Study: ‘Ubiquitous’ Nature Of Painkillers Lands Kids — Even Toddlers — In The ER

As the nation continues to confront an epidemic of opioid and prescription painkiller addiction and overdoses, its victims seem to flood emergency rooms. But a study out Monday highlights a surprising group of patients suffering from opioid poisoning at rates that have also marked a dramatic increase: adolescents, children and even toddlers.

Because of what the authors call “the now widespread availability of prescription opioids in the United States” — with retail sales of these medications quadrupling from 1999 to 2010 — they sought to examine for the first time the number of pediatric hospitalizations related to these drugs.

The findings, they say, indicate a need for comprehensive strategies that not only continue to tamp down on opioid prescriptions, but also step up efforts to raise awareness about the packaging and safe storage of these painkillers.

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“It’s exposure. Opioids are ubiquitous now,” said Julie Gaither, a postdoctoral fellow at Yale School of Public Health and the study’s lead author. “Enough opioids are prescribed every year to put a bottle of painkillers in every household. They’re everywhere, and kids are getting into them.”

Published in JAMA Pediatrics, the study analyzed hospitalization data for children between 1997 and 2012,  examining more than 13,000 hospital-discharge records for opioid poisonings and using Census data to extrapolate how common these pediatric opioid overdoses were. They used discharge records collected every three years between 1997 and 2012 by the Agency for Healthcare Research and Quality.

One possible limitation: The data stops in 2012 and, therefore, rates may not reflect a dipping or plateauing because of increased awareness of the opioid epidemic. But the findings track with adult rates of abuse and addiction, which have dropped since 2012 but remain troublingly high, experts say.

Overall, researchers found the number of children hospitalized because of opioid poisoning almost doubled during the 16-year period — from about 1.40 per 100,000 kids to 3.71 per 100,000. Much of that is likely an effect of kids getting into their parents’ medicine chests.

Specifically, the study found the rate of toddlers hospitalized more than doubled, going from 0.86 per 100,00 to 2.62 per 100,000. Many experts speculate these very young patients take the drugs because they think they are candy or a treat.

Teens are also at risk of overdosing on their parents’ meds. Of all children, this age group is most likely to get hospitalized for opioid poisoning, and are more likely to do so deliberately — likely, the researchers wrote, because teenagers are at a particularly high risk of depression. In 2012, 10.17 per 100,000 teenagers were hospitalized for opioid poisoning.

Importantly, the research underscores the need for doctors to talk to patients about ways to keep the drugs safely, especially if children are in the household, Gaither said.

That’s a good idea in theory, said Jonathan Chen, an instructor at Stanford Medical School who has researched the opioid issue. But doctors already face a lengthy list of sensitive subjects they should discuss with patients. And they aren’t always conditioned to consider how a patient’s health patterns may interact with the rest of the family.

“Conceptually, yes, of course that should be part of the conversation,” Chen said. “But there’s a lot of things we should discuss.  …  When I talk to a patient, I conceptualize them, and I don’t conceptualize who else is in their household as much as I should.” Chen was not involved with the study.

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Teenagers are the most likely to be hospitalized for opioid poisoning.

Pediatricians could also play a role, asking parents at well-child and well-baby visits about whether there’s a risk of children being exposed to opioids. But that sort of screening hasn’t traditionally been drilled into doctors the same way as discussing household risks, such as safe storage of cleaning supplies, whether the family has a swimming pool and even whether there are guns in the home.

Doctors also may not be conditioned to considering toddlers as particularly at risk of opioid poisoning.

“This is largely seen as an adolescent problem or an adult problem,” said Sharon Levy, who directs the adolescent substance abuse program at Boston Children’s Hospital and is an associate professor of pediatrics at Harvard Medical School. “But this paper really highlights that this really knows no age boundaries.” Levy was also not involved with the study.

It’s also unclear, Levy said, what the long-term health effects are for children who ingest opioids that weren’t prescribed to them. Younger people in general are more at risk of addiction. And toddlers who take these drugs at adult doses face the danger of serious respiratory complications.

“Opioids cause respiratory suppression,” she said. “If you are a 30-pound person and getting into the medication that was supposed to be for a 150-pound person, it’s going to be a whopping dose for you.”

The findings also suggest doctors should also be more thoughtful in prescribing to children, and especially teenagers. About 1 in 10 high school students reports having taken opioids for a non-medical reason — and close to 40 percent of them say they got those drugs through their own prior prescription. Meanwhile, the American Academy of Pediatrics notes, the rate of young patients being prescribed opioids almost doubled between the 1990s and 2000s.

The Centers for Disease Control and Prevention has been pushing doctors to prescribe pills in smaller amounts, so that people don’t end up finding and taking leftovers. That could help. Large prescriptions — coupled with the fact that many people don’t know how to dispose of drugs when they finish them — can make it easier for children and teens to get ahold of them, Gaither said.

That’s an important factor to consider, Chen said.  “Leftover pills aren’t used, but do they get returned to the pharmacy, or thrown in the trash? Nope. They’re stored in the medicine cabinet.”

Smaller prescriptions will likely help, but they won’t solve everything, Chen noted. After all, there are situations where a larger opioid dosage makes sense. For instance, someone suffering long-term cancer probably needs a larger amount of heavy duty painkillers, even if he or she has children in the house.

But children must be a part of the conversation, Gaither said.

“We’ve got to pay attention to children and the toll the opioid crisis is taking on them,” she said. “Kids make up about a fourth of the U.S. population, and they’re suffering from this crisis, too.”

Categories: Public Health, Syndicate

Tags: Children’s Health, Emergency Medicine, Pharmaceuticals

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Insurers, Hospitals Clash Over Help Paying Obamacare Premiums

MADISON, Wis. — Having health insurance is vital for 21-year-old Mercedes Nimmer, who takes several expensive prescription drugs to manage multiple sclerosis. So Nimmer was thrilled to get health insurance last year through the Affordable Care Act’s marketplace and qualify for a federal subsidy to substantially lower her cost.

Yet, the government assistance still left her with a $33 monthly premium, a hefty amount for Nimmer, who makes $11,000 a year as a part-time supply clerk.

Nimmer, though, doesn’t have to worry about even that expense thanks to a United Way of Dane County program that has provided premium assistance to about 2,000 low-income people since 2014. The program, called HealthConnect, is funded by a 2013 gift of $2 million from UW Health, a large academic hospital system connected to the University of Wisconsin that also runs its own marketplace health plan.

“Oh my gosh, this is a big deal for me to get this help,” Nimmer said, noting the insurance is vital to cover her medications. The money she saves from the assistance program goes to help pay for gas to get to work, she said.

HealthConnect is one of several community-based programs across the United States helping thousands of lower-income Americans with their Obamacare marketplace premiums. Similar efforts operate in Texas, Oregon, Washington, North Carolina and South Carolina.

This KHN story also ran in USA Today. It can be republished for free (details).

But premium assistance programs have come under fire from insurers. They argue that it is not fair for hospitals, other health providers and disease advocacy groups financed by providers to try to steer people who could be covered by Medicare or Medicaid into marketplace plans with higher reimbursement rates.

The federal government has banned hospitals from directly subsidizing patients’ health insurance premiums. But America’s Health Insurance Plans, the industry’s lobbying group, wants the Obama administration to prohibit all premium assistance programs that are funded directly or indirectly by hospitals and other providers with a financial interest in the patient’s care.

“In many cases these practices are harming patients and undermining the individual market by skewing the risk pool and driving up overall health care costs and premiums,” AHIP said in Sept. 22 letter to Andy Slavitt, the acting administrator of the Centers for Medicare & Medicaid Services. The letter notes specific concerns about plans assisting patients requiring kidney dialysis. It says one insurer saw its spending on those patients rise from $1.7 million in 2013 to $36.8 million in 2015 when the number of patients with serious kidney disease rose from 28 to 186.

AHIP officials also said patients could face consequences if the third-party groups stop paying premiums or the government determines patients are receiving a federal subsidy for which they are not eligible.

America’s Health Insurance Plans wants the Obama administration to prohibit all premium assistance programs that are funded directly or indirectly by hospitals and other providers.

America’s Health Insurance Plans wants the Obama administration to prohibit all premium assistance programs that are funded directly or indirectly by hospitals and other providers.

In response, CMS says it is considering new rules for third-party payment programs.

Nonetheless, insurers are taking action. Aetna, which announced this summer that it was scaling back its marketplace offerings, said that third-party groups steering patients to the individual market had contributed to an unhealthy mix of customers in its marketplace plans.

Blue Shield of California in July filed suit in a state court against CenCal Health, which manages the Medicaid program in Santa Barbara and San Louis Obispo counties. Blue Shield alleges that CenCal was avoiding millions of dollars in medical care claims by enrolling around 40 of its very ill members in Blue Shield’s individual health plans and paying the premiums on their behalf. CenCal denied the allegations in lawsuit, saying it paid the patients’ monthly Blue Shield insurance premiums so they could afford private insurance. It has since discontinued the practice.

UnitedHealthcare filed a lawsuit in federal court in July against kidney dialysis provider American Renal Associates, accusing it of encouraging patients in Florida and Ohio who were eligible for Medicaid or Medicare to move to the insurer’s commercial plans to extract up to 20 times more than the $300 or so that the federal programs pay in reimbursements. American Renal Associates has said the suit is without merit.

The suit alleges that the patients’ premiums were paid by the American Kidney Fund, an advocacy group for patients.

AHIP officials note that the fund is supported by dialysis providers who stand to benefit financially from patients gaining marketplace coverage over payments from Medicaid or Medicare.

The nonprofit American Kidney Fund has helped more than 6,400 people with their marketplace premiums. The fund’s officials said it’s not trying to steer people away from government coverage but trying to help those who otherwise couldn’t afford coverage.

“It is critically important to emphasize that people with disabilities in general — and with end-stage renal disease in particular — should not be broadly excluded as a class from the insurance marketplace if they are unable to afford their health insurance premiums,” LaVarne Burton, the fund’s CEO, said in a statement.

Some patient advocates, like those at HealthConnect in Wisconsin, say third-party payers have an important role in helping low-income customers afford their coverage. UW Health said in a statement that HealthConnect helps all providers, including UW Health, by reducing the number of uninsured patients and potentially helping people seek care earlier in their illness.

The program pays an average of $109 monthly per person in premium assistance. For every dollar spent, HealthConnect generates $2.26 in federal subsidies, said Krystal Webb, a spokeswoman for United Way of Dane County.

United Way said it structured HealthConnect to avoid a conflict of interest. Eligible people first buy their policy, which can be any of several silver-level plans on the federal marketplace. After that, they can apply for a HealthConnect subsidy. The program is administered by United Way, and UW Health plays no role in patients’ choice of health plan, although its marketplace plan, Unity Health, refers people who may be eligible there.

Despite AHIP’s concerns, some health insurers in Dane County say HealthConnect is filling a need, according to interviews with several plans. “We support United Way’s HealthConnect efforts as a way to provide affordable insurance options to the residents of Dane County,” said a spokesman for Dean Health Plan, one of the larger marketplace plans in the county.

In Texarkana, Texas, Christus St. Michaels Health System donated $200,000 last year to an assistance program serving 138 people with marketplace coverage. The program is run by a local government agency called the Ark-Tex Council of Governments, and Christus has no control over who enrolls or what plan they choose.

“Our mission is to help the poor and this is certainly one of the ways to do that, and it gives people the opportunity to have health coverage when they normally wouldn’t,” said Mike Hargrave, the hospital’s manager of employee assistance and community outreach services. People with incomes between 100 and 150 percent of the federal poverty level (about $11,880 to $17,820 for an individual) are eligible.

Hargrave doesn’t deny the hospital could benefit when more people gain insurance, but he notes other hospitals in the region benefit, too.

The insurance industry is also troubled by premium assistance programs funded by anonymous donors since they could be hospitals looking to protect their identity, said AHIP spokeswoman Clare Krusing.

For example, PremiumHealth.org, run by United Way of the Greater Triangle in North Carolina helps more than 850 people with incomes between 100 percent to 175 percent of the federal poverty level in Durham, Orange and Wake Counties.

An anonymous donor provided $1.2 million in funding for the program, said Melanie David-Jones, a senior vice president for United Way. She would not say why the donor wished to remain anonymous.

Noel Pitsenbarger, 48, of Durham, said the program made it possible for him to have health insurance this year by covering the $200-a-month premium for his Blue Cross Blue Shield of North Carolina policy. With insurance, he said, he got a colonoscopy, physical exam and help paying for several medications. And it saved him from having to pay a $1,000 bill after he cut his finger and had to go to the emergency room.

“It’s been extremely beneficial,” he said.

Categories: Health Industry, Insurance, Syndicate, The Health Law

Tags: Community Health, Premiums

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NHS funds need urgent boost, say MPs

NHS funds need urgent boost, say MPs

  • 31 October 2016
  • From the section Health
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A group of MPs says the government is incorrect to keep claiming it is allocating an extra £10bn to the NHS in England over the next five years.

The Health Committee has written to the chancellor to say using the figure gives the “false impression that the NHS is awash with cash”.

The group said the figure was closer to £4.5bn and called for more NHS funding in November’s Autumn Statement.

But the government insisted the £10bn figure was accurate.

NHS funding: Is £10bn rise really a cut?

The Health Select Committee, chaired by Dr Sarah Wollaston, has been hearing evidence over recent months on the state of NHS finances.

Its letter says what it was told by senior NHS figures “clearly demonstrated the financial pressure facing the NHS”.

But it warned that “the extent of this pressure is not sufficiently recognised” by government.

‘Enormous strain’

Ministers regularly state that there will be £10bn extra in funding for the NHS by 2020-21.

The £10bn figure is calculated in real terms once inflation has been taken into account and includes £2bn which was announced in the last Parliament.

The health committee says that while the figure is not incorrect, it is misleading because it can only be reached by adding an extra year to the spending review period, changing the date from which the real terms increased is calculated and disregarding the total health budget.

The committee says a substantial part of the extra funding for the NHS comes from cuts to other areas, such as public health.

Dr Wollaston, Tory MP for Totnes, told BBC Radio Four’s Today programme that the head of the NHS had been “very clear” about what the organisation needed, but the government was not delivering.

Media captionSarah Wollaston told Radio 4’s Today the real NHS spending figure was £4.5bn, not £10bn

The GP said: “We are going to be seeing a far more constrained situation and certainly not what Simon Stevens [head of the NHS] asked for.”

Now she is calling on senior cabinet members to meet with her and “increase the priority” of funding the health service, especially in social care.

“The point is that I think the government needs to actually look at the demand pressures in the NHS and social care, which are very unlike other departments,” added Dr Wollaston.

“We really do need some clarity and, if there isn’t anymore money, then to have an honest discussion about what that means for patient care. I think that is what people would like to see.”

‘Pressure is building’

The committee has called on Chancellor Philip Hammond to “seriously consider” finding more money for the NHS – and social care – in next month’s Autumn Statement.

Richard Murray, from think tank the King’s Fund, said: “The most urgent priority for the Autumn Statement is to increase funding for social care.

“Years of budget cuts have had a significant impact on older people, their families and carers and are exacerbating pressures on the NHS, with record numbers of patients who are fit to be discharged but delayed in hospital.”

Anita Charlesworth, director of research and economics at the Health Foundation, said: “The Autumn Statement is an opportunity for the government to take immediate action to support social care.

“But for the health service pressure is building, and building fast.

“With funding growth set to slow sharply from 2018, it’s hard to see how the range and quality of services for patients will be sustained.”

The British Medical Association said: “The NHS is already the most efficient health care system in the world. The notion that the funding crisis can be solved with further efficiency savings is a myth, and these are not savings, they are year-on-year cuts that have driven almost every acute trust in England into deficit, led to a crisis in general practice and a community and social care system on the brink of collapse.”

A government spokesman said there would be a “£10bn real-terms increase in its annual funding by 2020-21, for hospitals, GPs, and mental health services.

He said: “It is wrong to suggest otherwise.

“We have also allowed local government to increase social care spending in the years to 2020, with access to up to £3.5bn of new support by then.”

Other parts of the UK have recently reported health funding pressures. Audit Scotland says some Scottish NHS boards may not be able to balance their books this year.

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CMS Announces Updates to Dialysis Facility Compare: Patient Experience Ratings Now Available

October 28
by CMS

By: Kate Goodrich, M.D., Director, Center for Clinical Standards and Quality

Today, the Centers for Medicare & Medicaid Services (CMS) announced changes to the Dialysis Facility Compare (DFC) website on Medicare.gov, which provides information about thousands of Medicare-certified dialysis facilities across the country, including how well those centers deliver care to patients.

These changes are in direct response to the important feedback CMS has received from dialysis patients and their caregivers about what is most important to them in selecting their dialysis facility. CMS remains committed to seeking and incorporating input from all stakeholders, but especially patients, on an ongoing basis so that we can continually improve our Compare sites and make health care quality information more transparent and understandable for patients and their caregivers.

Since the initial release of the Dialysis Facility Compare website, patients have emphasized in their feedback to CMS that understanding how others like them view a dialysis center— in particular the cleanliness of the facility and how well the staff cares for them— is valuable information when choosing a facility. As a result, visitors to the updated Dialysis Facility Compare website will now be able to see how patients rate their experiences with dialysis facilities.

CMS collects patient experience data though the In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH-CAHPS) Survey, which measures patients’ perspectives on the care they received at dialysis facilities. A total of six ratings on patients’ experiences with care will be reported, including three that cover specific aspects of patient experience and three overall patient ratings of the kidney doctors, the facility staff and the dialysis facilities. For each dialysis center on Dialysis Facility Compare, the site will include this patient experience information, the quality star rating, and detailed clinical quality information.

CMS is also adding two quality measures to Dialysis Facility Compare:

  • The standardized infection ratio (SIR) is a ratio of the number of bloodstream infections that are observed at a facility versus the number of bloodstream infections that are predicted for that facility, based on national baseline data.
  • The pediatric peritoneal dialysis Kt/V measure equals the percent of eligible pediatric peritoneal dialysis patients at the facility who had enough waste removed from their blood during dialysis.

Other major changes to the site include modifications to the methodology for calculating dialysis facility star ratings based on recommendations from a 2015 Technical Expert Panel. The updated methodology for calculating star ratings:

  • Establishes a baseline to show improvement by taking into account year-to-year changes in facility performance on the quality measures compared to performance standards set in a baseline year. Star ratings will reflect if a facility improves (or declines) in performance over time.
  • Limits the impact of a few very low scores by applying a statistical method called truncated z-scores to percentage measures. This ensures that star ratings are not determined by extreme outlier performance on a single measure.
  • Ensures accuracy of ratings by keeping the continuity of the measures.

A final change to the DFC website relates to ratio measures:

  • The Standardized Mortality Ratio, Standardized hospitalization Ratio, Standardized Transfusion Ratio, and Standardized Readmission Ratio will now be reflected as rates to display them more clearly.

These changes reflect CMS’ ongoing commitment to making sure that Dialysis Facility Compare meets the needs of individuals with kidney disease and their caregivers. This Compare website and today’s updates are part of the agency’s larger effort to make health care quality information more transparent and understandable for consumers.  As part of that effort, CMS also has other Compare websites to help in selecting providers across the continuum of care, including Home Health Compare, Hospital Compare, Nursing Home Compare, and Physician Compare.

For more information, see the fact sheet: https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2016-Fact-sheets-items/2016-10-28.html 

###

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Brexit and US election 'among anxious young's concerns'

Brexit and US election ‘among anxious young’s concerns’

  • 31 October 2016
  • From the section UK

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The number of young people in the UK seeking help for anxiety has increased sharply, a children’s charity has said.

The NSPCC’s Childline counselled 11,706 young people for anxiety in 2015-16 – a 35% rise from the 8,642 in 2014-15.

Children as young as eight have contacted the charity, with girls seven times more likely to make contact for help about anxiety than boys, it said.

Issues raised ranged from personal and family problems to concerns about Brexit, the US election and Syrian war.

The NSPCC said the problem appeared to be getting worse, with provisional figures showing that from April to September Childline dealt with almost 6,500 cases where anxiety was cited as the main issue.

It said some youngsters talk to counsellors about problems in their day-to-day life, while others speak about disturbing events they have seen in the media and on social media.

The charity believes girls are particularly struggling with “the demands of the modern world”.

“Their exposure to online media and the way they are using social media [is] placing increasing pressure on them to attain a ‘perfect’ life, which is completely unrealistic and ultimately making them anxious about their place in the world,” a spokesman added.

Calleigh’s story

This is a story supplied to the BBC by Childline. The girl’s name has been changed to protect her identity.

Calleigh started dealing with mental health issues at the age of 11, including anxiety and depression.

“When I was at my lowest, I just wouldn’t want to get out of bed,” said the 17-year-old from London. “I’d stay there and hope I wouldn’t wake up.”

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Opening up about mental health issues has helped young people deal with anxiety and depression

“There is a huge amount of pressure for teenagers growing up. I went to an all-girls’ school and I think about 90% of my friends have all experienced depression and anxiety.”

She didn’t feel able to talk to her parents about the problems she was facing, but she turned to Childline online and was able to open up.

“I just typed away about how I was feeling and let it all out.”

Three years of talking to the charity helped her build the courage to speak to her parents about what she was going through.

“I still have my ups and downs, but I’m doing much better taking one day at a time.

“People say that mental health has a stigma, but we have the power to break that stigma by talking to others about how we feel.”

  • Childline is on 0800 1111 and at www.childline.org.uk.

‘Panic attacks’

Dame Esther Rantzen, who launched Childline, which is marking its 30th anniversary, said children and young people are sometimes frightened and distressed by events in the wider world.

She said: “Seeing pictures of crying and bewildered toddlers being pulled from bomb-damaged homes upsets all of us.

“Often we fail to notice the impact these stories are having on young people.

“The good news is that so many children are able to express their anxiety to Childline, knowing that we will take them seriously, so that we are able to reassure them.”

Peter Wanless, chief executive of the NSPCC, which formally joined forces with Childline in 2006, said: “The world can be a worrying place but we need to ensure our children are reassured rather than left overwhelmed and frightened.

“It’s only natural for children and young people to feel worried sometimes, but when they are plagued by constant fears that are resulting in panic attacks and making them not want to leave the house then they need support.”


Tips for helping children with anxiety

  • Listen carefully to a child’s fears and worries
  • Offer reassurance and comfort and avoid complicated and worrying explanations that could leave them more frightened and confused
  • Help them find advice and support to understand distressing events and feelings

Source: NSPCC


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D.C. Week: Mental Health Parity Gets Push

WASHINGTON — The White House gave mental health parity laws some teeth and earmarked $9.3 million for teaching state insurance regulators about compliance.

White House Puts Mental Health Parity in the Spotlight

A report issued Thursday by the Obama administration aimed at increasing enforcement of mental health parity laws is a welcome advance, according to several interest groups.

“APA welcomes this much-needed report to strengthen implementation and enforcement of existing mental health parity laws,” Maria Oquendo, MD, PhD, president of the American Psychiatric Association (APA), in Arlington, Va., said in a statement. “Full implementation and stronger enforcement will help ensure that psychiatric conditions are treated the same as other illnesses and individuals can access the treatment they need.”

The report was issued by the White House’s Mental Health and Substance Use Disorder Parity Task Force, which was established in late March by President Obama. The task force’s goal “is to essentially develop a set of tools, guidelines, mechanisms so that it’s actually enforced, that the concept is not just a phrase — an empty phrase,” the president said when he established it.

CMS Urges Health Plans to Ease Physician Reporting Burden

Commercial insurers can borrow from the lessons government payers gleaned from listening to physicians’ complaints, a leading public health administrator said here at AHIP’s National Conference on Medicare, Medicaid and Duals.

“All the ways that health plans, in many respects, use to differentiate themselves, that annoyed the crap out of doctors — just stop,” said Andy Slavitt, acting administrator for the Centers for Medicare and Medicaid Services (CMS).

Offering a brand-new portal that delivers information in a unique way only marginally better than the another version is not the way to impress providers or improve care, he continued.

“Even if you think [the portal] is 5% better, believe me, the doctor would rather have it 5% worse and have it [all] one way, because they’re going to use it,” he said.

FDA Warns of Testosterone Abuse

The FDA is adding a warning about the potential for abuse to the labels of testosterone products, the agency announced.

In a statement, the FDA said that abuse of testosterone — “usually at doses higher than those typically prescribed and usually in conjunction with other anabolic androgenic steroids” — is tied to “serious safety risks affecting the heart, brain, liver, mental health, and endocrine system.”

Serious adverse events that have been reported to FDA have included heart attack, heart failure, stroke, depression, hostility, aggression, liver toxicity, and male infertility, the agency said.

People who have abused testosterone at high doses have also reported withdrawal symptoms, such as depression, fatigue, irritability, loss of appetite, decreased libido, and insomnia, FDA said.

More Medicare APM Options for Docs

Physicians who are wondering if they can fit into any of the Advanced Alternative Payment Models (APMs) under the Medicare Access and CHIP Reauthorization Act (MACRA) will now have a few more options to consider.

The Centers for Medicare & Medicaid Services (CMS) “expects to re-open applications for new practices and payers in the Comprehensive Primary Care Plus (CPC+) model and new participants in the Next Generation Accountable Care Organization (ACO) model for the 2018 performance year,” the agency said Tuesday in a press release. “In addition, CMS is announcing that the Innovation Center’s Oncology Care Model with two-sided risk will now be available in 2017, which will qualify the model as an Advanced APM beginning in the 2017 performance year.”

Under the APM program, clinicians meeting specific requirements would earn incentive payments of approximately 5% for 5 years in a lump-sum payment every year from 2019 to 2024.

Anti-PD-1 Agent Gets First-Line Nod for NSCLC

The role of anti-PD-1 therapy in non-small cell lung cancer (NSCLC) has now reached first-line status, as the FDA has now approved pembrolizumab (Keytruda) as an option for initial therapy in selected patients, according to manufacturer Merck.

Announced late Monday, the approval granted a first-line indication for patients who have tumors with a tumor progression score (TPS) ≥50%, as determined by an FDA-approved test for PD-L1 expression, and no actionable EGFR or ALK mutations.

The implications of the new indication go far beyond the usual expanded-indication status granted by the FDA, said Roy S. Herbst, MD, PhD, of Yale Cancer Center.

“This is huge, to think that we have replaced chemotherapy in first line in lung cancer with an immunotherapy for a large number of patients,” Herbst told MedPage Today. “The assay for PD-L1 expression identified patients who were more likely to respond to PD-1 inhibition, and I think it represents a new standard of care.”

The expanded indication was based on data from the KEYNOTE-024, reported at the European Society for Medical Oncology conference.

Va. Gov Continues Fight for Medicaid Expansion

Gov. Terry McAuliffe (D-Va.) argued that Medicaid expansion would not only save lives but also create more jobs in his state. McAuliffe will continue to fight for what he sees as a needed reform in his fourth and final year in office.

“I have been a spectacular failure at being able to close the coverage gap in the Commonwealth of Virginia,” McAuliffe told his audience at AHIP’s National Conference on Medicaid, Medicare and Duals, here.

“It has not been for want of trying,” he added.

Sixty-six of the 100 members in Virginia’s House of Delegates are Republican, and that majority has prevented him from passing even “creative” waivers that would eliminate state liability.

Next Week

Congress continues its recess.

On Tuesday and Wednesday, the FDA’ s National Center for Toxicological Research Science Advisory Board will discuss the past year’s accomplishments, and FDA’s individual centers, including the Center for Drug Evaluation and Research, will report on their research strategic needs and the potential for collaboration.

On Wednesday through Friday, U.S. News & World Report will host the annual Healthcare of Tomorrow conference.

Also on Wednesday, the FDA’s Pharmacy Compounding Advisory Committee will discuss whether to include five bulk drug substances on the section 503A Bulks List.

On Thursday and Friday, the Medicare Payment Advisory Commission (MedPAC) will discuss Medicare payments and policies.

On Friday, the FDA’s Antimicrobial Drugs Advisory Committee will discuss an application to approve solithromycin for treating community-acquired bacterial pneumonia.

And the National Academy of the Sciences’ Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse will convene for its second workshop.

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Medicare Open Enrollment: the value of convenience

Have you ever bought milk from the convenience store just around the corner even though it’s a bit more expensive than buying it at the grocery store? Most of us have made decisions to do or not do something based on convenience.

The same is true when it comes to choosing a health plan: convenience matters. So in addition to cost, coverage, and benefits, here are some other things you may want to consider as you compare Medicare options this year:

Doctor and hospital choice

You want to be comfortable with the people you’re working with, especially when it comes to something as private as your health. Do the doctors you know accept your coverage? Where are the doctors’ offices? What are their hours? Do they often keep you waiting?

Pharmacy access

Is the pharmacy you use included in your drug plan’s network? Do they use e-prescribing? Can you get refills by mail? Remember that plan networks can change from year to year. If it’s important to you to stay with the same pharmacy, it’s worth checking to make sure they’ll still be in your plan’s network.

Travel

Maybe you travel a lot, or spend part of the year in a different state. If you do, see if your coverage will travel with you.

Quality

Ask yourself whether you’re truly satisfied with your medical care. Not all health care is created equal, and the doctors, hospitals and facilities you choose can impact your health. Look for plans with a 5‑star performance rating — the right expertise and care may help speed your recovery and improve your outcomes.

Your time is valuable — and so is your health. Only you know what mix of coverage and convenience is most important to you and your family.

We’re working hard to make sure you have choices in the way you get the Medicare benefits you’ve earned – and we want you to be comfortable. Use the Medicare Plan Finder to look at all of the health and drug plan options in your area.

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Smog chokes Indian capital as pollution hits hazardous levels

By Tommy Wilkes
| NEW DELHI

Residents of New Delhi woke up to a blanket of smog on Monday as air quality deteriorated sharply overnight in India’s capital, triggering warnings that even healthy people were at risk of respiratory problems.

New Delhi ranks among the world’s most polluted cities, with air quality usually worsening at this time of year, when smoke from firecrackers celebrating the Hindu festival of lights and crops burnt in nearby states envelops the city of 16 million.

Drivers crawled through a thick fog as experts warned people to avoid outdoor exertion.

“Last night, levels hit the severe category, which is the worst. You could see and sense how the visibility had come down and there was a choking haze all around,” said Anumita Roychowdhury at the Centre for Science and Environment.

Levels of PM 2.5, tiny particulate matter that reaches deep into the lungs, more than doubled within a few hours to 750 micrograms per cubic meter in the city’s worst affected parts, India’s Central Pollution Control Board said.

That is 30 times a mean guideline of 25 micrograms per cubic meter on average over a 24-hour period set by the World Health Organization (WHO), which says outdoor air pollution killed 3.7 million people worldwide in 2012.

The U.S. embassy in New Delhi said its air pollution index had late on Sunday breached the “hazardous” level upper limit of 500, at which it stops measuring levels of PM2.5. The index had rocketed to 1,126 by 2 a.m. (2030 GMT)

Roychowdhury said data was not available to assess if Delhi’s air was worse on average than in prior years. Air quality is usually poorest in Delhi’s winter months of December and January.

Authorities have responded with measures such as a ban on old trucks from entering the city and briefly trialing a scheme that limited private vehicle usage to alternate days, but experts say they have done little to reduce pollution.

India is home to four of the world’s 10 cities with the worst air pollution, the WHO said in May. New Delhi ranked 11th.

Almost one in seven children live in areas with high levels of outdoor air pollution, mostly in South Asia, U.N. children’s agency UNICEF said.

China shuts schools and offices if air quality deteriorates to extreme levels for three consecutive days, but India has not yet taken similar steps.

“Where is the plan for short- and medium-term action, and for emergency action?” Roychowdhury said. “We need one very urgently.”

(Reporting by Tommy Wilkes; Editing by Sanjeev Miglani and Clarence Fernandez)


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Insurers to CMS, Congress: For Lower Rx Costs, Hand Us the Reins

WASHINGTON — Congress and the administration can help rein in rising drug costs through a few key regulatory and legal fixes, said insurers and pharmacists at AHIP’s National Conference on Medicare, Medicaid and Duals on Tuesday.

“I think plans need to be given a little bit more leeway to truly assess the value of drugs to make a decision: does this drug at the cost really provide any additional value?” said Sarah Marche, PharmD, vice president of pharmacy services at Highmark, a Blue Cross affiliate in Pennsylvania.

She noted that not every drug Medicare covers adds value.

“Glumetza [a branded version of metformin] provides no value above and beyond what’s available, and if you look at a lot of the commercial formularies, it’s blocked,” she said. “Nobody’s dying. Nobody has any huge issues with that, but we don’t have that same flexibility within the Medicare space. So, you’re covering a drug that really provides no additional value, just increasing the cost.”

These difference are true across specialty pharmacies and utilization management, she added. “We’re just not being able to manage as aggressively as we could, while ensuring appropriate access in the right patient.”

Another panelist, Mark Owen, MBA, president of government programs for the the Blue Cross-affiliated Health Care Service Corp., highlighted three changes he thinks would help to better manage Medicare Part D costs.

  • Giving biosimilars the same discount as their predicate drugs in the coverage gap
  • Creating two tiers for specialty drugs
  • Allowing the option to restrict access to specialty pharmacies

“Biosimilars create an option for specialty drugs, but the way they’re treated now actually creates a disincentive for us to even put them on the formulary or for the member to get the drug,” said Owen.

Under current law, manufacturers are required to provide a discount for brand-name drugs of roughly 50% in the Medicare coverage gap or “donut hole,” said Owen. While biosimilars might initially be priced at 15% less than their predicate drugs — that is, the original biologics from which biosimilars are copied — biosimilar manufacturers are not required to apply the same discount.

Not only are the copays higher for the biosimilar, but beneficiaries who take the biosimilar over the predicate drug also don’t receive any credit towards their maximum out-of-pocket costs, he explained. For the predicates, however, the total cost including copays and discounts counts towards the out-of-pocket threshold for brand drugs.

This is significant because it means beneficiaries who choose a biosimilar will be stuck in the coverage gap for twice as long — 2 months versus 1 month — as those who choose the brand drug.

“So they have no incentive to take the lower-priced drug … We’ve got to fix that because it creates a disincentive for competition,” he said. Extending the discount to the biosimilar would require legislative action, as the Centers for Medicare and Medicaid Services have said the change is out of its jurisdiction, Owen added.

With regard to tiers, Owen favors implementing “preferred” and “nonpreferred” categories in the specialty drug tier. In modeling the concept, Owen suggested the preferred tier might have a 20% copay and the nonpreferred tier could offer a 34% copay.

This regulatory change would allow insurers to gain price concessions or rebates. In addition, the resulting premium decrease would not affect only the beneficiaries taking the drug but every member in that plan design, Owen added. The premium savings, with the additional tier in the proposed model, would yield $1.40 to $9.00 in savings per member per month, for all members in that plan.

Lastly, Owen argued that Medicare Part D sponsors should be allowed to limit beneficiary access to specialty pharmacies. Under current regulations, payers may limit access to a subset of their pharmacy network only when the FDA restricts distribution to a subset of physicians or sites, or when the drug requires “special handling, provider coordination, or patient education.”

While Owen noted that critics of the idea have said such a change could pose access challenges, he argued that allowing plans to direct beneficiaries towards only certain pharmacies could lower costs and increase adherence.

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Exclusive: Abortion by prescription now rivals surgery for U.S. women

By Jilian Mincer
| NEW YORK

American women are ending pregnancies with medication almost as often as with surgery, marking a turning point for abortion in the United States, data reviewed by Reuters shows.

The watershed comes amid an overall decline in abortion, a choice that remains politically charged in the United States, sparking a fiery exchange in the final debate between presidential nominees Hillary Clinton and Donald Trump.

When the two medications used to induce abortion won U.S. approval 16 years ago, the method was expected to quickly overtake the surgical option, as it has in much of Europe. But U.S. abortion opponents persuaded lawmakers in many states to put restrictions on their use.

Although many limitations remain, innovative dispensing efforts in some states, restricted access to surgical abortions in others and greater awareness boosted medication abortions to 43 percent of pregnancy terminations at Planned Parenthood clinics, the nation’s single largest provider, in 2014, up from 35 percent in 2010, according to previously unreported figures from the nonprofit.

The national rate is likely even higher now because of new federal prescribing guidelines that took effect in March. In three states most impacted by that change – Ohio, Texas and North Dakota – demand for medication abortions tripled in the last several months to as much as 30 percent of all procedures in some clinics, according to data gathered by Reuters from clinics, state health departments and Planned Parenthood affiliates.

Among states with few or no restrictions, medication abortions comprise a greater share, up to 55 percent in Michigan and 64 percent in Iowa.

Denise Hill, an Ohio mother who works full time and is pursuing a college degree, is part of the shift.

Hill, 26, became extremely ill with her third pregnancy, sidelined by low blood pressure that made it challenging to care for her son and daughter. In July, eight weeks in, she said she made the difficult decision to have a medication abortion. She called the option that was not available in her state four months earlier “a blessing.”

The new prescribing guidelines were sought by privately-held Danco Laboratories, the sole maker of the pills for the U.S. market. Spokeswoman Abby Long said sales have since surged to the extent that medication abortion now is “a second option and fairly equal” to the surgical procedure.

“We have been growing steadily year over year, and definitely the growth is larger this year,” Long said.

Women who ask for the medication prefer it because they can end a pregnancy at home, with a partner, in a manner more like a miscarriage, said Tammi Kromenaker, director of the Red River Women’s Clinic in Fargo, North Dakota.

GAME CHANGER

Medication abortion involves two drugs, taken over a day or two. The first, mifepristone, blocks the pregnancy sustaining hormone progesterone. The second, misoprostol, induces uterine contractions. Studies have shown medical abortions are effective up to 95 percent of the time.

Approved in France in 1988, the abortion pill was supposed to be a game changer, a convenient and private way to end pregnancy. In Western Europe, medication abortion is more common, accounting for 91 percent of pregnancy terminations in Finland, the highest rate, followed by Scotland at 80 percent, according to the Guttmacher Institute, a nonprofit research organization that supports abortion rights.

In the United States, proponents had hoped the medication would allow women to avoid the clinics that had long been targets of protests and sometimes violence.

But Planned Parenthood and other clinics remain key venues for the medication option. Of the more than 2.75 million U.S. women who have used abortion pills since they were approved in 2000, at least 1 million got them at Planned Parenthood.

Many private physicians have avoided prescribing the pills, in part out of concern that it would expose their practices to the type of protests clinics experienced, say doctors, abortion providers and healthcare organizations.

At the same time, the overall U.S. abortion rate has dropped to a low of 16.9 terminations per 1,000 women aged 15-44 in 2011, down from 19.4 per 1,000 in 2008, according to federal data. The decline has been driven in part by wider use of birth control, including long lasting IUDs.

In March, the U.S. Food and Drug Administration changed its prescribing guidelines for medication abortion. The agency now allows the pills to be prescribed as far as 10 weeks into pregnancy, up from seven. It cut the number of required medical visits and allowed trained professionals other than physicians, including nurse practitioners, to dispense the pills. It also changed dosing guidelines.

The changes were supported by years of prescribing data and reflect practices already common in most states where doctors are free to prescribe as they deem best.

Ohio, Texas and North Dakota took the unusual step of requiring physicians to strictly adhere to the original guidelines. Many abortion providers were reluctant to prescribe the pills under the older guidelines, which no longer reflected current medical knowledge, said Vicki Saporta, President and CEO of the National Abortion Federation.

Randall K. O’Bannon, a director at the anti-abortion National Right to Life organization, criticized the new guidelines but said his organization had no plans to fight them.

“What they did was make it more profitable,” O’Bannon said. “It will increase the pool of potential customers.”

Planned Parenthood said both types of abortion typically cost from $300 to $1,000, including tests and examinations. The group charges a sliding fee based on a patient’s ability to pay, regardless of which type of abortion they choose.

VARIED ACCESS

Despite a landmark U.S. Supreme Court ruling that abortion is a woman’s right, access varies widely by state. Some states maintain restrictions on both surgical and medication abortions; others have worked to increase access.

In rural Iowa, where clinics are few and far between, Planned Parenthood is using video conferencing, known as telemedicine, to expand access.

The way it works is, a woman is examined in her community by a trained medical professional, who checks vital signs and blood pressure and performs an ultrasound. The information is sent to an off-site doctor, who talks with the woman via video conference and authorizes the medications.

Since the telemedicine program began in Iowa in 2008, medication abortions increased to 64 percent of all pregnancy terminations, the highest U.S. rate.

In New York, Hawaii, Washington and Oregon, a private research institute, Gynuity Health Projects, works with clinics to send abortion pills by mail to pre-screened women.

“Medication abortion is definitely the next frontier,” said Gloria Totten, president of the Public Leadership Institute, a nonprofit that advises advocates.

And in Maryland and Atlanta, the nonprofit organization Carafem opened centers in the last 18 months that offer birth control and medication, but not surgical, abortions. It promotes its services with ads that read: “Abortion. Yeah, we do that.”

(Reporting By Jilian Mincer; Editing by Michele Gershberg and Lisa Girion)


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