The Food and Drug Administration has announced it will now place warnings on the popular pain reliever acetaminophen, better known as Tylenol.
NPR reports that the goal of the agency’s action is not to make people nervous about using the drug, but rather to make the public aware that its use may cause skin disorders. This may be anything from a simple skin rash to the more serious Stevens-Johnson syndrome.
Johnson and Johnson, the manufacturer of Tylenol, said, “The FDA’s information should be viewed within the context of the millions who have benefited from acetaminophen. The skin conditions cited by the agency, including Steven-Johnson Syndrome, are extremely rare, the causes of which remain the subject of debate.”
According to The Wall Street Journal, the FDA has reported 107 cases of serious skin conditions that were possibly related to acetaminophen, from the years 1969 to 2012. Of their research they found 12 deaths. Johnson and Johnson stated they will work with the FDA with the label changes and warning.
The FDA already places warnings about the risk of these disorders on several over-the counter-drugs including Advil, Motrin, Aleve and Midol.
The Obama administration’s decision to postpone implementation of the employer mandate until 2015 has bumped the cost of the Affordable Care Act up by $12 billion, based on a new estimate by the Congressional Budget Office. Reuters reports that the delay will also leave a million fewer Americans with employer-sponsored health insurance.
“Of those who would otherwise have obtained employment-based coverage, roughly half will be uninsured (in 2014),” CBO said in a July 30 letter to Representative Paul Ryan, Republican chairman of the House of Representatives Budget Committee. The agency added that the additional cost will be reflected in insurance-coverage provisions over the next decade.
In a separate piece on the CBO report, Employee Benefits News reports that the agency noted that even with the mandate’s delay, the health law is projected to reduce the deficit because of lower Medicare spending and other provisions that offset the cost of new coverage.
Meanwhile, a National Association of Health Underwriters spokeswoman says that while there are “short-term financial repercussions” to the employer mandate delay, “we believe this delay was necessary to continue the economic upturn we have seen in the past few months and ensure that American businesses will be able to provide their employees with the health insurance they want and need in the long term.”
What started as an aid to kick the cigarette habit has fast evolved into a trendy accessory that appeals to youth and teens as well as adult smokers. But are electronic cigarettes as harmless as their makers would have us believe?
“E-cigarettes”, while designed to look like the real thing, hold a battery that heats a liquid solution into a vapor. Puff on the device as you would a regular cigarette, and the device heats the liquid and changes it to a nicotine-filled vapor.
However, unlike chewing tobacco and traditional cigarettes, e-cigarettes are not regulated by the Food and Drug Administration. While marketed as a healthy alternative to smoking, the FDA and the American Lung Association do not support such claims.
According to the Licking County Health Department, a recent analysis of ingredients in the e-cigarette cartridge found levels of cancer-causing toxins. Also, the cartridges examined were inconsistent, with some nicotine found even in a cartridge marked as non-nicotine.
Eli Alelov, CEO of LOGIC Technology, maker of LOGIC e-cigarettes, told ABC News that e-cigarettes are not a health product, even though they contain no tar or tobacco, or produce no second-hand smoke. As for their usefulness as a smoking cessation tool, “We leave that up to the public: they can use their logic.”
An advisory panel for the Food and Drug Administration has recommended that Nasacort AQ, an allergy nasal spray, to allowed to switch from prescription to over the counter (OTC).
According to Medcape Medical News, the 10-to-6 vote supported the Sanofi drug’s switch to OTC status “for the treatment of seasonal and perennial allergic rhinitis for the temporary relief of hay fever and other respiratory allergies (nasal congestion, runny nose, sneezing, itchy nose).”
Nasacort would hardly be the first allergy medication to be available over the counter, but it is the first such drug to be made available as a steroid nasal spray, which is considered more effective than antihistamines, decongestants, and mast cell stabilizers.
Panel members expressed concern that people might not read all the instructions, might not know exactly what a “steroid” medication is, and might misuse it. Members all felt that the label, which as proposed would advise parents to tell their child’s doctor before using the spray, would need to clearly list potential risks to growing children.
While the FDA is not required to follow panel recomendations, it does more often than not.
Healthy teeth can contribute to a healthy mind, a new study indicates.
According to WebMD Health News, researchers from the University of Central Lancashire School of Medicine and Dentistry used donated brain samples to study a possible connection between oral health and Alheimer’s disease. Ten of the people had dementia, while 10 did not.
The researchers found the bacteria Porphyromonas gingivalis – a bacteria that may contribute to changes in the brain, leading to confusion and failing memory – in the brains of four of those with dementia. And improper diet and brushing habits could allow the bacteria to enter the brain.
This could mean that visits to the dentist could be vital for brain health, said Sim Singhrao, PhD, a senior research fellow at the university. “The future of the research aims to discover if P. gingivalis can be used as a marker, via a simple blood test, to predict the development of Alzheimer’s disease in at-risk patients.”
Studies like this highlight the potential benefits of regular dental care. MedBen Dental emphasizes a preventive approach through regular checkups and hygiene, while offering full-scale coverage. Every basic and major dental service, from x-rays and diagnostic casts to dentures and bridges, can be covered under the plan.
For additional information about MedBen Dental, contact Vice President of Sales and Marketing Brian Fargus at firstname.lastname@example.org.
Some recent concerns that certain diabetes drugs may increase the risk of developing pancreatic cancer are unfounded, according to a spokeswoman from the Food and Drug Administration. Pharmalot reports that the agency’s conclusions about GLP-1 inhibitors are similar to those reached last week by the European Medicines Agency.
“The FDA concurs with the EMA’s conclusions regarding the potential pancreatic effects of GLP-1 based therapies,” the FDA spokeswoman wrote Pharmalot. “The agency believes that the current labeling for approved GLP-1 based therapies reflects the extent of our understanding of the safety signals at this point in time. FDA’s review is ongoing as pancreatitis and pancreatic cancer data are being collected in the cardiovascular outcome trials being conducted with this class of drugs.”
The drugs, which mimic a hormone called GLP-1 to stimulate natural insulin production, include Merck’s Januvia; Onglyza, which is sold by Bristol-Myers Squibb and AstraZeneca; Byetta, which is also marketed by Bristol-Myers; the Tradjenta treatment sold by Eli Lilly and Boehringer Ingelheim, and Novo Nordisk’s Victoza.
Earlier ths year, a study published in Diabetes found, in humans, the drugs caused “marked” cell proliferation and damage, and displayed a potential for eventually transforming into cancer. An ensuing review of pancreas from 20 deceased human organ donors with type 2 diabetes found no evidence to substantiate the claim.
In the past few weeks, the biggest news about the Affordable Care Act has included a delay in the employer mandate, a new fee for self-funded groups, and a Chamber of Commerce survey that found many small businesses were concerned about their prospects under health care reform. Small wonder, then, that the Obama administration wanted to end the month of July on an “up” note.
USA Today reports that Alan Krueger, chairman of the White House Council of Economic Advisers, recently extolled the slow increase of health care costs over the past few years, as well as positive prospects ahead. Among the facts cited:
Krueger also stressed that the ACA is not affecting job growth, as industries that have traditionally not provided health insurance for their employees, such as restaurants, have reported higher employment. Conversely, he pointed to several changes that have taken place since the health care law was enacted as reasons why costs are going down.
“The law includes provisions intended to foster coordinated care, reduce preventable health complications during hospitalizations, and promote the adoption of more efficient health information technology,” Krueger wrote.
Doctors increasingly prescribe painkillers and CT scans for the treatment of routine back pain even though clinical guidelines recommend otherwise, a new study revealed.
According to the Los Angeles Times, researchers at Massachusetts’ Beth Israel Deaconess Medical Center and Harvard Medical School found that from 1999 to 2010, prescriptions for narcotic painkillers to treat back pain jumped 51%. Simultaneously, prescriptions for non-opiate drugs had fallen by the same amount.
The study authors wrote that “well-established guidelines for routine back pain stress conservative management, including use of nonsteroidal anti-inflammatory drugs (NSAIDs) or acetaminophen and physical therapy.” But while physical therapy remained steady during the study period, more and more doctors choose opoids over NSAIDs, in spite of an earlier analysis that showed painkillers to be ineffective for acute or chronic back pain.
The medical guidelines also recommended that doctors avoid early imaging or other aggressive treatments, except in rare cases. But researchers found that the use of computed tomography (CT) or magnetic resonance imaging (MRI) had increased by 57% over the study period.
MedBen has composed a paper that offers recommendations to address the emerging issue of pain management. To receive a copy, we invite you to contact our Sales & Marketing Department at (888) 627-8683.
John R. Graham, a chartered alternative investment analyst, offers a cautionary note to businesses regarding the 12-month delay of the employer mandate:
“[E]mployers need to be aware that they are offered only ‘transition relief’ for next year. IRS Notice 2013-45 states that employers are ‘encouraged to voluntarily comply with the information reporting provisions for 2014.’ Although political analysis suggests that the ‘relief’ will roll over to future years, the Notice waives only reporting requirements. Treasury cannot waive the actual tax.
“As a result, there may be little relief even from ‘red tape’. Will auditors grant relief from reporting a tax liability to businesses which owe the tax in 2014? This should be a topic of intense discussion within the accounting profession. If the profession sticks to the letter of the law, auditors will demand that businesses prepare good-faith calculations of taxes due to the employer mandate, and not to write them off until legislation really ‘fixes’ the problem. This should concern not only small business, but large businesses with low-wage hourly workers or franchisees.
“The delay of the employer mandate has caused more headache than relief.”
The U.S. Preventive Services Task Force has endorsed annual CT scans to detect lung cancer in current and former smokers, The Wall Street Journal reports. By doing so, about 20% of lung-cancer deaths might be avoided, the task force concluded.
“We might be able to prevent 20,000 deaths” yearly, estimated Michael LeFevre, co-vice chairman of the USPSTF.
The task force recommended that people consider screening for lung cancer if they are current or former smokers between the ages of 55 and 79, and have smoked the equivalent of a pack of cigarettes a day for 30 years and have smoked within the past 15 years.
But not everyone agrees that an annual test, which can cost $100-$300, is a good idea. A separate panel of doctors advising the National Cancer Institute cautioned that too much screening and too much early treatment can sometimes be harmful to patients.
“Physicians, patients and the general public must recognize that overdiagnosis is common and occurs more frequently with cancer screening. Overdiagnosis, or identification of indolent cancer, is common in breast, lung, prostate and thyroid cancer,” the doctors wrote in the Journal of the American Medical Association.
“We believe the benefits do outweigh the harms,” countered LeFevre, adding that the decision was largely based on a 2011 study sponsored by the NCI.
Employers are reporting greater satisfaction with health plan costs, based on the findings of the J.D. Power 2013 Employer Health Plan Study.
According to Employee Benefits News, the improved satisfaction is due in part to the increased availability of consumer-driven health plans. Over 80% of employers say that offering workers individual accounts to pay health case bills is helping to control costs.
Employer satisfaction with costs “went up significantly in all the attributes we measure. Significantly more employers are offering CDHP products to their employees and so that has been a cost shifting measure that they are satisfied with,” said Scott Hawkins, director of health care for J.D. Power.
Hawkins did note that employees need education on the proper use of the plans to ensure their higher satisfaction as well. “So I think it’s really important that employers work with the health plans to help their members understand how to manage those costs once they’re on those products or they’re going to have dissatisfied employees,” he said.
MedBen offers a complete line of CDHPs for self-funded and fully-insured groups. Plus, we offer on-site training to help ensure that plan members understand how to best use their account, and convenient online services that allow easy plan management.
As a Midwest leader in CDHP administration, MedBen the expertise to develop a health care plan that maximizes employer savings while still providing comprehensive benefits at competitive prices. To learn more, contact MedBen Vice President of Sales & Marketing Brian Fargus at email@example.com.
Asking questions is part and parcel of being a doctor, so it should come as little surprise that many doctors have questions – and no small degree of skepticism – about the Affordable Care Act.
According to NBC News, a new survey reveals that nearly 90% of physicians don’t think that their state’s new health insurance exchanges will meet the October 1 deadline to begin enrolling the uninsured. Further, about two-thirds of doctors who do believe the exchanges will be operational that day said they are “not at all familiar” with how important aspects of them work.
Shane Jackson, president and COO of LocumTenens.com, which conducted the survey, noted that a lack of knowledge about how exchanges work could affect their bottom line as well as their patients, who “rely on their doctor for a lot of information.”
Among other survey findings:
A few weeks back, we highlighted an article by a family physician that cautioned individuals about the dangers of using the Internet to self-diagnose medical concerns. Dr. Kenneth Lin warned that many health websites contain “flawed, inaccurate, or biased” information, and that any advice found online should only be followed in conjunction with a doctor’s care.
Still, with our increased reliance on the Internet as a repository of information, it’s unrealistic to expect that people won’t research just what may be causing their sore throat and headaches. So rather than warn patients away from the web, some physicians are doing just the opposite:
“Now more health-care providers are turning the tables, steering patients to new and improved computerized symptom-checkers that make it easier for them to get reliable information about possible diagnoses, research their condition and even connect directly to a doctor. Doctors are adding these tools to their websites and incorporating them into electronic medical records, encouraging patients to use them before office visits to save time and make consultations more productive. Another benefit: Results turned up by a symptom-checker may actually help doctors think of something they hadn’t considered.
“‘Patients are experts on their symptoms and doctors are experts in working out their probable causes,’ and need to work together to formulate a list of possible diagnoses, says Jason Maude, chief executive of Isabel Healthcare, launched in 2001 as a professional online diagnostic checklist for doctors.’
While many Americans are still willing to give the Affordable Care Act the benefit of the doubt, negative feelings about the health care reform law persist, two new surveys find.
According to Healthwatch, a new CBS poll revealed that 39% of the voters it surveyed want to repeal Obamacare, compared with 36% who said it should be left alone or expanded. The network noted it’s the most support its poll has ever found for repeal.
Results from the latest United Technologies/National Journal Congressional Connection Poll found a similarly high level of dissatisfaction, though many respondents said they aren’t ready to give up on the law quite yet. Given the choice to either repeal the ACA, wait and see how it takes effect, or add money to aid its implementation, 36% of adults picked outright repeal, while 30% chose to wait and see and 27% felt we should provide more money.
Asked their attitudes about the law in general, the CBS survey showed that the majority of respondents don’t think much of it: 54% said they disapprove of Obamacare, compared with just 36% who said they approve.
Menthol cigarettes may soon be in the government’s crosshairs. The Food and Drug Administration announced yesterday that the agency will consider stricter controls on the flavored cigarettes based on public feedback, the Hill’s RegWatch blog reports.
“Menthol cigarettes raise critical public health questions,” said FDA Commissioner Margaret Hamburg in a statement. “The FDA is committed to a science-based approach that addresses the public health issues raised by menthol cigarettes, and public input will help us make more informed decisions about how best to tackle this important issue moving forward.”
The agency is releasing data to the public to help it make an evaluation, including a study suggesting that menthol cigarettes could make it easier for people to begin smoking.
“While there is little evidence to suggest that menthol cigarettes are more or less toxic or contribute to more disease risk to the user than nonmenthol cigarettes, adequate data suggest that menthol use is likely associated with increased smoking initiation by youth and young adults,” the report found. “Further, the data indicate that menthol in cigarettes is likely associated with greater addiction.”
The report concludes that the data “make it likely that menthol cigarettes pose a public health risk above that seen with nonmenthol cigarettes.”
MedBen is pleased to announce the promotion of Erin Kelly to Group Leader of the Compliance Department. In her new role, Erin will manage the department’s daily operations in addition to working with clients to ensure that their group health plan documents adhere to federal and state regulations.
“As new health insurance regulations have been introduced under the Affordable Care Act, it’s crucial that we continually review our groups’ documents and make whatever changes are needed to keep them up to date,” said Annette McNair, MedBen Director of Compliance and Medical Management. “Erin has done a great job working with our clients in that role, and we know she’ll bring the same professionalism to managing the Compliance team.”
A 13-year veteran of the health care industry, Erin joined MedBen in 2007 as a Customer Service Representative. Prior to joining the Compliance Department last year, she also assisted clients as a Group Service Representative.
Erin is a graduate of George Mason University with a Bachelor of Arts in History. She resides with her husband Warren and two children in Heath, Ohio.
A new study contends that echocardiograms, while safe, are often unnecessary. Only one-third of patients who receive the noninvasive ultrasound heart tests see a change in treatment, HealthDay News reports.
“The majority of echocardiograms are appropriate in terms of current guidelines,” said lead researcher Dr. Susan Matulevicius, an assistant professor at Texas Southwestern Medical Center. “But no one has looked at what an echo does to change a patient’s management.
“If we keep using echoes all the time just because we can and we are not going to be doing something with that information, you are just using health care dollars that could have been used for someone else,” Matulevicius said.
Echocardiograms cost between $100 and $1,000, and account for almost half of all cardiac-imaging services performed in the country, according to the study. In 2010, echocardiograms accounted for more than $1.1 billion, or 11%, of total Medicare imaging costs, the researchers said.
Millions of dollars could be saved each year if only patients who needed the test got it, Matulevicius said.
The contraception mandate isn’t as broad as some critics make it out to be – but that doesn’t make the rule any less bewildering, POLITICO reports.
A provision of the The Affordable Care Act, the mandate require employers to cover birth control for female members. However, not every type of contraceptive approved by the Food and Drug Administration must be covered – and for some products, employers can charge a co-pay as long as they offer others for free.
Of course, while such flexibility may make the contraception mandate a less expensive proposition, it carries the potential for administrative headaches. And as the POLITICO article notes, a woman may not know precisely which category her specific prescription falls into until the pharmacy rings it up, as coverage costs may differ if a doctor gives her a specific prescription for health reasons.
Guidance on the mandate released by the federal government has so far done little to clear up the confusion. Instead, the rule permits plans to exercise “reasonable medical management.” That means the coverage requirement is satisfied if the plan offers options in each of five major contraceptive categories: barrier methods, hormonal methods, implanted devices, emergency contraception and permanent methods.
Employer Benefits News offers a timely reminder that most self-funded employers will need to file and pay by July 31 their first round of federal comparative effectiveness research fees imposed under the Affordable Care Act. The “PCORI fee", as it’s known, will fund comparative clinical effectiveness research to be conducted by the newly-established, non-profit Patient-Centered Outcomes Research Institute.
For the first plan year ending on or after October 1, 2012, a self-funded employer is required to pay a $1 fee for each individual covered under the group health plan. The total amount must be reported on IRS Form 720 and paid by no later than July 31 of the calendar year following the end of the relevant plan year. The amount of the fee will increase to $2 per covered individual for the following plan year, and will be increased further for inflation in subsequent years.
The IRS Office of Chief Counsel recently confirmed that PCORI fees paid by an employer are tax-deductible.
While the MedBen team cannot file the Form 720 on behalf of our self-funded groups, we will gladly provide help and advice. Clients with questions about the PCORI fee may contact Vice President of Compliance Caroline Fraker at firstname.lastname@example.org.
A recent Government Accountability Office report warns Americans about the risks of buying prescription drugs from Internet pharmacies, USA Today reports.
Federal investigators say that rogue Internet pharmacies skirt U.S. and state regulations and sell misbranded, adulterated and counterfeit drugs. Most of these operations are located overseas, which often puts them beyond U.S. enforcement action, and are also skilled at avoiding detection and identification.
According to the Food and Drug Administration, one in four online consumers has purchased medications online. Even though the agency has shut down thousands of illegal online pharmacies in recent months, there were more than 34,000 active rogue websites as of April 2013, according to Internet pharmacy verification service LegitScript.
To help educate the public, the National Association of Boards of Pharmacy publishes on its website a list of legitimate and illicit Internet pharmacies as a consumers’ guide. Additionally, both Google and UPS have stopped doing business with rogue pharmacies.