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Showing posts with label Prescription drug. Show all posts
Showing posts with label Prescription drug. Show all posts

Tuesday, May 5, 2015

Look Who Is Prescribing What

As part of the Administration’s goals of better, care, smarter spending, and healthier people, the Centers for Medicare & Medicaid Services announced the availability of new, privacy-protected data on Medicare Part D prescription drugs prescribed by physicians and other health care professionals in 2013. This data shows which prescription drugs were prescribed to Medicare Part D beneficiaries by which practitioners.
“This transparency will give patients, researchers, and providers access to information that will help shape the future of our nation’s health for the better,” said acting CMS Administrator Andy Slavitt. “Beneficiaries’ personal information is not available; however, it’s important for consumers, their providers, researchers, and other stakeholders to know how many prescription drugs are prescribed and how much they cost the health care system, so that they can better understand how the Medicare Part D program delivers care.”

The new data set contains information from over one million distinct health care providers who collectively prescribed approximately $103 billion in prescription drugs and supplies paid under the Part D program. The data characterizes the individual prescribing patterns of health providers that participate in Medicare Part D for over 3,000 distinct drug products. For each prescriber and drug, the dataset includes the total number of prescriptions that were dispensed, which include original prescriptions and any refills, and the total drug cost paid by beneficiaries, Part D plans, and other sources.

CMS created the new data set using drug claim information submitted by Medicare Advantage Prescription Drug plans and stand-alone Prescription Drug Plans. With this data, it will be possible to conduct a wide array of prescription drug analyses that compare drug use and costs for specific providers, brand versus generic drug prescribing rates, and to make geographic comparisons at the state level.

The Administration has set measurable goals and a timeline to move Medicare toward paying providers based on the quality, rather than the quantity, of care they give patients. This is part of a wide set of initiatives to achieve better care, smarter spending and healthier people through our health care system. Open sharing of data securely, timely and more broadly supports insight and innovation in health care delivery.

Today’s Part D prescriber data availability adds to the unprecedented information previously released on services and procedures provided to Medicare beneficiaries, including hospital charge data on common impatient and outpatient services as well as utilization and payment information for physicians and other healthcare professionals. In addition, under the Qualified Entity (QE) program, CMS releases Medicare data to approved entities for the purposes of producing public performance reports on physicians, hospitals, and other providers. To date, CMS has certified 11 regional QEs and one national QE.

To view a fact sheet on the Medicare Part D prescriber data, visit: http://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Medicare-Provider-Charge-Data/Part-D-Prescriber.html

Updated: May 15, 2015

Related articles
How Proposed Part D Changes Are Playing On Capitol Hill (workers-compensation.blogspot.com) 

Study: Cancer costs 'skyrocketed' despite drug cuts (workers-compensation.blogspot.com) 

Sunday, August 17, 2014

A California Hospital Charged $10,000 for a Cholesterol Test

Today's post was shared by Mother Jones and comes from www.motherjones.com

By now, I assume we all know that hospitals charge widely varying rates for similar procedures. But it's often hard to pinpoint exactly what's going on. Sometimes it's due to the amount of regional competition. Sometimes the procedures in question vary in ways that simple coding schemes don't pick up. Some doctors are better than others. And of course, hospitals inflate their list prices by different amounts.
All that said, be prepared for your jaw to drop:
Researchers studied charges for a variety of tests at 160 to 180 California hospitals in 2011 and found a huge variation in prices. The average charge for a basic metabolic panel, which measures sodium, potassium and glucose levels, among other indicators, was $214. But hospitals charged from $35 to $7,303, depending on the facility. None of the hospitals were identified.
The biggest range involved charges for a lipid panel, a test that measures cholesterol and triglycerides, a type of fat (lipid), in the blood. The average charge was $220, but costs ranged from a minimum of $10 to a maximum of $10,169. Yes, more than $10,000 for a blood test that doctors typically order for older adults, to check their cholesterol levels.
A lipid panel! This is as standardized a procedure as you could ask for. It's fast, highly automated, identical between hospitals, and has no association with the quality of the doctor who ordered the test. You still might see the usual 2:1 or 3:1 difference in prices, but 1000:1?
So what accounts for...
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Tuesday, August 12, 2014

Colgate Total Ingredient Linked to Hormones, Cancer Spotlights FDA Process

Today's post was shared by Steven Greenhouse and comes from www.bloomberg.com




Photographer: Daniel Acker/Bloomberg
The chemical triclosan has been linked to cancer-cell growth and disrupted development in animals. Regulators are reviewing whether it’s safe to put in soap, cutting boards and toys. Consumer companies are phasing it out. Minnesota voted in May to ban it in many products.
At the same time, millions of Americans are putting it in their mouths every day, by way of a top-selling toothpaste that uses the antibacterial chemical to head off gum disease -- Colgate-Palmolive Co.’s Total.
Total is safe, Colgate says, citing the rigorous Food and Drug Administration process that led to the toothpaste’s 1997 approval as an over-the-counter drug. A closer look at that application process, however, reveals that some of the scientific findings Colgate put forward to establish triclosan’s safety in toothpaste weren’t black and white -- and weren’t, until this year, available to the public.
Colgate’s Total application included 35 pages summarizing toxicology studies on triclosan, which the FDA withheld from view. The agency released the pages earlier this year in response to a lawsuit over a Freedom of Information Act request. Later, following inquiries from Bloomberg News, the FDA put the pages on its website.
The pages show how even with one of the U.S.’s most stringent regulatory processes -- FDA approval of a new drug -- the government relies on company-backed science to show products are safe and...
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Tuesday, July 29, 2014

Take Two: Just How Good Are Generic Meds Anyway?

Today's post was shared by Mother Jones and comes from www.motherjones.com

A few days ago I wrote a post about generic painkillers and the fact that doctors themselves—who should know better—often don't use them. "If physicians aren't really sold on generics in their own personal lives," I asked, "does this mean they're not really sold on them in their professional lives too?"
Well, perhaps I got it backwards. A friend sent me a link to a Forbes article from last year about the FDA retracting its approval of a generic version of Wellbutrin:
The episode is bringing momentum to a movement that has been quietly building among many doctors and medical societies that are increasingly willing to ask a question that borders on heresy: Are generics really identical to the branded products they are meant to replicate? To a surprising degree, they say, the answer is no.
If you’re a layperson, this is the way you probably think of generics: They’re the exact same products in different packaging; generics companies can sell such medications for a fraction of the cost of the originals because they don’t have to spend huge sums on drug development and marketing....But generic drugs diverge from the originals far more than most of us believe.
....The FDA’s rules effectively acknowledge that. The agency’s definition of bioequivalence is surprisingly broad: A generic’s maximum concentration of active ingredient in the blood must not fall more than 20% below or 25% above that of the brand name....
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Thursday, June 26, 2014

FDA Issues Guidances for Industry on Social Media

Today's article shared from Thomas Abrams

Ongoing changes in technology transform medical products – and the ways that both patients and health care providers learn about those products. In today’s world, in addition to traditional sources of medical product information, patients and health care providers regularly get information about FDA-regulated medical products through social media and other Internet sources, and those technologies continue to evolve. But regardless of the Internet source used to communicate about medical products, the public health is best served by clear, accurate, truthful and non-misleading information about them.

That’s why the agency has proposed two draft guidances for industry with recommendations to help manufacturers and their representatives accurately communicate online about prescription drugs and medical devices.

These documents strive to ensure that the information provided by drug and device companies is accurate and will help patients to make well-informed decisions in consultation with their health care providers.

Our first guidance provides recommendations for the presentation of risk and benefit information for prescription drugs or medical devices using Internet/social media sources with character space limitations, such as Twitter and the paid search results links on Google and Yahoo. These recommendations address the presentation of both benefit information and risk information in this setting. We understand that...

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Saturday, February 15, 2014

Medicines Made in India Set Off Safety Worries


NEW DELHI — India, the second-largest exporter of over-the-counter and prescription drugs to the United States, is coming under increased scrutiny by American regulators for safety lapses, falsified drug test results and selling fake medicines.


Dr. Margaret A. Hamburg, the commissioner of the United States Food and Drug Administration, arrived in India this week to express her growing unease with the safety of Indian medicines because of “recent lapses in quality at a handful of pharmaceutical firms.”


India’s pharmaceutical industry supplies 40 percent of over-the-counter and generic prescription drugs consumed in the United States, so the increased scrutiny could have profound implications for American consumers.


F.D.A. investigators are blitzing Indian drug plants, financing the inspections with some of the roughly $300 million in annual fees from generic drug makers collected as part of a 2012 law requiring increased scrutiny of overseas plants. The agency inspected 160 Indian drug plants last year, three times as many as in 2009. The increased scrutiny has led to a flood of new penalties, including half of the warning letters the agency issued last year to drug makers.


Dr. Hamburg was met by Indian officials and executives who, shocked by recent F.D.A. export bans of generic versions of popular medicines — such as the acne drug Accutane,...


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Found on



Related articles
India to flag market access of drugs and spices with US (vancouverdesi.com)
Indian Regulators to Shadow U.S. FDA on Plant Inspections (bloomberg.com)
A California Lesson: How to Kill Workers' Compensation Pill By Pill (workers-compensation.blogspot.com)
Prescription-Drug Coupons - No Such Thing as a Free Lunch (workers-compensation.blogspot.com)


Saturday, December 28, 2013

Senators Press Medicare for Answers on Drug Program

A Senate committee chairman said he is concerned about the “serious vulnerabilities” detailed in a ProPublica report about scams that target Medicare’s popular prescription drug program.

Sen. Tom Carper, D-Del., who chairs the Homeland Security and Governmental Affairs Committee, said in a statement that he plans to ask Medicare officials and the inspector general of the U.S. Department of Health and Human Services “to look into the specifics of these cases, as well as determine the extent of any program-wide vulnerabilities that may have allowed them to occur.” The committee monitors fraud in government programs.

ProPublica reporters, using Medicare’s own data, identified scores of doctors whose prescription patterns within the program bore the hallmarks of fraud. The cost of their prescribing spiked dramatically from one year to the next — in some cases by millions of dollars — as they chose brand-name drugs that scammers can easily resell.

The cost of medications prescribed by one Miami doctor jumped from $282,000 to $4 million in one year, but her lawyer said Medicare never questioned it. A Los Angeles psychiatrist said Medicare didn’t shut off his provider identification number, used to fill prescriptions, even though he claimed someone had forged his name on more than $7 million worth of them.

All told, just the schemes identified by ProPublica totaled tens of millions of dollars.

While credit card...

Wednesday, November 20, 2013

Drug overdose deaths have quadrupled since 1980

The Workers' Compensation system is embroiled in a debate over use of pain medications. As I noted before, the problem of prescription pain medication and the abuse of medical prescribers, Is not limited to Worker's Compensation alone. The problem is systemic in the medical delivery system throughout the United States and it is foolish to think that it is only an exclusive issue two of Worker's Compensation claims. What is actually occurring, is that the insurance carriers and employers in Worker's Compensation, are utilizing this issue to reduce the delivery of medical benefits at the cost of damaging the very Basic requirements of a Worker's Compensation system. Today's post was shared by RWJF PublicHealth and comes from knowmore.washingtonpost.com

Drug overdose deaths have quadrupled since 1980
Drug overdose deaths have quadrupled since 1980
Since 1980, the number of us who die of drug overdoses has quadrupled. Most of these deaths now result from prescription drugs, especially painkillers. “The dichotomy between good drugs prescribed by doctors and bad drugs sold on the street is just bad science,” one doctor told The New York Times a couple of years back.
The really upsetting maps above show this change over the decade that ended in 2009. Appalachia and New Mexico, as popular culture would lead you to expect, were particularly bad areas for drug fatalities fifteen years ago, but now, the problem is clearly a national one. “What other people had been saying was that this was predominantly a rural problem of drug poisoning,” Lauren Rossen, one of the people who put together this analysis, told me. “We were somewhat surprised to find that drug poisoning death rates were actually highest in metropolitan areas.” Exceptions are the state of New York and a narrow band running through the center of the contiguous states, from North Dakota to Texas.
Click “Know More” to read more about this troubling trend.
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Wednesday, November 13, 2013

FDA Proposes Letting Generic-Drug Makers Change Labels

Today's post was shared by FairWarning and comes from online.wsj.com

The Food and Drug Administration proposed allowing generic drug companies to change drug labels after getting reports of bad reactions in patients, a step that could open the generic industry up to greater potential legal liability.
In 2011 and again this year, the Supreme Court issued rulings that shielded generic drug makers from consumer personal-injury lawsuits, even though the justices have allowed similar product-liability claims against makers of branded drugs.
The step Friday by the FDA means that generic companies—which sell about 84% of the prescription drugs by volume in the U.S.—would have the same ability to change their labels as brand companies. The FDA would review any proposed changes, as it already does with changes to branded-drug labels.
"Our effort is to keep all the labels the same, and to level the playing field," said Janet Woodcock, director of the FDA's center for drug evaluation and research. The proposal, she said, "would change current procedures, where only the brand companies can unilaterally put certain safety information in the label."
The Generic Pharmaceutical Association reacted cautiously, saying it is concerned that multiple labels on the same drug "could drive up costs…and should be approached very carefully."
Some of the leading makers of generic drugs include Hospira Inc., HSP +0.55%Hospira Inc.U.S.: NYSE$38.74 +0.21+0.55% Nov. 12, 2013 4:00 pm Volume (Delayed 15m) : 2.36MAFTER HOURS$38.58 -0.16-0.43% Nov. 12, 2013...
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Thursday, November 7, 2013

New WCMSA Reference Guide is Now Available

An updated Workers’ Compensation Medicare Set-Aside Arrangement (WCMSA) Reference Guide is now available in the Downloads section found at the bottom of this page.  This version documents the current WCMSA review process and provides more detailed information on the actions performed by the Workers’ Compensation Recovery Contractor (WCRC).  

CMS is currently working on additional enhancements to the WCMSA process. Stakeholders will be notified of these proposed changes prior to implementation. Please continue to monitor the WCMSA website for updates.

The following sections of the Guide have been enhanced or added:
  • 9.4.1.1 – Most Frequent Reasons for Development Requests: The five most common omissions as provided by the WCRC.
  • 9.4.2  – WCRC Team Background and Resources Used: The expertise of the WCRC reviewers as well as the resources used when reviewing a WCMSA.
  • 9.4.3 – WCRC Review Considerations: Examples of the questions and factors that guide the WCRC’s review of WCMSA proposals.  The overarching guidelines used in treatment allocations and pricing is also provided.
  • 9.4.4 – Medical Review: A diagram and steps the WCRC follows in its medical review process with a general explanation of documentation requirements.
  • 9.4.5 – Medical Review Guidelines: Considerations and examples in specific medical cases and topics.
  • 9.4.6.1 – Prescription Drug Review: Details the process the WCRC follows in reviewing prescription medication allocations and the resources that may be used.
  • 9.4.6.2 – Pharmacy Guidelines and Conditions: Discusses specific drug usage and pricing considerations.
  • 10.1.8 – Pay history added to list of information needed for WCMSA submission.

Thursday, October 24, 2013

FDA Proposes Changes in Pain Medication Prescriptions

The US FDA has announced proposed changes will be forthcoming in labeling for pain relief medication:
Consumers and health care professionals will soon find updated labeling for extended-release and long-acting opioid pain relievers to help ensure their safe and appropriate use.
"In addition to requiring new labeling on these prescription medications, the Food and Drug Administration (FDA) is also requiring manufacturers to study certain known serious risks when these drugs are used long-term.
"The new labeling requirements and other actions are intended to help prescribers and patients make better decisions about who benefits from the use of these medications.

They also are meant to reduce problems associated with their use," says Douglas Throckmorton, M.D., deputy director of regulatory programs in FDA's Center for Drug Evaluation and Research. "Altogether, the actions we're now announcing are part of FDA's efforts to make opioids as safe as possible for those who need them," Throckmorton adds.
"He noted that the actions come after careful analysis of new safety information, including reviews of medical literature, and consideration of input from patients, experts and many other interested parties.

Sunday, October 13, 2013

The Soaring Cost of a Simple Breath

Cost in the US for pharmaceutical medications are a stressor for all including workers' compensation carriers. The blame is targeted to injured workers for causing the problem. In actuality it appears that big pharma maybe the problem. Perhaps Federal legislation should  allow cheaper rates for workers' compensation programs. Today's post is shared from nytimes.com.
The kitchen counter in the home of the Hayes family is scattered with the inhalers, sprays and bottles of pills that have allowed Hannah, 13, and her sister, Abby, 10, to excel at dance and gymnastics despite a horrific pollen season that has set off asthma attacks, leaving the girls struggling to breathe.
Asthma — the most common chronic disease that affects Americans of all ages, about 40 million people — can usually be well controlled with drugs. But being able to afford prescription medications in the United States often requires top-notch insurance or plenty of disposable income, and time to hunt for deals and bargains.
The arsenal of medicines in the Hayeses’ kitchen helps explain why. Pulmicort, a steroid inhaler, generally retails for over $175 in the United States, while pharmacists in Britain buy the identical product for about $20 and dispense it free of charge to asthma patients. Albuterol, one of the oldest asthma medicines, typically costs $50 to $100 per inhaler in the United States, but it was less than $15 a decade ago, before it was repatented.
“The one that...
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Thursday, October 3, 2013

Exercise 'can be as good as pills'

Medication can be replaced by exercise reports the the BBC. Today's post is shared from bbc.org.

Exercise can be as good a medicine as pills for people with conditions such as heart disease, a study has found.

The work in the British Medical Journal (BMJ) looked at hundreds of trials involving nearly 340,000 patients to assess the merits of exercise and drugs in preventing death.

Physical activity rivalled some heart drugs and outperformed stroke medicine.

The findings suggest exercise should be added to prescriptions, say the researchers. 
Man preparing to jog

Experts stressed that patients should not ditch their drugs for exercise - rather, they should use both in tandem.

Too few adults currently get enough exercise. Only a third of people in England do the recommended 2.5 hours or more of moderate-intensity activity, such as cycling or fast walking, every week.

In contrast, prescription drug rates continue to rise.

There were an average of 17.7 prescriptions for every person in England in 2010, compared with 11.2 in 2000.

For the study, scientists based at the London School of Economics, Harvard Pilgrim Health Care Institute at Harvard Medical School and Stanford University School of Medicine trawled medical literature to find any research that compared exercise with pills as a therapy.

They identified 305 trials to include in their analysis. These trials looked at managing conditions such as existing heart disease, stroke rehabilitation, heart failure and pre-diabetes.

When they studied the data as a whole, they found exercise and drugs were comparable in terms of death rates.

But there were...


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Friday, January 6, 2012

Medical Marijuana Maybe Permitted By State Authorization

English: U.S. states are shown in green where ...Image via Wikipedia

Workers' Compensation systems maybe legally  implementing distribution of marijuana for medical purposes on a state by state basis circumventing a Federal prohibition. A Federal Court ruled today that the state authorized distribution program was not subject to Federal restrictions.

Prescription drugs utilization has exploded both in cost factors and in volume leading to major concerns by both employers and insurance carriers. Compounding the issue is that prescription pain relief is being offered more frequently to avoid the both costly and risky surgical intervention and protocols. Additionally there is a concern that state governments merely want to get into the act in order to tax the prescription costs for the purposes of raising revenue.

All of this focuses on the issue of whether the nation's workers' compensation system is actually providing the necessary care to cure and relieve medical conditions as intended by the crafters a century ago.

Click here to read more from the Jurist: Federal judge grants ACLU motion to dismiss Arizona medical marijuana challenge
"A judge for the US District Court for the District of Arizona [official website] on Wednesday granted an American Civil Liberties Union (ACLU) [advocacy website] motion to dismiss a lawsuit [order, PDF] challenging Arizona's voter approved medical marijuana law, the Arizona Medical Marijuana Act [text, PDF]."

Friday, November 18, 2011

The Complex World of Workers' Compensation and Pharmaceutical Benefits

The Workers’ Compensation system, designed over a century ago, was intended to provide medical benefits that were to be delivered to injured workers in an efficient and effective manner. Over the decades, the benefit program has evolved into a complex and costly system that is difficult to navigate and provides uncertain outcomes. Pharmaceutical benefits have become a serious concern and have added complexity and costs to the program.

Prescription drugs have become an increasingly important issue in workers’ compensation law. Their use in workers’ compensation claims has resulted in both a major direct financial cost to the system, and has had substantial impact on the efficiency of the administrative process. The use of prescription drugs in workers’ compensation will require further discussion in order to maintain the system as the efficient, remedial social legislative system the crafters envisioned over a century ago.

Gelman, Jon L., The Complex World of Workers' Compensation and Pharmaceutical Benefits, New Jersey Law Journal, Vol. 206, p. 5, October 2011. 


Complete Article Available at SSRN: http://ssrn.com/abstract=1960708

For over 3 decades the Law Offices of Jon L. Gelman  1.973.696.7900  jon@gelmans.com have been representing injured workers and their families who have suffered occupational accidents and illnesses.