A program designed to help people who can’t afford prescription medications has recently come under government scrutiny, Pharmalot reports.
Created in 1992, the 340B Drug Pricing Program offers discounts to public and non-profit health care facilities that provide outpatient drugs. Through the program, participating hospitals and clinics can realize savings of 20-50% off the cost of drugs – and potentially generate additional revenue if government reimbusements exceed prices paid.
But a 2011 report by the US Government Accountability Office found that oversight of the program is inadequate to ensure that participating facilities administer the discounted drugs only to eligible patients, and that drugs are sold to those facilities at or below agreed upon prices. And last week, four Republican members of Congress wrote to several pharmaceutical organizations, including Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Organization (BIO), to request detailed information about 340B pricing and audits, and address possible incidents of hoarding.
“With the reliance on self-policing among participating manufacturers and covered entities and the increase in the number of new settings in which the program is offered, the risk of improper purchases or diversion of 340B drugs has significantly increased,” wrote US Senators Orrin Hatch, Chuck Grassley and Mike Enzi, as well as Congressman Joe Pitts.
The Department of Health and Human Services has released a final rule for the implement of state health insurance exchanges, a cornerstone of the Affordable Care Act. The 644-page document outlines details of the insurance marketplaces that will enable uninsured individuals and small businesses to purchase coverage beginning in 2014.
“The final rule outlined the minimum standards states must meet in establishing and operating their exchanges, such as individual and employer eligibility for enrollment. The rule also outlines minimum standards that health insurers must meet to participate in an exchange and the standards employers must meet to participate in the exchange.
“The regulation aims to offer states ’substantial discretion’ in both the design and operation of their exchanges, according to the rule.”
The rule will become effective 60 days after publication in the Federal Register. However, HHS will accept comment on some sections of the regulation, such as “provisions related to the ability of a state to allow agents and brokers to assist qualified individuals in applying for advance payments of the premium tax credit and cost-sharing reductions for qualified health plans, Medicaid and CHIP regulations, options for conducting eligibility determinations and verification for applicants,” as Modern Healthcare notes.
No doubt you’re aware there’s been a lot of talk about birth control lately. Under the Affordable Care Act, contraceptive coverage must be provided to women at no cost beginning August 1. But while the religious and moral implications of this rule have grabbed the headlines, of equal importance is just how far-reaching coverage is expected to go.
There are still a number of unanswered questions about what types of birth control must be covered and how insurers should structure their policies. So Kaiser Health News recently dove headfirst into the regulatory morass and attempted to clear things up a bit. You can read the complete answers at their website, but we’ll provide a preview here:
Are male-based contraceptive methods, such as vasectomies or condoms, covered by the rule? According to a Health and Human Services official, the preventive services guidelines apply to women only.
Are over-the-counter products like female condoms, spermicides, sponges covered by the rules and, if so, will they require a prescription and how will insurers reimburse policyholders for purchases at retail stores? Products that must be covered without cost-sharing include over-the- counter contraceptives when they are prescribed by doctors, the HHS official said. But what specific OTC products are to be included is unclear.
If a hospital stay is required for surgical procedures, such as when a women gets her tubes tied, would the procedure be covered without cost sharing? HHS has not weighed in on this question, but is expected to issue additional guidance in the coming months.
Will insurers be required to cover all products in a class, such as all IUDs, or all birth control pills? Can insurers require a co-pay for a brand-name drug if a generic is available? Insurers say HHS guidance allows them to use “reasonable medical management” to help control costs, which would include allowing them to charge patients for brand name drugs. The HHS official concurred, but stressed the plan must “accommodate any individuals for whom it would be medically inappropriate by having a mechanism for waiving the otherwise applicable cost-sharing for the branded version.”
Who will be covered for contraceptives without co-payments? The package of women’s preventive care benefits must be offered in all new insurance policies sold to individuals and employers starting Aug. 1, as well as in most policies that renew afterwards on the date that they renew. There is an exception for insurance provided by certain nonprofit religious employers who object to birth control.
The Food and Drug Administration may allow popular prescription drugs for high cholesterol, diabetes and other chronic conditions to be sold over the counter. Reuters reports that the agency has sought public comment this week on a plan to make these medications more readily accessible, and will hold a meeting about the proposal later this month.
Previously, the FDA had denied requests to sell cholesterol-lowering drugs without a prescription because of concerns that patients wouldn’t know how to take the drug safely. Proper use requires a knowledge of fat elevations in the blood, known as lipids, which consumers cannot easily determine.
Even considering such a change marks a major turnaround for the agency. Typically, over-the-counter drugs treat such short-term conditions as headache or runny nose, and require only a factbox or pamphlet to take safely. But as Reuters notes, such new technologies as self-serve kiosks, touchscreen pads or interactive videos may help to educate pharmacy customers about drug risks.
By increasing availability, the FDA is hoping that people with chronic conditions would be more vigilant about taking their medications.
A new study demonstrates that stick-to-it-tiveness pays big dividends when it comes to employee health. According to Medical Xpress, researchers found that employees who participated in a wellness program spent less on health care, while employers realized a return on investment (ROI) of almost $3 to $1 over three years.
To determine ROI, the study’s authors tracked the wellness program of a large financial services corporation. Analyzing participation and medical claims data for close to 50,000 employees, and factoring in the program’s implementation costs, they revealed a loss in year one with net savings in years two and three – a 2.45:1 overall ROI.
At MedBen, our clients have realized similar positive outcomes through our worksite wellness program. Our original idea was simple – detect and treat health risks and potentially chronic conditions as early as possible. And provide clear reports that show employers how the program is working.
We chose to offer a wellness program that involves your physicians and uses claims data to track progress. And employers who have put this program in place several years ago have seen measureable results – in a healthier workplace and a healthier bottom line.
To learn more about how wellness can benefit your business, we invite you to call MedBen Vice President of Sales and Marketing Brian Fargus at (888) 627-8683.
A consumer watchdog group’s claim that some popular soft drinks contains a cancerous chemical has brought a rebuttal from the Food and Drug Administation, Reuters reports.
The Center for Science in the Public Interest (CSPI) said Coca-Cola, Pepsi-Cola and Dr. Pepper contain unsafe levels of 4-methylimidazole (4-MI) in their caramel coloring agents. “Coke and Pepsi, with the acquiescence of the FDA, are needlessly exposing millions of Americans to a chemical that causes cancer,” said CSPI executive director Michael Jacobson.
In response, the FDA said it would consider the group’s petition but consider the drinks safe. “A consumer would have to consume well over a thousand cans of soda a day to reach the doses administered in the studies that have shown links to cancer in rodents,” noted Doug Karas, an FDA spokesman, in a statement.
The FDA’s limit for 4-MI in caramel coloring is 250 parts per million (ppm) prior to its dilution in soda. The highest levels of 4-MI found by CSPI were about 0.4 ppm, according to Reuters calculations.
The American Beverage Association also issued a statement: “This is nothing more than CSPI scare tactics. In fact, findings of regulatory agencies worldwide… consider caramel coloring safe for use in foods and beverages.”
Electronic patient records have been the subject of multiple studies, which have borne out the theory that the health information technology (HIT) reduces costs. But new research that focuses on how such information is used paints a very different picture.
According to The Wall Street Journal Health Blog, a study of medical test availability found that doctors who had computerized access to imaging tests and lab results were actually more likely to order more tests (in 18% of visits) than those who used paper records (12.9%). When more advanced imaging tests were considered, the difference spiked to 71% for doctors with electronic access.
So what’s going on here? The research isn’t clear on this point, but study co-author Danny McCormick of the Cambridge Health Alliance says he and his fellow authors speculate that because test results often fall in a grey area, “subtle factors such as the convenience of retrieving results” may spur a doctor to order an additional test.
“If [doctors know] that the image result will show up on the screen with no questions and no problems, it may subtly influence them to order” the test, says McCormick. Further, as the study observes, doctors who typically order tests may also be more likely to have HIT in place – making all the easier to view those tests.
An interesting opinion piece in the New York Times yesterday. Samuel D. Waksal, founder and chief executive of the biotechnology company Kadmon, believes that patients and insurance companies shouldn’t have to pay for prescription drugs unless they produce positive and provable results.
“Here’s how this ‘pay-for-response model’ would work: Say a drug company receives approval for a breast cancer drug. Potential patients would be screened to determine whether their cancer was likely to respond to the drug, depending on whether it had, for example, a particular genetic marker. Most of the cancers that do should respond to the drug, but the presence of the genetic marker is still no guarantee. The Food and Drug Administration could help to come up with criteria with which to determine whether a patient is responding to a drug. If the patient’s oncologist and radiologist determine that the patient is benefiting based on those criteria, then the drug company should be paid. For a cancer drug, these criteria could include anything from tumor shrinkage to survival…
“Not only would this save money, but it would also push drug companies to figure out why certain patients don’t respond to treatment and what to do about it, and researchers to aggressively study genetic variation in disease before beginning larger studies. It would also encourage testing with multiple drugs, approved and experimental, to target just the right pathways of disease in each and every population. Biotechnology companies like mine could stand to profit from this change, but the overall gains to the health care system would be far larger.”
The complete editorial is available on the Times website. (The paper does note that, prior to his work at Kadmon, Waksal spent five years in prison for insider trading.)
If you’ve checked your calendar lately, you may be aware that we’re fast approaching one of the most dreaded days of the year. Sunday, March 11 heralds the return of daylight savings time – which means one less hour of precious slumber.
Nor are the irritations of “springing forward” limited to losing sleep and resetting the clocks. According to Aparajitha Verma, M.D., medical director of the Sleep Disorders Center at the Methodist Neurological Institute in Houston, the average person needs about three or four days to adjust to the time change.
However, there are a few simple strategies minimize the impact to your internal clock. Verma suggests getting up an hour earlier and going to sleep an hour earlier. Take a nap in the afternoon on Sunday if needed, but not within a few hours of bedtime. Napping too close to bedtime can disrupt nighttime sleep.
An even better approach is to practice good “sleep hygiene” year-round, by following these tips (via Medical Xpress):
The Wall Street Journal Health Blog reports that only 10% of coronary stent recipients are given information on alternative treatment options, based on a survey of nearly 500 Medicare patients.
The study – which, it should be noted, was based solely on the patient’s recollection of events – also found that only 19% of coronary stent recipients recalled discussing the drawbacks of the procedure, and only 16% recalled being asked their preferences for treatment type.
A coronary stent is a tube placed in the heart arteries to keep the vessels open. According to Reuters Health, stenting procedures cost the United States about $12 billion every year and up to half of the procedures are unnecessary.
At MedBen, we promote informed heart treatment through Comprehensive Cardiovascular Care Management. Provided through inVentiv Care Management, this clinically accountable solution focuses on cost-effective, safe, and integrated care management for patients affected by cardiovascular disease.
Care management does not and will not overrule the decisions of a patient’s physician. It merely works with the doctor to ensure that the patient is receiving the proper level of treatment, and that his or her care is eligible for coverage under your company’s health care plan.
For additional information about Comprehensive Cardiovascular Care Management and other Accountable Care Solutions available through MedBen, contact Vice President of Sales and Marketing Brian Fargus at (888) 627-8683.
New presidential budget numbers that spike the estimated cost of government insurance subsidies has Republicans on Capitol Hill demanding an explanation, the Associated Press reports.
House Ways and Means Committee Chairman Dave Camp (R-Mi.) wants to know why revised budget numbers put the cost of helping individuals buy health coverage from state exchanges at $478 billion for the years 2014-2021 – about a 30% jump from last year’s budget estimate of $367 billion.
“This staggering increase … cannot be explained by legislative changes or new economic assumptions, and therefore must reflect substantial changes in underlying assumptions regarding … costs,” Camp wrote in a March 2 letter to Treasury Secretary Tim Geithner.
Administration officials claim the increase is due primarily to the effects of newly signed legislation that will raise the cost for one part of the Affordable Care Act, but still save money overall. “The estimates do not assume changes in what exchanges look like, the cost of insurance, or the number of Americans who will get their insurance in this new marketplace,” Treasury spokeswoman Sabrina Siddiqui said in a statement.
If you’re really determined to lose weight, it may aid your cause to hook up with some like-minded people. A recent study suggests that a dedicated team effort helps participants shed at least 5% of their initial body weight, according to WebMD.
“People around us affect our health behaviors,” says researcher Tricia Leahey, PhD. “It could be quite beneficial if a bunch of friends that choose to lose weight make healthy food choices together, and hold each other accountable to those choices.”
Researchers followed a 12-week online weight loss competition in 2009, composed of teams with between 5 and 11 members. They found that people who lost who lost a significant amount of body weight tended to be on the same teams, motivating each other. “If someone is doing really well, it could influence the whole group,” Leahey says.
Noteworthy in the study was the “virtual” nature of the teams, with members getting together via the web. “Social support helps people to do better, and there are a variety of ways to accomplish it,” says Louis Aronne, MD, founder and director of the Comprehensive Weight Control Program.
Does the thought of a dental exam make your teeth chatter? Chances are, your anticipation will far exceed the actual event. But if that knowledge does nothing to calm your fears, WebMD offers a few suggestions, which we summarize here (you can read detailed tips at their website):
By the way, if you’re covered under a MedBen Dental plan, here’s something else to keep in mind: Members have complete freedom of provider choice, so there are no limitations as to which dentist you can use. If one doesn’t “cater to cowards” as advertised, you’re welcome to take your teeth elsewhere.
Employers who would like to know more about MedBen Dental can contact Vice President of Sales and Marketing Brian Fargus at (888) 627-8683.
Unpleasant written warnings about the hazards of smoking will not be accompanied by even more unpleasant visual warnings. According to The Wall Street Journal Health Blog, U.S. District Judge Richard Leon ruled that the federal requirement to place graphic images on cigarette packs is unconstitutional.
The Food and Drug Administration announced the requirement in 2010, with the hopes that by displaying diseased lungs, tracheotomy holes and other disturbing imagery on packages, smokers would think twice before reaching for a cigarette. R.J. Reynolds and other tobacco companies filed a lawsuit against the agency last August, claiming that the rule violated their First Amendment protections against government-compelled speech.
In his ruling, Leon said that the Obama administration failed “to convey any factual information supported by evidence about the actual health consequences of smoking through its use of these graphic images.” He added that the government could have used alternative means to promote an anti-smoking message, such as changing the images to provide actual information rather than simply evoke an emotional response.
In November, Leon had halted the FDA requirement from moving forward pending the outcome of the lawsuit. At the time, he noted that cigarette makers would likely succeed in their effort.
Sometimes, its seems like the more we learn about better health, the less we know. New research can modify or even negate the wellness information that we’ve taken as gospel for years.
Leslie Goldman at Oprah.com recently examined four extablished health rules that no longer hold water – one, literally – and new rules to consider in their place. We’ve summarized them below.
Old Rule: Drink eight glasses of water a day. New Rule: Eat your water.
Much of your daily requirement of water is contained in foods, such as fruits, vegetables, beans, and cooked whole grains like oatmeal. And they offer the added bonus of nutrients.
Old Rule: Eat nine servings of fruits and vegetables. New Rule: Fill half your plate with produce.
Put away the measuring tools, and just make half of every meal produce. And quality counts: Even two or three daily servings of deeply hued fruits and veggies (like blueberries or red peppers) may help reduce your risk of cancer and heart disease.
Old Rule: Avoid red meat. New Rule: Beef in moderation can be healthy.
A recent study found that the cardiovascular risk of red meat comes from processed varieties, such as sausage, hot dogs, and cold cuts – not from steak and hamburgers. Three 4- to 5-ounce servings per week is a good source of iron and immunity-boosting zinc.
Old Rule: Keep your BMI between 18.5 and 24.9. New Rule: Eat healthy, exercise, and let your weight settle naturally.
Cirtics say body mass index ignores a person’s muscle mass and hip circumference. Instead of BMI, focus on eating a nutritious diet and logging 150 minutes of exercise per week.
By a narrow 51-48 vote – mainly along party lines – the Senate rejected an amendment that would have exempted employers and insurers from covering contraceptive devices if it went against their moral beliefs, NPR reports.
Missouri Republican Roy Blunt, who sponsored the amendment, said it was meant to protect First Amendment rights. “The first freedom in the founding documents is freedom of religion,” he said.
Democrat Frank Lautenberg of New Jersey said he found the amendment’s language vague, in that it appeared to give employers the right to opt out of any benefit to which they considered objectional. “Imagine that your boss is going to decide whether or not you’re acting morally,” he said.
In related news, a new poll from the Kaiser Family Foundation found that most Americans also support the birth control mandate. While reponses were divided based on age and political affiliation (see chart below – click to enlarge), 63% overall said health plans should provide free contraceptives.
A class of popular prescription sleeping pills may increase the user’s risk of death, according to a new study. WebMD reports that the pills in question, called hypnotics, include such popular drugs as Ambien, Lunesta and Resterol.
Using 2002-2007 data from a large Pennsylvania health system, researchers reviewed medical records for 10,529 people who were prescribed hypnotic sleeping pills and matched them with 23,676 patients who were never prescribed sleeping pills. They found that the top third of sleeping-pill users had over a five times higher dealth risk, as well as a 35% greater risk of cancer.
Hypnotic pills differ from other types of sleeping aids, in that they actually cause a person to fall asleep. By contrast, a supplement like melatonin promotes sleep through relaxation.
Sanofi-Aventis, the maker of Ambien, responded in a statement to WebMD: “Ambien has more than 17 years of real-world experience and is safe and effective when prescribed and taken according to its labeling.”
Also questioning the study’s validity is Nancy Collop, MD, president of the American Academy of Sleep Medicine. “You cannot assume, just because you find this kind of association, that hypnotics are killing people. People who go on sleeping pills are a sicker population. I know they tried to control for that, but these people simply are not as healthy,” she said to WebMD.
Another provision of health care reform is in danger of getting the boot – but unlike the Supreme Court-bound individual mandate, this one is threatened by the legislative branch.
According to the Hill’s Healthwatch, the House Energy and Commerce Health subcommittee today voted 17-5 in favor of repealing the Affordable Care Act’s Independent Payment Advisory Board. The 15-member board can recommend provider payment cuts if Medicare costs grow faster than a targeted amount (Congress can overrule its suggestions with a supermajority, however).
All but two of the votes for repeal were by Republicans, who early on derided the IPAB as a “death panel” or “rationing board". Prior to the vote, Subcommittee Chairman Joe Pitts (R-Pa.) argued that the board would supplant lawmakers’ ability to run Medicare policy.
“[Supporters of IPAB] are not troubled by the fact that there is no requirement for public comment prior to IPAB issuing its recommendations,” Pitts said. “That IPAB’s actions are not subject to judicial review does not alarm them.”
Committee member Rep. Henry Waxman (D-Ca.) countered that the board merely serves as a means to control Medicare health spending in Congress. “We all hope the IPAB will be irrelevant. If the Act works… it will be,” he said. “Let’s recognize today’s vote for what it is: an attempt to discredit the Affordable Care Act and embarrass the president.”
Earlier this week, the American Medical Association reiterated its support for appealing IPAB. You can also read more about that at the Healthwatch blog.
Makers of statins must revise their labels to warn about risks of elevated blood sugar levels – a cause of type 2 diabetes – and memory loss, HealthDay reports. The Food and Drug Administration made the announcement, but also stressed that the benefits of the cholesterol-lowering drugs far outweigh the potential dangers.
“We want health-care professionals and patients to have the most current information on the risks of statins, but also to assure them that these medications continue to provide an important health benefit of lowering cholesterol,” Dr. Mary Parks, director of the FDA’s Division of Metabolism and Endocrinology Products, said in a news release. The agency made the change following recent clinical trials and isolated reports of side effects.
The full list of statins include: Lipitor (atorvastatin), Lescol (fluvastatin), Mevacor (lovastatin), Altoprev (lovastatin extended-release), Livalo (pitavastatin), Pravachol (pravastatin), Crestor (rosuvastatin), and Zocor (simvastatin). Combination products include: Advicor (lovastatin/niacin extended-release), Simcor (simvastatin/niacin extended-release), and Vytorin (simvastatin/ezetimibe), the FDA said.
Statins are popularly precribed to patients who have high cholesterol or at risk for fatal and non-fatal cardiovascular events. Healthy individuals with one or more cardiovascular risk factors can also benefit from the drug.
A recent study of over one million female patients revealed that women having heart attacks are less likely to seek immediate care than men, and more likely to die in the hospital.
USA Today reports that many women fail to take advantage of such treatments as clot-busting drugs, balloon procedures to open the arteries or bypass surgery. Consequently, 15% of female heart attack patients die in the hospital, compared with 10% of men. And that doesn’t take into account women who don’t make it to the hospital in the first place.
One thing working against females, especially younger ones, is that they appear less likely to suffer chest pain or pressure – 42% of the women studied didn’t experience this classic heart attack symptom, compared to 31% of men. But they may develop shortness of breath, nausea, vomiting, light-headedness and pain in the back or jaw, according to the American Heart Association. A sudden onset of fatigure may also be a warning sign.
Men and women alike should know their cholesterol levels, blood pressure and blood sugarcardiologist, notes Nieca Goldberg, medical director of NYU Langone Medical Center’s Tisch Center for Women’s Health. “We should use this study as an eye-opening bit of news to these women,” she says.