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“Suspicious” painkiller orders, DEA suspends a FL drug distribution center’s sales

http://www.fox4now.com/news/suspicious-painkiller-orders-fl-pharmaceutical-drug-distribution-sales-suspended

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Trump Signs Order to ‘Ease the Burden of Obamacare’

http://www.medscape.com/viewarticle/874779?

Soon after he was sworn in, President Donald Trump signed a series of executive orders, including one to “ease the burden” of the Affordable Care Act (ACA), according to news reports.

The executive order was not yet on the White House website as of press time. But in a version posted on Twitter, the order first notes the President’s intention to seek the “prompt repeal” of the ACA, and says that in the meantime, it was seeking to offer flexibility to states to create a more “free and open healthcare market.”

The order grants authority to the heads of all federal agencies, including the Secretary of Health and Human Services to “waive, defer, grant exemptions from or delay the implementation of any provision or requirement of the Act that would impose a financial burden on individuals, families, healthcare providers, health insurers, patients, recipients of healthcare services, purchasers of health insurance, or makers of medical devices, products, or medications.”

Essentially, this means that any tax imposed by the ACA would be overturned.

The executive order also directs federal agencies to grant states maximum flexibility in implementing “healthcare programs,” and to encourage the development of “a free and open market in interstate commerce for the offering of healthcare services and healthcare insurance with the goal of achieving and preserving maximum options for patients and consumers.”

During the campaign, President Trump said that he wanted to make it possible for insurers to sell policies across state lines.

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Not sure if just Pharmacists or all licensed medical healthcare providers got this email in Florida… warning them that the actions of the DEA against Mc Kesson drug wholesaler may compromise their pt’s ability to obtain their necessary controlled medications.

This warning is a result of actions by the DEA 

McKesson said it would pay $150 million settles investigation on controlled substances

in which – as usually – the DEA took actions based on “HARD FACTS” that the DEA came to based on their opinions, beliefs, and suspicions.  Of course, the collateral damage to pts that have a valid medical necessity for taking controlled substances… is just not really the problem of the DEA…

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Walgreens again in hot water over refusal to fill prescription

https://www.abqjournal.com/931967/yt.html

ALBUQUERQUE, N.M. — The two women had never met, but it took only a few moments for them to connect over a singular act that still makes them shudder – first with shock, then with anger – just like it did when they each walked into a Walgreens pharmacy and felt as if they were hurled back into the Dark Ages.

“It’s just hard to believe this is still happening,” says Susanne Koestner, a married woman in her 30s who made headlines when she fought back after a pharmacist refused to refill her prescription for birth control pills in June 2012 because of his religious beliefs. “It freaks people out when I tell them the story.”

That story led to a January 2013 agreement from the nationwide drugstore chain to affirm its policy of filling prescriptions, including birth control medications, “as efficiently as other prescriptions without imposing any burden on the customer.”

But four years later and in spite of that agreement, here we are again with another case alleging that a prescription was not filled because of a Walgreens pharmacist’s refusal to do so – a violation of the state Human Rights Act, the American Civil Liberties Union of New Mexico contends.

And so here we are with the two women in the offices of the ACLU, which supported Koestner and now plans to do the same for the latest Albuquerque woman to accuse a Walgreens pharmacist of denying her service.

As a reminder, it is 2017.

In a letter submitted Jan. 12 by the ACLU to Walgreens corporate honchos in Deerfield, Ill., the woman in the latest story is listed as Jane Doe. In this conference room, she is a longtime Albuquerque Public Schools teacher in her 40s and the mother of a teenage daughter. It is the latter role that leads her to ask not to be named so as not to identify her daughter.

She says that because of struggles with difficult menstrual cycles and birth control medications, her daughter, in consultation with her gynecologist, opted to try an intrauterine device. In preparation for the procedure in August 2016, Doe said, she went to a Walgreens at Coors and Montaño NW to fill her daughter’s three prescriptions – a mild pain reliever, an anti-anxiety medication and misoprostol, a synthetic hormone used to soften the cervix in preparation for the insertion of the IUD.

Misoprostol is also often prescribed to treat stomach ulcers. But it also can be used to induce an abortion.

That last usage is believed to be the conclusion the pharmacist erroneously jumped to – as if he should have jumped at all.

The teen’s mother was told the first two prescriptions would be filled but the misoprostol would have to be picked up at another Walgreens, even though the medication was in stock. When she asked the pharmacist why he could not fill the misoprostol prescription, she says, he told her that it was against his “personal beliefs.”

Like Koestner had been years ago, the teen’s mother says she, too, was confused at first. Stunned. Ashamed, though she didn’t know why.

But as she made her way through rush-hour traffic to another Walgreens about 3 miles away, anger and indignation set in.

Koestner knew those feelings too.

“It’s like someone else takes power over your life, your choices,” Koestner says. “It’s like you are being judged.”

Doe says she turned around and went back to the first Walgreens, confronted an assistant manager and then the pharmacist.

“I told him he was discriminating against me, that he should be ashamed for judging us, that he didn’t know my daughter’s medical history or her complications or conversation with her doctor that explained everything about sexual health and how can accessories like the Juno panty vibrator can help with this. That he didn’t know what the medication was for,” she says. “And he just looks at me and says, ‘Oh, I have a pretty good idea.’ ”

Like Koestner, she started making calls to Walgreens officials. She contacted the Southwest Women’s Law Center, which in turn helped her contact the ACLU of New Mexico.

The ACLU letter to Walgreens points out that forcing customers to travel to another pharmacy after being denied service places a significant burden on the woman – especially if the woman relies on public transportation or has limited time or if that woman lives in a rural area where Walgreens pharmacies are few and far between.

As it did in the letter written on Koestner’s behalf, the ACLU also asked the company to immediately address the discriminatory practice and specify what steps the company planned to take to prevent a similar occurrence – and a lawsuit contending a violation of the state Human Rights Act, which protects from discrimination, including on the basis of gender.

“Religious liberty does not mean the right to discriminate against others,” attorney Erin Armstrong wrote. “Walgreens should take reasonable steps to accommodate employees’ religious beliefs and practices, but it cannot do so by imposing additional discriminatory burdens on women.”

Walgreens issued the following statement late Tuesday:

“We take very seriously our responsibility to serve the prescription needs of our patients. While we cannot comment on the specifics of this incident, we can tell you that our policy is intended to meet the needs of our patients while also respecting the sincerely held views of our pharmacists. We believe our policy has been very effective in doing that.”

After our meeting, the two women hugged, happy to have found some solace in knowing they were not alone, troubled by not knowing how many other women had been similarly denied and how many more might still be in the future.

UpFront is a daily front-page news and opinion column. Comment directly to Joline at 823-3603, jkrueger@abqjournal.com or follow her on Twitter @jolinegkg. Go to www.abqjournal.com/letters/new to submit a letter to the editor.

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FDA says investigations underway into counterfeit medications

http://www.walb.com/story/34304503/fda-says-investigations-underway-into-counterfeit-medications

DEA now getting involved in ILLEGALLY IMPORTED medications that ARE NOT CONTROLLED SUBSTANCES… The question has to be asked is where did they get the statutory authority under the CONTROLLED SUBSTANCE ACT to do this…  the medications that they are referring to in this article are not controlled substances ?

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Prescription Drug Monitoring Programs   <— click to open PDF

Reality of how they really work is a whole DIFFERENT ANIMAL.. Unfortunately, the vast majority – if not all –  of politicians/bureaucrats … still believe in the THEORY after a couple of decades.

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Former Tomah VA Doctor David Houlihan Surrenders Medical License

http://www.disabledveterans.org/2017/01/19/tomah-va-candy-man-david-houlihan-md-surrenders-license/

After a three year battle, former Tomah VA chief of staff David Houlihan MD agreed to surrender his medical license to evade further investigation.

In a statement from Sen. Ron Johnson (R-Wis.), Dr. David Houlihan has reportedly agreed to permanently surrender his license to practice medicine in Wisconsin.

Despite never admitting fault in the numerous instances of malpractice at Tomah VA, the psychiatrist will no longer practice medicine in the state.

This is a major win for advocacy groups, journalists, and my own clients who fought against the whitewash pushed by Wisconsin lawmakers in covering up Tomah VA failures before 2014. Dr. Houlihan and his supporters fought like mad to keep a lid on the opiate scandal that led injury and death to numerous veterans.

Personally, Dr. Houlihan’s attorney threatened me for writing about the truth as reported by victims and other journalists concerning his outrageous conduct. I am glad he was finally taken to task by Wisconsin even though VA refused to do the right thing.
Houlihan Victory A States Rights Win

This was a States Rights win over attempts by the federal government to whitewash the bad conduct of a powerful employee. Glad fellow Wisconsinites won the day on this one.

The Department of Veterans Affairs needs to reconsider its overt disrespect for the state law and patient rights in medical centers like Tomah VA.

Maybe next time, the agency will cooperate when American citizens confront a medical center about wrongdoing. Tomah VA, despite being small relative to other VA medical centers, received a ton of negative press since the scandal escalated.

Though, had it not been for agency arrogance, no one would have leaked the Hungry Hungry Hippos video clip of Tomah VA employees playing human Hungry Hippos on company time last Halloween.

Or, what about this classic video leaked to me where Tomah VA staff made a vaccine parody using Ghost Busters to encourage employees to get the flu vaccine in an attempt to increase employee vaccination from 54% to 60%?

Big Senate Report

Last May, the Senate Homeland Security and Government Affairs Committee released a 359-page report covering the Tomah VA scandal. The report detailed systemic failures by VA and VA OIG in their investigation of the crimes at the facility. According to that report, which led to the newest development, problems included:

“The lack of transparency and not having an independent watchdog over the facility are the primary culprits. Now that appropriate oversight and publicity have occurred, those responsible for these tragedies have been held accountable. They no longer work for the VA, and can do no further harm to veterans. I look forward to working with VA officials and the new VA inspector general that I was proud to help confirm to enact necessary reforms to prevent tragedies like what occurred at the Tomah from ever happening again. The finest among us – our veterans – deserve no less.”

Dr. Houlihan never admitted fault, but he will also never touch another Wisconsin citizen ever again, at least in his capacity as a psychiatrist. As part of his settlement, he agreed to the black marks being including in a national registry against him.
Sen. Ron Johnson Tomah VA Press Release

Wednesday, January 18, 2017

WASHINGTON — Sen. Ron Johnson (R-Wis.), chairman of the Senate Homeland Security and Governmental Affairs Committee, had this to say following reports that Dr. David Houlihan, also known as “candy man” at the Tomah VA Medical Center in Tomah, Wis., permanently surrendered his license and registration to practice medicine in Wisconsin. Chairman Johnson issued a 359-page report in May 2016 detailing the tragedies at the Veterans Affairs Medical Center in Tomah. The report can be found here.

“This news brings to mind the Wisconsin veterans and families who were affected by the tragedies at the Tomah VA Medical Center. According to the Wisconsin Department of Safety and Professional Services, Dr. Houlihan failed to provide appropriate medical care to at least 22 veterans and engaged in misconduct over the course of several years. As my committee’s investigation also found, the Tomah VA and Houlihan repeatedly failed to honor this nation’s promises to the finest among us. Our veterans deserve world class care, as well as accountability for those who fail to provide it.”

Wednesday’s order from the Wisconsin Department of Safety and Professional Services means that Houlihan will never practice medicine in Wisconsin again and that the state’s ruling will be placed in a national physician database.

###

Now that Candy Man is shut down, at least in Wisconsin, does anyone else wonder exactly what human research he was conducting at Tomah VA with his zombie cocktail that zapped the life out of veterans he treated, both figurative and literally speaking?

Again, this is a massive win for States Rights. The federal government wanted this one to go away, but Wisconsin said, “Hell no!”

I want to give a shout out to my friend Ryan Honl and reporter Aaron Glantz for being on the forefront. Had I not reported on what Glantz wrote, I never would have been erroneously threatened with a SLAPP suit by Houlihan’s attorney.

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The black hole of drug pricing explained (ahem by industry)

http://medcitynews.com/2017/01/black-hole-drug-pricing-explained/

A new study conducted by the Berkeley Research Group provides some fresh insight into how the pharmaceutical supply chain works, who pays what, and where the profits go.

There is one major caveat to note upfront: The study was funded by PhRMA, an industry lobbying group for biopharmaceutical companies.

Taking that into account, the data and discussion still add valuable context and another perspective to the drug price debates.

Importantly, the study helps explain some of the factors influencing pharmaceutical list prices. These numbers are determined by the manufacturer and often trigger fresh outcry from politicians, providers and patients.

Gilead’s Sovaldi sells for $84,000. Alexion’s Soliris is priced at $537,000 per year and the most recent sticker shock, Biogen’s Spinraza, is listed at $750,000 for the first year of treatment.

That’s not an issue in of itself, explained Aaron Vandervelde, a managing director at BRG and co-author of The Pharmaceutical Supply Chain: Gross Drug Expenditures Realized by Stakeholders.

The list price is nearly always subject to retrospective rebates, discounts and fees throughout the pharma supply chain, he said. That ultimately impacts how much different stakeholders pay for the drug and how much the manufacturer receives.

The industry and PhRMA have been saying this for some time, but the BRG study may be one of the first to back it up with numbers.

For brand-name drugs, manufacturers made $219 billion in 2015. That amounts to 63 percent of ‘total gross spending,’ aka the list price, the report states.

Over one-third of the list price was lost through rebates to pharmacy benefit managers (PBMs), health plans, the government, or retained by other stakeholders in the supply chain.

In a recent phone interview, Vandervelde said that his firm’s research also found that the rebates and discounts are getting larger every year. BRG looked at data beginning in 2013 and saw a substantial increase in the discounts PBMs and health plans negotiated from manufacturers.

“In 2013, manufacturers paid about $67 billion in retrospective rebates, discounts and fees,” Vandervelde said. “By 2015, that amount had grown to $106 billion. That was the single biggest contributing factor to the decreasing percentage of the gross drug expenditures that are retained by the brand manufacturers.”

Herein lies the issue with list prices. The manufacturer has total say. If mandatory rebates and discounts rise, it can increase the list price to offset those added costs. It’s a vicious cycle that might already be in play.

“I think there is an argument to be made that manufacturers may be responding to that growth by increasing list prices,” Vandervelde said, though he stressed that it is very complicated and his firm’s research didn’t address that question directly.

A significant percentage of the rebates are mandated, including those that fall under the Medicaid Drug Rebate Program or that qualify for 340B discounts. Both of these categories have grown in recent years, Vandervelde said, which puts pressure on biopharma profits.

Other rebates are optional, usually made by the drug companies to improve patient access or to remain competitive when other drugs are made available in their therapeutic space.

While critics of the industry often fixate on the list price of a drug, it’s really only an opening bid.

“Are some payers paying list price? Yes. Is that the case for the life cycle of a drug? Very rarely,” Vandervelde said. “It’s much more common at the launch of the drug and then typically as the therapeutic class becomes more competitive you’ll see steeper and steeper discounts over time.”

It also depends on the therapeutic area. Hepatitis C drugs introduced today will be taking a significant hit on their list price. Gilead had a lot more power to resist those forces when its first-in-class drugs, including Sovaldi, were introduced.

What does all of this mean for drug pricing? Biopharmaceutical companies aren’t off the hook, but there’s a lot more happening behind the scenes.

Some experts argue that drug companies are exploiting the complexities of the supply chain. The Washington Post recently highlighted the manipulative use of coupons. Others have argued that pharma companies overcompensate for the discounts by raising the list price by more than 10 percent a year.

Based on this latest report, it appears there is a significant amount of inefficiency in the supply chain. If drug prices are too high, the wider health system needs to be taken into account.

The list price is used for the first point of sale, from the manufacturer to the wholesaler. To turn a profit, the wholesaler charges what are commonly referred to as prompt pay discounts and stocking fees. Wholesalers then contract with both pharmacies and providers. 

Pharmacy benefit managers (PBMs) are not part of this supply chain — unless they operate a mail order pharmacy. For the most part, their role is to negotiate reimbursement rates with the pharmacies and the manufacturers, on behalf of their health plan clients.

At the end of the day, it’s too complex to summarize in a 140-character tweet on drug prices. Pharma companies may have been using that to their advantage, pointing to the rebates and discounts as an excuse for high list prices. Whether that’s true or not, the argument isn’t working. New regulations and penalties are surely on the horizon.

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Walgreens to pay $50 million to resolve U.S. prescription kickback case

http://www.reuters.com/article/us-walgreens-boots-lawsuit-idUSKBN1532YW

Walgreens Boots Alliance Inc (WBA.O) will pay $50 million to resolve a U.S. lawsuit accusing it of violating federal law by providing beneficiaries of government healthcare programs discounts and other incentives to fill their prescriptions at its pharmacies.

The settlement, announced by Manhattan U.S Attorney Preet Bharara on Thursday, resolves a whistleblower lawsuit that the government joined related to the national pharmacy chain’s Prescription Savings Club program.

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