AbbVie Deal Heralds Changed Landscape for Hepatitis Drugs

Today's post is shared from NYTimes.com/ In a sign that price competition may take hold for hepatitis C drugs, the nation’s largest manager of prescriptions will require all patients to use AbbVie’s newly approved treatment rather than two widely used medicines from its rival Gilead Sciences. The pharmacy benefit manager, Express Scripts, said it had negotiated a significant discount from AbbVie in exchange for making the drugmaker’s treatment, Viekira Pak, the exclusive option for 25 million people. Express Scripts also said it would allow all people with hepatitis C to be treated with AbbVie’s drug, not only those with more serious liver damage. “We really believe we want all patients treated,” Dr. Steve Miller, the chief medical officer of Express Scripts, said in an interview Sunday. He said that AbbVie had made that affordable by offering “a significant discount.” Gilead’s drugs have set a new standard, curing the vast majority of patients in only 12 weeks with few side effects. But their prices have ignited an outcry. One drug, Sovaldi, has a list price of $84,000 for a typical 12-week course of therapy, or $1,000 per daily pill. The newer Harvoni costs $94,500 for 12 weeks. Gilead says the prices reflect the value the drugs bring to patients and the health care system. But some health plans, state Medicaid programs and prison systems say the drugs are busting their budgets. Many have been limiting treatment to only the sickest patients. Congress has...

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Nursing Homes Rarely Penalized For Oversedating Patients

Today's post was shared by Take Justice Back and comes from www.npr.org

NPR's analysis of government data found that harsh penalties are almost never used when nursing home residents get unnecessary drugs of any kind. Antipsychotic drugs have helped many people with serious mental illnesses like schizophrenia or bipolar disorder. But for older people with Alzheimer's or other forms of dementia, they can be deadly. The Food and Drug Administration has given these drugs a black box warning, saying they can increase the risk of heart failure, infections and death. Yet almost 300,000 nursing home residents still get them. “ There are many near misses, whether it's hospitals or nursing homes, where medication might be given that's not needed and doesn't cause permanent harm. We view that as a learning opportunity. - Dr. Patrick Conway, chief medical officer, Centers for Medicare and Medicaid Services So in 2012, the federal government started a campaign to get nursing homes to reduce their use of these drugs. But an NPR analysis of government data shows that the government rarely penalizes nursing homes when they don't get with the program. Take Texas for example. More than a quarter of nursing home residents there still get antipsychotic drugs. Since the beginning of the federal initiative, the nationwide average has dropped below 20 percent. That puts Texas in last place compared with other states and the District of Columbia. So Texas is playing catch-up. The state recently conducted a series of trainings to teach nursing home employees that...

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Upcoming Enhancement to the Workers’ Compensation Medicare Set Aside Portal (WCMSAP)

Today's post is shared from cms.gov

As of October 6, 2014, portal users will be able to enter
information on the new Prescription Drugs page for any
new and Work In Progress case before it is submitted
through the WCMSAP.
• Entry of the prescription drug information will be required,
when applicable, prior to submission of a case using the
portal.
• As is the current procedure, prescription drugs will be
verified and priced using the monthly Redbook Drug
Reference that is in effect at the date of submission.
• The new and revised WCMSAP pages that support entry of
prescription drug information are as follows:

1. The Prescription Drugs page displays after a user clicks [Next] on the Diagnosis Codes page. 
2. • This page requires users to indicate if a claimant is currently taking or is expected to take prescription drugs as a result of the workers’ compensation injury. 
3. • If prescription drugs are anticipated, the user will click the [Drug Lookup] button to locate and select the applicable drug(s). 

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Florida, Oxycodone Trafficking, Workers Compensation and Blame

The announcement by the US Attorney in Florida of the indictment today of 24 individuals for trafficking Oyxcodone puts a cloud over the claims that the workers compensation system is to blame. With the alleged bad apples caught, the announcement should refocus concern not on the work comp system, but rather on those outsiders who attempt to prey on it for personal gain. 

If anything, the system needs more safeguards to protect both the injured workers as well as the taxpayers. Pending legislation in Florida that restricts prescribed medications in workers' compensation claims only emasculates the social remedial benefit program further forcing the disabled to seek help outside the system. Why blame the victims and punish them.

"Wifredo A. Ferrer, United States Attorney for the Southern District of Florida, Mark R. Trouville, Special Agent in Charge, Drug Enforcement Administration (DEA), Christopher B. Dennis, Special Agent in Charge, Health and Human Services, Office of Inspector General (HHS-OIG), José A. Gonzalez, IRS Special Agent in Charge, Director James K. Loftus, Miami-Dade Police Department, Al Lamberti, Sheriff, Broward Sheriff’s Office, and H. Frank Farmer, M.D., State Surgeon General, Florida Department of Health (DOH), announced the unsealing of a federal indictment charging twenty four defendants for their participation in, among other things, conspiracy to distribute oxycodone and oxymorphone, and conspiracy to defraud Medicare. Twenty-one of the defendants, including a doctor, a pharmacist and two pain clinic operators are currently in custody after a multi-agency takedown was executed early this morning. Three defendants, Hattie Mae Green, Eliezer Salgado and Ronald Regains, remain at large.

Researchers from the Centers for Disease Control and Prevention report that Schedule II prescription painkillers, like oxycodone, today cause more drug overdose deaths than cocaine and heroin combined. Oxycodone and other Schedule II drugs have a high potential for abuse and can be crushed and snorted, or dissolved and injected, to get an immediate high. This abuse can lead to addiction, overdose, and sometimes death.

The nine-count indictment, filed on September 30, 2011 and unsealed today, charges all defendants with conspiracy to possess with intent to distribute controlled substances, namely oxycodone and oxymorphone (Count 1), and conspiracy to commit health care fraud (Count 9). Several of the defendants also face substantive charges of possession with intent to distribute controlled substances (Counts 2-6, 8), and attempted possession of controlled substances (Count 7).

Charged in the indictment are Aiman Izzedin Aryan, 40, of Pinecrest, Emerson Carmona, 40, of Miami,Frank J. Ballesteros, M.D., 57, of Miami, Gerardo Gomez, 38, of Miami, Juan De Dios Gomez, 40, of Miami, Danay C. Manso, 22, of Miami, Danilo Falcon, 38 of Miami, Eliezer Salgado, 29, of Hialeah,Francisco Hernandez, 57, of Miami, Leroy Paige, 49, of Madison, Alyssa Lyn Paige, 32, of Madison,Cynthia Suzette Adderley, 53, of Ft. Pierce, Victor D. Alexander, 50, of Ft. Lauderdale, Aaron Lamar Allen, 44, of Ft. Lauderdale, Henry Louis Conley, Jr., 53, of Miami, Hattie Mae Green, 53, of Miami,Petronella Smith Howard, 52, of Ft. Pierce, Eric Fyke Miller, 42, of Ft. Lauderdale, Annie Mims Simmons, 72, of Miami, Bobbie Lee Anderson, 58, of Gifford, Denise Darcelle Dardy, 48, of Miami, Margaret Marie Elliott, 54, of Ft. Pierce, Billy Joe McCoy, 53,of Ft. Pierce, and Ronald Regains, 56, of Ft. Lauderdale.

U.S. Attorney Wifredo Ferrer stated, “According to recent estimates, Florida prescribes ten times more oxycodone pills than all other states combined. Each day, individuals die from prescription drug overdoses. To stop this drug epidemic, we have previously charged clinic owners, operators, and doctors who deal drugs while hiding behind a medical license. Today, we have focused our efforts on those pharmacies who are churning out pills that are fraudulently prescribed at area pain clinics. We will continue to tackle South Florida’s pill mill epidemic from all angles and at all levels to eradicate these drug dealing organizations.”

DEA Special Agent in Charge Mark R. Trouville said, “The Drug Enforcement Administration continues its relentless attack on those who supply the prescription drug epidemic in our country, state, and local communities. With today’s arrests, twenty four people will no longer add to this drug problem.”

“Today’s multi-agency operation makes clear that drug trafficking and health care fraud make for a vile combination that simply cannot be tolerated,” said Christopher B. Dennis, Special Agent in Charge for the HHS-OIG region based in Miami. “Schemes to steal from taxpayers to pay for highly addictive, highly profitable street drugs , as the government alleges in this case, will trigger investigation and prosecution.”

“The Internal Revenue Service will continue to provide its financial investigative expertise to further the prosecution of criminals, especially those involved in complex financial schemes,” said IRS Special Agent in Charge Jose Gonzalez.

“The trafficking of oxycodone and oxymorphone has seeped into our community and extends beyond the borders of Miami-Dade County. We stand committed to working with our state and federal partners in the ongoing effort to apprehend these drug dealers who are destroying lives with their criminal behavior,” said Miami-Dade Police Department Director James K. Loftus.

“Through operations like this one, prescription drug peddlers are getting the message that pill pushing is no longer tolerated in Florida,” Broward Sheriff Al Lamberti said. “Federal and local enforcement efforts have turned the tide but we need to keep up the good work.”

“The Florida Department of Health has been diligently working with our law enforcement partners to identify unscrupulous practitioners who are inappropriately prescribing controlled substances,” stated Florida Surgeon General Dr. Frank Farmer. “When DOH learns that a practitioner is not following the law, we suspend that practitioners license. We will aggressively continue to fight the prescription drug problem in Florida.”

According to the indictment, from as early as November 2007 September 2011, defendants Gerardo Gomez, Juan De Dios Gomez, and Danay C. Manso operated and utilized pain clinics in Miami-Dade and Broward Counties. These pain clinics housed physicians, including defendant Frank J. Ballesteros, M.D., who would fraudulently prescribe oxycodone and oxymorphone for co-conspirator beneficiaries of Medicare and other prescription drug insurance plans. The beneficiaries would then present the fraudulent prescriptions obtained from the Gomezes’ pain clinics at complicit pharmacies operated by defendants Aiman Izzedin Aryan and Emerson Carmona. Once the prescriptions were filled, Aryan and Carmona would bill Medicare, and other insurers, for the cost of the prescriptions, knowing that the drugs were medically unnecessary and were being re-sold by the beneficiaries.

Defendants Leroy Paige, Alyssa Lyn Paige, Cynthia Suzette Adderley, Victor D. Alexander, Aaron Lamar Allen, Henry Louis Conley, Jr., Hattie Mae Green, Petronella Smith Howard, Eric Fyke Miller, and Annie Mims Simmons facilitated the drug-trafficking and health care fraud conspiracies by recruiting the corrupt health insurance beneficiaries to visit the Gomezes’ pain clinics and Dr. Ballesteros. Often, these recruiter defendants further participated by transporting the beneficiaries to the pain clinics to obtain the prescriptions and then to the pharmacies where they were filled. At the pharmacies, these defendants would receive and take control of the drugs from the beneficiaries. Once these defendants had the drugs, they would distribute them to Gerardo Gomez, Juan De Dios Gomez, Danilo Falcon, and Eliezer Salgado.

Defendants Bobbie Lee Anderson, Denise Darcelle Dardy, Margaret Marie Elliott, Billy Joe McCoy, and Ronald Regains were beneficiaries who posed as patients to obtain the fraudulent prescriptions for oxycodone and oxymorphone, which they then sold.

The indictment contains a forfeiture allegation seeking approximately $40,000,000 which is listed as the amount of proceeds derived by the defendants from the drug trafficking offenses charged in Counts 1 to 8 of the indictment.

If convicted, the defendants face a statutory maximum penalty of 20 years in prison on Counts 1 to 8, and a statutory maximum penalty of 10 years in prison on Count 9.

Today’s case, named Operation Gotham, is the result of the ongoing efforts by the Organized Crime Drug Enforcement Task Force (OCDETF), a partnership between federal, state and local law enforcement agencies. The OCDETF mission is to identify, investigate, and prosecute high level members of drug trafficking enterprises, bringing together the combined expertise and unique abilities of federal, state and local law enforcement.

Mr. Ferrer commended the DEA, the HHS-OIG, the IRS, the Miami-Dade Police Department, the Broward Sheriff’s Office, and the Florida Department of Health, for their work on Operation Gotham. This case is being prosecuted by Assistant U.S. Attorney Dwayne E. Williams.

An indictment is only an accusation and the defendants are presumed innocent until proven guilty.

Attachments:
Indictment (PDF)
A copy of this press release may be found on the website of the United States Attorney's Office for the Southern District of Florida at http://www.usdoj.gov/usao/fls. Related court documents and information may be found on the website of the District Court for the Southern District of Florida athttp://www.flsd.uscourts.gov or on http://pacer.flsd.uscourts.gov.

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Massachusetts Sues Purdue Pharma for Illegally Marketing Opioids and Profiting From Opioid Epidemic

More than 670 Massachusetts Residents Prescribed Purdue Opioids Died from Opioid-Related Overdoses since 2009; Purdue Sales Reps Made 150,000 Visits to Medical Offices Since 2008, Sold 70 Million Doses Generating $500 Million in Revenue

Attorney General Maura Healey sued Purdue Pharma L.P. and Purdue Pharma Inc. (Purdue) for misleading prescribers and consumers about the addiction and health risks of their opioids, including OxyContin, to get more people to take these drugs, at higher and more dangerous doses, and for longer periods of time to increase the companies’ profits.

FDA takes action against thousands of illegal Internet pharmacies

The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, took action this week against more than 4,100 Internet pharmacies that illegally sell potentially dangerous, unapproved drugs to consumers. Actions taken include civil and criminal charges, seizure of illegal products, and removal of offending websites.

The announcement takes place during the 5th annual International Internet Week of Action (IIWA), a global cooperative effort to combat the online sale and distribution of potentially counterfeit and illegal medical products. This year’s effort – Operation Pangea V – operated between Sept. 25 and Oct. 2 and resulted in the shutdown of more than 18,000 illegal pharmacy websites and the seizure of about $10.5 million worth of pharmaceuticals worldwide.

The goal of this annual effort, which involved law enforcement, customs and regulatory authorities from 100 countries, is to identify producers and distributors of illegal pharmaceutical products and medical devices and remove these products from the supply chain.

“Consumers in the United States and around the world face a real threat from Internet pharmacies that illegally sell potentially substandard, counterfeit, adulterated or otherwise unsafe medicines,” said FDA Commissioner Margaret A. Hamburg, M.D. “This week’s efforts show that strong international enforcement efforts are required to combat this global public health problem. The FDA is committed to joining forces to protect consumers from the risks these websites present.”

Last week, the FDA reinforced its online efforts with the launch of a national campaign to educate Americans about the risks of buying prescription medications over the Internet. BeSafeRx – Know Your Online Pharmacy seeks to raise public awareness about the health risks of using fraudulent Internet pharmacies and what consumers can do to protect themselves.

During Operation Pangea V, the FDA targeted websites selling unapproved and potentially dangerous medicines. In many cases, the medicines can be detrimental to public health because they contain active ingredients that are approved by FDA for use only under the supervision of a licensed health care practitioner or active ingredients that were previously withdrawn from U.S. market due to safety issues.

Among the illegal medicines identified through the operation were:
Domperidone: This medicine was removed from the United States market in 1998 because it may cause serious adverse effects, including irregular heartbeat, stopping of the heart, or sudden death. These dangers could convey to the nursing baby of breastfeeding women, who may be using domperidone to try increase milk production (which is not an approved use).

Isotretinoin (previously marketed as Accutane in the United States): This medicine is used to treat severe nodular acne and carries significant potential risks, including severe birth defects if pregnancy occurs while using this medicine. To minimize potential risks to consumers, FDA-approved isotretinoin capsules are only available through restricted distribution in the United States.

Tamiflu (oseltamivir phosphate): This medicine, which is used to treat the flu, is often sold online as “generic Tamiflu.” However, there is no FDA-approved generic version of Tamiflu. Previous FDA tests found that fraudulent versions of “generic Tamiflu” contained the wrong active ingredient, which would not be effective in treating flu. In these cases, the wrong active ingredient was similar to penicillin and may cause a severe allergic reaction, including a sudden, potentially life-threatening reaction called anaphylaxis, in consumers allergic to penicillin products.

Viagra (sildenafil citrate): This medicine is used to treat erectile dysfunction. Due to its vasodilation effects, sildenafil citrate should not be used by consumers with certain heart conditions. Consumers taking this medicine without the supervision of a health care professional may not learn about potential drug interactions, such as increased blood pressure lowering effects of organic nitrates when taken with sildenafil citrate.

The FDA sent Warning Letters to the operators of more than 4,100 identified websites. As a follow up, the agency sent notices to Registries, Internet Service Providers (ISPs), and domain Name Registrars (DNRs) informing them that these websites were selling products in violation of U.S. law. The FDA is working with its foreign counterparts to address the remaining websites that continue to offer unapproved or misbranded prescription medicines to U.S. consumers.

“Internet pharmacies that illegally sell unapproved, counterfeit, or potentially adulterated or substandard drugs are an inherently international crime problem,” said John Roth, director of the FDA’s Office of Criminal Investigation. “The FDA is pleased to work with INTERPOL, the international police agency, to fight this problem. Because these criminals do not respect international borders, the international coordinated law enforcement response represented by Operation Pangea demonstrates that international cooperation is the best way to protect the American public from the risk of unsafe drugs.”

The FDA coordinated the efforts of this year’s Operation Pangea V, including screening all drug products received through the international mail facilities during the IIWA. Preliminary findings showed that certain products from abroad, such as antibiotics, antidepressants, and other drugs to treat high cholesterol, diabetes, and high blood pressure, were on the way to U.S. consumers. Many of those products can pose health risks if taken without the supervision of a health care practitioner or if the products have been removed from the market for safety reasons.

The FDA encourages consumers to report suspected criminal activity at www.fda.gov/oci.

The IIWA is a collaboration between FDA, INTERPOL , the World Customs Organization, Permanent Forum of International Pharmaceutical Crime, Heads of Medicines Agencies Working Group of Enforcement Officers, the Medicines and Healthcare products Regulatory Agency of the United Kingdom, the Irish Medicines Board, the London Metropolitan Police, the U.S. Department of Homeland Security, the Center for Safe Internet Pharmacies, and national health and law enforcement agencies from 100 participating countries.

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Health Care Continues to Eat Away at Employee Earnings

Family Health Premiums Rise 4 Percent to Average $15,745 in 2012, National Benchmark Employer Survey Finds

Throughout the nation Workers' Compensation systems have been impacted by health care costs that now take a large piece of the premium dollar. Traditional health care offered by employers mirrors the same problem of economic stress. Running two parallel systems creates added costs and  delays the delivery of medical care. The recent Kaiser Survey just released for 2012 reports that costs in the health care field continue to outpace employee compensation. 

Annual premiums for employer-sponsored family health coverage reached $15,745 this year, up 4 percent from last year, with workers on average paying $4,316 toward the cost of their coverage, according to the Kaiser Family Foundation/Health Research & Educational Trust (HRET) 2012 Employer Health Benefits Surveyreleased today.

This year’s premium increase is moderate by historical standards, but outpaced the growth in workers’ wages (1.7 percent) and general inflation (2.3 percent). Since 2002, premiums have increased 97 percent, three times as fast as wages (33 percent) and inflation (28 percent).

“In terms of employee insurance costs, this year’s 4 percent increase qualifies as a good year, but it still takes a growing bite out of middle-class workers’ wages, which have been flat or falling in real terms,” Kaiser President and CEO Drew Altman, Ph.D. said.

“Premium growth is at historic lows, which greatly benefits workers. Continuing to ensure that Americans have coverage options that are affordable is vitally important for our nation’s health,” said Maulik Joshi, Dr.P.H., president of HRET and senior vice president for research at the American Hospital Association.

The 14th annual Kaiser/HRET survey of more than 2,000 small and large employers provides a detailed picture of trends in employer-sponsored health insurance costs and coverage. In addition to the full report and summary of findings being released today, the journal Health Affairs is publishing a Web First article with select findings, and Dr. Altman authored a “Pulling It Together” column reflecting on this year’s results.

The survey reveals significant differences in the benefits and worker contributions toward family premiums between firms with many lower-wage workers (at least 35 percent of workers earn $24,000 or less a year) and firms with many higher-wage workers (at least 35 percent of their workers earn $55,000 or more a year).

Workers at lower-wage firms on average pay $1,000 more each year out of their paychecks for family coverage than workers at higher-wage firms ($4,977 and $3,968, respectively). This occurs even though the firms with many lower-wage workers on average pay less in total premiums for family coverage than firms with many higher-wage workers ($14,694 and $16,427, respectively).

In addition, workers at lower-wage firms are also more likely to face high deductibles than those at higher-wage firms. Specifically, 44 percent of covered workers at firms with many low-wage workers face an annual deductible of $1,000 or more, compared with 29 percent of those at firms with many high-wage workers. Across all employers, a third of covered workers (34 percent) face a deductible of that size, including 14 percent with deductibles of at least $2,000 annually.

“This year’s survey suggest that working families at the low end of the wage scale face significant out of pocket costs for coverage,” said study lead author Gary Claxton, a Kaiser Vice President and director of the Foundation’s Health Care Marketplace Project. “Firms with many lower-wage workers ask employees to pay more out of pocket than firms with many higher-wage workers even though the coverage itself tends to be less comprehensive.”

Health Reform and Employers

The survey estimates that 2.9 million young adults are currently covered by employer plans this year as a result of a provision in the 2010 Affordable Care Act that allows young adults up to age 26 without employer coverage of their own to be covered as dependents on their parents’ plan. That’s up from the 2.3 million in the 2011 survey. Young adults historically have been more likely to be uninsured than any other age group.

The survey also finds that 48 percent of covered workers are in “grandfathered” plans as defined under health reform, down from 56 percent last year. Grandfathered plans are exempted from some health reform requirements, including covering preventive benefits with no cost sharing and having an external appeals process. To retain this status, employers must not make significant changes to their plans to reduce benefits or increase employee costs.

Employer Expectations for 2013

In addition to the comprehensive survey conducted in the spring, employers were asked in August whether they had information about the change in premiums (or total cost for self-funded plans) for their current health plan with the largest enrollment. The average increase reported by employers who had received information for their current plan is 7 percent.

These early reports may not match what employers and workers ultimately end up paying next year, as firms can raise deductibles or otherwise change the health benefits and plans they offer to lower premiums. This year, for example, more than half (54 percent) of employers who offer health benefits reported that they had shopped around for new coverage. Of that group, significant shares switched carriers (18 percent) or changed the type of plans they offer (27 percent).

Other findings from the study include:
Worker-only coverage. Premiums for worker-only health coverage increased 3 percent in 2012 to reach $5,615 annually. Workers on average pay $951 toward this coverage.
Offer rate. This year, 61 percent of firms offer health benefits to their workers – statistically unchanged from last year. 

Cost-sharing for office visits, emergency care and drugs. Covered workers facing co-payments for in-network physician office visits on average pay $23 for primary care and $33 for specialty care. For emergency-room visits, average co-pays are $118. For drug plans with three or more tiers, average co-pays are $10 for generic drugs, $29 for preferred brand-name drugs, $51 for non-preferred brand-name drugs, and $79 for specialty drugs.
Domestic partner benefits. In 2012, 31 percent of employers offer health benefits to same-sex domestic partners, up from 21 percent three years earlier. This year 37 percent of firms offer such benefits to unmarried opposite-sex partners, up from 31 percent in 2009.
Flexible Spending Accounts and Pre-Tax Premiums. Large employers are more likely than small ones to allow workers to pay their share of premiums with pre-tax income (91 percent, compared to 41 percent) and to contribute pre-tax dollars to Flexible Spending Accounts (76 percent, compared to 17 percent).

Now in its 14th year, the survey is a joint project of the Kaiser Family Foundation and the Health Research & Educational Trust. The survey was conducted between January and May of 2012 and included 3,326 randomly selected, non-federal public and private firms with three or more employees (2,121 of which responded to the full survey and 1,205 of which responded to a single question about offering coverage). A research team at Kaiser, HRET and NORC at the University of Chicago, led by Kaiser’s Gary Claxton, designed, conducted and analyzed the survey. For more information on the survey methodology, please visit the Survey Design and Methods Section at http://ehbs.kff.org.

....
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 work related accident and injuries.

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Intoxication, Work, And Workers' Compensation Don’t Mix

Today's post comes from guest author Paul J. McAndrew, Jr. from Paul McAndrew Law Firm of Iowa.

Most of us know that, for both professional reasons and in the interest of safety, remaining sober while on the job is essential. However, it is important to also recognize that workers who are intoxicated at the time that they sustain a work injury stand a far lower chance of ever collecting workers’ compensation.

If the blood test shows the presence of alcohol or drugs, odds that the employee will be able to collect workers’ compensation are much lower.

This is because of the intoxication defense: if an employer can prove that intoxication was the cause of the workers’ injury, then they employer is not required to provide workers’ comp for that injury. Now, there are some notable

Little evidence to support sleep/wake drugs for shift workers: study

Today's post was shared by Safe Healthy Workers and comes from in.reuters.com

NEW YORK (Reuters Health) – - Many shift workers use over-the-counter and prescription drugs to stay awake or fall asleep at the appropriate times – but the evidence behind those practices is weak, researchers say. Use of these drugs for this purpose “has been studied to a very limited extent and the studies that have been published mostly have not been of sufficient quality to allow firm conclusions,” said Dr. David Neubauer, associate director of the Johns Hopkins Sleep Disorders Center in Baltimore, Maryland. “Considering the large number of people who do shift work, it certainly is unfortunate that minimal research has been performed to offer clinical guidance to address the problems of inadequate alertness or sleepiness,” Neubauer, who was not involved with the new study, told Reuters Health by email. For the study, Dr. Juha Liira of the Finnish Institute of Occupational Health in Helsinki and colleagues gathered data from 15 trials involving 718 participants. The trials evaluated the effect of melatonin and hypnotic drugs on sleep after the shift, and the effect of modafinil, armodafinil and caffeine plus naps on sleepiness during the shift. They found that taking a nap and caffeine before a night shift may improve alertness, and daytime melatonin may add around 24 minutes of extra sleep during daylight hours, but the evidence is weak. For some workers, modafinil improves alertness at work but carries the risk of side effects like...

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Opioid Epidemic: Walgreens to Pay $5.5 Million Over Alleged Overcharges for Prescription Drugs

Walgreens Overcharged for Drugs Covered by State Workers’ Compensation System. A Settlement was entered into with Massachusetts Attorney General's’ Office to fund programs that address the Opioid Epidemic.

Pain Relievers Maybe Complicating Workers' Compensation Claims

NSAIDs commonly prescribed for pain relief in workers' compensation claims, to relieve pains and aches, may in fact be really making the health status of the injured worker worse in patients with cardiovascular symptomatology.

"The use of NSAIDs is associated with persistently increased coronary risk regardless of time elapsed after first-time MI. We advise long-term caution in using NSAIDs for patients after MI."

Click here to read "Long-Term Cardiovascular Risk of NSAID Use According to Time Passed After First-Time Myocardial Infarction: A Nationwide Cohort Study" CIRCULATIONAHA.112.112607Published online before print September 10, 2012,doi: 10.1161/​CIRCULATIONAHA.112.112607

"More than 80 million people in the United States have some form of cardiovascular disease (CVD)—for example, coronary heart disease, stroke, high blood pressure, or heart failure—and millions of others are at increased risk for these diseases. Over half of these people are also affected by arthritis and other disorders of the musculoskeletal system—the muscles, bones, joints, ligaments, tendons, and bursa. The pain associated with these chronic conditions is often treated with a class of medications known as nonsteroidal antiinflammatory drugs (NSAIDs). However, it has been shown that taking some NSAIDs can increase a person’s risk of having a heart attack or stroke. This risk is likely greatest in patients who have a prior history of CVD or who are at high risk for CVD. "

Click here to read "Can Patients With Cardiovascular Disease Take Nonsteroidal Antiinflammatory Drugs?" Circulation.2008; 117: e322-e324doi: 10.1161/​CIRCULATIONAHA.107.749135

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How Proposed Part D Changes Are Playing On Capitol Hill

Officials at the Centers for Medicare & Medicaid Services are proposing to remove some drugs from Medicare’s prescription drug plans and limit how many plans insurers can offer. KHN’s Mary Agnes Carey and CQ Roll Call’s Emily Ethridge discuss.

>> Click here to listen to audio of the conversation.

MARY AGNES CAREY: Welcome to Health on the Hill. I’m Mary Agnes Carey.

A series of proposed changes to the Medicare prescription drug program -- also known as Medicare part D -- have been getting a lot of attention on and off of Capitol Hill. Patient groups and lawmakers in both parties say easing current requirements on what drugs plan must cover could cause hardships for some patients. There’s also bipartisan opposition to a provision that would limit the number of plans insurers could offer.

With me now to discuss these issues is Emily Ethridge of CQ Roll Call. Emily, thanks so much for coming.

EMILY ETHRIDGE, CQ ROLL CALL: Thanks for having me.

MARY AGNES CAREY: Now CMS currently -- that’s the Centers for Medicare & Medicaid Services, which oversees the Medicare part D program -- they currently require that Part D plans cover the vast majority of drugs in six specific classes. And they’re proposing to drop two of these categories next year, and another might be dropped in 2015. What are these drugs that could lose this "protected status," as they call it, and why are people so...


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FDA Asks Recalcitrant Compounder to Recall Products, Again

Today's post was shared by Take Justice Back and comes from blogs.wsj.com

FDA officials have asked a compounding pharmacy with which they have repeatedly sparred to recall all of its sterile products over concerns that medicines that are currently circulating may be contaminated and present a risk of illness or injury, according to a letter sent yesterday to Downing Labs, which operates NuVision Pharmacy in Dallas, Texas. The move comes after the FDA found a host of problems during an inspection earlier this summer and warned health care providers and consumers not to use the medicines made by the compounder. In fact, this was the third such warning in 15 months that the agency issued about NuVision and the safety of its compounded drugs. “Given the high rate of contamination, there is a high probability that contaminated units from other purportedly sterile drug product lots produced at the Downing Labs facility are currently in distribution,” the FDA wrote in what the agency calls a ‘formal request.’ “Based on the inspectional findings, FDA has serious concerns about the conditions and practices at the facility for the production of sterile drugs, which result in a lack of sterility assurance.” The letter goes on to cite various manufacturing problems, such as a lack of “sound scientific data” to support explanations for sterility failures and an inability to identify the cause of the...

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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

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Details Lacking on Prescription Drug Coverage in New Health Law

Today's post was shared by WCBlog and comes from www.nytimes.com

Among the most troubling questions facing consumers as they shop for insurance under the Obama administration’s new health care law is whether the plans will cover the drugs they take — and how much they will have to pay for them. But with less than two weeks remaining until enrollment opens on Oct. 1, the answers are still elusive and anxiety is growing for consumers whose well-being depends on expensive medications. States running the marketplaces where the plans will be offered have not released details about which drugs will be covered. Insurers have said little about how much consumers will be asked to contribute or what types of restrictions will be placed on certain medicines. Of the few states that have revealed specifics, some have plans that will require patients to contribute as much as 50 percent of the cost of the most expensive drugs. “I’ve got to be honest and say I’m a little bit nervous,” said Jessica Thomas, a mental health counselor in North Carolina who takes the drug Tecfidera to treat her multiple sclerosis. Ms. Thomas, 34, has been enrolled for two years in a program for people with expensive medical conditions that is run by North Carolina. But that program is ending in December, and she must select a new plan in the state marketplace. At the top of her mind is how much she will have to pay for Tecfidera, which costs more than $4,000 a month. “I think that’s the hard thing right now is that it’s...

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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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