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Senators Unveil Legislation To Protect Patients Against Surprise Medical Bills

Kaiser Health News:Insurance - September 19, 2018

With frustration growing among Americans who are being charged exorbitant prices for medical treatment, a bipartisan group of senators Tuesday unveiled a plan to protect patients from surprise bills and high charges from hospitals or doctors who are not in their insurance networks.

The draft legislation, which sponsors said is designed to prevent medical bankruptcies, targets three key consumer concerns:

  • Treatment for an emergency by a doctor who is not part of the patient’s insurance network at a hospital that is also outside that network. The patients would be required to pay out-of-pocket the amount required by their insurance plan. The hospital or doctor could not bill the patient for the remainder of the bill, a practice known as “balance billing.” The hospital and doctor could seek additional payments from the patient’s insurer under state regulations or through a formula established in the legislation.
  • Treatment by an out-of-network doctor or other provider at a hospital that is in the patient’s insurance network. Patients would pay only what is required by their plans. Again, the doctors could seek more payments from the plans based on formulas set up by state rules or through the federal formula.
  • Mandated notification to emergency patients, once they are stabilized, that they could run up excess charges if they are in an out-of-network hospital. The patients would be required to sign a statement acknowledging that they had been told their insurance might not cover their expenses, and they could seek treatment elsewhere. Don't Miss A Story

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“Our proposal protects patients in those emergency situations where current law does not, so that they don’t receive a surprise bill that is basically uncapped by anything but a sense of shame,” Sen. Bill Cassidy (R-La.) said in his announcement about the legislation.

Kevin Lucia, a senior research professor at Georgetown University’s Center on Health Insurance Reforms who had not yet read the draft legislation, said the measure was aimed at a big problem.

“Balance billing is ripe for a federal solution,” he said. States regulate only some health plans and that “leaves open a vast number of people that aren’t covered by those laws.”

Federal law regulates health plans offered by many larger companies and unions that are “self-funded.” Sixty-one percent of privately insured employees get their insurance this way. Those plans pay claims out of their own funds, rather than buying an insurance policy. Federal law does not prohibit balance billing in these plans.

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Cassidy’s office said, however, that this legislation would plug that gap.

In addition to Cassidy, the legislation is being offered by Sens. Michael Bennet (D-Colo.), Chuck Grassley (R-Iowa), Tom Carper (D-Del.), Todd Young (R-Ind.) and Claire McCaskill (D-Mo.).

Cassidy’s announcement cited two recent articles from Kaiser Health News and NPR’s “Bill of the Month” series, including a $17,850 urine test and a $109,000 bill after a heart attack.

In a statement to Kaiser Health News, Bennet said, “In Colorado, we hear from patients facing unexpected bills with astronomical costs even when they’ve received a service from an in-network provider. That’s why Senator Cassidy and I are leading a bipartisan group of senators to address this all-too-common byproduct of limited price transparency.”

Emergency rooms and out-of-network hospitals aren’t the only sources of balance bills, Lucia said. He mentioned that both ground and air ambulances can leave patients responsible for surprisingly high costs as well.

Lucia said he was encouraged that both Democrats and Republicans signed on to the draft legislation.

“Any effort at the federal level is encouraging because this has been a challenging issue at the state level to make progress on,” Lucia said.

KHN reporter Carmen Heredia Rodriguez contributed to this article.

First Comprehensive HHS Data Sharing Report Released

HHS Gov News - September 18, 2018

Today, the Office of the Chief Technology Officer published a comprehensive report of the data sharing environment at the U.S. Department of Health & Human Services (HHS). The report explores the challenges of sharing data between HHS agencies: https://www.hhs.gov/idealab/data-insights/

Led by HHS Chief Data Officer Dr. Mona Siddiqui, a small team of HHS staff interviewed agency leadership and staff from eleven HHS agencies, including at the NIH, CDC, FDA, CMS, and AHRQ, about the challenges and opportunities in sharing data between agencies. This report focuses specifically on data assets identified by the agencies as having high value and that are restricted or nonpublic.

The report is part of an ongoing effort to build and implement an enterprise-wide data strategy at HHS. Creating a data-driven department requires implementing a cohesive data governance structure as well as a platform to encourages data sharing, acknowledge data as an asset, and design policy around evidence.

According to the report, HHS lacks a consistent, transparent, and standardized protocol for interagency data sharing. While there are project-by-project successes, there is significant opportunity to develop a framework to efficiently scale. The report also outlines legal, technical, and cultural challenges.

Across the federal government, there is a growing consensus around the value of data governance to minimize costs and maximize efficiency. This report aims to highlight opportunities for improvement so that HHS can become a more data-driven organization. The findings indicate a need for continued engagement across HHS agencies to ensure success in building a cohesive data strategy.

Read the full report here: https://www.hhs.gov/idealab/data-insights/

Paper Jam: California’s Medicaid Program Hits ‘Print’ When The Feds Need Info

Kaiser Health News:States - September 18, 2018

In the shadow of Silicon Valley, the hub of the world’s digital revolution, California officials still submit their records to the feds justifying billions in Medicaid spending the old-fashioned way: on paper.

Stacks and stacks of it.

Stuck with decades-old technology, the nation’s largest Medicaid program forces federal officials to sift through thousands of documents by hand rather than sending electronic files. That’s one of the critical findings in a Sept. 5 report from the federal government’s chief watchdog citing inefficient and lax oversight of Medicaid nationwide.

To illustrate, the U.S. Government Accountability Office published a photo showing piles of records submitted for one three-month period. One folder was placed upright to show the height of the heap.

“It’s really amazing when you look at that picture,” said Carolyn Yocom, a health care director at the GAO who focuses on Medicaid, the federal-state health insurance program for low-income people. “For this type of reporting on expenditures, California really should be able to provide that electronically.”

California, with more than 13 million Medicaid enrollees, said it’s hamstrung because it uses 92 separate computer systems to run its Medicaid program — although it has plans underway to modernize its technology.

“Given system limitations and the magnitude of the supporting documentation, providing it electronically is currently not feasible,” the California Department of Health Care Services said in a statement.

The state’s Medicaid program, known as Medi-Cal, has struggled with technology for years. The state thought it had a solution in 2010 when it awarded a $1.7 billion contract to Xerox, which included $168 million for a new system. But after years of delay, the state scrapped the contract in 2016 and started from scratch, leaving the patchwork system in place a few more years.

Nationwide, despite industry buzz about electronic medical records, smartphone apps and artificial intelligence, a lot of paper is still being pushed across the health care system. Consider all those forms patients repeatedly fill out in the waiting room, the screeching sound of fax machines inside doctors’ offices and the bulging binders of patients’ records in file rooms.

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Under Medicaid, states submit data quarterly to the federal government on their spending and include supporting documents such as invoices, cost reports and eligibility records. In California, reports on spending are shared electronically, but the copious supporting documentation required for federal review is not, according to the GAO.

When the Xerox venture failed, the company agreed to pay California more than $123 million as part of a settlement agreement, according to state officials.

Meantime, Conduent, the services unit of Xerox that was spun off into a separate company, was left to keep operating the system and process claims.

Last month, the state awarded a contract to DXC Technology of Tysons, Va., to take over some operations from Conduent. The state said the contract could be worth $698 million over 10 years.

Separately, California’s Medicaid officials are working on plans for a new system that would cost an estimated $500 million. Under the federal-state partnership on Medicaid, the federal government would cover 90 percent of those costs for design and implementation, and the state’s share would be about $50 million.

Pressure has been mounting on California to fix the situation. The Medicaid IT system “needs to be replaced, because it is more than 40 years old, its operations are inefficient, maintaining the system is difficult and there is a high risk of system failure,” state auditor Elaine Howle wrote in a June 26 letter to Gov. Jerry Brown and legislative leaders.

In her letter, Howle said the state was paying about $30 million annually to maintain the legacy system.

Overall, Medi-Cal serves 1 in 3 Californians. The annual Medicaid budget in California is about $104 billion, counting federal and state funds.

Beyond California, the GAO criticized the U.S. Centers for Medicare & Medicaid Services (CMS) more broadly. One complaint: Federal officials assign a similar number of staff to states for reviewing case files — even though some states, like California, pose a far bigger risk for enrollment errors and misspent money due to their size and complexity.

For instance, the report’s authors said, CMS reviewed claims for the same number of newly eligible Medicaid enrollees — 30 — in California as it did in Arkansas, even though California had 10 times the number of newly enrolled patients under the Affordable Care Act.

The report also said CMS devoted a similar number of staff to review both California, which represents 15 percent of federal Medicaid spending, and Arkansas, which accounts for 1 percent.

CMS “needs to step back and assess where are the biggest threats and vulnerabilities,” Yocom said. “If you aren’t looking, you don’t know what you aren’t catching.”

Overall, from fiscal years 2014 to 2018, federal Medicaid spending increased by about 31 percent, according to the GAO report. But the full-time staff at CMS dedicated to financial oversight declined by roughly 19 percent over the same period.

In a July 18 letter to the GAO, the U.S. Department of Health and Human Services agreed with the agency’s recommendations for improving oversight efforts.

HHS wrote that it “will complete a comprehensive national review to assess the risk of Medicaid expenditures reported by states and allocate resources based on risk.”

This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.

SAMHSA’s Annual Mental Health, Substance Use Data Provide Roadmap for Future Action

HHS Gov News - September 15, 2018

Today the Substance Abuse and Mental Health Services Administration released the 2017 National Survey on Drug Use and Health (NSDUH). The annual survey comprises highly anticipated data that help provide a statistical context for the country’s opioid crisis and other behavioral health matters.

“SAMHSA’s National Survey on Drug Use and Health contains annual data that provides critical information which helps us understand important concepts around mental health and substance misuse across the nation,’’ said Department of Health and Human Services Secretary Alex M. Azar II. “President Donald Trump, Assistant Secretary Elinore McCance-Katz and I share a vision for a path forward, one that involves connecting Americans to the evidence-based treatment they need.”

Among the findings of the 2017 NSDUH:

  • The number of individuals initiating heroin use decreased by more than 50 percent in 2017 compared to 2016. 
  • Significantly more people received treatment for their substance use disorder in 2017 than in 2016 (e.g., for illicit drug use disorder, 9.2 percent in 2016 to 13.0 percent in 2017); this was especially true for those with heroin-related opioid use disorders, from 37.5 percent in 2016 to 54.9 percent in 2017.
  • Frequent marijuana use, in both youth (aged 12-17 years) and young adults (aged 18-25 years), appears to be associated with opioid use, heavy alcohol use, and major depressive episodes.
  • Several indicators for young adults continue to be a source of concern. They have higher rates of cigarette use, alcohol initiation, alcohol use disorder, heroin-related opioid use disorder, cocaine use, methamphetamine use, and LSD use than their younger and older counterparts. In 2017, 18-25 year olds had higher rates of methamphetamine and marijuana use than they did in 2016.  This population also had increasing rates of serious mental illness and major depressive episodes.
  • Several data trends between 2015 and 2017 for pregnant women are also of concern with data trending in the wrong direction with respect to use of illicit drugs, including cocaine, marijuana, and opioids. Approximately 7 percent of pregnant women have used marijuana in the past 30 days with 3 percent reporting daily use.
  • Co-occurring issues must be addressed. Approximately 8.1 percent of individuals are living with a co-occurring mental and substance use disorder.  Further, those who have any mental illness or serious mental illness are significantly more likely to use cigarettes, illicit drugs, and marijuana, misuse opioids and pain relievers and binge drink than individuals with no mental illness.

“The NSDUH data provide an essential roadmap for where we must focus our efforts,” said Assistant Secretary for Mental Health and Substance Use, Elinore F. McCance-Katz, MD, PhD. “SAMHSA works daily to connect Americans living with these conditions with much needed services and supports in their communities”.

Through SAMHSA, the Trump administration is directing billions of dollars in treatment support funding to states; is creating a national hub to leverage community-level expertise to strengthen treatment access through technical assistance; is educating providers in the detection and treatment of opioid use disorders; and is expanding first responders’ access to the overdose-reversing medication naloxone.

SAMHSA has been working to expand access to treatment for serious mental illnesses and serious emotional disturbances. SAMHSA also serves as the lead agency in the Interdepartmental Serious Mental Illness Coordinating Committee, a federal advisory council working with nongovernmental partners to make the nation’s mental health care system as cohesive and responsive to Americans’ needs as possible.

The NSDUH report and a video presentation of the data are available at https://www.samhsa.gov/data/nsduh/reports-detailed-tables-2017-NSDUH.

For more information, contact the SAMHSA Press Office at 240-276-2130.

OCR Issues Guidance to Help Ensure Equal Access to Emergency Services and the Appropriate Sharing of Medical Information During Hurricane Florence

HHS Gov News - September 13, 2018

As Hurricane Florence makes landfall, the HHS Office for Civil Rights (OCR) and its federal partners remain in close coordination to help ensure that emergency officials effectively address the needs of at-risk populations as part of disaster response.  To this end, emergency responders and officials should consider adopting, as circumstances and resources allow, the following practices to help make sure all segments of the community are served:

  • Employing qualified interpreter services to assist individuals with limited English proficiency and individuals who are deaf or hard of hearing during evacuation, response, and recovery activities;
  • Making emergency messaging available in languages prevalent in the affected area(s) and in multiple formats, such as audio, large print, and captioning and ensuring that websites providing disaster-related information are accessible;
  • Making use of multiple outlets and resources for messaging to reach individuals with disabilities, individuals with limited English proficiency, and members of diverse faith communities;
  • Considering the needs of individuals with mobility impairments and individuals with assistive devices or durable medical equipment in providing transportation for evacuation;
  • Identifying and publicizing accessible sheltering facilities that include accessible features, such as bathing, toileting, eating facilities, and bedding;
  • Avoiding separating people from their sources of support, such as service animals, durable medical equipment, caregivers, medication, and supplies; and
  • Stocking shelters with items that will help people to maintain independence, such as hearing aid batteries, canes, and walkers.

Being mindful of all segments of the community and taking reasonable steps to provide an equal opportunity to benefit from emergency response efforts will help ensure that the disaster management in all areas affected by Hurricane Florence is successful.

In addition, as part of his declaration of a Public Health Emergency (PHE), HHS Secretary Alex Azar has waived sanctions and penalties under certain provisions of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule that may otherwise apply to covered hospitals, including provisions that generally require covered entities to give patients the opportunity to agree or object to sharing information with family members or friends involved in the patient’s care.  This waiver applies only to the emergency area and for the emergency period identified in the PHE declaration and only to hospitals that have instituted a disaster protocol.  Qualifying hospitals can take advantage of the waiver for up to 72 hours from the time the hospital implements its disaster protocol unless the PHE declaration terminates first.

Even without a waiver, the Privacy Rule allows patient information to be shared to assist in disaster relief efforts and to assist patients in receiving the care they need.  As explained in more detail in OCR’s Bulletin on Hurricane Florence and HIPAA linked below, the Privacy Rule permits covered entities to share information for treatment purposes, public health activities, and to prevent or lessen a serious and imminent threat to health or safety.  The Privacy Rule also allows the sharing of information with individuals’ family, friends, and others involved in their care in emergency situations to ensure proper care and treatment.

“HHS is committed to leaving no one behind during disasters, and this guidance is designed to help emergency responders and health and human service providers meet that goal,” said Roger Severino, OCR Director. “OCR also provides technical assistance on HIPAA and civil rights to emergency responders and hospitals so they feel empowered to help people and families in crisis.”

For more information regarding how Federal civil rights laws apply in an emergency, visit the OCR’s Civil Rights Emergency Preparedness page.

For information about how the HIPAA Privacy Rule applies in an emergency, visit the OCR’S HIPAA Emergency Preparedness, Planning, and Response page or you may use the HIPAA Disclosures for Emergency Preparedness Decision Tool.

For information about emergency requirements for long-term care facilities, visit the CMS Emergency Preparedness Rule page.

For information regarding Title VI of the Civil Rights Act of 1964, Section 504 of the Rehabilitation Act of 1973, and other civil rights authorities, visit the OCR’s Civil Rights Laws and Regulations Enforced page.

For general information about the HIPAA statute and the implementing regulations, including the HIPAA Privacy, Security, and Breach Notification Rules, visit the OCR’s HIPAA for Professionals Page .

DISCLAIMER: These guidance documents are not a final agency action, do not legally bind persons or entities outside the Federal government, and may be rescinded or modified in the Department’s discretion. Noncompliance with any voluntary standards (e.g., recommended practices) contained in these documents will not, in itself, result in any enforcement action.

Podcast: KHN’s ‘What The Health?’ A Detour On A Smoking Off-Ramp

Kaiser Health News:HealthReform - September 13, 2018
Sarah Jane Tribble

Kaiser Health News

@sjtribble

Read Sarah Jane's Stories Rebecca Adams

CQ Roll Call

@RebeccaAdamsDC

Read Rebecca's Stories Stephanie Armour

The Wall Street Journal

@StephArmour1

Read Stephanie's Stories Kimberly Leonard

Washington Examiner

@leonardkl

Read Kimberly's Stories

The Food and Drug Administration declared Wednesday that vaping among teenagers has reached “an epidemic proportion.” The agency told five major e-cigarette manufacturers that they had 60 days to find ways to keep their products away from minors.

“I use the word epidemic with great care,” FDA Commissioner Scott Gottlieb said in a Wednesday news release. “E-cigs have become an almost ubiquitous — and dangerous — trend among teens.” Yet, as the panel discusses, health advocates warned that the actions may not be strong enough.

This week’s panelists are Sarah Jane Tribble of Kaiser Health News, Stephanie Armour of The Wall Street Journal, Kimberly Leonard of the Washington Examiner and Rebecca Adams of CQ Roll Call.

They also look at Arkansas’ announcement that more than 4,000 Medicaid enrollees will be suspended for not meeting new work requirements, the Census Bureau’s announcement that the nation’s uninsured rate was unchanged last year, legislation under consideration on Capitol Hill that will affect the Affordable Care Act and efforts to stem the opioid epidemic.

Among the takeaways from this week’s podcast:

  • The FDA’s announcement on e-cigarettes appears to be a turning point on officials’ views of how to handle the issue. It was spurred by reports of dramatic growth in teen vaping. Sen. Dick Durbin (D-Ill.) recently reported that teen use has increased by 75 percent in the past year.
  • The e-cigarette industry is largely unregulated. Many brands offer a variety of sweet flavors, even though makers of traditional cigarettes are prohibited from doing that.
  • Arkansas’ move to cut adults from the Medicaid expansion program the state rolled out under the ACA is likely to be challenged in court.
  • The Trump administration has been a strong supporter of work requirements in the Medicaid program and Seema Verma, who heads the Centers for Medicare & Medicaid Services, tweeted Wednesday night after the Arkansas announcement that she was excited about the work Arkansas has done to connect beneficiaries to jobs and education.
  • The Census Bureau’s report Wednesday is the first time since the implementation of ACA coverage expansions that the national uninsured rate did not fall.
  • The Republican-led House is expected to vote soon on a package of bills that will remove or postpone more taxes in the ACA, including the penalty for employers who do not offer coverage for workers and a tax on tanning salons. It is doubtful, however, that the measure will get through the Senate this year.

Plus, for extra credit, the panelists recommend their favorite health stories of the week they think you should read, too:

Sarah Jane Tribble: Bloomberg News’ “The Secret Drug Pricing System Middlemen Use to Rake in Millions,” by Robert Langreth, David Ingold and Jackie Gu

Kimberly Leonard: Harper’s Magazine’s “Can Hospitals Learn to Better Treat Deaf Patients?” by Katie Booth

Rebecca Adams: The New York Times and ProPublica’s “Top Cancer Researcher Fails to Disclose Corporate Financial Ties in Major Research Journals,” by Charles Ornstein and Katie Thomas

Stephanie Armour: The Financial Times’ “Opioid Billionaire Granted Patent for Addiction Treatment,” by David Crow

To hear all our podcasts, click here.

And subscribe to What the Health? on iTunesStitcher or Google Play.

Insurer To Purdue Pharma: We Won’t Pay For OxyContin Anymore

Kaiser Health News:Marketplace - September 13, 2018

The largest insurer in Tennessee has announced it will no longer cover prescriptions for what was once a blockbuster pain reliever. It’s the latest insurance company to turn against OxyContin, whose maker, Purdue Pharma, faces dozens of lawsuits related to its high-pressure sales tactics around the country and contribution to the opioid crisis. Last fall, Cigna and Florida Blue both dropped coverage of the drug.

Top officials at BlueCross BlueShield of Tennessee say newer abuse-deterrent opioids work better, and starting in January, the insurer covering 3.5 million Tennesseans will pay for those opioids made by other pharmaceutical companies instead.

“We felt it was time to move to those products and remove Oxycontin from the formulary, which does still continue to have a higher street value,” said Natalie Tate, the insurer’s vice president of pharmacy.

OxyContin was reformulated in 2010 to make the drug harder to misuse — but it’s still possible to crush or liquefy in order to snort or inject it.

The latest long-acting opioids that BlueCross BlueShield of Tennessee is going to start covering — Xtampza and Morphabond — are still more difficult to misuse, according to the company and some pharmaceutical experts.

Motives Questioned

In a page-long response a reporter’s query, a Purdue Pharma spokesman pointed out that no opioid drug is “abuse proof” or less addictive, accusing BCBST of financial motives that remove choices for many patients.

“We believe that patients should have access to FDA-approved products with abuse-deterrent properties,” Purdue’s Robert Josephson wrote in an email. “The recent decision by BlueCross BlueShield of Tennessee limits prescribers’ options to help address the opioid crisis.”

In response, BCBST’s Tate argued that ditching one of the most recognized names in opioids is not designed to save money, though it could in a roundabout way.

This move could reduce fraudulent prescriptions to street dealers or drug-seeking people with active addictions and cut down on costly hospital stays for overdoses, said pain consultant and pharmacist Jeff Fudin, an adjunct professor at Albany College in New York.

“It’s a smart idea to use dosage forms that have proven to have been better abuse-deterrent formulations,” he said. “In the long run, it actually will cost them a whole lot less money.”

Fudin said he’s often at odds with insurers over their decisions about which drugs to cover, but he applauds this decision, which he expects more insurers to follow.

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Alternative Therapies

Practicing pain physicians in Tennessee — who regularly battle with insurance companies — also approve of the change, though they said OxyContin was already falling out of favor. And they argue trading one opioid for slightly safer ones doesn’t address a larger gripe that physicians have with insurers over paying for other, non-addictive types of treatment.

“We will have denials and prior authorizations on a muscle relaxer, and we will have no issue getting an opioid through the insurance company,” said Dr. Stephanie Vanterpool, an anesthesiologist at the University of Tennessee and the president-elect of the Tennessee Pain Society.

“The physicians or the doctor’s offices jump through hoops to get the better medication for the patients,” said Vanterpool. “And when I say better medication, I mean the medication that’s treating the cause of the pain, not just the medication that’s covering up the pain.”

BlueCross BlueShield of Tennessee is adding some alternative pain therapies in the coming year, according to its announcement last week. But Vanterpool would like to see a philosophical about-face.

Not to say OxyContin won’t be sorely missed by some patients.

“There are plenty of people who benefit from that drug,” said Terri Lewis, a patient advocate and rehabilitation specialist from Cookeville, Tenn.

She’s suspicious of BCBST’s motives since the insurer may be blamed for its role in the opioid crisis. Embattled Purdue Pharma could be a convenient scapegoat.

“Maybe this is a good decision,” Lewis said. “But it smells like a political decision.”

And this would be just the latest decision inserting politics into a nuanced medical problem.

A Blessing In Disguise?

The Tennessee legislature instituted some of the tightest opioid prescribing regulations in the country this year — a three-day limit for most people who aren’t already on opioids. And even long-term pain patients are having trouble getting refills.

John Venable of Kingsport, Tenn., was shown the door by his pain clinic in July after more than a decade on oxycodone — a generic, short-acting version of OxyContin.

“I just felt like I was in a hopeless state, like, ‘there is no help for John,'” he recalled.

At their worst, he said his headaches get so debilitating “that death would be a relief.” Despite his dread, he’s noticed something surprising over the last few months without opioids — his crippling headaches haven’t gotten that much worse, if at all.

“It very well might be a blessing in disguise,” Venable said.

The retired builder and one-time pastor said he prays that those losing OxyContin also will get to use the moment as an opportunity, though he knows many can’t cut ties with opioids. And he worries some will turn to more dangerous drugs off the street or even contemplate ending their own lives.

Experts point out that the number of opioid prescriptions has already been falling around the country. And in Tennessee, BCBS has experienced a 26 percent drop in opioid prescription claims over three years.

But restricting legal access to opioids hasn’t turned back the rise in overdose deaths, which hit a record in Tennessee and nationwide last year.

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

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

Much Touted For Cancer, ‘Precision Medicine’ Often Misses The Target

Kaiser Health News:Insurance - September 13, 2018

Facing incurable breast cancer at age 55, MaryAnne DiCanto put her faith in “precision medicine” — in which doctors try to match patients with drugs that target the genetic mutations in their tumors. She underwent repeated biopsies to identify therapies that might help.

“She believed in it wholeheartedly,” said her husband, Scott Primiano of Amityville, N.Y., a flood-insurance broker. “You live on hope for so long, it’s hard to let go.”

Around this point in the average news story, readers would learn how DiCanto — mother to a blended family of five — took a chance on an experimental drug that no one expected to work.

She would be the scrappy protagonist whose determination to “keep fighting” enabled her to beat the odds — allowing us to celebrate the triumph of modern science and worry a bit less about our own mortality.

But there’s a serious problem with talking about precision medicine for cancer this way.

It misleads the public.

In spite of DiCanto’s high hopes, none of it helped. DiCanto died last year at age 59.

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Doctors and hospitals love to talk about the patients they’ve saved with precision medicine, and reporters love to write about them. But the people who die — patients like DiCanto, who succumb to advanced cancer despite the advanced testing — still vastly outnumber the rare successes.

“There are very few instances in which we can look at a genomic test and pick a drug off the shelf and say, ‘That will work,’” said Dr. Nikhil Wagle, a cancer specialist at Boston’s Dana-Farber Cancer Institute who helped develop precision-medicine tests. “That’s our goal in the long run, but in 2018 we’re not there yet.”

Reflecting on his family’s experience with “precision” treatment, Primiano said, “You think it’s going to be more precise, like a laser versus a shotgun. But it’s still a shotgun.”

There has been real progress, of course.

MaryAnne DiCanto(Courtesy of Scott Primiano)

Testing for genetic mutations has become the standard of care in lung cancer, melanoma and a handful of other tumor types. But the number of people with advanced cancer eligible for these approaches is just 9 percent to 15 percent, experts estimate. These targeted therapies help about half of patients who try them, said Dr. Vinay Prasad, an associate professor at Oregon Health and Science University.

Targeted therapies tend to be less successful in patients like DiCanto, who have exhausted all standard treatments. In a large study published last year in Cancer Discovery, precision medicine failed to help 93 percent of the 1,000 patients who signed up for the study.

At the most recent meeting of the American Society of Clinical Oncology — the largest cancer meeting in the world — researchers presented four precision-medicine studies. Two were total failures. The other two weren’t much better, failing to shrink tumors 92 percent and 95 percent of the time.

The studies received almost no news coverage.

Some experts, including Dr. David Hyman of New York’s Memorial Sloan Kettering Cancer Center, say that such testing should be available to everyone with advanced cancer, because no one can predict which individual might have a rare mutation that can be targeted with a new or experimental drug. When patients respond to these drugs, they tend to do very well, and some survive much longer than expected.

But Hyman acknowledged that many people who pursue precision medicine will be disappointed, because testing won’t lead to a new treatment. Precision medicine “is not addressing the needs of the majority of cancer patients,” he said.

Many of the doctors I interview as a health care reporter are uncomfortable talking about patients who don’t survive.

While acknowledging that not all patients are helped by tumor sequencing, they quickly pivot to talking about people they’ve saved. They rush past the disappointing present and fast-forward to a future in which every patient gets the treatment she or he needs. If you don’t listen carefully, you could easily be led to believe those future cures are already here.

There are very few instances in which we can look at a genomic test and pick a drug off the shelf and say, ‘That will work.’

Dr. Nikhil Wagle, cancer specialist at Boston’s Dana-Farber Cancer Institute

Hospitals promote their precision-medicine programs by showcasing the stories of long-term survivors. Companies such as Foundation Medicine, Caris Life Sciences and Guardant Health — which sell the tests that look for cancer mutations — highlight only the best-case scenarios on their websites. In drug company marketing, patients are cheerleaders for the latest treatment fad.

Against this backdrop of hope and desperation, how are patients supposed to make informed decisions?

DiCanto gave precision medicine everything she had, including biopsies from her lungs and liver, where her cancer had spread. Over 2½ years, her doctor sent seven blood and tissue samples to specialized labs for “next-generation sequencing,” which can quickly scan hundreds of genes. The tests aim to locate a cancer’s Achilles’ heel — a genetic vulnerability that can be targeted with a drug.

MaryAnne DiCanto preps for a biopsy. Doctors took samples of cancer cells from her lung, liver and blood.(Courtesy of Scott Primiano)

DiCanto’s first genomic test matched her to a newly approved drug she would have tried anyway, Primiano said. When it stopped working, she had another biopsy.

That time, tests matched her to a different drug approved for breast cancer. But it proved so toxic that it “nearly killed her,” Primiano said.

Additional tests matched DiCanto to drugs available only in clinical trials. Eligibility criteria for clinical trials are notoriously strict, however, and often exclude people who’ve been heavily treated with other medications. DiCanto wasn’t eligible for any of them. Even when patients are eligible for trials, many turn them down. They’re just too frail and sick to travel to the metropolitan areas where most trials are run.

Although DiCanto benefited from standard cancer treatments, none of the targeted therapies recommended through genetic testing extended her life, Primiano said.

“She didn’t give up,” Primiano said. “Her body gave up. Her body just couldn’t take it anymore.”

Primiano said patients should remember that precision medicine is in its infancy. Although scientists have identified tens of thousands of genetic “variations” — changes from normal DNA that could play a role in cancer — doctors have only a few dozen drugs with which to target them. In the majority of cases, genetic mutations are of “unknown significance”; they’re essentially useless, because scientists don’t know if they affect how patients respond to drugs.

Even when drugs are a good match for a specific mutation, they don’t always work. A targeted therapy that works in melanoma, for example, doesn’t help people with colorectal cancer — even when patients have the exact same mutation, said Wagle, a member of the medical advisory board for Living Beyond Breast Cancer, a patient advocacy group in which DiCanto was active.

MaryAnne DiCanto and her husband, Scott Primiano, spoke with Democratic presidential candidate Hillary Clinton about health care costs during the 2016 campaign. Primiano says Clinton stayed in contact with DiCanto throughout her treatment and called on the day she died to thank her.(Courtesy of Scott Primiano)

Paying for tests and treatment poses its own hurdles. Insurers often tell patients that next-generation sequencing is unproven. Even when insurers agree to cover the testing, they won’t necessarily cover nonstandard or experimental treatments that sequencing companies recommend.

Primiano, a insurance broker, said his family was able to handle the costs: $500,000 out-of-pocket on his wife’s cancer care over 13 years. But managing his wife’s cancer “was a full-time job — doing the research, finding the clinical trials, dealing with the insurance companies, managing the money.”

He worries about people with fewer resources, especially patients tempted to drain their savings account to pay for a treatment with little to no chance of working.

The very words “precision medicine” suggest a high rate of success, Primiano said. While its successes should be celebrated, its failures must be acknowledged and tallied, reminding us how much is left to learn. When patients and their families have so much on the line, they deserve to understand what they’re paying for.

“Let’s not pretend this is something it isn’t,” Primiano said. “I’m not saying we shouldn’t try it. I just don’t want people to have false hope.”

KHN’s coverage of these topics is supported by John A. Hartford Foundation and Gordon and Betty Moore Foundation

HHS Secretary Azar Declares Public Health Emergency in Virginia Due to Hurricane Florence

HHS Gov News - September 12, 2018

Health and Human Services Secretary Alex M. Azar today declared a public health emergency in Virginia to prepare for potential impacts of Hurricane Florence. The declaration follows President Trump’s emergency declaration for the state and gives Centers for Medicare & Medicaid Services’ (CMS) beneficiaries and their healthcare providers and suppliers greater flexibility in meeting emergency health needs.

“As the President has emphasized, we are fully prepared to support communities that need our help because of the storm,” Secretary Azar said. “We are working closely with state health and emergency management officials to anticipate communities’ needs and be ready to meet them.”

 Secretary Azar acted under his authority in the Public Health Service Act and Social Security Act in declaring the public health emergency in Virginia and authorizing flexibilities to support CMS beneficiaries. These actions and flexibilities are retroactive to Sept. 8, 2018.

In addition to making this declaration, HHS worked with FEMA to pre-position approximately 400 medical and public health personnel from the U.S. Public Health Service Commissioned Corps, the National Disaster Medical System and across the department, along with caches of medical equipment for HHS medical teams, so that they are readily available immediately after the storm. Approximately 150 additional HHS health responders are on alert to deploy if needed.

Approximately 300 ambulances are standing ready to assist with patient care, transport and evacuation. Two 250-bed Federal Medical Stations are staged to support care for displaced people with special health needs, including those with chronic health conditions, limited mobility, or common mental health issues.

The HHS Office of Civil Rights issued guidance to state and local agencies and community organizations to help ensure equal access to emergency services and the appropriate sharing of medical information during Hurricane Florence, including how federal civil rights laws apply in an emergency, how HIPAA laws apply in an emergency. OCR also provided a HIPAA Disclosures for Emergency Preparedness Decision Tool.

The HHS Secretary’s Operation Center, managed by the Assistant Secretary for Preparedness and Response (ASPR), remains activated 24/7 to coordinate federal public health and medical support, bringing to bear the federal government’s full range of health-related assets and resources. The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) also activated their emergency operations centers to support the Secretary’s Operations Center and to coordinate hurricane response activities across their divisions and with their state and private sector partners.

ASPR and CMS collaborated to provide information to state health officials in South Carolina, North Carolina and Virginia on the number of Medicare beneficiaries who rely on dialysis or on special medical equipment at home and the type of equipment, such as oxygen concentrators, in the potentially impacted areas. This information assists health and emergency management agencies in saving lives, particularly after extended power outages.

HHS divisions continue to work with state and private sector contacts to prepare for the storm. FDA, for example, is prepared to assist manufacturing firms in the hurricane’s projected path if needed after the storm. Potential flooding is one of the greatest concerns for manufacturing facilities.

To learn more about how to prepare, and for health safety information, visit the HHS emergency website.

Secretary Azar Praises Unprecedented FDA Enforcement Actions Against Retailers and Manufacturers over Youth E-Cig Sales

HHS Gov News - September 12, 2018

On Wednesday, HHS Secretary Alex Azar issued the below statement regarding the FDA’s largest coordinated enforcement effort in agency history. FDA issued more than 1,300 warning letters and civil money penalty complaints to retailers who illegally sold e-cigarettes to minors.

“No child should be using any tobacco or nicotine-containing product. We commend the FDA for the critical, immediate and historic action to address the sale and marketing of these products to kids, while it examines additional aggressive steps to stem the troubling trend of their use among youth.”

To read more about FDA’s actions, please visit:
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM620184.htm

In Trump’s First Year, Nation’s Uninsured Rate Unchanged

Kaiser Health News:HealthReform - September 12, 2018

Despite Republican resistance to the federal health law, the percentage of Americans without health insurance in 2017 remained the same as during the last year of the Obama administration, according to a closely watched report from the Census Bureau released Wednesday.

However, the uninsured rate did rise in 14 states. It was not immediately clear why, because the states varied dramatically by location, politics and whether they had expanded Medicaid under the federal health law. Those states included Texas, Florida, Vermont, Minnesota and Oregon.

The uninsured rate fell in three states: California, New York and Louisiana.

An estimated 8.8 percent of the population, or about 28.5 million people, did not have health insurance coverage at any point in 2017. That was slightly higher than the 28.1 million in 2016, but did not affect the uninsured rate. The difference was not statistically significant, according to the Census report.

About 17 percent of Americans were uninsured in 2010, the year the Affordable Care Act was enacted.

The Census numbers are considered the gold standard for tracking who has insurance because the survey samples are so large.

(Courtesy of the U.S. Census Bureau)

Analysts credit the health law with helping drive down the number of uninsured. But also a factor: The proportion of people without insurance typically falls as unemployment rates decline. That’s because more people can get health coverage at work or can better afford buying insurance on their own.

The nation’s unemployment rate has generally been falling since before 2011 and was 4.1 percent for the last quarter of 2017, the lowest level since before the Great Recession began in December 2007.

Critics of the health law said the report emphasized its deficiencies. “Today’s report is another reminder that Obamacare has priced insurance out of the reach of millions of working families,” Marie Fishpaw and Doug Badger of the Heritage Foundation said in a statement. “Despite a growing economy and very low unemployment rate, the uninsured rate remains virtually unchanged.”

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But the law’s supporters instead saw the glass as half full.

“These numbers show the resilience of the Affordable Care Act,” said Judith Solomon, senior fellow at the Center on Budget and Policy Priorities. She said people still value the coverage they receive from the health law even as it’s been under attack by President Donald Trump and Republicans who want to repeal it. “It’s good news because the numbers show the strength of the ACA but bad news in that we have not seen further progress.”

Solomon expressed concern, though, about the large number of states seeing uninsured rates increase.

Uninsured rates last year ranged from a high of more than 17 percent in Texas to low of just under 3 percent in Massachusetts.

West Virginia had one of the sharpest increases in uninsured.

About 14 percent of the state’s residents were uninsured in 2013 before the ACA’s premium subsidies and Medicaid expansion began. That rate fell by nearly two-thirds by 2016. Last year, however, West Virginia’s uninsured rate crept up 0.8 percentage points to 6.1 percent, according to the Census report.

Carol Bush, who has worked as a health insurance navigator the past three years in West Virginia, expects to be uninsured by month’s end. She is losing her job amid Trump administration cuts to the Affordable Care Act navigator program.(Courtesy of Carol Bush)

Carol Bush, 58, of Elkins, W.Va., expects to lose coverage Oct. 1 because her job is ending.

It’s an unfortunate irony: Elkins has served for the past three years as a navigator helping people in her community find coverage in the health law marketplaces. Federal officials have largely scrapped that program.

The Trump administration cut funding by more than 80 percent during the past two years, saying it had no proof that navigators were helping people find coverage. Only if consumers signed up in the presence of the navigator was a session considered a success.

Bush had coverage through the University of West Virginia, which has a navigator contract that ends at the end of this month. Without employer coverage, Bush said, the cheapest insurance she could find would be about $1,100 a month. She won’t qualify for a federal subsidy to lower her premium because of her family’s income. Her husband is insured through Medicare.

Although she said she has strongly considered going without insurance because of the cost, she knows she needs it.

“In all honesty, I’ve always had some kind of health insurance, and the thought of being without it worries me,” she said. “I can’t risk getting seriously ill and incurring enormous debt at this point in my life. Peace of mind has a value too.”

Shenandoah Community Health Center, a federally funded health clinic in Martinsburg, W.Va., has started to see an increase in uninsured patients the past year, although it’s still below levels it saw before the health law’s coverage expansion began in 2014, said CEO Michael Hassing. Hassing said he believes many patients have dropped coverage, thinking the ACA’s individual mandate was repealed.

“Folks say, ‘I don’t need to have it anymore,’ and they let it go,” he said.

While the GOP failed last year to repeal the law, Congress was able to strip out one of its key features — the individual penalty for not having coverage. The vote last December eliminated that penalty starting in 2019 — meaning Americans are still required this year to have health coverage or face the consequences on their 2018 taxes.

Doctor To The Stars Disciplined Over Use Of Controversial Menopause Therapy 

Kaiser Health News:Marketplace - September 12, 2018

In a conversation with Sarah “Fergie” Ferguson, the Duchess of York, that aired on the Oprah Winfrey Network, Dr. Prudence Hall said age isn’t what determines health and vitality. “It’s about how healthy your hormones are,” she said. Hormone therapy means “we don’t have to grow old and grow ill,” she said. Hall was disciplined late last month by the Medical Board of California. (Screen grab from “Dr. Prudence Hall | Finding Sarah | Oprah Winfrey Network” on YouTube)

A Santa Monica doctor who touted a controversial menopause therapy on the Oprah Winfrey Network and received testimonials for her work from such celebrity patients as model Cindy Crawford and actress-author Suzanne Somers has been disciplined by California’s medical board for gross negligence.

This story also ran on People.com. This story can be republished for free (details). In a settlement approved late last month, the Medical Board of California put Dr. Prudence Hall on probation for four years, faulting her for being “unaware” of potential risks posed by the plant-based hormones — including cancer — and failing to monitor her patients properly.

Hall used numerous hormones to treat two women, according to the board, missing an aggressive uterine cancer in one patient and treating the other based on an “incorrect diagnosis in a manner such that [Hall] stood to gain financially.”

“My jaw was on the floor. This is just egregious,” said Dr. Jen Gunter, a San Francisco Bay Area OB-GYN who reviewed the medical board’s report. “You hear about all these self-described functional medicine doctors providing these treatments. Never in my wildest dreams did I think it would be in this ballpark.”

A statement issued by Hall’s publicist Monday did not address the specifics of the board’s findings but generally defended the doctor’s results and commitment to patients.

“Dr. Hall continues to devote her career and life to helping patients achieve optimal health and wellness,” the statement said.

“She utilizes advances in modern medicine plus proven natural therapies. Safely incorporating results of the latest medical research has allowed her to achieve exceptional results for her patients.”

The statement added that Hall “joins respected physicians worldwide who are also using” this type of hormone therapy.

The hormone therapies prescribed by Hall are supposedly customized to individual patients’ needs and are generally not approved by the Food and Drug Administration. They are known as “bioidentical” because their molecular structure is the same as the natural hormones found in a woman’s body, including estrogen and progesterone.

Hall has claimed to have treated more than 40,000 patients with them over 30 years. Under the terms of her settlement with the board, she is no longer allowed to promote herself as a specialist in hormone therapy, an OB-GYN or an endocrinologist, and she must submit her medical practice to oversight by an outside physician who will report to the board. She is allowed to continue treating women for menopause management and other health issues.

Her case stands as a possible warning to many other physicians and providers who have embraced such unproven hormone treatments. Popularized by testimonials from celebrity women, these made-to-order hormones are used by up to 2.5 million women in the United States, according to one study.

Representatives for Crawford and Somers said they chose not to comment at this time.

Hall has been hailed by supporters as a “pioneer” in this type of personalized bioidentical hormone therapy, appearing on national television and infomercials and promoting such treatments as a virtual fountain of youth.

“It’s not about age; it’s about how healthy your hormones are,” Hall told Sarah Ferguson, the Duchess of York, in a conversation on the Oprah Winfrey Network in 2011. “It’s new to think we don’t have to grow old and grow ill.”

In her appearances, Hall offers an appealing message to women entering their 50s and 60s who are looking for “natural” relief from hot flashes, night sweats, loss of libido, aging skin or other concerns.

The hormone treatments she provides are “like water to a plant,” Hall told Somers on an episode of Somers’ television program, “The Suzanne Show.” “How could water be bad for a plant? … Hormones do not cause cancer.”

Dr. David Gorski, a surgical oncologist, professor of surgery at Wayne State University School of Medicine and a longtime critic of unproven alternative medicine, rejected Hall’s analogy. “I’m not a gardener by any stretch of the imagination,” he said, “but even I know that too much water can kill a plant.”

Many other clinicians and researchers say there’s no evidence to back up the claims by Hall and other doctors that these customized treatments are more effective or safer or that they act any differently in the body than FDA-approved hormone replacement therapies.

Some bioidentical hormones, unlike the ones primarily used by Hall, are FDA-approved. They are manufactured in pharmaceutical plants using standard formulas and have been shown to relieve menopausal symptoms — though they have not been tested in large, long-term trials — according to a report in Harvard Women’s Health Watch.

The customized therapies used by Hall and other doctors are mixed in compounding pharmacies and generally are not tested for safety and efficacy, according to Harvard Women’s Health Watch and other reports.

Compounded bioidenticals are big business. In 2013, U.S. sales of these products were estimated in one study at $845 million, compared with a $3.7 billion market for traditional, FDA-approved hormone replacement medications.

“There’s a definite concern that for some women they may be dangerous,” said Dr. Janet Pregler, director of the Iris Cantor-UCLA Women’s Health Center. “Often these [hormones] are presented as risk-free, when we as physicians know that nothing you put in your body is risk-free.”

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Women flocked to bioidentical hormone treatment after the Women’s Health Initiative, a massive federally funded study on a widely used hormone replacement therapy for menopausal women, was halted prematurely in 2002 over concerns about an elevated risk of breast cancer, heart disease and stroke.

Hall, according to medical board investigators, put a patient with a family history of uterine cancer on a regimen of bioidentical hormones after the woman complained of “zero libido” and menstrual migraines. She also prescribed iodine and two adrenal hormone supplements. The patient started to bleed — a potential warning sign of uterine cancer — but Hall prescribed her more hormones, according to the medical board.

Ultimately, the patient developed a cancerous mass in her uterus — but board investigators alleged that Hall failed to detect it, after performing ultrasounds on the patient that she was not certified to analyze. She charged the patient $7,000 over three years for the treatment, according to the board.

In the two cases for which she was disciplined — which occurred between 2011 and 2015 — the medical board found that Hall treated women who were not yet in menopause but whom she incorrectly diagnosed as being in perimenopause. Those are the years immediately before menopause that can create uncomfortable symptoms such as hot flashes and low libido. Their lab tests showed hormone values within normal limits, the board said.

The second patient had numerous other conditions including diabetes and a history of psychiatric disorders, according to the board. The board said Hall diagnosed the patient with hypothyroidism when no clinical evidence supported such a diagnosis — and that later aberrations that surfaced in lab testing had actually been caused by the physician’s treatment.

Hall presented herself to patients as a specialist in “hormone balance,” or endocrinology,” but does not have any post-medical school training by an accredited fellowship in either medical or reproductive endocrinology, according to the board.

It’s not the first time California’s medical board has disciplined a doctor for prescribing such bioidentical hormones. In 2009, the board put Dr. Michael Platt of Rancho Mirage on five years’ probation after charging him with negligence and incompetence for his treatments of several patients. The doctor, author of “The Miracle of Bio-identical Hormones,” later was forced to surrender his license.

Experts say such doctors take advantage of patients’ vulnerability as they age.

“We all fear getting older and loss of sexuality, and the way society makes women feel, women are more vulnerable to it, for sure,” said Gunter, the Bay Area OB-GYN. “I don’t blame the patients for going to the doctor and putting trust in them. I blame the doctors for saying this can somehow help them.”

Sheila Cosgrove Baylis of People magazine contributed to this report.

KHN’s coverage of these topics is supported by California Health Care Foundation and The David and Lucile Packard Foundation

This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.

HHS Secretary Azar Declares Public Health Emergencies in North Carolina and South Carolina Due to Hurricane Florence

HHS Gov News - September 11, 2018

Following the lead of President Trump’s emergency declarations for North Carolina and South Carolina, Health and Human Services Secretary Alex M. Azar today declared public health emergencies in the two states as Hurricane Florence continues its track toward the eastern seaboard. The declarations give HHS’ Centers for Medicare & Medicaid Services’ (CMS) beneficiaries and their healthcare providers and suppliers greater flexibility in meeting emergency health needs.

“Hurricane Florence is an intense storm and is predicted to be highly destructive, which poses a significant threat to the health and safety of those in its path,” Secretary Azar said. “These actions help ensure that Americans who rely on Medicare and Medicaid have continuous access to the care they need when the storm makes landfall.”

In addition to making these declarations to increase the flexibility in providing services to, and assistance for, CMS beneficiaries, HHS strategically pre-positioned approximately 230 medical personnel from the National Disaster Medical System and their caches of medical equipment in North Carolina and Maryland so these assets are available quickly to help state and local authorities respond to communities’ medical needs. HHS also activated the U.S. Public Health Commissioned Corps’ Rapid Deployment Force to assist if needed after the storm. Additional staff is on standby to assist.

HHS staff from the Office of the Assistant Secretary for Preparedness and Response (ASPR) also coordinated with the Federal Emergency Management Agency to activate a national contract that makes additional ambulances available to evacuate hospitals and nursing homes if needed. ASPR regional emergency coordinators are staffing operations centers in impacted states to stay abreast of potential public health and medical needs post-storm.

ASPR and CMS also coordinated to provide information to North Carolina and South Carolina health officials on the number of Medicare beneficiaries who rely on dialysis or on special medical equipment at home and the type of equipment, such as oxygen concentrators, in the potentially impacted areas. With this information, health and emergency management agencies can respond better, particularly after power outages, to save lives.

Secretary Azar acted under his authority in the Public Health Service Act and Social Security Act in declaring the public health emergency and authorizing flexibilities for CMS beneficiaries. These actions and flexibilities are retroactive to September 7, 2018, in North Carolina, and to September 8, 2018, in South Carolina.

Public health and safety information for Hurricane Florence can be found on the HHS emergency website, https://www.phe.gov/emergency/events/2018-Severe-Storms/Pages/default.aspx

HHS Awards $21 Million to Support Health Center Participation in NIH’s All of Us Research Program

HHS Gov News - September 11, 2018

Today, the Department of Health and Human Services’ (HHS) Health Resources and Services Administration (HRSA) awarded $21 million to 46 community health centers to support their participation in the National Institutes of Health’s (NIH) All of Us Research Program. All of Us is a national effort to gather data from one million or more U.S. residents to accelerate research and improve health by taking individuals’ differences in lifestyle, environment, biology and other factors into account. HRSA’s investment supports community health centers’ capabilities to enroll and retain participant partners in All of Us, which seeks to advance precision medicine.

 “HRSA-supported community health centers’ participation in the All of Us Research Program is a critical opportunity for individuals from all walks of life to be represented in research and support the next generation of medical innovation,” said HHS Secretary Alex Azar. “All of Us will lay the scientific foundation for a new era of personalized, highly effective health care. We look forward to working with people of all backgrounds to take this major step forward for our nation’s health.”

The HRSA funding will also advance health centers’ interoperability functionality, preparedness to use and share patient data, and capacity to participate in future research opportunities.

“Community health centers provide high-quality preventive and primary health care. They can help engage participants from underserved communities, which will be vital to All of Us in producing meaningful health outcomes,” said HRSA Administrator George Sigounas, MS, Ph.D. “We are proud to be a part of this historic effort to gather data from people across America to advance medical research and improve health.”

For more than 50 years, health centers have delivered affordable, accessible, quality and cost-effective primary health care services to patients. Today, nearly 1,400 health centers operate more than 11,000 service delivery sites nationwide serving more than 27 million people.

“Community health centers are vital to engaging people who have been underrepresented in research,” said NIH Director Francis S. Collins, M.D., Ph.D. “The success of the program will rely on a diverse population of participants, and the collaboration with HRSA will help accomplish the All of Us mission to enable individualized prevention, treatment and care for all populations.”

For a list of HRSA’s Advancing Precision Medicine grant award recipients, visit: https://bphc.hrsa.gov/programopportunities/fundingopportunities/apm/awards.html.

To learn more about HRSA’s Health Center Program, visit: http://bphc.hrsa.gov/about.

To locate a health center, visit: http://findahealthcenter.hrsa.gov.

To learn more about NIH’s All of Us Research Program, visit: https://allofus.nih.gov

Unwitting Patients, Copycat Comments Play Hidden Role In Federal Rule-Making

Kaiser Health News:Marketplace - September 11, 2018

A proposal to sharply cut a drug discount program that many hospitals rely on drew some 1,400 comments when the Trump administration announced its plan last year. Hundreds appeared to come from patients across the country — pleas from average Americans whose treatments for diseases such as cancer depend on costly medicines.

But a review of the responses found that some individuals were not aware they apparently had become part of an organized campaign to oppose what’s known as the “340B” program. Some had no memory of signing anything, much less sending their opinions about it.

Of the 1,406 comments that specifically mentioned 340B — part of several thousand comments submitted on a broad proposal to revise medical payment systems — about half included the same or similar wording and were submitted anonymously, an analysis by Kaiser Health News found. Those comments lamented “abuse” of the drug discounts, faulted hospitals for being “greedy” and used phrasing such as “quality, affordable, and accessible.”

Two that were duplicated hundreds of times made the very same grammatical mistake.

They “are clearly related,” said Robert Leonard, a forensic linguistic expert at Hofstra University whose team analyzed the submissions for KHN.

In fact, the wording in the duplicate comments tracks language in a formal letter submitted to regulators by a nonprofit trade group, the Community Oncology Alliance, which receives funding from pharmaceutical companies.

Cancer survivor Janice Choiniere’s name is on a public comment saying reform of the 340B program will help “those suffering from this insidious disease.” But when reached by phone, the 69-year-old Florida resident said she had “no idea” what the program is and didn’t recall signing a petition.

“My first thought is, I don’t fill out and send in responses casually,” Choiniere said. “I’m hoping nobody lifted my information.”

The quarter-century-old federal program requires pharmaceutical companies to sell certain drugs at steep discounts to eligible hospitals and clinics, which don’t have to share their savings with patients. Critics, including Republican lawmakers, have questioned what the facilities do with the money. Doctors in private practice, who are not eligible for the reduced rates, have warned that the program’s continued growth makes it susceptible to exploitation.

The administration’s plan, finalized in November, reduced by $1.6 billion annually what the Centers for Medicare & Medicaid Services pays for the targeted drugs. In late July, the agency proposed expanding those payment cuts.

As with any proposed rule, the purpose of requesting public comments is to help lawmakers and regulators consider the potential effects of their actions. But the pattern identified in the 340B comments, which were posted online by CMS, suggests the system can easily be manipulated. Patients may be especially vulnerable to being used.

“It feels like inappropriate influence,” said Peter Ubel, a physician and behavioral scientist at Duke University’s Fuqua School of Business. “When you have a life-threatening illness, you need to know you can trust your physician to care about your interests ahead of their own.”

KHN reached 10 individuals whose names appeared in the comments — either as a signature on a personal note or on a petition also signed by others. All were patients, former patients or caregivers seen at private practices connected to the Community Oncology Alliance.

Two patients confirmed they had written notes, although they couldn’t say when. Several said they must have signed or written something amid the paperwork handed to them at a doctor’s office during appointments or in follow-up correspondence. A few drew mental blanks.

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The name of an 84-year-old melanoma patient shows as an online signature in an individual public comment that described the program’s reform as a matter of “life or death.” But the Florida man, who asked not to be identified, had little recollection of writing it. His wife remembered that he signed something at his doctor’s office “out front on a clipboard” before getting his biweekly cancer treatment.

“If my doctor wanted me to sign something, I would sign it for him,” the man said. He “saved my life.”

Julie Yarbrough, whose husband received treatment at New England Cancer Specialists in Maine, remembered signing a petition “at the [doctor’s] check-in area” about hospitals abusing 340B discounts. She was the only individual contacted who had a basic understanding of the program.

The patients reached by KHN sought care at either New England Cancer Specialists, which has three locations in Maine, or Florida Cancer Specialists, which runs nearly 100 treatment centers in that state. Data posted on the federal website regulations.gov show that more than 60 percent of the 340B-specific comments originated in Florida.

“We do a good job of educating patients and letting them know how to get involved,” said Michael Diaz, director of patient advocacy for Florida Cancer Specialists and vice president on the Community Oncology Alliance’s executive committee. “They need to be able to contribute and give their opinion.”

Steve D’Amato, executive director of New England Cancer Specialists and an Alliance board member, mentioned patients’ support in a letter accompanying a petition posted multiple times to the government portal Oct. 10. The petition included the trade group’s website; D’Amato noted that “patient signatures obtained in just 2 days” were attached.

When asked recently about patients who didn’t recall signing something, D’Amato said he did not have the petition in front of him and referred all questions to the Alliance’s executive director, Ted Okon. In an interview, Okon denied that the organization had any role in soliciting patient comments.

“We didn’t do anything with patient petitions,” said Okon, although talking points and material were sent to practices nationwide for them to use when submitting comments. “This is what we do in terms of advocating.”

Susannah Rose, scientific director of research in the Cleveland Clinic’s patient experience office, said there is “always a worry about coercion” when doctors make a request of patients, but more so when oncologists do the asking.

“Cancer patients often feel very much in the hands of their oncologists, and they are often suffering from significant distress,” said Rose, who serves on the ethics committee of the American Society of Clinical Oncology.

The Washington-based Alliance represents private oncology practices as well as about 50 corporate members, according to its website. Formed in 2003 when Congress approved Medicare’s prescription drug program, it was a leading critic of a controversial 2016 proposal to change how CMS paid for some drugs in Medicare. The group’s revenue nearly quadrupled that year, to $16.3 million from $4.4 million in 2015, according to federal tax filings. The proposal never became reality.

Pharmaceutical giants Sanofi, Pfizer, Eli Lilly, Bristol-Myers Squibb and Merck each confirmed paying annual dues of $75,000 to the Alliance. The five companies also paid it nearly $1 million between 2014 and 2017 for research papers, conferences, filming and patient education, according to corporate transparency reports.

Walgreens and PhRMA, the pharmaceutical industry trade group, also confirmed membership but did not disclose how much they pay in dues. Okon said corporate membership fees range from $25,000 to $75,000 annually while individual oncologists and their practices pay “usually on the order of a thousand dollars, two thousand dollars.”

Drug manufacturers do not influence the Alliance’s position on 340B, he said, noting in an email that “correlation is not causality.”

After the comment period ended, CMS slashed 340B payments to hospitals by $1.6 billion annually. Medicare had been paying hospitals 6 percent above a drug’s average sales price; it now pays them 22.5 percent less than the average sales price.

CMS Administrator Seema Verma and Eric Hargan, deputy secretary of the Health and Human Services Department, emphasized that public comments played into their decision. In the 1,133-page final rule, they said they shared the concern that current Medicare payments “are well in excess of the overhead and acquisition costs” for drugs bought under the program.

“We thank the commenters for their support,” they wrote.

Kaiser Health News data correspondent Sydney Lupkin contributed to this report.

How KHN Found The Duplicated Rhetoric On 340B

Kaiser Health News data correspondent Sydney Lupkin downloaded thousands of publicly filed comments from regulations.gov regarding a rule that revised Medicare payments to hospitals. Lupkin found that of the 1,406 comments on the docket that explicitly mentioned “340B,” three separate comments were duplicated hundreds of times. Those three widely repeated comments made up more than half (763) of all the comments posted about the 340B drug discount program. (Note: The analysis did not review PDF attachments that were submitted as comments.)

Hofstra University professor Robert Leonard, and analysts Juliane Ford and Dakota Wing who work for his consulting firm, compared those three comment types with a letter submitted to regulators in September by Community Oncology Alliance, a nonprofit advocacy group. COA’s comment letter included 2,928 words. The three duplicated comments used 242, 260 and 306 words.

The analysts used a technique that tallies the number of N-grams, which is a set of serial words found in a string, shared in each document. They found multiple examples. One near 10-gram sequence that appeared in all 763 comments is a variation of the sentence: “The mission of COA is to ensure that cancer patients receive quality, affordable, and accessible cancer care in their own communities.” It varied by the use of a few words, such as changing “communities” to “community” or using the word “local” instead.

Notably, the use of an Oxford comma in the same string of words — “quality, affordable, and accessible” — appeared in all four comments.

“It defies imagination that three or four individual people would pick the same words in the same strain,” said Leonard, who is director of the graduate program in forensic linguistics at Hofstra University.

The frequent use of the informal word “bad” also caught the attention of researchers. And two comments that were duplicated hundreds of times made the same grammatical mistake — using a non-standard plural “American’s” with a superfluous apostrophe.

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

The Remedy For Surprise Medical Bills May Lie In Stitching Up Federal Law

Kaiser Health News:HealthReform - September 10, 2018

When Drew Calver had a heart attack last year, his health plan paid nearly $56,000 for the 44-year-old’s four-day emergency hospital stay at St. David’s Medical Center in Austin, Texas, a hospital that was not in his insurance network. But the hospital charged Calver another $109,000. That sum — a so-called balance bill — was the difference between what the hospital and his insurer thought his care was worth.

Though in-network hospitals must accept pre-contracted rates from health plans, out-of-network hospitals can try to bill as they like.

Calver’s bill eventually was reduced to $332 after Kaiser Health News and NPR published a story about it last month. Yet his experience shines a light on an unintended consequence of a wide-ranging federal law, which potentially blindsides millions of consumers.

The federal law — called ERISA, for the Employee Retirement Income Security Act of 1974 — regulates company and union health plans that are “self-funded,” like Calver’s. That means they pay claims out of their own funds, even though they may be administered by a major insurer such as Cigna or Aetna. And while states increasingly pass laws to protect patients from balance bills as more hospitals and doctors go after patients to collect, ERISA law does not prohibit balance billing.

Although Texas is one of nearly two dozen states that provide consumers with some degree of protection against surprise balance bills, those state laws don’t apply to self-funded plans.

It’s a fairly common problem. About 60 percent of workers who get coverage through their job have self-insured plans, and 18 percent of people with coverage through a large employer who were admitted to the hospital in 2016 received at least one bill from an out-of-network provider, according to an analysis by the Kaiser Family Foundation. (Kaiser Health News is an editorially independent program of the foundation.)

Health researchers and advocates have identified a number of potential solutions that could tackle the problem at the federal or state level. The courts are another option. Yet whether these efforts are politically feasible when health care is in play as a partisan football is another matter.

Polarized views on appropriate reimbursement levels for medical services “limit stakeholders at both the federal and state level from making progress,” said Kevin Lucia, a research professor at Georgetown’s Center on Health Insurance Reforms, who has analyzed state laws that restrict balance billing.

A look at options that experts say might address the problem:

Change Federal Law

The simplest way to stop surprise bills would be through restrictions imposed by federal legislation that would apply to both state-regulated policies sold by insurers and employer-sponsored self-funded health plans, which are federally regulated.

There’s a precedent for this. The Affordable Care Act added provisions that apply to both types of plans. That law requires plans that cover dependents to allow children to stay on their parents’ plans until they turn 26, for example, and cover preventive benefits without charging patients anything out-of-pocket.

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New legislation could plug a big loophole in the ACA. The health law offered some consumer protections for out-of-network emergency care, one of the biggest trouble spots for balance billing. Not only do people sometimes wind up at out-of-network hospitals when they have an emergency, but even if they visit an in-network hospital, the emergency physicians, specialists and other providers such as pathologists and labs may not be in their health plan’s network.

The ACA limited a patient’s cost sharing for emergency services to what they would face if they were at an in-network facility. It also established standards for how much health plans have to pay the hospital or doctors for that care.

But the law didn’t prohibit out-of-network emergency doctors, hospitals and other providers, such as ambulance services, from balance billing consumers for the amounts their health plan didn’t pay.

Federal legislation could close that loophole by prohibiting balance billing for emergency services, as well as hospital admissions related to that emergency care.

Analysts at the University of Southern California-Brookings Schaeffer Initiative for Health Policy, who have suggested such a remedy, say the federal law could apply to any doctors and hospitals that participate in the Medicare program, as most do, to ensure that the effect would be widespread.

They also propose prohibiting balance billing in non-emergency situations when someone visits an in-network facility but receives care from out-of-network doctors or is referred for outpatient lab or diagnostic imaging that is outside of the person’s health plan network.

Still, the deep political scars left by the health law battles would seem to preclude any bipartisan efforts in Washington to change it.

“I’d love to see any kind of federal action,” said Loren Adler, associate director at the USC center, who co-authored the proposal. “It’s just hard to be super optimistic about anything happening in the near future.”

Revise Federal Regulations

The federal executive branch could also weigh in on fixing the problem for self-insured coverage. The Department of Labor could, for example, issue a ruling that clarifies that states can regulate provider payment, or require self-funded plans to participate in state dispute-resolution programs.

But experts say relying on regulatory changes to fix surprise bills may also be a nonstarter in this political climate.

“I don’t foresee the administration taking a hard look at the limits of its powers under the ACA,” said Sara Rosenbaum, professor of health law and policy at George Washington University.

Look To The States

More than 20 states have laws protecting consumers to some degree from surprise bills from out-of-network emergency providers or in-network hospitals if they’re covered by a state-regulated insurance policy, according to an analysis by Georgetown researchers published by the Commonwealth Fund.

State laws vary. Texas, for example, requires that consumers in HMO plans be held harmless from balance billing in out-of-network emergency and in-network situations, but consumers in PPO plans can be balance-billed.

New York’s law is more comprehensive, covering both types of plans and settings. New York protects consumers from liability for out-of-network emergency and other surprise bills, requires plans to disclose how they determine a reasonable provider payment and has a binding independent dispute-resolution process.

These laws typically don’t apply to self-funded plans, however. But that could change. A New Jersey law that went into effect last month allows self-funded plans to opt in to the state’s balance billing dispute-resolution process. If a federally regulated plan decides to participate in the state program, doctors, hospitals and labs would be prohibited from balance-billing those consumers, and any disputes will be handled through a binding arbitration process.

For self-funded employers, especially those who choose to pay their employees’ surprise bills, “this provides for a more formal structure and some relief,” said Wardell Sanders, president of the New Jersey Association of Health Plans.

There are other possibilities for addressing surprise bills at the state level, policy experts say. While states can’t regulate self-funded health plans, they do regulate doctors and hospitals and other providers.

States could simply cap the amount that providers can charge for out-of-network care, for example, or prohibit practitioners like radiologists and pathologists, who don’t deal directly with patients, from billing them for services, said Adler.

“As long as providers can charge whatever they please, the problem won’t go away,” said Adler.

Will The Courts Weigh In?

These billing disputes rarely end up in court, mainly because attorneys are hesitant to take them since there are no guaranteed attorney’s fees.

A recent Colorado case was a rare success for a patient. A jury in June sided with Lisa French, a clerk at a trucking company, who was stunned by a $229,000 balance bill for spinal fusion surgery. Saying the charges were unreasonable, the jury knocked down her share of that bill to just $766.74.

The hospital was paid nearly $75,000 by her health coverage, an amount her insurer felt built in a fair profit margin, but the hospital claimed fell short.

That raises the question at the heart of many disputes over balance billing: What is a fair price?

Hospitals argue they should get whatever amount they set as charges on their master list of prices. Attorneys for patients, however, argue that a fair price should be closer to those discounted rates hospitals accept in their contracts with insurers.

Hospitals generally refuse to disclose those discounted rates, leaving patients fighting surprise bills little information about what other people pay.

Several recent court cases — including state Supreme Court rulings in Georgia and Texas — required hospitals to provide those discounted rates, although the rulings did not say those discounted prices are ultimately what patients would owe.

HHS Awards Nearly $60 million to Support Community Health Centers Impacted by Hurricanes Harvey, Irma, and Maria

HHS Gov News - September 07, 2018

Today, the U.S. Department of Health and Human Services (HHS) awarded nearly $60 million to 161 community health centers in six southern states and two U.S. territories that were impacted by hurricanes Harvey, Irma and Maria. Administered by the Health Resources and Services Administration (HRSA), Capital Assistance for Hurricane Response and Recovery Efforts (CARE) funding will help ensure continued access to primary health care services at community health centers in areas affected by the hurricanes.

“Health centers serve as lifelines to services and networks of resources in their communities every day, and especially during a crisis,” said HHS Secretary Alex Azar. “These grants build on other HHS investments to ensure that health centers can continue to serve communities impacted by Hurricanes Harvey, Irma, and Maria, and strengthen their readiness to respond to the needs of the community after future hurricanes or other disasters.”

This funding was made available by the Bipartisan Budget Act, signed by President Trump in February. CARE offers capital assistance and support for minor alteration, renovation and equipment costs to assist impacted HRSA-funded health centers providing services in Alabama, Florida, Georgia, Louisiana, South Carolina and Texas as well as Puerto Rico and the U.S. Virgin Islands.

“In the aftermath of the hurricanes, we granted affected health centers flexibility in the use of HRSA funds to ensure continuity of services and assist in recovery efforts,” said HRSA Administrator George Sigounas, MS, Ph.D. “This funding is the latest in HRSA’s efforts to support these communities as they continue to recover.”

For more than 50 years, health centers have delivered affordable, accessible, quality and cost-effective primary health care services to patients. Today, nearly 1,400 health centers operate more than 11,000 service delivery sites nationwide.

For a list of CARE award recipients, visit: https://bphc.hrsa.gov/programopportunities/fundingopportunities/care/fy2018awards/index.html

To learn more about HRSA’s Health Center Program, visit: http://bphc.hrsa.gov/about

To locate a health center, visit: http://findahealthcenter.hrsa.gov

Insulin’s High Cost Leads To Deadly Rationing

Kaiser Health News:Insurance - September 07, 2018

Diabetic ketoacidosis is a terrible way to die. It’s what happens when you don’t have enough insulin. Your blood sugar gets so high that your blood becomes highly acidic, your cells dehydrate, and your body stops functioning.

Nicole Smith-Holt lost her son to diabetic ketoacidosis, three days before his payday, because he couldn’t afford his insulin.

“It shouldn’t have happened,” Smith-Holt said, looking down at her son’s death certificate on her dining room table in Richfield, Minn. “That cause of death of diabetic ketoacidosis should have never happened.”

The price of insulin in the U.S. has more than doubled since 2012 alone. That’s put the lifesaving hormone out of reach for some people with diabetes, like Smith-Holt’s son Alec Raeshawn Smith. It has left others scrambling for solutions to afford the one thing they need to live. I’m one of those scrambling.

Not Enough Time

Most people’s bodies create insulin, which regulates the amount of sugar in the blood. The roughly 1.25 million of us in the U.S. with Type 1 diabetes have to buy insulin at a pharmacy because our pancreases stopped producing it.

My first vial of insulin cost $24.56 in 2011, after insurance. Seven years later, I pay more than $80. That’s nothing compared with what Alec was up against when he turned 26 and aged off his mother’s insurance plan.

Smith-Holt said she and Alec started reviewing his options in February 2017, three months before his birthday on May 20. Alec’s pharmacist told him his diabetes supplies would cost $1,300 a month without insurance — most of that for insulin. His options with insurance weren’t much better.

Alec’s yearly salary as a restaurant manager was about $35,000. Too high to qualify for Medicaid, and, Smith-Holt said, too high to qualify for significant subsidies in Minnesota’s Affordable Care Act insurance marketplace. The plan they found had a $450 premium each month and an annual deductible of $7,600.

“At first he didn’t realize what a deductible was,” Smith-Holt said. She said Alec figured he could pick up a part-time job to help cover the $450 per month.

Then Smith-Holt explained to her son what a deductible was.

“You have to pay the $7,600 out-of-pocket before your insurance is even going to kick in,” she recalled telling him. Alec decided going uninsured would be more manageable. Although there might have been cheaper alternatives for his insulin supply that Alec could have worked out with his doctor, he never made it that far.

He died less than one month after going off of his mother’s insurance. His family thinks he was rationing his insulin — using less than he needed — to try to make it last until he could afford to buy more. He died alone in his apartment three days before payday. The insulin pen he used to give himself shots was empty.

“It’s just not even enough time to really test whether [going without insurance] was working or not,” Smith-Holt said.

The price of insulin in the U.S. has more than doubled since 2012. That’s put the lifesaving hormone out of reach for some people like Smith-Holt’s son Alec, and left others with Type 1 diabetes scrambling to find ways to afford the medicine they must take each day to survive.(Bram Sable-Smith for NPR)

A Miracle Discovery

Insulin is an unlikely symbol of America’s problem with rising prescription costs.

Before the early 1920s, Type 1 diabetes was a death sentence for patients. Then researchers at the University of Toronto — notably Dr. Frederick Banting, Charles Best and J.J.R. Macleod — discovered a method of extracting and purifying insulin that could be used to treat the condition. Banting and Macleod were awarded a Nobel Prize for the discovery in 1923.

For patients, it was nothing short of a miracle. The patent for the discovery was sold to the University of Toronto for only $1 so that lifesaving insulin would be available to everyone who needed it.

Today, however, the list price for a single vial of insulin is more than $250. Most patients use two to four vials per month (I personally use two). Without insurance or other forms of medical assistance, those prices can get out of hand quickly, as they did for Alec.

Depending on whom you ask, you’ll get a different response for why insulin prices have risen so high. Some blame middlemen — such as pharmacy benefit managers, like Express Scripts and CVS Health — for negotiating lower prices with pharmaceutical companies without passing savings on to customers. Others say patents on incremental changes to insulin have kept cheaper generic versions out of the market.

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For Nicole Smith-Holt, as well as a growing number of online activists who tweet under the hashtag #insulin4all, much of the blame should fall on the three main manufacturers of insulin today: Sanofi of France, Novo Nordisk of Denmark and Eli Lilly in the U.S.

The three companies are being sued in U.S. federal court by diabetic patients in Massachusetts who allege the prices are rising at the expense of patients’ health.

Eli Lilly and Company did not make anyone available for an interview for this story. But a company spokesman noted in an email that high-deductible health insurance plans — like the one Alec found — are exposing more patients to higher prices. In August, Eli Lilly opened a help line that patients can call for assistance in finding discounted or even free insulin.

A Dangerous Solution

Rationing insulin, as Nicole Smith-Holt’s son Alec did, is a dangerous solution. Still, 1 in 4 people with diabetes admit to having done it. I’ve done it. Actually, there’s a lot of Alec’s story that feels familiar to me.

We were both born and raised in the Midwest, just two states apart. We were both diagnosed at age 23 — pretty old to develop a condition that used to be called “juvenile diabetes.” I even used to use the same sort of insulin pens that Alec was using when he died. They’re more expensive, but they make management a lot easier.

“My story is not so different from what I hear from other families,” Smith-Holt recently told a panel of Senate Democrats in Washington, D.C., in a hearing on the high price of prescription drugs.

“Young adults are dropping out of college,” she told the lawmakers. “They’re getting married just to have insurance, or not getting married to the love of their lives because they’ll lose their state-funded insurance.”

I can relate to that too. My fiancée moved to a different state recently and soon I’ll be joining her. I’ll be freelancing, and won’t have health benefits, though she will, via her job. We got married — one year before our actual wedding — so I can get insured, too.

This story is part of a partnership that includes Side Effects Public Media, NPR and Kaiser Health News. A version of this story appears in The Workaround podcast.

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

Podcast: KHN’s ‘What The Health?’ Health Policy Goes To Court

Kaiser Health News:HealthReform - September 06, 2018
Julie Rovner

Kaiser Health News

@jrovner

Read Julie's Stories Mary Agnes Carey

Kaiser Health News

@MaryAgnesCarey

Read Mary Agnes' Stories Alice Ollstein

Politico

@AliceOllstein

Read Alice's Stories Margot Sanger-Katz

The New York Times

@sangerkatz

Read Margot's Stories

A federal judge in Texas seemed sympathetic to the argument by GOP state officials that the Affordable Care Act soon will no longer be constitutional, since Congress eliminated the penalty for not having insurance. The case was filed by 18 state attorneys general and two governors.

Sixteen Democratic attorneys general are defending the health law because the plaintiff in the case — the Trump administration — agrees in part with the Republican officials. The administration argues that while the elimination of the tax penalty might not render the entire law moot, it should result in striking down the part of the law that protects people with preexisting conditions.

The case could eventually wind up at the Supreme Court, a fact not lost on Senate Democrats questioning nominee Brett Kavanaugh at his confirmation hearings this week.  Kavanaugh was also grilled on how he might vote on such an ACA case and on his stance on abortion — but he revealed little. If he wins confirmation, he may have a number of abortion-related cases to consider before long.

Among the takeaways from this week’s podcast:

  • The case being argued in federal court in Texas is putting pressure on GOP candidates in the midterm elections because Democrats are arguing that Republicans’ arguments will destroy the ACA’s protections for people with preexisting conditions.
  • Ten Republican senators say a bill they are pushing will help people with preexisting health problems if the federal court in Texas strikes down the ACA. But while the bill requires insurers to sell coverage to these people, it does not require the companies to cover treatment for those medical conditions.
  • A bill sent to California Gov. Jerry Brown would require state colleges to stock drugs for medical abortions at their health centers to make them more accessible to students. The effort points up how even after these drugs became available, their use has been widely curtailed by abortion opponents.
  • The Trump administration finally made grant awards to family planning groups that provide services under the federal family planning program. But the grants were for only seven months rather than the usual three years. Some reproductive health advocates argue that short time frame was designed to give the administration time to finalize regulations aimed at evicting Planned Parenthood from the program.

Rovner also interviews Chad Terhune, who wrote the latest “Bill of the Month” feature for Kaiser Health News and NPR. It’s about a Texas high school teacher with very good insurance who still got a six-figure hospital bill after treatment for a heart attack. You can read the story here.

Send Us Your Medical Bill

Do you have an exorbitant or baffling medical bill? Join the KHN and NPR’s Bill-of-the-Month Club and tell us about your experience. We’ll feature a new one each month.

Submit Your Bill

If you have a medical bill you would like NPR and KHN to investigate, you can submit it here.

Plus, for “extra credit,” the panelists recommend their favorite health stories of the week they think you should read, too:

Julie Rovner: The New York Times’ “The Last Company You Would Expect Is Reinventing Health Benefits,” by Reed Abelson

Margot Sanger-Katz: MedPage Today’s “’Death Certificate Project’ Terrifies California Doctors,” by Cheryl Clark

And: The New York Times’ “How a Supreme Court Shaped by Trump Could Restrict Access to Abortion,” by Adam Liptak

Alice Ollstein: Health Affairs’ “Medicaid Recipients’ Early Experience With the Arkansas Medicaid Work Requirement,” by Jessica Greene

Mary Agnes Carey: Kaiser Health News’ “Giuliani’s Consulting Firm Helped Halt Purdue Opioid Investigation In Florida,” by Fred Schulte

To hear all our podcasts, click here.

And subscribe to What the Health? on iTunesStitcher or Google Play.

Listen: The GOP Case Against ACA’s Preexisting Condition Protections Begins

Kaiser Health News:HealthReform - September 06, 2018

A federal judge in Fort Worth, Texas, heard oral arguments in the latest challenge to the Affordable Care Act on Wednesday. The case pits a group of 18 Republican state attorneys general and two Republican governors against a coalition of Democratic state attorneys general led by California’s Xavier Becerra.

Ashley Lopez of member station KUT in Austin reports on the first day in court, and KHN’s chief Washington correspondent Julie Rovner discusses what it all means on NPR’s “All Things Considered.”

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