The War on Drugs Is Also a War on Pain Patients

https://www.cato.org/blog/war-drugs-also-war-pain-patients

In a March 22 opinion column in the New York Times entitled “The DEA Needs to Stay Out of Medicine,” Vanderbilt University Medical Center associate professor of anesthesiology and pain management Shravani Durbhakula, MD, documents powerfully how patients suffering from severe pain—many of them terminal cancer patients—have become collateral casualties in the government’s war on drugs.

Decrying the Drug Enforcement Administration’s progressive tightening of opioid manufacturing quotas, Dr. Durbhakula writes:

In theory, fewer opioids sold means fewer inappropriate scripts filled, which should curb the diversion of prescription opioids for illicit purposes and decrease overdose deaths — right?

I can tell you from the front lines that that’s not quite right. Prescription opioids once drove the opioid crisis. But in recent years opioid prescriptions have significantly fallen, while overdose deaths have been at a record high. America’s new wave of fatalities is largely a result of the illicit market, specifically illicit fentanyl. And as production cuts contribute to the reduction of the already strained supply of legal, regulated prescription opioids, drug shortages stand to affect the more than 50 million people suffering from chronic pain in more ways than at the pharmacy counter.

Dr. Durbhakula provides stories of patients having to travel long distances to see their doctors in person due to DEA requirements about opioid prescriptions. However, despite their efforts, they find that many of the pharmacies do not have the opioids they require because of quotas. She writes:

Health care professionals and pharmacies in this country are chained by the Drug Enforcement Administration. Our patients’ stress is the result not of an orchestrated set of practice guidelines or a comprehensive clinical policy but rather of one government agency’s crude, broad‐​stroke technique to mitigate a public health crisis through manufacturing limits — the gradual and repeated rationing of how much opioids can be produced by legitimate entities.

In the essay, Dr.Durbhakula does not question or challenge the false narrative that the overdose crisis originated with doctors “overprescribing” opioids to their pain patients.

Unfortunately, Dr. Durbhakula’s proposed policy recommendations would do little to advance patient and physician autonomy. She would merely transfer control over doctors treating pain from the cops to federal health bureaucracies and let those agencies set opioid production quotas. For instance, she claims, “It’s incumbent on us [doctors] to hand the reins of authority over to public health institutions better suited to the task.”

No. The “reins of authority” belong in the hands of patients and doctors.

Dr. Durbhakula suggests that “instead of defining medical aptness, the DEA should pass the baton to our nation’s public health agencies” and proposes that the Centers for Disease Control and Prevention and the Food and Drug Administration “collaborate” to “place controls on individual prescribing and respond to inappropriate prescribing.” She elides the fact that these public health agencies will “respond” to doctors or patients who don’t comply with their regulations by calling the cops.

To be sure, Dr. Durbhakula has good intentions. But replacing actual cops—the DEA—with federal health agencies that can order those cops to arrest non‐​compliant doctors and patients is like rearranging the deck chairs on the Titanic. True, her proposed new pain management overlords would have greater medical expertise, but they would still reign over doctors and patients and assault their autonomy. And, as we learned during the COVID-19 pandemic, they will not be immune to political pressures and groupthink.

While her policy prescriptions may be flawed, Dr. Durbhakula deserves praise for having the courage to point out that the war on drugs is also a war on pain patients. Alas, courageous doctors are in short supply these days. Most doctors keep their heads down and follow the cops’ instructions.

After I read her essay, I wrote the following (unpublished) letter to the editor of the New York Times:

Dear Editor—

Kudos to Dr. Durhakula for speaking out against the Drug Enforcement Administration’s intruding on doctors’ pain treatment (“The DEA Needs to Stay Out of Medicine,” March 22, 2024). As my colleague and I explained in our 2022 Cato Institute white paper, “Cops Practicing Medicine,” for more than 100 years, law enforcement has been increasingly surveilling and regulating pain management.

The DEA maintains a schedule of substances it controls, and it categorizes them based on what the agency determines to be their safety and addictive potential. The DEA even presumes to know how many and what kind of controlled substances—from stimulants like Adderall to narcotics like oxycodone—the entire US population will need in future years, setting quotas on how many each pharmaceutical manufacturer may annually produce.

The DEA restricts pain management based on the flawed assumption that what they consider to be “overtreatment” caused the overdose crisis. However, as my colleagues and I showed, there is no correlation between the opioid prescription rate and the rate of non‐​medical opioid use or opioid addiction. And, of course, as fear of DEA reprisal has caused the prescription rate to drop precipitously in the last dozen years, overdose deaths have soared as the black market provided non‐​medical users of “diverted” prescription pain pills first with more dangerous heroin and later with fentanyl.

Researchers at the University of Pittsburgh School of Public Health found that overdose fatalities have been rising exponentially since at least the late 1970s, with different drugs predominating during various periods. Complex sociocultural, psychosocial, and socioeconomic forces are at the root of the overdose crisis, requiring serious investigation. Yet policymakers have chosen the lazy answer by blaming the overdose crisis on doctors treating pain.

When cops practice medicine, overdoses increase, drug cartels get richer, and patients suffer.

Sincerely,

Jeffrey A. Singer, MD, FACS

Senior Fellow, Cato Institute

When cops practice medicine, overdoses increase, drug cartels get richer, and patients suffer.

Filed under: General Problems | 2 Comments »

Be cautious in signing up for Medicare-c (Advantage) prgms,  These programs are provided by FOR PROFIT INSURANCE COMPANIES. An increasing number of large healthcare corporations are canceling their contracts with Medicare-C programs. Patients in these programs may find themselves having to change primary healthcare providers, hospitals, and other providers that they have a relationship with.

Hospitals’ Medicare Advantage problem hits an inflection point

https://www.beckershospitalreview.com/finance/hospitals-medicare-advantage-problem-hits-an-inflection-point.html

As Medicare Advantage enrollment climbs to nearly 34 million people and the federal government implements new insurance policies, the scene has been set for tensions between hospitals and payers to intensify.

“The relationship between hospitals and managed care is strained at best right now,” Chip Kahn, president and CEO of the Federation of American Hospitals, told Becker’s. “[Insurers] are finding every way to not pay for the care that Medicare beneficiaries should receive. I don’t know how the issue gets worse — we’re at a critical stage, and I think CMS is sending those signals.” 

On April 1, CMS finalized a slight decrease in MA benchmark payments for 2025. The agency has also enacted stricter prior authorization rules this year and cracked down on when MA plans must cover inpatient care.

The health insurance industry has said the new rates will “put even more pressure on the benefits and premiums” of MA beneficiaries, a warning that individual insurers echoed in recent months.

“Payers know that they’re going to have to cut supplemental benefits, and premiums may even have to go up, but I wouldn’t want to be the first one to do it,” Scott Ellsworth, founder and president at Ellsworth Consulting, told Becker’s.

Mr. Ellsworth is a former senior insurance executive, overseeing large divisions at Centene, Optum and a BCBS plan throughout his career.

“Seniors have seen their benefits get better every year, but now we’re at an inflection point and the free lunch is over,” he said. “There is going to be a sharing of the pain. Providers have disproportionately shared the pain and now you’re seeing many of them say ‘enough is enough, we’re out.'” 

In 2023, Becker’s reported on at least 15 hospitals and health systems nationwide that dropped some or all of their Medicare Advantage contracts. Among the most commonly cited reasons are excessive prior authorization denial rates and slow payments from insurers. Some systems have noted that most MA carriers have faced allegations of billing fraud from the federal government and are being probed by lawmakers over their high denial rates.

“It’s become a game of delay, deny and not pay,” Chris Van Gorder, president and CEO of San Diego-based Scripps Health, told Becker’s in September. “Providers are going to have to get out of full-risk capitation because it just doesn’t work — we’re the bottom of the food chain, and the food chain is not being fed.” 

Scripps terminated MA contracts in January for its integrated medical groups, citing an annual loss of $75 million on its contracts with insurers.

In March, Bristol (Conn.) Health announced it was eliminating 60 positions, 21 of which are occupied and will result in layoffs. Its CEO laid blame on Medicare Advantage, saying, “All the nice-to-haves are being taken out by the lack of insurance payment and the lack of reimbursement.”  

In January, the Healthcare Financial Management Association released a survey of 135 health system CFOs, which found that 16% of systems are planning to stop accepting one or more MA plans in the next two years. Another 45% said they are considering the same but have not made a final decision. The report also found that 62% of CFOs believe collecting from MA is “significantly more difficult” than it was two years ago.

“Medicare Advantage net reimbursement right now is terrible for hospitals — our clients average about 85 cents on the dollar, and it’s only getting worse,” Mr. Ellsworth said. “MA is a race to the bottom and I would argue that we’ve hit that bottom. Payers are going to struggle with this too, but no one wants to be the first to blink.”

Medicare Advantage denials increased almost 56% for the average hospital from January 2022 to July 2023, according to data from a joint American Hospital Association and Syntellis report. The denials and inconsistent reimbursement led to a 28% drop in hospital cash reserves.

Both Mr. Ellsworth and Mr. Kahn noted that it isn’t feasible for most health systems to completely walk away from Medicare Advantage given that it now makes up more than half of the Medicare population. Instead, many hospitals are paring down contracts and looking for payer partners that align best with their financial objectives. Some systems are even exploring launching their own MA plan built in tandem with one insurer. Others have partnered with grocers or other health systems.

“We will ultimately pick a couple of partners going forward, and I think a lot of health systems are going to do this,” Will Bryant, CFO of Chapel Hill, N.C.-based UNC Health, told Becker’s in November. “They’re going to be the partners who act like partners and not who deny care in order to bolster their billions of dollars of quarterly earnings.”

Sachin Jain, MD, CEO of SCAN Group — one of the nation’s largest nonprofit Medicare Advantage companies — cautioned hospitals that dropping MA plans is a short-term trend that is “going to backfire in a big way for these large health systems.”

“You’re a nonprofit system saying you’re no longer going to accept the insurance that low-income people actually have,” he said. “We’ll see how that works out for you.” 

Dr. Jain said any public policy program is going to create unintended consequences, adding, “What I would say to anybody who’s critical about the program is that you’re right, but let’s fix that.”  

Former CMS Administrator, Don Berwick, MD, told Becker’s in February that the battle between hospitals and Medicare Advantage is a “manifestation of an underlying broken system in which everyone that gives care wants to give more, and everyone that pays for care wants to pay less.”

“To me, the untold story yet is about the physicians and nurses who don’t feel directly tied to ongoing Medicare Advantage trends, but they are certainly immersed in a changing financial landscape,” Dr. Berwick said. “As venture capital, private equity and ownership of healthcare by private interests increases, it changes their worlds, what it’s like to practice, their feelings about themselves, and the degrees of freedom they have to care for their patients. That chicken is going to come home to roost.”

Despite the tensions with hospitals, the MA program has bipartisan support in Congress and a 95% quality satisfaction rating among enrolled members in 2023. There are about 4,000 MA plans being offered this year nationwide, and MA members spend an average of $2,434 less on out-of-pocket costs and premiums per year compared to traditional Medicare enrollees.

“Medicare Advantage is very important, especially for low-income seniors,” Mr. Ellsworth said. “Hospitals need to acknowledge the reimbursement problem and proactively address their relationships [with payers] head-on.”

Filed under: General Problems | Leave a Comment »

All police states have a modus operandi by which they can be recognized. One of those is the absolute and unreasonable, almost random, destruction of people selected to be an “example” to terrify the population. The most educated physician in American history, Dr. Xiulu Ruan, is still languishing in prison because, while the DEA has no right to dictate the practice of medicine, they have the unconstrained power to destroy those who do not toe the party line. And if the government has its way… Dr. Meredith Norris is next.

Filed under: General Problems | 1 Comment »

Payback: Tracking the Opioid Settlement Cash

The Tobacco Money Settlement is running out soon. Just about EVERYONE has their HAND OUT for some of the Opioid Settlement Money. From bureaucraties that had employees who are/were dealing with addiction and wants to recoup the money paid out for treating those employees, to Grandparents raising their Grandkids because their parents OD’d and they want financial assistance in raising their Grandkids.  Doesn’t Social Security pay kids $$ when a parent dies?

Not to mention the bureaucracies that the bureaucrats are creating to manage the distribution of those funds.

The total money that is to be paid out over the next 18 yrs, is but a drop in the bucket as to what the Tobacco Settlement amounted to. What industry is next?

Maybe they will go after the Tobacco wholesalers & retailers that didn’t get “taken to the cleaners” with the original settlement? There is always the Liquor industry, but will they sue those states that only sell liquor thru state-owned stores?

I am sure that they will find some other industry that is selling some legal product that they can fabricate some harm to people or with the current “green mindset”, products that “they” believe is harming our environment.

Maybe these law firms and bureaucrats have created a qazi  Rube Goldberg machine https://en.wikipedia.org/wiki/Rube_Goldberg_machine or a qazi “ATM machine” that never runs out of money!

One thing that no one wants to talk about is all this money that is being paid out or has been paid out from the Tobacco Settlement, These tobacco companies are still around and the price of their products are substantially higher than they were back in 1999, way above what the CPI/COLA increases would suggest.

Same thing with all these Opioid fines and settlements that started in the early 2010 decade and now will continue into the 2040 decade. While the DOJ/DEA & state AG’s are attempting to reduce the number of controlled meds produced and sold.

Filed under: General Problems | Leave a Comment »

Driving down health care costs: Independent pharmacies, patients and lawmakers take steps to rein in PBMs

https://spectrumnews1.com/oh/columbus/news/2024/04/03/pbm-ohio-independent-pharmacy

Filed under: General Problems | Leave a Comment »

Could a chronic pain pt, who lives in Minnesota, could they sue for being denied controlled Rxs to treat their pain, because they are disabled? After all, maintaining and optimizing a pt’s QOL is time-sensitive!

Court Rules Against Pharmacist Who Refused Emergency Contraception Prescription

https://www.medpagetoday.com/pharmacy/pharmacy/10942

Case will be appealed to state Supreme Court or returned to district court

The Minnesota Court of Appeals has ruled that a pharmacist who refused to provide emergency contraceptives to a customer because of his personal beliefs engaged in discrimination.

The three-judge panel ruled Monday that pharmacist George Badeaux engaged in business discrimination in 2019 when he wouldn’t fill a prescription for an emergency contraception that is used to stop a pregnancy before it starts. The customer seeking the prescription said she then traveled about 100 miles (160 kilometers) round trip from the pharmacy in McGregor to another pharmacy in Brainerd, where she filled the prescription.

The customer, Andrea Anderson, later filed a lawsuit claiming discrimination under Minnesota’s Human Rights Act.

“Badeaux’s refusal to dispense emergency contraception because it may interfere with a pregnancy is sex discrimination,” Judge Jeanne Cochran wrote in the ruling.

The appeals court decision means the case will either be appealed to the Minnesota Supreme Court or returned to district court, where a jury in 2022 found the pharmacist had not discriminated but that Anderson was owed $25,000 because of emotional harm. However, Anderson couldn’t collect that money because there was no finding of discrimination.

Jess Braverman — an attorney for Anderson and the legal director of Gender Justice, an advocacy organization for gender equity — said this may be the first ruling in the country to find that a refusal to dispense emergency contraception is a form of sex discrimination. Alison Tanner, senior litigation counsel for reproductive rights and health at the National Women’s Law Center, agreed.

Braverman said the ruling made clear to Minnesota businesses “that you can’t just turn away patients in need of reproductive healthcare.”

Rory Gray, senior counsel at Alliance Defending Freedom, a Christian advocacy group, represented Badeaux and criticized the decision.

“As a devout Christian, George believes every human life has value. As such, George cannot provide or facilitate the use of any potential abortion-causing drugs,” Gray said in a statement. “The court failed to uphold George’s constitutionally protected freedom to act consistent with his beliefs while at work.”

Anderson tried unsuccessfully to buy the emergency contraception, called Ella, at the drug store. The store previously was owned by Aitkin Pharmacy Services, and an attorney for the business did not immediately respond to requests for comment by phone and email.

Gender Justice appealed the jury’s ruling last year, arguing that Badeaux discriminated against Anderson on the basis of her sex when he refused to fill her prescription for a drug that is only prescribed to women.

In 2015, Badeaux refused to dispense Plan B, a different type of emergency contraception, to a woman, resulting in a complaint to the pharmacy’s owner, the judges wrote. The owner and Badeaux then developed a plan for dispensing emergency contraception, which involved getting another pharmacist to come in to fill the prescription the same day or the next day, or transferring the prescription elsewhere.

Tanner, at the National Women’s Law Center, said the Monday ruling “is important because there should be no reason that folks who are in need of emergency contraception are delayed access to that care. It is a time-sensitive medication.”

Since the U.S. Supreme Court ended constitutional protections for abortion in 2022, some states have expanded access to emergency contraceptives and birth control while other states have restricted access and enacted abortion bans.

Dozens of universities across the country now carry emergency contraceptives in vending machines according to the American Society for Emergency Contraception. Some, such as the University of Tulsa in Oklahoma, are in states where abortion is largely banned

Although Minnesota has protected abortion access neighboring states have banned or severely restricted the procedure.

Filed under: General Problems | Leave a Comment »

Bill that would allow medical professionals to deny care based on conscience clears hurdle in House

https://www.newsfromthestates.com/article/bill-would-allow-medical-professionals-deny-care-based-conscience-clears-hurdle-house

House Bill 303, which would allow medical professionals to refuse medical service based on conscience, passed second reading 65-35 in the House on Monday.

“I’d like my health care provider to have a conscience,” said Rep. Steve Gunderson, R-Libby, in support of the bill.

Sponsor Rep. Amy Regier, R-Kalispell, said on the floor that the bill, which will need to pass third reading before heading to the Senate, was aimed not at particular persons, but at procedures, as she had in committee. She listed objections “concerning lifestyle, elective procedures and treatments,” like assisted suicide, gene editing, dispensing marijuana or opioids and abortion.

However, several Democrats spoke in opposition to the bill, the first being Rep. Zooey Zephyr, D- Missoula, the first trans woman elected to the statehouse who serves on the House Judiciary Committee where the bill was heard last week. Medical professionals and organizations had opposed it in committee.

Zephyr said Regier’s characterization the bill was focused on procedures and not people doesn’t accurately reflect its broad language, including definitions for health care service that span from research to any service performed or provided by a medical practitioner.

Zephyr spoke to the impact the bill could have on the trans community, as she and advocates did in committee. She said that the likely consequence would be denial will be based on diagnosis.

“That is inherently discriminatory, because you cannot parse my diagnoses from who I am,” she said. “To deny me based on my diagnosis of gender dysphoria is to deny me based on my being a trans woman.”

Proponents said the bill allows medical professionals to live their values, with Regier citing it as a way to help retain healthcare workers in the state.

Rep. Jerry Schillinger, R-Circle, said in an “oftentimes profit driven world,” healthcare providers who hold traditional values need protection.

Rep. Laura Smith, D-Helena, said she was rising in opposition to the bill due to the impact on parental rights. She said parents would have less ability to advocate for family members in the hospital, giving the example of a family advocating for an unconscious patient where medical staff initially denied a procedure to help her breathe due to concerns over suffering. In Smith’s telling, the young girl made a full recovery after the family pushed for care.

“I think we all have to be honest with ourselves that this is not something that couldn’t fall upon any of us in our lives, our kids or our grandkids,” Smith said.

Rising as a proponent, Rep. Kerri Seekins-Crowe, R-Billings, said her healthcare provider stopped providing service to her after a vote she had taken during the 2021 session on wolves.

“And even though it was a blow to me, because I really did like the healthcare I was getting from her, I really do believe …that she has the right to not to give me care if she believes that strongly,” she said. “Her oath of ‘do no harm,’ she can no longer uphold that if that’s what she believed in.”

Filed under: General Problems | 1 Comment »

This test could be a very slippery slope for this company and any practitioner who uses it and its results. Addiction has substantial underlying mental health issues. Mental health issues are all pretty much subjective health issues and can be various subsets of the total mental health spectrum.

What happens when a pt shows a “positive” test result and is not given or taken off their opioid pain meds, and the pt suffers health consequences for under/untreated pain?

On the other side, the pt shows a “negative” test result and is given opioids for their pain, and they end up becoming an addict because the negative ended up being a false negative.

I suspect that some entity is going to be sued for damages, will it be the pharma or the prescriber who ordered the test?

I hope that the FDA takes the recommendation of its committee of experts and withdraws this test from the marketplace. Of course, FDA is protected by sovereign immunity from being sued for any damages.

Genetic Test for Opioid Addiction Risk Should Be Withdrawn, Experts Tell FDA

https://www.medpagetoday.com/neurology/opioids/109508

Methodology behind AvertD DNA test questioned

A group of 31 physicians and researchers called on the FDA to reverse its decision about AvertD, a test that uses DNA to identify whether adults may have an elevated risk of developing opioid use disorder (OUD).

In a letter to FDA Commissioner Robert Califf, MD, experts in genetics, addiction, psychiatry, public health, and device regulation asked the agency to revoke its recent approval of AvertD, based on research that doesn’t support the methodology used by the test’s sponsor.

The group also sent a letter to Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure asking CMS to deny coverage of AvertD.

The FDA approved AvertD in December 2023. The prescription-only genetic test from SOLVD Health is expected to be on the market soon.

AvertD detects the presence of 15 single nucleotide polymorphisms (SNPs) to help identify people who may have an increased risk of OUD. It’s intended to be used in combination with clinical evaluations and patient assessments when oral prescription opioids are being considered to treat acute pain.

The major risks associated with AvertD are false-negative and false-positive results, the FDA said. Before the agency approved it, an FDA advisory committee voted strongly against an earlier version of AvertD, with false-negative and false-positive test results being a primary concern.

“The FDA seems to believe the test isn’t a very good test but that it’s better than nothing. They’ve got it wrong,” said Andrew Kolodny, MD, an opioid policy expert at Brandeis University in Massachusetts, who signed the letters to the FDA and CMS.

“The problem isn’t that the test has weak specificity and sensitivity,” Kolodny told MedPage Today. “The problem is that it doesn’t work at all. It’s 100% bogus.”

The AvertD test will harm people, Kolodny emphasized. “Patients who test negative, and their clinicians, will be left with a false sense of security, which can result in overuse of opioids and addiction,” he said.

“Patients who test positive will be falsely branded as prone to a highly stigmatized condition,” he continued. “And they may become fearful of taking opioids, even in situations where use is beneficial.”

Genetic tests for opioid addiction have a checkered history. The FDA approval of AvertD last year was an industry first.

Like many genetic tests, confounding is part of the problem, Kolodny and colleagues said. An independent evaluation using methodology like the one used to test AvertD found that the algorithm gave the appearance of predicting genetic risk but was not a true measure of genetic risk, they noted.

“With proper controls for ancestry, genetic predictors from the 15 variants used in AvertD did not predict risk of OUD any better than chance,” they said in their letters to the FDA and CMS.

SOLVD Health said it was aware of the letters to FDA and CMS and is reviewing them.

“We believe the FDA approval of AvertD represents a significant step forward in helping clinicians and patients have informed discussions about opioid-sparing techniques or alternative pain management options, if medically appropriate,” the company said in an email to MedPage Today.

“Consistent with regulatory guidelines and standards, AvertD was clinically validated through a blinded, multicenter study evaluating participants at least 1 year after their initial exposure to prescription oral opioids,” SOLVD noted. “In the hands of physicians, the test results can be a critical tool to help combat opioid use disorder.”

The company also said it is conducting prospective post-market studies to further evaluate the test’s performance in real-world settings.

Filed under: General Problems | 1 Comment »

I remember reading a story- many years ago – about a young man who was a brittle type-1 diabetic. He had called his refill into his pharmacy- mid-week- to get refilled and while the Rx had indicated two refills remaining, it was over 1 yr old and the refills had expired. The pharmacist requested for more additional refills for this guy’s insulin from the prescriber.  This young man came in on a Saturday or Sunday to pick up his refill, but the prescriber’s office had never followed thru on authorizing more refills.  The Pharmacist informed the guy this and the Pharmacist declined to refill the guy’s insulin Rx. A day or so later this fellow DIED, just because no one did their job.

The last contract that I worked under was to help turn around a large company that provided nursing homes with respiratory and other needs. The owner had suffered a serious brain clot/stroke and was incapacitated and eventually died. One of the older employees was a type-1 diabetic and was having trouble affording his Insulin. He was “rationing” his insulin. I printed out this website https://www.rxassist.org/ and gave it to him. He came back to my office a few days later, telling me that he had contacted this website and they were going to send him THREE BOTTLES OF HIS INSULIN, and they were going to continue providing him his insulin going forward. I don’t remember if it was going to be sent to him free of charge or for a very inexpensive cost, that he could afford. Needless to say, he was very happy.

Wisconsin family speaks out against PBMs after the loss of their son

https://www.wjfw.com/news/wisconsin-family-speaks-out-against-pbms-after-the-loss-of-thier-son/article_489e5590-e003-11ee-ae20-fb51d5ece985.html

Cole Schmidtknecht was a 22-year-old young man living in Appleton, Wisconsin who loved video games and sports. His parents Bil and Shanon described him as an inspirational free spirit with a love for being heard.

“He was definitely one of a kind,” said Shanon.

Cole was diagnosed with severe asthma at only a year old. He had just recently moved out on his own with opportunities to chase his dreams, until his life was cut short earlier this year.

“January 10^th,, he went to the pharmacy to get his prescription and was told it was no longer covered by his insurance,” said Shanon.

He was told there was no alternative option and no generic drug would be covered. Cole didn’t know how to respond and couldn’t cover the extreme out-of-pocket cost of his Advair inhaler on a $19/hour income. An inhaler-dependent patient left the Walgreens Pharmacy with no medication. Five days later he suffered an extreme asthma attack and was taken to the hospital. He arrived at the Emergency Room lifeless and spent the next six days in the ICU on a ventilator.  

“We were told he’s never going to wake up again,” said Bil.   

A generic version of Advair only costs $15-$20. What happened to Cole is happening all over the country, according to Hometown Pharmacy co-founder Dan Strause.

“Unfortunately, we see even the state plan now no longer will allow for the generic, they force people into the brand. Why? It’s not hard to figure out it must be about the profit margin. Unfortunately, they’re making people decide between life-saving medicine [and paying bills, even though] the cost of the actual item is so low,” said Strause.

“We find this absolutely wrong, its infuriating we should all be angry, and we hope you tell your legislators this needs to be addressed sooner than later,” said Strause.

Hometown Pharmacy had to close a location in St. Germain partially due to the influence of PBMs. A pharmacy benefit manager acts as a middleman between drug manufacturers and pharmacies.

In the last state legislative session, the pharmacy benefit manager regulation bill wasn’t brought to a vote. The bill was designed to create transparency in the system and prohibit the PBMs’ control over the pharmaceutical industry as a whole.

“We’re very frustrated that it never got a chance to be voted upon,” said Strause.

Strause said there is a lot of speculation as to why the bill didn’t make it to the floor.

“In politics, there’s a lot of moving parts and we believe that the recent vote for Wisconsin mapping is part of it, because there’s a lot of energy and focus with what the next election is going to be and of course elections are very expensive, and you have to fund those elections.

Strause believes that money from lobbying groups associated with PBMs have a strong influence on lawmakers.

“Unfortunately, it means that money and influence is a significant factor in us passing bills especially ones that affect all of our lively hoods and our health,” said Strause.

Bil and Shanon said after learning of PBMs and the tactics that cost them their son they were angry and decided it was time to speak up.

“I don’t want you to ever have to imagine, I don’t want anyone to ever have to experience this,” said Shanon.

Their goal is to share Cole’s story and raise awareness.  

“We just kind of feel like this is now our fight to fight for him. If we can prevent it for one other person just that alone would be a little solace or a little something I know we can never have our son back, he’s gone,” said Bil.

Cole’s situation is not the only one, and this could happen anyone. Everyday life saving medications are becoming inaccessible to patients who need them.

“We need our senators and our congressmen to help this process that’s why they’re there in office for our complaints, our concerns our needs and the games that are played are just costing lives,” said Bil.    

Filed under: General Problems | Leave a Comment »

HHS Cracks Down on Care Facilities for Failure to Turn Over Medical Records

https://www.medpagetoday.com/special-reports/features/109455

Office for Civil Rights fines two facilities that stalled on giving access for more than 100 days

The Department of Health and Human Services (HHS) Office for Civil Rights (OCR) has settled two cases involving healthcare facilities that failed to provide timely access to medical records.

OCR announced settlements with Essex Residential Careopens in a new tab or window in New Jersey (doing business as Hackensack Meridian Health, West Caldwell Care Center) and Phoenix Healthcareopens in a new tab or window in Oklahoma (doing business as Green County Care Center).

Both care facilities failed to provide medical records to a patient’s personal representative within 30 days as mandated by the Health Insurance Portability and Accountability Act (HIPAA), OCR stated.

“It is unacceptable for a healthcare provider to delay or deny requests to release medical records for months, and we are calling on providers everywhere to be compliant to help empower patients,” OCR director Melanie Fontes Rainer, JD, said in a statement.

On Monday, OCR announcedopens in a new tab or window that West Caldwell Care Center (WCCC) — a skilled nursing facility that provides long-term care and rehabilitation services — would have to pay a $100,000 penalty for not providing timely access to patient records.

According to the agency’s notice of final determination, Peter Lindsay requested a copy of his mother’s medical records from WCCC via email. His request was denied on April 22, 2020, and an administrator asked for a copy of his power of attorney, medical proxy, or similar document signed by his mother, Lois Lindsay, establishing him as her representative.

Peter Lindsay sent the power of attorney via email on April 23, 2020, but still didn’t receive any records. He filed a complaint with OCR on May 19, 2020, alleging WCCC and its parent company failed to give him access to his mother’s medical records, even after providing proof of his status as her representative.

Peter Lindsay finally received a copy of the records on Dec. 1, 2020, as a result of an OCR investigation — 161 days after his initial request, the determination stated.

Late last week, OCR announced that Phoenix Healthcare in Oklahoma will pay $35,000 to settle claims that it didn’t provide access to patient medical records in a timely fashion.

In this case, a daughter who was not named filed a complaint with OCR alleging that Phoenix Healthcare wouldn’t give her access to medical records for her mother as her representative.

After attempts at “technical assistance” and “attempts to get the records by OCR,” the facility provided the records on Jan. 30, 2020 — 323 days after the initial request, according to an OCR press releaseopens in a new tab or window.

“The Office for Civil Rights continues to receive complaints from individuals and personal representatives on behalf of individuals who do not receive timely access to their health records,” Fontes Rainer said in a statement. “OCR will continue to vigorously enforce this essential right to ensure compliance by healthcare facilities across the country.”

Filed under: General Problems | Leave a Comment »