Statement from HHS Secretary Xavier Becerra on the 33rd Anniversary of the Americans with Disabilities Act

When Congress pass the Americans with Disability Act, they INTENTIONALLY made the law VERY VAGUE, their intention was that the ADA would be defined in our court system. Since Congress is typically 40% attorneys, the ADA could also be called … make law firms more money act.  The agency that was put in charge of enforcing the ADA was created within the Attorney General Office – the same Presidential Cabinet position that the DEA is under. I may have missed it, but I have never seen ADA agency going after some medical vendor because they denied to treat or under treat chronic pain pts.

Statement from HHS Secretary Xavier Becerra on the 33rd Anniversary of the Americans with Disabilities Act

https://www.hhs.gov/about/news/2023/07/26/statement-from-hhs-secretary-xavier-becerra-33rd-anniversary-americans-with-disabilities-act.html

Today marks 33 years since the signing of the Americans with Disabilities Act (ADA). This sweeping legislation protects people with disabilities from discrimination by state and local governments and employers. It ensures equal access to healthcare, social services, transportation, telecommunications, and other critical services. The ADA guaranteed disabled people the right to live the lives they want to live, with equal access to all our country has to offer.

Passing the ADA was a significant victory in the fight for disability rights. In the years since it was passed, our country has made strides toward the ADA’s promise of true inclusion. Unfortunately, far too many people with disabilities are still unable get the services and supports they need to live in their communities. Lack of accessible housing and transportation creates insurmountable barriers to independence and equal opportunity for many. Bias still closes doors, threatening access to vital services like health care.

I started my career as a legal aid attorney helping people with mental health disabilities and advocating for disability rights – and I have continued this work for nearly four decades. I am proud of the work HHS is doing to address the health disparities of people with disabilities, expand home and community-based services, ensure equitable access to health care, and more.

In his proclamation marking the ADA anniversary, President Biden calls for action to expand access to home and community based services and accessible transportation, improve employment opportunities, protect voting rights, and more. We must challenge ourselves, and our nation, to accelerate our progress and make inclusion and equal opportunity for people with disabilities a reality. The fight for disability rights continues, and we at HHS remain committed.

People with disabilities are valued and vibrant members of communities across the country. As we mark the anniversary of the landmark Americans with Disabilities Act legislation – which makes it possible for so many of our loved ones to go to school, work, and enjoy life – we must all double down on our ongoing commitment to build a more inclusive America.
HHS Deputy Secretary, Andrea Palm

The passage of the ADA was an important milestone in the fight for disability rights, but 33 years later, its promises remain unfulfilled for far too many disabled people. Making the ADA’s powerful provisions a reality for everyone will require a concerted, committed effort from all of us. ACL is proud to continue the fight – alongside people with disabilities and their families, our networks, and partners across the country – until disabled people truly have equal access to all of our country’s opportunities.
Administration for Community Living Acting Administrator, Alison Barkoff

The Americans with Disabilities Act embodies our nation’s commitment to ensuring that disabled Americans have the same rights to live, work, and flourish in their communities—and to control their own lives and choices—as anyone else.  Although we have not yet fully realized the promises of that law, HHS works every day to advance equality, opportunity, and community living for Americans with disabilities. It is our great honor at the Office of General Counsel to support and advance that work.
– General Counsel, Samuel R. Bagenstos

On this 33rd anniversary of the ADA, the Office for Civil Rights remains committed to enforcing its promise of equal opportunity and full inclusion for people with disabilities in all aspects of society. We will continue our work to combat inequality in health and human services through ensuring compliance and investigating complaints to fulfill the ADA’s purpose: eliminating discrimination against people with disabilities.
Office for Civil Rights Director, Melanie Fontes Rainer

Relentless advocacy resulted in the passage of the Americans with Disabilities Act 33 years ago. Today, that advocacy continues so children and adults with disabilities in our nation have their rights protected in how they live, work and learn.
Administration for Children and Families Assistant Secretary, January Contreras

The Americans with Disabilities Act was a breakthrough for people with disabilities in the fight for civil rights, but 33 years later the struggle isn’t over. The COVID-19 pandemic exposed the gaps that Americans with disabilities experience in access, quality, safety, and appropriateness of healthcare, and we need to work together as a nation to reduce fragmentation in care and not lose further ground. Much more work is needed to ensure that the promise of the ADA is fulfilled.
– Agency for Healthcare Research and Quality Director, Robert Otto Valdez, Ph.D., M.H.S.A.

At the Advanced Research Projects Agency for Health, we know the toughest challenges can’t be solved without all of us working together and our mission to accelerate better health doesn’t end until we reach everyone. The Americans with Disabilities Act marked a huge step forward. We know there is still much more to be done to achieve the promise of ADA, and we at ARPA-H are committed to making our agency, and our nation, a place where all can thrive.
– Advanced Research Projects Agency for Health Director, Renee Wegrzyn, Ph.D.

As we commemorate the 33rd anniversary of the Americans with Disabilities Act, we remember the protections this bi-partisan law has afforded millions of Americans with disabilities. We also know there is much more work to be done, and I look forward to working with Congress and leaders across the Department towards fulfilling the law’s promise.
– Acting Assistant Secretary for Legislation, Melanie Egorin

ASPE is committed to ensuring that HHS’ policies and programs enhance the well-being of people with disabilities and are informed by the strongest evidence. To achieve this, we recognize that people with disabilities must be central to the evidence development process, and that our work must reflect their diverse perspectives and needs.
– Deputy Assistant Secretary for Human Services Policy, Miranda Lynch-Smith

When disaster strikes, no one should be left behind. At ASPR we are committed to ensuring that people with disabilities have access to the information and resources they need to stay safe in a disaster or public health emergency.
– Assistant Secretary for Preparedness and Response, Dawn O’Connell

While the ADA broke down barriers to inclusion, the work is far from over. We know people with disabilities continue to face discrimination and stigma. At CDC, we are committed to helping the disability community thrive.
– Centers for Disease Control and Prevention Director, Mandy K. Cohen, M.D. MPH

The Americans with Disabilities Act (ADA) was historic and affirmed the inherent dignity of people with disabilities. At CMS, our goal is to support all enrollees in getting the care they need through the three “M’s” of CMS – Medicare, Medicaid and the Children’s Health Insurance Program, and the Marketplaces. These programs serve more than one in three Americans, including millions of people with disabilities – and thanks in part to the ADA’s landmark advancements, our programs support the goals of people with disabilities to live and thrive in their communities.
Centers for Medicare and Medicaid Services’ Administrator, Chiquita Brooks-LaSure.

The Americans with Disabilities Act affirmed that disability rights are indeed human rights and paved the way for an inclusive and equitable society. However, we must continue to defend these hard-fought rights and strive to close the gap between legislation and lived reality, thus further ensuring that we fulfill the promise of the ADA.
Departmental Appeals Board Chair, Constance B. Tobias

Inspired by the Americans with Disabilities Act and its supporters, we at the FDA are committed to ensuring equal opportunities for individuals with disabilities. We aim to foster an inclusive work environment that values diversity and empowers every individual to participate and contribute to their fullest potential. To achieve this, we actively promote a culture of inclusiveness, eliminate barriers to fair treatment and equal employment opportunities, and ensure accessibility and reasonable accommodations. Furthermore, we seek to educate our workforce about the advantages of diversity, equity, and inclusion; provide a platform to address allegations of discrimination; and facilitate the resolution of workplace grievances. Thirty-three years later our work implementing the ADA continues and will continue as we help seek to make it possible for people with disabilities to participate in the everyday commercial, economic, and social activities of American life.
Food and Drug Administration Commissioner of Food and Drugs, Robert Califf, M.D.

This Disability Pride Month, we commemorate the Americans with Disabilities Act and honor those who have made strides to ensure that every person is treated equally and empowered to have a healthy, successful life. At HRSA, we’ve taken important steps to ensure that every child who has a chronic physical, developmental, behavioral, or emotional condition gets the services they need, that those with HIV receive whole-person care in a supportive and stigma free environment, and that our HRSA-funded health centers continue to provide accessible primary care services, with supports like sign language services, insurance eligibility assistance, and transportation services to reduce barriers to care and improve health outcomes. We also recognize there is more work to be done. Today, and every day, we recognize all the things that make us unique and recommit our agency to challenging misconceptions about disabilities and providing the best possible care to everyone.
– Health Resources and Services Administration Administrator, Carole Johnson

Every person deserves equal access to healthcare, regardless of their abilities. The Americans with Disabilities Act has been instrumental in ensuring that individuals with disabilities have the same opportunities to receive quality medical care. Let’s mark the anniversary of ADA by continuing to advocate for inclusive and accessible healthcare for all.
– Intergovernmental and External Affairs Director, Marvin Figueroa

The Indian Health Service is committed to improving the health of people with disabilities and building cultural competency and an inclusive environment across Indian Country. In the unwavering pursuit to defend the rights protected by the Americans with Disabilities Act, we reinforce our efforts to fulfill the promise of equality and encourage our partners and collaborators to become allies in the movement toward acceptance and appreciation of all people within the communities we serve, regardless of ability.
– Indian Health Service Director, Roselyn Tso.

This month we commemorate the 33rd anniversary of passing the Americans with Disabilities Act. This piece of legislation served as a landmark moment of progress in civil rights history – but it was just the beginning of ensuring disability rights. People of color, LGBTQI+ people, and other marginalized groups with disabilities face discrimination and difficulty accessing necessary health care. This disability pride month and every month, we work towards an equitable future where all Americans — including those with disabilities — can lead happy and healthy lives.
Assistant Secretary for Health, Adm. Rachel L. Levine

ONC is continually working to advance the use of data to represent social needs and the conditions in which people live, learn, work, and play. The United States Core Data for Interoperability, which ONC updates annually, includes ‘disability status’ as a standardized data element so that relevant information about patients with disabilities can be recorded and shared as appropriate to their care.
National Coordinator for Health Information Technology, Micky Tripathi, Ph.D., M.P.P.

The anniversary of the Americans with Disabilities Act commemorates a landmark legislation that broke down barriers and incorporated inclusion for millions of individuals. SAMHSA honors the diversity and uniqueness of each person who has a disability, including those with behavioral health disabilities. We are committed to ensuring that the promise of the ADA is fulfilled as we continue the work to fully realize its potential.
– Substance Abuse and Mental Health Services Administration Assistant Secretary for Mental Health and Substance Use, Miriam E. Delphin-Rittmon, Ph.D.

 

CVS health: Corporate consolidation is ruining pharmacies and hurting patients

The top 5 PBM’s are now owned by the top 5 insurance companies, so those two industries are the largest creator of “pharmacy deserts”

CVS health: Corporate consolidation is ruining pharmacies and hurting patients

https://minnesotareformer.com/2023/07/26/cvs-hellth-corporate-consolidation-is-ruining-pharmacies-and-hurting-patients/

If you spent any time in a pharmacy on July 10 or 11, you may have noticed prescriptions were delayed, and the staff seemed even more stressed than usual.

CVS Caremark, the pharmacy benefit manager (PBM) component of CVS Health, was non-operational for multiple days, meaning when the pharmacy tried to electronically submit a claim to insurance, it did not process. Pharmacy staff were unable to determine whether any prescriptions would be covered, or what patients’ co-pays would be.

If America had a robust, competitive PBM market, perhaps this outage would have not been particularly disruptive. Unfortunately, like many markets these days, instead we have an oligopoly, and Caremark alone processes about one-third of all prescriptions in the country.

The first CVS Pharmacy in Minnesota opened in the fall of 2004, which coincidentally is exactly when I was starting pharmacy school at the University of Minnesota. As a result, I have had a front row seat to witness the effect the now sixth-largest corporation in the country has had on our state.

Earlier in 2004 in other parts of the country, CVS had already acquired rival pharmacy chain Eckerd, which continued a long pattern of CVS buying other pharmacy chains using cheap debt, most notably Revco in 1997.

Minnesota apparently did not have a local chain of pharmacies amenable to purchase by CVS, so the company was forced to expand into the state via organic growth. CVS needed to hire pharmacists to work in their new stores, so I and all my classmates were aggressively recruited as we completed our studies. The personal highlight of my recruitment store tour of the Grand Avenue location in St. Paul was a pharmacy software system that still ran on MS-DOS in 2007.

This time period also represents a clear shift in corporate strategy, as CVS began to pursue vertical integration, acquiring Minneapolis-based MinuteClinic to gain some control over prescribers of medication. But the major paradigm shift came when CVS acquired Caremark, a leading PBM negotiating prescription drug coverage and pricing for millions of insured patients. After the merger, CVS was able to control payments to their pharmacy competitors, and require insured patients covered through Caremark to use pharmacies owned by CVS.

Using this market leverage, CVS spent the intervening years consolidating its power. The most obvious local manifestation of that power was the CVS takeover of Target Pharmacy in 2015. I received so many texts and social media alerts from concerned pharmacists the day it was announced that my phone battery died before I left work. Several of my classmates had previously worked for CVS, and sought a better work environment at Target, only to be re-absorbed.

Working conditions inside CVS Pharmacies — never ideal — have steadily declined to the point of harming workers’ and patients’ health. An entire labor movement called #PizzaIsNotWorking has arisen in protest. Underpayment from Caremark has caused many non-CVS pharmacies to close, creating “pharmacy deserts” in many urban neighborhoods and rural areas.

Across Minnesota, there are 32 small towns that had a local pharmacy in 2006, but today have none. Unfortunately this list includes Harmony, my hometown, where my father was the town pharmacist for many years.

Other alleged abuses of power by CVS include contributing to the opioid epidemic, stealing money from state governments, overcharging patients’ insurance companies, abusing federal government programs, and wasting valuable local real estate.

CVS Health has been able to achieve and abuse its power through a series of mergers and acquisitions. Had our existing antitrust laws — such as the Clayton Act — been enforced correctly, this consolidation should never have been allowed.

Unfortunately, beginning in the Reagan administration, legal ideology about corporate mergers significantly changed, oriented around the thought that larger corporations would achieve “efficiencies,” which would lower prices for consumers.

The past 40 years have provided ample evidence of the dangers of unchecked corporate power, however, resulting in a new political movement to restore enforcement of our antitrust laws to their original intent when they were written and passed by Congress. Minnesota’s own Sen. Amy Klobuchar, recently published a great book on the subject.

Two of the movement’s leaders are Lina Khan and Jonathan Kanter, head of the Federal Trade Commission and the Antitrust Division of the Department of Justice, respectively. These agencies have recently proposed to update the official merger guidelines, which if adopted would make mergers and acquisitions that lessen competition — like the many that created CVS Health — less likely.

You can participate in the process.

Click here, and then select “Comment,” to send your own personal message to the FTC and DOJ on how you have been affected by any mergers and acquisitions.

These comments can be informal and are important to help law enforcers understand the issue, and guide their actions to prevent harmful monopolies.

This is not limited to CVS Health.

Did Ticketmaster charge you pointless fees for your Taylor Swift tickets at the Vikings stadium?

Did airline service and prices get worse when Delta bought Northwest Airlines?

Are you annoyed that the Gophers football stadium is named for a bank headquartered at ground zero of Buckeye fandom?

Clearly, Minnesota is at least starting to understand anticompetitive mergers, given the backlash to the proposed Sanford Health merger with Fairview Health Services.

Your life has likely been negatively affected by a monopolistic merger or acquisition. This is your chance to help prevent any industries you care about become even more dominated by one or a small group of corporations.

 

CVS:where working conditions have steadily declined harming workers’ and pt’s health

I found this little gem online. Thank you for this excellent piece.
While media attention might not solve this, the more people are aware of the truth, the easier the fight. State and federal lawmakers must step in.
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DEA: celebrating 50 yrs of a failed program and looking to continue it going forward

50th Anniversary

https://www.getsmartaboutdrugs.gov/quiz/dea-50th-anniversary-quiz

Government’s Fentanyl Crackdown Is Bound to Fail, Like All Prohibitions Do

Government’s Fentanyl Crackdown Is Bound to Fail, Like All Prohibitions Do

https://www.thedailybeast.com/fentanyl-crackdown-is-bound-to-fail-like-all-prohibitions

Lawmakers are right to want to do something that stops the rise in overdose deaths. But adding one category of opioids to the list of Schedule 1 drugs is an exercise in futility.

Overdose deaths recently reached a record high of 109,000 Americans, with roughly three-quarters involving opioids and 90 percent involving illicit fentanyl. As a result, lawmakers have decided to rearrange the deck chairs on the Titanic, passing toothless laws that will make little difference in reducing harm.

Drug cartels make illicit fentanyl using several simple, readily available chemicals. As law enforcement cracks down on illicit fentanyl, it merely induces cartels to synthesize more potent analogs of fentanyl, called fentanyl-related substances (FRSs), which can be easier to smuggle in smaller sizes and subdivide into more units to sell.

One recent example is para-flourofentanyl, which is increasingly found in combination with or in place of fentanyl.

This is what economists call the iron law of prohibition: the harder the enforcement, the harder the drug.

Recently, the U.S. House of Representatives passed the HALT Fentanyl Act, which would place all FRSs, including those not yet invented, on the list of Schedule 1 drugs, which means they have “no currently accepted medical use and high potential for abuse.” The bill awaits action in the Senate, and although its changes to the law may seem sensible, the legislation is, in reality, nothing but political theater.

It is not going to work any better in controlling FRSs than it has in controlling the 100-plus existing Schedule 1 drugs, three dozen of which are FRSs, already on the list. Others include heroin, marijuana, and psychedelics.

Furthermore, much like Schedule 1 classification hampered cannabis and psychedelics research, declaring as-yet-undiscovered drugs as having “no accepted medical use” may deprive people of crucial new drug innovations, such as analgesic drugs with improved efficacy, tolerability, and perhaps even a lower abuse potential.

Legal fentanyl has existed since the 1960s, and doctors widely use it for anesthesia and pain management. It is on the World Health Organization’s list of essential drugs. The Drug Enforcement Administration classifies fentanyl as Schedule II, meaning it has a medically approved use, but has a high potential for abuse. For years, doctors have safely used more potent fentanyl-related substances for anesthesia. These analogs, such as alfentanil, sufentanil, and remifentanil, are also Schedule II.

The HALT Fentanyl Act exempts those drugs, but not future discoveries.

Lawmakers haven’t yet accepted that they cannot repeal the iron law of prohibition any more than the universal law of gravitation. For some time, we have been getting troubling reports of the veterinary tranquilizer xylazine—drug users call it “tranq”—becoming an additive to fentanyl and other illicit narcotics. This tranquilizer greatly potentiates opioids’ effects, producing more powerful “highs.”

Likewise, in 2019, health departments in Europe, Canada, the United Kingdom, and the United States began seeing another class of synthetic opioids called nitazenes appearing in overdose toxicology screens. Last fall, the Tennessee Department of Health reported that nitazene-related overdose deaths increased fourfold between 2019 and 2021.

Because most health departments have not been testing for nitazenes, public health officials don’t know how prevalent nitazenes are becoming among black market drugs. But don’t be surprised if, before long, Congress holds hearings about the “nitazene crisis.”

Lawmakers are right to want to do something that stops the alarming rise in overdose deaths. But adding one category of opioids to the list of Schedule 1 drugs is an exercise in futility. If lawmakers were serious, they would remove government obstacles that make it difficult or even illegal for harm reduction organizations to save lives in their communities.

This includes repealing or amending the federal “crack house statute” (21 U.S.C. Sec. 856), which blocks organizations from opening overdose prevention centers. There are 147 government-sanctioned OPCs in 91 locations in 16 countries. Some have been operating since the mid-1980s. The federal ban makes the U.S. an outlier among developed countries.

States should repeal drug paraphernalia laws that outlaw the equipment which drug users can use to test the drugs they bought on the black market for fentanyl and other contaminants. It also means removing government barriers to methadone treatment by allowing clinicians to treat patients in their offices—like everyone else with a health problem—thus expanding access to this proven addiction treatment.

If policymakers double down on the same prohibitionist policies they have employed for over 50 years, deaths from illicit drug overdoses will continue to rise. Doing the same thing repeatedly, with even more vigor this time, will only result in the appearance of more potent and dangerous drugs.

 

Cigna Sued Over Algorithm Allegedly Used To Deny Coverage To Hundreds Of Thousands Of Patients

Cigna owns the PBM Express Scripts – according to this article https://www.drugchannels.net/2022/04/the-top-pharmacy-benefit-managers-of.html  Express Script is the SECOND LARGEST PBM,  HOWEVER, recent announced merger between Humana & United Health, suggests that merger will push Express Script down to THIRD PLACE.

One of the basics of the practice of medicine is starting, changing, stopping a pt’s therapy. While Cigna is just denial payment for a particular therapy, not technically stopping the pt’s therapy, but few people can afford to pay “rack rate” for some fairly expensive tests and/or procedures. Some would argue that denying payment for a expensive test or procedure is basically stopping a pt’s therapy because the pt has a health insurance policy – which is technically a contract – and generally a contract between two parties and party is paying money for payment for necessary medical services and the other party ends up playing games and finding excuses to not fulfill the terms of the contract. Some would consider that FRAUD.

According to this lawsuit, this is not just a few examples, but involves denial of care to hundreds of thousands of pts and the denials are being done on a wholesale level.

Cigna Sued Over Algorithm Allegedly Used To Deny Coverage To Hundreds Of Thousands Of Patients

https://www.forbes.com/sites/richardnieva/2023/07/24/cigna-sued-over-algorithm-allegedly-used-to-deny-coverage-to-hundreds-of-thousands-of-patients/

The software system allows claim rejections without doctors ever opening patient medical records, according to the lawsuit.


Cigna, the healthcare and insurance giant, was hit with a lawsuit on Monday that alleges the company systematically rejects claims in a matter of seconds, thanks to an algorithmic system put in place to help automate the process—further raising questions about how technology could harm patients as more healthcare organizations look to embrace AI and other new tools.

The suit, which was filed in California and is seeking class action status, was brought forth by a pair of plaintiffs who were denied coverage by Cigna. One plaintiff, Suzanne Kisting-Leung, was referred for an ultrasound because of a suspected risk of ovarian cancer. Another, Ayesha Smiley, had been tested for a vitamin D deficiency at the order of her doctor.

The health insurer’s digital claims system, called PXDX, is an “improper scheme designed to systematically, wrongfully, and automatically deny its insureds medical payments owed to them under Cigna’s insurance policies,” the complaint alleges.

After the lawsuit was filed Monday, Cigna defended the software system. “PXDX is a simple tool to accelerate physician payments that has been grossly mischaracterized in the press,” spokesperson Justine Sessions said in a statement. “The facts speak for themselves, and we will continue to set the record straight.”

The suit follows a Propublica investigation in March that detailed Cigna’s software system for approving and denying claims in batches. The algorithm works by flagging discrepancies between a diagnosis and what Cigna considers “acceptable tests and procedures for those ailments,” according to the lawsuit.

Over two months last year, the company denied more than 300,000 claims, spending an average of 1.2 seconds on each claim, Propublica reported. While medical doctors signed off on the denials, the system didn’t require them to open patient medical records for the review. The complaint says that this violates a California competition law for unfair and fraudulent business acts. The suit also alleges the system violates the state’s insurance code for failing to adopt a “reasonable standard” for processing claims.

The complaint comes as a boom in artificial intelligence and other advanced technology has raised questions about the future of work, potentially upending every industry from advertising to insurance. Healthcare is one sector where a high-tech makeover could both be beneficial—aiding doctors in filling out burdensome paperwork or helping narrow down diagnoses—but also fraught, due to issues of patient privacy, access to care and the high cost of medical bills.

Cigna isn’t alone in adopting new tech to remake its processes. In April, Google’s cloud division unveiled new tools for healthcare claims processing that uses AI to organize data and streamline decision-making. Blue Shield of California and Bupa are among the companies using the tool.

The firm representing the plaintiffs, Malibu, California-based Clarkson Law, has previously taken on tech giants when it comes to AI. Earlier this month, the firm filed lawsuits against OpenAI, the company behind ChatGPT, and Google, which has its own generative chatbot called Bard, for allegedly stealing the data of millions of people—including artists and writers who copyrighted their works—to train and build their AI products.

CRPS and the Need for Early Diagnosis & Treatment – RSDSA AKA “the suicide disease”

Patient harmed, 1,800 doses of controlled drugs lost at CVS pharmacy, regulator says

Patient harmed, 1,800 doses of controlled drugs lost at CVS pharmacy, regulator says

https://ohiocapitaljournal.com/2023/07/24/patient-harmed-1800-doses-of-controlled-drugs-lost-at-cvs-pharmacy-regulator-says/

Pharmacy giant CVS continues to call them “isolated incidents” even after reports emerged earlier this month that the Ohio Board of Pharmacy found hundreds of problems that could endanger patients at eight of the company’s understaffed pharmacies. 

Then on Thursday, the board released inspection reports from yet another CVS pharmacy that detailed additional serious problems. They include the loss of 1,800 doses of controlled substances and a patient who was harmed after being given the wrong medication.

CVS, the nation’s largest pharmacy retailer, has for years been buying out competitors, closing them and then transferring prescriptions from those pharmacies into the closest CVS stores. CVS workers told state inspectors and the Capital Journal that in at least some instances, CVS didn’t add to its already bare-bones staff to handle the extra business. 

Severe understaffing at CVS stores seems to have contributed to weeks-long waits to fill prescriptions, lack of proper controls over narcotics, expired and adulterated drugs not being removed from shelves, prescriptions being improperly dispensed and other problems, according to Ohio Board of Pharmacy reports. In addition, the strain of such understaffing has contributed mass turnover at CVS pharmacies, inspectors reported and CVS workers told the Capital Journal.

Reports previously obtained by OCJ found problems at CVS pharmacies in Canton, Dayton, Columbus, Painesville, Toledo, Massillon, Wooster and Reynoldsburg. Then last week, it received inspection reports for CVS store No. 4351 in Willoughby, 20 miles northeast of Cleveland.

One said that on Jan. 13, 2022, a patient picked up a prescription for what was labeled ropinirole, a dopamine agonist used to treat symptoms of Parkinson’s disease, restless leg syndrome and other ailments.

“Patient 1 ingested approximately 27 tablets of the incorrect medication and experienced adverse effects including increased anxiety, rapid heart rate, and sweating,” the report said.

Weeks later, the mistake was discovered.

“On or about February 3, 2022, Patient 1 picked up a prescription refill from the pharmacy and realized the tablets looked different than those she had ingested from the previous bottle,” the report said.

While the initial prescription bottle was labeled ropinirole, it actually contained digoxin, the report said. That’s a drug used to treat heart failure and arrhythmia. 

Even after switching to the correct medication, problems apparently persisted. The patient went to the emergency room on Feb. 14, 2022 for “accidental drug ingestion,” but no digoxin toxicity was found, the report said. 

A pharmacist approved a prescription he shouldn’t have, but Board of Pharmacy investigators said other safeguards broke down as well.

“The dispensing software permitted the medication to be verified without scanning the bottle or alerting the pharmacist the standard safety procedure may or may not have been completed,” the report said.

Asked about the error, CVS spokesman Matthew Blanchette said in an email, “We have comprehensive policies and procedures in place to support prescription safety. Prescription errors are very rare, but if one does occur, we take steps to learn from it in order to continuously improve quality and patient safety.”

Investigators found other problems at the Willoughby pharmacy.

In April and May of 2021, the store reported the loss of the addictive sedatives lorazepam and diazepam, better known as valium. However, CVS reported in both cases that “the loss was not significant, listing the loss as 0 tablets.” 

When the Board of Pharmacy contacted a CVS loss prevention manager, that person said, “the pharmacy was recently remodeled and believed the loss was due to disorganization and inventory control issues.”

Subsequent reports of “Theft and Loss” said that 141 1mg lorazepam tablets and 106 5mg diazepam tablets were gone — considerably more than the zeroes originally reported. And inspectors on July 21, 2021 found conditions similar to what they found in several other CVS pharmacies.

“Agents observed medications spilling off the pharmacy shelving in the back of the pharmacy and numerous medication stock bottles stored on the floor of the pharmacy,” the report said. “Additionally, the pharmacy was observed to be dirty.” 

Perhaps more concerning were reports the Board of Pharmacy received from the Willoughby CVS last year:

  • The store reported that on June 9, 2022, it detected the loss of 575 50 mg tablets of the painkiller tramadol
  • It reported that on April 12, 2021, it detected the loss of 499 2mg tablets of the sedative alprazolam.
  • And on Aug. 24, 2021, the store detected the loss of 479 10mg tablets of the sedative-hypnotic zolpidem tartrate, better known as Ambien.

All of the drugs the Willoughby reported lost are Schedule IV controlled substances and pharmacy workers couldn’t find paperwork that is required in response to losses of them. In addition, as was the case in several other harried CVS stores it inspected, the Willoughby store did not have a Responsible Person properly listed with the Board of Pharmacy. 

That person, a pharmacist, is legally responsible for the dangerous drugs in the store and when there’s a change in that position, all such drugs are required to be inventoried. However, amid massive staff turnover, the Board of Pharmacy found several instances in which such a person was improperly designated at Ohio CVS stores, or no such person was designated at all.

The board has the power to fine and reprimand pharmacies or revoke their licenses altogether. A hearing into problems found at a CVS store in Canton is scheduled for the board’s Nov. 7-8 meeting. Others are yet to be scheduled.

Asked to comment on problems found at CVS’s Willoughby store, Blanchette, the spokesman, sent a quote almost identical to one the company sent in response to the lengthy list of problems the Board of Pharmacy found in eight other Ohio stores.

“We’re continuing to work with the Board of Pharmacy to resolve allegations of isolated incidents, most of which date back a year or more,” Blanchette said.  

 

Investors Pressure Firms on Opioid Crisis

Just one more attack on the chronic pain community to separate them from their necessary medications.

Investors Pressure Firms on Opioid Crisis

Five types of opioid-related shareholder resolutions are currently on ballots.

https://www.morningstar.com/sustainable-investing/investors-pressure-firms-opioid-crisis

As the opioid crisis continues to rage in the United States, publicly traded companies that manufacture, market, or sell the prescription drugs at the center of the epidemic are facing shareholder resolutions for governance reforms and improved disclosure of risks around their involvement in the making or sale of the drugs.

In the process, this effort is turning the spotlight to how major fund companies and other big investors are casting their proxy votes in 2019.

Starting this week and continuing over the next month, shareholders of Johnson & Johnson JNJ [1], Mallinckrodt MNK, and CVS Health CVS will be voting on opioid-related resolutions. They join shareholders of Walgreens Boots Alliance WBA and AmerisourceBergen ABC who have already voted on comparable resolutions in 2019.

In all, since July 2017 (which is considered to be the start of the 2018 proxy season), 19 shareholder resolutions that at least partially relate to the opioid crisis have been placed on the ballots of 10 companies, according to the Morningstar Fund Votes proxy database.

The companies with opioid measures on the docket count as major shareholder firms such as Vanguard, BlackRock, DFA, and OppenheimerFunds. For mainstream mutual fund companies, these votes are a test of their responsiveness to an issue that matters from the standpoints of social impact, corporate governance, and shareholder value via companies’ bottom-line performance.

Of the 19 resolutions, 14 have come to vote to date (24 April), averaging 35% support, a relatively high level of support given that, across the board, management of targeted companies recommended investors vote against the resolutions. And at three companies–Assertio Therapeutics ASRT, Rite Aid RAD, and Walgreens Boots Alliance–support was north of 60%.

Between 1999 and 2017, 400,000 people died from opioid overdose in the US. In 2017 alone, opioid overdoses claimed 47,600 lives, representing another high–around 10% more than in 2016–in the deepening crisis.

The cost to the economy can be measured by its impact on the labor market, healthcare, and justice systems and is estimated to have been more than $500 billion, or 2.8% of gross domestic product, in 2015, according to a 2017 White House Council of Economic Advisers report.

Over 1,500 lawsuits have been brought against large pharmaceutical manufacturers and distributors by individuals, unions, hospitals, Native American tribes, cities, counties, and states. These were recently consolidated into a multidistrict litigation procedure. The suits claim that manufacturers failed to warn of the potential for abuse, given evidence they had of opioids’ highly addictive properties, and that distributors failed to report overprescription of the drugs. In addition, some states are pursuing independent civil lawsuits against specific pharmaceutical distributors for their role in a chain of alleged deception that enabled and fueled overprescription.

The claims run into billions of dollars, which could represent a significant direct investment risk to pharmaceutical company stockholders and, therefore, to mutual fund shareholders.

Many of the resolutions have been organized by Investors for Opioid Accountability, an investor campaign led by the UAW Retirees Medical Benefits Trust and Mercy Investments. The IOA, which was formed in 2017, has 53 investor members with $3.4 trillion in assets under management. Members include asset managers Domini, Hermes, Aegon, Neuberger Berman, Calvert, and NEI Investments as well as unions, public pension funds, and state treasurers’ offices and other organizations. (The full list of members is available here.)

Roughly, opioid-related shareholder resolutions can be sorted into five types, asking that companies:

• disclose governance strategy to address financial and reputational risks of the opioid crisis,

• disclose direct and indirect lobbying activity,

• adopt policy requiring independent board chairperson,

• adopt policy that incentive compensation metrics not exclude legal and compliance costs, or

• disclose incentive pay clawbacks linked to misconduct.

While these measures are considered good general governance practice, in the case of the resolutions identified in the first exhibit, they are explicitly motivated by reference to the legal and regulatory scrutiny of business practices related to opioids, or to the reputational risks from media attention to the company’s lobbying around drug-related legislation or support of lobbying groups.

Two of the most successful resolutions were those at Rite Aid and Walgreens, earning more than 60% support from shareholders notwithstanding recommendations of management in both cases to vote against the resolutions. Both resolutions urge boards to describe the governance changes in place to more effectively monitor the financial and reputational risks related to the opioid crisis, including compensation metrics, stakeholder inputs, and company political activities.

The top three fund company holders of Rite Aid shares are BlackRock, Vanguard, and OppenheimerFunds, and the top three fund company owners of Walgreens are Vanguard, BlackRock, and State Street.

It’s not yet public how U.S. mutual fund companies cast their votes on the more recent resolutions. Funds are only required to disclose their votes annually, and the information for the year ending June 30, 2019, won’t be available until the end of August.

But in the exhibit below, we highlight votes by select fund managers on resolutions that came to vote in the 12 months ended in June 2018. The voting record was mixed in this sample, although in the two resolutions most directly connected to the opioid crisis–at AmerisourceBergen and Assertio Therapeutics, earning 41% and 62% support, respectively–the “for” votes were stronger.

On April 25, shareholders of Johnson & Johnson vote on a motion filed by the New York City comptroller on behalf of city pension funds that asks for disclosure of any senior executive incentive pay clawbacks linked to misconduct, noting Johnson & Johnson’s defendant status in litigation alleging the use of overly aggressive opioid sales tactics.[1]

At Mallinckrodt’s upcoming May shareholder meeting, Mercy Investment Services and co-filers will ask the board to:

“…report to shareholders by December 31, 2019 on the governance measures Mallinckrodt has implemented since 2012 to more effectively monitor and manage financial and reputational risks related to the opioid crisis in the United States (U.S.), given Mallinckrodt’s sale of opioid medications and active pharmaceutical ingredients in opioid medications, including whether Mallinckrodt has assigned responsibility for such monitoring to the Board or one or more Board committees, revised senior executive compensation metrics or policies, adopted or changed mechanisms for obtaining input from stakeholders, or altered policies or processes regarding company lobbying activities.”

Mallinckrodt–maker of generic opioid drug Oxycodone–faces two other opioid-related governance resolutions on its May ballot. The board recommends a “for” vote on the lobbying disclosure resolution, a rarity for the proxy process. In 2017, the company agreed to pay $35 million to settle government allegations that it failed to report suspicious drug orders.

The number of resolutions slated to be voted on doesn’t reflect the full scale of the effort by shareholders. They are also making headway through direct engagement with company managements, according to the 2019 Proxy Preview report published by shareholder advocacy group As You Sow. (The report can be downloaded here.)

Since the start of the 2019 proxy season, in 22 of the cases where IOA coalition investors asked for either a board risk report or misconduct clawback disclosure, the company agreed to the measures without having to go to a vote.

Illinois Treasurer Michael Frerichs, whose office oversees investments totaling around $30 billion, withdrew a 2019 resolution filed at CVS Health asking for disclosure of a broad range of governance responses to opioid-related risks. This followed a successful engagement by the treasurer’s office and IOA members that led to the publication of a stand-alone report on CVS board’s role in overseeing the company’s Opioid Action Plan as well as new web pages describing a companywide strategy in place for addressing prescription abuses. Max Dulberger, director of corporate engagement & investment operations for the treasurer’s office, notes that the Illinois State Treasurer’s Office, as part of IOA’s collective efforts, plans to continue dialogue with this and other investee companies as a fiduciary whose constituents are affected financially and many other ways by this unfolding crisis.

With the proxy process under threat from lobby groups backed by industry trade associations, investors’ use of shareholder resolutions to address the investment risks related to the opioid crisis stands as a reminder of the crucial role of shareholder advocacy and proxy voting in channeling investor market vigilance and providing a framework for constructive dialogue about strategies for addressing investment risks.

[1] JNJ’s resolution was voted on Thursday, 25 April, and on Friday, 26 April, the company posted the results of the vote on its 2019 AGM. Forty-six percent of shareholders supported the shareholder-sponsored request for annual disclosure of whether, and why, incentive compensation was recouped from, or was required to be forfeited by, any senior executive. This raises the average level of support for opioid-related resolutions over the past two seasons to 36% from 35% over 13 resolutions voted so far.

Interesting concept: could be a funding source for the community to take healthcare corp to court

https://www.cbs.com/shows/video/xVWlsc4Lk2pmULPIyri9PWdcNuUiCOpJ/

The story Ligation Funding Burford Capital starts at abt TWO MINUTES.

There is no mention of them funding class action lawsuits.

HOWEVER, if one of the major wholesalers or major chain pharmacies are taken to court and the chronic pain pt and/or community prevails.  That would suggest that a lot of other class action law firms would be lining up to sue these large healthcare corporations.

According to this article, this “finance” company has a 95% success rate, but of course they are fairly selective in what cases they will finance, and if/when they win.. they want TWICE the money they put out for the lawsuit back, but if the case is a LOSER…the plaintiff owes nothing.

Of course, I am sure that most chronic pain pts would be happy to get little money from a lawsuit, if they could get their pain management therapy back.  I suspect that a sizeable award from one of these large healthcare companies, many other law firms that will take a class action law suit on a contingency basis.  I would think that to get these large healthcare corporations to redirect their lobbying dollars to lobbying for a change in how DOJ/DEA are going after those in the legal opioid distribution system and let doctors to be more free to prescribe control meds to legit chronic pain pts and other dealing with subjective diseases and in need of controlled meds.  Perhaps even taken the production quotas off of the pharmas that produce controlled meds

Obviously, It is going to take one or more in the community to make some phone calls. Apparently Burford Capital is just one of several companies that are in this business of backing lawsuits.

Normally, it only takes 1-2 plaintiffs in a class action case, I am not an attorney, but in this particular case, I think that it would need a plaintiff from every decade of age. To demonstrate to the court that chronic pain, has nothing to do with a certain age. Preteen pts can be dealing with numerous disease issues that generate pain, including terminal cancer among other health issues.

Here is a link to national class action law firms  https://usalegal.com/20-class-action-law-firms-nationwide/

https://bestlawfirms.usnews.com/civil-rights-law/overview

https://www.bestlawyers.com/united-states/civil-rights-law