Are insurance policies saving patients money, or keeping them from the treatment they need?

first_img Dr. Kenneth B. Blankstein, oncologist Related: Karin Keyes was diagnosed with rheumatoid arthritis roughly eight years ago while enduring excruciating pain. Alice Proujansky for STAT As science makes once-unthinkable treatments available, patients are increasingly facing a harsh reality: Insurance companies are forcing them to try older, less expensive therapies for months before covering pricier ones.Insurers have long relied on a cautious approach to control costs and spare patients from expensive medications they might not need. But in more than a dozen interviews with doctors and patients, a picture has emerged of insurers growing more aggressive as they respond to financial pressures.The result is a reliance on what is known as “step therapy,” whereby patients are forced to try cheaper treatments before they graduate to more expensive ones, even when health care providers are confident the inexpensive treatments will not work.advertisement Tags drug therapyhealth insurancepatients HealthAre insurance policies saving patients money, or keeping them from the treatment they need? Take Karin Keyes, a 45-year-old psychotherapist on Long Island. Keyes was diagnosed with rheumatoid arthritis roughly eight years ago while enduring excruciating pain.Her doctor prescribed Orencia, one of an expensive new generation of so-called “biologic” anti-inflammatory drugs that can cost as much as $50,000 annually.Keyes’s insurer at the time said it would not cover Orencia unless she tried methotrexate, a far less expensive treatment. Methotrexate helped slightly, but Keyes was still in pain and had limited movement. Still, because she technically responded to the drug, she didn’t qualify for Orencia.When she changed to a new insurer, her doctor prescribed Orencia again, this time with success. “My pain went to zero,” Keyes said. “I started hiking, living a normal life.”It was not a permanent solution. When that insurer filed for bankruptcy protection earlier this year, Keyes’s new insurer said it would not cover Orencia unless she failed on methotrexate again.“They had all the documentation. They’d seen that I’d not done as well on methotrexate,” she said. “They still denied it.”Keyes, a 45-year-old psychotherapist, holds a dose of her anti-arthritis medication. Alice Proujansky for STATDoctors and patient advocacy groups said insurance companies often insist on step therapy regardless of past medication failures. For some patients, though, one trip through the process can bring significant risks and strain.Kathleen Arntsen, of Verona, N.Y., said her ophthalmologist prescribed Travatan Z eye drops in 2014 to treat glaucoma because he feared that other medications might trigger side effects and because her eye responded well to samples of the medication.Arnsten’s insurer said she would have to try two cheaper drugs first. Over the course of seven weeks, those medications led to “massive” swelling and pressure, she said.At the end of the span, the insurer approved Travatan Z, but her vision continued to deteriorate. She is blind in that eye, and is considering having the eye removed because of persistent pain.Arntsen, who has advocated for step-therapy regulations in New York, said she and her doctor cannot say for sure whether the delay caused her vision loss, but she believes it was a contributing factor.“I’m an educated advocate, and my doctor didn’t give up on this, yet I was forced to fail a treatment he predicted I’d fail on,” she said.Pearson, of ICER, said there’s no effective way of determining how well or poorly insurers are handling step-therapy disputes with doctors and patients. In a 2014 Health Affairs report he coauthored Rahul Nayak, Pearson set forth some ethical guidelines for fairly applying step therapy.Chief among them: clearly define failure; don’t cause long-term harm; rapidly review relevant new evidence in developing step-therapy guidelines; and give doctors quick and easy ways to appeal an insurer’s decision. Please enter a valid email address. Spurred by stories like these, state legislators, who regulate Medicaid plans and much of the nation’s private insurance, have begun pushing back. In recent months, at least five states, including California and Indiana, have passed legislation to rein in step therapy approaches, known by critics as “fail first” policies. More than a dozen other states now have such laws on the books.advertisement “The patient’s being told to use a drug we know isn’t going to work, but we have to use it anyway for someone with terminal illness? To me that’s just insane.” Related:center_img Newsletters Sign up for Pharmalot Your daily update on the drug industry. By Bob Tedeschi Aug. 22, 2016 Reprints In one example, a woman with lupus said her vision was severely affected after an insurer forced her to try multiple medications before paying for one that her doctor initially wanted to prescribe. In another, a patient with lung cancer took a break from a successful chemotherapy regimen, then was blocked by her insurer from resuming it until she had tried other drugs. Leave this field empty if you’re human: State laws restricting the practice of step therapy vary widely.According to the National Patient Advocate Foundation, a nonprofit group, Indiana’s law is the most aggressive. Among other things, it bars insurers from restarting the step-therapy sequence if they had already failed certain treatments with a previous insurer, and insurers must adjudicate appeals within three days.Advocates said that patients in other states will do well to review the step-therapy policies of prospective insurers before signing up. Larger insurers will often post lists of drugs that are subject to step-therapy restrictions, but sometimes even those restrictions can vary based on a particular employer’s health plan, for instance.“Step therapy can have a place in a reasonable plan design,” said Alan Balch, chief executive of the National Patient Advocate Foundation. But that plan should be transparent to patients and allow for appeals, he said. “There is no humane reason to deny a patient access to a therapy that has the best chance of curing them.” An ‘insurance warrior’ fights to get pricey therapies covered Privacy Policy Insurers argue that, beyond individual patient cases, step therapy has improved their ability to cover a wide range of patients and medications.“Step therapy is addressing the problem of making sure patients get the right treatment at the right time, and if there’s an affordable alternative, they have access to it first,” said Clare Krusing, a spokeswoman for America’s Health Insurance Plans, a trade group.Doctors and ethicists generally do not dispute that theory. Dr. Steven D. Pearson, founder of the Institute for Clinical and Economic Review, a health care industry think tank, said that in situations in which two treatments would likely offer equal benefits, “most people would say it’s reasonable to try the less expensive one first.”But “the important nuance comes when there might be specific reasons where a patient or doctor feels like the more expensive drug would work better,” he said. “So it all depends on what the harm would be if they tried the less expensive one first.”The rise in step therapy policies is being driven by a host of factors, including rising drug costs. Employer-sponsored health plans are growing more restrictive with coverage, analysts said, as businesses seek to control healthcare spending. Participants in Affordable Care Act health care exchanges have also been affected: Many patients have switched carriers, either by choice or because insurers have exited the exchanges. When they do, patients are often told to restart step therapy protocols anew. J. Russell Teagarden, a health care industry consultant with experience in setting drug coverage policies for health insurance plans, said the last recommendation in particular is “very difficult” to follow because the complexity of many cases means it takes time and medical specialists to resolve them.Teagarden, a former executive at the pharmacy benefits management company Medco Health Solutions, which was acquired by Express Scripts in 2012, said that step-therapy policies and decisions “would keep us up at night. It’s a big job to stay on top of. It requires people and a lot of money and not every company can do it. It’s a real issue.”Some insurers, he said, “play games with these things, and put them in place simply because it’s a barrier. They’re looking for attrition. No one will admit it, but that’s the case. And shame on them.”Patients’ frustration is shared by doctors, who have grown accustomed to — but no less frustrated by — the insurance industry’s efforts to contain costs. Sometimes the insurer’s step-therapy decisions perplex doctors.Dr. Kenneth B. Blankstein, an oncologist in Flemington, N.J., is treating a woman for lung cancer. She responded well to the first chemotherapy drugs he prescribed. When her health was stable, he gave her a “temporary break” from chemo to spare her some of its side effects.But when he tried to return her to the treatment, the insurer balked, saying that the “temporary break” was evidence that the treatment had failed. Despite Blankstein’s protests, the insurer said she would have to move next to Tarceva, another treatment.“She had under a 5 percent chance of a response on Tarceva,” he said. “Yet they insisted, so we had to.”As Blankstein expected, the patient did not respond, but instead of letting her return to the first chemo cocktail, the insurer insisted she try another drug first.The patient ultimately switched to Medicare, which covered the first chemotherapy protocol. Her health is stable.“The patient’s being told to use a drug we know isn’t going to work, but we have to use it anyway for someone with terminal illness? To me that’s just insane, but it’s the way they do things,” Blankstein said. “It’s taken away clinical judgment. It’s managing by algorithms.” More health plans want to pay for drugs based on patient outcomes last_img read more

‘We have to get back on track’: Democrats lose patience with Trump on drug pricing

first_imgPolitics About the Author Reprints Log In | Learn More What is it? GET STARTED ‘We have to get back on track’: Democrats lose patience with Trump on drug pricing [email protected] What’s included? Erin Mershon Senior News Editorcenter_img Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED President Trump spent the last several weeks blasting Democrats for refusing to work with Republicans on health care. Now, two of the Democrats who have shown the most willingness to work with him on one specific health issue ― drug pricing ― are blasting him back.Reps. Peter Welch of Vermont and Elijah Cummings of Maryland made headlines when they agreed to meet Trump at the White House in March to discuss efforts to bring down drug prices, even as many of their colleagues worked to distance themselves from the president. The pair came away from that meeting optimistic about Trump’s willingness to press for relatively liberal changes, like allowing the importation of drugs from Canada or letting Medicare negotiate drug prices. Alex Hogan/STAT By Erin Mershon June 23, 2017 Reprints Tags Congressdrug pricingpharmaceuticalspolicySTAT+TrumpWhite House @eemershon STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond.last_img read more

They get to name genes ‘happyhour’ and ‘Pavarotti.’ Fly researchers have all the fun

first_img What is it? Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED They get to name genes ‘happyhour’ and ‘Pavarotti.’ Fly researchers have all the fun GET STARTED In the Lab Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. Log In | Learn More STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. What’s included? By Megha Satyanarayana Oct. 25, 2017 Reprints Tags researchSTAT+ “Do you know what unc-64 stands for?”This is actually a reasonable question, coming from a “fly person” to a “worm person.” Dominic Hart/NASAlast_img read more

Utah lawmaker is working on a plan to import medicines from Canada

first_img About the Author Reprints @Pharmalot Alden Pellett/AP Ed Silverman Seeking a way to alleviate high drug prices, a Utah lawmaker hopes to introduce a bill that would allow the state to import prescription medicines from Canada, a move that is likely to accelerate a fierce debate over drug costs and patient safety.Over the next several weeks, Rep. Norman Thurston, a Republican, plans to submit legislation to authorize state officials to designate an existing pharmaceutical wholesaler to purchase prescription drugs from a wholesaler in Canada. His hope is that retail pharmacies based in Utah would then be able to buy and sell medicines at lower prices. What is it? Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. What’s included? GET STARTED Tags drug pricingpharmaceuticalsSTAT+center_img Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED Log In | Learn More Pharmalot By Ed Silverman Oct. 26, 2017 Reprints STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. [email protected] Utah lawmaker is working on a plan to import medicines from Canada Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr.last_img read more

Blood test may help predict which breast cancers will recur

first_img Women in the study had a CellSearch test five years on average after their cancer was found and treated.Among those with estrogen-fueled disease, 5 percent had cancer cells in the blood test, and they turned out to have a 22-fold higher risk of recurrence within roughly two years compared to women whose blood test was negative.About 65 percent of women with hormone-positive disease and a positive blood test did not have a new breast cancer within two years, but that doesn’t mean the blood test gave a false alarm, Sparano said.“We haven’t followed the patients long enough” — it could be that more tumors become evident with more time, he said.The blood test seemed to do a good job of identifying which of these hormone-positive patients were at low risk of recurrence, suggesting that women who test negative may be able to forgo an additional five years of hormone-blocking medicines.The test did not predict recurrence risk in the rest of the women in the study, whose tumors were not fueled by estrogen. They have a lower risk of recurrence after five years to start with.The study was funded by the Breast Cancer Research Foundation, Susan G. Komen Foundation and the National Cancer Institute.— Marilynn Marchione Can a ‘liquid biopsy’ detect cancer and save lives? Related: On the other hand, “if you had a negative test, there was a 98 percent chance you would not have a recurrence in the next two years” and perhaps could skip further treatment, he said.Sparano led the study and gave results Friday at the San Antonio Breast Cancer Symposium.advertisement A blood test five years after breast cancer treatment helped identify some women who were more likely to relapse, long before a lump or other signs appeared, a preliminary study found.It was the largest experiment so far to use these tests, called liquid biopsies , for breast cancer. Results suggest they someday may help reveal which women need longer preventive therapy and which ones can be spared it.“It could be providing an early warning sign” for some women that cancer is returning, said Dr. Joseph Sparano of Montefiore Einstein Center for Cancer Care in New York.advertisement A patient has her blood drawn for a liquid biopsy. Jacqueline Larma/AP Related: HealthBlood test may help predict which breast cancers will recur center_img The test — CellSearch, sold by Menarini-Silicon Biosystems — looks for stray cancer cells in the blood. By Associated Press Dec. 8, 2017 Reprints Newer birth control pills still modestly raise risk of breast cancer Breast cancer survivors may be tempted to rush out and get it, but doctors say it’s too soon for that. Although it’s been used for about a decade to monitor certain patients with advanced cancer during treatment, its value for helping to predict breast cancer relapse risk is not well established, and insurers won’t pay the $600 to $900 tab.The new study should spur more research on this right away, said Dr. Massimo Cristofanilli, a breast cancer specialist at Northwestern University in Chicago who has used these tests and consults for another company developing one.“Clearly, to me, we have to do something” now that this study suggests a wider role for them, he said.It involved 547 women in long-term follow-up from an earlier cancer drug study. Two-thirds of them had cancers fueled by estrogen, and in most cases it had spread to lymph nodes but not more widely.All had surgery and chemotherapy followed by hormone-blocking medicines for five years. Guidelines now recommend considering hormone blockers for up to 10 years, but they have side effects and their benefit beyond five years is fairly small. So finding a way to tell who really needs that would be a big help. About the Author Reprints Associated Presslast_img read more

Medical device tax comes back Jan. 1, but opponents trying to ease its effects

first_img WASHINGTON — For the first time in years, the medical device tax will take effect Jan. 1, after Congress left town without delivering on a long-promised delay or repeal. But opponents of the tax, both in industry and on Capitol Hill, aren’t giving up yet: They’re scrambling to find another solution that could offer some relief at the start of the new year.Already they’ve secured commitments from congressional leaders that they will delay or repeal the 2.3 percent excise tax early in 2018. And now some lobbyists and lawmakers are working with the Treasury Department in hopes that the Trump administration will waive the penalties associated with problematic compliance in the early weeks of the year, before Congress might make good on its effort to address the tax. That will help companies whose accounting and reporting systems might not be ready for the Jan. 1 start date, an industry official said. By Erin Mershon Dec. 22, 2017 Reprints Tags policy GET STARTED STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. @eemershon Politics What’s included? What is it? About the Author Reprintscenter_img Rep. Erik Paulsen (R-Minn.), a longtime opponent of the medical device tax Alex Wong/Getty Images Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. Erin Mershon Senior News Editor Unlock this article — plus daily intelligence on Capitol Hill and the life sciences industry — by subscribing to STAT+. First 30 days free. GET STARTED [email protected] Medical device tax comes back Jan. 1, but opponents trying to ease its effects Log In | Learn More last_img read more

CDC requests funds to build new maximum-security laboratory

first_img A CDC researcher works in a BSL4 laboratory, where the most dangerous pathogens are studied. CDC By Helen Branswell Feb. 23, 2018 Reprints About the Author Reprints Senior Writer, Infectious Disease Helen covers issues broadly related to infectious diseases, including outbreaks, preparedness, research, and vaccine development. The Centers for Disease Control and Prevention is asking Congress for money for a new building to house the laboratories that work on the deadliest pathogens known to humankind. The existing building, which went into service in 2005, will need to be replaced by 2023 or so to avoid major disruptions in the work, senior agency staff told STAT.“The concerns are that the facility we’ve been in now is beginning to show signs of age,” said Dr. Inger Damon, head of the division of high consequence pathogens and pathology. That division works on viruses like smallpox and Ebola, which can only be studied in laboratories of the highest biosafety and biosecurity ratings, BSL4.The request, which is currently in the proposed budget for fiscal year 2018, is for $350 million. But more will be needed later; the new high containment continuity laboratory, as it is called, would be built on the site of one of only a few parking facilities on the CDC’s main campus.advertisement In the LabCDC requests funds to build new maximum-security laboratory Trending Now:center_img Comparing the Covid-19 vaccines developed by Pfizer, Moderna, and Johnson & Johnson (The main campus is in a part of the city not served by the Atlanta subway system; parking on the site is already inadequate for the number of people who work there.)The existing facility contains a number of BSL4 labs and labs that are one step down the biosafety and biosecurity ladder, BSL 3 enhanced. That’s where research on dangerous avian influenza viruses like H5N1 and H7N9 is conducted.advertisement Buildings that house these types of labs simply require a lot of maintenance, explained Dr. Dan Jernigan, head of the CDC’s influenza branch.“We’re just faced with the realities of what it takes to maintain something as complex as the high containment lab,” he said.These types of buildings incorporate complicated air filtration and other systems designed to allow the researchers to work safely as well as to ensure that the bad bugs they contain stay on the inside.The CDC’s goal is to have the new facility built in time to ensure the transition from the current labs to the new ones is seamless, Damon said. It will take a number of years to build the new facility and have it certified for select-agent research.“We’ve always tried to maintain that continuity. I think there’s just too much that’s unpredictable,” Damon said. “When you need that facility … you want to have it available. You don’t know when the next SARS is going to happen, or the next large Ebola outbreak.” Helen Branswell @HelenBranswelllast_img read more

Placing more regulations on air medical services would be bad for patients

first_img About the Author Reprints Please enter a valid email address. First OpinionPlacing more regulations on air medical services would be bad for patients On the night after Christmas 2013, as Whitney Corby was driving to the gym in Corning, N.Y., the University at Albany lacrosse player’s car hit black ice and smashed into a tree. The crew who arrived at the scene knew they couldn’t treat Whitney and that she was running out of time. They called the closest air medical provider, Guthrie Air from Sayre, Pa., and drove Whitney to a nearby school football field where the helicopter could land with the critical care team. They flew her to the closest Level 2 trauma hospital, which was back in Pennsylvania, to treat her fractured skull, traumatic brain injury, broken collarbone, and more.Corby’s story isn’t unique. Air medical providers fly approximately 375,000 patients each year. Ninety percent of those patients are transported because they have suffered a serious cardiac event, stroke, or other trauma. Many of those flights cross state boundaries to take patients to the closest, most appropriate hospital. In many rural communities across the country, hospital closures have decreased access to emergency care and essential medical services, requiring rapid transport by air over longer distances, and in many cases across state lines, to larger hospitals.Private insurers are now putting patients helped by air medical transport in the middle of payment issues. Not only are insurers limiting which air medical companies are in their provider networks, and therefore affecting whether the transport is covered, they are also limiting the amount they will pay for the cost of the emergency transportation and the treatment received on board. That means patients needing air transport are often left with unpaid bills in spite of paying monthly premiums for health care coverage.advertisement Richard Sherlock A pilot prepares a medical helicopter at Dartmouth-Hitchcock Medical Center in New Hampshire in 2016. Dom Smith/STAT [email protected] A different proposal, this one contained in the Federal Aviation Administration Reauthorization Act of 2018, would have a devastating impact on access to air medical services. Section 412(h) of this act would allow each state to regulate air medical services according to arbitrary state- or even county-level preferences. The net effect would be a crazy quilt of regulations that would essentially create borders in the sky and make it more difficult for emergency air medical providers to get patients to the best, closest medical facility.If this section passed, an air ambulance based in Maryland that picks up a patient in Virginia and delivers her to a hospital in Washington, D.C., would be subject to different laws and regulations in three different jurisdictions. Those regulations could affect everything from the equipment on these aircraft to how the aircraft are operated, where control centers are located, and the medical staff on board.When Congress enacted the Airline Deregulation Act in 1978, one of the primary purposes was to encourage expansion of the air transportation industry by exempting air carriers from overly burdensome and disparate regulations by the states. Air medical services were part of the discussion as lawmakers considered the broad impact of this change to federal oversight of the aviation industry.Among other provisions, the Airline Deregulation Act says that a state “may not enact or enforce a law, regulation, or other provision having the force and effect of law related to a price, route, or service of an air carrier.” This allows air ambulance companies to provide lifesaving services and make decisions based on what is in the best interest of the patient, rather than on arbitrary state, county, or municipal boundaries. Related: WATCH: A helicopter medic grapples with trauma across vast distances By Richard Sherlock May 1, 2018 Reprints Tags advocacyCongressemergency medicine Leave this field empty if you’re human: By their very nature, air ambulances operate on an interstate basis. Every day they transport more than 30 percent of their patients across state lines for definitive care. Exempting air medical services from the deregulation act would drastically change the way the air medical transport system works, and not for the better.Section 412(h) also requires air medical services to split their charges into two categories: aviation related and non-aviation-related charges. This would allow insurers to further limit coverage for the emergency medical transportation that uses highly specialized medical helicopters, state-of-the-art medical equipment, and very experienced pilots and focus only on the “allowable treatment” provided on board. While that would lower insurance company payments, it would leave patients with a bigger portion of the bill.Although Section 412(h) is supposed to be aimed at protecting patients from onerous charges, it does absolutely nothing to lower the bills that patients get for air medical transport. In addition to eroding uniform federal oversight of the aviation industry, it is likely to create a more complicated payment structure that will benefit health insurance companies at the expense of patients.If the intent of Congress is to address the issues of access to emergency care and cost of air medical services, then it must address the root cause of the problem — vast under-reimbursement by Medicare — by passing the Ensuring Access to Air Ambulance Services Act and eliminating Section 412(h) of the FAA Reauthorization Act.Richard Sherlock is the president and CEO of the Association of Air Medical Services. Privacy Policy Newsletters Sign up for First Opinion A weekly digest of our opinion column, with insight from industry experts. Congress could help fix a big part of the problem by passing the Ensuring Access to Air Ambulance Services Act. This bipartisan legislation would require all air medical transport providers to submit their costs for transport to CMS so it can update its reimbursement schedule based on the actual cost of care today, not 20 years ago. This will go a long way toward preserving access to air medical services that provide not only emergency care but also timely access to our nation’s emergency health care systems for those whose life depends on this care.advertisement To make matters worse, Medicare and Medicaid payments for air transport are low — sometimes as low as half of what it costs — in part because the Centers for Medicare and Medicaid Services hasn’t evaluated what it pays for air medical transport in nearly 20 years. Seventy percent of patients’ bills for air medical transport are paid at the Medicare rate or less. In some cases, private insurers base their rates on a percentage of what Medicare pays.last_img read more

Obesity surgery may lower risk of heart attack and stroke in diabetics

first_imgMore than 30 million Americans have diabetes, mostly Type 2 where the body loses the ability to produce or use insulin to turn food into energy. By Associated Press Oct. 16, 2018 Reprints Please enter a valid email address. Obesity surgery can cost $20,000 to $25,000. Insurers are increasingly covering it, but some impose strict limits.The new findings suggest insurance coverage should be expanded for the right patients, Dr. Sayeed Ikramuddin of the University of Minnesota wrote in an accompanying editorial.Surgery is thought to help by affecting hormones, gut bacteria and other substances that affect how the body handles insulin and blood sugar. Weight loss without surgery also helps, but is difficult for many people to achieve.Most weight loss surgery today is done through small incisions. The dangers are similar to other surgeries, including a small chance of life-threatening complications, and some people need to have their surgeries repeated.— Carla K. Johnson HealthObesity surgery may lower risk of heart attack and stroke in diabetics Newsletters Sign up for Morning Rounds Your daily dose of news in health and medicine. Comparing the Covid-19 vaccines developed by Pfizer, Moderna, and Johnson & Johnson Trending Now: Leave this field empty if you’re human: Other research has shown obesity surgery can reverse and even prevent diabetes. Taken together, it means doctors should discuss weight loss surgery more often, said study co-author Dr. David Arterburn of Kaiser Permanente Washington Health Research Institute in Seattle.advertisementcenter_img Privacy Policy Doctors usually mention insulin and pills, “but it’s not always brought up that weight loss surgery is another available treatment option,” Arterburn said.Researchers analyzed records from four U.S. health care systems: HealthPartners in Minnesota and Kaiser Permanente in Washington state, Northern California and Southern California. Results were published Tuesday in the Journal of the American Medical Association.The study can’t prove cause and effect because patients weren’t randomly assigned to get surgery. The researchers tried to match patients for gender, age, blood sugar levels and other factors. But other things they didn’t account for could have contributed to the surgery patients’ better results.Everyone in the study had a BMI, or body mass index, of at least 35. For instance, someone who is 5-foot-8-inches and weighs 230 pounds has a BMI of 35.Of the more than 5,300 who had surgery, most had gastric bypass, the most common type of stomach-shrinking operation. Some had gastric sleeve or gastric band procedures. The rest, nearly 15,000 people, had usual care. Associated Press About the Author Reprints SEATTLE  — Obesity surgery may dramatically lower the danger of heart attacks and strokes in patients with diabetes, new research suggests, reinforcing evidence that benefits extend beyond weight loss.The study tracked about 20,000 severely obese patients with Type 2 diabetes. Those who had weight loss surgery had a 40 percent lower chance of developing a heart attack or stroke in the five years following surgery compared to those who got usual care with diabetes medicines or insulin.For every 1,000 patients in the study who had surgery there were roughly 20 heart attacks or strokes compared to 40 such events per 1,000 who got regular care.advertisement Gareth Fuller/PA Wire/AP Tags diabetespatientsresearchlast_img read more

Experimental treatment appears effective against gonorrhea in small study

first_img Related: HealthExperimental treatment appears effective against gonorrhea in small study Neisseria gonorrhoeae, the bacterium that causes gonorrhea infections. NIAID A case study in the fast-rising threat of antibiotic resistance Related: By Helen Branswell Nov. 7, 2018 Reprints Please enter a valid email address. A new oral antibiotic drug currently in development appears to be effective at treating gonorrhea, an infection for which there is a critical need for new therapeutic options, a study published Wednesday suggested.The findings are the result of a Phase 2 trial, a small study done to determine if further, larger studies are warranted. Evidence from larger Phase 3 trials would be needed to persuade the Food and Drug Administration or other regulatory agencies to license the one-dose drug, zoliflodacin.But the data, published in the New England Journal of Medicine, appear to be good news to a field that is overdue for some. Since the dawn of the antibiotic era, Neisseria gonorrhoeae, the bacterium that causes gonorrhea infections, has steamrollered its way through all the drugs that have been placed in its path.advertisement But these are the last treatments in the antibiotic armamentarium to reliably cure gonorrhea; already there are signs this combination’s power is eroding. Resistance to azithromycin is rising and there have been a few cases of resistance to ceftriaxone reported as well.Each new case unsettles the cadre of doctors who treat the common sexually transmitted disease, knowing as they do that very hard-to-treat or even untreatable gonorrhea infections may soon loom on the horizon.Gonorrhea is spread through sexual contact, and infection can occur in the genitals, the rectum, and the throat.If it is not successfully treated, gonorrhea can cause pelvic inflammatory disease and infertility in women and sterility in men. Babies can contract it from infected mothers during birth, which can leave the infant blind. It increases a person’s risk of contracting HIV and can lead to joint infections in rare cases. Planning is currently underway for a Phase 3 trial for zoliflodacin; the trial is expected to start in 2019. The Phase 2 trial was financed by the National Institute of Allergy and Infectious Diseases and the Phase 3 will be co-financed by Entasis Therapeutics — which owns the intellectual property — and a nonprofit group called Global Antibiotic Research and Development Partnership, or GARDP.In exchange for help developing the drug, GARDP will receive an exclusive license to the drug that will allow it to bring it to market at an affordable price in 160 low- and middle-income countries — if it’s approved. Entasis, which is based in Boston, retains the rights in high-income countries.The Phase 2 results look promising. Zoliflodacin was nearly as effective as ceftriaxone at curing gonorrhea infections in the urethra and in the rectum, though the number of people who had rectal infections was small and therefore the results have to be viewed with some caution.However, the drug didn’t appear as effective in curing infections in the pharynx — an infection site that has bedeviled other oral antibiotics as well. Even though the trial was small, Handsfield didn’t hold out a lot of hope that a Phase 3 trial would come to a different conclusion.“I think it will surprise experts in the field if the Phase 3 trial shows strong efficacy for pharyngeal infection. I suspect it will not, based on admittedly small numbers in this trial,” he said. Helen Branswell @HelenBranswell No more ‘sledgehammer’: As gonorrhea grows resistant to antibiotics, researchers look to bespoke treatments About the Author Reprints He and the trial’s principal investigator, Dr. Stephanie Taylor of Louisiana State University Health Sciences Center, didn’t feel that would prevent the drug from being licensed, if the Phase 3 trial shows it is effective against urethral and rectal gonorrhea.Taylor said a number of other antibiotics that have been the standard of care in the past had similar problems combatting pharyngeal gonorrhea. The belief, she said, is that the oral administration makes it difficult to get a high enough concentration of drug in the throat to quell the bacteria.But Dr. Lindley Barbee, an assistant professor of infectious diseases at the University of Washington and medical director of the Public Health – Seattle & King County STD Clinic, said having an antibiotic that can’t routinely cure pharyngeal gonorrhea would not be ideal — especially if ceftriaxone fails and the Centers for Disease Control and Prevention needs to recommend zoliflodacin as a first-line therapy.“I really believe that any regimen that’s going to be recommended at the CDC level needs to be able to eradicate the [bacteria] from the pharynx because the site goes underscreened so often,” said Barbee, who was not involved in the study.“I do think it’s something we need to think about, thinking on the big picture — the population level. What happens if we put forward a drug — and make it a standard of care — that doesn’t treat one anatomic site and potentially even induces resistance because of that anatomic site?” she asked.The Phase 2 study involved very few women, a limitation of the work. Taylor said it is hard to enroll women in this type of trial. Research safety rules require that women enrolled must have been on and continue to use effective contraception for the duration of the trial to ensure they are not given an experimental drug while they are pregnant.“In all other drugs that have ever been studied, the regimens that work well for urethral gonorrhea in men also work well for genital infection in women and generally they work well for rectal infection in women and men having sex with men,” Handsfield noted.The drug works by a different mechanism than other antibiotics — a feature that experts hope might make it less vulnerable to the development of antibiotic resistance. But Taylor wasn’t ready to count out wily gonorrhea.“Well, you know, gonorrhea has developed resistance to every drug in the past. So, yes, we’re hopeful,” she said. “But you know, considering historically what has happened we have no idea. We’ll know that answer in a few years.” Leave this field empty if you’re human: The current recommended treatment for gonorrhea is a combination of an injectable antibiotic, ceftriaxone, and another that comes in pill form, azithromycin. Experts hope that the use of two drugs — so-called dual therapy — will slow the development of antibiotic resistance to the drugs.advertisement Privacy Policy Newsletters Sign up for Morning Rounds Your daily dose of news in health and medicine. Senior Writer, Infectious Disease Helen covers issues broadly related to infectious diseases, including outbreaks, preparedness, research, and vaccine development. “If the promise of these results is confirmed in Phase 3 studies, then zoliflodacin stands to become a very important drug in gonorrhea treatment worldwide. That’s in the future, but that’s the promise that this study suggests,” said Dr. Hunter Handsfield, a professor emeritus of medicine at the University of Washington’s Center for AIDS and STD. Handsfield was not involved in the study. Tags Bostoninfectious diseasespublic healthlast_img read more