https://cdernextgenportal.fda.gov/publicportal/s/dsm-submission
FDA’s new reporting of drug shortages
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FDA’s new reporting of drug shortages
Posted on July 15, 2024 by Pharmaciststeve
FDA’s new reporting of drug shortages
Asked to share!
Posted on July 15, 2024 by Pharmaciststeve
APDF works so hard to change policy! We will do just about anything to help pain patients!
Washington State Patients please read and help! Maria Higginbotham is my mentor and best friend! She works so hard even with her disabilities and needs your help in Washington State! Thank you all!
Bob, can you post to APDF and ask Washington patients to virtually attend the WMC (Washington medical commission) meeting this Friday at 9am.
The commission will be voting on the petitions that Kat and I prepared and I need patients to Comment and add that they support the petitions I submitted. This is our one chance to actually make changes that could trickle down to other states!!
In my previous post I posted information on how to attend this Fridays meeting with the medical commission, I have submitted my petitions and they will be voted on at that meeting. Public Comments are open immediately after the meeting starts SO PLEASE attend and speak to the commission, tell them you support the petitions submitted by Maria Higginbotham,
THIS IS YOUR OPPORTUNITY TO HELP CHANGE THE RULES!!
You register now and then join on Friday at about 8:50 am.
You stay on mute, when they get ready to ask for public comment which will be just after 9am, raise your hand, when they call on you, unmute yourself, identify yourself and speak, you will have 2 minutes!
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More call for violence: MS congressman’s staffer says ‘don’t miss next time’ after Trump assassination attempt
Posted on July 14, 2024 by Pharmaciststeve
Mississippi congressman’s staffer says ‘don’t miss next time’ after Trump assassination attempt
A now-deleted Facebook post by a staffer of Mississippi’s lone Democrat congressman appeared to support the attempted assassination of former President Donald Trump on Saturday.
The deleted post by Jacqueline Marsaw, a field director for U.S. Rep. Bennie Thompson, D-Mississippi, said “I don’t condone violence but please get you some shooting lessons so you don’t miss next time ooops [sic] that wasn’t me talking.”
The Mississippi Republican Party’s X account said Thompson should “FIRE his field director for condoning the attempted assassination of President @realDonaldTrump !!!” The post also said state Democrats “must repudiate these despicable statements.”
Trump was wounded in the ear and rushed off the stage Saturday at a rally in Butler, Pa. by U.S. Secret Service agents and other law enforcement officers.
In a post to X after the shooting, Thompson said “There is no room in American democracy for political violence. I am grateful for law enforcement’s fast response to this incident. I am glad the former President is safe, and my thoughts and prayers go out to everyone involved.”
Thompson is the author of the Denying Infinite Security and Government Resources Allocated toward Convicted and Extremely Dishonorable Former Protectees Act. House Resolution 8081 would strip Secret Service protection for anyone convicted of a state or federal crime and sentenced to a year or more in prison.
With Trump having already been convicted in May of 34 counts in New York of falsifying business records related to hush money paid to porn actress Stormy Daniels, the bill by the ranking Democrat on the House Committee on Homeland Security is clearly aimed at the former president.
The bill introduced on April 19 has yet to receive a committee hearing or a floor vote.
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Is this a call for violence: Biden Threat ‘To Put Trump in a Bullseye’
Posted on July 14, 2024 by Pharmaciststeve
Biden Threat ‘To Put Trump in a Bullseye’ Met With Shrugs, in Contrast With Firestorm Over Palin ‘Crosshairs’
“It’s time to put Trump in a bullseye,” President Biden is heard telling supporters in a recent conversation. Will he be accused of advocating violence the way, say, Governor Palin of Alaska was accused of inspiring an attempt on a congresswoman’s life?
On Monday, in a donors-only call given to Politico, Mr. Biden said he wanted to “move forward” and was “done talking about the debate.” It was then that he made the remark about “bullseye.”
This incident invites comparison to Ms. Palin — known to readers of the Sun as the Alert Alaskan — the Republican vice-presidential nominee in 2008. In 2010, a graphic designer for her PAC used what the New York Times deemed “stylized crosshairs” to mark congressional districts the PAC was contesting.
One of Ms. Palin’s aides said the illustrations were “surveyors symbols,” and the creative flourish was politically inert until the following January. An Arizona Democrat representing one of the enumerated districts, Congresswoman Gabrielle Giffords, was targeted by an assassin.
Jared Loughner wounded 12 and killed six, leaving Ms. Giffords with brain injuries that forced her retirement. Loughner had a murky political ethos, although he listed “The Communist Manifesto” among his favorite books. The opportunity to blame his act on Ms. Palin and others on the right — including my late boss, Rush Limbaugh — proved irresistible to their opponents.
In 2017, the Times resurrected the map myth after a left-wing gunman, James Hodgkinson, targeted congressional Republicans at baseball practice. He shot six and almost killed the House Majority Whip, Congressman Steve Scalise.
Unlike Loughner, Hodgkinson had a political motive. He railed against Republicans and worked for the campaign of the presidential Democratic-Socialist, Senator Sanders. “Conservatives and right-wing media were quick,” the Times wrote, “to demand forceful condemnation of hate speech and crimes by anti-Trump liberals.”
The Times agreed that the left “should of course be held to the same standard of decency that they ask of the right.” It then cited Ms. Palin’s map as a moral equivalence, writing that “the link to political incitement was clear” between it and Loughner. After an outcry, they added a correction that “no connection … was ever established.”
The Washington Post wrote that the editorial “showed how pervasive this debunked talking point still is on the political left.” Ms. Palin sued the Times for libel. The case was dismissed in 2022, but her appeal is pending before the Second Circuit.
As the Times did with Ms. Palin’s map, Mr. Biden has made hay of divining evil motives to Trump’s rhetoric. In March, Mr. Biden stripped a speech his opponent gave to Ohio automobile employees of all context to pluck out a single word.
The autoworkers, Trump said, are “not going to be able to sell” cars if he loses. “It’s going to be a bloodbath.” One definition of the word in Merriam-Webster’s is “a major economic disaster.” Mr. Biden chose the more violent definition and cast it as threatening murder in the streets.
Unlike bloodbath, “bullseye,” has no banal application. Mr. Biden can say he was using hyperbole and colorful language; he’s welcome to do so. If he’s going to infer the most extreme intent from Trump’s words as the Times did with Ms. Palin’s map, though, then turnabout is fair play.
There’s little doubt that if Mr. Biden’s “forceful message,” as Politico described it, had come out of Trump’s mouth, the left would be outraged and the incumbent would be exploiting it to the hilt.
As tiresome as this “What if…?” game is in politics, Mr. Biden’s “bullseye” crack cries out for application of that even-handed “standard of decency” the Times mentioned in its correction, yet nobody has printed a word of objection.
After the FBI was given an authorization to use lethal force in its raid on Mar-a-Lago, Trump accused Mr. Biden of trying to “assassinate” him.
If he repeats the allegation in light of the “bullseye” remark, expect to find that those who imagine links between the right’s rhetoric and violence to shrug until the next time seizing on someone’s words aligns with their political bent.
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CVS Health Co: CMS cites Aetna in 1st No Surprises Act audit
Posted on July 14, 2024 by Pharmaciststeve
CMS cites Aetna in 1st No Surprises Act audit
https://www.beckerspayer.com/payer/cms-cites-aetna-in-1st-no-surprises-act-audit.html
Aetna failed to accurately calculate qualified payment amounts for air ambulance services, CMS’ first audit of an insurer’s No Surprises Act compliance found.
The audit, issued May 29, examined the rates Aetna Health in Texas charged for an out-of-network air ambulance provider between January and June 2022.
The No Surprises Act requires insurers to calculate a qualified payment rate for out-of-network emergency services. This rate is generally the median contracted rate the insurer has with other providers for similar services in the area.
CMS’ audit found Aetna used the wrong methodology to calculate the qualified payment rates, calculating the amount based on claims paid rather than contracted rates.
In its audit, CMS instructed Aetna to conduct a self-audit of all of the qualified payment amounts it calculated for air ambulance services in Texas during the audit period, and refund members if their cost-sharing should have been lower based on the correct payment amount.
The agency also found that Aetna failed to give providers required notice that they may initiate the independent dispute resolution process within four days after the end of the open-negotiation process. Aetna also failed to share the qualified payment amount it calculated to providers in notice or denial of payment.
“This routine audit took place during the first six months of 2022, following the initial implementation of the requirements,” an Aetna spokesperson said in a statement shared with Becker’s. “We addressed all the report’s findings to CMS’ satisfaction.”
Aetna could be subject to more audits of its payment rates in the future, CMS said.
The audit is the first examination CMS has published on an insurer’s compliance with the No Surprises Act. The bill passed at the end of 2020 in an effort to end surprise medical bills for emergency care.
In February, the American Hospital Association called on CMS to up its oversight of payers compliance with the act, adding it is “deeply concerning that the departments have not completed a single audit of payers when the law has been in effect for nearly two full years.”
Provider groups have expressed concerns that the act’s current enforcement and dispute resolution process favors payers.
The law has faced several legal challenges, and a backlog of disputed claims. Data published in February found the number of disputes initiated during the first six months of 2023, were 13 times greater than federal agencies initially anticipated.
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House committee hears from FTC commissioners on PBM report
Posted on July 14, 2024 by Pharmaciststeve
House committee hears from FTC commissioners on PBM report
https://ncpa.org/newsroom/qam/2024/07/11/house-committee-hears-ftc-commissioners-pbm-report
On Tuesday—the same day the agency released its interim report on PBMs—the five FTC commissioners testified before the U.S. House Committee on Energy and Commerce on their FY25 budget request. Numerous committee members wanted to hear from the commissioners about the new report, however.
Rep. Mariannette Miller-Meeks (R-Iowa) highlighted the year-over-year increase in PBM control over prescriptions nationwide, speaking with Commissioner Alvaro Bedoya about the risks of vertical integration and consolidation in the health care industry, as well as PBM noncompliance with the FTC’s information requests in compiling the report. Bedoya in particular pointed to the harms caused by PBMs steering patients towards preferred pharmacies.
Rep. Buddy Carter (R-Ga.) spoke extensively about the challenges pharmacists face as a result of PBMs, noting the loss rate of one pharmacy closure per day. Carter also sought reassurance from Commissioner Melissa Holyoak that her dissent in releasing the interim report was only due to her desire to see a more comprehensive report from the FTC, rather than any support for PBM practices. Holyoak pointed to her work as Utah Solicitor General in holding PBMs accountable.
Other members who used their time to speak to the PBM problem included Rep. Larry Bucshon (R-Ind.) who noted serious concerns about PBMs’ new group purchasing organization (GPO) arrangements, and Rep. Diana Harshbarger (R-Tenn.) who askedFTC Chair Lina Khan about the issue of pharmacy deserts, especially in rural and underserved areas. In her conversation with Bedoya, he specifically highlighted the portion of the report detailing the faxed, opt-out-only nature of PBM contracts and the frequent changes PBMs make to them. NCPA looks forward to the FTC’s continued investigation into this issue, and to finding ways to hold PBMs accountable.
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Insurance Companies finding new ways to deny care?
Posted on July 14, 2024 by Pharmaciststeve
If you have traditional Medicare, the vendor is required to notify the pt up front that Medicare is not expected to pay for the product/procedures, and the pt understands that they are responsible for costs associated with the product/procedure provided. That is called an Advance Beneficiary Notice of Non-coverage, https://www.medicare.gov/basics/your-medicare-rights/your-protections if the pt was not notified upfront and did not sign such a form. The pt is not required to pay for the products/services not covered and paid for.
However, since Medicare Part-C (Advantage) prgms are provided by for-profit private insurance companies, this policy & form may or may not apply. I guess that insurance companies are moving from using the prior authorization process to being able to deny care. To give the vendor a prior authorization approval upfront and then come back after the product/procedure was provided to “question” if the product/service was medically necessary and try to claw back the monies paid to the vendor or deny to pay the vendor.
ASCs see post-procedure payer clawbacks intensify
As scrutiny increases on payer prior authorizations, health plans are using a new tactic to disrupt provider cash flows: post-procedure clawbacks.
ASCs in some markets have noticed insurance companies scrutinizing even previously approved claims post-procedure and denying care or re-evaluating circumstances of the case to recover funds.
“All the insurance carriers are now hiring companies to look at a post-procedure type of prior authorization, or post-authorization,” said Adam Bruggeman, MD, a spine surgeon at San Antonio-based Texas Spine Care Center and chief medical officer of MPOWERHealth, during a June 21 panel at the 21st Annual Spine, Orthopedic & Pain Management-Driven ASC + The Future of Spine Conference in Chicago. “Essentially you’d perform the procedure and then after the procedure, using all the same data they asked for going into surgery, they’re now asking hospitals, surgery centers and doctors again to confirm that they really should have approved the surgery the first time and then they’re clawing back the money, or not paying the money as a result.”
To combat the clawbacks, Dr. Bruggeman’s team has identified the information payers ask for post-procedure and gathering it from physician offices before surgery.
Columbia (Mo.) Orthopaedic Group has seen similarly aggressive tactics by local payers and built a whole department focused on preauthorizations and post-surgery payer requests. The group spends hundreds of thousands of dollars per year to maintain the department, which is a heavy lift for an independent organization. But so far, the investment has paid off.
“Our physicians feel the pain in the clinic, but they haven’t felt it in their wallets yet because our departments are really, really good at making sure we get the money that’s theirs,” said Andrew Lovewell, CEO of Columbia Orthopaedic Group. “We have a lot of robust processes ahead of time where the doctors know the day before surgery exactly what codes are approved. They have to email if they do anything differently in the case. They have to tell us immediately or they face a penalty inside of our own group. We take both sides of it, not only to educate our providers but then go directly after the payers.”
Mr. Lovewell’s center does around 2,000 total joint replacements per year and a big payer has taken aim at the procedures.
“They’re going back and retro trying to deny implants we put in from six months ago. They’re doing a huge sweep,” said Mr. Lovewell. “They’ve hired a third party and then we’re spending money and time sending all these records back to them and they approve every single one of them. It’s just a nuisance headache.”
The payer requested almost 6,000 patient records on implants over a two-year period after approving everything upfront. Mr. Lovewell asked for an increase in rates because the business office will spend significant time pulling those records. He also threatened to go out of network and send those procedures back to the hospital.
“What I think we’re going to see, as more light gets focused on prior authorization, they’re going to shift to post-procedure techniques to try and extract the same amount of money and reduce the same payments,” said Dr. Bruggeman.
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PBM Leeches
Posted on July 13, 2024 by Pharmaciststeve
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I ask perplexity.ai what percentage of total medical expenses is prescription costs
Posted on July 12, 2024 by Pharmaciststeve
Back in the day… before there was NO PBM industry. I remember it being reported that Rx costs were about 6% of total healthcare expenditures.
The PBM industry was a result of an AUW contract at the end of 1969. I don’t remember, but probably the effective date was the first of 1970.
Back then, the average Rx price was $4 to $5 each. Brand name meds were 90% to 95% of all Rxs. There was also no DEA. There was no PDMP, No prior authorizations, no mandatory generic substitution, no step therapy, no days supply limitations, and on and on that the PBM industry & DEA gave us.
According to this question, I asked perplexity.ai. The cost of medication today is upwards of 20% of total medical/healthcare expenses. Today 90% of Rxs are paid for by one of the 60 PBMs, and the top 3 PBMs control 80%-90% of all Rxs paid for by the PBMs. 85%-90% of prescriptions are now filled with generics.
I suggest that you watch this blog post from two months ago by Senator Elizabeth Warren, ripping the President of United Health a “new one”. https://www.pharmaciststeve.com/warren-blasts-united-health-ceo-for-monopolistic-practices-that-harm-patients/
The same United Health that is endorsed by AARP and sells its Medicare programs to AARP members
Then there is this video by Dr. Eric Bricker, he demonstrates how Medicare Advantages sort of “cooks the books” so that they are technically not spending as much on pt care as their contract with Medicare/Feds they agreed to pay on pt care.
Dr. Bricker also has this website where he has created videos that describe what he has uncovered about how our healthcare system is not much more than your basic for-profit corporations
what percentage of total medical expenses is total prescription costs?
Based on the search results provided, prescription drug costs represent a significant portion of total medical expenses in the United States. Here are the key points:
1. In 2021, the U.S. health care system spent $603 billion on prescription drugs, before accounting for rebates. Of this amount, $421 billion was spent on retail drugs[2].
2. Total inflation-adjusted expenditures on prescription drugs grew from $520 billion in 2016 to $603 billion in 2021, a 16 percent increase[2].
3. In 2016, prescription drug costs accounted for $329 billion out of $3,337 billion (17.9% of GDP) spent on national health expenditures[1].
4. As of 1998, prescription drugs accounted for almost 16 percent of total health care expenditures[3].
5. Specialty drugs, which are typically high-cost medications, represented 50% of total drug spending in 2021[2].
While the exact percentage for the most recent year is not explicitly stated in the search results, we can infer that prescription drug costs continue to represent a substantial portion of total medical expenses. Based on the trend from 1998 to 2016 and the continued growth in drug spending, it’s likely that prescription drugs currently account for somewhere between 15-20% of total medical expenses in the United States.
It’s important to note that these figures can vary depending on factors such as whether retail or non-retail drugs are included, and whether rebates and discounts are accounted for in the calculations.
Citations:
[1] https://www.actuary.org/content/prescription-drug-spending-us-health-care-system
[2] https://aspe.hhs.gov/sites/default/files/documents/88c547c976e915fc31fe2c6903ac0bc9/sdp-trends-prescription-drug-spending.pdf
[3] https://hpi.georgetown.edu/rxdrugs/
[4] https://www.cbo.gov/publication/57772
[5] https://www.healthsystemtracker.org/chart-collection/health-expenditures-vary-across-population/
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Thinking Out Loud: The Chevron Doctrine
Posted on July 11, 2024 by Pharmaciststeve
Thinking Out Loud: The Chevron Doctrine
https://www.acsh.org/news/2024/07/03/thinking-out-loud-chevron-doctrine-48846
Thank God for the Supreme Court. If not for their reversal of the Chevron doctrine, we would continue to be subject to the regulatory whims of a faceless, often agenda-driven, unelected bureaucracy. With a sweep of its magisterial pen, the justices have turned over the fine details that Congress in its infinite wisdom avoids, to – wait for it – a largely faceless, often agenda-driven, unelected judiciary.
AI image
Whether you believed the Chevron Doctrine was wrong or not, the Supremes have moved us from the proverbial “pan into the fire.”
“Agencies have no special competence in resolving statutory ambiguities. Courts do.”
– Chief Justice John Roberts
I have been following the case brought by Loper Bright for some time. The issue of who pays for oversight on a fishing trawler was interesting in its merits. My friend and colleague, Dr. Billauer, has taught me all I know about admitting scientific evidence into court through the federal judiciaries Daubert standard. [1]
This raises my first concern about Chevron’s reversal. Not only does the judiciary lack any “standing” (Sorry, Dr. B, I know this is not the correct use) in adjudicating any scientific controversy because of a lack of scientific knowledge, but the very basis of law requires a degree of certainty unusual in applying science. Contrast the words of Chief Justice Roberts,
“Courts, understand that such statutes, no matter how impenetrable, do — in fact, must — have a single, best meaning.”
with the words of a scientist.
“Lack of certainty is precisely what makes conclusions more reliable than the conclusions of those who are certain: because the good scientist will be ready to shift to a different point of view if better elements of evidence, or novel arguments emerge.”
– Carlo Rovelli, Ph.D
The law has done an abysmal job of translating and applying science. If regulatory decisions are to be “whim-based,” wouldn’t we all prefer that those whims be based on first-hand scientific knowledge rather than second-hand, “friends of the Court” briefs or the highest-paid expert witness?
My second concern is that Chevron’s history will be repeated. The Chevron Doctrine, written in 1984, found that when a federal statute delegating policymaking authority to an agency was ambiguous, courts should typically defer to the agency’s determination. Why? Because “judges are not experts,” and accountability for the actions of those faceless, unelected, agenda-driven bureaucrats resides in the political appointees heading the agencies, who are accountable to a president, who, in turn, is responsible to us.
With the Reagan presidency in full ascendency, Chevron worked in favor of Republicans who controlled our regulatory agencies. The Democrats, or at least those favoring regulations as the means of change, were put back on their heels. Fast-forward to the Obama administration and the Chevron Doctrine had lost much of its appeal to those on the right while bolstering the hopes and actions of those on the left. Regulations, especially those based on science, should not be the whim of either political wing. Regulation of a host of environmental and health issues should be based on science, not the moment’s ascendant ideology.
My third concern is that this decision will reduce our agility to respond to novel situations while further clogging the Courts and enriching lawyers at our expense. It takes two to three years for a federal rule to be enacted. The Loper Bright case took a bit longer than four years to be adjudicated by the Supreme Court and remanded to the lower courts.
“[Chevron] reflects the reality of government, and thus more adequately serves its needs.”
-Justice Antonin Scalia
With the end of Chevron, we might hope the legislators will reduce the ambiguity in their lawmaking. They needn’t legislate specifics based on understanding and judging science; that would be far too much to ask of them, but they can indicate that the regulating agency should write this or that group of regulations. They can make their deferral to expertise clear.
Moreover, as ACSH has championed for some time, the science underlying those regulations should come from a more diverse group of “stakeholders.” That’s right, diversity can be crucial. There is no reason to automatically exclude “special interests,” all that does is make them find other less transparent ways to influence regulation. (See the Wolves of K Street for the frightening details)
The Supreme Court’s reversal of the Chevron Doctrine marks a significant shift in how regulatory power is allocated between agencies, representing the executive branch and the judiciary. While it addresses concerns about unchecked bureaucratic authority, it leads the way for unchecked judicial authority. Chevron reflected the reality of government, that not all can be known, and that the details are sometimes messy and often uncertain. Putting the details in the hands of the judiciary will not achieve balanced, effective regulations that serve the public interest without falling prey to political whims.
[1] Dr. Billauer’s writing on the subject are too numerous to link to individually, here you can find her work with ACSH
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