Podcast: ‘What The Health?’ Taxes, Medicare And The Year-End Mess

Weeks ago, the tax bill under consideration in Congress became a health bill, too. But now it could also trigger major cuts to the Medicare program.

In this episode of “What the Health?” Julie Rovner of Kaiser Health News, Joanne Kenen of Politico and Paige Winfield Cunningham of The Washington Post discuss how a little-known law prohibiting federal deficits could force big cuts to Medicare and many other defense and domestic programs if the tax bill passes as currently configured in the House and Senate.

Among the takeaways from this week’s podcast:

  • A possible delay in negotiating a year-end spending bill puts the fate of the Children’s Health Insurance Program in doubt. States are starting to run out of money for the program, whose federal authorization expired Oct. 1.
  • A Senate committee heard from Alex Azar, a former drug company executive and President Donald Trump’s nominee to head the Department of Health and Human Services. Much of the discussion was about what he might do to contain drug prices.
  • The National Academy of Medicine issued its own recommendations about how to make drugs more affordable, including the idea of letting government programs negotiate with drugmakers and possibly limit which drugs the government would pay for.

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

Julie Rovner: ProPublica’s “A Hospital Charged $1,877 to Pierce a 5-Year-Old’s Ears. This Is Why Health Care Costs So Much,” by Marshall Allen.

Joanne Kenen:  The Atlantic’s “No Family Is Safe From This Epidemic,” by James Winnefeld.

Paige Winfield Cunningham: The Washington Post’s “597 days. And still waiting,” by Terrence McCoy.

To hear all our podcasts, click here.

And subscribe to What the Health? on iTunes, Stitcher or Google Play.

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If Your Insurer Covers Few Therapists, Is That Really Mental Health Parity?

It’s been nearly a decade since Congress passed the mental health parity act, with its promise to make mental health and substance abuse treatment just as easy to get as care for any other condition. Yet today, in the midst of the opioid epidemic and a spike in the rate of suicide, patients still struggle to access treatment.

That’s the conclusion of a report published Thursday by Milliman Inc., a national risk management and health care consulting company. The report was released by a coalition of mental health and addiction advocacy organizations.

Among the findings:

  • In 2015, behavioral care was four to six times more likely to be provided out-of-network than medical or surgical care.
  • Insurers pay primary care providers 20 percent more for the same types of care as they pay addiction and mental health care specialists, including psychiatrists.
  • State statistics vary widely. In New Jersey, 45 percent of office visits for behavioral health care were out-of-network. In Washington D.C., the figure was 63 percent.

The researchers at Milliman examined two large national databases containing medical claims records from major insurers for PPOs — preferred provider organizations — covering nearly 42 million Americans in all 50 states and the District of Columbia from 2013 to 2015.

“I was surprised it was this bad. As someone who has worked on parity for 10-plus years, I thought we would have done better,” said Henry Harbin, former CEO of Magellan Health, a managed behavioral health care company. “This is a wake-up call for employers, regulators and the plans themselves that whatever they’re doing, they’re making it difficult for consumers to get treatment for all these illnesses. They’re failing miserably.”

The high proportion of out-of-network behavioral care means mental health and substance-abuse patients were far more likely to face the high out-of-pocket costs that can make treatment unaffordable, even for those with insurance.

In a statement issued with the report, the coalition of mental health groups, including Mental Health America, the National Association on Mental Illness, and The Kennedy Forum, called on federal regulators, state agencies and employers to conduct random audits of insurers to make sure they are in compliance with the parity law.

Harbin, now a consultant on parity issues, said the report’s finding that mental health providers are paid less than primary care providers is a particular surprise. In nine states, including New Hampshire, Minnesota, Vermont, Maine and Massachusetts, payments were 50 percent higher for primary care providers when they provided mental health care.

Because of such low reimbursement rates, he said, mental health and substance abuse professionals are not willing to contract with insurers. The result is insurance plans with narrow behavioral health networks that do not include enough therapists and other caregivers to meet the demands of patients.

For years, insurers have maintained that they are making every effort to comply with the Mental Health Parity and Addiction Equity Act, which was intended to equalize coverage of mental health and other medical conditions. And previous research has found that they have gone a long way toward eliminating obvious discrepancies in coverage. Most insurers, for example, have dropped annual limits on the therapy visits that they will cover. Higher copayments and separate mental health deductibles have become less of a problem.

Still, discrepancies appear to continue in the more subtle ways that insurers deliver benefits, including the size of provider networks.

Kate Berry, a senior vice president at America’s Health Insurance Plans, the industry’s main trade group, said the real problem is the shortage of behavioral health clinicians.

“Health plans are working very hard to actively recruit providers” and offer telemedicine visits in shortage areas, said Berry. “But some behavioral health specialists opt not to participate in contracts with providers simply because they prefer to see patients who are able to pay out of their pocket and may not have the kind of severe needs that other patients have.”

“This is a challenge that no single stakeholder in the health care infrastructure can solve,” she added.

Carol McDaid, who runs the Parity Implementation Coalition, countered that insurers have been willing and able to solve provider shortages in other fields. When there was a shortage of gerontologists, for example, McDaid said, insurers simply increased the rates and more doctors joined the networks. “The plans have the capacity to do this; I just think the will hasn’t been there thus far,” she said.

The scarcity of therapists who accept insurance creates a care landscape that is difficult to navigate for some of the most vulnerable patients.

Ali Carlin, 28, said she used to see her therapist in Richmond, Va., every week, paying a copay of $25 per session. But in 2015, the therapist stopped accepting her insurance, and her rate jumped to $110 per session.

Carlin, who has both borderline personality disorder and addiction issues, said she called around to about 10 other providers, but she couldn’t find anyone who accepted her insurance and was taking new patients.

“It’s such a daunting experience for someone who has trouble maintaining their home and holding a job and friendships,” said Carlin. “It makes me feel like no one can help me, and I’m not good enough, and it’s not an attainable goal.”

In Virginia, the Milliman report found that 26 percent of behavioral health office visits were out-of-network — more than seven times more than for medical care.

With no alternative, Carlin stuck with her old therapist but must save up between sessions. She has just enough to cover a visit once every few months.

“I make $30,000 a year. I can’t afford an out-of-pocket therapist or psychiatrist,” said Carlin. “I just can’t afford it. I’m choosing groceries over a therapist.”

Angela Kimball, director of advocacy and public policy at the National Alliance on Mental Illness, said she worries many patients like Carlin simply forgo treatment entirely.

“One of the most common reasons people give of not getting mental health treatment is the cost. The other is not being able to find care,” she said. “It’s hurting people in every corner of this nation.”

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GSK starts big African study of injectable drug to prevent HIV

(Reuters) – ViiV Healthcare, GlaxoSmithKline Plc’s HIV unit, said on Thursday it started an African study to evaluate long-acting injectable drug for the prevention of HIV infection in sexually active women.

FILE PHOTO: A GlaxoSmithKline logo is seen outside one of its buildings in west London, February 6, 2008. REUTERS/Toby Melville/File Photo

The cabotegravir study seeks to enrol 3,200 women aged 18 to 45 years from sub-Saharan African countries, ViiV Healthcare said in a statement.

The HPTN 084 Phase III study will evaluate injections given every two months, ViiV Healthcare said.

The study is being conducted through a public-private funding by ViiV Healthcare, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Bill & Melinda Gates Foundation, the company said.

Viiv Healthcare in 2016 had started a large study on HIV-uninfected men and transgender women who have sex with men to test an experimental long-acting injection for preventing the virus that causes AIDS.

Reporting by Subrat Patnaik in Bengaluru; Editing by Akshay Lodaya

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FDA clears first medical device accessory for Apple Watch

(Reuters) – The U.S. Food and Drug Administration on Thursday cleared a device embedded in an Apple Inc watch band that monitors a user’s heart rate, detects when something is amiss and prompts the user to take an electrocardiogram.

Apple watches are seen at a new Apple store in Chicago, Illinois, U.S., October 19, 2017. REUTERS/John Gress

The device, made by AliveCor, pairs the ability to take a personal 30 second electrocardiogram (EKG) with a feature that uses artificial intelligence to continuously evaluate the correlation between heart and physical activity.

When the device, known as KardiaBand, detects that a user’s heart rate and activity are out of sync, it prompts the user to capture an EKG by touching the band. The results display instantly on the watch face.

The device is designed to capture information that can help doctors help manage atrial fibrillation, the most common heart arrhythmia that is a leading cause of stroke and affects more than 30 million people worldwide.

The device costs $199 and requires a subscription to the company’s premium service for $99 a year.

AliveCor said in a statement it uses advanced artificial intelligence, mobile, cloud and micro-electrode technology to change the dynamic in cardiac care.

Reporting by Toni Clarke in Washington; editing by Diane Craft

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Patients with rare diseases and congress square off over orphan drug tax credits

November 30, 2017

Taking the credit away, Taylor said, “eliminates the possibility for my child to have a bright and happy future.”

Taylor, whose 9-year-old son, Aiden, has a rare connective tissue disorder, spoke as part of a small rally thrown together this week by the National Organization for Rare Disorders (NORD) — the nation’s largest advocacy group for patients with rare diseases.

Earlier this month, House Republicans proposed eliminating the orphan drug tax credits, which Congress passed as part of a basket of financial incentives for drugmakers in the 1983 Orphan Drug Act. The law, intended to spur development of medicines for rare diseases, also gives seven years of market exclusivity for drugs that treat a specific condition that affects fewer than 200,000 people.

The Senate Finance Committee, led by Sen. Orrin Hatch (R-Utah), put the tax credit back into the tax legislation. After some negotiations, the committee settled on reducing the credit to 27.5 percent of the costs of preapproved clinical research, compared with the current 50 percent. The committee also restored a provision that would have eliminated any credits for drugmakers who repurpose a mass-market drug as an orphan.

“As with any major reform, tough choices have to be made,” a Hatch spokesperson wrote in an emailed statement, adding that the senator will continue to work “to make the appropriate policy decisions” to deliver a comprehensive tax overhaul.

Hatch, a member of a rare-disease congressional caucus, received $102,600 in campaign contributions from pharmaceutical and related trade group political action committees in the first half of 2017, making him the top recipient of pharmaceutical cash in the Senate.

If the Senate provision remains untouched, reducing the tax credit would save the federal government nearly $30 billion over a decade, according to a markup of the bill released late last week.

Orphan drug development has become big business in recent years and advocates as well as critics of the industry say tax credits have been an important motivation for companies. Orphan drugs accounted for 7.9 percent of total U.S. drug sales last year, according to a report released by QuintilesIMS and NORD.

Because patient populations for rare-disease drugs are relatively small, companies often charge premium prices for the medicines. EvaluatePharma, a company that analyzes the drug industry, estimates that among the top 100 drugs in the U.S. the average annual cost per patient for an orphan drug last year was $140,443. Giant pharmaceutical companies such as Celgene, Roche, Novartis, AbbVie and Johnson & Johnson have led worldwide sales in the orphan market, according to EvaluatePharma’s 2017 Orphan Drug Report.

Jonathan Gardner, the U.S. news editor for EvaluatePharma, said the orphan drug tax credit is “probably the most important incentive for developing an orphan drug.” Cutting the credit will force even the large companies to question development of drugs for rare diseases, Gardner said.

Dr. Aaron Kesselheim, an associate professor of medicine at Harvard Medical School, has been critical of the Orphan Drug Act’s incentives and of companies taking advantage of the law’s financial incentives for profit. But he warned against rushing to eliminate the tax credit.

“We need to think about ways we can improve the Orphan Drug Act and stop people from gaming the system and exploiting it,” Kesselheim said. But there “are a lot of rare diseases that don’t have treatments. So, we need to be careful in making changes.”

The battle over the tax credit is the latest controversy for the Food and Drug Administration’s orphan drug program. FDA Commissioner Scott Gottlieb announced a “modernization” plan for the agency this summer, closing a pediatric testing loophole and eliminating a backlog of corporate applications for orphan drug status. And, this week, the agency confirmed that Dr. Gayatri Rao, director for the Office of Orphan Products Development, is leaving.

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Meanwhile, the Government Accountability Office confirmed this month that it recently launched an investigation of the orphan drug program. The GAO’s review was sparked by a letter from top Republican Sens. Hatch, Chuck Grassley (R-Iowa) and Tom Cotton (R-Ark.), asking the agency to investigate whether drugmakers “might be taking advantage” of the drug approval process.

When the 1983 Orphan Drug Act was passed, the law described an orphan drug as one that affects so few people that drugmakers might lose money after covering the cost of developing a drug. Congress added the 200,000-patient limit in 1984.

Today, many orphan medicines treat more than one condition and often come with astronomical prices. Many of the medicines aren’t entirely new, either. A Kaiser Health News investigation, which was also aired and published by NPR, found that more than 70 of the roughly 450 individual drugs given orphan status were first approved for mass-market use, including cholesterol blockbuster Crestor, Abilify for psychiatric conditions, cancer drug Herceptin and rheumatoid arthritis drug Humira, which for years was the best-selling medicine in the world.

More than 80 other orphans won FDA approval for more than one rare disease and, in some cases, multiple rare diseases, the KHN investigation showed.

The pharmaceutical industry has had a muted response to the tax bill, which includes a corporate tax cut. The powerful industry lobbying group PhRMA said it is pleased Congress is looking at overhauling the tax code but “encourages policymakers to maintain incentives” for rare diseases. BIO, the Biotechnology Innovation Organization that represents biomedical companies, said it was “gratified” the Senate committee chose to partially retain the credit but would prefer to keep the existing incentive.

The group that rallied Tuesday — wearing bright-orange shirts that read “Save the Orphan Drug Tax Credit” — planned to meet with a couple of dozen lawmakers, including Grassley, who is a member of the Senate Finance Committee.

NORD, like many patient advocacy groups, receives funding from pharmaceutical companies, but the organization’s leaders say the industry does not have members on the board and does not dictate how general donations are spent.

On Tuesday, NORD leaders said they are open to discussions about the tax credit and whether the overall law is working as intended.

“We’re here to have that conversation, we’re ready to have that conversation,” said Paul Melmeyer, director of federal policy for NORD. “Sadly, that’s not the conversation we are having today.”

Abbey Meyers, a founder of NORD and the leading advocate behind passing the initial 1983 law, said she fears the high cost of the drugs will make it impossible to sustain the orphan drug program. Now retired, Meyers said she has followed the law’s success over the years and believes the tax credit should not be changed.

“There are other things that have happened since the law was passed where there wasn’t any logic to what they did,” Meyers said, adding “because somebody went to a senator and they put into the law.”

KHN’s coverage of prescription drug development, costs and pricing is supported by the Laura and John Arnold Foundation. Kesselheim’s work is also supported by the foundation.


Kaiser Health NewsThis article was reprinted from khn.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.

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Studies provide insights into potential effects of weight on individuals with rheumatoid arthritis

November 30, 2017

New research provides insights on the potential effects of weight on the health of individuals with rheumatoid arthritis (RA). A study published in Arthritis Care & Research examines how overweight and obesity may affect the likelihood of achieving remission in early RA. A separate study in Arthritis & Rheumatology focuses on weight change in early RA and patients’ subsequent risk of early death.

Research has suggested that weight may influence the effectiveness of RA therapies. In an Arthritis Care & Research study, Susan Goodman, MD, of the Hospital for Special Surgery and Weill Cornell Medical School, and her colleagues investigated the potential impact of weight on the likelihood that patients would achieve remission in the early years after an RA diagnosis. The team examined data from the Canadian Early Arthritis Cohort, a multicenter observational trial of patients with early RA who were treated by rheumatologists using guideline-based care.

“Our study looks at people with recently diagnosed, early RA, who should have the best outcomes and best responses to treatment, and sees how many are either overweight or obese, and then determines if those who are overweight or obese have worse outcomes than those with healthy weight,” said Dr. Goodman.

Of 982 patients, 32 percent had a healthy BMI, 35 percent were overweight, and 33 percent were obese. Within three years, 36 percent of patients experienced sustained remission. Compared with patients with a healthy BMI, those who were overweight were 25 percent less likely to experience sustained remission, and those who were obese were 47 percent less likely to do so, despite receiving similar treatments.

The research represents the largest study demonstrating the negative impact of excess weight on the RA disease activity and supports a call to action to better identify and address this risk in patients.

“These findings have important implications for clinical care since rates of overweight and obesity continue to rise,” said Dr. Goodman. “Our findings highlight the high proportion of newly diagnosed RA patients who are overweight or obese and who may have disease that is harder to treat. For people with RA who haven’t had an adequate response to treatment, this may be another factor to consider.”

In other studies, obesity has been associated with a decreased risk of early death; however, follow-up studies suggest that this “obesity paradox” may be explained by unintentional weight loss in the few years preceding death, rather than a truly protective effect of obesity. According to this explanation, patients with longstanding RA who reached normal or underweight BMI have higher observed mortality and are relatively less healthy than RA patients who maintained obesity or overweight.

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To investigate the issue, Jeffrey Sparks, MD, MMSc, of Brigham and Women’s Hospital and Harvard Medical School, and his colleagues evaluated the effect of weight change in the early stages of RA on subsequent mortality risk. Their Arthritis & Rheumatology study included 902 women diagnosed with RA in the Nurses’ Health Study and 7884 matched women without RA.

Women with RA had higher mortality rates than women without RA. Among women with RA, 41 percent died during an average follow-up of 17.0 years after the early RA period; among women without RA, 29.2 percent died during an average follow-up of 18.4 years. In both groups, women who had severe weight loss (>30 pounds) had the highest mortality rates after the early RA period. Weight gain in the early RA period was not associated with mortality for either group.

“Our study is the first to focus on weight change around RA diagnosis and risk of death, rather than weight change in patients who had RA for many years, as in previous studies,” said Dr. Sparks. “Our findings provide evidence that the results of earlier studies–that patients who had normal weights were at higher risk of death–may have been related to unintended weight loss as opposed to a protective effect of being overweight or obese. Our results demonstrate that these prior findings were less likely to be directly related to RA and were likely a phenomenon of frailty and aging of the general population.”

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University Was Tipped Off To Possible Unauthorized Trials Of Herpes Vaccine

WASHINGTON — The university that employed a controversial herpes vaccine researcher has told the federal government it learned last summer of the possibility of his illegal experimentation on human subjects. But Southern Illinois University did not publicly disclose the tip or its findings about researcher William Halford’s misconduct for months, according to a memo obtained by Kaiser Health News.

Last week, Kaiser Health News reported that Halford conducted an experiment in which he vaccinated patients in U.S. hotel rooms in 2013 without any safety oversight and in violation of U.S. laws, according to patients and emails they provided to KHN to support their allegations.

They told KHN those injections occurred three years before Halford tested a herpes vaccine he created on human subjects in a house in St. Kitts in 2016, again without routine safety oversight. Halford died of cancer at the end of June.

While the university has refused to respond to questions about the 2013 injections, an Oct. 16 memo to the federal government obtained by KHN under open-records law shows that SIU learned of such possible activity at the end of July. According to the memo, Rational Vaccines, the company that Halford co-founded, and another SIU professor disclosed that “human subjects research might have occurred prior to the … clinical trial in St. Kitts.”

SIU reported in the memo to the Department of Health and Human Services and the Food and Drug Administration that its institutional review board, or IRB, found Halford’s activities to be a “serious noncompliance” and said it recommended the university conduct a “confidential” investigation to determine if he committed any other misconduct.

“Dr. Halford willfully and intentionally engaged in human subjects research without the approval and oversight of the IRB, in violation of IRB policies and in violation of applicable law and regulation,” SIU wrote in the memo.

Previously, the university had said it was not responsible for Halford’s St. Kitts trial because he conducted it independently through Rational Vaccines.

Before releasing the memo to KHN, the university blacked out some of the details. It’s unclear whether the “serious noncompliance” involved the 2013 injections or some other unauthorized human subject research.

“This is a very serious matter for the university,” said Robert Klitzman, a doctor and director of the master’s program in bioethics at Columbia University in New York.

Klitzman said the Office for Human Research Protections (OHRP), the HHS division that oversees compliance with rules on human trials, could halt all of the university’s research as a result of the finding. The National Institutes of Health could also freeze its funding to SIU, he added, even though Halford’s research was not federally funded.

OHRP and the FDA said they have policies of not discussing potential or ongoing investigations. SIU did not respond to questions.

Several participants from both trials told KHN they have asked SIU for help. They said Tuesday that they felt the university should be informing them of its investigation into unauthorized experiments and its findings.

“Halford tested his vaccine on humans using SIU’s facilities and resources,” said one Colorado woman who has tried to talk to the university about her experience in the St. Kitts trial. “They [SIU] deny knowing anything about it. SIU hasn’t been very forthcoming.”

Klitzman said the university did have a responsibility to the participants who were injected with Halford’s vaccine. Two of them — including the Colorado woman — have filed so-called adverse event complaints with the FDA, saying that Halford’s vaccine may have caused side effects.

“Ethically, the university should contact the participants to let them know that some participants have developed adverse events,” he said.


KHN’s coverage of these topics is supported by
Laura and John Arnold Foundation and
Gordon and Betty Moore Foundation

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The Ratcheting Cost Of The Pneumococcal Vaccine: What Gives?

Every November, like clockwork, she gets the same letter, said Dr. Lindsay Irvin, a pediatrician in San Antonio.

It’s from the drug company Pfizer Inc., and it informs her that the price tag for the pneumococcal vaccine Prevnar 13 is going up. Again.

And it makes her angry.

“They’re the only ones who make it,” she said. “It’s like buying gas in a hurricane — or Coke in an airport. They charge what they want to.”

The Advisory Committee on Immunization Practices (ACIP), a consultatory panel to the federal Centers for Disease Control and Prevention, recommends Prevnar 13 for all children younger than 2 — given at 2, 4, 6 and 15 months — as well as for adults 65 and older.

It protects against pneumonia as well as ear and other infections. Many states require proof that children have received the vaccine in order to attend school.

The vaccine’s formulation has remained mostly unchanged since its 2010 federal approval, but its price continues creeping up, increasing by about 5 or 6 percent most years. In just eight years, its cost has climbed by more than 50 percent.

It is among the most expensive vaccines Irvin provides her young patients.

Doctors and clinics purchase the vaccine and then, once they inject patients, they typically recoup the cost through patients’ insurance coverage. In most cases there are no out-of-pocket costs.

But the steady rise in prices for branded drugs contributes indirectly to rises in premiums, deductibles and government health spending, analysts say.

A full pediatric course of the vaccine typically involves four shots. In 2010, a single shot cost about $109, according to pricing archives kept by the CDC. It currently costs about $170, according to those archives. Next year, Pfizer says, a shot will cost almost $180.

“Pfizer and other drug companies are raising their prices because they can,” said Gerard Anderson, a health policy professor at Johns Hopkins University who studies drug pricing. “They have a patent, and they have a CDC recommendation, which is a double whammy — and a strong incentive for price increases.”

The company disagrees — arguing vaccine pricing supports research for new immunizations, along with ongoing efforts to keep products safe and to improve effectiveness. For instance, Prevnar 13’s shelf life was extended from two years to three years this year. Pricing also doesn’t affect access.

“Thanks to comprehensive health authority guidelines, Prevnar 13 is one of the most widely available public health interventions, supported by broad insurance coverage and innovative federal programs that guarantee access to vulnerable populations,” Pfizer spokeswoman Sally Beatty said in an email.

But such arguments don’t justify the pattern of “consistent price increases,” suggested Ameet Sarpatwari, an epidemiologist and lawyer at Harvard Medical School, who studies drug policy.

“Does that explain what’s going on? Probably not,” he said. “The onus should be on them to show us why this is needed.”

Consumers are not likely to feel a pinch from these increases directly. The Affordable Care Act requires that ACIP-recommended vaccines are covered by insurance, with no cost sharing.

There are other implications, though.

Higher vaccine prices make it harder for physicians to stock up, noted Michael Munger, a family doctor in Overland Park, Kan., and president of the American Academy of Family Physicians.

They have to buy immunizations in advance to provide them for patients. Insurance will eventually reimburse them — typically at cost — but it can take months for that to come through, which is an especially tough proposition for small practices on tight budgets.

“You’ve got to keep track of your inventory, and make sure you don’t have any waste, and are going to get adequate reimbursement,” he said. “The cost of vaccines is definitely something in primary care we worry about, because we’re on thin margins. … You don’t want to provide a service you lose money on, even if it’s as important as immunization.”

Gardasil, the HPV vaccine, has also seen its price climbing. And, in a similar response, OB-GYNs are providing it in smaller numbers.

A vaccine like Prevnar 13 is harder to make than older vaccines that are much cheaper, said William Moss, a professor at Johns Hopkins Bloomberg School of Public Health who specializes in vaccines and global children’s health. It provides immunization for 13 different variations of pneumococcal infection. That makes it a more effective vaccine, but also one that requires greater investment.

Critics, however, note that those investments were made by another company, Wyeth Pharmaceuticals. Pfizer bought Wyeth in 2009, along with the rights to the vaccine.

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

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Sign-up pace much slower in week 4 of 2018 Obamacare enrollment

NEW YORK (Reuters) – The pace of people signing up for individual insurance under Obamacare slowed significantly during the fourth week of 2018 enrollment, as nearly 37 percent fewer people signed up for the healthcare plans than in the previous week, a U.S. government agency reported on Wednesday.

FILE PHOTO: A sign on an insurance store advertises Obamacare in San Ysidro, San Diego, California, U.S., October 26, 2017. REUTERS/Mike Blake/File Photo

The U.S. Department of Health and Human Services said that 504,181 people signed up for 2018 Obamacare individual insurance in the 39 states that use the federal government website HealthCare.gov for the week ended Nov. 25, down from 798,829 people in the previous week. New consumer sign-ups fell to 152,243 from 220,323 in the previous week.

Total sign-ups reached 2.78 million during the first four weeks of enrollment, which lasts through Dec. 15.

Despite the slowdown, enrollment is up from last year, according to Evercore ISI analyst Michael Newshel.

But surpassing last year’s mark will be challenging because President Donald Trump’s administration cut Obamacare advertising by 90 percent and shortened the enrollment period by half.

“Exchange enrollment could still end up more stable than initially feared,” Newshel said in a research note. “Ultimately the final outcome is still highly dependent on how strong the surge of new sign-ups is in the final days into the Dec. 15 deadline and also what happens off-exchange.”

The figures do not include enrollment in Washington, D.C., or the 11 states that run their own enrollment and websites. The subsidized individual insurance is part of former President Barack Obama’s healthcare law, commonly known as Obamacare.

Reporting by Michael Erman; editing by Chizu Nomiyama and Jonathan Oatis

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U.S. says patient charity helped drugmakers, revokes approval

(Reuters) – One of the largest U.S. patient assistance charities may close after the federal government revoked its authorization, citing findings that the group, mainly funded by pharmaceutical companies, enabled drugmakers to influence prescriptions.

The Department of Health and Human Services’ Office of Inspector General notified Caring Voice Coalition in a letter on Tuesday that it would rescind the charity’s 2006 authorization after finding that it may have given drugmakers more ability to raise prices while insulating patients from the immediate effects of increases, leaving federal health care programs like Medicare to bear the cost.

Caring Voice, headquartered in Mechanicsville, Virginia, says it is dedicated to improving the lives of patients with chronic illnesses, including helping them afford costly drugs by covering co-payments and other costs.

In recent months, companies including Pfizer Inc and Johnson and Johnson have announced that they were the subject of a U.S. probe into drugmakers’ financial support of charities offering assistance to patients seeking help to cover out-of-pocket costs. Health insurers, however, still end up paying more for the drugs they cover if prices are increased.

Drug companies are prohibited from subsidizing co-payments for patients enrolled in government healthcare programs like Medicare. But companies may donate to nonprofits providing co-pay assistance as long as they are independent.

Amid increased attention to rising drug prices, concern has arisen that donations from drugmakers to patient-assistance groups may be contributing to price inflation.

The OIG said Caring Voice “has represented it may cease operations,” but the group is not required to close down.

Officials at Caring Voice did not immediately respond to requests for comment.

Reporting By Deena Beasley; Editing by Frances Kerry

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