“Sepsis is the body’s overwhelming response to an infection. It can occur in virtually anyone with an infection, though it’s more likely to appear among elderly individuals and those who have undergone surgery. While health care providers are broadly aware of the condition and its symptoms, it can be difficult to identify early.
Sepsis can start off with a fever and increased heart rate, but can quickly become more serious as it causes difficulty breathing, changes in skin color, and organ failure. The initial treatment for sepsis, antibiotics and intravenous fluids, is deceptively simple and widely accepted among health professionals. The big treatment challenge is time, because with every hour that passes during which the patient isn’t treated, the prognosis worsens significantly.
To help ensure timely, consistent, and high-quality care for sepsis patients, the Centers for Medicare and Medicaid Services adopted in 2015 the Sepsis National Hospital Inpatient Quality Measure (SEP-1) that had been developed by the National Quality Forum. This metric assesses hospitals’ timely treatment of sepsis, which costs more than $27 billion annually. Going a step further, the Centers for Medicare and Medicaid Services on Wednesday began publishing sepsis treatment statistics for all hospitals across the country. This is the first time that this information is being made publicly available.
To find your hospital’s score, visit Medicare’s Hospital Compare website. Type in your ZIP code, then the hospital’s name. On the hospital’s page, click the “Timely & effective care” tab and then click the “Sepsis care” drop-down menu. You can then see the hospital’s score and compare it to state and national averages.
A high score shows that a hospital has been following sepsis treatment protocols and that, when patients develop sepsis, they are generally treated properly. A low score indicates poor sepsis care.
Hospital Compare currently includes SEP-1 scores for the first nine months of 2017. The first full year of data will follow in October…. (A)
“More than half of hospitals on average fail to comply with the CMS’ sepsis treatment requirements, new data from the agency reveals.
The data, publicly released Wednesday on Hospital Compare for the first time, show that the national average compliance rate for the CMS’ sepsis treatment measure was 49%. But patient safety experts say the generally low compliance rate for the measure doesn’t necessarily mean sepsis treatment is poor at hospitals. The measure is a process measure, so it doesn’t directly reflect outcomes for patients with sepsis. Additionally, clinical nuance and trouble reporting the measure must be taken into account when looking at the data.
The measure—called the Severe Sepsis and Septic Shock Early Management Bundle—was adopted by the CMS in July 2015 to improve hospitals’ identification and treatment of sepsis, a serious and life-threatening condition. More than 200,000 people die each year from sepsis, according to the agency. A study last year also found the mortality rate from the condition has worsened in recent years.
The measure requires hospitals to follow multiple, time-sensitive steps to comply. Physicians and researchers say that early dedication and intervention is critical to prevent death from sepsis…
“What CMS has done with sepsis has elevated everyone’s game and made us all aware of the importance of compliance but I take these numbers with a grain of salt,” he said.
The CMS data set includes performance of 3,005 hospitals for the first nine months of 2017.” (B)
Not all clinicians agree…
“Guidelines that go beyond guidance and move to regimented, time-based prescriptions of care must be based on unassailable evidence. Even then, the clinician’s assessment of the individual patient should allow a diversion from the guideline directed care.
The current iteration of the Surviving Sepsis Campaign Guidelines (2018) fails on all counts:
The recommendations are based on low to moderate quality evidence. Even this level of evidence lumps into one group various severities of illness.
Despite this, the recommendations are made at a Strong level without conditionals
No consideration is made for the judgment of clinician as to whether the individual patient in front of them will be helped or harmed by the recommendations
No consideration has been made for the downstream effects these guidelines will have on other non-septic patients being cared for simultaneously.” (C)
More than one in 10 children hospitalized with sepsis die, but when a series of clinical treatments and tests is completed within an hour of its detection, the chances of survival increase considerably, according to a new analysis led by the University of Pittsburgh School of Medicine.
The results, published today in the Journal of the American Medical Association, support an initially controversial New York mandate established after 12-year-old Rory Staunton died from undiagnosed sepsis in 2012 following an infection from a scrape. These results will likely encourage the mandate’s expansion to other states…
Rory’s Regulations require New York hospitals to follow protocols regarding sepsis treatment and submit data on compliance and outcomes. The hospitals can tailor how they implement the protocols, but must include a blood culture to test for infection, and administration of antibiotics and fluids within an hour to any child suspected of sepsis.
Seymour and his team analyzed the outcomes of 1,179 children with sepsis reported at 54 New York hospitals. The children had an average age of just over 7 years, and 44.5 percent were healthy before developing sepsis. A total of 139 patients died.
Completion of the sepsis protocol within one hour decreased the odds of death by 40 percent. When only parts of the protocol were completed within an hour – for example, giving fluids but not testing for infection or giving antibiotics – the patients did not fare better. The finding held only if the entire protocol was completed in an hour.
“It’s clear that completing the entire sepsis protocol within an hour is associated with lower mortality,” said lead author Idris V.R. Evans, M.D., assistant professor in Pitt’s Department of Critical Care Medicine. “But the mechanism of benefit still requires more study. Does each element of the protocol contribute to specific biologic or physiologic changes that, when combined, improve outcomes? Or is it that completion within an hour may simply be an indication of greater awareness by doctors and nurses caring for the child? Or could it be something else entirely?”
The researchers note that testing the sepsis protocol in a future randomized clinical trial will be very difficult. Such work would require leaving off some protocol elements for some septic children but not others in a random fashion – a design which would not currently align with the standard of care. But if more states adopt rules and regulations similar to New York’s, and also mandate data reporting, future work could expand on these results.” (D)
“The prognosis of patients with sepsis is related to the severity or stage of sepsis as well as to the underlying health status of the patient. For example, patients with sepsis and no ongoing sign of organ failure at the time of diagnosis have about a 15%-30% chance of death. Patients with severe sepsis or septic shock have a mortality (death) rate of about 40%-60%, with the elderly having the highest mortality rates. Newborns and pediatric patients with sepsis have about a 9%-36% mortality rate.” (E)
“Patients today tend to have options when seeking hospital care. Those aware of the dangers of sepsis may well look for hospitals with more favorable sepsis ratings. This isn’t a Yelp review or blog post; it’s an official report from the Centers for Medicare and Medicaid Services. Since hospitals no longer have the option to conceal this information, it pushes the issues of transparency and accountability to the surface, which are absolute necessities to drive change.
Hospitals are working to combat sepsis: employing special training to educate staff on the warning signs of sepsis; mandating the use of protocols; and deploying electronic surveillance and alerting systems. Many such systems frequently fire false alerts. Over time, staff members tend to ignore these alerts, due to what is known as alert fatigue. A highly accurate and effective alerting system can be a game-changer in saving lives.
Institutions need to look closely at their sepsis performance and it will be a sobering moment for some. But this new trove of data has the potential to be historic in combating the deadliest condition in U.S. hospitals. July 2018 could be the dawn of a new era of sepsis treatment, one in which more patients will be as fortunate as the young hunter I cared for and make full recoveries from this deadly and fast-moving condition.” (A)
(A) Hospital Compare lifts the veil on sepsis care. Check your hospital’s score, by Steve Claypool, https://www.statnews.com/2018/07/26/hospital-compare-lifts-veil-on-sepsis/
(B) Just 49% of hospitals follow CMS’ sepsis treatment protocols, By Maria Castellucci, https://www.knoxnews.com/story/news/health/2018/07/27/sepsis-treatment-how-do-east-tennessee-hospitals-score/844117002/
(C) Surviving Sepsis Campaign: Retract the SSC 2018 Guidelines, by: Emcrit P, https://www.thepetitionsite.com/772/830/097/surviving-sepsis-campaign-sccm-esicm/
(D) Pediatric sepsis care within an hour increases chances of survival, shows study, https://www.news-medical.net/news/20180725/Pediatric-sepsis-care-within-an-hour-increases-chances-of-survival-shows-study.aspx
(E) Sepsis (Blood Poisoning), by Charles Patrick Davis, https://www.medicinenet.com/sepsis/article.htm#what_causes_sepsis
Note: This blog shares general information about understanding and navigating the health care system. For specific medical advice about your own problems, issues and options talk to your personal physician.
“No Surprise Charges” is one of the key Lessons Learned in Elisabeth Rosenthal’s fabulous new book AN AMERICAN SICKNESS (Penguin Press, 2017). “Hospitals in your network should also be required to guarantee that all doctors who treat you are in your insurance network.”
We have all harshly experienced or heard about under-the counter out-of-network hospital charges:
“A Kaiser Family Foundation survey finds that among insured, non-elderly adults struggling with medical bill problems, charges from out-of-network providers were a contributing factor about one-third of the time. Further, nearly 7 in 10 of individuals with unaffordable out-of-network medical bills did not know the health care provider was not in their plan’s network at the time they received care.”(A)
A study that looked at more than 2 million emergency department visits found that more than 1 in 5 patients who went to ERs within their health-insurance networks ended up being treated by an “out-of-network” doctor — and thus exposed to additional charges not covered by their insurance plan.” (B)
Here is a brief case study:
“When Janet Wolfe was admitted to the hospital near Macon, Georgia, a few years ago, her lungs were functioning at just one-fifth their normal capacity. The problem: graft-versus-host disease, a complication from a stem cell transplant she received to treat lymphoma. Over the course of three days she saw three different doctors. Unbeknownst to Janet and her husband, Andrew, however, none of them was in her health plan’s network of providers. That led the insurer to pay a smaller fraction of those doctors’ bills, leaving the couple with some hefty charges.” (C)
So what can you do to avoid out-of-network charges?
– Speak with a practice representative before being seen to understand the costs of seeing your doctor on an out-of-network or a cash basis. (DOCTOR note: maybe you need to leave and go to an in-network physician instead)
– If you need additional services, such as surgery, imaging or physical therapy, ask your doctor to refer you to an in-network facility to keep your costs down. (D)
A New York law is a great start toward transparency to reduce out-of-network surprises.
Under a recent New York law, Hold Harmless Protections for Insured Patients, “… patients are generally protected from owing more than their in-network copayment, coinsurance or deductible on bills they receive for out-of-network emergency services or on surprise bills.
A bill is considered a surprise if consumers receive services without their knowledge from an out-of-network doctor at an in-network hospital or ambulatory surgical center, among other things. In addition, if consumers are referred to out-of-network providers but don’t sign a written consent form saying they understand the services will be out of network and may result in higher out-of-pocket costs, it’s considered a surprise bill.” (E)
“Advocates for patients, senior citizens, labor unions, and businesses hailed Gov. Phil Murphy’s signing of a complex and controversial measure designed to curb the impact of costly “surprise” medical bills in New Jersey. Supporters said the law, nearly 10 years in the making, is the strongest of its kind nationwide…
The Democratic governor, who pledged his support for the bill in March, said the law closed a loophole to protect patients and make healthcare more affordable; sponsors called it the right thing to do to protect vulnerable residents. “We have put patients first. We have made clear that New Jersey stands for transparency when it comes to health care,” …
The reform is designed to protect patients, businesses, and others who pay for medical care from the high-cost bills associated with emergency or unintentional care from doctors or other providers who are not part of their insurance network. The law requires greater disclosure from both insurance companies and providers — so patients are clear on what their plan covers — ensures patients aren’t responsible for excess costs, and establishes an arbitration process to resolve payment disputes between providers and insurers, a mechanism intended to better control costs…
“It’s a solution that is fair to healthcare providers and consumers alike because it strikes a balance between providing reasonable compensation to facility-based providers, while protecting consumers from unexpected, nonnegotiable bills that drive health insurance premiums higher,” said NJBIA president and CEO Michele Siekerka. “This was an extremely difficult and complicated issue, and NJBIA commends the governor and the bill sponsors who worked hard to address the concerns of all stakeholders.”” (F)
A price transparency RFI released by the agency this week asks for input on how CMS might develop consumer-friendly policy. In a request for information announced Thursday, the Centers for Medicare & Medicaid Services asked whether providers and suppliers should be required to tell patients, in advance, how much a given healthcare service will cost out-of-pocket. If the agency were to move forward with a price transparency requirement on physician practices, it could prove controversial. Many doctors say they themselves lack the training they would need to have effective conversations about how much the healthcare services they provide will ultimately cost patients.
But CMS has repeatedly indicated that it aims to get more pricing information to consumers one way or another. “We are concerned that challenges continue to exist for patients due to insufficient price transparency,” the agency wrote in its RFI, which is included in proposed revisions to the Physician Fee Schedule, Quality Payment Program, and other policies for 2019…
In order to determine what additional actions may be appropriate to connect consumers with accessible price information, the CMS price transparency RFI includes a variety of questions, including the following:How should the phrase “standard charges” be defined in various provider and supplier settings?
Which information types would be most useful to beneficiaries, and how can providers and suppliers empower consumers to engage in price-conscious decision-making?
Should providers and suppliers have to tell patients how high their out-of-pocket costs are expected to be before providing a service?” (G)
“Patients are at a higher risk of receiving surprise medical bills on Affordable Care Act exchanges, according to a new report.
In 2018, more than 73% of plans available in the exchange marketplace offered restrictive networks, compared with 48% in 2014, according to the report (PDF) commissioned by Physicians for Fair Coverage. PFC is a nonprofit alliance of physician groups which advocates for ending surprise insurance gaps and improving patient protections…
“This research confirms what patients and physicians across the country have known for some time,” said PFC President and CEO Michele Kimball in a statement. “Insurers have been systematically narrowing their networks and increasing premiums, creating surprise insurance gaps that patients don’t realize exist until it’s too late. While insurers are making record profits, patients are paying more for less.”
The coalition, which includes tens of thousands of emergency physicians, anesthesiologists and radiologists from across the country, is pressing for more states to adopt legislation to solve the problem of surprise medical bills. The problem often occurs when a patient seeks care at an in-network hospital but is then surprised the doctor treating them is out of their insurance company’s network—a fact they usually find out when they get the doctor’s bill.
“When it comes to health care, nobody likes a surprise. This study confirms what we’ve been hearing from patients for years: there is no real way for patients to avoid a ‘surprise’ medical bill, even when they’re insured and try to stay in-network. We need a transparent healthcare system designed for patients, not profits,” Rebecca Kirch, executive vice president of healthcare quality and value at the National Patient Advocate Foundation, said in a statement…
The best estimates indicate that 1 out of 7 times someone goes to the emergency department, they are going to be stuck with a surprise bill.” (H)
A patient came to see me with lower abdominal pain. Was she interested in my medical opinion? Not really. She was told to see me by her gynecologist who had advised that the patient undergo a hysterectomy. Was this physician seeking my medical advice? Not really. Was this patient coming to see me as her day was boring and she needed an activity? Not really. After the visit with me, was the patient planning to return for further discussion of her medical status? Not really.
So, what was going on here. What had occurred that day was the result of an insurance company practice that I had thought had been properly interred years ago.
The woman had pelvic pain and consulted with her gynecologist. An ultrasound found a lesion within her uterus. A hysterectomy was advised. The insurance company directed that a second opinion be solicited. A second gynecologist concurred with the first specialist. The patient advised me that the insurance company wanted an opinion from a gastroenterologist that there was no gastrointestinal explanation for her pain. In other words, they did not want to pay for a hysterectomy that they deemed to be unnecessary.
How should we respond? (I)
“In the absence of laws barring balance bills and surprise bills, there are steps hospitals and health plans can take to protect consumers from medical debt. The Healthcare Financial Management Association urges hospitals to inform patients that they may be eligible for financial assistance provided directly by the hospital and make clear to patients what services are and are not included in their price estimates. Hospitals also need to communicate better with uninsured patients about medical costs and options for sharing costs..
Health plan best practices include helping members estimate expected out-of-pocket costs and sharing price information for providers in a given region.
Beyond that, hospitals need to double down to ensure they have contracts with as many in-network providers as possible. “It requires the physicians, hospitals, health plans all working together to make sure that everybody’s in-network or, if they’re not, the patient knows that clearly up front,” says Rick Gundling, HFMA’s senior vice president for healthcare financial practices. “It’s kind of a three-legged stool.”
Consumers also need to become savvier when it comes to costs of medical care. Most people do see providers in their network, says Gupta. However, “because of their high-deductible health plan, they often don’t recognize until they get hit with a bill that the same MRI might be $3,000 after the deductible at a local hospital that is convenient for them versus $1,000 a mile down the street at an imaging center,” he adds.” (J)
“Cooper works as a physician assistant and hears about medical billing problems all the time.
So when she initially found out she was pregnant, this health care provider did everything she could to make sure anyone associated with her pregnancy would be considered what’s referred to as “in-network.”
She contacted her insurance company, Aetna, and she also contacted Banner Gateway Hospital, the hospital where she planned to give birth. The hospital then sent her written confirmation that she had nothing to worry about.
“She said, ‘Send me a picture of your insurance card front and back and I’ll double check that you’re covered.’ And, she sent me back an hour later saying, ‘Yes, you are in network,'” Cooper said.
Cooper eventually delivered her little girl at Banner Gateway Hospital. But, not long after, Cooper started getting a number of large “out-of-network” medical bills.
“Aetna then sent me back something that said, ‘No you are out-of-network’ and that’s how everything started to trickle through,” she said.
“Out-of-network.” How could that happen? Remember, she got written confirmation from Banner Gateway Hospital indicating she was “in-network.”…
When she added them all up, her medical bills came to around $18,000, money she shouldn’t have been responsible for. Still, she says she wasn’t getting any resolution…
We asked them to review Cooper’s case and after they did, they acknowledged there was a mistake.
As a result, Aetna reprocessed all of Heather’s bills as “in-network.”..
That means Cooper will now only have to pay just $750 out of pocket, the cost of her deductible rather than $18,000. Cooper said she couldn’t be happier and says it all happened with the help of 3 On Your Side.” (K)
“On the first morning of Jang Yeo-im’s vacation to San Francisco in 2016, her eight-month-old son Park Jeong-whan fell off the bed in the family’s hotel room and hit his head.
There was no blood, but the baby was inconsolable. Jang and her husband worried he might have an injury they couldn’t see, so they called 911, and an ambulance took the family — tourists from South Korea — to Zuckerberg San Francisco General Hospital.
The doctors at the hospital quickly determined that baby Jeong-whan was fine — just a little bruising on his nose and forehead. He took a short nap in his mother’s arms, drank some infant formula, and was discharged a few hours later with a clean bill of health. The family continued their vacation, and the incident was quickly forgotten.
Two years later, the bill finally arrived at their home: They owed the hospital $18,836 for the 3 hour and 22 minute visit, the bulk of which was for a mysterious fee for $15,666 labeled “trauma activation,” which sometimes is known as “a trauma response fee.”
Update: After this story was published on June 28, Zuckerberg San Francisco General Hospital agreed to waive the $15,666 trauma response fee charged for Park Jeong-whan’s visit to the hospital. In a letter, the hospital’s patient experience manager said the hospital did a clinical review and offered “a sincere apology for any distress the family experienced over this bill.” Further, the hospital manager wrote that the case “offered us an opportunity to review our system and consider changes.” (L)
“The health insurer Anthem is coming under intense criticism for denying claims for emergency room visits it has deemed unwarranted…
The insurer initially rolled out the policy in three states, sending letters to its members warning them that, if their emergency room visits were for minor ailments, they might not be covered. Last year, Anthem denied more than 12,000 claims on the grounds that the visits were “avoidable,” according to data the insurer provided to Senator Claire McCaskill, a Democrat from Missouri, one of the affected states.
But when patients challenged their denials, Anthem reversed itself most of the time, according to data the company gave Ms. McCaskill. The report concludes that the high rate of reversals suggests that Anthem did not do a good initial job of identifying improper claims, meaning some patients who did not challenge their denials may have been stuck paying big bills they should not have been responsible for.” (M)
(A) Surprise Medical Bills by Karen Pollitz, kkf.org, http://kff.org/private-insurance/issue-brief/surprise-medical-bills/
(B) Many get hit with surprise ‘out-of-network’ bill after emergency rooms: Study” by Dan Mangan, CNBC, http://www.cnbc.com/2016/11/16/many-get-hit-with-surprise-out-of-network-bill-after-emergency-rooms-study.html
(C) When Out-Of-Network Charges Pop Up, Try An Appeal, by Michelle Andrews, NPR, http://www.npr.org/sections/health-shots/2011/06/21/137304710/when-out-of-network-charges-pop-up-try-an-appeal
(D) (D) What It Means If Your Doctor is Out of Network, by Sergio Viroslav, Angie’s list, https://www.angieslist.com/articles/what-it-means-if-your-doctor-out-network.htm
(E) (E) N.Y. Law Offers Model For Helping Consumers Avoid Surprise Out-Of-Network Charges by Michelle Andrews, KHN http://khn.org/news/n-y-law-offers-model-for-helping-consumers-avoid-surprise-out-of-network-charges/
(F) Governor Signs Nation’s Strongest Law on ‘Surprise’ Medical Bills, by Lilo H. Stainton, https://khn.org/news/n-y-law-offers-model-for-helping-consumers-avoid-surprise-out-of-network-charges/
(G) SURPRISE MEDICAL BILLS: SHOULD CMS MAKE DOCTORS GIVE PRICE INFO UP FRONT?, by STEVEN PORTER, https://khn.org/news/n-y-law-offers-model-for-helping-consumers-avoid-surprise-out-of-network-charges/
(H) Patients on ACA plans at higher risk for surprise bills, physician coalition says, by Joanne Finnegan, https://www.fiercehealthcare.com/practices/aca-exchanges-restrictive-networks-surprise-bills-physicians-for-fair-coverage
(I) Let’s tell the truth about what’s going on, by Michael Kirsch, https://www.medpagetoday.com/blogs/kevinmd/74070?xid=nl_mpt_hemoncvideo_2018-07-20&eun=g1223211d0r&pos=9&utm_source=Sailthru&utm_medium=email&utm_campaign=Daily%20Headlines%202018-07-20&utm_term=Daily%20Headlines%20-%20Active%20User%20-%20180%20days
(J) Some patients fight back against surprise medical bills, by Meg Bryant, https://www.healthcaredive.com/news/some-patients-fight-back-against-surprise-medical-bills/526576/
(K) Gilbert mom fighting medical bills she says she shouldn’t owe, by LiAna Enriquez, http://www.azfamily.com/story/38722098/gilbert-mom-fighting-medical-bills-she-says-she-shouldnt-owe
(L) A baby was treated with a nap and a bottle of formula. His parents received an $18,000 bill, by Jenny Gol and Sarah Kliff, https://www.vox.com/2018/6/28/17506232/emergency-room-bill-fees-health-insurance-baby
(M) A Health Insurer Tells Patients It Won’t Pay Their E.R. Bills, but Then Pays Them Anyway, https://www.nytimes.com/2018/07/19/upshot/anthem-emergency-room-bills.html?utm_source=STAT+Newsletters&utm_campaign=24e499fa7a-MR_COPY_09&utm_medium=email&utm_term=0_8cab1d7961-24e499fa7a-149527969
“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
“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/
“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/
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:
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…
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.
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.
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
“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/