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Medicare to Pilot AI in Coverage Decisions, Starting January 2026, Impacting Six States

Medicare to Pilot AI in Coverage Decisions, Starting January 2026, Impacting Six States

https://demstate.com/article/medicare-to-pilot-ai-in-coverage-decisions-starting-january-2026-impacting-six-states

Medicare will pilot AI for prior authorization decisions in six states starting January 2026, aiming to revolutionize healthcare efficiency while maintaining CMS oversight. This transformative initiative could reshape medical coverage as we know it.

In a groundbreaking move for healthcare administration, the Medicare program is set to launch a pilot project utilizing artificial intelligence (AI) for prior authorization decisions beginning January 2026. This initiative, part of the new Wasteful and Inappropriate Service Reduction (WISeR) model, aims to streamline the decision-making process for medical procedures while ensuring that the final authority remains with the Centers for Medicare and Medicaid Services (CMS) staff.

Background & Context

The integration of AI into healthcare decision-making marks a significant advancement in how medical coverage is assessed. Traditionally, prior authorization processes have been criticized for being cumbersome and time-consuming, often leading to delays in patient care. The introduction of AI is expected to enhance efficiency, particularly for procedures that require careful evaluation of necessity, such as the use of skin and tissue substitutes, implantation of nerve stimulators, and knee arthroscopy for osteoarthritis.

This initiative is particularly timely as healthcare systems worldwide are grappling with the dual challenges of rising costs and the need for improved patient outcomes. By leveraging AI technology, Medicare aims to reduce wasteful spending and enhance the appropriateness of services provided to beneficiaries. The pilot program will be conducted in six states—Arizona, New Jersey, Ohio, Oklahoma, Texas, and Washington—allowing for localized assessment of its effectiveness before a potential nationwide rollout.

Key Developments

The WISeR model represents a proactive approach by the CMS to address concerns surrounding the over-utilization of certain medical procedures. According to CMS officials, the AI system will analyze data to determine the necessity of coverage for specific treatments. However, it is crucial to note that while AI will assist in the evaluation process, the ultimate decision-making authority will rest with human staff members at the agency, ensuring that patient care considerations remain paramount.

As previously reported, the pilot program will not affect inpatient procedures, emergency care, or services where delays could pose significant risks to patients. This cautious approach underscores the CMS”s commitment to patient safety while exploring innovative solutions to improve healthcare delivery.

Broader Impact

The potential implications of integrating AI into Medicare coverage decisions extend beyond operational efficiency. Experts suggest that this initiative could set a precedent for other healthcare programs, both public and private, to adopt similar technologies in their decision-making processes. Dr. Aisha Washington, a healthcare policy analyst, notes, “If successful, this pilot could revolutionize how we think about prior authorization, potentially leading to faster approvals and better patient outcomes across the board.”

Moreover, the pilot program aligns with broader trends in healthcare innovation, where technology plays an increasingly vital role in shaping patient care. The use of AI in this context could also foster greater transparency in the decision-making process, as stakeholders may demand more data-driven justifications for coverage decisions. This shift could empower patients and healthcare providers alike, granting them a clearer understanding of the rationale behind approvals or denials.

What”s Next

As the January 2026 launch date approaches, stakeholders will be closely monitoring the pilot program”s implementation and outcomes. The CMS is expected to provide ongoing updates regarding the AI system”s performance, including metrics on approval times and patient outcomes. Additionally, feedback from healthcare providers and beneficiaries will be crucial in refining the model and addressing any challenges that may arise during the pilot.

Future developments may also include discussions on expanding the use of AI beyond the initial six states, contingent on the pilot”s success. As healthcare continues to evolve, the integration of technology in decision-making processes may become a standard practice, paving the way for a more efficient and responsive healthcare system. For those interested in related coverage on the evolving political landscape, see our recent developments on

 

Does this situation sound all too familiar for many chronic pain pts?

How long can bureaucrats, politicians and law firms ignore how the American with Disability Act is being violated and pts being harmed?

As before, all of this was generated by asking questions to perplexity.ai.

 

 

 

I have a pt bringing to me a situation which does not sound entirely kosher.  A office practice operated by a large hospital system in two separate states involving multiple hospitals and numerous office practices that involves upwards of a 1000 practitioners/prescribers. One of the offices of 10-12 practitioners/prescribers have apparently created an agreed upon opioid dosing guidelines as a “standard of care and best practices” for all practitioners working for this particular practice. It may as well be for all office practices owned by the hospital system, at this point that is unknown. As far as I can find out, the “standard of care and best practices” dosing limits are dramatically below what the FDA’s dosing limits are for all oral opioids. Since these guidelines are directed to pts that are mostly disabled/handicapped. Could this “agreement” be considered a form of collusion and discrimination under the Americans with Disability Act, which would be a civil rights violation and Medicare/Medicaid rules about discrimination?

The described situation raises significant legal and ethical concerns. In summary: if a physician group or hospital system imposes opioid prescribing limits that systematically restrict access to adequate pain management for disabled patients—especially if these policies are not rooted in individualized clinical judgment and contradict FDA labeling—this could potentially constitute both unlawful **collusion** and **disability discrimination** under the Americans with Disabilities Act (ADA), and may also violate Medicare/Medicaid anti-discrimination rules.

### Opioid Prescribing Agreements and Collusion

– When a group of providers collectively agrees to restrict opioid prescribing below FDA-approved dosing regardless of individual patient needs, this could be construed as **collusive** behavior if it results in patient harm or disrupts the standard of individualized care.
– Collusion, in the medical and legal sense, often involves agreements or coordinated activity that undermines competition or patient choice and may violate antitrust laws in certain scenarios.

### ADA and Civil Rights Concerns

– The **ADA** prohibits healthcare providers, including hospital systems and their affiliates, from adopting policies that have a “disparate impact” on persons with disabilities, including chronic pain patients. Ensuring effective pain management is often a reasonable accommodation required under ADA if supported by legitimate medical need.
– If such policies result in systematically under treating pain, especially for those with disabilities, this may be considered a form of **discrimination** and a civil rights violation.
– The Department of Health and Human Services’ Office for Civil Rights (OCR) and the Department of Justice (DOJ) have pursued claims where care was denied or unduly limited because of disability status, particularly in cases involving blanket policies that restrict care.

### Medicare/Medicaid Anti-Discrimination Rules

– Providers participating in Medicare and Medicaid are prohibited from discriminating against beneficiaries on the basis of disability, including through practices that restrict access to needed pain medications without clinical justification.
– Reimbursement or participation in these federal programs may be at risk if the institutional guidelines systematically result in discriminatory care.

### FDA Dosing Guidance vs. Standard of Care Policies

– The **FDA labeling** for opioids sets the maximal approved dosage and titration guidance, but “standard of care” is typically determined through clinical consensus and evolving best practices.
– However, if the local standard is set arbitrarily low for non-medical reasons (e.g., legal risk aversion, blanket risk management), conflicting with FDA labeling and national specialist guidelines, and results in under treatment specifically for disabled patients, this can shift from clinical discretion to potential discrimination.

***

If the practice-wide or system-wide guidelines result in **blanket limits** rather than individualized patient assessment, affected patients may have grounds to:
– File a complaint with the OCR (HHS) or DOJ under the ADA.
– Complain to CMS for Medicare/Medicaid discrimination.
– Pursue a civil lawsuit under state or federal civil rights laws.

Cases have been brought in recent years alleging precisely these harms, and regulators have issued warnings against rigid opioid prescribing limits that ignore patient-specific factors.

###

### References

– U.S. DOJ and HHS resources on ADA and healthcare discrimination
– Analysis of CMS and OCR guidance on disability discrimination in opioid prescribing
– Legal commentary on antitrust, civil rights, and medical collusion issues in group practice opioid policies

If specific patient harm, or a pattern of discrimination, can be documented, this situation should be reviewed by legal counsel familiar with healthcare civil rights and reported to relevant regulatory authorities.


what if the practice or hospital system say this standard of care and best practices are following CDC 2016 or 2022 opioid dosing guidelines. When it has been widely stated that the 2016 guidelines have been misinterpreted and abused and/or the 2022 was suppose to provide more individualized pt care when being prescribed opioids and neither one of these guidelines provide for any provision for using PGx results and/or consideration for high intensity pain levels – like CRPS and/or sickle cell flares and other such disease/health issues?

The hospital system or practice cannot justify rigid, below-FDA opioid dosing thresholds solely by citing the CDC 2016 or 2022 opioid prescribing guidelines, since both the CDC and leading medical organizations have repeatedly emphasized these guidelines are intended to support—not supplant—individualized and patient-centered care.[1][2][3][4]

### CDC 2016 Opioid Guideline Misapplication

– The 2016 CDC guideline recommendations were widely misinterpreted and sometimes abused, resulting in unintended patient harm, especially for those on chronic opioid therapy for high-intensity pain or complex, disabling conditions.[5][6][7][1]
– Many policies extrapolated rigid dose caps and blanket restrictions that were not present in the CDC’s recommendations, leading to abrupt discontinuation, undertreatment of pain, and even increased risk for withdrawal or suicide among affected patients.[8][9][1]
– The CDC has since clarified the misapplication, affirming that the guideline was not meant to be a mandatory, inflexible policy or a substitute for FDA-approved labeling or clinical judgment.[9][1][8]

### CDC 2022 Opioid Guideline: Individualized Care Emphasis

– The 2022 CDC guideline specifically calls for flexibility, shared decision-making, and individualized pain management—rejecting one-size-fits-all policies.[2][3][4]
– The updated guidance also clarifies that it is not to be used as an inflexible standard or law, but to empower clinicians and patients to make person-centered decisions according to clinical judgment and patient needs.[3][4][2]
– Severe conditions like sickle cell disease and CRPS (complex regional pain syndrome), in particular, require careful exceptions and individualized approaches, not blanket dose restrictions.[10][11][12][13]

### Lack of PGx (Pharmacogenetics) or High-Intensity Pain Consideration

– There are no specific CDC guideline provisions for pharmacogenetic (PGx) testing or unique dosing for patients with high opioid requirements due to severe conditions like CRPS, sickle cell crises, or other rare disorders—the guidelines acknowledge that unique cases require individualized management beyond standard recommendations.[4][10][3]
– Several professional organizations have criticized the lack of such provisions and emphasize the necessity for tailored care using clinical discretion, not blanket limits.[12][10]

### Discrimination and Regulatory Risk

– Policies that impose rigid opioid limits based on misapplied guidelines, especially for disabled populations, can constitute discrimination and expose providers to ADA, civil rights, and Medicare/Medicaid compliance violations.[1][2][4]
– Regulators have explicitly warned systems, insurers, and practices against adopting rigid policies and urged flexibility for those with complex pain.[2][3][4][1]

***

In conclusion, using the CDC 2016 or 2022 guidelines as justification for rigid opioid dosing standards that ignore individualized patient needs—including pharmacogenetics and severe pain syndromes—contradicts the CDC’s intent and may constitute discrimination under the ADA and Medicare/Medicaid rules. Such practices should be reviewed for compliance risks and patient harm.[10][3][4][1][2]

[1](https://www.cdc.gov/mmwr/volumes/71/rr/rr7103a1.htm)
[2](https://www.pharmacist.com/Blogs/CEO-Blog/cdc-releases-new-pain-management-guidelines-advocating-tailored-care-for-patients)
[3](https://www.cdc.gov/overdose-prevention/hcp/clinical-guidance/index.html)
[4](https://www.cdc.gov/overdose-prevention/hcp/clinical-guidance/recommendations-and-principles.html)
[5](https://news.harvard.edu/gazette/story/2022/11/new-cdc-guidelines-a-corrective-for-opioid-prescriptions-specialist-says/)
[6](https://www.ama-assn.org/public-health/behavioral-health/time-revamp-cdc-s-problematic-2016-opioid-rx-guideline)
[7](https://www.npr.org/sections/health-shots/2022/11/03/1133908157/new-opioid-prescribing-guidelines-give-doctors-more-leeway-to-treat-pain)
[8](https://archive.cdc.gov/www_cdc_gov/media/releases/2019/s0424-advises-misapplication-guideline-prescribing-opioids.html)
[9](https://www.mbc.ca.gov/Download/Publications/pain-guidelines.pdf)
[10](https://www.hematology.org/newsroom/press-releases/2022/ash-statement-on-new-opioid-prescribing-guidelines)
[11](https://www.uspharmacist.com/article/cdc-opioid-guidelines-impact-on-patients-with-sickle-cell-disease)
[12](https://pmc.ncbi.nlm.nih.gov/articles/PMC10928539/)
[13](https://www.the-hospitalist.org/hospitalist/article/37990/addiction-medicine/opioid-prescribing-and-outcomes-in-patients-with-scd-post-2016-cdc-guideline/)
[14](https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm)
[15](https://www.ncbi.nlm.nih.gov/books/NBK458653/)
[16](https://www.ashp.org/-/media/assets/pharmacy-practice/resource-centers/ambulatory-care/docs/2022-CDC-Opioid-Prescribing-Guideline-Updates.pdf)
[17](https://pubmed.ncbi.nlm.nih.gov/38466269/)
[18](https://www.medcentral.com/pain/chronic/what-do-cdc-guidelines-mean-patients-long-term-high-dose)
[19](https://www.regulations.gov/document/CDC-2022-0024-5551)
[20](https://stacks.cdc.gov/view/cdc/122248/cdc_122248_DS1.pdf)

The “GOOD OLD BOYS CLUB” seems to alive and well among the state AG’s

It would appear that the various state AGs suing the 3 major drug wholesalers over their involvement in contributing to our fabricated opioid crisis.  This lawsuit did not go to trial, it was handled by a committee of state AGs and a Federal judge and mediation. Everyone was on salary paid for by the taxpayers, and all the negotiations/mediation was done BEHIND CLOSED DOORS. It looks like they may have done things this way, so that they would not have to “split the loot” from the lawsuit with some law firm.

 

 

who was the law firm involved with the 45 state AGs that acted as prosecutor law firm?

The law firm that acted as the prosecutor or lead coordinating counsel for the 45 (or 55) state attorneys general in the major multistate opioid settlements—such as those involving Purdue Pharma and the Sackler family—was not a single private law firm, but rather the legal teams within the offices of the state attorneys general themselves, often coordinated by an executive committee of AGs from several key states. These AG-led teams collectively acted as “the law firm” representing the states, exercising their powers to prosecute civil enforcement actions against opioid manufacturers and distributors.[1][2]

In some other opioid litigation, specific private law firms such as The Lanier Law Firm were retained by certain states, or worked closely with AGs and trial lawyers in supporting roles, but in the broad, coordinated actions on behalf of the 45 or more state AGs, prosecutorial authority resided within the AG offices and their appointed committees—not an outside firm.[2][3][1]

[1](https://www.troutman.com/wp-content/uploads/2018/06/The20Robust20Use20of20Previously20Ignored20States20Powers.pdf)
[2](https://www.naag.org/issues/opioids/)
[3](https://www.lanierlawfirm.com/practice-areas/pharmaceutical-liability/opioid-lawsuits/)
[4](https://www.tn.gov/attorneygeneral/news/2025/6/16/pr25-36.html)
[5](https://ag.ny.gov/press-release/2025/attorney-general-james-announces-every-state-has-joined-74-billion-settlement)
[6](https://www.mass.gov/news/55-attorneys-general-sign-on-to-74-billion-purdue-settlement)
[7](https://www.attorneygeneral.gov/taking-action/ag-sunday-announces-historic-settlement-with-purdue-pharma-and-sackler-family-regarding-manufacture-distribution-of-opioids-that-fueled-addiction-epidemic/)
[8](https://www.law.alaska.gov/press/releases/2025/061625-Purdue.html)
[9](https://journals.law.harvard.edu/jlpp/wp-content/uploads/sites/90/2021/01/Cordova-Parens-Patriae.pdf)
[10](https://ag.ny.gov/press-release/2024/attorney-general-james-secures-150-million-multistate-settlement-principle-hikma)
[11](https://oag.ca.gov/news/press-releases/attorney-general-bonta-signs-74-billion-purdue-settlement)
[12](https://www.doj.state.or.us/media-home/news-media-releases/attorney-general-dan-rayfield-secures-720-million-from-eight-opioid-drug-makers/)
[13](https://goultralaw.com/tools/opioid-settlement-calculator-for-individuals/)
[14](https://oag.dc.gov/release/attorney-general-schwalb-secures-21-million-purdue)
[15](https://legislativeanalysis.org/wp-content/uploads/2024/12/Opioid-Litigation-Proceeds-Summary-of-State-Laws.pdf)
[16](https://attorneygenerallynnfitch.com/opioidsettlement/)
[17](https://ncdoj.gov/55-attorneys-general-sign-on-to-7-4-billion-purdue-settlement/)
[18](https://www.nbcnews.com/politics/elections/opioid-firms-kept-donating-state-ags-while-negotiating-settlements-n1050671)
[19](https://www.texasattorneygeneral.gov/news/releases/attorney-general-ken-paxton-and-multistate-coalition-reach-74-billion-settlement-purdue-pharma-its)
[20](https://illinoisattorneygeneral.gov/news/story/attorney-general-raoul-secures-720-million-from-eight-opioid-manufacturers)

 

 

 

tobacco lawsuit/settlement and the states took the risk of cost of carrying the overhead of the lawsuit, so that they took the case to federal court – where everyone (judge, state AGs, etc) on the “prosecutor’s” side of the lawsuit – was basically on the payroll… the only extra money that may have to be spent is for some ancillary para-legals. So there was really no “trial”, just mediation, so it was sort of a bench trial? So this legal proceeding was basically “behind closed doors”?

State attorneys general did adopt elements of the tobacco litigation approach, but with important differences in structure, risk, and legal process. In tobacco cases, many outside law firms were retained on contingency contracts and took substantial financial risk to carry litigation overhead, with states depending on fee arrangements negotiated beforehand. In the opioid litigation, most states relied primarily on their own AGs’ offices and internal legal teams, sometimes supplemented by outside counsel, but the risk and cost were largely handled by state legal infrastructure—rather than private firms.[1][2]

Most opioid proceedings were centralized in federal court (MDL 2804, Northern District of Ohio) under Judge Dan Polster, who organized the process around settlement negotiations rather than extended jury trials. These negotiations were generally conducted through mediation and “negotiation classes,” often without the public or traditional trial proceedings, meaning much of the key decision-making was effectively “behind closed doors” among judge, AGs, defense, and mediators. The result was less a bench trial and more a series of court-facilitated mediations and settlements, with federal oversight, documentation requirements, and some limited open proceedings, but very few actual contested trials.[3][4][5]

Unlike jury trials, these legal actions did not feature public evidentiary hearings or cross-examination; instead, settlements were brokered through judicial mediation efforts, negotiations, and sometimes approval by a federal judge, reflecting a process that was not very transparent to the public, with key decisions occurring in judicial chambers and closed mediation sessions. Thus, while the structure echoes parts of the tobacco template, opioid litigation by state AGs was a more internally managed, mediation-oriented process that often lacked the open adversarial features of conventional trials.[6][4][3]

[1](https://pmc.ncbi.nlm.nih.gov/articles/PMC5871135/)
[2](https://www.classaction.com/news/opioid-lawsuits-big-tobacco/)
[3](https://www.congress.gov/crs_external_products/LSB/PDF/LSB10365/LSB10365.2.pdf)
[4](https://law.stanford.edu/2019/10/01/opioid-negotiation-class-may-be-organic-procedure-evolution/)
[5](https://www.ohnd.uscourts.gov/mdl-2804)
[6](https://www.npr.org/2021/09/01/1031053251/sackler-family-immunity-purdue-pharma-oxcyontin-opioid-epidemic)
[7](https://nashp.org/understanding-opioid-settlement-spending-plans-across-states-key-components-and-approaches/)
[8](https://legislativeanalysis.org/wp-content/uploads/2024/12/Opioid-Litigation-Proceeds-Summary-of-State-Laws.pdf)
[9](https://www.naccho.org/uploads/downloadable-resources/OpioidSettlementsPDFFinal.pdf)
[10](https://nationalopioidsettlement.com/executive-summary/)
[11](https://www.tn.gov/attorneygeneral/working-for-tennessee/filings-of-interest/opioids.html)
[12](https://www.naag.org/issues/opioids/)
[13](https://www.attorneygeneral.gov/wp-content/uploads/2021/07/2021-07-21-Final-Distributor-Settlement-Agreement.pdf)
[14](https://goultralaw.com/tools/opioid-settlement-calculator-for-individuals/)
[15](https://lawecommons.luc.edu/context/luclj/article/2776/viewcontent/4_Art_Aaron__11_87_.pdf)
[16](http://law.stanford.edu/wp-content/uploads/2022/07/Engstrom-Rabin-73-Stan.-L.-Rev.-285-1.pdf)
[17](https://legislativeanalysis.org/wp-content/uploads/2023/01/Opioid-Litigation-Proceeds-Summary-of-State-Laws.pdf)
[18](https://www.tn.gov/attorneygeneral/news/2018/3/21/pr18-09.html)
[19](https://www.sciencedirect.com/science/article/pii/S0955395923000464)
[20](https://attorneygenerallynnfitch.com/opioidsettlement/)

 

being paid out, when these wholesalers did not have any first hand information on who prescribed these controlled meds, no first hand medical/healthcare information on the pts who were prescribed these medications. Did anyone involved in these negotiations have any medical education/backgrounds or review of the medical records on these same pts that would end up with less controlled meds that they had been receiving previously for years or decades.

The final opioid settlement agreements with the three major drug wholesalers—AmerisourceBergen, Cardinal Health, and McKesson—did result in new distribution controls for controlled medications, which have led to reports of patient access limitations, including for people with longstanding, medically justified needs for these drugs. Many chronic pain patients, some of whom are disabled, have expressed that these restrictions are causing hardship and could be seen as discriminatory. There is an ongoing legal and ethical debate about whether such blanket policies run afoul of the Americans with Disabilities Act (ADA), which prohibits discrimination against individuals with disabilities, including those treated for conditions requiring opioids. However, courts have generally found it difficult to prove that these policies exclusively or disproportionately deny access to people with disabilities—official rulings so far have not held the wholesalers’ new policies to be ADA violations.[1][2][3][4][5]

Regarding the use of medical expertise in mediation negotiations, available documentation indicates that negotiations relied heavily on public health officials, attorneys general, government lawyers, and some outside counsel, but did not feature systematic review of the medical records of individual patients affected by reduced opioid access. Instead, settlements and compliance policy changes were focused on population-level distribution data, reporting, and aggregate public health harms rather than individual review or medical necessity determinations. There is no evidence that prescribers’ clinical records or individual disability claims were substantively reviewed during the final settlement processes.[6][7][5]

For shareholders, the settlements did have substantial financial impacts on the companies as billions in payouts reduced available profits, created legal risk, and depressed stock prices at times, even though the companies themselves did not handle prescribing decisions or have patient medical records access. The legal theory of liability was based on distribution and reporting failures rather than individual patient harm or prescriber intent.[8][5][9]

In summary:
– Many disabled patients are experiencing reduced access, but legal obstacles remain in proving ADA violations by distributors.[2][3][4]
– No systematic review of affected disabled patients’ medical records occurred in settlement mediation.[7][6]
– Financial harm to shareholders has been significant, despite distribution companies not prescribing or directly managing patients.[9][8]

[1](https://www.healthlawadvisor.com/doj-considers-opioid-use-disorder-an-ada-covered-disability-and-pursues-claims-against-a-provider-for-refusing-medical-services-to-opioid-users)
[2](https://www.pharmacytimes.com/view/patient-alleges-chain-s-opioid-policy-violates-antidiscrimination-statutes)
[3](https://www.ada.gov/resources/opioid-use-disorder/)
[4](https://adata.org/factsheet/ada-addiction-and-recovery-private-businesses)
[5](https://www.nytimes.com/2021/07/21/health/opioids-distributors-settlement.html)
[6](https://www.expertinstitute.com/resources/insights/mdls-to-watch-national-prescription-opioid-litigation/)
[7](https://www.propublica.org/article/pharmaceuticals-pay-doctors-drugs)
[8](https://www.morningstar.com/sustainable-investing/what-investors-should-know-about-26-billion-opioid-settlement)
[9](https://www.hbs.edu/faculty/Pages/item.aspx?num=61311)
[10](https://www.justice.gov/archives/opa/pr/justice-department-secures-settlement-resolve-disability-discrimination-against-people-opioid)
[11](https://pmc.ncbi.nlm.nih.gov/articles/PMC7859880/)
[12](https://www.lac.org/news/doj-settlement-with-skilled-nursing-facility-excluding-people-on-addiction-medication-violates-the-ada)
[13](https://www.kaplangrady.com/first-court-ruling-clarifying-that-title-ii-of-the-ada-protects-individuals-engaging-in-illegal-drug-use/)
[14](https://goultralaw.com/tools/opioid-settlement-calculator-for-individuals/)
[15](https://www.bmj.com/content/368/bmj.m409)
[16](https://www.opioidsettlementtracker.com/globalsettlementtracker)
[17](https://pmc.ncbi.nlm.nih.gov/articles/PMC6140023/)
[18](https://www.justice.gov/usao-ma/pr/us-attorneys-office-settles-disability-discrimination-complaint-skilled-nursing-facility)
[19](https://jm-aq.com/opioid-litigation-settlements-remediating-the-harms-caused-by-the-opioid-crisis/)
[20](https://www.afslaw.com/perspectives/alerts/opioid-use-and-the-ada-eeoc-issues-new-guidance)

October – Nat Breast Cancer Month & Down Syndrome

There is a difference between pharmacy’s policies and state/federal law



IMO, the female Pharmacist told the patient that she knew that the pt needed the medication, the pharmacist CONFIRMED that she had met her responsibility of “corresponding responsibility”

The statement that a pt must see a practitioner within a certain number of miles. In June of 2024 the SCOTUS decided that NO FEDERAL AGENCY had the statutory authority to create new regulations and/or interpretations of the federal statue that they were in charge of enforcing. 


The phrase “corresponding responsibility” is found within the Controlled Substances Act’s implementing regulations, specifically in 21 CFR § 1306.04(a). This regulation states that while the responsibility for proper prescribing of controlled substances lies with the practitioner, a corresponding responsibility rests with the pharmacist who fills the prescription. Both practitioner and pharmacist are subject to penalties should prescriptions for controlled substances be issued or filled not in the usual course of professional practice or for illegitimate medical purposes.

Exact Language from 21 CFR § 1306.04(a)

“The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.”

This requirement is a cornerstone of DEA enforcement regarding pharmacist conduct and has significant regulatory and legal implications in pharmacy practice.


The Supreme Court, in June 2024, officially overturned the Chevron doctrine—a foundational legal principle for administrative law used for the past 40 years. In a 6-3 decision, the Court held that judges, not federal agencies, must decide the meaning of ambiguous federal laws, ending the longstanding practice of courts deferring to agencies’ interpretations when the statute is unclear.

Background and Chevron Doctrine

The Chevron doctrine stemmed from the 1984 case Chevron U.S.A. v. Natural Resources Defense Council. Under Chevron, courts would uphold an agency’s interpretation of an ambiguous statute if it was reasonable, giving agencies significant leeway to interpret and implement federal law.

The 2024 Decision

The pivotal case—Loper Bright Enterprises v. Raimondo—made clear that courts are now required to make their own independent judgments about statutory ambiguities. Chief Justice John Roberts, writing for the majority, called Chevron “fundamentally misguided” and argued that the Administrative Procedure Act (APA) requires courts, not agencies, to decide legal questions.

The Court found that Congress had not delegated law-interpreting power to agencies simply because a statute is ambiguous. Instead, the majority held that agencies do not have special competence to resolve statutory ambiguities—courts do.

Dissents and Concerns

Justice Elena Kagan led the dissent, warning the decision “will cause a massive shock to the legal system.” She expressed concern that shifting this power to the courts could undermine expertise-driven regulatory decisions—especially in complex areas like health, environmental, or financial regulation.

Practical Consequences

  • Courts are no longer obligated to defer to agency expertise just because a law is ambiguous; instead, they must decide such questions themselves.

  • The ruling potentially opens the door for more challenges to federal regulations and could slow the regulatory process, as agencies may have less authority and predictability in interpreting statutes.

  • Previous cases decided under Chevron are not automatically reopened or invalidated, but the approach to interpreting new or existing regulations will be fundamentally different going forward.

Summary Table: Key Changes

Before (Chevron Doctrine) After Jun 2024 SCOTUS Decision
Courts defer to reasonable agency interpretations Courts make independent judgments on law
Agencies had leeway with ambiguous statutes Agencies’ interpretations no longer binding
Doctrine used in environmental, health, labor Courts likely to scrutinize more agency rules
Applied for 40 years, cited in 18,000+ cases Agencies may face legal uncertainty, more litigation

This decision marks the end of judicial deference to agency interpretations under the Chevron doctrine, fundamentally altering administrative law and federal regulatory practice in the United States.


Kentucky does not have a specific mileage limitation for pharmacists filling controlled substance prescriptions from out-of-state practitioners. Kentucky law focuses instead on verifying the legitimacy of the prescription, ensuring the prescriber is properly authorized, and that the prescription follows all required documentation and prescribing limits for that particular practitioner type (such as APRN or PA), as if the prescriber were practicing in Kentucky

Pharmacists must still use professional judgment and verify the legitimacy of the patient-practitioner relationship, but there is no state law setting a maximum distance or mileage from the prescriber’s practice to the pharmacy or patient for out-of-state controlled substance prescriptions. All other federal and state requirements for controlled substance prescriptions remain in force, including e-prescribing mandates.

In summary, Kentucky law does not impose a mileage or distance restriction, but pharmacists must comply with practitioner authority, prescription validity, and documentation requirements when filling out-of-state controlled substance prescriptions.

There is no provision within the federal Controlled Substances Act (CSA) or DEA regulations that sets a specific mileage or distance limit for how far a patient can travel to have an office visit with a practitioner in order to receive a controlled substance prescription. The CSA focuses instead on ensuring that prescriptions for controlled substances are issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.

While traveling an unusual or long distance may be considered a “red flag” by regulatory agencies, pharmacies, or insurers—and may prompt additional scrutiny as a possible sign of diversion—there is no federal statutory or regulatory limit on the distance itself. Practitioners and pharmacists must exercise professional judgment and document the validity and appropriateness of the prescribing relationship, but the act of traveling a long distance alone is not prohibited under federal law.

In summary, the CSA does not contain any rule or statutory provision that limits the number of miles a patient may travel for a controlled substance office visit or prescription.The federal Controlled Substances Act (CSA) and DEA regulations do not specify any maximum mileage or distance that a patient cannot exceed when traveling for an office visit with a practitioner to obtain a controlled substance prescription. The law requires only that prescriptions are issued for a legitimate medical purpose in the usual course of professional practice, and that practitioners see patients at appropriate intervals, but no explicit mileage or distance limitation exists in the CSA itself.

While a long distance between the patient’s home and the prescriber may be considered a “red flag” suggesting diversion or improper prescribing, it is not in itself prohibited by federal law—such encounters may require closer scrutiny but do not violate the CSA strictly on grounds of travel distance. Instead, prescribers and pharmacists must properly document the medical necessity and legitimacy, regardless of the patient’s travel distance.


updated 09252025 This is going to be an evolving story of a Disabled Female chronic pain pt

Pt’s statements in RED: My words are in Green

Remember she is doing speech to text

This disabled female pt reached out to me Aug 4th and her doc had just abruptly cut her oral opioids she had been taking for ~ 10yr from 90 MME/day to 30 MME/day and put a Buprenorphine patch on her the next day. This is just starting to evolve but I am going to leave this post at the top of the first page and update as things happen – STAY TUNE

This is Aug 5th:

My. Primary. Just upped my blood. Pressure meds he said. It could ending up having. A stroke    Could it be the patch. Causing my blood. Pressure. Going. Up. So. High

Is your doctor just an employee of a large hospital system. I would like to put a spot light on his employer – let me know

 

 

 

A day or two after she put the buprenorphine patch on she was scheduled to have a treadmill cardiac stress test. Before the test, they took her blood pressure and it was 240/120 – what the American heart Association claims is a hypertensive crisis level. This test was done in part of a hospital system. Of course the stress test was cancelled, and the staff just SENT HER HOME. Before she had the patch on, her blood pressure was more normalish. Here is the American Heart Association on its definition of blood pressure. You may have to click on the graphic TWICE to make it enlarge and more readable

 

 

 

 

 

 

 

09-09-2025 This pt and her story has fallen off my radar – but today she told me that they had cut her opioid from 15 mg QID to either 10 mg 1-2 X daily.  Her BP is ONLY 230/120.  Within 20 minute of taking a dose.. she starts feeling better and two hrs later, she appears to be going into some level of withdrawal again..  IMO… this suggests that she is a fast/ultra fast metabolizer. I have suggested that she get a pharmacogenomic DNA test (PGx) to determine her metabolism of opioids. Will the practitioners involved even believe in this test. I have found that some practitioners are still practicing with the knowledge they obtained during their time in college.


Aug 20,2025 Apparently this pt’s PCP is just started adding pharma blood pressure meds. The PCP tells her that her high BP – currently hanging in the 230/120 range and the pt is suffering from frequent nose bleeds is because she is in WITHDRAWAL .. I hate to tell her PCP (Medical Deity) that her journey to hell started about 5 weeks ago and for the most part her – since she is dependent – not addicted to opioids – her withdrawal should pretty much be over and her hypertensive crisis is caused by under/untreated pain.

Apparently her PCP is “smart enough” to diagnose that she is in withdrawal, but “not smart enough” to know how he could get her out of her hypertensive crisis. Maybe if he read her hospital notes when at one time they gave her enough opioids to manage her pain and her BP went down.

The PCP can only tell her that she needs to go back to her pain doc that wants to put a bupe patch back on her, which is the genesis of the path she has been on for almost 6 weeks.


Aug 25 2025 update:

This poor woman’s pain doc – prescribed her as he described it –  different medication.  It all started abt 5-6 weeks ago, when her pain doc, reduced her opioid she had been taking for 10+ yrs from 15 mg 4Xd to 5-10 mgs 2xd, and concurrently putting her on a buprenorphine patch, which threw her into a hard/cold withdrawal issues and her pain upwards toward the high end of the scale.

Last week the pain doc told her that he was putting her on a entirely different medication, but he prescribed her buprenorphine film tab – that the pt is to put in the buccal area – between her gums and her cheek

Literature suggests that the buccal dose will max blood level in ~ 2 hrs where the topical patch would take ~ 60-72 hrs. So, this pain doc that I first summarized as INCOMPETENT, is now totally unaware of the fact that the two meds are the same -OR – is LYING TO THE PT!

I tried to reach out to the Ohio Medical Licensing board,  I could only leave a voice mail and apparently because my phone number is NOT FROM OHIO – they were not going to talk to anyone that was not based in Ohio.

 

 

Most criminal defendants are guaranteed the right to a “speedy trial” under the Sixth Amendment

Does SIX YEARS meet the definition of a “speedy trial”?

Most criminal defendants are guaranteed the right to a “speedy trial” under the Sixth Amendment and federal or state laws, but in practice, very few actually receive what most people would consider a truly “speedy” trial, especially in recent years.natecrowleylaw+2

Legal Framework and Practical Realities

The federal Speedy Trial Act generally requires trials to begin within 70 days of indictment, with many states imposing similar or even stricter deadlines. However, courts often grant exceptions for pretrial motions, scheduling conflicts, or other delays, so the deadlines are not absolute. Defendants may also waive their right to a speedy trial, sometimes for strategic reasons such as more time for case preparation.wikipedia+2

Are Speedy Trials Happening in Practice?

The reality is that court backlogs, complex cases, and routine delays mean that trials are frequently postponed well beyond the intended statutory timeframe. For example, only about 83% of felony cases are resolved within a year, and 77% of misdemeanors within 180 days; many cases linger far longer, especially if they go to trial instead of ending in a plea bargain. Federal data from 2025 shows an average of over 2 years (810 days) from criminal referral to sentencing or acquittal by trial, a figure that does not reflect the original intent of “speedy trial” laws.greggcohenlaw+2

Consequences and Enforcement

When delays completely exceed accepted time frames, defense attorneys may file motions for dismissal based on speedy trial violations. In some jurisdictions (like parts of New York), the rate of such dismissals has increased, but violations typically result in dismissal of charges only in a minority of cases and often after protracted motions litigation. Many defendants remain in pretrial detention for months or even years if the backlog is severe, and the impact is felt disproportionately by certain demographic groups.datacollaborativeforjustice+2

Summary Table: Typical US Criminal Trial Timelines

Case Type Statutory Time Limit Typical Resolution Time % Resolved Within Statutory Limit
Felonies 70 days (federal) 83% within a year Majority, but 17% delayed
Misdemeanors 70–90 days 77% within 180 days Majority, but 23% delayed

Most defendants technically receive some protection against excessive delay, but actual speedy trials as envisioned by law are the exception, not the rule, especially in federal courts or jurisdictions facing significant backlogs.nacdl+2

Add to follow-up
Check sources
  1. https://www.natecrowleylaw.com/practice-areas/federal-criminal-defense/possible-federal-defenses/pre-trial-defenses-an-introduction/speedy-trial-violation/
  2. https://en.wikipedia.org/wiki/Speedy_trial
  3. https://www.nacdl.org/Landing/Speedy-Trial
  4. https://www.law.cornell.edu/constitution-conan/amendment-6/scope-of-the-right-to-a-speedy-trial
  5. https://www.greggcohenlaw.com/blog/how-long-does-a-criminal-trial-last/
  6. https://www.nacdl.org/Content/Court-Backlogs-Speedy-Trial
  7. https://tracreports.org/whatsnew/email.250611.html
  8. https://datacollaborativeforjustice.org/wp-content/uploads/2025/04/Discovery_Report-1.pdf
  9. https://www.tsiglerlaw.com/blog/how-long-does-a-criminal-case-take-in-new-york/
  10. https://www.justice.gov/archives/jm/criminal-resource-manual-628-speedy-trial-act-1974
  11. https://constitution.congress.gov/browse/essay/amdt6-2-1/ALDE_00012979/
  12. https://www.oyez.org/issues/233
  13. https://scholarlycommons.law.northwestern.edu/cgi/viewcontent.cgi?article=3572&context=jclc
  14. https://www.lisastrausslaw.com/blog/the-right-to-a-speedy-trial-what-it-means-and-how-to-enforce-it/
  15. https://thefederaldocket.com/category/speedy-trial/
  16. https://www.uscourts.gov/data-table-topics/trials
  17. https://www.tncourts.gov/press/2022/04/20/tennessee-supreme-court-holds-trial-court-committed-reversible-error-allowing
  18. https://www.uscourts.gov/data-news/reports/statistical-reports/statistical-tables-federal-judiciary/statistical-tables-federal-judiciary-june-2025
  19. https://khalil.law/speedy-trial-just-how-fast-is-speedy
  20. https://nelsondefensegroup.com/blog/how-long-does-a-criminal-case-usually-take

Urge Media to Highlight Harm of Opioid Therapy Restrictions

https://www.change.org/p/urge-media-to-highlight-harm-of-opioid-therapy-restrictions

The Issue

Chronic pain patients (CPP) are facing dire consequences due to excessive restrictions on opioid therapy. With regulations limiting access to essential pain relief, thousands are left with no option but to undergo unnecessary procedures like epidurals and nerve ablations, which not only fail to address their pain but can also cause significant harm to their bodies. This situation has left many CPPs bedridden, stripped of their quality of life (QOL), and unable to participate in their own lives.

The DEA’s role in enforcing these restrictions has profound implications on a vulnerable population, often leaving them improperly medicated and suffering in silence. Media outlets have a critical role in shedding light on the individual stories of pain, suffering, and the anguish experienced by these patients who find their cries for help unheard. It’s time to showcase the real-life impact of these restrictive measures and bring a human face to the policy decisions affecting the chronic pain community.

Patient narratives illustrate the harsh reality of those who, due to the DEA’s crackdown on opioid prescriptions, face insurmountable hurdles in accessing necessary care. These stories reveal the devastating effects of being forced into ineffective and harmful treatments, ultimately worsening their physical and mental well-being.

We call on media organizations to dedicate time and resources to report on this critical issue, ensuring that the narratives of CPPs are heard. Highlighting these experiences will not only bring awareness but could also drive policy change, encouraging a reevaluation of the current approach to opioid prescription for chronic pain. Your signature can make a difference by compelling the media to take immediate action and advocate for a fairer, more compassionate approach to pain management. Sign this petition to stand with CPPs and demand media attention to this pressing human

Our focus is really on what we can do to pull the doctor out of the visit

This medical startup uses LLMs (Large Language Model) to run appointments and make diagnoses

https://www.technologyreview.com/2025/09/22/1123873/medical-diagnosis-llm/

Imagine this: You’ve been feeling unwell, so you call up your doctor’s office to make an appointment. To your surprise, they schedule you in for the next day. At the appointment, you aren’t rushed through describing your health concerns; instead, you have a full half hour to share your symptoms and worries and the exhaustive details of your health history with someone who listens attentively and asks thoughtful follow-up questions. You leave with a diagnosis, a treatment plan, and the sense that, for once, you’ve been able to discuss your health with the care that it merits.

Related Story

The catch? You might not have spoken to a doctor, or other licensed medical practitioner, at all.

This is the new reality for patients at a small number of clinics in Southern California that are run by the medical startup Akido Labs. These patients—some of whom are on Medicaid—can access specialist appointments on short notice, a privilege typically only afforded to the wealthy few who patronize concierge clinics.

The key difference is that Akido patients spend relatively little time, or even no time at all, with their doctors. Instead, they see a medical assistant, who can lend a sympathetic ear but has limited clinical training. The job of formulating diagnoses and concocting a treatment plan is done by a proprietary, LLM-based system called ScopeAI that transcribes and analyzes the dialogue between patient and assistant. A doctor then approves, or corrects, the AI system’s recommendations.

“Our focus is really on what we can do to pull the doctor out of the visit,” says Jared Goodner, Akido’s CTO. 

According to Prashant Samant, Akido’s CEO, this approach allows doctors to see four to five times as many patients as they could previously. There’s good reason to want doctors to be much more productive. Americans are getting older and sicker, and many struggle to access adequate health care. The pending 15% reduction in federal funding for Medicaid will only make the situation worse.

But experts aren’t convinced that displacing so much of the cognitive work of medicine onto AI is the right way to remedy the doctor shortage. There’s a big gap in expertise between doctors and AI-enhanced medical assistants, says Emma Pierson, a computer scientist at UC Berkeley.  Jumping such a gap may introduce risks. “I am broadly excited about the potential of AI to expand access to medical expertise,” she says. “It’s just not obvious to me that this particular way is the way to do it.”

AI is already everywhere in medicine. Computer vision tools identify cancers during preventive scans, automated research systems allow doctors to quickly sort through the medical literature, and LLM-powered medical scribes can take appointment notes on a clinician’s behalf. But these systems are designed to support doctors as they go about their typical medical routines.

What distinguishes ScopeAI, Goodner says, is its ability to independently complete the cognitive tasks that constitute a medical visit, from eliciting a patient’s medical history to coming up with a list of potential diagnoses to identifying the most likely diagnosis and proposing appropriate next steps.

Under the hood, ScopeAI is a set of large language models, each of which can perform a specific step in the visit—from generating appropriate follow-up questions based on what a patient has said to to populating a list of likely conditions. For the most part, these LLMs are fine-tuned versions of Meta’s open-access Llama models, though Goodner says that the system also makes use of Anthropic’s Claude models. 

During the appointment, assistants read off questions from the ScopeAI interface, and ScopeAI produces new questions as it analyzes what the patient says. For the doctors who will review its outputs later, ScopeAI produces a concise note that includes a summary of the patient’s visit, the most likely diagnosis, two or three alternative diagnoses, and recommended next steps, such as referrals or prescriptions. It also lists a justification for each diagnosis and recommendation.

ScopeAI is currently being used in cardiology, endocrinology, and primary care clinics and by Akido’s street medicine team, which serves the Los Angeles homeless population. That team—which is led by Steven Hochman, a doctor who specializes in addiction medicine—meets patients out in the community to help them access medical care, including treatment for substance use disorders. 

Previously, in order to prescribe a drug to treat an opioid addiction, Hochman would have to meet the patient in person; now, caseworkers armed with ScopeAI can interview patients on their own, and Hochman can approve or reject the system’s recommendations later. “It allows me to be in 10 places at once,” he says.

Since they started using ScopeAI, the team has been able to get patients access to medications to help treat their substance use within 24 hours—something that Hochman calls “unheard of.”

This arrangement is only possible because homeless patients typically get their health insurance from Medicaid, the public insurance system for low-income Americans. While Medicaid allows doctors to approve ScopeAI prescriptions and treatment plans asynchronously, both for street medicine and clinic visits, many other insurance providers require that doctors speak directly with patients before approving those recommendations. Pierson says that discrepancy raises concerns. “You worry about that exacerbating health disparities,” she says.

Samant is aware of the appearance of inequity, and he says the discrepancy isn’t intentional—it’s just a feature of how the insurance plans currently work. He also notes that being seen quickly by an AI-enhanced medical assistant may be better than dealing with long wait times and limited provider availability, which is the status quo for Medicaid patients. And all Akido patients can opt for traditional doctor’s appointments, if they are willing to wait for them, he says.

Part of the challenge of deploying a tool like ScopeAI is navigating a regulatory and insurance landscape that wasn’t designed for AI systems that can independently direct medical appointments. Glenn Cohen, a professor at Harvard Law School, says that any AI system that effectively acts as a “doctor in a box” would likely need to be approved by the FDA and could run afoul of medical licensure laws, which dictate that only doctors and other licensed professionals can practice medicine.

The California Medical Practice Act says that AI can’t replace a doctor’s responsibility to diagnose and treat a patient, but doctors are allowed to use AI in their work, and they don’t need to see patients in-person or in real-time before diagnosing them. Neither the FDA nor the Medical Board of California were able to say whether or not ScopeAI was on solid legal footing based only on a written description of the system.

But Samant is confident that Akido is in compliance, as ScopeAI was intentionally designed to fall short of being a “doctor in a box.” Because the system requires a human doctor to review and approve of all of its diagnostic and treatment recommendations, he says, it doesn’t require FDA approval. 

At the clinic, this delicate balance between AI and doctor decision making happens entirely behind the scenes. Patients don’t ever see the ScopeAI interface directly—instead, they speak with a medical assistant who asks questions in the way that a doctor might in a typical appointment. That arrangement might make patients feel more comfortable. But Zeke Emanuel, a professor of medical ethics and health policy at the University of Pennsylvania who served in the Obama and Biden administrations, worries that this comfort could be obscuring from patients the extent to which an algorithm is influencing their care.

Pierson agrees. “That certainly isn’t really what was traditionally meant by the human touch in medicine,” she says.

DeAndre Siringoringo, a medical assistant who works at Akido’s cardiology office in Rancho Cucamonga, says that while he tells the patients he works with that an AI system will be listening to the appointment in order to gather information for their doctor, he doesn’t inform them about the specifics of how ScopeAI works, including the fact that it makes diagnostic recommendations to doctors. 

Because all ScopeAI recommendations are reviewed by a doctor, that might not seem like such a big deal—it’s the doctor who makes the final diagnosis, not the AI. But it’s been widely documented that doctors using AI systems tend to go along with the system’s recommendations more often than they should, a phenomenon known as automation bias. 

At this point, it’s impossible to know whether automation bias is affecting doctors’ decisions at Akido clinics, though Pierson says it’s a risk—especially when doctors aren’t physically present for appointments. “I worry that it might predispose you to sort of nodding along in a way that you might not if you were actually in the room watching this happen,” she says.

An Akido spokesperson says that automation bias is a valid concern for any AI tool that assists a doctor’s decision-making and that the company has made efforts to mitigate that bias. “We designed ScopeAI specifically to reduce bias by proactively countering blind spots that can influence medical decisions, which historically lean heavily on physician intuition and personal experience,” she says. “We also train physicians explicitly on how to use ScopeAI thoughtfully, so they retain accountability and avoid over-reliance.”

Akido evaluates ScopeAI’s performance by testing it on historical data and monitoring how often doctors correct its recommendations; those corrections are also used to further train the underlying models. Before deploying ScopeAI in a given specialty, Akido ensures that when tested on historical data sets, the system includes the correct diagnosis in its top three recommendations at least 92% of the time.

But Akido hasn’t undertaken more rigorous testing, such as studies that compare ScopeAI appointments with traditional in-person or telehealth appointments, in order to determine whether the system improves—or at least maintains—patient outcomes. Such a study could help indicate whether automation bias is a meaningful concern.

“Making medical care cheaper and more accessible is a laudable goal,” Pierson says. “But I just think it’s important to conduct strong evaluations comparing to that baseline.”