families-extension/
(C) Trump admin lost track of parents of 38 young migrant children, by Julia Ainsley, https://www.nbcnews.com/politics/immigration/trump-admin-asks-more-time-reunite-kids-parents-separated-border-n889301
(D) The scramble to reunite immigrant kids with their families is a case study in poor project management, by Annalisa Merelli & Heather Timmons, https://qz.com/1322700/how-will-hhs-and-dhs-reunite-separated-immigrant-children-with-parents/
(E) Donald Trump has no answers for the border crisis. And things are about to get worse, by Chris Cillizza, https://www.cnn.com/2018/07/05/politics/immigration-separation-border-trump/index.html
(F) In a Migrant Shelter Classroom, ‘It’s Always Like the First Day of School’, by Dana Goldstein and Manny Fernandez, https://www.nytimes.com/2018/07/06/us/immigrants-shelters-schools-order.html

Share on LinkedInShare on Google+Share on FacebookTweet about this on Twitter