October – Nat Breast Cancer Month & Down Syndrome

When healthcare providers end up really being healthcare deniers

I got the email below on Jan 1, 2024.  This pt’s story is not a unique issue. Another example of bureaucrats and politicians attempting to “solve” our fabricated opioid crisis by creating a “one size fits all” on pain management.

After having this blog for 12-13 yrs, I have developed a fairly sizeable network of chronic pain pts, chronic pain advocates, and numerous healthcare practitioners.  I shared this woman’s email with a couple of select people that I believed might be able to STEP UP. And one did:

When a pt’s long term medical records mean nothing when seeing a new practitioner

When everything seemed to start to fall into place for this young lady. This young lady’s pharmacist and the mid-level practitioner who was forcing her to reduce her pain meds had to step in to make sure that things were not going to change the way that this mid-level practitioner wanted things to happen. Here is a video this young lady sent that she personally explains what has happened.

Hi Steve,

I have sent you my story before. I am a single disabled palliative care sick patient in Maine. In September of 2021, my doctor and I were targeted by the assistant attorney general, Michael Miller. We think it was for 2 reasons-he was very effective at getting patients disability, testings, procedures, equipment, etc and because I require a high dose of opiates to physically and mentally function. Dr. Lommler believes Michael Miller made a deal with the insurance companies and profited somehow for taking him out. Michael Miller used at least 2 agencies to target, harass, and destroy us. They suspended Dr. Lommler’s license for going over the 100 MME limit on my prescription. However, Maine has a palliative care exemption that allows people (like me) to have access to opiates for pain control and disease treatment options. It also allows us to go over the 100 MME limit. They refused to lift the suspension unless he transferred to a “board approved” facility. He chose to retire because he wanted to stay at his independent office with his 200 complicated and unique patients. They gave neither one of us any due-process! They used backdoor methods and I believe they were illegal! There was a covering LNP seeing me for a year. We tried to find a doctor everywhere in Maine to see me but because of the Opiate Task Force and doctors getting red-flagged for going over the 100 MME limit and being dragged in front of the board, no one would see me. I was forced to transition to the hospital where all of my specialists are. You see, Maine and New Hampshire were the 2 states prescribing the most Opiates so they created a New England Opiate Task Force and sent them to work with the Governor Mill’s administration to red-flag doctors prescribing over the 100 MME limit and drag them in front of the board of medicine! They have forced independent providers to either retire or transfer to a “board approved” facility. These “board approved” facilities all have anti-opiate one-size-fits-all policies. The hospital that I am at has an anti-opiate provider masquerading as a “pain specialist.” She believes Opiates are life threatening and dangerous to everyone. She is force tapering me off all my pain medication! I am complicated and unique-I have multiple health conditions. I had an original medical nightmare that left me with life altering physical deformities and severe debilitating pain. I have Crohn’s disease, vitamin and bone deficiencies, and neuropathy-all of these cause malabsorption so I have to take double doses of all of my medication! I cannot have the conventional pain management treatments because I am allergic to everything and sensitive to anything and I have a prosthetic heart valve. I have Scoliosis and severe Osteoporosis with dangerously low Scores. I am 46 in an 86 year old’s body.
They are stereotyping anyone on opiates as addicts and forcing them off pain medication. The only option they give you is Suboxone-I cannot take this because the side effects would be catastrophic to my body. I had nothing but recovery and progress with my 8 1/2 year stable pain regimen. I was able to semi function independently with a decent quality of life. Since this provider has been force tapering me, I can no longer function independently at all and I have zero quality of life! According to Maine’s own definition and standards, what this facility and provider are doing to me is disability abuse! I tried to contact patient services for an advocate but was told there wasn’t one. The woman I spoke with for 2 minutes, asked me what my concerns were. I explained to her what was happening to me. 2 days later I received a letter stating my concerns were forwarded to the Medical Director and Operations Manager and they agree with the provider force tapering me. They also said there was no medical justification for my pain medication. I filed a public accommodation discrimination complaint with the Maine’s Human Rights Commission but haven’t heard a word since intake months ago! The letter gave an 800 number to call if you disagreed with their decision. It was the board of licensure telling you to submit a complaint. I already filed a complaint with the board of medicine and nurses months ago. So, you have to go to the same people that are red-flagging and harassing doctors going over the 100 MME limit. I won’t hold my breath! These are the same people that asked Dr. Lommler how he didn’t know that I was taking half of my pain medication and selling the other half! Dr. Lommler provided them with 7 1/2 years worth of passed urine screens and passed frequent random pill counts! I wasn’t even allowed to attend or participate into the investigation into my opiate use-I could’ve answered that question myself-I have never misused my pain medication! In fact, I did everything that I was supposed to do! How in the world can I trust they will help me!
Since this provider has been forcing me off my pain medication, I have had sky high blood pressures-202/129, severe bloody noses, I have been discharged from aquatic therapy-which I needed to get into my Crow Walker boot, I am completely dependent on my sons, I have had to quit tutoring for supplemental income, I can no longer walk on my crutches so I am trapped in my wheelchair, and I cannot mentally or physically function! My counselor and former providers have tried talking with this provider but she refuses to listen because she knows best. I had to spend my Christmas in the ER and I am now watching my right leg and foot do exactly what my left leg and foot did in my original medical nightmare. When my body is in severe stress, my multiple conditions play off of one another and wreak havoc on my body. Last time, the severe stress was an allergic reaction to hardware (we didn’t know why at the time, it took years to figure it out). This time, it is force tapering my pain medication! This time, it’s the providers choice to force taper me because of her personal feelings about a medication! Medical providers are supposed to do what is in the best interest of the patient, not what is in the best interest of their personal feelings! I have cellulitis in my right leg and foot with ulcers everywhere! I maintain my left leg and foot with Cuban for compression. I tried to wrap my right leg and foot but it’s not used to being wrapped, and I get continuous Charley Horses. They are intolerable with all of my pain medication being taken away! I have severe PTSD and zero trust in doctors from my original medical nightmare! I never ever wanted to go back to that sick person trapped in a wheelchair, I thought I left it behind for ever! This time, I don’t have a heart valve to lose! I am petrified and profoundly devastated because I worked so hard for 8 1/2 years to recover and progress and now that has been destroyed! I see people helping doctors that have been arrested but what about people, like me, who have been targeted, harassed, discriminated against, and literally going through disability abuse-who tells our story and helps us?
My counselor gave me a brochure for adult protective services and she told me to call because what they are doing to me is discrimination and disability abuse. I called and the lady said there is no process for this situation. She told me that it does qualify but the only thing I can do is file a complaint with the board of medicine and nurses because they are the only entities that have authority and jurisdiction over medical providers. I told her that I already filed complaints but it will take months because they only meet one day a month! I told her my body won’t make it that long and I asked her, “what if I die in the meantime?” She said, “let’s hope it doesn’t come to that but good luck!” WHAT? It’s like a nightmare that I cannot wake up from! I have contacted every politician in Maine and asked for their help. Crickets…I requested assistance from Governor Mills but she doesn’t even think she has to answer to her constituents. I have reached out to every volunteer lawyer’s projects and disability rights groups but they all claim no to have the resources to help me. I have documented, taken pictures, recorded videos, screenshot messages from my portal between her and I, audio recorded my video appointments exposing her discrimination and disability abuse! I cannot find an attorney in Maine to help me. This provider only saw me one time in person! She never looked at any areas causing my pain, she’s not monitoring my vitals or everything that is happening to me, she doesn’t even have the correct MRI’s-she’s going by a 2008 one when I was a normal person and could walk on my own, and she’s retaliating against me for filing a complaint! I need help and I don’t know where or who to go to! I even have an appointment with cancer care, January 23rd. I have MGUS and the blood work markers and symptoms all point to it turning into Multiple Myeloma. I asked her to please pause the force taper until I can get into my appointment. She said, “Oxycodone will not cure Multiple Myeloma so the force taper will continue!” How cruel is that!
I was hoping that you may have some direction or advice to help me. If I knew how to file a civil lawsuit against the hospital and provider, I would do it myself. Since September of 2021, I have had to be my own advocate, case manager, and attorney!
I already missed about 6 years of my sons’ lives because of my original medical nightmare! I can do no physical activity without my pain medication! I really don’t think my body will make it through this force taper! Opiates are literally life saving for me! They knew that I wouldn’t be able to find another doctor to see me and Michael Miller and the board of medicine took 2 doctors from me! The provider force tapering me filed a complaint against the LNP that saw me for a year. In it, she said that she felt compelled because Kaye endangered my life by prescribing these life threatening and dangerous medications. She also accused me of bribing Kaye in her complaint. That is ludicrous-I have never bribed anyone! Kaye made it very clear in her response that no one forced or bribed her. She also made it clear that I was the only patient she ever prescribed narcotics for in her entire medical career! I have been accused of selling half of my pain medication and bribing doctors! I am a law abiding Mainer and American just trying to live my life!
Thank you for taking your time to read my email. You can reach me any time at xxx.xxx.xxxx

most societies/communities have 1 or more agitators, disruptors, false prophets, scammers, traitors, saboteurs and cult leaders

Some believe our country is on the verge of a Civil War, they may be right, but it won’t be a bilateral war like our last Civil War..  Our society has voluntarily divided itself in – for lack of a better description – TRIBES.

The chronic pain community is not all that different from our country of as a whole.

Recently a fellow chronic pain pt who had been advocating for end stage pediatric pts in a large hospital system that has a “no opiate” policy.  All of a sudden the advocated was told that he was no longer permitted to advocate for these end of life pediatric cancer pts.  I suppose that this major hospital system will return to treating these pediatric pts with NSAIDS and Acetaminophen and let them live the rest of their lives in a torturous level of pain.

There are rumors as to who said what and to whom… I am not going to elaborate. However, they know who they are and what was said to cause this to happen.  One can only imagine the deprived mental status of those who have been involved in this.

Some have told me that this tribe of malcontents have monetized chronic pain pts’- personal information  and several other covert processes. I started my blog in 2012 and have tried to motivate and educate chronic pain pts in some ways that they can navigate their way to getting their pain management back.  Some chronic painers have told me that I should charge for my advice.  My Pharmacy degree, license and career has provided for Barb and myself a comfortable retirement.

After this issue with these end of life pediatric pts,  Going forward… I am going to ASK of people that want my advice to make a contribution to one of the four national charities listed below, these are all about THE KIDS… and charities we support.  Maybe in some small way, my advice can help more than just one person/family. 

 

https://www.stjude.org/ St. Jude Children’s Research Hospital – deals with kids dealing with cancer and/or life threatening health issues

https://lovetotherescue.org/ Shriners Hospital – deals with kids, born with “broken bodies” and birth defects

https://rmhc-kentuckiana.org/ Ronald Mc Donald House – this is near us and just a few blocks from a very large regional pediatric hospital ,3 other major hospitals within blocks, one being a teaching hospital and having the only LEVEL ONE TRAUMA CENTERS for 100 miles and part of a medical university and  helps provide housing for families with kids in the hospital

https://t2t.org/ Tunnel to Towers Foundation – helps get handicapable housing for veterans, first responders with “broken bodies” , families with spouse/parent killed in the line of duty and Gold Star Families

 

 

SCOTUS Petition Takes Aim at Ambiguous Federal Opioid RX Laws Aug 5 Written By Ronald Chapman II Lubetsky v. United States

SCOTUS Petition Takes Aim at Ambiguous Federal Opioid RX Laws

Lubetsky v. United States

https://ronaldwchapman.com/blog/lubetsky-supreme-court

By: Ronald W. Chapman II

Dr. Ronald Lubetsky, a Florida physician, takes aim at the Controlled Substances Act in a new Supreme Court petition filed on August 5, 2024. His case is both shocking and tragic but his fight is not over.

Dr. Ronald Lubetsky Petitions Supreme Court

Dr. Ronald Lubetsky photo credit, the Florida Bar.

The government’s prosecution of Dr. Lubetsky centers around the ambiguous language of the CSA, particularly the phrase “outside the usual course of his professional practice, other than for a legitimate medical purpose.” The government has moved away from the original intent of the CSA, which was to target drug trafficking, and instead has begun prosecuting physicians based on increasingly vague and shifting standards of medical practice.

At trial, the government’s medical expert, Dr. Rubenstein, testified that Dr. Lubetsky’s prescriptions were issued outside the usual course of professional practice. This testimony was based solely on audio recordings of the patient visits and did not include a review of any medical records, diagnostic imaging, or the patient’s prescribing histories.

Rubenstein’s testimony was based solely on audio recordings of the patient visits and did not include a review of any medical records, diagnostic imaging, or the patient’s prescribing histories.

Dr. Rubenstein asserted that the lack of a detailed physical examination and comprehensive medical history in these specific cases rendered the prescriptions illegitimate. However, this opinion was formed without considering the full context of Dr. Lubetsky’s practice and the treatment of thousands of legitimate pain patients.

The Circuit Split and Post-Ruan Interpretation

A key legal issue in Dr. Lubetsky’s case is the circuit split over how the ambiguous language of the CSA should be interpreted. Specifically, courts are divided on whether the requirement for a prescription to be issued “for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice” should be read conjunctively or disjunctively.

• Conjunctive Reading: Under this interpretation, both elements—issuing for a legitimate medical purpose and acting in the usual course of professional practice—must be satisfied for a prescription to be considered lawful.

• Disjunctive Reading: Under this interpretation, a prescription could be deemed unlawful if it fails to meet either of these elements. This reading lowers the threshold for criminal liability, as a physician could be prosecuted even if they prescribe for a legitimate medical purpose but allegedly do not follow the usual course of professional practice.

The Eleventh Circuit, where Dr. Lubetsky was tried, has adopted the disjunctive reading. This approach has significant implications, as it allows the government to prosecute physicians even when there is no clear evidence that the prescriptions were issued for anything other than a legitimate medical purpose. This interpretation is in conflict with other circuits that have adopted the conjunctive reading, which provides greater protection to physicians by requiring that both elements be proven before a conviction can be secured.

The Supreme Court’s decision in Ruan v. United States was expected to clarify this issue, but it has instead led to further narrowing by the U.S. Circuit Courts. In Ruan, the Court recognized the ambiguity in the language of the CSA and highlighted the importance of a strong scienter requirement to avoid overdeterrence. Despite this, the Eleventh Circuit has continued to uphold the disjunctive reading, creating a situation where physicians are left with little clarity on the standards they must meet to avoid criminal liability.

Government’s Shifting Standards

Dr. Lubetsky’s case also underscores a troubling trend: the government’s shifting standards for what constitutes acceptable medical practice under the CSA. Historically, the CSA was used to target physicians who were clearly engaged in drug trafficking—those who prescribed controlled substances without any medical justification, often to patients who explicitly stated they intended to use the drugs for non-medical purposes. However, in recent years, the government has broadened its interpretation of the CSA, prosecuting physicians based on vague and unenumerated standards of medical practice that often go beyond what state laws require.

In Dr. Lubetsky’s case, the government’s expert applied a standard for prescribing that exceeded Florida’s requirements. Florida law mandates that a complete medical history and physical examination must be conducted before beginning opioid treatment, but there is no requirement for a physical examination at every follow-up visit. The expert, however, testified that a physical examination was required at every visit when opioids were prescribed, thus holding Dr. Lubetsky to a higher standard than what is legally required in the state.

This evolving and inconsistent application of standards places physicians in an untenable position, where they must navigate not only state laws but also fluctuating federal expectations that may not align with established medical practices. The consequence is a chilling effect on the practice of pain management, where doctors may avoid prescribing necessary medications out of fear of prosecution, leaving patients to suffer.

Interested Parties May File an Amicus Brief with the Court

Given the complex legal and medical issues at play in this case, it is imperative that advocacy groups concerned with patient care, medical ethics, and physician rights take action. Filing amicus briefs in support of Dr. Lubetsky’s petition to the Supreme Court is crucial to ensure that the Court fully understands the broader implications of this case. These briefs can help the Court appreciate the potential harm of allowing ambiguous and overly stringent interpretations of the CSA to persist.

Dr. Lubetsky’s defense counsel and authors of the brief are Ronald W. Chapman II and Matthew Pelcowitz of the Chapman Law Group.

PDF of the 75 page filing  click here

 

911: ALL HANDS ON DECK

 

This is a post from Dr Mark Ibsen.  Mark has been caring for a dozen or so of what has been labeled as “opioid refugees”. The only pharmacy that he could find that would fill the opioid Rxs from Dr Ibsen was in FLORIDA and that pharmacy unfortunately got “trashed” by those two different hurricanes that hit Florida over the last few weeks and is temporarily “out of business”  Mark is looking for another pharmacy – preferably a compounding pharmacy – that Mark can reach out to.

Mark has these dozen or so intractable chronic pain pts that are in or on the verge of being thrown into a cold turkey withdrawal.

Medicare Advantage star ratings decline: 5 things to know

Medicare Advantage star ratings decline: 5 things to know

https://www.beckerspayer.com/payer/medicare-advantage-star-ratings-decline-5-things-to-know.html

Average Medicare Advantage star ratings declined for the third year in a row, according to CMS data published Oct. 10. 

The average Medicare Advantage star rating for 2025 is 3.92, down from 4.07 in 2024. 

Plans must earn a rating of 4 or higher to receive bonus payments from CMS. 2025 star ratings affect the quality bonus payments plans receive in 2026. 

Here are five things to know about the star ratings: 

  1. Just seven plans received a five-star rating in 2025, down from 38 in 2024.
  2. Around 40% of Medicare Advantage-Part D plans received four stars or higher. Around 62% of MA-PD enrollees are in plans rating four or higher, according to CMS.
  3. CMS did not make any major changes in star ratings methodology, according to the release.
  4. Medicare Advantage-Part D plans are rated on 40 clinical quality and member service measures. CMS determines cut points for measure each year. For 2025, many cut points increased, meaning plans had to perform better to get higher star ratings.
  5. Several factors influenced the tougher cut points, CMS said. The agency removed extreme outliers from the lower end of performance, a more compressed distribution on scores and an increasing number of high-scoring contracts. Some measures are improving to pre-pandemic levels, increasing cut points, CMS said.

Potential challenges to CMS’ star ratings could loom. Earlier in October, Humana said its star ratings for 2025 dropped significantly from 2024. In 2025, just 25% of its members will be in contracts rated plans four stars and above, down from 94% in 2024. The company said it expected the drop was driven by “narrowly missing industry cut points on a small number of measures.” In regulatory filings, the company said it believes there may be potential errors in CMS’ calculations. 

UnitedHealthcare is also challenging CMS’ star ratings. The company filed a lawsuit Sept. 30, challenging CMS’ inclusion of a secret shopper phone call in its star ratings that UnitedHealthcare said never connected. 

In June, CMS recalculated 2024 star ratings for all Medicare Advantage plans. Judges sided with SCAN Health Plan and Elevance Health in lawsuits challenging the methodology CMS used to calculate the ratings. 

In addition to determining bonus payments, star ratings guide beneficiaries’ decisions on which plan to enroll in. Open enrollment begins Oct. 15 and runs until Dec. 7.

NCPA: Drug price negotiations will fail without fair and timely pharmacy reimbursement

NCPA: Drug price negotiations will fail without fair and timely pharmacy reimbursement

https://ncpa.org/newsroom/qam/2024/10/07/ncpa-drug-price-negotiations-will-fail-without-fair-and-timely-pharmacy

ALEXANDRIA, Va. (Oct. 3, 2024) – The National Community Pharmacists Association today warned that President Biden’s plan to negotiate drug prices in Medicare will fail and patient access to the first 10 negotiated drugs will be jeopardized beginning in 2026 because the Centers for Medicare & Medicaid Services neglected in its final guidance to prevent pharmacy benefit managers and manufacturers from paying pharmacies too little and too late.  

In comments to CMS on the draft guidance, NCPA stressed the need for the agency to ensure that PBMs reimburse community and long-term care pharmacies fairly for maximum fair price (MFP) drugs — at a negotiated price that is no lower than the maximum fair price plus a commensurate professional dispensing fee. NCPA also emphasized that manufacturers must refund pharmacies within 14 days of adjudicating the claim. Otherwise, according to an NCPA analysis, the average pharmacy will have to float over $27,000 every month waiting to be made whole from the manufacturer refunds. Collectively among community and LTC pharmacies, the cash flow effect would be around half a billion dollars every month for just the first year of the program.  

An informal NCPA poll of community/LTC pharmacy owners and managers in October 2024 finds that 92 percent of them are considering not stocking MFP drugs as a result.

The final guidance makes clear that CMS isn’t heeding these warnings, however: “CMS is not establishing requirements for dispensing fees for selected drugs at this time but will monitor complaints and audits related to this issue. CMS encourages plan sponsors to work with pharmacies to ensure adequate and fair compensation for dispensing selected drugs.” The CMS final guidance also says that pharmacies will not get paid within 14 days of dispensing the prescription, and NCPA anticipates it could take 30 days or longer.

“We had hopes that this program would bring benefit to the patients that we serve,” said NCPA CEO B. Douglas Hoey, pharmacist, MBA. “Instead, with how CMS is proposing to run it, it appears pharmacy will be collateral damage — left holding the bag again, just as we were with the launch of Part D. More than 1,100 community pharmacies closed at that time. With the industry in such turmoil today, CMS’ head-in-the-sand approach to how PBMs will reimburse pharmacies for MFP drugs and how slowly manufacturers will refund them will lead pharmacies to close, limit patient access to MFP drugs, and set the program up for colossal failure. We implore the White House and CMS to change course.”

###

Founded in 1898, the National Community Pharmacists Association is the voice for the community pharmacist, representing over 19,400 pharmacies that employ more than 230,000 individuals nationwide. Community pharmacies are rooted in the communities where they are located and are among America’s most accessible health care providers. To learn more, visit www.ncpa.org.

Helene Poses Big Problems for Mail Service in Western NC

Helene Poses Big Problems for Mail Service in Western NC

https://www.theassemblync.com/politics/elections/mail-postal-service-ballots-medicine-hurricane-helene/

From medication to ballots, the U.S. Postal Service is a critical delivery method. Here’s what to know about the state of services following Hurricane Helene.

In the days since Hurricane Helene made landfall in Western North Carolina, about 1.2 million people have lost their postal delivery service, and could see that disrupted for weeks to come.

The U.S. Postal Service announced the suspension of mail delivery operations in the areas with zip codes beginning with 286, 287, 288, and 289, and has not given any updates on when it will resume.

The most obvious barrier is a lack of mailboxes or even homes to deliver to in flood-ravaged parts of the state. The North Carolina Department of Transportation also estimates as many as 390 road closures including parts of Interstate 40.

“Is there an address remaining to which it can be delivered?” said Thomas Birkland, the former director for the Infrastructure Management and Hazard Response program at the National Science Foundation. “Is there a functioning post office available to process the mail, to deliver it? Are there people available to deliver it? And are the roads open so that you can deliver the mail? If any one of those answers is no, then the mail is going to be delayed.”

Birkland said one way researchers measured the impact of Hurricane Katrina in 2005 was by assessing the extent to which mail was deliverable.

“If the house is destroyed, or the business is destroyed, there’s no point to which it can deliver the mail, and so [the postal service would] have to hold on to it,” Birkland said.

Philip Bogenberger, spokesperson for the North Carolina and Virginia districts of the U.S. Postal Service, said in a statement that the agency is working to restore delivery service to western North Carolina.

“The safety of our customers and employees is the Postal Service’s top priority in the aftermath of Hurricane Helene,” Bogenberger wrote. “At this time, we are still assessing damages and impacts. We are dispatching recovery teams to affected areas.”

DEA Issues Warning About Illegal Online Pharmacies

DEA Issues Warning About Illegal Online Pharmacies

https://www.dea.gov/alert/dea-issues-warning-about-illegal-online-pharmacies

October 4, 2024 – The U.S. Drug Enforcement Administration has seen an increase in illegal online pharmacies selling and shipping counterfeit pills made with fentanyl and methamphetamine to unsuspecting customers in the United States who believe they are purchasing real pharmaceutical drugs such as Oxycodone, Adderall, Xanax, and other drugs from legitimate pharmacies. 

As Americans increasingly turn to online pharmacies to purchase necessary medications[1], DEA is issuing this Public Safety Alert to warn of an increase in illegal online, often foreign-based websites that are deceptively targeting American consumers. DEA has identified websites being operated in India and the Dominican Republic. Many of these sites purport to be legitimate, U.S. based or FDA approved sites, but are actually working with drug traffickers to fulfill online orders with fake pills. These website operators are going to great lengths to make the websites look like legitimate online pharmacies – they offer 24-hour customer service, post online reviews and safety facts, and offer deep discounts to deceive customers into believing they were buying from a reputable business.

Often these illegal, online websites use U.S. website addresses and professional-looking designs to appear legitimate when, in fact, they are not. These companies operate illegally, deliberately deceiving American customers into believing they are purchasing safe, regulated medications when they are actually selling fake, counterfeit pills made with fentanyl or methamphetamine.  Fake medications can lead to serious health risks, including harmful side effects, ineffective treatment, and even death. 

During Operation Press Your Luck, announced on Monday, September 30, 2024, DEA discovered that a U.S. based victim had ordered what she believed to be oxycodone from an online pharmacy, only to receive a fake pill made with fentanyl. The pill looked identical to a real oxycodone, but it was not – it was made with fentanyl and filler. Days after receiving the medication, the victim passed away from acute fentanyl poisoning as a result of taking one of the pills sent to her.  

The DEA has identified the following fake pharmacies in a recent criminal investigation: 

  • www.Curecog.com
  • www.Pharmacystoresonline.com
  • www.Careonlinestore.com
  • www.yourphamacy.online 
  • www.MD724.com
  • www.Greenleafdispensarystore.com
  • www.Whatishydrocodone.weebly.com
  • www.Orderpainkillersonline.com
  • www.USAMedstores.com

If you have purchased alleged medication from any of these websites, you should immediately stop using it and contact your local DEA office or report the incident here

The only safe prescription medications are those prescribed by a licensed medical provider and dispensed by a trusted pharmacy. 

Patients should remain vigilant when purchasing medications online. 

DEA remains committed to the safety and health of the American people, which is why we are urging consumers to exercise extreme caution when purchasing medications online. While it can be difficult to identify an illegal online pharmacy, the following are possible red flags that a website is not a legitimate:  

  • Sells prescription drugs without requiring a valid prescription from a healthcare provider
  • Offers much cheaper prices than what is typically seen in the market
  • Lists prices in a foreign currency
  • Does not contain proof of a valid pharmacy state license or DEA registration 
  • Medicine arrives in broken or damaged packaging or in a foreign language
  • Medicine does not have an expiration date or is expired 
  • Medicine looks different from what you have received in the past from your trusted pharmacist

For more information on how to keep you and your loved ones safe from illegal and fake pills, visit DEA’s One Pill Can Kill resource page. Visit the U.S. Food and Drug Administration’s BeSafeRx campaign page for information on how to safely buy prescription medicines online and to locate a state-licensed online pharmacy. You can also contact your state board of pharmacy to verify a pharmacy’s license. 

DEA is committed to working jointly with the medical community to ensure legitimate controlled substances are not being diverted for illegal use. Learn more about DEA’s Diversion Control Division here

How opioid prescriptions are tracked and monitored by law enforcement and health care providers

How opioid prescriptions are tracked and monitored by law enforcement and health care providers

https://whyy.org/segments/how-opioid-prescriptions-are-tracked-and-monitored-by-law-enforcement-and-health-care-providers/

Medical sociologist Liz Chiarello discusses the effects of prescription drug monitoring programs on both patients and physicians.

Associate Professor of Sociology at Saint Louis University, Liz Chiarello, argues that new drug surveillance programs called Prescription Drug Monitoring Programs (PDMPs) blur the lines between law enforcement and health care. 

In her recently published book, “Policing Patients: Treatment and Surveillance on the Frontlines of the Opioid Crisis,” Chiarello discusses instances of patients being denied care and doctors being prosecuted for overprescribing pain medications. 

PDMPs were put in place as one solution in response to the growing number of opioid-related deaths in the United States. 

A PDMP is a database that tracks prescriptions of controlled substances, like morphine or oxycodone. These programs were made to document and flag doctors who overprescribe opioids to patients and identify patients who visit several doctors to obtain new prescriptions. Law enforcement agents, prosecutors, physicians, and pharmacists all have access to this database and medical information. This brings up questions about privacy, says Chiarello, and whether or not access to this information goes against the privacy rights of the individual or the patient. 

[The PDMP], “undermines the way that we usually think that medicine should work and the privacy protections that are associated with our health data,” says Chiarello.   

PDMPs do not only affect patients. They flag physicians too. 

“If doctors violate the stipulations under which they’re allowed to provide these controlled medications, then they’re extremely vulnerable because you go from being a doctor in the eyes of the law to being a drug dealer in the eyes of the law,” Chiarello says.  

Physicians can face arrest, prosecution, and even jail time if law enforcement notices a pattern of overprescribing opioids to their patients. 

So, what happens when a patient with suspicious opioid-use history goes to the pharmacy to request a new prescription? 

Chiarello says a pharmacist might say, “Well, I looked you up in the database and the database shows me that you just went to two different doctors in the last month. And so, this is too soon for me to dispense this to you.” 

Chiarello says this direct communication from the pharmacist, “says to the patient, I’m looking at you. And I have data about what you’ve been doing when you’re not at my pharmacy. But then it also tells them, you’re not really welcome back here. Like, don’t come back to me because I’m surveilling you.” 

The goal of these programs is to deter people from overusing opioids, and therefore lessen the impact of the opioid crisis. However, people who use opioids, larger amounts that might be flagged by a PDMP, are not all opioid abusers. For example, there are patients with chronic pain who have been living with a certain prescription that allows them to function normally in their daily lives. Without it, they would be living in constant pain. 

Chiarello dives deeper into the topic of PDMPs and how these programs impact patients with chronic pain and the future of drug prescription regulation in a conversation with Maiken Scott, host of The Pulse.

Interview Highlights: 

Doctors’ response to PDMPs

Doctors have had to figure out how to rework their practice to navigate a shifting legal territory. And so what a lot of doctors have done is they just refused to provide opioids. And they feel like that protects them, but it doesn’t necessarily protect their patients. So this is a space where the ethics of medicine and the care for the patient bump up against the fear of law enforcement.

… [Doctors] have patients sign pain contracts, which are these legalistic documents that say things like, I am your only doctor, you’re only going to see me, you are only going to go to this one pharmacy. I’m going to test your urine when I want to. You’re not going to go to the hospital asking for opioids, and if you do any of those things, if you violate the stipulations of our contract, you are no longer my patient. I will cut you off.

What happens to patients who rely on opioid prescriptions to get through the day just because their chronic pain is so terrible?

It’s really devastating what’s happened to those patients. The biggest driver is the CDC guidelines on using opioids to treat pain that came out in 2016 … and they make a lot of suggestions about what dosage patients should be on, when to initiate a dose. And it’s really supposed to be for people who are newly on opioids. But by the time those came out, there were people who had been on opioids for 20 years, who were in chronic pain, who are on very high doses of opioids. And there was a lot of pressure to taper those people down. The measurement is … called a morphine milligram equivalent, an MME. And the CDC guidelines say that people should be under 90. And a lot of people are on 300 or 350. And so a lot of doctors are concerned that that creates a red flag for them to law enforcement. And so they then try to cut those patients down often very quickly and without consent. So you have patients who had been well managed on opioids, who suddenly are not well managed. And, they’re thrust into pain. And then they can’t find another doctor who’s willing to prescribe for them. And so those patients, those patients are really suffering.

Could you see the PDMPs being used in any other way? Could you see their use being expanded?

I have made the argument that the PDMP is a law enforcement surveillance tool. And that, even if it’s in health care, it retains the vestiges of being a law enforcement surveillance tool … And so, we have to rethink whether we think prescription data is private data, or if we think it’s something else, the way that it’s being treated right now. 

But you also asked if I can see it expanding, and you know the saying… matter can be neither created nor destroyed. Well, technology is so easily created and very difficult to destroy. Because once you’ve created the technology, suddenly you realize there are all kinds of different uses for the technology. And so, one of the things that has changed with PDMPs is in a couple of states, they’ve started to put drug arrest data in the PDMP. So, they’re actually combining law enforcement data with health care data in the same system. 

But we can also certainly imagine a lot of other drugs being policed. I’m thinking about drugs used for reproductive health. I’m thinking about drugs used for gender affirming care. Once you have this kind of system, it’s very easy to add other drugs and to track other kinds of drugs. And so, I think they’ve only just barely dipped their toes into what kinds of medications they’re going to surveil.

More Deception from Express Scripts!

More Deception from Express Scripts!

https://pharmacistactivist.com/2024/September_2024.shtml

The lead commentary in the August issue of The Pharmacist Activist was, “Express Scripts Attempts to Change its Identity,” that responds to its full-page advertisement in major newspapers. The PBM has followed that with another full-page ad that continues the deception and lies, but provides no transparency regarding its operations, rebates from pharmaceutical companies, steering patients to its own pharmacies, and other “facts” which they accuse its critics of ignoring. The new ad begins with the following pronouncement in large type.

WE FIGHT FOR YOUR HELP EVERY DAY.
TODAY, THAT MEANS FIGHTING THE FTC.

The text of the ad notes:

“We feel we have no choice but to sue the Federal Trade Commission. This was an extremely difficult decision to make so we want to make ourselves unequivocally clear as to why.”

(Editor’s comment: This may be the first time that Express Scripts has attempted to be “unequivocally clear,” but it is just another charade).

“But their report about the Pharmacy Benefit Manager industry published on July 9, 2024, leads us, as well as an FTC Commissioner, to believe that the agency is not acting in the public interest. That is why we are calling on the FTC to retract the report.”

(Editor’s comment: A majority of the FTC Commissioners approved the report but Express Scripts prefers that the public knows the opinion of the one Commissioner who dissented).

“We’re advocates for affordability, not misinformation.”

(Editor’s comment: The large increase in drug prices during Express Scripts’ “watch” contradicts any claims of success in achieving affordability).

“…programs we’ve developed result in up to 27% higher medication adherence and 23% fewer inpatient hospitalizations. The FTC’s report fails to acknowledge any of these findings.”

(Editor’s comment: Express Scripts can provide very specific data when it considers it to be in its own interest to do so. There are some references provided in very small type at the bottom of the advertisement. The two references provided as the source of the two statistics noted are attributed to Evernorth, the parent company of Express Scripts. There is no reason to think that this self-generated report is any more credible than the other claims made by Express Scripts).

“Reports outlining how PBMs pass nearly 100% of rebates and fees to employers, labor unions, government agencies, and health plans.”

(Editor’s comment: The most revealing word in this statement is “nearly.” Express Scripts is able to identify the specific percentage of rebates but refuses to do so. Does 90% qualify as “nearly?” 75%? 51%? The claims processed by the three major PBMs have a cost of billions of dollars. Even if they retain only a small percentage of the fees and rebates, the amount is huge. The rebate game is a self-enrichment contest that creates an incentive for higher drug prices and benefits only the PBMs and pharmaceutical companies. Everyone else loses – it is fraudulent and must be terminated).

“We’re advocates for facts, not conjecture.”

“We’re advocates for objectivity, not bias.”

“We’re advocates for due process, not convenient timing. Billions of data points were provided by the PBMs to the FTC in response to their demands.”

(Editor’s comment: “Billions of data points” suggest that the PBMs were responsive to the FTC’s request for information. However, the FTC was delayed and frustrated in addressing concerns about PBMs because they did not respond in providing requested information on a timely basis and most likely are still withholding information needed for a complete analysis of its operations and monopolistic practices. The allegation by Express Scripts that the FTC used “convenient timing” in issuing its report is disingenuous. The FTC had announced its plan to sue Express Scripts and other PBMs. It is actually Express Scripts that is exercising “convenient timing” by suing the FTC as a preemptive action before the FTC filed its lawsuit. Express Scripts is taking a page out of Walmart’s playbook when, several years ago in anticipation of a lawsuit by the federal government for its role in opioid overdosage deaths, Walmart sued the federal government. Walmart’s lawsuit was dismissed and the one filed by Express Scripts should also be dismissed).

“We’re advocates for people. We’re advocates for health.”

“Pharmaceutical companies set and raise drug prices. PBMs lower them.”

(Editor’s comment: PBMs receive larger rebates for the most expensive drugs. More expensive drugs are often placed in the more favorable tiers of their formularies, even when less expensive alternatives are available. Patients, employers, and taxpayers pay more. Pharmacists are also victims of the greed, fraud, and policies of the PBMs, and many pharmacies have closed because they can’t survive financially).

The Express Scripts suit against the FTC seeks to have the agency retract its report that is critical of the PBMs… To challenge the statements in the FTC report, Express Scripts primarily relies on the “research” of an economist who essentially concludes that the FTC’s claims about the PBMs “are not supported by the data.” The economist’s conclusions are strongly refuted in a comprehensive analysis by 46Brooklyn Research in its detailed report of September 20, “Express Scripts, Inc. vs. The Federal Trade Commission.” The CEO of 46Brooklyn Research is Antonio Ciaccia whose investigations exposed the PBM fraud in Ohio several years ago.

The FTC lawsuit

On September 20 the FTC sued the three largest PBMs. The title and subtitle of the FTC press release are noted below:

“FTC Sues Prescription Drug Middlemen for Artificially Inflating Insulin Drug Prices”

“Caremark, Express Scripts, Optum, and their affiliates created a broken rebate system that inflated insulin drug prices, boosting PBM profits at the expense of vulnerable patients, the FTC alleges.”

The FTC press release includes the following allegations:

“CVS Health’s Caremark, Cigna’s ESI (Express Scripts), and United Health Group’s Optum, and their respective GPOs (group purchasing organizations)…have abused their economic power by rigging pharmaceutical supply chain competition in their favor, forcing patients to pay more for life-saving medication.”

“The three PBMs created a perverse drug rebate system that prioritizes high rebates from drug manufacturers, leading to artificially inflated insulin list prices…even when lower list price insulins became available that could have been more affordable for vulnerable patients, the PBMs systemically excluded them in favor of high list price, highly rebated insulin products.”

Rahul Rao, the Deputy Director of the FTC’s Bureau of Competition, notes: “Caremark, ESI, and Optum–as medication gatekeepers–have extracted millions of dollars off the backs of patients who need life-saving medications. The FTC’s administrative action seeks to put an end to the Big Three’s exploitative conduct and marks an important step in fixing a broken system…”

“…the PBMs are not the only potentially culpable actors–the Bureau also remains deeply troubled by the roles that drug manufacturers like Eli Lilly, Novo Nordisk, and Sanofi play in driving up list prices of life-saving medications like insulin. Indeed all drug manufacturers should be on notice that their participation in the type of conduct challenged here raises serious concerns, and that the Bureau of Competition may recommend suing drug manufacturers in any future enforcement action.”

“The PBMs financial incentives are tied to a drug’s list price, also known as the wholesale acquisition cost. PBMs generate a portion of their revenue through drug rebates and fees, which are based on a percentage of a drug’s list price. PBMs, through their GPOs, negotiate rebate and fee rates with drug manufacturers. Products with higher list prices generate higher rebates and fees for the PBMs and GPOs, even though the PBMs and GPOs do not provide drug manufacturers with any additional services in exchange.”

“The complaint alleges that PBMs keep hundreds of millions of dollars in rebates and fees each year and use rebates to attract clients. PBMs’ clients are payers such as employers, labor unions, and health insurers.”

For many years, pharmacists have been victimized by the deception and fraud of the PBMs, and have been very frustrated in not having our important concerns understood and/or effectively addressed by regulators, legislators, and federal agencies. Although there is much still to be accomplished, it is very encouraging that the FTC has investigated and understands the problems, and has taken action to sue the PBMs. The leaders and membership of the National Community Pharmacists Association (NCPA) are to be highly commended for providing numerous specific examples and other information that have exposed the egregious policies and terms of the PBM programs. The American Pharmacists Association (APhA) has also been very active in this regard, and both of the organizations, as well as others, are strongly supporting proposed federal legislation with bipartisan support to accomplish PBM reform. The time to accomplish this is short. Every pharmacist should contact their Senator and Representative to ask them (if it is not already known) if they are supporting the legislative proposals and urge them to support them. The specific legislative proposals are:

S. 2973/H.R. 5378: the Modernizing and Ensuring PBM Accountability (MEPA) Act;

S. 127: the Pharmacy Benefit Manager Transparency Act;

S. 3430: Better Mental Health Care, Lower-Cost Drugs, and Extenders Act.

Others have also exposed the deceptive actions of the PBMs. Matt Stoller is the Director of Research at the American Economic Liberties Projects, and an expert on monopolies. He is the author of the book Goliath: The Hundred Year War Between Monopoly Power and Democracy, and also writes the Substack publication BIG. His commentary on September 23, “Monopoly Round-Up: Lina Khan, Pharma Middlemen and ‘Tasty Rebates,'” provides excellent coverage of the FTC suit. Using Lantus as an example, he notes that its list price in 2019 was $403 for a one-month supply. During 2019, its manufacturer (Sanofi) was giving OptumRx 80% of the list price to be the preferred insulin for its patients. “That’s just $64 going to Sanofi for the drug, and $339 going to OptumRx as a kickback.” In describing how PBMs work, he states:

“They aren’t just middlemen, they are allocators of what really looks perilously close to organized crime loot to a series of conspirators, from pharmaceutical firms to insurers to benefit consultants to large employers.”

Wall Street Journal editorial

The lead editorial in the September 26 issue of The Wall Street Journal is titled, “Higher Health Premiums for All,” and the subtitle is “Lina Khan piles on the anti-PBM bandwagon, to ill effect for consumers.” I responded with the following letter to the editor:

“I usually agree with and learn from the WSJ’s editorial opinions. However, the apparent obsession with criticizing Lina Khan results in undeserved support for pharmacy benefit managers (PBMs). The PBMs wield more power and control in the selection, distribution, use, and cost of medications than prescribers, pharmacists, and even the pharmaceutical companies. Ironically, the cyclical blame game between the PBMs and Pharma enriches both groups (i.e., list prices and rebates/fees both increase). The policies of the PBMs are economically motivated and override the decisions of prescribers and pharmacists who provide the services and care for individual patients. Patients/consumers are the greatest victims when the decisions regarding medications made by their healthcare providers are challenged, changed, and/or delayed by the PBMs. I and many other health professionals are of the opinion that the PBMs have had a highly destructive impact on the scope and quality of health care, and the attainment of personalized, effective, and safe drug therapy. In many situations, the non-negotiable amount that the PBMs pay pharmacists for the medications they dispense is considerably less than the cost pharmacists pay for the medication. Many pharmacist-owned independent pharmacies have not been able to survive financially and have closed, creating a much larger number of “pharmacy deserts,” resulting in greater inconvenience and delays for patients in obtaining prescribed medications.

The FTC is on target in challenging the PBMs. If it is to be faulted at all, its action should be applicable to all prescription medications and not just insulins.”

It is unlikely that my letter will be published, but I couldn’t be silent after reading it. If any readers can use any or all of the content of this letter in your communications with the media, legislators, or others, please feel free to do so in your own message. It is not necessary to identify me as the source.

Doctors Cut Back on Seeing Medicare Patients as Another Pay Cut Looms

Doctors Cut Back on Seeing Medicare Patients as Another Pay Cut Looms

Which – how many politicians – are saying that we all need a single healthcare insurance system? Thru the end of Aug, 2024 we have had abt 30 pharmacies closing their doors – for good – every day. 

https://www.pharmaciststeve.com/2275-pharmacies-have-closed-so-far-in-2024/  So the PBMs are running community pharmacies out of  business and Congress is cutting what practitioners in private practice are getting reimbursed for their services.  Here is a video how  Medicare -C insurance companies are “cooking the books” https://www.pharmaciststeve.com/payvider-health-insurance-payer-and-healthcare-provider-combination-explained/ and being able to almost triple the net profit that they are able to produce while contractually committed to spend 85% of premiums they collect on pt care. Insurance companies are pulling their Medicare-C out of certain market and large healthcare system are refusing to sign on with some particular Medicare-C insurance companies. Medicare Advantage insurers ranked by prior auth denial overturn rates

Those still seeing Medicare patients struggle to stay in private practice

https://www.medpagetoday.com/practicemanagement/reimbursement/112273

Will his independent practice be able to survive another Medicare payment cut? That’s what Terre Haute, Indiana internist Pardeep Kumar, MD, wonders each day as the next round of cuts looms.

“We have to see,” Kumar said in a phone interview. “We have around 40% of the population of patients that are on Medicare … Our overall ability to sustain as a private practitioner is significantly under distress because of these cuts.”

Can We Stay in Business?

Kumar and his wife, who is also an internist, are in private practice together and each has taken on outside work at various points in order to keep the practice viable, he said. “I used to be the director of a hospice company outside the practice, and I also [work at] another hospital for geriatric psychiatric patients. I go and see them so that we have additional revenue to sustain our practice.”

CMS is proposing a 2.8% cut in the Medicare fee schedule for the 2025 fiscal year, which would, if approved by Congress, come on top of a 1.69% cut in 2024. Often, Congress reverses the cuts, although this year they did so only partially. The cut is currently in limbo — along with the rest of the federal budget — now that Congress has passed a short-term budget deal keeping the government funded at current levels through mid-December, after the election.

Doctors’ groups such as the American Medical Association, to which Kumar belongs, argue that instead of cutting doctor pay, CMS should adopt an inflation-adjusted reimbursement model. “When the cost of living goes up, there should be some [similar] adjustment in the physician reimbursement model,” Kumar said. “That will provide sustainability, especially for the private practice.”

Helping private practices stay in business, rather than forcing doctors to close their private practices and work for hospital systems, “will actually eventually lower the cost of care … because reimbursement in private practice is relatively lower than hospital-based [reimbursement] so there’s a cost saving for health insurers,” including Medicare, said Kumar.

Although there is some movement in Congress toward site-neutral payment, in which hospitals would get the same pay as private practices for providing the same outpatient services, “hospitals are fighting that, because they are saying that they are employing more and more physicians now … They’re getting site benefit from that, and they’re able to pay the physicians to keep them employed,” he said. “I also sit on the hospital board here, and they are saying their margins are very shrunken and they will not be able to sustain or at least employ as many physicians if they [institute site-neutral payment].”

Primary Care Shortage Persists

Donaldo Hernandez, MD, a hospitalist in Santa Cruz, California, has seen first-hand how continued Medicare payment cuts are keeping patients from getting care. “Central and northern California can be somewhat expensive places to conduct healthcare business for a number of reasons,” Hernandez said during a telephone interview at which a press person was present. “Even prior to the pandemic … it was really the commercial marketplace that allowed medical practices that have enough money to invest in staff and all the other things that they do to maintain themselves.”

“As we emerged from the pandemic, with the inflationary pressures exerted by the pandemic and the ongoing issues with hiring staff and sundry other things that occurred — such as increases in the cost of electricity, for example, from Pacific Gas & Electric — those pressures really were exerted on medical practices to a much greater extent,” said Hernandez, who is immediate past president of the California Medical Association.

Doctors “really want to see this Medicare population, and yet the economics really forces physicians into sort of a Sophie’s Choice between, ‘Do I see these patients because I want to, and I know they have a need, or do I save my practice from financial uncertainty and the challenges that exist in me being able to hire MAs [medical assistants], back office people and [deal with] all the administrative burdens that are inserted on all medical practices?'” he said.

Hernandez recalled a recent patient he had seen at his hospital for a severe hypoglycemic episode; the patient — who had recently moved to California from Oklahoma to care for her ailing father-in-law — had been in 2 weeks before for a myocardial infarction. “That was treated, managed, and she was placed on some new medications in order to manage that particular medical problem, and was told to follow up with her doctor,” he said. “Well, it turns out she really didn’t have a community doctor that was managing her problems. There was nobody managing those [medication] alterations in an effective way in the outpatient setting … As a consequence, she took her diabetes medications erroneously, and ended up having low blood sugar.”

“The challenge for me was that day and the following day was to try to find her someplace that she could get follow-up,” said Hernandez. “I had two social workers working on it for 48 hours to try to find her a medical home, including within our safety net system, who at this time isn’t taking you Medicare patients because they’re at capacity.” He finally called in a favor with a doctor he knew personally, and was able to get the patient into that practice.

“That’s what we’re seeing throughout the state, is physician practices are just not able to take these new patients on,” he added. “With every subsequent cut or pullback … It continues to be, in my opinion, an ongoing risk factor for these patients moving forward.”

A Personal Effect of the Shortage

For Rene Bravo, MD, a 65-year-old pediatrician in San Luis Obispo, CA, the cumulative effect of the previous Medicare cuts hit him very personally. He had had private health insurance for himself and had gotten care without a problem, “and I finally went on Medicare and tried to find a physician,” Bravo said in a phone interview. “I couldn’t find one — they were all either full up or not available … I finally found an internist who took Medicare, but I had to pull some strings.”

“If I have trouble finding a physician, what’s going on for other folks in the population?” he said. “The fact that these reimbursement cuts are coming — everybody is aware of these things, and it just creates a profound amount of insecurity in the system.”

“This has got to be fixed once and for all,” Bravo said. “The Medicare payment system needs to be significantly revamped because this is creating a lot of stress on healthcare provision for seniors. There’s nothing about this that is right.”