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Has your health insurer denied your care?…. how to appeal !!!
Posted on November 28, 2018 by Pharmaciststeve
CMS proposal would leave HIV therapies as well as antidepressants and cancer treatments unprotected
Posted on November 28, 2018 by Pharmaciststeve
Trump Medicare Plan Targets Drugs From AstraZeneca to Roche
The latest proposal from the U.S. Centers for Medicare and Medicaid Services (CMS) to let insurers use step therapies, or to drop protections on certain classes of drugs if price increases outpace inflation, may harm a wider circle of drugmakers, ranging from GlaxoSmithKline to Gilead.
Amgen, Regeneron Pharmaceuticals and Roche Holding are often cited as the drugmakers having the most to lose in proposed changes to Medicare. Regeneron’s Eylea, Roche’s Avastin and Amgen’s franchise of blood boosters get a good part of their revenue from sales under Medicare. Yesterday’s
CMS proposal would leave HIV therapies as well as antidepressants and cancer treatments unprotected.
Gilead and Glaxo, as the top HIV manufacturers, as well as makers of anti-depressants and antipsychotics like AstraZeneca, Pfizer, Allergan, Bausch Health, Lilly and Otsuka Holdings may face new challenges and may be deterred from price hikes, Height analyst Andrea Harris wrote in a note to clients. Harris predicts “a fairly modest impact on drug manufacturers and Medicare plan sponsors” overall and says the final rule, expected by April, will likely differ from the proposal.
Veda analyst Spencer Perlman agrees. “Whether this policy will be finalized is an open question; it remains to be seen if CMS can withstand withering political pressure likely to come from patient advocacy groups concerned with the potential loss of access to certain medications.”
The proposals may be a boon for insurers though, and also favor pharmacy benefit managers. UnitedHealth, for example, is already using step-therapy, where patients try cheaper drugs first before turning to more expensive treatments, in some of its Medicare Advantage plans, Perlman noted.
New rules could benefit UnitedHealth, Humana and WellCare the most, while Aetna, Anthem and Cigna may be less affected, Leerink analyst Ana Gupte wrote. She sees insurers spending less on drugs, and an enhanced role for private plans in the future. And Evercore ISI’s Ross Muken sees PBMs getting “incremental negotiating leverage” where they previously had none.
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That NOISE you hear is the Medicare Part D program CRASHING
Posted on November 28, 2018 by Pharmaciststeve
Don’t look now… but the Medicare folks who are chronic pain pts are at risk of being sucker punched by their Part D and/or Medicare Advantage programs. Medicare open enrollment period is now open and closes on Dec 7th.
CMS has given these FOR PROFIT private insurance companies some dosing guidance on opiate and other controlled substances. This is where things get FUZZY… apparently these companies can put into effect any limits they wish up to the limits issued by the CMS.
Apparently – per CMS – there are soft edits at 90 MME and supposedly the pharmacist can override this fairly easily and then there is a HARD EDIT at 200 MME – NOT ABOVE 200 MME – so if you are taking MS Contin 100mg twice daily… you have hit the HARD EDIT – how stupid is that.
From what I understand once you reach the HARD EDIT level… is when the insurance companies DECIDES if you really need that high a dose… remember we are dealing with FOR PROFIT INSURANCE COMPANIES and denial of care of pt’s medication needs… will drop directly to their net profit/bottom line.
Now here is where pts may get really screwed… in about 10 days (Dec 7th) open enrollment ends for Medicare… BUT.. the insurance companies are not going to announce/publish their final dosing limits until maybe as late as Jan 1, 2019. So no matter what program that you are signing up for now… may end up being a “pig -in – a-poke” because what ever they claim is their policies may or may not have any relationship to what their policies are going to be come 2019. AND… you can’t make any changes to your insurance provider until the end of 2019 for 2020.
Back in jan , 2006 when Medicare Part D program was first implemented, maybe pts should consider this may happen again in 2019 when these new dosing guidelines are implemented. There was a lot of Medicare folks back in 2006 that showed up at the pharmacy on Jan 1, 20016 with their new Part D insurance card – out of medication – and expecting to get part of the medication costs covered.. Problem was this new system CRASHED… pharmacists in every store in every state… couldn’t get claims processed.
At that time, expecting something like this would happen … I made sure that Barb had enough medication to last until at least mid-January and when she need her refills… all of the “bugs” in the system had been worked out and refilled in a timely manner.
This year Dec 31st is a Monday and I would not be surprised to see some/many/all of these Medicare insurance programs will not publish their new dosing policies until that day.. and .. of course the next day being a national holiday… many pharmacies will be open but few/no prescriber’s office will be.
DEA law permits a prescriber to prescribe a 90 days supply of opiates and other controlled substances, state laws and insurance policies may or may not allow this.
I have already talked to our PCP about getting a 90 days supply of controls in Dec and he is fine with it.
Keep in mind that there are some 130 million people on Medicare medication program of one form or another.
This year Jan 1, 2019 is a TUESDAY, everyone is going to be coming back to work from a THREE – FOUR DAY weekend.
I would not be surprised to see these Part D programs to publish their NEW GUIDELINES late on FRIDAY Dec 28, 2018 and not be back in business until Jan 2, 2019. How many of those 130 million Medicare folks are going to be finding out that their controlled substance falls under some new dosing guidelines.. that they – and maybe their prescriber – don’t have a clue about ?
it is my recommendation to anyone needing a controlled substance filled the first of the year to talk to your prescriber and pharmacist and see if you can get 60 or 90 days supply in your state filled in December.
If the Part D implementation of 2006 is any indication of what could happen with this new implementation it could resemble a MAJOR CHAOS !!! It is not going to be business as usual. Pharmacies and prescriber’s offices could be TOTALLY OVERWHELMED at least the first week of Jan – which is a SHORT WORK WEEK !
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Tonight 8PM EST (11/28/2018) CONSPIRACIES AGAINST WELLNESS Guest Dr. Moshe Dekel
Posted on November 28, 2018 by Pharmaciststeve
Tonight 8PM EST
CONSPIRACIES AGAINST WELLNESS
Guest Dr. Moshe Dekel
Tune in either at www.cawnation.com
OR
YouTube channel:
Conspiracies Against Wellness Live Stream
Call in with questions or comments at
(415) 915-2291
#CAW360NETWORK #TheDoctorsCorner
#CAW #WeR1
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Some politicians – THAT LIE – didn’t get RE-ELECTED !
Posted on November 27, 2018 by Pharmaciststeve
Claire McCaskill cites disproven figure on opioid use
The state of opioid abuse in America has been deemed an epidemic.
Overdose related deaths involving prescribed opioids have reached an all-time high, jumping from 19,000 in 2014 to 22,000 in 2015, according to the Centers for Disease Control and Prevention. Considering all opioids (not just prescribed ones), the figures get even worse: In 2015, 33,091 died from opioid related overdoses.
Missouri Sen. Claire McCaskill has set her sights on curbing the issue, writing an op-ed in the Kansas City Star and dedicating a page of her website to facts and figures. One tweet in particular caught our eye: “We have 5% of world population. 80% of opioids.”
Such drastic numbers paint a dire picture for the state of opioid use and abuse in America. We wanted to fact-check her claim.
What we found was that while America certainly consumes more opioids than any other country, the notion that we consume 80 percent of the global supply is greatly exaggerated.
‘One startling number’
Checking the first part of McCaskill’s claim was simple: The United States’ population is, according to the U.S. Census bureau, 324.8 million. The global population is 7.4 billion. That means the United States accounts for roughly 4.4 percent of the total world population.
Checking the other half was more complicated.
We reached out to McCaskill’s spokesperson, Drew Pusateri, and he supplied us with the source of the figure: a CNBC article published on April 27, 2016.
And while the article provides the figures McCaskill cited, it is vague about where exactly the 80 percent figure comes from. Upon its first reference it is simply “one startling number from recent years,” and later it is noted that the figure was “cited in various studies,” including one by Express Scripts.
The Express Scripts study, “A Nation In Pain,” was released on Dec. 9, 2014. And while it does cite the 80 percent figure, it was not a study designed to measure American opioid consumption or global consumption.
The reality, according to Christopher Jones, the director of the Division of Science Policy in the Department of Health and Human Services, is that America consumes 30.2 percent of globally distributed opioids.
30.2 percent
According to data collected by the International Narcotics Control Board, the United States consumed roughly 30.2 percent of opioids in 2015.
A Vienna-based “quasi-judicial expert body,” the International Narcotics Control Board is tasked with tracking global opioid consumption, among a myriad of other things.
The board releases three annual reports on narcotic drugs. “Narcotic Drugs: Estimated World Requirements for 2017; Statistics for 2015” is the most recent publication, and includes data for the year 2015.
Using the International Narcotics Control Board figures, Jones calculated that the United States consumed 173,332 kilograms of 574,693 kilograms of opioids consumed globally (382,131.6 of 1,266,981.2 pounds), or 30.2 percent.
The drugs Jones included in the measurements are: codeine, dihydrocodeine, ethylmorphine, hydrocodone, morphine, oxycodone, pholcodine, dextropropoxyphene, diphenoxylate, methadone, pethidine and tilidine. The figures also include the calculated consumption of buprenorphine.
To be clear, Jones noted, such data is limited in several ways. The first is that it is government-reported data. The second is that many drugs are marketed in one country and not another; while used frequently in the United States, hydrocodone is virtually unused elsewhere.
Additionally, some of the data include drugs that may have been exported from the country of manufacture and consumed in another country. Thus, data from INCB should be considered with great care when comparing consumption levels of narcotic drugs across countries.
And finally, the board makes special note that comparing countries by the weight of opioids consumed is not recommended. Instead they suggest using a statistical measurement called “defined daily doses.”
Defined daily doses
A defined daily dose is the quantity of a particular narcotic drug used in a day by one individual. It is not a recommended dosage, but rather it is a calculation created by the International Narcotics Control Board to statistically measure opioid use with a ratio that directly relates a country’s population to its consumption.
For example, the daily dose of hydrocodone is 15 milligrams. So, if 60 milligrams are consumed, four defined daily doses would be recorded. The final results are calculated per million inhabitants.
The United States consumed the most using this measure from 2013 to 2015: 47,580 doses of narcotic drugs were consumed per day per million people.
Canada comes in second with 34,444 defined doses consumed per day, and Germany in third with 30,796.
Using such a measurement, it is easy to see that consumption in America, while noticeably higher than in similarly developed countries, is not as astronomical as McCaskill’s cited figure makes it appear.
‘A life of its own’
Jones said it’s common for people to cite the 80 percent figure that McCaskill did, despite its inaccuracy.
“I would say it is a commonly quoted statistic…people across a variety of disciplines, who even are somewhat expert on the topic, have repeated that statistic,” he said.
Jones said he believes the number originated as the percentage of oxycodone that America consumes compared to the world.
From there, he said, the figure has “taken a life of its own. It’s now a ‘fact’ because it’s been repeated so many times.”
But it’s not the full picture. Because while America does consume over 75 percent of oxycodone, and 99 percent of hydrocodone, it doesn’t consume even half of all opioids globally, according to the International Narcotics Control Board data.
Which, in part, according to Jones, has to do with marketing. Oxycodone and hydrocodone are marketed in America. Similar opioids are more prevalent elsewhere.
Drug control systems
Despite conflated numbers, experts agree there is a problem.
Martha Maurer, a policy program manager and researcher at the Pain and Policy Studies Group at the University of Wisconsin-Madison, agreed that opioid abuse in the United States was an epidemic.
But part of the solution, she said, was continuing to figure out how to view the problem.
“It’s clear that there has been a lot of harm associated with overdose and abuse,” Maurer said, “but it goes back to the question of where (abused) medication is coming from, which we just don’t know.”
Something worth noting, Maurer said, was that when you look at the milligram-per-person statistics, “some countries, including Germany, Austria, Denmark and Switzerland, have opioid-consumption levels comparable to that in the US, but they are not having the same problems with harms caused by overdose. Their drug-control systems ensure a balanced approach to opioid access.”
For Jones, it’s about finding the right balance.
“From a policy perspective, we’re trying to ensure that opioids are available when they are needed, but that they are being used as a part of comprehensive evidence-based pain care,” he said, “not that we’re relying on them just because they’re the easiest thing to prescribe, or there are other external pressures to prescribe them.”
Our ruling
In setting out to combat America’s opioid epidemic by holding pharmaceutical companies accountable, Missouri Sen. Claire McCaskill said that with just 5 percent of the population, the United States consumes “80 percent of opioids.”
McCaskill’s figure, widely cited as it is, is inaccurate. It presents a narrow view of opioid consumption globally, where some opioids are marketed in select countries, but not others. It also discounts using defined daily doses, which provide a far more accurate representation of consumption when comparing nations.
So, while the United States is clearly the largest consumer of opioids, it, at most, accounts for roughly 30 percent of global consumption. We rate McCaskill’s claim False.
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Teva Recalls All Amlodipine/Valsartan Combination Products in US
Posted on November 27, 2018 by Pharmaciststeve
Teva Recalls All Amlodipine/Valsartan Combination Products in US
https://www.medscape.com/viewarticle/905630
Teva Pharmaceuticals has recalled all lots of amlodipine/valsartan combination tablets and amlodipine/valsartan/hydrochlorothiazide combination tablets in the United States after N-nitroso-diethylamine (NDEA) was detected in an active pharmaceutical ingredient (API) manufactured by Mylan India.
NDEA is a probable human carcinogen. The Teva recall, announced November 27, marks the latest recall of tainted sartan products in the United States.
To date, Teva has not received any reports of adverse events related to this recall, the company said.
Detailed information on the recalled product, including lot numbers, expiration dates, strengths, bottle size, and national drug codes are available on the US Food and Drug Administration (FDA) website.
Teva Pharmaceuticals USA is notifying its distributors and customers by certified mail and is arranging for return/reimbursement of returned recalled products. Distributors and retailers that have product that is being recalled should immediately stop distribution and quarantine any quantities remaining in their control and return the recalled product.
Providers and patients with questions about this recall are advised to contact Teva’s Medical Information by phone at 888-838-2872, option 3, then option 4, or by email at druginfo@tevapharm.com.
On November 20, as reported by theheart.org | Medscape Cardiology, Mylan Pharmaceuticals announced a recall of 15 lots of medicines containing valsartan because of the presence of the NDEA.
The FDA is continuing to investigate the presence of NDEA and another probable carcinogen, N-nitrosodimethylamine, in angiotensin II receptor blockers and has pledged to take “swift action” when it identifies unacceptable impurities in API and finished drug products.
Adverse reactions or quality problems associated with the use of sartan products should be reported to the FDA’s MedWatch Adverse Event Reporting Program.
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FDA Warns of ‘Disturbingly’ High Levels of Heavy Metals in Kratom Products
Posted on November 27, 2018 by Pharmaciststeve
FDA Warns of ‘Disturbingly’ High Levels of Heavy Metals in Kratom Products
https://www.medscape.com/viewarticle/905604
Some kratom products contain “disturbingly” high levels of heavy metals, the US Food and Drug Administration (FDA) warned today.
“Among the heavy metals we found were lead and nickel at levels not considered safe for human consumption,” FDA Commissioner Scott Gottlieb, MD, said in a statement.
FDA scientists tested 26 different kratom products. “While the levels of the specific products we’ve tested so far are not likely to result in immediate acute heavy metal poisoning from a single use, some of these products included levels that, with chronic use, could cause some people to suffer from heavy metal poisoning,” Gottlieb said.
The agency is concerned that there may be other kratom products on the market that also contain heavy metals.
No Approved Use
Kratom is derived from the leaves from the kratom tree (Mitragyna speciosa), which is native to Thailand, Indonesia, and Papua New Guinea. The botanical’s popularity has been increasing in the United States, with those who take it and manufacturers claiming it can help treat pain, anxiety, depression, and more recently, opioid withdrawal.
Earlier this year, an analysis of kratom by FDA scientists found that its compounds act like prescription-strength opioids, as reported by Medscape Medical News.
The scientific data and adverse event reports have “clearly revealed” that compounds in kratom make it “not just a plant — it’s an opioid,” Gottlieb, MD, said in a statement back in February. “Claiming that kratom is benign because it’s ‘just a plant’ is short-sighted and dangerous,” he added.
Kratom has been linked to numerous deaths in the United States. There are currently no FDA-approved uses for kratom, and the agency has advised against using kratom or its psychoactive compounds mitragynine and 7-hydroxymitragynine in any form and from any manufacturer.
The FDA continues to crackdown on companies selling unapproved kratom products with unsubstantiated claims about its purported benefits.
Over the past year, the agency issued numerous warnings about the serious risks associated with the use of kratom, including risks because of the variability in how kratom products are formulated, sold, and used both recreationally and by those seeking to self-medicate for pain or opioid withdrawal symptoms.
Kratom products have also been found to be contaminated with Salmonella resulting in numerous illnesses and product recalls.
Health providers are encouraged to report any adverse reactions related to kratom products to MedWatch, the FDA’s safety information and adverse event reporting program.
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Tonight -11/27/2018- 8pm est THE DOCTOR’S CORNER w/ DR. KLINE & JONELLE ELGAWAY
Posted on November 27, 2018 by Pharmaciststeve
Tonight -11/27/2018- 8pm est
THE DOCTOR’S CORNER w/
DR. KLINE & JONELLE ELGAWAY
Topic: How to deal w/ your illness w/out pain meds and questions from the audience.
Tune in on www.cawnation.com and click “Listen.”
OR
YouTube Channel: THE DOCTOR’S CORNER.
Direct link: https://www.youtube.com/
Call in w/ questions (415) 915-2291
#CAW360Network
#WeR1
#TDCwithDrKline
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Anthem among health insurers refusing to pay ER bills, doctors say
Posted on November 27, 2018 by Pharmaciststeve
https://www.cbsnews.com/news/anthem-among-health-insurers-refusing-to-pay-er-bills-doctors-say/
On Aug., 1, 2017, Brittany Cloyd of Frankfort, Kentucky, said she experienced pain “worse than childbirth.” Her mother — who had been to nursing school — drove her to the nearest emergency room. Brittany thought her appendix had burst, but tests at the ER found she had ovarian cysts. She was given pain medication and told to follow up with her primary doctor.
Cloyd had an Anthem Blue Cross PPO health insurance plan and thought she would get charged just a co-pay for her ER visit. Instead, 15 days later she received a letter from health insurer Anthem. “Your condition does not meet the definition of emergency,” read the letter. She was responsible for the total ER bill — $12,596.
What Brittany endured is becoming more common in the health insurance industry, according to a Doctor Patient Rights Project (DPRP) study. It highlighted Anthem, which through its affiliated networks is the nation’s largest private health insurer. The DPRP contends that Anthem has instituted an organized policy of denial designed to make its subscribers — particularly those who are poor and reside in rural areas — too afraid to go to an ER for fear of receiving a bill like Cloyd’s, or more, for the visit.
“The purpose of this program is to spread fear,” said Dr. Ryan Stanton, a critical care and emergency medical specialist in Lexington, Kentucky.
Anthem spokesperson Joyzelle Davis, who said she hadn’t seen the study yet, issued an all-purpose response. “Anthem’s Emergency Department Review aims to encourage consumers to receive care in the most appropriate setting,” Davis said. “Anthem’s review [of claims] aims to reduce the trend in recent years of inappropriate use of emergency departments for non-emergency use.”
Anthem did not provide specific guidelines for what would be an appropriate visit to an emergency room. But in a letter addressed to companies insured by Anthem and obtained by the DPRP, the insurer made it clear that it didn’t want individuals insured by its policies to seek “care right away” at an ER when they could just as easily be treated at a doctor’s office or retail health clinic.
According to Anthem, more than a quarter of its subscribers’ emergency room visits could be treated elsewhere. “If we could reduce unneeded ER visits, we can cut health care costs by $4.4 billion a year,” the letter said. Consequently, Anthem noted, that would cut its member companies’ costs by more than a billion dollars.
“Controversial and dangerous”
Kentucky isn’t the only state where Anthem is rolling out this policy. It’s spreading across the South and Midwest, also. In Georgia, the American College of Emergency Physicians and the Medical Association of Georgia have filed suit in federal court to get Anthem to “rescind its controversial and dangerous … policy that retroactively denies coverage for emergency patients.”
Sen. Claire McCaskill, D-Missouri, sent a letter to both the U.S. Department of Health and Human Services and the Department of Labor asking them to look into whether certain health insurers had violated the “Prudent Layperson Standard” by denying claims. McCaskill is leaving office in January, and her staff did not respond to questions about whether her letter had been answered.
But her question goes to the heart of the matter. Congress enacted the Prudent Layperson Standard for Medicare and Medicaid managed care plans in 1997 and included group and individual health insurance plans in 2010. It defines an “emergency condition” as one in which the average person’s knowledge of health and medicine would dictate that you could go to the ER for treatment of acute symptoms of sufficient severity.
Do you have the ability to diagnose your own pain or injury, and if so, what do you do about it? If you go to the ER, will your insurer deny your claim, leaving you in economic peril? “Patients should never be in the position of correctly diagnosing their … emergency” before seeking help, McCaskill said in her letter.
137 million ER visits annually
But that puts millions of Americans in a vise. In an average year, nearly one in five people report going to the ER, according to the DPRP, for a total of 137 million visits. Doctors, patients and insurers note that statistics from 2012 indicating the average cost of an ER visit, at $1,233, is outdated. One reason for the surge in price since then, according to a University of Maryland study: the increased number of substance abuse cases — particularly among young and middle-aged adults — that now pass through an ER.
Anthem said even a small savings could benefit the health care system, in which Americans spent nearly $3 trillion dollars in 2015. The percentage of patients who leave the ER with no treatment whatsoever is 5 percent according to Anthem, while the Centers for Disease Control and Prevention (CDC) said it’s at least 3.3 percent. Some of these may be psychiatric patients.
But CDC data also appears to show that going to the ER might be the right choice for a serious condition such as chest or stomach pain and high fever. It said 43 percent of all ER cases lead to hospital admissions.
Critics said Anthem will likely keep pushing its policy of denying ER treatment unless it’s stopped. “Anthem is the big boy on the block, but other health insurers are picking up on it,” said Dr. Stanton. “They’re like a child getting into daddy’s wallet. They take a few dollars at a time and, if they don’t get caught, keep going.”
How to file an appeal
Those who feel they’ve been wronged can always appeal. “Patients should first appeal to the insurer,” said Executive Director Stacey Worthy of the Aimed Alliance, a health care coalition dedicated to innovation in medicine. If you get a written denial explaining the reason, then submit documentation and justification for the necessity of the ER treatment.
If you get a second denial, request an external review by an independent party, possibly a state insurance regulator, or someone it appoints. Worthy said it’s labor-intensive for the patient “because the insurer wants you to give up during the process.”
But it often doesn’t get that far, patient advocates said. The Affordable Care Act makes it clear that ER patients have the law on their side, if they can prove a true emergency. “Insurers can’t require you to get prior approval,” the ACA states. And a 2016 study found that 52 percent of retroactive denials were ultimately overturned after independent review.
Brittany Cloyd lost her first appeal, but she refused to take no for an answer. So she sent Anthem a second appeal with documentation and a rebuke.
“I’m not sure how one knows if they’re bleeding internally,” she wrote. “But I hope that it’s apparent … perpetuating scare tactics could certainly convince patients not to go the emergency room. I foresee an onslaught of wrongful death suits in Anthem’s future.”
Cloyd said Anthem then paid her entire $12,596 ER bill.
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CMS FINAL CALL RULES ON OPIOID PRESCRIBING | EVERYTHING YOU NEED TO KNOW
Posted on November 26, 2018 by Pharmaciststeve
https://youtu.be/lGfQ1YJ4-TM
Filed under: General Problems | 5 Comments »