Medicaid Denial for Hep C Drugs Nearing 50% in Some States

Posted on November 10, 2016 by Pharmaciststeve

 

death_panelMedicaid Denial for Hep C Drugs Nearing 50% in Some States

http://www.medscape.com/viewarticle/854708?src=WNL_confprev_161110_MSCPEDIT&uac=75309AG

 

SAN FRANCISCO — Medicaid programs in Delaware, Maryland, New Jersey, and Pennsylvania denied nearly half of all claims in recent months for direct-acting antiviral hepatitis C drugs, according to an analysis of pharmacy data presented here at the Liver Meeting 2015.

The finding confirms anecdotal reports from physicians in the United States that they are unable to provide these life-saving medications to some of their most impoverished patients, said Vincent Lo Re, MD, assistant professor of medicine, biostatistics, and epidemiology at the University of Pennsylvania in Philadelphia.

“The only thing that that was surprising was the magnitude of the denial rate,” he told Medscape Medical News. “It’s so much higher than Medicare.”

Dr Lo Re and his colleagues found that Medicare denies just 5% of claims for the drugs in these four states, whereas commercial insurers deny 10%.

To understand what factors are actually leading to the rejection of patient claims, the researchers analyzed data from Burman’s Specialty Pharmacy, which fills prescriptions for a large number of people with hepatitis C in the mid-Atlantic states.

They focused on direct-acting antiviral prescriptions written for patients with hepatitis C genotype 1, 2, or 3 infections from November 1, 2014 to April 30, 2015. Prescriptions that required prior authorization by outside pharmacies were excluded from the analysis, as were patients covered by insurers that mandated the use of a different pharmacy and patients with no health insurance.

Of the 2342 eligible patients, 517 were covered by Medicaid, 800 were covered by Medicare, and 1025 were covered by commercial insurance.

There was no significant difference in age, race, or history of treatment for hepatitis C between the Medicaid, Medicare, and commercially insured patients.

Medicaid patients were more likely than Medicare patients to be women, have genotype 1 infections, and have HIV infections, but these differences were small.

In each insurance group, at least 80% of the prescriptions were for ledipasvir, sofosbuvir, plus ribavirin; prescriptions for sofosbuvir plus ribavirin were a distant second.

Twenty-one patients had incomplete prior authorization. Of the remaining 2321 patients, coverage was denied for 16.2%. One patient whose claim was denied received patient assistance from a drug company.

Denial was significantly more common in Medicaid patients than in those covered by Medicare or commercial insurance (46% vs 5% vs 10%; P < 0.001). And the median wait for prescriptions was longer for Medicaid patients than for those covered by Medicare or commercial insurance (24 vs 14 vs 14 days).

 

Insurers most often cited “incomplete data to determine medical need” and “lack of medical necessity” as reasons for denying a claim.

Table: Reasons for Denial of Coverage

Reason Medicaid, % (n = 503) Medicare, % (n = 795) Commercial Insurance, % (n = 1023)
Incomplete data to determine medical need 22 1 2
Lack of medical necessity 14 2 5
Unknown (no denial letter received) 8 2 3
Drug or alcohol use 2 0 1
Nonpreferred direct-acting antiviral drug 0 1 0

 
The researchers found no correlation between absolute denials and age, race, sex, viral genotype, hepatitis C treatment history, or HIV infection.

But they found that patients who did not have signs of cirrhosis were more likely to be denied coverage (odds ratio [OR], 2.85; 95% confidence interval [CI], 2.00 – 4.07), which is consistent with the theory that states are denying coverage for people with the least-advanced disease.

Patients with prescriptions written in the earlier part of the study period — from November 1, 2014 to January 31, 2015 — were more likely to be denied coverage than patients with prescriptions written in the later part of the study (OR, 3.16; 95% CI, 2.21 – 4.50).

The study fills an important gap in the conversation about coverage for hepatitis C treatments, said Ronald Sokol, MD, from the University of Colorado Anshutz Medical Campus in Denver. “We lack this type of data,” he told Medscape Medical News.

States Can’t Afford to Treat Everyone

New drugs can cost more than $80,000 for a course of treatment, putting them out of reach for many people whose insurance won’t cover them.

But states can’t afford to treat everyone infected with the virus, said Matt Salo, executive director of the National Association of Medicaid Directors.

We would be spending as much on that one drug as all the other drugs in Medicaid combined.

“We would be spending as much on that one drug as all the other drugs in Medicaid combined. That’s not a sustainable factor to deal with,” he said. The proportion of people infected with hepatitis C is higher in the Medicaid population than in the Medicare population.

Medicaid is run by states, and states are under more pressure to balance their budgets than the federal government, which runs Medicare.

And because hepatitis C takes a long time to cause serious liver damage, most of the infected people now covered by Medicaid will be covered by Medicare by the time they need transplants or other expensive care, Salo told Medscape Medical News.

As a result, state Medicaid programs are “prioritizing coverage to those who need it the most,” he explained.

States are using the extent of a patient’s liver fibrosis and whether or not the patient is addicted to alcohol or using illegal drugs to prioritize coverage, he said. Patients with substance abuse problems might not complete their courses of treatment and might become reinfected, which increases the risk that more resistant strains of the virus will evolve.

This approach raised a red flag at the Centers for Medicare and Medicaid Services (CMS), prompting letters to be sent to all 50 state Medicaid directors, warning them that they could be breaking the law if they deny coverage to patients with appropriate prescriptions.

States are free to develop criteria for coverage, but “the effect of such limitations should not result in the denial of access to effective, clinically appropriate, and medically necessary treatments,” wrote Alissa Mooney DeBoy, acting director for the CMS Disabled and Elderly Health Programs Group.

A spokesperson for the Maryland Medicaid program declined to comment on the study or the CMS letter, and no one from the New Jersey program responded to a request for comment.

 

Kathleen Gillis, from the Pennsylvania Department of Human Services, said that the state revised its guidelines for providing hepatitis C care after the study ended.

As of July, it covers direct-acting antivirals for patients with “less severe liver damage and patients at a higher risk for disease progression or complications, such as people with HIV or hepatitis B virus coinfection.”

It has removed a requirement for 6 months abstinence from drugs or alcohol before treatment and abstinence during treatment. Instead, it requires counseling on the risks of alcohol or intravenous drug abuse and referrals for substance abuse treatment.

 

Cynthia Denemark, pharmacist administrator for the Delaware Division of Medicaid and Medical Assistance, questioned whether the findings apply to the current Delaware program. During the study period, the program’s “entire drug benefit was in transition from fee-for-service to being part of the managed care benefit,” she said told Medscape Medical News.

But Steve Groff, Delaware’s Medicaid director, confirmed that the state requires screening for illegal substance use and evidence of fibrosis stage 4 or cirrhosis before covering the cost of hepatitis C drugs.

And Jeff Myers, chief executive officer of Medicaid Health Plans of America, told Medscape Medical News that his association believes such restrictions are legal because they are “clinically appropriate and medically necessary.”

Asking the Manufacturers to Step In

Myers said that another letter from CMS, written to the drug manufacturers, is more significant. This letter asked Gilead, AbbVie, Johnson & Johnson, and Merck & Company what pricing programs they offer to various types of payers, and how they plan to help states pay for the drugs.

Johnson & Johnson and Merck are both working on new direct-acting antiviral drugs for hepatitis C.

Johnson & Johnson did not respond to an inquiry from Medscape Medical News about the CMS letter, but a spokesperson for Merck said in an email that the company is in “exploratory discussions with CMS on how we can work together on this unprecedented opportunity to address the burden of hepatitis C in the United States.”

An AbbVie spokesperson said only that the company is preparing to reply to the letter.

But Gilead defended its pricing. “Gilead believes the price of Sovaldi [sofosbuvir] and Harvoni [ledipasvir and sofosbuvir combination] reflects the innovation of the medicines,” said Cara Miller, a spokesperson for the company.

 

With rebates and discounts, the cost of treatment with sofosbuvir or the combination of ledipasvir and sofosbuvir is now less than the cost of previous treatment regimens, she explained. The company provides a discount of more than 21% to Medicaid, and the Department of Veterans Affairs “pays less than half of the published wholesale acquisition cost or list price.”

So how can these treatments be made available to everyone who needs them?

Competition has already lowered the cost of treatment, said Salo. For example, the price dropped from $1000 a pill when Gilead had the only direct-acting antiviral on the market to $600 a pill now that Gilead is competing with AbbVie.

 

But even with several other drugs in development, Salo is not optimistic that market forces alone will drive the price low enough.

What might help is an Act of Congress or some other intervention by the federal government, which is a possibility, he said, pointing out that the Department of Health and Human Services has organized a national summit on the issue of drug costs for this Friday.

Dr Lo Re has disclosed no relevant financial relationships. Dr Sokol reports relationships with Gilead and AbbVie.

 

The Liver Meeting 2015: American Association for the Study of Liver Diseases (AASLD). Abstract LB-5. Presented November 16, 2015

 

Filed under: General Problems | Leave a Comment »

DEA: Better death reporting will give us more “bodies” to justify the war on drugs ?

Posted on November 10, 2016 by Pharmaciststeve

DEA seeks more accurate drug-death numbers

http://www.readingeagle.com/news/article/dea-seeks-more-accurate-drug-death-numbers

Reading, PA

Four months after two widely distributed reports gave vastly different numbers for deaths caused by drug overdoses in Pennsylvania, the federal Drug Enforcement Administration said it has teamed with an academic agency to take drug death reporting and analysis to a new and more sophisticated level.

The DEA’s Philadelphia field office said it would collaborate with the University of Pittsburgh School of Pharmacy’s Pennsylvania Heroin Overdose Prevention Technical Assistance Center on getting timely and accurate drug death data from Pennsylvania’s 67 counties.”They have an ability to analyze that is far superior to anything we can do,” Patrick Trainor, a DEA spokesman, said Wednesday. “And it is from a public health perspective.”

TODAY’S SPONSOR:

In July, the Reading Eagle reported that glaring differences existed in reports issued by the DEA and the Pennsylvania State Coroners Association on drug deaths in 2014.For instance, one report said there were 82 deaths in Chester County that year, while the other said there were 36.At the time, Berks County Coroner Dennis J. Hess said the state Department of Drug and Alcohol Programs had changed numbers given to it by coroners. DDAP, in turn, served as a resource for the DEA report.A DDAP spokesman subsequently said any assertion it gave out information significantly different from what it collected was false.A DEA spokeswoman said a spreadsheet from DDAP used in the 2014 report was understood to be incomplete, and the DEA later revised figures in its 2014 report.The DEA’s announcement of its new partnership did not mention DDAP.Trainor could not say whether the state agency was involved. A DDAP spokeswoman Wednesday did not immediately answer questions about whether it was involved.The death counts contained in reports from the DEA and coroners association are widely reported by the media and cited by state lawmakers.On Wednesday, Hess welcomed the involvement of the university.”The more people we talk about it with the better,” he said.The center at the university gets grant funding from the Pennsylvania Commission on Crime and Delinquency. It manages OverdoseFreePA, a project partnership between communities and organizations to work on the overdose problem.Trainor said he expected the DEA’s next statewide overdose report to be a joint effort of the federal agency and the university-managed partnership.Contact Ford Turner: 610-371-5037 or fturner@readingeagle.com.

Filed under: General Problems | 3 Comments »

U.S. Enforcing Insurance Law to Help Fight Opioid Abuse

Posted on November 9, 2016 by Pharmaciststeve

U.S. Enforcing Insurance Law to Help Fight Opioid Abuse

www.nytimes.com/2016/11/08/us/mental-health-parity.html

We have abt TWO MILLION serious opiate substance abusers and 116 million chronic pain pts and look at where the administration is using its FORCE to get certain pts appropriate therapy ?

WASHINGTON — In one of President Obama’s last major health care initiatives, the administration is stepping up enforcement of laws that require equal insurance coverage for mental and physical illnesses, a move officials say will help combat an opioid overdose epidemic.

A White House task force on Oct. 27 said insurers needed to understand that coverage for the treatment of drug addiction must be comparable to that for other conditions like depression, schizophrenia, cancer and heart disease. As an example, the administration said, insurers may not require prior approval for drugs to treat opioid addiction, like buprenorphine, if they do not impose similar restrictions on drugs with similar safety risks that are prescribed for physical illnesses.

Federal laws and rules requiring mental health parity have been adopted with bipartisan support over the last 20 years, but the task force found that compliance was lagging.

“While the right laws are on the books, they are too often ignored or not enforced,” Hillary Clinton, the Democratic nominee for president, said in August, promising stronger enforcement of parity laws as part of an ambitious mental health agenda.

The White House task force called for more frequent audits of health plans and warned insurers against imposing stricter requirements on mental health services than on other types of medical care.

More than 40 million people — about one in five American adults — experience some kind of mental illness each year, the administration said, and more than 20 million have a “substance use disorder” involving drugs or alcohol.

Mr. Obama created the task force in March. Along with its final report last month, the administration issued a guide for consumers explaining that they have a legal right to see the criteria used by insurers to determine if a specific mental health treatment is medically necessary.

In the last five years, the Labor Department conducted 1,515 investigations of possible parity violations and issued 171 citations for noncompliance by employer-sponsored health plans.

Those 171 citations are more significant than the number might appear, said Phyllis C. Borzi, an assistant secretary of labor. When the government finds violations, she said, it requires insurers to correct all their health plans, so that a single citation may produce “global changes” affecting tens of thousands of group health plans with millions of participants.

Kate Berry, a senior vice president for America’s Health Insurance Plans, a trade group for insurers, praised the report, saying it included “a lot of good recommendations to help consumers understand what parity means.” Insurers are “working very hard to comply and have made significant progress,” she said.

The Obama administration said that insurers clearly violated the law if they charged higher co-payments for mental health care than for other care, or if they imposed stricter limits on the number of visits to mental health professionals.

Certain other practices do not automatically violate the law, but they do raise a red flag and must be justified by insurers, the administration said.

If, for example, a health plan requires prior approval, or preauthorization, for all mental health care services or all addiction treatments, the government may investigate. Likewise, federal officials said they could investigate if an insurer required a psychiatrist to file a treatment plan or a progress report on a patient every 30 days, or paid only for mental health treatments that produced a “measurable and substantial improvement” within 90 days.

Insurers would have to show that they imposed similar requirements for medical and surgical benefits.

Under a 1996 law, health plans were forbidden to set annual or lifetime dollar limits on mental health care that were lower than the limits for other services. But insurers got around the law by replacing dollar limits on mental health care with numerical limits on doctor visits or days in the hospital. In 2008, Congress banned such differential standards in large employer-sponsored health plans and provided protection for addiction treatments as well. Two years later, in the Affordable Care Act, Congress extended similar protections to people enrolled in individual health insurance policies.

Since then, federal agencies have issued rules and guidelines to ensure that prior authorization requirements, medical necessity criteria and other cost-control techniques do not become barriers to mental health care and addiction treatment.

Patients’ advocates welcomed the new initiative, but said it did not go far enough.

“Enforcement still relies too heavily on complaints,” said Carol A. McDaid, the coordinator of a coalition of mental health advocates. “The government still puts the onus on consumers to understand a complex law and file complaints.”

Ellen M. Weber, an expert on health law at the University of Maryland school of law, said, “It would be much better to require insurers to show compliance up front, as a condition of obtaining approval to offer plans on the market.”

“Regrettably,” Professor Weber said, “some insurers continue to discriminate against their members, who pay high premiums for substance use and mental health coverage.”

The task force found “significant shortages” of psychiatrists, clinical social workers and providers of addiction treatment. And state officials have found that some insurers do not have enough providers in their networks.

Ms. Berry, of the insurance industry group, said insurers were not to blame for such shortages of mental health providers.

“You can’t have them in your network if they don’t exist,” or if they are unwilling to join an insurer’s network, she said.

Filed under: General Problems | 3 Comments »

Failure … let me count the ways !

Posted on November 9, 2016 by Pharmaciststeve

failureOnce again the chronic pain community has failed to create unity

Yesterday’s election abt 98% of the incumbents got re-elected… So how does the chronic pain community expects change.. if they don’t participate in causing change.

Untold number of Face Book pages have been created to get the chronic pain to unify.. Unity WILL NOT HAPPEN the more FACE BOOK PAGES that there are.

There has been dozens of petition to the White House, Congress and others… each needing 100,000 signatures and most getting LESS THAN 1,000 signatures. Another chronic pain community failure

There was a effort to create a “legal war chest” to fund hiring a law firm to help PUSH BACK against all the injustices that are being dumped on the chronic pain community..  after a month $600 + was collected from a couple of dozen people.. with two people each contributing $100 each… that was ABANDONED for apparent lack of interest.. another failure of the chronic pain community

We don’t know how many people have had meetings with the elected members of Congress when they are back in their local districts… don’t hear much about it… so very little must have occurred – ANOTHER FAILURE

How many chronic painers have shared news articles about chronic painers committing suicide with their local TV/news medias … on their FACE BOOK PAGES  and/or TWITTER feed. Seemingly the known suicides of chronic painers .. just get a YAWN out of the chronic pain community.. ANOTHER FAILURE.

But rest assured that on various internet medias… many from the chronic pain community will continue to WHINE …. BITCH… and MOAN…  on a daily basis about their under/untreated pain… and if history is any suggestion how successful this will be in the future to change the path that our country is on .. in the treatment of chronic painers… the future will be very bleak for those with chronic pain… BECAUSE NOTHING WILL CHANGE… within the chronic pain community’s unity.

quicksand1

 

 

Filed under: General Problems | 19 Comments »

Case dismissed against doctor accused of over prescribing meds that led to patient ODs

Posted on November 9, 2016 by Pharmaciststeve

Case dismissed against doctor accused of over  prescribing meds that led to patient ODs

HOWARD COUNTY, Ind. (WLFI) – A Howard County doctor accused of overprescribing powerful painkillers that led to patient overdoses has the case dismissed.

“Shocked,” said Kokomo resident Allen Butler. “I think, whatever they say is wrong with her, she still deserves some kind of punishment.”

On Tuesday, a Howard County judge granted the dismissal in the case against Dr. Marilyn Wagoner.

Kokomo resident Margaret Haworth said she’s disappointed in the decision.

“There’s too many people’s lives, young people’s lives and older people’s lives, that she’s messed up,” said Haworth. “They’re all messed up.”

Prosecuting attorney Mark McCann filed a motion to dismiss the case against Dr. Marilyn Wagoner, wife of Dr. Don Wagoner who was sentenced in July 2014 to two years behind bars for seven felony charges in connection to the case.

As News 18 previously reported, police said the Wagoner Clinics in Burlington and Kokomo were operating as “pill mills,” overprescribing dangerous painkillers that led to numerous overdoses. As many as 27 patient deaths may have been linked to the case. Court documents show a total of nine people were arrested and faced a combined 95 felony charges.

Butler said not only have people died at the hands of the Wagoner Clinic doctors, former patients are still suffering.

“He can’t go to no other doctor because they think all of her patients are there just for the drugs, even though he needs the medication,” Butler explained. “So, it’s not just affected him but everybody that went there.”

In the state’s motion to dismiss, McCann cited several reasons:

  • Marilyn Wagoner is currently living in an assisted living facility.
  • She is of an advanced age of 79 years.
  • Marilyn Wagoner’s heath care provider says she is suffering from mental incapacity, has been diagnosed with memory loss, and her cognitive functions continue to decline.
  • The doctor provided a medical report which states she is unable to stand trial.

Haworth thinks another doctor should review the case.

“If she’s that sick like they say she is, I want more than one opinion of it,” said Haworth.

Marilyn Wagoner’s bond order has been released and her trial date has also been lifted.

Filed under: General Problems | 8 Comments »

Recall alert: heroin overdose kit may not work

Posted on November 9, 2016 by Pharmaciststeve

Recall alert: heroin overdose kit may not work

http://www.daytondailynews.com/news/recall-alert-heroin-overdose-kit-may-not-work/BeAPnAd0FAAdvqWAtm8cpL/

The maker of a nasal spray in naloxone kits used by local law enforcement, individuals and other agencies to reverse overdoses from heroin and prescription painkillers has issued a nationwide recall for some of the atomizers used to administer the drug because they may not properly dispense the drug.

The recalled atomizers may dispense the drug as a stream, rather than a spray. But the drug itself is not defective, and there have been no incidents reported locally in which the nasal kits failed to revive victims who might otherwise have died as a result of an overdose, according to officials at Montgomery County Alcohol, Drug Addiction & Mental Health Services, which is spearheading the fight to combat the heroin and prescription drug epidemic in the area.

“So far in Montgomery County, we have not heard of any problems with the atomizers, but everybody should check the numbers,” said ADAMHS spokeswoman Ann Stevens, referring to recalled lot numbers for the product that can be found on the agency’s website at mcadamhs.org. “What we’re concerned about right now is the general public who may have a kit in their home and not realize it is affected by the recall.”

Consumers who may have purchased naloxone kits directly from a pharmacy or had naloxone prescribed by a doctor have been advised to return the kits to the location where they purchased them. Consumers can also check for pharmacies that may have sold the product, from Illinois-based Teleflex Medical, at the State of Ohio Board of Pharmacy website. In addition, the Ohio Department of Health has established a toll free hotline for questions about the recall at 844-364-4063.

“People who have naloxone at home should try to go back to where they purchased it, and and see if they can get another atomizer,” Stevens said. “If the atomizer doesn’t work correctly, it’s going to be less effective in helping somebody come out of an overdose quickly. And in an overdose, time is of the essence.”

Local law enforcement and EMS professionals get the naloxone kits from a central repository, and they have already begun checking for the recalled products, Stevens said.

“They’re going through all the lot numbers at the repository to see if any of the atomizers are affected by this recall,” she said, pointing to a list of 32 recalled lot numbers. “We just got the (recall) notice late last week, so there’s a lot of supply that needs to be checked. That’s what people are doing right now. We hope we don’t have a large stock (of the recalled items), but we’re checking just to make sure.”

MAD300 nasal atomizer lot numbers impacted by the recall are as follows:

160108 160231 160440 160708 160117 160300 160500 160718 160126 160313 160518 160728 160145 160327 160602 160800 160146 160400 160611 160804 160200 160409 160621 160814 160219 160422 160631 160816 160225 160432 160701 160823

 

 

Filed under: General Problems | 1 Comment »

Pharmacy board member fined for conflict of interest

Posted on November 9, 2016 by Pharmaciststeve

Pharmacy board member fined for conflict of interest

http://www.ibj.com/blogs/17-the-dose/post/61158-pharmacy-board-member-fined-for-conflict-of-interest

The vice president of the Indiana Board of Pharmacy has agreed to pay a $600 fine for participating in several votes involving a pharmacy he was buying.

Steven Anderson, a registered pharmacist and member of the pharmacy board since 2003, signed a settlement admitting that he violated state ethics laws when he voted on matters involving McGrady’s Family Pharmacy in New Castle, about 50 miles east of Indianapolis.

The small, independent pharmacy had been struggling financially after the pharmacy board found five violations in 2014 and placed the owner’s license on probation for three years and fined it $5,000.

The trouble started when owner James Vincent McGrady failed to renew his Drug Enforcement Administration license and could not dispense drugs. But according to state documents, McGrady continued to dispense drugs, was caught by the DEA and had to surrender his license.

McGrady told the board in 2015 he was unable to pay his fine and asked for an extension. A few months later, in a possible solution, he told the board’s compliance officer he had received a purchase offer from Walgreen’s Pharmacy, and said if the sale went through, he would be able to pay the fine.

Anderson, the pharmacy board member, was present during a meeting with the pharmacy board’s staff when the subject of the Walgreen’s purchase was discussed, according to a report filed by the Indiana Inspector General’s office.

Anderson had a one-third ownership in Panacea Pharmacy Inc. along with his nephew, Joshua Anderson, and an associate, Lester Burris. In May 2015, the three partners began discussing an interest in purchasing McGrady’s Family Pharmacy.

“After learning that the owner might be selling the pharmacy, the nephew asked [Anderson] to give the owner his phone number at the June 2015 board meeting,” the Inspector General’s report said. “[Anderson] approached the owner at the June 8, 2015 board meeting and asked the owner to call his nephew prior to selling the pharmacy to another company.”

story continues below

On June 13, the owner called the nephew to begin discussions. Afterward, the three partners agreed to buy the pharmacy.

Their company, Panacea, entered a contract on June 15 to serve as the central fill pharmacy for McGrady’s while the sale was being completed. A month later, on July 8, 2015, the three partners formed another company, Anderson Burris Inc., that paid $50,000 to buy McGrady’s.

The state pharmacy board voted Nov. 9 to approve on the new store application for McGrady’s submitted by Anderson Burris. During the vote, Anderson recused himself and left the room.

However, Anderson participated in three votes on June 8 involving the store while he was in discussions to buy it. The votes were to approve the probationary appearance for McGrady, to modify his probationary order to allow him to make monthly payments on his fine, and to issue an order to show cause for unpaid fines for the pharmacy’s license.

“Although he recused himself from some votes, he participated in several other votes in which both he and a business organization in which he serves as a partner had a financial interest in the outcome,” according to the Inspector General’s report.

Anderson, who works as a pharmacist at Crowder’s Pharmacy in Bedford, told IBJ he disagreed with the allegations. He said Anderson Burris wasn’t even formed when he voted on the matters last summer. However, he agreed to the settlement for financial reasons.

“To fight it, it gets very expensive,” Anderson said. “I did fight it for a little while, but there was the expense of a lawyer, compared to a small fine. I just couldn’t continue with the defense.”

The Indiana State Ethics Commission voted Oct. 13 to approve the settlement.

Filed under: General Problems | Leave a Comment »

Sugar Is the New Tobacco, so Let’s Treat It That Way ?

Posted on November 8, 2016 by Pharmaciststeve

unclesambadSugar Is the New Tobacco, so Let’s Treat It That Way

http://www.medscape.com/viewarticle/871064

I was recently asked to speak at the UK parliamentary “Sugar Summit.” This event was convened by Rend Platings, a mother so disturbed by England’s chief medical officer’s revelation that, as a result of obesity, today’s generation of parents may be the first to outlive their children, that she launched a campaign, Sugarwise, to help consumers identify foods with added sugar.[1]

Keith Vaz, chairman of the All-Party Parliamentary Group for Diabetes, chaired the event, whose audience was made up of a number of representatives from such high-profile UK retailers as Tesco, Caffè Nero, and the Jamie Oliver Group, as well as such influential stakeholders as the UK Department of Health, Public Health England, the British Soft Drinks Association, and the Food and Drink Federation.[2]

I began by welcoming the UK government announcement of an introduction of a 20% tax on sugar-sweetened beverages in 2017. I similarly welcome the recent statement calls by the World Health Organization (WHO) to tax sugary drinks by at least 20% in order to curb the global epidemics of obesity and type 2 diabetes. We mustn’t forget that the substantial decline in tobacco consumption in the past three decades, which was the single most important factor driving a decrease in cardiovascular mortality during that period, only happened after legislative measures that targeted the affordability, availability, and acceptability of smoking.[3]

Health Effects

Oxford researchers have estimated that a 15% reduction in sugar consumption through such a tax would prevent 180,000 people in the UK from becoming obese within a year and a larger number from becoming overweight.[4] But the scientific evidence reveals that the positive health benefits for the whole population of such a tax goes beyond a mere reduction in calories:

  • An econometric analysis of 175 countries (considered the highest quality of study with the exception of randomized controlled trials) revealed that for every additional 150 sugar calories available for consumption, there was an 11-fold increase in the prevalence of type 2 diabetes in the population. This is compared with 150 calories from another source such as fat or protein and independent of body mass index (BMI) and physical activity levels.[5]
  • The prevalence of type 2 diabetes in the US population between 1988 and 2012 increased by 25% in both obese and normal-weight populations,[6] which goes to show that type 2 diabetes is not a condition related purely to obesity.
  • A high-quality prospective cohort study revealed a trebling in cardiovascular mortality among US adults who consumed more than 25% of calories from added sugar versus those who consumed less than 10%, with consistent findings across physical activity levels and BMI.[7]
  • The positive health effects of reducing sugar intake appear to be quite rapid. In a study of 43 Latino and African American children with metabolic syndrome, keeping total calories and calories from carbohydrate identical, a reduction from a mean of 28% of calories from added sugar to 10% significantly reduced triglycerides, LDL cholesterol, blood pressure, and fasting insulin within just 10 days.[8]

    How Much Sugar Is Safe?

    So, how much sugar do we need? For the purpose of health, the optimum consumption is zero. Added sugar has no biological requirement and is, therefore, not by any definition a “nutrient.” It is the fructose component (sucrose is 50% glucose and 50% fructose) that fulfils four criteria that justify its regulation: toxicity, unavoidability, the potential for abuse, and its negative impact on society.[9]

    How much sugar is safe? The consumption of just small amounts of free sugar, which includes all added sugar and sugar present in fruit juice, syrups and honey, on a daily basis, has a deleterious impact on the most common noncommunicable disease globally: tooth decay. Treatment of dental disease is responsible for 5%-10% of health expenditures in industrialized countries, and in the UK, tooth decay is the number-one cause of chronic pain and hospital admission in young children.[10,11]

    As pointed out by researchers from the London School of Hygiene & Tropical Medicine, there is a powerful argument that the WHO should recommend a maximum limit of sugar consumption to make up no more than 3% of daily calories (about three teaspoons).[12] The average UK and US citizen, however, consumes at least four to seven times that amount.[13,14] This is perhaps not surprising when one acknowledges that it has been almost impossible for the consumer to avoid sugar, as it is so prevalent in the food environment and much of it is hidden. In the United States, almost half of all sugar consumption comes from foods one wouldn’t normally associate as having added sugar, such as ketchup, salad dressings, and bread. A third of sugar consumption comes from sugary drinks, and a sixth from foods that people normally perceive as junk, such as chocolates, cookies, and ice cream.[14]

    In the United States, there isn’t any reference dietary intake for sugar on food labels. In Europe, the labelling exists but doesn’t differentiate between children and adults. One can of regular cola contains nine teaspoons of added sugar, which is triple the 2009 upper limit intake suggested by the US Department of Agriculture for an 8-year-old child. The UK Guideline Daily Amount label describes these nine teaspoons of sugar as 39% of the guideline daily amount. On the basis of this false reassurance, it would be understandable for parents to believe that it is safe for their child to drink two and a half cans per day.[15]

     

    The food industry often argues that the public should have a “personal responsibility” when choosing what foods to eat, which deflects blame from their own culpability in the obesity epidemic to the consumer. The truth is that the public lacks knowledge because of confusing food labels, and the public lacks choice because sugar is added to approximately 80% of processed foods.

    Big Tobacco, Big Sugar

    The fact that it took 50 years before the first links between smoking and lung cancer were published in the British Medical Journal and before effective regulation was introduced is testament to how Big Tobacco was able to defend its practices. Key to the strategy was denial, planting doubt, confusing the public, buying the loyalty of scientists, and giving ammunition to political allies.[16]

     

    The similarities between Big Tobacco and the sugar industry are disturbing. As a recent publication in JAMA Internal Medicine showed, the sugar industry paid three influential Harvard scientists to downplay sugar’s role in heart disease and to shift the blame to fat.[17] Last year, the New York Times exposed that the Coca-Cola Company paid millions of dollars to fund research that downplayed the role of sugary drinks in obesity and push lack of exercise as the main factor.[18] And, according to one former UK shadow health minister, the incorrect advocacy of a low-fat, high-carbohydrate, and high-sugar diet by “morally corrupt scientists and politicians who allowed themselves to be manipulated by food suppliers” is to blame for global obesity.[19]

    The recent calls by the WHO to tax sugary drinks are very welcome news for health campaigners. The public health messaging, however, has to be more clear. There is nothing wrong with the occasional treat, but sugar has no place as part of a “healthy balanced diet.” Similar to smoking, any further regulatory measures to reduce sugar consumption, such as banning of sugary drink advertising and dissociating sugary drinks with sporting events, will have a further impact on improving population health within a short time. The science is more than sufficient; the case against sugar is overwhelming. Sugar is the new tobacco, so let’s start treating it that way.

Filed under: General Problems | 4 Comments »

Per DEA: Finding more reasons to generate fines and cause pts to be denied care ?

Posted on November 8, 2016 by Pharmaciststeve

DEA Posts Significant Change to Registration Renewal

http://www.natlawreview.com/article/dea-posts-significant-change-to-registration-renewal

The US Department of Justice Drug Enforcement Administration (DEA) recently posted to its website notice of a significant change to its registration renewal process. This change eliminates the informal grace period which the DEA had previously allowed registrants to renew their registrations.

The DEA announced that, starting January 1, 2017, it will send only one renewal notification to each registrant. The renewal notification will be sent to the registrant’s “mail to” address approximately 65 days prior to the expiration date. No other reminders will be provided by DEA.

Most significantly, the DEA noted that a failure to file a renewal application by 12 am EST of the expiration date will result in the “retirement” of the registrant’s DEA number. Any registrant who fails to meet the deadline will be required to apply for a new DEA registration and will receive a new DEA registration number.

In addition to the direct implications for any registrant who fails to renew in a timely fashion, this change in DEA’s longstanding approach will also have implications for pharmacies and others in the supply chain. All such entities, which are required to validate DEA numbers in the ordinary course of performing their own roles, will need to exercise additional diligence.

Filed under: General Problems | 3 Comments »

DEA cancels hearing, wants to pull pain doctor’s registration

Posted on November 8, 2016 by Pharmaciststeve

DEA cancels hearing, wants to pull pain doctor’s registration

http://www.seattletimes.com/seattle-news/health/dea-cancels-hearing-wants-to-pull-pain-doctors-registration/

Already ONE DOCUMENTED SUICIDE  Just another STATISTIC of the WAR ON DRUGS ? how many suicides goes unreported ?     Because of the actions of the DEA in closing down this medical practice.  But DEATHS from DEA/Judicial’s actions… are just COLLATERAL DAMAGE ?  8000 opiate dependent chronic pain pts being thrown to “the curb” …how many more SUICIDES will there be… and how many will we not hear about ?

Federal Drug Enforcement Administration (DEA) officials have canceled a Tuesday hearing to consider a Seattle pain doctor’s ability to prescribe powerful narcotics, recommending instead that Dr. Frank Li’s privileges be revoked.

The former medical director of Seattle Pain Centers, a chain of Washington clinics, had been set Tuesday to defend his right to retain his DEA registration, which allows prescription and distribution of all controlled substances, including opiate painkillers.

 But a DEA administrative law judge ruled last month that Li isn’t eligible for registration because his medical license has been suspended in Washington and California, said Jodie Underwood, a special agent and spokeswoman for the DEA.

The federal Controlled Substances Act requires that medical providers who prescribe controlled substances be appropriately licensed.

Through lawyers, Li had previously said that he would contest the revocation of his DEA registration because his medical license is merely suspended and could be reinstated. A lawyer representing Li did not immediately respond to questions about the proposed revocation.

State Medical Commission members suspended Li’s license in July amid charges that care by Li and Seattle Pain Centers providers MAY have contributed to the deaths of at least 18 patients since 2010.

California medical-board officials took similar action within weeks.

Li, 48, is accused of failing to properly monitor patients taking high doses of opiate painkillers.

Following the charges, the eight Seattle Pain Centers sites across Washington were closed, leaving an estimated 8,000 opiate patients and as many as 25,000 patients seen since 2008 in need of care.

The move threw the state’s pain-care system into chaos, leaving many patients without care and providers scrambling to help them. One former patient committed suicide and blamed the loss of Seattle Pain Centers in a note left behind.

Li is scheduled for a hearing before the Medical Commission next April.

Filed under: General Problems | 5 Comments »

« Previous Page — Next Page »