Tagged Health Industry

To Circumvent Patent Challenges, This Pharma Company Made A Deal With A Native American Tribe

Now that the deal has been made public, other drugmakers are taking interest. In other pharmaceutical news, the struggle to create a Zika vaccine highlights a broader public health problem, FDA is changing the way it approves orphan drugs, the House has begun work on a bill that would boost the agency’s oversight of over-the-counter drugs, and more.

Stat: Allergan Patent Deal With Mohawk Tribe Prompts Interest From Other Drug Makers
In the wake of a startling deal in which Allergan (AGN) is selling some patents to a Native American tribe, an attorney for the tribe indicated other drug makers have asked about such arrangements. “I can’t provide specific information, but your assumptions are pretty correct” that representatives for other pharmaceutical companies have made inquiries since the deal was announced last Friday, said Chris Evans of the Shore Chan DePumpo law firm, which brought the deal to the tribe. (Silverman, 9/13)

Stat: Race For A Zika Vaccine Slows, A Setback For Efforts To Head Off Outbreaks
The development of a type of Zika vaccine that authorities had hoped to usher to the market has proven more challenging than some scientists and pharmaceutical companies had expected, people involved in the research have told STAT, posing a setback for efforts to avoid future outbreaks of the disease. Although vaccines typically take years to produce, test, and license, U.S. health officials had voiced confidence that Zika would not be a difficult target, and some predicted that a vaccine could be made and fully tested, ready for Food and Drug Administration assessment, within two to three years. Others predicted a licensed Zika vaccine could be available sometime in 2020. (Branswell, 9/13)

Kaiser Health News: FDA Moves To Guard Against Abuse Of ‘Orphan Drug’ Program
The Food and Drug Administration is changing the way it approves medicines known as “orphan drugs” after revelations that drugmakers may be abusing a law intended to help patients with rare diseases. In a blog post Tuesday, FDA Commissioner Scott Gottlieb said he wants to ensure financial incentives are granted “in a way that’s consistent with the manner Congress intended” when the Orphan Drug Act was passed in 1983. That legislation gave drugmakers a package of incentives, including tax credits, user fee waivers and seven years of market exclusivity if they developed medicines for rare diseases. (Tribble, 9/13)

Roll Call: House Begins Work On Over-The-Counter Drug Fees
The House began public deliberations Wednesday on a bill that would boost the Food and Drug Administration’s oversight of over-the-counter drugs in exchange for industry-paid fees. A bipartisan draft bill released earlier this week has support from the FDA and the over-the-counter drug industry. Under the new proposal, drug manufacturers would pay an annual fee for their facilities and an extra fee each time they submit a request to review proposed changes related to their product. (Siddons, 9/13)

Los Angeles Times: Bill To Shed More Light On Prescription Drug Prices Heads To Gov. Jerry Brown’s Desk
Powered by increasing scrutiny of costly prescription drugs, a measure that would require sweeping new disclosure on how medicines are priced cleared its final legislative hurdle Wednesday. The state Senate approved the bill with no debate, belying the fierce behind-the-scenes jockeying that pit pharmaceutical companies against health insurers, labor unions and liberal activists. (Mason, 9/13)

San Jose Mercury News: California Drug Price Transparency Bill Heads To Gov. Brown
The nation’s most comprehensive legislation aimed at shining a light on prescription drug prices is heading to California Gov. Jerry Brown’s desk. … It would do so by requiring pharmaceutical companies to notify health insurers and government health plans like Medi-Cal at least 60 days before scheduled prescription drug price hikes that would exceed 16 percent over a two-year period. (Seipel, 9/13)

The Associated Press: Pharma Bro Martin Shkreli Has Bail Revoked, Heads To Jail
Defense attorneys had argued at a hearing in federal court in Brooklyn that the post by Shkreli, offering a $5,000 bounty to anyone who could grab him one of Clinton’s hairs while she’s on a book tour, was political satire. But U.S. District Judge Kiyo Matsumoto didn’t see the humor, saying the offer could be taken seriously by fellow Clinton detractors. (Hay, 9/13)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

Advocates Pressing Medicare To Promote Advance Directives Among Beneficiaries

Some lawmakers and organizations want the government to help get the word out about advance directives and to encourage people to create them. Also, a look at some of the experimental programs being run by Medicare to change how doctors are reimbursed.

Modern Healthcare: Healthcare Groups, Lawmakers Push Medicare To Promote Advance Directives
Although the CMS reimburses clinicians for advance care planning during Medicare patients’ yearly wellness visits, the agency has yet to encourage patients to set up these plans. It shows: Two-thirds of American adults do not have advance directives to guide their healthcare if they become unable to communicate. … But even if a person has an advance directive, it may be hard to use. (Amdt, 9/13)

Modern Healthcare: Providers Find Success In CMS’ Multipayer Model
Dr. Katherine Clark was tired of the fee-for-service status quo. Every day, she would go through the same motions: see patients, treat their ailment and not see them again until they had a new health issue. But those patients weren’t getting better in the long run, and she wanted the cycle to end. That required a change in how she and other members in her practice were paid. … When the practice was accepted into the CMS’ Comprehensive Primary Care Initiative, it moved from the standard care pattern to one that put more emphasis on preventive screenings and follow-ups. Not only did she notice an overall improvement in quality of care, her practice also achieved notable savings under the model. (Dickson, 9/13)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

Reporter’s Notebook: In Health Care, A Good Price Is Hard To Find

A recent story about why Northern California is the most expensive place in the country to have a baby began as a tip from an obstetrician. Dr. Sarah Azad told me that insurers were paying her just a third of what they pay doctors employed by large hospital systems in her town of Mountain View, Calif.

Unfortunately, she explained, she could speak only in general terms. She couldn’t share her actual payment rates with me because she was barred from doing so by a gag clause in her contracts with insurers.

So, I called the insurers who pay her, and the hospital systems that employ most of the other obstetricians in Mountain View. They all had the same answer: It would be illegal for them to tell me the dollars and cents.

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As it turns out, the vast majority of contracts between doctors or hospitals and insurance companies are subject to a gag clause, which prohibits either party from disclosing negotiated rates. That means it’s almost impossible for consumers, researchers or journalists to find actual, accurate numbers, despite the fact that cost differentials among doctors can be so stark. And it’s particularly problematic for the growing number of people who have insurance plans with deductibles that can run more than $10,000 for a family.

The underlying problem of our health care system — beyond the corrosive partisan politics — is its high cost. I have long understood that the lack of price transparency is one reason our system stays so expensive. It was a surprise, though, to find out that this opacity is cemented by legally binding contracts.

Think about what this would look like for a mundane purchase, say, a gallon of milk. Advertisements and price tags would disappear, so you couldn’t compare prices at different stores. And you wouldn’t even know how much you had paid for the milk until you got a bill in the mail weeks or months later. On top of that, the store and the dairy farmer would be barred from telling a journalist or an economist what you had paid.

It’s absurd, but I wasn’t going to let the absurdity kill my story.

I started by asking all of the health policy analysts, researchers and economists I could find, “How can I find these rates, by physician, for an uncomplicated vaginal delivery?” Everyone told me the same thing: You can’t get that.

I searched online, but most of the websites claiming to offer health price transparency offered only “average costs” for specific services in your area. Not much help if you’re trying to compare the costs of individual doctors.

Next, I asked Castlight, a “transparency tool” that gathers payment data and allows employees of certain companies to estimate the costs of their medical care. But Castlight told me that as a journalist, I wasn’t allowed to have access to the exact pricing information of individual providers. It, too, was subject to the gag clause.

So I turned to the consumers who might have access to those tools. I asked friends and colleagues, and put out social media requests: Would anyone be willing to share the information from the cost estimators they got from their employers or insurers? I found a few willing sources and was able to mine the results of their inquiries to find out the basic cost differentials between independent doctors and those employed by large systems, including Sutter Health.

Unfortunately, these estimators are difficult to use and often provide incomplete data. And when I tried to confirm that information, I ran up against the gag clauses again.

Finally, I found out about a health data company called Amino that was willing to send me the claims data it had been gathering. At last! The Holy Grail! It had hundreds of claims for vaginal births performed by obstetricians in the Bay Area. KHN data correspondent Sydney Lupkin helped me decipher a Medicare provider database to determine where each doctor worked. In cases where the doctor’s employment status was unclear, I called the health system or physician directly. We then calculated the median billing amount, on average, for a routine vaginal birth for each health system.

Weeks of digging and data analysis confirmed the imbalance Dr. Azad had told me about at the start of my quest. The few independent doctors left in the Bay Area receive a median amount of $2,408.45 for a routine vaginal delivery, which includes prenatal and postnatal visits. That compares with $5,238.13 for the same bundle of services provided by Stanford physicians and $8,049.84 when the doctors are employed by University of California-San Francisco — a fourfold difference.

Hard data, hard won.

The database we built gave us a strong sense of the cost variation between doctors who work at other health systems and those who have remained independent. But it did not include enough claims from the largest hospital system in the region, Sutter Health. For Sutter, I used the data from the online cost estimators, and found that obstetricians employed by the system are reimbursed about $6,452 for a vaginal delivery.

It’s no accident that data on physician costs are so hard to find. Its inaccessibility allows hospitals to keep raising their prices. It’s simply not in their interest for the public to know how much they’re charging. And insurers don’t want other doctors or hospitals to see the high prices they’ve agreed to pay, for fear they would demand the same.

In the end, all of us — through our insurance premiums and our taxes — pay a price for non-transparency.

Categories: Cost and Quality, Health Care Costs, Health Industry

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FDA Moves To Guard Against Abuse Of ‘Orphan Drug’ Program

The Food and Drug Administration is changing the way it approves medicines known as “orphan drugs” after revelations that drugmakers may be abusing a law intended to help patients with rare diseases.

In a blog post Tuesday, FDA Commissioner Scott Gottlieb said he wants to ensure financial incentives are granted “in a way that’s consistent with the manner Congress intended” when the Orphan Drug Act was passed in 1983. That legislation gave drugmakers a package of incentives, including tax credits, user fee waivers and seven years of market exclusivity if they developed medicines for rare diseases.

A KHN investigation earlier this year, which was published and aired by NPR, found many drugs that now have orphan status aren’t entirely new. Of about 450 drugs that have won orphan approval since 1983, more than 70 were drugs first approved by the FDA for mass-market use. Those include cholesterol blockbuster Crestor, Abilify for psychiatric disorders and rheumatoid arthritis drug Humira, the world’s best-selling drug.

Gottlieb announced plans to close a loophole that allows manufacturers to skip pediatric testing requirements when developing a common-disease drug for orphan use in children. He also signaled that bigger changes are being considered, announcing a public meeting to explore issues raised by scientific advances, such as the increase in precision medicine and biologics.

“We need to make sure our policies take notice of all of these new challenges and opportunities,” he wrote. Gottlieb, through his agency, declined multiple requests for interviews.

Over the years, drugmakers have fueled a boom in orphan drugs, which often carry six-figure price tags. Nearly half of the new drugs approved by the FDA are now for rare diseases — even though many of them also treat and are marketed for common diseases.

Gottlieb became commissioner in May, a few months after three key Republican senators called for a federal investigation into potential abuses of the Orphan Drug Act, and the Government Accountability Office agreed to investigate.

The GAO has yet to begin its investigation, saying it doesn’t expect to start work until late this year, when staff is available. Regardless, in late June, Gottlieb announced what would be the first in a series of updates that shift the way the FDA handles orphan drugs.

Those include:

  • Eliminating a backlog in drug applications for orphan designation or status. Getting a “designation” is a critical first step if a company wants to win orphan incentives once the drug is approved for treatment use. And, much like the rise in approvals, the requests by companies to get drugs designated with orphan status has also skyrocketed. Gottlieb said in June that he wanted to get rid of the backlog; on Tuesday, he said the effort was complete. About half of the 200 applications from drugmakers won orphan status.
  • Mandating that drugmakers prove their medicine is clinically superior before getting the market exclusivity that comes with being an orphan. The agency had lost a lawsuit in which a company said it was owed the exclusivity period regardless of whether its medicine was better. And two more lawsuits had been filed by Eagle Pharmaceuticals and, more recently, another by United Therapeutics. The FDA Reauthorization Act, which passed last month, made it law that a drug has to be clinically superior to get the incentives.
  • Closing the loophole for pediatric orphan drugs by requiring all drugs approved for common adult diseases, like inflammatory bowel disease, undergo pediatric testing when getting approval as a pediatric orphan drug. Pediatric testing is not required for orphan drugs, and last month Congress mandated that orphan drugs for cancer be tested for children. Still, the American Academy of Pediatrics celebrated the proposed change but warned it was only a “first step.” Dr. Bridgette Jones, chair of American Academy of Pediatrics Committee on Drugs, said late Tuesday that orphan drugs are “still mostly exempt from pediatric study requirements … children deserve access to safe, effective medications.”

Dr. Martin Makary, who wrote a critical 2015 paper on orphan approvals, said the changes at the agency indicate that Gottlieb seems “concerned about all the right things.”

“The government does a lot of lip service in general,” Makary said. “This is not lip service.”

The restructuring has been swift in some ways.

Sandra Heibel, a senior consultant at Haffner Associates, a firm that helps companies submit orphan drug applications, noted that the approval process for designations definitely sped up over the summer, and “we are absolutely getting responses from the FDA back in 90 days. That has come through.”

Other changes to the agency, though, will evolve slowly. For example, the orphan drug office has begun reaching across the FDA’s divisions for help in reviewing drugs. In May, the FDA’s orphan reviews began to work with the office of pediatric therapeutics to review pediatric applications — ideally increasing the expertise applied when considering a company’s request for orphan drug use in children.

In an emailed note Tuesday, the agency confirmed that Gottlieb’s orphan modernization plan is part of a larger effort to increase competition and decrease drug prices. One focus is on targeted drugs — especially those that affect rare diseases or diseases for which there is no effective therapy, the agency said.

“Such drugs present some of the biggest opportunities in medicine to treat and cure debilitating and very costly diseases,” the agency stated.

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

Categories: Cost and Quality, Health Industry, Pharmaceuticals

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Viewpoints: At HHS, ‘Waste Scores A Victory’; Home Care Costs; Misreading The Opioid Crisis

A selection of opinions on health care from around the country.

The Washington Post: Tom Price Decides He Doesn’t Want Medicare To Save Money
The coming crisis is as predictable as it is worrying. Nearly a fifth of every dollar spent in this country is spent on health care. Without reform, that number will only rise as the baby boomers retire. Younger generations will suffer, as money is taken from building roads and educating children to paying for Medicare to cover boomers’ health costs. … Yet waste scored a victory when Health and Human Services Secretary Tom Price decided to stop or scale back “bundled payment” experiments the Obama administration had begun. (9/12)

The Wall Street Journal: Why Home Care Costs Too Much
As baby boomers age into long-term care facilities, Medicaid costs will go through the roof. Americans already spend—counting both public and private money—more than $310 billion a year on long-term support services, excluding medical care, for the elderly and the disabled. Medicaid accounts for about 50% of that, according to a 2015 report from the Kaiser Commission on Medicaid and the Uninsured. Other public programs cover an additional 20%. … There’s an urgent need to find ways of providing good long-term care at a lower cost. One fix would be to deregulate important aspects of home care. (Paul Osterman, 9/12)

The Wall Street Journal: The Way We Pay Doctors Is Hurting Health Care
For several decades, specialists in the U.S. have been paid considerably more than primary-care physicians. On average, orthopedic surgeons, cardiologists, radiologists and plastic surgeons make about twice as much as internists, pediatricians and family medicine doctors. True, most specialists train for a longer period of time than primary-care providers, but the degree of divergence in compensation has little to do with market forces or input costs. The difference has consistently been tied to how we pay for care with our emphasis on volume, procedures and technology, rather than prevention, care coordination, evaluation expertise and outcomes. (Howard Forman, 9/12)

Los Angeles Times: The Great Medi-Cal Paper Waste
Remember the telephone book? That giant, multi-thousand-page behemoth that used to land on your doorstep once a year? Well, neither do we, barely. The heyday of the phone book is long gone, and yet communications with friends and businesses is easier than it’s ever been before. Can it be that California officials haven’t noticed that? A new federal rule that took effect in July allows health insurance plans to stop automatically printing and mailing lengthy Medi-Cal provider directories, some of which are the size of phone books, to all new enrollees and make the information available digitally. Anyone without online access or who preferred having a hard copy could still request one. (9/12)

The Washington Post: Poor, Middle Class Saw Solid Gains Last Year, But We’ll Need Better Policy To Keep It Going
Poverty fell, middle-class incomes rose, and the share of Americans without health coverage ticked down to a historical low last year, according to data released Tuesday morning by the Census Bureau. This trifecta of gains for poor and middle-income households, as well as the uninsured, shows that the seven-year expansion, along with the Affordable Care Act, has continued to lift the living standards of many American households. However, last year’s gains were even stronger for those at the top of the income scale, suggesting that the inequality of economic outcomes continues to grow in America. (Jared Bernstein, 9/12)

The Washington Post: The Media Gets The Opioid Crisis Wrong. Here Is The Truth.
Lawmakers and the media have devoted much of their attention recently to deaths from opioid overdoses, as well as to the broader “deaths of despair” that include suicides and deaths from alcoholic liver disease and cirrhosis. But despite the intense focus on the topic, misinformation about the epidemic runs rampant. By conventional wisdom, tackling this crisis would require extending Medicaid and improving how it functions, cracking down on prescription painkillers and getting more health-care resources into rural communities. (Anne Case and Angus Deaton, 9/12)

San Antonio Press-Express: ‘Bad Paper’ Denying Vets Needed Services
Like [Mike] Gerardo, thousands are discharged from the military though the behaviors that got them this attention are service connected. Suffering from PTSD, for instance, often means self-medicating with drugs and alcohol. These service members are deemed problems and are discharged without being provided the services other “wounded” vets are accorded. (9/12)

WBUR: How To Talk To Your College-Age Kids About Depression And Suicide
School’s back in session, and parents ushering kids to college for the first time will undoubtedly deliver some emotional nuggets of advice. But they should also have a potentially life-saving talk with their kids in the first semester of college to avert a possible tragedy — suicide. (Nancy Rappaport, 9/13)

The New York Times: The Nazis’ First Victims Were The Disabled
I sit facing the young German neurologist, across a small table in a theater in Hamburg, Germany. I’m here giving one-on-one talks called “The Unenhanced: What Has Happened to Those Deemed ‘Unfit’,” about my research on Aktion T4, the Nazi “euthanasia” program to exterminate the disabled. “I’m afraid of what you’re going to tell me,” the neurologist says. (Kenny Fries, 9/13)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

Perspectives: Pharma Regulations Are Filled With Loopholes Nimble Companies Can Profit From

Read recent commentaries about drug-cost issues.

Los Angeles Times: A Legal Spat Between Pharmaceutical Companies Defines What’s Wrong With Our Drug Regulations
Lawsuits in the pharmaceutical industry are as common as TV ads promoting wonder drugs, never mind the horrific side effects relegated to a breathless, fast-talking voice over at the end. Typically, however, the plaintiffs in these lawsuits accuse the defendants of patent infringement. (The defendants typically strike back by claiming the patents should never have been issued in the first place.) (Michael Hiltzik, 9/12)

The Hill: Misguided Regulation Helped Create The Drug Price Crisis
We should have seen the drug price crisis coming. Over thirty years ago Robert Bork, chief architect of modern antitrust law, warned “predation by abuse of government procedures, including administrative and judicial procedures, presents an increasingly dangerous threat to competition.” (David Balto, 9/6)

Health Affairs: A Billion Here, A Billion There: Selectively Disclosing Actual Generic Drug Prices Would Save Real Money
Despite totaling more than $100 billion, reimbursement for generic drugs has received relatively little policy attention. The combination of a complex distribution system and limited information about actual prices artificially inflates what patients and insurers pay retail pharmacies for generic drugs. A recent study by the Washington State Office of the Insurance Commissioner confirms that retail pharmacies profit more when dispensing generic versus brand drugs. (Steven Lieberman, Margaret Darling, and Paul B. Ginsburg, 9/12)

Morning Consult: When It Comes To The Drug Pricing Debate, Talk Is Cheap
n the last several months, individual companies have begun to take actions in an attempt to address pricing concerns and demonstrate their ability to “self-police” — especially in the face of bad actors that have fueled hatred of the pharmaceutical industry by taking significant price increases on single-source products. These actions have ranged from taking pledges to limit annual price increases to improving transparency of pricing — including disclosing price increases, entering into value-based pricing schemes and devising innovative partnerships to lower the cost of certain medicines for patients — to entering into new partnerships to provide discounts on the medicines they sell at the pharmacy. (Zacherau and Claassen, 9/6)

The Washington Post: Don’t Let Pharma Take Down A New Maryland Price Gouging Law
In May, Maryland became the first state to take action against the alarming trend of price gouging of off-patent brand-name and generic drugs. The state’s concise new law, which permits the attorney general to argue in front of a court when the price of an older essential medication increases so precipitously as to “shock the conscience,” passed with overwhelming bipartisan votes and broad popular support. Other state legislatures are looking to introduce similar laws across the country. The generic pharmaceutical industry would prefer to see it overturned. (Jeremy A. Greene, 9/8)

Cincinnati Enquirer: Issue 2 To Give Ohio Power To Cut Drug Prices
Americans pay, by far, the highest prices for prescription drugs in the entire world. Couple this with skyrocketing prices for health services, and you have a growing health care crisis. Everyone should be able to afford the medicine their health care providers prescribe. (Nina Turner, 9/11)

The Wall Street Journal: Clinical Drug Trials May Be Coming To Your Doctor’s Office
Roger Pickar was diagnosed with a rare cancer in December 2014. A chef, comedian, husband, father and champion of the local arts community, he was successfully treated for more than a year with standard therapies. When the cancer eventually returned, his oncologist prescribed an “off label” drug—one the Food and Drug Administration had approved for other types of cancer, but not the one that afflicted Roger. That meant it wouldn’t necessarily be covered by insurance. (Amy Abernethy and Sean Khozin, 9/12)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

When Exciting Breakthrough Treatments Come With Astronomical Price Tags

News outlets report on stories related to pharmaceutical pricing.

The New York Times: New Gene-Therapy Treatments Will Carry Whopping Price Tags
The first gene therapy treatment in the United States was approved recently by the Food and Drug Administration, heralding a new era in medicine that is coming faster than most realize — and that perhaps few can afford. The treatment, Kymriah, made by Novartis, is spectacularly effective against a rare form of leukemia, bringing remissions when all conventional options have failed. It will cost $475,000. (Kolata, 9/11)

NPR: R&D For Cancer Drugs May Cost A Fraction Of What Industry Claims
The analysis, published in the current issue of JAMA Internal Medicine, concludes that it costs, on average, $650 million to develop a new cancer drug. The authors add in another $100 million or so to account for income those companies could have had if that money had been invested in the stock market instead of in new products. That total is far lower than the $2.7 billion figure that the drug industry frequently points to when it justifies the soaring cost of medicine. (It’s far higher than $320 million — an inflation-adjusted figure from a 2001 study by the consumer group Public Citizen). (Harris, 9/11)

Stat: Why Is The FDA Chief So Worried About Pharma Profits?
Developing new drugs is a costly business. So, too, is paying for the ever more expensive therapies that come to market each year. Statutorily, neither of those things is the Food and Drug Administration’s problem. But the agency’s new commissioner argues forcefully that the FDA can bring down drug prices for patients — by making life a little easier for Big Pharma. (Garde, 9/11)

Stat: FDA’s Gottlieb Plans To Close An Orphan Drug Loophole
Amid rising complaints that drug makers are exploiting loopholes to win approval of so-called orphan drugs, the Food and Drug Administration plans to close at least one of them. In a blog post, FDA Commissioner Scott Gottlieb acknowledged concerns that the Orphan Drug Act, which allows the agency to approve medicines for treating rare diseases affecting fewer than 200,000 people, needs fixing. As he put it, some drug makers are using orphan designations “as a way to sidestep other important public health goals set out by Congress.” (Silverman, 9/12)

The Wall Street Journal: Drug Companies Tie Costs To Outcomes
For decades, health insurers and patients have paid for prescription drugs based on the volume of pills or vials purchased—whether or not the medicines helped individual patients as intended. Now the outcry over high drug prices has raised the profile of a different approach to paying for prescription drugs. Pharmaceutical companies increasingly are offering to tie a portion of their reimbursements from insurers to how well drugs work in patients. (Loftus, 9/12)

Modern Healthcare: Providers Reduce Waste To Work Around Ballooning Drug Prices
Cleveland Clinic is one of the most prolific users of the heart drugs nitroprusside and isoproterenol, so when their respective prices surged 30-fold and 70-fold over a three-year span, it caught the provider’s attention. Doctors have long relied on the widely used drugs during life-threatening situations. They use nitroprusside to lower blood pressure and treat critical hypertension and congestive heart failure, as well as to keep blood pressure low during surgery. Isoproterenol is used primarily for treating low heart rate and heart block and is used to increase a patient’s heart rate while doctors operate. Valeant Pharmaceuticals acquired the rights to the off-patent drugs in 2015 and drastically increased the prices. (Kacik, 9/11)

Stat: Pharma’s Five Favorite Tricks To Protect A Monopoly
If you invent a wonder pill, you get a patent and thus a monopoly. The catch is that the patent must one day expire, opening the door to cheap generics and forcing inventors back to the well to start the cycle all over again. But it can be quite hard to say goodbye to a monopoly and the riches it brings. And so drug companies tend to get creative in the waning days of patent exclusivity, stretching the law to translucent lengths in the name of protecting profits. That became quite evident (again) last week, when Allergan surprised the pharma world by announcing it had sold patent rights on a lucrative eye drug to a Native American tribe to avoid facing certain legal challenges by generics. (Garde, 9/11)

The New York Times: How To Protect A Drug Patent? Sell It To A Native American Tribe
The drugmaker Allergan announced Friday that it had transferred its patents on a best-selling eye drug to the Saint Regis Mohawk Tribe in upstate New York — an unusual gambit to protect the drug from a patent dispute .Under the deal, which involves the dry-eye drug Restasis, Allergan will pay the tribe $13.75 million. In exchange, the tribe will claim sovereign immunity as grounds to dismiss a patent challenge through a unit of the United States Patent and Trademark Office. The tribe will lease the patents back to Allergan, and will receive $15 million in annual royalties as long as the patents remain valid. (Thomas, 9/8)

The Wall Street Journal: Allergan Partners With Indian Tribe To Protect Drug Patents
Allergan has taken a novel step to protect top-selling drug Restasis from generic competition: The company has sold the drug’s patents to an Indian tribe in upstate New York. The aim is to block rivals from challenging the patents for the dry-eye drug at the U.S. Patent and Trademark Office based on the tribe’s special legal status as a sovereign government, which the tribe says gives it immunity from patent-office review. (Rockoff, 9/8)

Bloomberg: This Shield of Patents Protects the World’s Best-Selling Drug
Humira, a treatment for inflammatory diseases such as rheumatoid arthritis and psoriasis made by AbbVie Inc., is the planet’s best-selling drug. It’s also been around almost 15 years. Those two facts alone would normally have rival drugmakers eagerly circling, ready to roll out generic versions that could win a piece of the aging medicine’s $16 billion in annual sales. Yet last year, when the patent on Humira’s main ingredient expired, not a single competitor launched a copycat version. Figuring out how to manufacture it wasn’t the obstacle. The real challenge was the seemingly impregnable fortress of patents AbbVie has methodically constructed around its prized moneymaker. (Koons, 9/7)

NPR: First FDA-Approved Drug For Chagas Raises Price Concerns
The Food and Drug Administration recently approved the first U.S. treatment for childhood cases of Chagas disease — a parasite-driven illness that, over time and unless treated early, can cause serious heart problems in about a third of the people it infects. There are perhaps 300,000 cases in the U.S., according to the Centers for Disease Control and Prevention; the illness is much more common in Latin America, where it affects millions. (Columbus, 9/10)

Stat: Amgen’s Cholesterol Drug Would Have To Sell For Around $2,000 To Be Cost Effective
An updated analysis of Amgen’s (AMGN) Repatha, which is one of the newest cholesterol drugs, has been released and suggests the price would have to drop a whopping 85 percent to 88 percent off the existing list price of $14,500 in order to be considered cost effective. This works out to between $1,725 and $2,240, which is still substantially less than the $8,970 price after Amgen gives rebates and discounts to payers, according to sales data cited in the new report from the Institute for Clinical and Economic Review, a non-profit that assesses the value of medicines. (Silverman, 9/11)

NPR: One-Third Of People Stop Taking Prescriptions And Don’t Tell The Doctor
Almost one-third of people have stopped taking a prescription drug at some time without telling their health care provider, according to the latest NPR-Truven Health Analytics Health Poll. And while cost certainly influences whether and how people take their drugs, only 10 percent of people in this poll cited it as the reason for their behavior. A separate question asked people who filled a prescription recently whether they missed at least one dose. A full quarter said they had. (Hobson, 9/8)

Stat: California Moves Closer To Adopting A Drug Pricing Transparency Law
A California bill that would require drug makers to report and justify price hikes took a big step toward reality on Monday night. The state Assembly overwhelmingly passed the legislation and it now goes to the Senate for approval, which legislative sources say may occur as soon as today. The bill, which has been vociferously fought by the pharmaceutical industry, could become one of the most comprehensive state efforts to address pricing transparency. For instance, drug makers would have to provide 60-day notice to insurers and government health plans before increasing list prices of a medicine that costs more than $40, by 16 percent in a two-year period. (Silverman, 9/12)

San Jose Mercury News: California Assembly Passes Drug Price Transparency Bill
The California State Assembly on Monday overwhelmingly approved Senate Bill 17, controversial legislation that could soon become the nation’s most comprehensive law aimed at shining a light on prescription drug prices. … It would enable health insurers to negotiate lower prices for drugs or, in many cases, replace those drugs with cheaper alternatives, according to its supporters. (Seipel, 9/11)

Stat: Vertex Shuts Down Study Of Long-Acting Kalydeco But Insists Development Still On Track
Vertex Pharmaceuticals (VRTX) terminated a small clinical trial involving an important, long-acting version of its cystic fibrosis drug Kalydeco that was acquired from Concert Pharmaceuticals (CNCE) earlier this summer. An update to a listing on the government web site ClinicalTrials.gov shows Vertex shut down the study of the drug known as CTP-656 on Sept. 10. No reason other than “decision by sponsor” is given. (Feuerstein, 9/11)

The Wall Street Journal: Alexion To Cut Workforce By 20%, Shift Headquarters To Boston
Alexion Pharmaceuticals Inc. is cutting its workforce by 20%, relocating its headquarters to Boston and closing sites as it works to reduce its overhead and move on from a sales-practices controversy. The rare-disease drugmaker has seen a slew of management changes during the past year, including hiring a new chief executive, after an internal investigation showed senior management pressured staff to persuade customers to order its flagship drug earlier than needed to meet financial targets. (Hufford, Rockoff and de Avila, 9/12)

The Associated Press: Judge To Hear Arguments On Whether To Lock Up Pharma Bro
A judge is set to hear arguments about whether the provocative online antics of former pharmaceuticals company CEO Martin Shkreli are bad enough to put him behind bars. The hearing before U.S. District Judge Kiyo Matsumoto on a government demand to revoke the convicted Shkreli’s bail was scheduled for Wednesday in federal court in Brooklyn. (Hays, 9/13)

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State Highlights: Del. Governor Signs Law To Help Patients With Disabilities Get Transplants; Wash. Hospitals Fall Short On Charity Care Duties

Media outlets report on news from Delaware, Washington, Minnesota, California and Ohio.

The Associated Press: New Law Ensures Disabled Are Eligible For Organ Transplants
Gov. John Carney is signing legislation aimed at ensuring that individuals with mental and physical disabilities are not denied access to organ transplant procedures based solely on their disability. The bill being signed Wednesday prohibits health care providers from deeming a person ineligible to receive an anatomical gift or organ transplant, related medical services, or referrals based solely on a physical or mental disability. (9/13)

Seattle Times: Report: Washington Hospitals Stingy With Charity Care, With Language Barrier An Issue 
Hospitals around Washington appear to be falling short in their charity-care duties, according to a report by Columbia Legal Services (CLS), which helped Andres-Juan get her pay back, and Attorney General Bob Ferguson, who announced last week a lawsuit against St. Joseph Medical Center in Tacoma. St. Joseph has withheld charity care from tens of thousands of low-income patients since 2012, Ferguson alleged. Senior managers at the hospital, part of the CHI Franciscan chain along with Highline Medical Center, knew about the problems but did nothing, he said. (Young, 9/12)

Pioneer Press: United Hospital’s Emergency Center Expansion Is Designed To Cut Wait Times 
New renovations to United Hospital revealed Tuesday are designed to curb wait times and promote patient safety. A ribbon cutting for the St. Paul hospital’s $1.4 million emergency care center expansion was held Tuesday morning. Improvements include: six new care spaces, a shared welcome desk for United and Children’s Hospital and security personnel, larger triage areas and hybrid rooms for medical and mental health patients. (Faircloth, 9/12)

KQED: After Rallies And A Resolution, These Patients Will Stay In San Francisco
After months of protests from families, city supervisors and public health officials, California Pacific Medical Center (CPMC) announced that it will continue to care for 28 patients with complex medical needs, instead of transferring them to other facilities outside the city. In June, the patients and their families received letters from CPMC saying that the skilled nursing unit where they lived at St. Luke’s Hospital, known as a “subacute” unit, was closing permanently. (Klivans, 9/12)

Columbus Dispatch: Nationwide Children’s Studying Kids’ Genetics For New Cancer Treatments
[Richard] Wilson is the executive director of the Institute for Genomic Medicine at Nationwide Children’s Hospital in Columbus. He opened his labs last week to give hospital employees and others a peek at the machines and researchers who are taking the first steps to help find new cancer treatments, reveal rare diseases and change the way medicine is practiced. (Viviano, 9/13)

Los Angeles Times: Experts At Suicide Awareness Conference Highlight The Brain’s Role In Depression
A conference held in conjunction with Worldwide Suicide Prevention Day drew mental health professionals and lay people to USC Verdugo Hills Hospital where they learned about the biology of the suicidal brain, how genetics are involved, and ways one can support a deeply depressed individual. The Sept. 9 event, which carried the theme, “Shattering the Silence,” was the hospital’s second annual Suicide Awareness and Prevention Conference, and attendance was up this year. (Sanderson, 9/12)

California Healthline: Kaiser Permanente Names Dean Of New California Medical School
When health policy expert and pediatrician Mark Schuster searched for a book to help parents speak easily and accurately with their children about sex and sexual health, he couldn’t find one he liked. So, the Harvard professor — a leader in research on child, adolescent and family health — enlisted the help of a medical school classmate to write the 2003 guide for parents  “Everything You Never Wanted Your Kids To Know About Sex (But Were Afraid They’d Ask).” (O’Neill, 9/12)

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A New Weapon In The War Against Cancer: Tumor-Destroying Vaccines

The research on the new therapy is part of a wider push to tap into immune cells’ cancer-fighting powers. In other public health news: myths and vaccines, the cancer death rate, epilepsy, patient mobility in hospitals, soda, and sperm.

The Wall Street Journal: Scientists See Progress For Cancer Vaccines
Conventional vaccines prevent people from getting sick in the first place. Now scientists are testing a new type of vaccine that treats existing cancers by spurring immune cells to go on the attack. These drugs—known as therapeutic vaccines—hold the potential to plunge cancers into remission without causing the side effects of treatments such as chemotherapy. (Gormley, 9/12)

The Wall Street Journal: Myths About Vaccines Are Hard To Dispel
For people who believe myths about vaccines, the facts aren’t very convincing. That’s the result researchers got when they tested if people could be persuaded to change their incorrect beliefs that certain vaccines cause autism or have lesser but still harmful side effects on children. The test subjects stuck to their opinions even after being shown facts about the matter. In fact, their beliefs were stronger afterward, according to Sergio Della Sala, a neuroscience professor at the University of Edinburgh and one of three researchers who conducted the study. (Dizik, 9/12)

The Philadelphia Inquirer/Philly.com: Cancer Death Rate Continues To Decline Amid Progress, Challenges, Researchers Report
The 2017 report hails the 25 percent fall in  U.S. cancer death rates from 1991 to 2014, while five-year survival rates for all cancers rose from 49 percent in the mid-1970s to 69 percent in 2013. Moreover, in the past year, the FDA has approved nine new cancer drugs and expanded the approved uses for eight more. Two of the new drugs are in the revolutionary class of immunotherapies, called “checkpoint inhibitors,” that includes Keytruda. (McCullough, 9/12)

Stat: Sage’s Epilepsy Drug Fails To Do Better Than Placebo In Key Clinical Trial
Sage Therapeutics’ closely watched drug, brexanolone, did not do much better than a placebo in helping patients with a severe type of epilepsy, data from a phase 3 clinical trial show. Sage, which is based in Cambridge, Mass. expected brexanolone to lead to its first-ever drug approval. Instead, its shares dropped 25 percent to $66 in pre-market trading. (Feuerstein, 9/12)

The Wall Street Journal: Hospitals Increasingly Tell Patients To Get Up And Move
To prevent falls that cause injuries, hospitals often encourage patients who haven’t undergone surgery to stay in bed. But some medical experts say that may be a big mistake. Numerous studies have shown that immobility increases the likelihood of muscle atrophy, blood clots, bed scores and delirium. For elderly or very sick patients, the danger is even greater: Being immobilized even for a few days can lead to a permanent functional decline, making it more difficult for patients to return home. (Ward, 9/12)

Bloomberg: Emails Show How The Food Industry Uses ‘Science’ To Push Soda
There are few federal food policies as contentious as the U.S. Dietary Guidelines, developed every five years after a report by the independent U.S. Dietary Guidelines Advisory Committee. The guidelines not only inform individual consumers about what’s healthy and what isn’t but are also used to develop approaches to everything from food labeling regulations to school lunch menus and food stamp benefits. … So it’s not surprising that following the 2015 committee report, which had recommended that Americans reduce their consumption of red and processed meat and sugar-sweetened foods and beverages, the food and beverage industry scrambled to respond. (Shanker, 9/13)

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Postcard From The Hill: Senators Shelve Histrionics In Search Of Obamacare Fix

After a summer of flame-throwing over the Affordable Care Act’s repeal, Republicans and Democrats are now engaged in a serious collaborative effort to find a legislative solution that would ward off predicted premium rate hikes this year.

Sen. Lamar Alexander, who chairs the Senate Health, Education, Labor and Pensions (HELP) Committee, and his colleagues are up against a tight deadline to craft a bill to steady premiums in the Affordable Care Act’s shaky markets. Insurers must nail down plans late this month for the coming enrollment season.

If that weren’t challenging enough, the Tennessee Republican and the committee’s ranking Democrat, Sen. Patty Murray of Washington, have insisted their bill also be simple, bipartisan and balanced.

Two much-discussed ideas so far are funding subsidies that help moderate-income consumers pay out-of-pocket costs for health care and giving states more leeway on insurance coverage and plans for their residents.

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Over three hearings in two weeks, senators solicited ideas and insights from bipartisan panels of governors, state insurance commissioners, government researchers and insurance company executives. Before the hearings, there were informal “coffee sessions” so that non-committee members from both parties could drop by to ask questions.

Noticeably absent: Democratic press conferences griping about the Republicans’ failure to permit hearings or seek input on their plans to repeal and replace the Affordable Care Act, also known as Obamacare. Such public airings were a fixture last summer when a Republican task force chosen by Senate Majority Leader Mitch McConnell drafted a replacement bill that was defeated in late July.

Civility has ruled the HELP committee’s hearings, kept them policy-focused — and mostly as dry as day-old toast. They are nearly incomprehensible to anyone but health policy experts.

On Tuesday, Alexander queried a witness about the nuances of segmenting invisible high-risk pools, and Sen. Sheldon Whitehouse (D-R.I.) asked about two types of reinsurance.

The committee’s members are a cross section of each party’s politics — from Sen. Rand Paul (R-Ky.) on the right to Sen Elizabeth Warren (D-Mass.) and Sen. Bernie Sanders (I-Vt.) on the far left.

But all 23 members get the same time to question witnesses — five minutes each. On occasion, Alexander is lenient with Democrats and Republicans alike, allowing them extra time to get detailed policy answers from witnesses.

There is no talk of death spirals, collapsing markets or sabotage — terms that colored past debates about Obamacare. Instead, HELP senators bat around the nuances of actuarial equivalence, budget neutrality and reinsurance programs.

“So far, we’ve had focused, substantive discussions in our first two hearings — and in our many conversations off the committee — on areas of significant common ground around these goals,” Murray said in her opening statement Tuesday.

This atmosphere is the antithesis of the rancor that hung over the “repeal and replace” debates. Sen. Al Franken (D-Minn.), a former comedian, has even had time to joke with Republicans.

Partisan posturing hasn’t been entirely missing at these hearings, though. Warren used some of her questioning time last week to denounce the Trump administration’s threats to end reimbursements to insurance companies for the “cost-sharing reduction” discounts they provide to enrollees with incomes under 250 percent of the federal poverty level.

Sen. Bill Cassidy (R-La.) used his time to advocate for reducing federal spending on Medicaid.

Categories: Health Industry, Repeal And Replace Watch, The Health Law


Viewpoints: Bracing For Health Data Breaches; The Economics Of Opioid Abuse And Despair

A selection of opinions on health care from around the country.

RealClear Health: Your Health Data Will Be Breached
Just a couple of weeks ago, NHS Lanarkshire, the third largest health system in Scotland and one that employs over 12,000 staff, fell victim to a malware attack. On the heels of a broad cyberattack affecting much of the National Health Service (NH) in May, medical operations were put on hold, and patients were even told to not go to the hospital unless it was absolutely necessary. Though occurring on the other side of the Atlantic, this event stood as a stark reminder that many hospitals, health systems and other companies in the health care space are vulnerable to a cyberattack. (Cori McKeever Ashford and Kristen Thistle, 9/12)

Bloomberg: Which Came First, The Opioids Or The Despair?
Anne Case and Angus Deaton’s 2015 article on rising mortality among middle-aged white Americans — and the 2017 follow-up that attributed this rise to an increase in suicides, drug overdoses and alcohol-related deaths among those without college educations — was among those rare academic papers that changed public debate. (Justin Fox, 9/11)

Boston Globe: We Can’t Fight The Opioid Crisis Without Adequate Health Care
Health care and social workers, counselors, and law enforcement agencies, as well as policy makers and administrators at the local, state, and federal levels of government are already putting it all on the line to help people overcome addiction. We must give them the tools and support they need so we can win this fight. (Sen. Elizabeth Warren, 9/11)

The New York Times: Blaming Medicaid For The Opioid Crisis: How The Easy Answer Can Be Wrong
The theory has gained such prominence that a United States senator is investigating it. “Medicaid expansion may be fueling the opioid epidemic in communities across the country,” Senator Ron Johnson, Republican of Wisconsin, wrote recently. Some conservative opponents of the Affordable Care Act have been passing around the same theory for months. It’s a politically explosive (and convenient) argument, but is it true? Substantial evidence suggests the answer is no, but let’s give it a fair hearing. (Aaron E. Carroll and Austin Frakt, 9/12)

Cincinnati Enquirer: Issue 2 To Give Ohio Power To Cut Drug Prices
Don’t be fooled when pharmaceutical companies argue that their pricing strategy is simply based on supply and demand. We all know that is not true. It’s time that Ohioans demand pharmaceutical companies bring down their outrageously overpriced drugs. (Nina Turner, 9/11)

Stat: Cancer Treatment Should Qualify As A Reason For Student Loan Deferment
Iwas first diagnosed with cancer when I was a senior in college, preparing to get a job and begin paying off my student loans. I was fortunate to have school administrators who advocated for me, and my loans were quickly deferred. But many of the 70,000 young adults diagnosed with cancer each year in the United States aren’t so lucky. They continue to rack up interest as they put their lives on hold to go through lifesaving cancer treatments. That’s why I urge Congress to pass the Deferment for Active Cancer Treatment Act of 2017 this session. This essential but under-the-radar piece of legislation would allow cancer patients to qualify under existing laws for student loan deferments while they undergo treatment. (Samantha Watson, 9/11)

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State Highlights: Conn. Hospitals Wary Of Governor’s Tax Plan; Needs Of Appalachia Overlooked In Health Care Debate

Media outlets report on news from Connecticut, Virginia, Louisiana, California, Ohio, Kansas, Missouri, Wisconsin, Tennessee Pennsylvania and Florida.

The CT Mirror: CT’s Hospitals See Huge Risk In Malloy’s Fix For Budget Impasse
Gov. Dannel P. Malloy’s bid to end the state’s budget impasse hinges on convincing legislators to take a leap of faith about the state’s hospital tax. Specifically, the governor is asking for a 55 percent tax increase on hospitals and saying that his new plan to pump the proceeds of that tax hike — and more — back into the industry won’t evaporate as his original one did six years ago. (Phaneuf, 9/12)

The Associated Press: Appalachian Poor, Left Out Of Health Debate, Seek Free Care
They arrived at a fairground in a deep corner of Appalachia before daybreak, hundreds of people with throbbing teeth, failing eyes, wheezing lungs. They took a number, sat in the bleachers and waited in the summer heat for their name to be called so they could receive the medical help they can’t get anywhere else. (Lovan, 9/12)

New Orleans Times-Picayune: At Least 12 Patients Contract Rare Infection After Children’s Hospital Heart Surgeries: Report
At least 12 patients have contracted a rare infection after heart surgeries at Children’s Hospital in New Orleans, according to The New Orleans Advocate. The hospital pointed to a piece of operating room equipment as the source of the infection, which was caused by bacteria known as Mycobacterium Abscessus. …The Centers for Disease Control and Prevention notes that Mycobacterium Abscessus is commonly found in water, soil and dust, and can cause “a variety of infections.” Typically, “health-care associated infections” associated with it “are usually of the skin and soft tissues under the skin.” (Brasted, 9/11)

Los Angeles Times: Mexican Papaya Recalled After Salmonella Outbreak
A Southern California company has recalled papaya imported from Mexico after health authorities linked its fruit shipments to a salmonella infection that has killed one person and sickened 13 others in three states. Bravo Produce Inc. of San Ysidro, issued a recall notice Sunday, after federal investigators last week traced an infected sample of Maradol papayas to shipments the company imported from a Tijuana packer. (Mohan, 9/11)

The Washington Post: Pet-Store Puppies Linked To Bacterial Outbreak Among People In 7 States, CDC Says
Federal health officials said Monday that they are investigating a multistate outbreak of Campylobacter infections traced to puppies sold at Petland, a nationwide chain of about 80 pet stores. The bacteria, a common cause of diarrheal illness that can spread through contact with dog feces, has sickened at least 39 people in Ohio, Kansas, Missouri, Wisconsin, Tennessee, Pennsylvania and Florida. Nine people have been hospitalized since last September, but no deaths have been reported, according to officials with the Centers for Disease Control and Prevention. (Brulliard and Sun, 9/11)

San Francisco Chronicle: Software Strives To Shrink Emergency Room Waits
Qventus’ software helps health care institutions manage staffing in hospitals and pharmacies. It processes data, including the number of patients and doctors in the hospital, the length of wait times, and where slowdowns are occurring, so that, for example, more nurses can be sent to the area of the hospital where they are most needed, or managers can get the latest information on what rooms need to be cleaned. (Salian and Thadani, 9/11)

San Jose Mercury News: UC Aligns Cancer Centers To Battle Deadly Diseases
For the 176,000 Californians diagnosed with cancer this year, Monday’s announcement that the University of California’s five academic cancer centers are forming an alliance to stem the disease’s rising toll here couldn’t come soon enough. Experts say cancer is on its way to overtake heart disease as the Golden State’s leading cause of death. (Seipel, 9/11)

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‘We Did Really Well’: After Bracing For Disaster, Florida Hospitals Breathe Sigh Of Relief

Most hospitals fared well during the storm, and hospital officials credited changes and additions they’ve made in the past decade to strengthen their buildings against natural disasters.

The Washington Post: Florida’s Hospitals Weather The Storm
Doctors, nurses and staff at hospitals up and down Florida’s Gulf and Atlantic coasts were nearly breathless with surprise and relief Monday: Their patients — and their buildings — had survived the monster named Irma. “We’re wonderful,” said Cheryl Garn, spokeswoman for Lee Health’s four hospitals in Fort Myers. “Minimum damage. The sun is out and shining. We have some leaks where wind or rain blew in, but the patients are safe and comfortable.” (Nutt, 9/11)

Miami Herald: Hurricane Irma: South Florida Hospitals Begin Returning To Normal
In the wake of Hurricane Irma, Florida hospitals are returning to regular operations, discharging high-risk patients who had sheltered at their facilities during the storm, and preparing for an influx of emergency room visits from people suffering falls, cuts and other mishaps related to the recovery. But not all hospitals and healthcare facilities are ready to rebound after Irma. (Chang, 9/11)

Reuters: Hospital Shares Rise As Irma Damage Lighter Than Feared
Stocks of U.S. hospital companies rose on Monday as damage from Hurricane Irma in Florida appeared to be lighter than feared. Shares of Tenet Healthcare Corp rose 3.9 percent, Community Health Systems Inc shares were up 2.8 percent, Envision Healthcare Corp rose 1.7 percent and HCA Health shares were up 1.4 percent in morning trading. (Erman, 9/11)

Orlando Sentinel: Hurricane Irma: Data On Hurricane-Related Injuries Remains Scant
Before Hurricane Irma arrived, Dr. Kenneth Alexander decided to put together a list of anticipated short-term and long-term injuries after the hurricane so that he and his colleagues could better prepare at the hospital. He started researching the current literature, and to his surprise there were very few studies on the topic. (Miller, 9/11)

Georgia Health News: Power Outages Spread Across South Georgia As Irma Rolls In
The northern bands of Tropical Storm Irma knocked out power to more than 400,000 Georgia Power and EMC customers in coastal and South Georgia on Monday morning. More than 80,000 Georgia Power customers were without power in the Savannah area, as were another 94,000 from Brunswick and St. Simons south to St. Marys, at the Florida line, the AJC reported. (Miller, 9/11)

Meanwhile, in Texas —

The New York Times: Houston’s Floodwaters Are Tainted With Toxins, Testing Shows
Floodwaters in two Houston neighborhoods have been contaminated with bacteria and toxins that can make people sick, testing organized by The New York Times has found. Residents will need to take precautions to return safely to their homes, public health experts said. It is not clear how far the toxic waters have spread. But Fire Chief Samuel Peña of Houston said over the weekend that there had been breaches at numerous waste treatment plants. The Environmental Protection Agency said on Monday that 40 of 1,219 such plants in the area were not working. (Kaplan and Healy, 9/11)

Texas Tribune: Fifteen No-Cost Abortions Scheduled Through Harvey Relief Effort
Fifteen patients have scheduled no-cost abortions as part of an effort launched by Whole Woman’s Health Clinic to pay for procedures for women affected by Hurricane Harvey. Six of those abortions will take place in the clinic’s San Antonio location and nine are scheduled in Austin, a spokeswoman for the clinic said. (Platoff, 9/11)

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Rule Changes For Medigap Supplemental Plans Leaves New Beneficiaries With Tough Choices

Medigap Plans F and C, which are quite popular among Medicare beneficiaries, will close to new enrollment in 2020. In other Medicare news, federal officials have proposed some changes in home health payment policies, and public health officials ponder a rise in sepsis cases among beneficiaries.

Chicago Tribune: Why Seniors Should Choose Wisely When Selecting Medigap Supplement Insurance
In 2020, people who are on Medicare and don’t already have what’s known as Plan F or Plan C Medigap insurance won’t be able to buy it because the federal government will close those plans to new participants. That means that when people go onto Medicare at 65, or if they switch Medicare-related insurance during the next couple of years, they are going to have to be diligent about scrutinizing insurance possibilities before some of those doors start to close. (MarksJarvis, 9/8)

Modern Healthcare: CMS’ Proposed Home Health Payment Model Alarms Providers. Would It Boost Access For Medically Complex Patients?
The CMS has proposed the largest overhaul of Medicare home health payment in many years, out of concern that the current reimbursement system discourages providers from serving patients with clinically complex or chronic conditions. Critics say Medicare’s system now gives home health providers incentives to select patients who need higher-paying therapy services, such as joint replacement, rather than those needing help with traumatic wounds or poorly controlled chronic conditions or who are dually eligible for Medicaid and Medicare. (Meyer, 9/8)

Modern Healthcare: Aggressive Diagnoses And Care Spark Big Rise In Medicare Sepsis Discharges
The number of Medicare inpatient discharges for sepsis has been on a steady rise, and in 2015 it beat out major joint replacements as the most common discharge for the first time. On first glance, the results are jarring considering how the federal government and providers have made concentrated efforts in recent years to curb sepsis. But patient safety experts claim that the rise likely stems from changes in clinical practice over the last 15 years to diagnosis more patients with infections as septic sooner so they can treat the infection quickly before it develops into severe sepsis and becomes life-threatening. (Castellucci, 9/7)

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Lawmakers Enthusiastically Reject Trump’s Proposal To Cut NIH Funding

The Senate Appropriations Committee approved a bipartisan bill last week providing $36.1 billion for the health institutes. Senator Roy Blunt (R-Mo.) said it was the third consecutive year in which he had secured a $2 billion increase for the agency, and, in a separate hearing the audience erupted in applause when Senator Lamar Alexander, Republican of Tennessee, announced the boost in funding.

The New York Times: Congress Rejects Trump Proposals To Cut Health Research Funds
Back in March, when President Trump released the first draft of his budget proposal for the coming fiscal year, he asked lawmakers for deep cuts to one of their favorite institutions, the National Institutes of Health — part of a broad reordering of priorities, away from science and social spending, toward defense and border security. Six months later, Congress has not only rejected the president’s N.I.H. proposal; lawmakers from both parties have joined forces to increase spending on biomedical research — and have bragged about it. (Pear, 9/11)

In other news from Capitol Hill —

The Hill: Booker Signs On To Sanders’s ‘Medicare-For-All’ Bill 
Sen. Cory Booker is throwing his support behind a “Medicare for all” bill being introduced by Sen. Bernie Sanders (I-Vt.), becoming the latest Democrat floated as a 2020 contender to back the legislation. The New Jersey senator told NJTV News that he would sign on as a co-sponsor of the bill, which is scheduled to be rolled out on Wednesday. (Carney, 9/11)

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ACA Navigators Begin Shutting Down Operations

The government has slashed funding for the organizations that help people enroll in coverage through the Affordable Care Act. Health reform experts predict that without adequate navigator services, enrollment in the exchanges will plummet.

Modern Healthcare: With Funding Slashed And No Contracts In Hand, ACA Marketplace ‘Navigators’ Are Shutting Down
Navigator groups that help educate and enroll consumers in the Affordable Care Act insurance exchanges are shutting down because the federal government isn’t paying them. Several navigator organizations, including the University of South Florida, which received the country’s largest federal grant for navigation services in 2016, are suspending education and outreach activities ahead of the 2018 open enrollment period that is slated to begin Nov. 1. (Livingston, 9/11)

In other health law news —

The New York Times: For One Hedge Fund, A Bet On The Affordable Care Act Sours
Wagering that the new federal health care law would be a boon, the billionaire investor Larry Robbins bet big on hospital stocks five years ago. Those investments helped propel his hedge fund, Glenview Capital Management, to the ranks of the top-performing funds in 2013. Since then, the bet has soured. Glenview suffered steep losses as the stocks of many for-profit hospital chains sank, hurt by weak earnings and, more recently, by uncertainty over the lasting impact of the law, the Affordable Care Act. (Creswell and Abelson, 9/11)

Bloomberg: Equifax Holds Contract To Verify Data Of Obamacare Customers
Equifax Inc., which said last week it suffered a breach that exposed the personal data of 143 million Americans, holds a contract to check incomes and other data of people who bought health insurance in the Obamacare markets. The credit data firm has a $329 million, five-year government contract which ends in March to verify the incomes of people purchasing coverage through the health exchanges. The Affordable Care Act provides subsidies to help people afford health insurance depending on their income levels. (Edney and Murphy, 9/11)

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Viewpoints: Coal Country Health Study Is ‘No Waste Of Time’; The Fight Against The Opioid Epidemic Continues

A selection of opinions on health care from around the country.

The Washington Post: Trump Says He Cares About People In Coal Country. So Why Halt A Study On Their Health?
One would imagine that the Trump administration, which swept into power claiming to support the people who live in coal country, would prioritize federal spending on those very people’s health. Instead, the Interior Department has halted a study on how so-called mountaintop-removal coal mining affects people who live around these landscape-stripping operations. Ostensibly, the halt is part of a broad budgetary review. If so, Interior should restart the study quickly. It is a worthwhile use of government research money, and it should proceed no matter which constituency the president had promised to support. (9/10)

The New York Times: A Helpful Tool To Combat The Opioid Crisis
The opioid crisis is so complex and so large — drug-related deaths now exceed those caused by cars, H.I.V. or guns — that there is no single solution. Among the partial ones: prescription drug monitoring programs, an approach highlighted in the draft report from President Trump’s Commission on Combating Drug Addiction and the Opioid Crisis. (Austin Frakt, 9/11)

Chicago Tribune: Illinois Vs. The Opioid Epidemic
The epidemic of opioid overdose deaths has been geographically lopsided. West Virginia has the highest rate, followed by New Hampshire, Ohio and Kentucky. Illinois’ rate is one-third of West Virginia’s, but that’s only modest comfort. Last year, 1,889 people died from opioid overdoses in Illinois. … In recent days, a report put together by a group of state agencies mapped out a comprehensive strategy to eliminate one-third of opioid overdose deaths by 2020. And Gov. Bruce Rauner appointed a task force to look for ways to implement the strategy. … A big need is greater access to “medication-assisted treatment” (MAT), which offers methadone and buprenorphine , drugs proven useful helping those with “opioid use disorder” (addiction, in common parlance) beat the habit. (9/11)

Kansas City Star: Medicaid Is Not To Blame For The Opioid Crisis
Saying that Medicaid expansion is fueling the opioid epidemic is kind of like saying that a sump pump can cause flooding in your basement. The iffy underpinning for this argument is the fact that many of the states that expanded Medicaid coverage under the Affordable Care Act do have higher overdose death rates. (9/10)

Topeka Capital Journal: Time To Debate Medicaid Expansion
Considering its significance for 150,000 Kansans — as well as hospitals and businesses around the state — Medicaid should be a major issue during this campaign. We should demand robust debate, and we can’t allow candidates to obscure the facts (for example, those who oppose expansion often cite its costs and ignore the economic benefits mentioned above). Kansans support Medicaid expansion, and we need to remind our future governor of this fact. (9/9)

Stat: How Good Is A Doctor At The End Of A 28-Hour Shift?
It isn’t terribly reassuring to know that doctors who might need to make life or death decisions about your health could be doing so after having been awake for so long. Would they be on top of their game at hour 16? What about hour 22? In medicine, the devil can be in the details — what if the doctor was too tired to notice something small that might not actually be that small? But according to the organization that sets the rules on how long resident physicians like me are allowed to work, the Accreditation Council for Graduate Medical Education (ACGME), this is OK. (Christopher Bennett, 9/8)

The Columbus Dispatch: Better Care For The Vulnerable
When it comes to caring for the most vulnerable elderly and mentally ill, Franklin County can take pride in the Guardianship Service Board. It has helped remake a system that once permitted shameful exploitation of wards into one of the state’s best. A new agreement between the board and Ohio State University’s Wexner Medical Center demonstrates how its impact can grow even more. (9/11)

Los Angeles Times: Trump And Sessions Are Ignoring Voters’ Overwhelming Support For Medical Marijuana. Will Congress Listen?
Never mind what President Trump said on the campaign trail. His administration and GOP leaders appear determined to eliminate protections for medical marijuana growers, sellers and users. Every year since 2014, Rep. Dana Rohrabacher (R-Costa Mesa) has inserted an amendment into a federal spending bill to prevent the Justice Department from prosecuting medical marijuana businesses that comply with their state’s laws. It’s been a temporary but necessary fix to address a fundamental contradiction: that even though 26 states have legalized medical marijuana, the drug is still prohibited under federal law. … But last week, the House Rules Committee killed the amendment at the urging of Atty. Gen. Jeff Sessions, a hard-line marijuana prohibitionist. (9/9)

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Perspectives: On Obamacare, Is Trump ‘Throwing In The Towel’ Or Using ‘Bureaucratic Sabotage’?

Editorial writers take on a variety of health policy issues, ranging from what’s next for the Affordable Care Act, to whether bipartisan reforms are possible and even who is really to blame.

The Washington Post: Are Trump And Republicans Finally Throwing In The Towel On Obamacare?
The single biggest win that President Trump has scored for his economically struggling supporters thus far is his failure to repeal Obamacare. This fact is sitting right at the center of one of the biggest and most-discussed stories in Washington right now — the possibility that Trump may be in the midst of rethinking his approach, and pivoting toward a more sustained effort to make bipartisan deals with Democrats — yet the centrality of it is largely passing unnoticed. (Greg Sargent, 9/8)

USA Today: Trump Shows GOP How It’s Done: Scrap Absolutism, Deal With Reality
Turns out as well that repealing the Affordable Care Act, aka Obamacare, is not popular either — especially when the Congressional Budget Office has found that every variation on a replacement would cost people more, take away consumer protections, and insure far fewer — up to 24 million fewer in one case. Those protesting repeal at town meetings included conservatives and Trump voters as well as liberal Democrats. Those seeking a bipartisan compromise to stabilize markets and improve the law include more than a few Republican senators and governors. Those trying to get Congress to abandon repeal and move on include … Trump. At least as of Friday. (Jill Lawrence, 9/10)

The Washington Post: Obamacare Doesn’t Deserve A Bailout
Those who cheered for Senate Republicans to fail have been celebrating ever since, and we’re now hearing calls for bipartisan solutions. While most reasonable people would welcome a bipartisan outcome to this mess, the solutions proffered thus far would do little more than shore up the bad policies already in place with another slate of bad policies. We need legitimate, long-term reforms. (Sen. Orrin Hatch, 9/8)

Sacramento Bee: Is Bipartisan Health Reform Possible?
As a doctor, I know many Americans are concerned about the future of health care. Nobody should have to worry that an unexpected medical bill could threaten their family’s financial security. … As Congress returns from summer recess, we have a clear decision to make: Can we work together to fix health care? … But in order for Congress to make improvements, both sides need to honestly discuss the law’s shortcomings. (Rep. Ami Bera, 9/8)

St. Louis Post-Dispatch: Trump Administration Tries Bureaucratic Sabotage To Kill Obamacare
While attention was focused last week on President Donald Trump’s move to end the Deferred Action for Childhood Arrivals program, his administration was moving to sabotage another, much-larger Obama-era achievement: the Affordable Care Act. The Department of Health and Human Services is cutting the budget for outreach programs intended to help Americans sign up for health insurance coverage in 2018. In addition, HHS has cut the sign-up period that begins Nov. 1 from 90 to 45 days. (9/10)

The Washington Post: The ‘Progressives’ Are To Blame, Too, For Mismanaging Our Government
As I have written countless times, the semi-automatic expansion of programs for the elderly (mainly Social Security, Medicare and long-term care under Medicaid) is slowly crowding out many other government programs, from defense to the Centers for Disease Control and Prevention. The paradoxical result is that government spending will grow larger even while it grows less effective. The conventional wisdom in Washington is that the Republicans are responsible for this mess. Their fixation with sizable tax cuts leaves government perpetually dependent on massive borrowing. There is much truth to this. … The other half is the refusal of Democrats — “liberals” and “progressives” — to cut almost any Social Security and Medicare benefits. They’re essentially off-limits, even though life expectancy has increased and many elderly are well-off. (Robert J. Samuelson, 9/10)

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Despite Serious Safety Issues, Hospital Watchdog Didn’t Change Its Rating Of Facility

An investigation by The Wall Street Journal finds that the Joint Commission, which is the accrediting organization for almost 80 percent of U.S. hospitals, typically takes no action to revoke or modify accreditation when state inspectors find serious safety violations. Meanwhile, an expert talks to Politico about hospitals and health care spending.

The Wall Street Journal: Hospital Watchdog Gives Seal Of Approval, Even After Problems Emerge
Patient-safety problems were so serious at Cooley Dickinson Hospital in Northampton, Mass., that the federal Medicare agency threatened to cut it off. Most patients never knew. Two babies died within six weeks in late 2013 and early 2014. That was just a couple of months after a pregnant woman died when the hospital didn’t ensure she was treated for high blood pressure from a condition called pre-eclampsia, according to a federal inspection report. (Armour, 9/8)

And in news from the states —

Boston Globe: Humane Treatment Comes At Last To Bridgewater State Hospital, Where Prisoners Have Become ‘Persons Served’
In April, a private firm hired by the Baker administration replaced almost all the guards at Bridgewater State Hospital with a specially trained security force, along with psychiatrists and other clinicians equipped to provide more humane methods of handling distressed patients. … Five months in, the results are remarkable, beyond the imagining of mental health advocates. (Rezendes, 9/8)

KCUR: KU Hospital Denies Patient’s Allegations Of Cancer Misdiagnosis And Cover-Up 
The University of Kansas Hospital is denying allegations by a patient that it wrongly diagnosed her with pancreatic cancer and then covered it up. In an answer filed this week, the hospital says that many of the allegations made by Wendy Ann Noon Berner “reference undisputable hearsay and speculation, and many would arguably constitute defamation” if they were not part of a lawsuit. (Margolies, 9/8)

Boston Globe: Former Medical Center Site Said To Have No Takers
Boston-area health care providers have not shown interest in locating their operations at the former Quincy Medical Center site, according to its owner, who had hoped to have a reuse plan for the property before the end of the year. FoxRock Properties, a Quincy commercial real estate firm that bought the former hospital in December 2016, has been marketing the property to health care providers, but they have told FoxRock that the complex is too old and outdated, company representative Chet Clem told more than 50 people at a recent neighborhood meeting. (Terreri Ramos, 9/8)

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In Search Of Genetic Marker For Suicide: Scientists Envision Medication That Could Save Lives

It will be a long and complicated path even if it’s successful, but researchers think searching DNA for links to suicide will eventually lead to them being able to create a pill to stop it. In other public health news: melanoma, doctors and Yelp, breast milk, chemotherapy, tick saliva and more.

Stat: Could A Pill Prevent Suicide? A New Genetics Study In Utah Seeks The Answer
The project, unveiled Friday, seeks to advance existing genetic research on suicide by potentially developing new medications that could help prevent patients from ending their lives. Utah’s famously expansive DNA database makes it an ideal setting for the research. The state also has one of the highest suicide rates in the country — more than 22 per 100,000 people — and suicide is the leading cause of death among youths between the ages of 10 and 17. (Ross, 9/11)

The Washington Post: New Clinical Trial Might Change The Standard Treatment For Melanoma
In a head-to-head comparison of two immunotherapy drugs used to prevent relapse in certain patients with advanced melanoma, one treatment was the clear winner — and it’s not the one that most people get. The international study, released Sunday, involved 900 patients whose tumors were removed by surgery but who remained at high risk of recurrence of melanoma, an often aggressive form of skin cancer. (McGinley, 9/10)

Bloomberg: Don’t Yelp Your Doctor. Study Finds Ratings Are All Wrong. 
If you’re looking for the best doctor, online ratings are unlikely to be much help. That’s the determination of researchers at Cedars-Sinai Medical Center in Los Angeles, who compared reviews of 78 of the medical center’s specialists on five popular ratings sites with a set of internal quality measures and found there was essentially no correlation. The results suggest that in a world awash in online feedback for seemingly every consumer choice, reliable, easy-to-interpret information on how good doctors are at their jobs remains scarce. (Tracer, 9/8)

The Washington Post: Neonatal Facilities Increasingly Use Donated Breast Milk To Save Premature Babies
The weekly shipment arrived at noon Thursday — 300 ounces of breast milk donated by women across the country and pasteurized at a milk bank in Austin. It was packed with dry ice and shipped via FedEx to feed the most medically fragile premature infants in the neonatal intensive care unit at Children’s National Health System. “Liquid gold,” said Victoria Catalano, a NICU dietitian at the children’s hospital in Washington, holding up a plastic bottle containing three ounces of frozen milk. Then she corrected herself. “Well, that’s liquid gold,” she said, pointing to two large deep freezers stocked with milk the infants’ mothers had produced. “This is the next best thing,” she said. (Chandler, 9/10)

The Washington Post: She Rejected Chemotherapy And Chose To Die Of Cancer — So She Could Give Birth To Her Child
The headaches began sometime in March. They didn’t think much of them, other than that they were possible migraines — until she started vomiting.An initial scan showed a mass in Carrie DeKlyen’s brain. More tests showed that it was a form of cancer, possibly lymphoma, but treatable. But a pathology exam revealed a more grim diagnosis. The 37-year-old mother of five from Wyoming, Mich., had glioblastoma, an aggressive form of brain cancer. If lucky, she could live for five more years. (Phillips, 9/10)

Pittsburgh Post-Gazette: Tick Saliva May Be A Secret Ingredient To Help HIV Patients
The blacklegged tick — the one that carries Lyme disease — may have some value: its spit. The insect’s saliva — which helps it feed on hosts by blocking blood coagulation — is now part of experiments examining ways to reduce heart disease in people living with HIV. Their risk of heart attack and stroke is nearly double that of the general population, according to a study last year. That risk was found even in people whose virus was undetectable in their blood because of antiretroviral drugs. (Daly, 9/9)

The Oregonian: Genetic Test Bumps Breast Cancer Patients Down A Stage Or 2 
For decades, tumor size has been crucial to the treatment and prognosis of breast cancer. Bigger usually meant the cancer was more advanced and at a higher stage, required more treatment and brought a worse outlook. But now physicians have biological tests that help them determine how aggressive the cancer is likely to be and the best course of treatment. (Terry, 9/10)

The Washington Post: e Cyclists’ recovery from brain injuries can be slow, but death rate has dropped
On the day that would change his life forever, Ryan Brown went on his regular morning run. He rode his bicycle the quick mile to work at the U.S. Trademark and Patent Office in Alexandria, Va., where he was an examiner for plant molecular biology patents. Late in the afternoon, he headed home to take his two sons to dinner while his wife finished teaching a piano lesson. He never made it. (Arcement, 9/9)

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The Long Months Of Uncertainty Are Wearing On Insurers

And insurance providers aren’t banking on a lifeline being tossed from Congress anytime soon.

Modern Healthcare: Left In The Lurch: Ongoing Uncertainty Is Taking A Toll On Health Insurers 
For nearly a year, health insurers have operated under a cloud of political and regulatory uncertainty that has taken a toll on finances, and for some, their day-to-day operations. Even though Congress shifted its focus from bulldozing the Affordable Care Act to stabilizing the troubled individual market in the short term, big questions remain, particularly around future funding for cost-sharing reduction subsidies that insurers say are crucial to steadying that business line. (Lee and Livingston, 9/9)

The Hill: Groups Fear Trump Funding Cuts Will Lower ObamaCare Enrollment 
Groups that for years have helped people sign up for ObamaCare say the White House’s cuts to their funding will almost certainly lower enrollment in the insurance exchanges this year. Some of the groups, known as navigators, say they’re worried they’ll have to permanently cut back on staff, as well as education and outreach about the health-care law ahead of an open enrollment period beginning Nov. 1. (Roubein, 9/8)

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