Federal judge cast cloud over CVS-Aetna merger

Federal judge cast cloud over CVS-Aetna merger

https://ctmirror.org/2019/06/07/federal-judge-cast-cloud-over-cvs-aetna-merger/amp/

Washington – With the approval of the Justice Department and five key states, the $69 billion merger between Aetna and CVS was considered a done deal.

But that was before a federal judge here questioned how the merger would affect the health insurance marketplace and said he would not be a “rubber stamp” on the  deal.

U.S. District Court Judge Richard Leon held two days of hearings on the merger this week and scheduled additional oral arguments on the case in July.

If Leon does not sign off on an agreement between the Justice Department with CVS and Aetna — an agreement that led to Aetna’s divestiture of its Part D business — his ruling may be capable of unwinding the merger, or at least place new hurdles in front of the marriage of one of the nation’s largest health insurers and one of its largest retailers.

Leon held the hearing under a 1974 federal law, known as the Tunney Act, that requires courts to review agreements in which the government approves corporate mergers to protect the public against monopolies.

On the first day of the hearings Tuesday, Leon accused the Justice Department of keeping him “in the dark, kind of like a mushroom” about the actions CVS and Aetna were undertaking to consummate their $69 billion deal while his review of their settlement was pending.

On that first day of the hearings, three witnesses, including one representing the American Medical Association, expressed concern that the merger would further consolidate the health insurance market and drive up out-of-pocket costs for consumers.

U.S. District Court Judge Richard Leon

“We are not only losing a competitor,” said University of Southern California professor Neeraj Sood, the expert called by the AMA, referring to Aetna. “We are losing a strong competitor in this market.”

The Justice Department has determined that Aetna’s divestiture of its Medicare Part D business – which the Hartford-based insurer is selling to WellCare – alleviates its concerns about the merger’s impact on competition in the health care industry.

But the AMA, and a number of consumer groups, say that’s not enough. They say the divestiture would actually reduce competition in the prescription drug business because Aetna was a competitor with CVS and other providers.

“The AMA has concluded that a merger of these two rivals would harm competition and patients, even with the divestiture proposed in the merger settlement,” the organization representing the nation’s doctors said. “The divestiture of Aetna’s prescription drug business to WellCare will reduce competition in the (prescription drug plan) market, rather than restore it to premerger levels.”

When CVS and the Justice Department called their witnesses on Wednesday, Leon expressed skepticism that the settlement did enough to ensure continued competition in the health care industry.

CVS witness Lawrence Wu, a former Federal Trade Commission staff economist, testified the merger would not quash competition  and that the sell off of Aetna’s Medicare Part D business resolved any anti-competitive issues.

Wu also said the merger could result in lower markups to drug prices and more access to medical care in rural areas which have CVS “Minute Clinics.”

But Leon said the merger gives CVS extra leverage because it gains so many new clients by partnering with Aetna and gives CVS an unfair advantage with drug manufacturers, who would favor CVS over other pharmacy benefit managers, or PBMs.

PBMs serve as middlemen between drug companies and pharmacies. While CVS’s pharmacy benefit manager now handles Aetna’s prescriptions, that agreement was set to expire in 2023.

Leon said the merger would not allow Aetna to shop for another PBM.

“It’s different now,” he said. “If they merge, they own it.”

Aetna did not return requests for comment. CVS said it has no comment on the court proceedings this week.

After the Justice Department signed off on the deal last year, Aetna and CVs began to consolidate their operations.

And CVS announced this week it plans to take a dramatic step toward becoming a heath care provider by opening 1,500 HealthHUB stores by the end of 2021, remodeling its drugstores to increase their focus on health services and health products.

David Balto, a former policy director of the Federal Trade Commission who is representing U.S. PIRG and Consumer Action, groups advocating stricter scrutiny of the merger, said Leon could force the Justice Department to “go back to the table” and renegotiate the terms of the merger with CVS and Aetna.

The judge could also force the DOJ to go to court to challenge the merger, Balto said.

“He seemed very skeptical of the pig in the poke remedy the Justice Department has come up with,” Balto said. “But he’s carefully going through everything.”

Judicial system turns a blind eye to the DEA violating the 4th amendment ?

 

https://imgur.com/gallery/r5yqQTz#aMKvXZg

If I am not mistaken… evidence obtained without a warrant is considered  “fruit of the poison tree” and it typically tossed out by the court.  They often claim that no one is above the law… but.. apparently there is an exception of law enforcement themselves and the judicial system that has been put in place to guard against the constitution is being violation BY ANYONE

Critics say laws that legalize assisted suicide abandon the vulnerable

Critics say laws that legalize assisted suicide abandon the vulnerable

Kristen Hanson, community relations advocate with the Patients Rights Action Fund, says assisted suicide laws send the message that some lives are not worth living.

Opinion: CVS Health President Larry Merlo Says U.S. Healthcare Outdated

Opinion: CVS Health President Larry Merlo Says U.S. Healthcare Outdated

https://www.wsj.com/video/opinion-cvs-health-president-larry-merlo-says-us-healthcare-outdated/F0C72EA9-1840-4AA1-9907-FD0E8A7DC256.html

I tend to agree with Larry Merlo, but not for the same reasons…  Our healthcare is “controlled” by the insurance industry and because in 1945 the 79th Congress gave the insurance industry an EXEMPTION from the Sherman Antitrust Act with the McCarran Ferguson Act 

https://en.wikipedia.org/wiki/McCarran–Ferguson_Act  At the time, it was a valid necessity so that the insurance industry could share actuarial data so that better cost estimates could be determined using a much larger population database.

Like all good things, you give a industry a “inch” and they will take a “mile”. Today when the sharing of actuarial databases are no longer needed, the insurance industry has expanded this exemption into many areas that was not initially intended .. or even a potential issue – nor existed – back in 1945.

Under the CVS HEALTH UMBRELLA, CVS has a Prescription Benefit Manager (PBM) and Silver Scripts (Part D Insurance) both are licensed as insurance companies and enjoy the exemption of Sherman and they are trying to acquire Aetna Insurance with some 40 million beneficiaries .

When the PBM first appeared on the scene (1969-1970) they claimed that they “negotiated” reimbursements with Pharmacies… their “negotiations” involved with here is what we are going to pay you “take it or leave it”.  Back then 70%-80% of pharmacies were independents and if more than one pharmacy tried to “negotiate” what was offered.. the DOJ sent our warning letters that the pharmacies were involved in “price fixing” and the DOJ would take them to court.

Now, entities like CVS, can dictate the profit margins of the pharmacies competing with its 10,000 community pharmacies.  They can – as they do with Silver Scripts – charge pts higher copay if the pts don’t get their Rxs filled at one of their “preferred pharmacies” .. except … all of their preferred pharmacies are CVS pharmacies, or they can MANDATE that the pt have all their prescriptions filled via a CVS owned mail order facility.

With CVS trying to acquire Aetna, will those Aetna beneficiaries be required to go to a CVS Minute Clinic ( “nurse in a box”) or get charged a larger copay or deductible if they don’t and if they get a Rx from their visit at the Minute Clinic… they will be required – or have a financial inducement – to get any Rxs filled at the CVS pharmacy.

How far is CVS from acquiring a hospital system with a vast community physician practice network and the pt has any part of a CVS service… their will be a financial inducement to exclusively use other CVS services.

So does Mr Merlo reference that our healthcare is outdated… because… many pts still have a personal freedom of choice of where – and from whom – they receive their care ?

Unfortunately, the insurance industry has one of the largest “pot of money” to fund lobbying activity and it will probably take hell freezing over before the McCarren Ferguson Act is repealed and as long as it remains on the books… people, like Mr Merlo, will try every trick in the book to gain control over who provides you healthcare services..  It won’t matter if you like or believe that the person you are dictated to see… is likeable or even fully competent.

 

total misuse rate of 0.6 percent in over 560,000 patients prescribed opioids for acute and post-op pain between 2008 and 2016

Scapegoating opioid makers lets true offender get away

https://www.upi.com/Top_News/Voices/2019/04/24/Scapegoating-opioid-makers-lets-true-offender-get-away/6371556106270/

April 24 (UPI) — John Oliver is a brilliant comedian with a large platform, and he has been using it of late to demonize the pharmaceutical companies that produce opioids. Major targets of his attack are Purdue Pharma and its Sackler family principals, developers of OxyContin, which, until around 2010 was a drug of choice for non-medical users.

Like the tobacco companies in the 1990s, it is understandable to focus indignation at companies, driven by the profit motive, that purvey products that can cause harm and even death. It is reasonable to question and criticize their marketing ethics and aggressiveness.

But at the end of the day, extracting a pound of flesh from the Sacklers won’t stop the overdose rate from climbing. That’s because the standard narrative that overprescribing of opioids caused the overdose crisis is based upon misinformation — as is the belief that opioids have a high overdose and addiction potential.

Data from the National Survey on Drug Use and Health, as well as the Centers for Disease Control and Prevention, clearly show no correlation between the number of opioid prescriptions dispensed and “past month non-medical use” or “pain reliever use disorder” among adults over age 12. As high-dose opioid prescriptions dropped 58 percent from 2008 to 2017 and overall prescriptions dropped 29 percent in that time period, the overdose rate continued to climb. Decreasing the availability of prescription pain relievers for diversion into the black market only drives non-medical users to more dangerous heroin and fentanyl.

In 2017, heroin and fentanyl comprised 75 percent of opioid-related overdose deaths. Deaths from prescription pain pills also involved drugs like cocaine, heroin, fentanyl, alcohol and benzodiazepines 68 percent of the time. Less than 10 percent of overdoses from prescription pain pills in 2017 did not involve other drugs.

Opioids prescribed in the medical setting have been repeatedly shown to be safe. Researchers following over 2 million North Carolina patients prescribed opioids noted an overdose rate of 0.022 percent, and nearly two-thirds of those deaths had multiple other drugs in their system. A 2011 study of chronic pain patients treated in the Veterans Affairs system found an overdose rate of 0.04 percent. A larger population study found an overdose rate of 0.01 percent.

Researchers at Harvard and Johns Hopkins universities recently found a total misuse rate of 0.6 percent in over 560,000 patients prescribed opioids for acute and post-op pain between 2008 and 2016. Cochrane studies, highly regarded for their rigor, found addiction rates in chronic pain patients on opioids of roughly 1 percent.

People often mistakenly equate physical dependency with addiction. Physical dependency is seen with a variety of drugs, including antidepressants, anti-epileptics, and beta blockers. A person can be slowly weaned off these drugs. But addiction is a compulsive behavioral disorder with a genetic component featuring repeated use despite self-destructive consequences. The director of the National Institute on Drug Abuse points out in a 2016 paper that true opioid addiction “occurs in only a small percentage of persons who are exposed to opioids — even in those with pre-existing vulnerabilities.”

As researchers at the University of Pittsburgh recently demonstrated, non-medical use has been on a steady exponential increase at least since the mid-1970s and shows no signs of slowing down. The only things that have changed over the years are the drugs in vogue for non-medical use. It seems sociocultural factors are at play. In fact, young people seem more willing to engage in risky drug use than their predecessors. A 2017 study showed 33.3 percent of heroin users initiated with heroin.

At the end of the day, the drug overdose problem is the result of sociocultural dynamics intersecting with drug prohibition — and all the dangers that a black market in drugs present. Prohibition also presents powerful incentives to corrupt doctors, pharmacists and pharmaceutical representatives who seek the profits offered by the underground trade.

When Portugal decriminalized all drugs in 2001, it saw a 75 percent drop in its population of heroin addicts by 2015, and now has the lowest overdose rate in Europe, at 6 per million population (compared to 312 per million in the United States). Along with Portugal, most of the developed world has put an emphasis on harm reduction strategies over restrictionist, prohibitionist approaches, one reason they have lower death rates than the United States. These strategies include medication-assisted treatment with drugs like methadone and buprenorphine; safe injection facilities; needle-exchange programs; and making the overdose antidote naloxone more available.

None of this is meant to defend the conduct of a few pharmaceutical companies or those who work for them. It is meant to refocus energy and anger where it belongs.

The real villain is the war on drugs. Yet it’s getting off scot-free.

Dr. Jeffrey A. Singer is a general surgeon in Phoenix and a senior fellow at the Cato Institute.

If you get your Rxs from mail order… this is what it could look like “filling” your Rxs

What Happens When YOU Need Help And Can’t Get It?

https://youtu.be/zC0GOmI0nns

This is probably the most important “News Shot” I’ve done to date. Countless millions suffer from chronic pain…. a REAL epidemic! What’s even more appalling is the fact that relief exists for those who are suffering, but the relief is out of reach…. NOT because of a shortage, but because of a phony “War on Drugs” that does nothing but make the rich, richer and the suffering, suffer horribly. The truth is a lonely warrior…. https://www.yahoo.com/news/armed-data… https://www.cdc.gov/nchs/fastats/lead… Read more at http://www.TheDailySheeple.com and #WakeTheFlockUp

Senate committee focuses on pain sufferers denied painkillers amid opioid crisis

Senate committee focuses on pain sufferers denied painkillers amid opioid crisis

https://www.foxnews.com/health/chronic-pain-patients-opioids-senate-committee-hearing

As the national focus on the opioid crisis centers on cracking down on overprescribing practices and addressing addicts, Sen. Lamar Alexander, who chairs the upper chamber’s health committee, is putting a spotlight on a critical side of the debate that has been neglected — people who suffer chronic debilitating pain.

The veteran Tennessee Republican lawmaker is holding hearings — one was in February, and another may take place this summer — to hear from sufferers of debilitating pain, who in the last two years have reported being forcibly tapered down or outright abandoned by doctors who had been treating them.

The senator said he is determined to expand the focus on opioids at the same time other federal and state officials have begun to acknowledge that many doctors are taking drastic and medically dangerous steps out of fear of being targeted by authorities in the current anti-opioid climate.

The result is what public health experts are calling a “pain crisis,” with numerous patients across the country being undertreated for intense pain that has driven many to consider or carry out suicide, and others to turn to heroin.

“As we address the opioid crisis, we must keep in mind the millions of Americans who are in chronic pain,” Alexander said in an email to Fox News.

Alexander said that the next hearing before the Senate Health, Education, Labor and Pensions Committee will take up a federal task force’s just-released recommendations on how to balance the needs of pain patients against policies tightening opioid prescription practices. The task force is an advisory committee of the Department of Health and Human Services that was authorized by the Comprehensive Addiction and Recovery Act (CARA), which was signed into law in July 2016.

“I am grateful for the work of this task force, and I’m reviewing the final report,” Alexander said. “Earlier this year, the Senate health committee held a hearing on the causes of pain and how we can improve care for patients with pain. I plan to hold another hearing this year to discuss the recommendations of the task force.”

Chronic pain patients number 50 million, and for at least half of them, prescription opioids are the only – or a crucial part of – treatment that brings enough relief to allow them to get out of bed without suffering. They are medically dependent on, but not addicted to, legal opioids.

But the drug overdose epidemic that has claimed tens of thousands of lives has resulted in a sweeping war on prescription painkillers, even though most of the fatalities or emergency room cases have involved black-market opioids such as illicit fentanyl and heroin.

“The main impetus for the hearing,” Alexander told Fox News in a telephone interview, “was knowing that in a country where you have more than 50 million Americans who have chronic pain, and 20 million who have high-impact chronic pain, when you put in concerted efforts to take away the most effective painkiller for them, you’re going to have trouble.”

Alexander said it’s been eye-opening to learn about the unintended consequences of hardline actions to address the overdose epidemic.

“There’s no doubt that the goal was not to end the use of opioids, which are effective painkillers,” Alexander said. “Our goal was to stop abuse of opioids, which was caused by overprescribing by doctors or diversion by people who got their hands on opioids and used them for the wrong purpose.”

At least 33 states have enacted some type of legislation related to prescription limits, according to the National Conference of State Legislators. Many of the policies and regulations put into place have been based on a since-revised 2016 guideline by the Centers for Disease Control and Prevention (CDC) that was meant as a resource, not a mandate for primary care physicians prescribing opioids to patients who were taking them for the first time.

Earlier this month, both the Food and Drug Administration (FDA) and the CDC warned doctors not to abruptly stop prescribing opioid painkillers to patients who are taking them for chronic debilitating pain, generally lasting more than three months.

The FDA is also amending labels on opioids that inform doctors how to taper them.

“We found that there was a good deal of misunderstanding about what the CDC guideline was intended to do,” Alexander said. “They’re not supposed to be a substitute for an individual doctor’s decision about what the appropriate prescription is for a patient. We have this problem when the federal government or a government agency issues guidelines, they suddenly become ‘law.’ People become afraid. You have insurance companies refusing to reimburse for opioid prescriptions. It’s easier just to follow [the guidelines] rather than make your own decision.”

In legislation he has co-sponsored to combat the overdose epidemic, Alexander said, “We resisted federal rules on opioid prescription limits…It was the wisest thing we did in the entire legislation. That’s why our hearing [in February] was important and why another hearing, on the HHS task force review and possible revision of the CDC guidelines, [is] in order.”

“Now that we have started to turn the train around and head in a different direction on the use of opioids, everyone – doctors, nurses, insurers, and patients – will need to think about the different ways we should treat and manage pain,” he said.

Though they are an accepted tool to treat severe pain from serious injuries, surgery and cancer, opioid medications can be addictive and dangerous even when used under doctors’ orders. Prescriptions have fallen in the U.S. by nearly a quarter since peaking at more than 255 million prescriptions in 2012.

But health care experts and pain patients argue that targeting legal opioids has done nothing to solve the overdose fatality rate, which has continued to rise.

One of the most often-heard complaints by prescribers about why they are undertreating or abandoning pain patients who long have been given opioids for their conditions is that they fear the Drug Enforcement Administration (DEA) coming after them, which has been happening with more frequency when the agency suspects that a doctor may be prescribing beyond what is necessary.

The DEA did not respond to requests for comment, but in past interviews, told Fox News that contrary to the criticism, they are not gunning for doctors or other prescribers.

Alexander said that requesting DEA officials go to the next hearing to respond to the criticism of prescribers and explain how they decide whom to pursue “seems to be in order.”

Texas Medical Board President Dr. Sherif Zaafran, who served on the HHS task force, said it would be an important move for Alexander to have DEA officials testify.

“It would be very helpful if the hearing and Congress hold them accountable,” Zaafran said. “Doctors know they’re prescribing correctly, but they’re afraid to keep prescribing. They say ‘Yeah, but the DEA comes on my neck.’ It creates a lot of confusion, the DEA puts them in a bind, the DEA is practicing medicine without a license.”

“Congress can direct the DEA to work more closely with state regulatory agencies,” he said. “There has to be clear direction to make sure patients’ needs are balanced with illicit use of drugs that are out there.”

Many pain patients, along with the doctors who treat them and advocacy groups — long frustrated by discussions about prescription opioids that excluded their voices — are starting to feel optimistic that their experience with painkillers as being safe and crucial to their ability to have a quality of life is finally gaining attention.

“Things are really starting to shift,” said Kate Nicholson, a former federal prosecutor who credits her opioid treatment with allowing her to function after years of being bedridden. “There’s the work of the HHS task force, the HHS, and other federal agencies saying there’s a problem with the CDC guideline.”

“Senator Alexander has been a leader on the issue, he’s courageous, he’s been willing to hear from people with chronic pain,” said Nicholson, who has met with the senator’s aides about the issue.

My money is on that whatever DEA representative that shows up for this hearing – if they bother to show up at all  – will LIE THRU THEIR TEETH about how they are NOT going after prescribers…. or… the committee will ask such “softball questions” that the whole process will be mostly meaningless.

After all Senator Alexander is one of the attorneys that makes up about 40% of Congress.  With TN having one of the more severe opiate crisis… and the state legislature passing some very draconian laws effecting chronic pain pts… does it seem logical that Alexander would have a very different mindset towards pain management ?

Judges: Feds must act if asked to take a fresh look at pot

Judges: Feds must act if asked to take a fresh look at pot

http://www.dailyjournal.net/2019/06/03/us-marijuana-lawsuit/

NEW YORK — A federal appeals court has ruled that the Drug Enforcement Administration must “act promptly” if formally asked to take another look at laws that consider marijuana as dangerous as heroin or LSD.

The ruling came Thursday in a 2-to-1 vote by judges from the 2nd U.S. Circuit Court of Appeals who agreed that the plaintiffs in a lawsuit against the DEA and other parts of the federal government needed to ask the agency to change its designations for marijuana before bringing the issue to the courts.

The plaintiffs — which include the Cannabis Cultural Association and an Iraq war veteran who suffers from post-traumatic stress disorder — now have an opening to persuade federal authorities to change how they classify marijuana. Many states have legalized recreational pot use, but marijuana is still illegal under federal law.

“It is possible that the current law, though rational once, is now heading towards irrationality; it may even conceivably be that it has gotten there already,” wrote Judge Guido Calabresi.

“A sensible response to our evolving understanding about the effects of marijuana might require creating new policies just as much as changing old ones,” Calabresi added in a majority opinion that included the conclusions of Judge Jed S. Rakoff, a district judge sitting on the Manhattan appeals court temporarily.

Calabresi noted that the plaintiffs claimed that marijuana has extended their lives, cured seizures and made pain manageable.

“If true, these are no small things. Plaintiffs should not be required to live indefinitely with uncertainty about their access to allegedly life-saving medication or live in fear that pursuing such medical treatment may subject them or their loved ones to devastating consequences,” he said.

In urging swift action, Calabresi said plaintiffs had shown that it took an average of nine years to reclassify drugs.

“Although agencies, like legislatures, are often the best decisionmakers, this is so only when they actually do decide,” the majority opinion said.

Calabresi wrote that the panel will retain jurisdiction in the case “exclusively for the purpose of inducing the agency to act promptly.”

In a dissent, Judge Dennis Jacobs mocked the other judges for citing urgency and then giving the plaintiffs six months to ask the DEA to make changes.

He said he viewed as “contrived and fanciful” the claims of the parents of severely ill children who said they suffer fear that they might be subject to federal prosecution because of their involvement in their children’s medical treatment.

“Nobody need fear severe consequences for administering medical marijuana to sick children,” Jacobs said.

“I doubt that the DEA will be hurrying its work on an application that these plaintiffs have not yet filed, seeking administrative action on an old and ramified controversy,” Jacobs said. “As and when this case returns to this Court and this panel, I will be an interested and bemused spectator.”

In a statement, the Cannabis Cultural Association called the ruling “great news.”

“This is the first decision of its kind and will afford the plaintiffs the rapid decision that they and all Americans deserve,” said Nelson Guerrero, the association’s president.

What happens when these mail order companies and CVS run our local pharmacies out of business?

Some of you may or may not be aware, but I have gestational diabetes while I am pregnant. That means I have to take insulin while I am pregnant to control my blood sugar, but it should return to normal after the baby is born. This post, however, is not about me…

I have been getting my insulin filled at Sullivans where I know and trust the pharmacists and techs. More importantly, they have been extremely helpful in getting me started on the insulin, showing me how to use the blood meters, test strips, lancing device, pen needles, syringes, etc. They have helped me monitor the constant dose changes and everything I need to know and do. They communicate with doctors to make sure I’m getting the right doses, brands, etc. I honestly would have been lost without them. I was extremely nervous about giving myself insulin shots, and there has been a lot to learn and changes to make through this entire process so I couldn’t be grateful enough for their knowledge and support.

I’ve been on insulin for about a month now, doing great, getting used to checking my blood sugar and giving myself shots. With all of the dose changes, it’s been so convenient to be able to swing by Sullivan’s and pick up what I need and to ask any questions.

Unfortunately, I got a letter from my prescription insurance CVS Caremark saying I can save money by switching to mail order or CVS pharmacy. I obviously didn’t want to make the switch. Yesterday, I went to fill my Novolog, and the copay was almost $400. I called CVS Caremark, and they said I have to start paying 50% of the drug cost if I continue to fill at my local pharmacy. The drug is free to me if I get a 90-day supply from CVS or mail order. Problem is there in no “local” CVS, and I’m due in August which means I won’t even be on this medication for 90 more days. I tried to explain this to them, but they would not budge. So now, to avoid a $400 copay, I have no choice but to get my insulin mail ordered. I will also be receiving an extra month of an $800 medication that I will have no choice but to throw away. What a waste…

This is the problem with our pharmaceutical industry. I’m extremely frustrasted. What happens when these mail order companies and CVS run our local pharmacies out of business? Do they care about me like my local pharmacy? Are they going to give me the care, concern, and support like I have received at Sullivan’s? Heck no. I’m just another number, just money in their pocket. Something has got to change…