https://youtu.be/vSMjLdaOvlI

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West Virginia AG Sues Walmart, CVS Over Opioid Pill Flood

https://www.usnews.com/news/best-states/west-virginia/articles/2020-08-18/west-virginia-ag-sues-walmart-cvs-over-opioid-pill-flood

West Virginia Attorney General Patrick Morrisey has accused Walmart and drugstore chain CVS of failing to monitor and report suspicious orders of prescription painkillers to their retail pharmacies.

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Sure sounds like Kessler is a “hired gun” and his medical specialty was PEDIATRICS.  It is amazing that the law – DECADE OF PAIN 2000 – that was passed by Congress and signed into law by Bush 43. Pain became the “5th vital sign” and Joint Commission made it a MAJOR STANDARD for those healthcare facilities that they credentialed.  But that was not considered an encouragement to prescribers to properly treat a pt’s pain ? So it would appear that the New York bureaucrats are suing over a issue of increased opiate prescribing that could have been – at least in part –  by actions of our Federal Congress.

https://legalnewsline.com/stories/548505991-new-york-s-opioid-case-no-improper-prescriptions-no-misled-docs-big-damages

CENTRAL ISLIP, N.Y. (Legal Newsline) – Former Food and Drug Administration Commissioner

David Kessler acknowledged in the opening hearing of a high-profile trial in New York that he didn’t talk to any doctors or make any attempt to quantify how prescription drugs contributed to the state’s opioid crisis.

Lawyers defending the opioid industry are trying to exclude Kessler’s expert testimony by showing he lacks a rigorous scientific basis for his opinion that drug manufacturers and distributors are responsible for opioid abuse. Kessler, who has earned millions of dollars as an expert witness for plaintiff attorneys since leaving the FDA in 1997, said his opinion is based upon his experience as FDA chief and internal documents showing the companies engaged in improper marketing practices and “deviations” from FDA rules.

The State of New York and Nassau and Suffolk counties have agreed, in advance, that they will present no evidence that defendant companies sold opioids to anyone who wasn’t licensed to distribute them, or that were sold without a legal prescription. As in federal multidistrict litigation, they will instead argue that doctors and other medical professionals were improperly influenced to issue too many prescriptions for addictive drugs, leading to abuse and overdose deaths. 

After a delay of several months due to COVID-19, the New York trial will proceed in two stages – first to determine liability and then damages.

The questioning of Kessler over two days offered a preview of the state’s case and the industry’s defense. Hunter Shkolnik, the private lawyer representing New York under a contingency-fee contract that could yield his firm hundreds of millions of dollars, led Kessler through his theory of how the increased availability of dangerous drugs increases the risk of abuse. Kessler said that as head of the FDA, he oversaw the agency’s enforcement of rules prohibiting drug companies from making marketing claims that aren’t supported by scientific evidence.  

Kessler also looked at contributions by opioid companies to independent groups that advocated for the increased use of opioids to treat chronic pain. The American Pain Foundation got $5.3 million from Endo Pharmaceuticals, for example, and issued a brochure saying the risk of addiction was low and urging patients to seek a pain specialist.

“A company cannot pay a third-party organization to do what it itself cannot do,” Kessler said.

Attorney Steve Brody of O’Melveny Myers, representing Johnson & Johnson, opened by asking Kessler if he had earned “millions of dollars” as an expert witness. 

“You had to anticipate this question,” interjected Suffolk County Justice Jerry Garguilo. “You made money.”

Kessler said yes and Brody went on, repeatedly asking whether he investigated the cause-and-effect relationship at the heart of the case, which is whether the drug companies caused physicians to prescribe too many opioids.

“Did you ask any doctors why they prescribed opioids?” Brody asked, with Kessler answering “no.” “You’re not going to identify a single medically unnecessary prescription in the state of New York, are you?”

“I’m not going to get into necessary or unnecessary on an individual prescription, no,” Kessler answered.

Brody also asked Kessler about drug salesperson “call notes” he included in his report, part of the evidence plaintiff attorneys culled from millions of pages of documents they received from defendant companies in discovery. One involved a conversation about Duragesic, a Johnson & Johnson fentanyl patch that the company maintains was particularly hard to abuse. 

The note included the phrase “they all said low abuse potential,” which would have instantly triggered a law-firm word search. But Kessler couldn’t identify who the “they” was, who “Nicole” in the note was, or whether the drug rep was telling the doctor about low abuse potential or the other way around.

“I wouldn’t look for one anecdotal conversation,” he said. “I was looking at the record as a whole.”

The drug companies are trying to undermine Kessler’s status as an expert under New York’s Frye standard, which requires experts to present opinions grounded on methods that are scientifically sound and generally accepted as reliable. Toward that end, Brody attempted to show that Kessler will testify improper marketing was the cause of New York’s opioid crisis without having performed any analysis of other potential causes, from illegal heroin and fentanyl to the U.S. government’s own reports, going back to the 1970s, identifying chronic pain as a serious problem costing hundreds of billions of dollars a year.

Kessler kept describing such inquiries as “beyond the scope,” a legal term referring to rules of evidence. At one point Justice Garguilo barked: “Beyond the scope of what?” 

Brody concluded by accusing Kessler of lacking a methodology that could reliably show the role any individual company played in the drug crisis.

“I have a learned methodology that manufacturers contributed with marketing to increased use, and increased use led to addiction,” he answered. “Promotion has an effect on prescription sales, those sales made increased opioids available, and their availability leads to increased abuse.” 

Other witnesses who will be questioned in pretrial hearings include James Rafalski, a former Drug Enforcement Agency official, and Lacy Keller, a data expert plaintiff attorneys have relied upon to show defendant companies shipped billions of orders that would should have been flagged as “suspicious.”

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nothing is going to change until Trump and all of his enablers are out of office. The only hope I have is that I believe Biden and Harris both have empathy and have critical thinking skills and can think “outside the box.” It starts from the top, and hopefully Biden will put qualified intelligent people in charge who will be willing to listen and acknowledge the “unintended consequences” and devastation that is being done to chronic pain patients and will not be afraid to speak out and start to fix this horror we are going through. One of many reasons IMO to vote no matter how hard Trump and his cronies try to invalidate ballots.

Does anyone know what Biden/Harris platform really is ?  First of all they are both ATTORNEYS… We had that  also with Obama/Biden 8 yrs…  Biden got his license to practice law in the early 70’s … not sure if he ever really practiced law… but at about the same time that the DEA was created.  Around the same time that I got out of college and I know the propaganda/fear that the DEA spread around back then.   They were actually going after the cartels, because there was no computerized PDMP databases for them to data mine on prescribers.

Harris is also an attorney and according to Wikipedia she si She is the first African-American, the first Asian-American, and the third female vice presidential running mate on a major party ticket https://en.wikipedia.org/wiki/Kamala_Harris.  But her parents were from Jamaica and India. According to this website https://www.quora.com/Are-Jamaicans-living-in-the-United-States-considered-African-Americans-Do-they-consider-themselves-African-Americans it is unusual for some from Jamaica to identify as black or African/American.  Maybe she is just following in Elizabeth Warren’s footsteps when she claimed that she was a “native American”

Those hoping that Biden/Harris will listen to the chronic pain community on being unfairly treated, but according to her felony conviction rate:

Felony conviction rate

Just prior to Harris taking office the felony conviction rate was 50 percent;^[51] by 2009 it was 76 percent.^[52] Convictions of drug dealers increased from 56 percent in 2003 to 74 percent in 2006.

It has been reported that she sent 1500 people to jail for smoking MJ, yet in a public interview… admitted to using MJ. Didn’t we have another President – who was an attorney – that admitted to “trying” MJ ?

During the Presidential debates Harris accused Biden of being a racist and agreed with the women that accused Biden of inappropriate touching.  Now that doesn’t seem of concern to her ?

Yesterday during one of their first public appearances, they refused to take any questions from the press that was in attendance ?

This is Biden’s THIRD TIME running for President – the previous two times .. he never got any traction and Harris’ attempt this time, she dropped out of the race BEFORE THE FIRST PRIMARY.

Of course this has happened before, Nixon lost to Kennedy and then came back a few years later to be elected President and this Presidency brought us the Controlled Substance act/DEA , Watergate, and his resignation and his VP Spiro Theodore Agnew had resigned – only the second VP in our history to do so and we got Gerald Ford as President .. because he was Speaker of the House and next in line in our order of succession.

If you consider what both Biden & Harris stated during the Presidential debates… they are for “Medicare for all”… but what has been described is really “Medicaid for all” … no premiums, no deductibles, no copays… price tag… about 3-4 trillion/yr…  and if they confiscated all the assets of the billionaires that would pay for the first six months and then confiscate all the assets of all the millionaires would pay for the second 6 months… I guess they haven’t thought out how they are going to pay for it after the first year.. If anyone wants to get a idea of what a national health insurance would look like.. just look at our VA medical system… that is a single payer system.

They indicated that they want to get rid of fracking… there goes a lot of jobs in PENN & Ohio… fuel prices jump dramatically… remember back in early 2000 when fuel was $4.00+/gal ?  and we will no longer be energy independent… and have to purchase energy from some countries that really are not our friends.

Both Biden/Harris has indicated that they want open borders and Harris has stated in a interview that she wanted everyone that is in our country would be entitled to safety, education and healthcare.

But wait, while she was CALF Attorney General she wanted more money to fund police but now she is behind defunding law enforcement or just rearrange how money is used by law enforcement.

She has already stated she is in favor of a “mandatory buy-back of  AR type guns”.. by the way “AR” stands for AUTOMATIC RIFLE and only the military have AR’s that are capable of shooting automatically..the ones sold to the general public are SEMI-AUTOMATIC and those AR guns are  only involved in < 1% of mass shooting.  Beside a mandatory buy-back of guns is basically a confiscation of guns.  First it is rifles… then it will be all hand guns… and there goes the second  amendment !  They want to defund law enforcement and disarm our citizens.

Just pay attention, Illinois has one of the most strict gun ownership laws and yet Chicago typically has at least a couple of dozen of shooting EVERY WEEKEND.

According to this Harris is a anti-catholic bigot and Biden is a active practicing Catholic

Our national debt was 10 trillion when Obama took over and he passed a 20 trillion debt  to Trump and if Nancy & Chuckie gets want they want on this next “pandemic money” our country will end this fiscal year (09/30/2020) with a national debt at or exceeding 30 trillion..  We are quickly becoming the Argentina of North America.

My Father’s had a favorite saying … that I heard often when I screwed up as a kid… “now that you have shit in your nest… you will just have to learn to sit in it’

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https://pharmacistactivist.com/2020/August15_2020.shtml

Two are Needed and Two Should be Rescinded!

The cost of many drugs is far too high!

Pharmaceutical companies, pharmacy benefit “managers” (PBMs), and health insurance companies have been engaged in a “blame game” for many years in faulting the others for the high cost of drugs. While they do this, drug costs continue to increase! These companies will not identify an equitable strategy and solution that will serve society well.

Elected officials and government agencies are engaged in partisan politics to such an extent that they have failed to effectively address the issue of excessive drug costs. This political impasse is not likely to be resolved anytime soon. The victims of these failures are patients and society, and the prescribers, pharmacists, and other health professionals who have the responsibility for assuring the most appropriate and effective use of medications with the least risk possible.

President Trump has issued four executive orders (EOs) regarding drug prices. I give him credit for recognizing the importance of taking action and his boldness in acting at a time when others who should be effectively addressing these matters have failed to do so. We can’t expect anyone who does not have expertise in the areas of health care and medication use and costs to be in a position to identify the best strategies and actions. Indeed, many of the “experts” in health care, including health professionals do not agree on a course of needed action. However, the added challenges for the President are that many of those who have the greatest access to him and the opportunity to contribute to and influence decisions, have vested interests and/or political agendas. The consequence is actions that include some that are flawed. Let’s consider the EOs on an individual basis.

Access to affordable life-saving medications

This EO is applicable to insulin and epinephrine (e.g., EpiPen) products. Federally qualified health centers (FQHCs) and hospitals that serve eligible patients (e.g., those with low income who do not have health insurance) participate in the 340B program and are able to obtain medications at large discounts from pharmaceutical companies. The EO directs FQHCs to pass along discounts for insulins and epinephrine (“life-saving” drugs) to patients.

This is a needed and important action BUT, it must be viewed as a small first step in eliminating the widespread abuses in the 340B program. The EO is only applicable to FQHCs and not the hospitals and PBMs involved in the program, it only includes the drugs considered life-saving, and the policies for implementation and monitoring compliance with the order have not yet been identified.

Increasing drug importation to lower prices for American patients

This is a seriously flawed concept and order, and should be rescinded! This EO would permit individual states to develop programs that would enable safe importation of certain drugs, and would enable personal importation waivers at authorized pharmacies. Such a system would be a great disservice for patients and place them at increased risk of drug-related problems. It would enable even more fragmentation of health care and drug therapy for patients, create additional questions about the quality and potency of imported medications, have a disruptive impact on the supplies of drugs in the countries from which they are imported, have a harmful economic impact on many pharmacies and other healthcare entities in the U.S., and require inefficient and costly regulations and procedures that would erode much of the anticipated cost savings.

The problem of excessive prices for many drugs has occurred and been enabled and exploited in the U.S., and must be resolved within this country!

Lowering prices for patients by eliminating kickbacks to middlemen

This EO is needed and extremely important BUT, it must be viewed as an essential first step in restoring the integrity of drug prices and the drug distribution system. Although there are some relatively small PBM middlemen who are committed to providing transparent and financially responsible services, the marketplace is dominated by three huge PBMs – CVS Caremark, Express Scripts, and Optum – that engage in secretive, deceptive, and highly profitable (for themselves) practices. If government officials and the public were specifically aware of the high percentage (often well above 50%) of the price of some drugs that is extracted as kickbacks/rebates by PBMs, there would be outrage and refusal to tolerate the continuation of these self-serving practices that are at the expense of patients, society, and health professionals. The terms of their secret deals are so fiercely hidden and protected that even government officials are not able to obtain the details of the financial arrangements. Government regulators in Ohio, West Virginia, Pennsylvania, and some other states have made progress in identifying the deception and fraud in certain government-funded programs, but even they are stonewalled and mislead by these PBMs.

Eliminating kickbacks from pharmaceutical companies to PBMs is a positive first step. However, this action must be accompanied by strong regulation of PBM practices in both government-funded and other prescription benefit programs, prohibiting direct and indirect remuneration (DIR) clawback fees from pharmacies, very close regulatory monitoring of their operations, and strong criminal and/or civil actions when harm from and fraud in their operations and programs are identified. Even if rebates from companies to PBMs are eliminated, if these other reforms and actions are not also taken, these PBMs will identify other secretive strategies to recoup their losses and continue their costly programs to the great disadvantage of patients, health professionals, and the healthcare system. More whistleblowers who are current or former employees of these PBMs are needed!

Restricting prices of the most costly Medicare Part B drugs to no more than the amounts charged in other economically comparable countries

This is the second seriously flawed concept and EO that should be rescinded! Suffice it to say that, if government regulators are not able to completely and accurately identify the amounts of kickbacks/rebates and other financial parameters of drug pricing in this country, there is no way of obtaining specific and accurate drug pricing information in other countries beyond knowing that their drug prices are lower.

Recommendations

Pharmaceutical companies, PBMs, and health insurance companies will continue their current drug pricing strategies and programs, and further increase drug prices, unless firm actions are taken to prevent them from doing so. The President, other elected officials, and appropriate government agencies must learn from and act on the counsel and recommendations of patients, pharmacists, and other health professionals who are victims of the destructive present healthcare system. They must give the highest priority to eliminating kickbacks from pharmaceutical companies to PBMs, and to eliminating the unnecessary and costly involvement of PBMs, or rigidly controlling their policies, operations, and programs. Organizations of pharmacists and other health professionals must work together with a united voice and strategy to lower drug prices and attain reforms in the health care system.

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Book smarts vs age/experience/wisdom ?

An old geezer became very bored in retirement and decided to open a medical clinic.
His sign read: “Dr.Geezer’s clinic. Get your treatment for $500, if not cured, get back $1,000.”
Doctor “Young,” who was positive that this old geezer didn’t know beans about medicine,
thought this would be a great opportunity to get $1,000. So he went to Dr.Geezer’s clinic.

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Is the Medicare ‘Inpatient Only’ List History?

— “Drastic” changes in CMS proposed rule worry surgeons: outpatient amputation is “kind of crazy”

https://www.medpagetoday.com/surgery/generalsurgery/88061

Medicare’s new proposed rule would move 266 procedures — including dozens of amputation, replantation, and bone graft surgery codes — out of the federal “inpatient only,” or IPO, reimbursement list so they could be performed in a hospital outpatient department.

If the rule is finalized by the Centers for Medicare & Medicaid Services, beneficiaries undergoing those procedures would generally have an option to leave the facility the same day, or before two midnights have elapsed, to complete their recovery at home.

CMS also is pushing to entirely eliminate the list, which now contains 1,740 procedures, saying “we no longer believe there is a need … to identify services that require inpatient care.”

Rather, “the physician should use his or her clinical knowledge and judgment, together with consideration of the beneficiary’s specific needs,” to determine whether an inpatient or outpatient setting is more appropriate, the agency said, saying that “emerging new technologies” are making it safe for these operations to be performed outside of an acute care setting.

The remaining 1,474 codes would be phased out over the next several years if the rule is approved.

But approving this rule as is, which would take effect Jan. 1, 2021, also could delay care and pave the way for many unintended consequences that may not be in the patient’s best interest.

That’s the opinion of the American Academy of Orthopaedic Surgeons, which called the proposed change “drastic” and said it could increase the burden on physicians to appeal health plan denials, and make it tougher for doctors to make sure the patient’s surgery takes place in the safest, most appropriate setting, which may be more expensive.

Orthopedists Are Nervous

AAOS members are worried that the rule could pave the way for health plans to use less expensive surgical settings as the default sites for such procedures and require lengthy appeals and prior authorization paperwork to override those defaults.

“Sometimes contesting those denials is easy, but sometimes it can take months,” said Joseph A. Bosco, III, MD, AAOS president, who called the process a series of “onerous hoops.” The resulting delay can carry its own form of harm.

The AAOS said that’s what happened when total knee and hip replacement procedures were removed from the IPO in recent years. Health plans interpreted the rule as requiring that beneficiaries must have these procedures as outpatients, going home the same day or early the next.

“In pushing forward such a drastic change, CMS may exacerbate many of the unresolved issues that our surgeons continue to face as a result of hip and knee arthroplasty being recently removed from the Inpatient Only list,” the AAOS said in a statement.

“Payers, including Medicare Advantage and commercial carriers, often misinterpret the policy change to mean that these procedures must be performed exclusively in the outpatient setting.”

Bosco, vice chair of NYU Langone Health’s department of orthopedic surgery, emphasized that physicians and surgeons must consider each patient’s environment and social support concerns during their recovery at home, especially if a post-surgical complication might arise.

But health plans may not always think about that or be aware of those considerations, he said.

“You have an 80-year-old woman or man who lives in a five-story walk-up in New York, and they have no family or friends that can take care of them,” he said. “To expect that person to go home the same day after a hip or knee replacement and take care of themselves and make it up five flights of stairs and be independent — it’s not tenable. No surgeon I am aware of would allow that patient to go home to an apartment on the fifth floor if they can’t make it up the stairs.”

“Kind of Crazy”

A second concern is the high level of complexity and risk in many of the 266 procedures that CMS thinks could be done safely in an outpatient setting, Bosco noted. Given today’s surgical tools and skills, some are just too dangerous for an outpatient setting.

“If a person in New York gets run over by the subway and gets his foot amputated, you’re going to reattach that foot on an ambulatory basis? I don’t think so,” he said.

“That’s kind of crazy that you would consider doing a hand reimplantation, or if a person, God forbid, has their arm amputated as an outpatient, and upper extremity from shoulder to elbow? It’s silly.”

“These are major large procedures, after which the patients need intensive monitoring in an inpatient setting.”

Bosco acknowledged that times can change and probably will. Decades ago, surgeons couldn’t imagine performing an outpatient hip replacement, while today such surgeries are more routine.

“In 30 years, will we be doing hand transplants or replants safely if our patients are outpatients? I don’t know. But I can tell you nowhere in the near future will we able to do so.”

The bottom line, he said, is that it would be fine to entirely eliminate the IPO list, which was established 20 years ago, but only if “the physician is unencumbered, and is allowed to make that decision, again, along with consultation with the patient, on where the procedure should take place.”

ASCs Left Out for Now

CMS is not proposing that those codes would be reimbursed in ambulatory surgical centers, at least not yet. But historically, many codes that have been removed from the IPO have been added to the ASC payable list one or two years later.

None of the codes currently on the IPO list in 2020 are eligible to be added to the ASC payable list for 2021. However, Kara Newbury, director of government affairs for the Ambulatory Surgical Center Association, which represents 5,800 Medicare-certified ASCs nationally, said in an ASCA podcast that “ASCA will certainly advocate strongly for those codes that our members tell us are safe and should be eligible for the ASC payable covered procedure list moving forward.”

“CMS has acknowledged that many of these codes are not only being done in hospital outpatient departments already on private payer cases, but also in the ASC setting,” she said.

The ASCA hopes that will be the next step for Medicare beneficiaries too, and CMS will eliminate the two payment silos separating reimbursement for ASCs and hospital outpatient departments. They also hope that commercial payers take a cue from the removal of these 266 codes from the IPO list and approve payment for ASCs to take some of them on.

IPO Needs Fixing

Ted Mazer, MD, a past president of the California Medical Association, and a San Diego otolaryngologist, acknowledged that some health plans may push to drive some cases to the outpatient ambulatory surgical center. But on the other hand, “the fact is, the list of procedures required to be inpatient is way out of date with respect to safety. It needs to be revised. The physician should decide the appropriate site of service.”

While this proposed list of 266 procedures that would be dropped from the IPO list all involve the musculoskeletal system, Mazer encountered a similar problem with some neck procedures that “are completely safe as outpatient surgery, whether at a hospital or an ASC.”

Yet, he said, he is told by hospital administration and payers, “I must schedule and treat as an inpatient (because it’s on the IPO list). That needs to be changed.”

Mazer suggested that perhaps regulations could be developed, at least for Medicare Advantage plans and for commercial payers with help from state regulatory oversight, that would require a plan to justify a decision to override a physician’s preference for site of service. Such rules, he said, should include anti-retaliation protections for physicians who might feel pressure to follow plan rules.

Because so many of the procedures scheduled to be cut Jan. 1 involve orthopedic surgeries, it’s not surprising the AAOS was the first to weigh in. But other major stakeholders are still studying the proposal.

The American Hospital Association and the California Hospital Association, whose members see many procedures moving to physician-owned surgery centers, said they had not had time to form an opinion on the rule and could not comment. Likewise, the American College of Surgeons and the American Medical Association was still digesting the proposed rule.

The rule could have other ramifications as well: an impact on the beneficiary’s pocketbook.

If finalized, some stakeholders told CMS that the new rule would mean that if a procedure is now an outpatient surgery, falling under Part B instead of Part A, beneficiaries would pay 20% of their cost in co-payments. Currently, Part A, or hospital care, requires the patient to pay a deductible of $1,408 for each benefit period up to a 60-day hospital stay.

But CMS says in its proposed rule that those procedures that might be separately billed would be grouped as a single episode of care and capped at the applicable Part A deductible amount, so the patient may not have to pay more.

Comments on the proposed rule are due no later than 5 p.m. ET on Oct. 5.

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