May is national mental health month

Is 42 USC 1395: Prohibition against any Federal interference in medical care a LEGAL MIRAGE?

42 USC 1395: Prohibition against any Federal interference

https://uscode.house.gov/view.xhtml?req=(title:42%20section:1395%20edition:prelim)
From Title 42-THE PUBLIC HEALTH AND WELFARE CHAPTER 7-SOCIAL SECURITY SUBCHAPTER XVIII-HEALTH INSURANCE FOR AGED AND DISABLED
§1395. Prohibition against any Federal interference

Nothing in this sub chapter shall be construed to authorize any Federal officer or employee to exercise any supervision or control over the practice of medicine or the manner in which medical services are provided, or over the selection, tenure, or compensation of any officer or employee of any institution, agency, or person providing health services; or to exercise any supervision or control over the administration or operation of any such institution, agency, or person.

(Aug. 14, 1935, ch. 531, title XVIII, §1801, as added Pub. L. 89–97, title I, §102(a), July 30, 1965, 79 Stat. 291 .)

So I asked www.perplexity.ai:

Has anyone in law enforcement/DOJ enforced this law: 42 USC 1395: Prohibition against any Federal interference The law has only “been on the books” since 1935 – 35 yrs before the CSA was signed into law & in my opinion the CSA limits the actions of the DOJ/DEA… but as they say “no one is above the law… except those who are in charge of enforcing our laws …”

Enforcement of 42 USC 1395: Prohibition Against Federal Interference

Summary of the Law

42 USC 1395 states:

“Nothing in this subchapter shall be construed to authorize any Federal officer or employee to exercise any supervision or control over the practice of medicine or the manner in which medical services are provided…”5

This provision, part of the original Medicare statute, is intended to prevent federal authorities from interfering directly in the clinical decisions of medical practitioners.

Has Law Enforcement or DOJ Enforced 42 USC 1395?

Direct Enforcement History

  • There is no evidence in the search results of the Department of Justice (DOJ), Drug Enforcement Administration (DEA), or any other law enforcement agency directly enforcing 42 USC 1395 as an independent statutory right or using it to limit their own actions5.

  • The statute functions more as a limiting principle on the scope of federal authority under Medicare, rather than as a criminal or civil law that is actively enforced by law enforcement agencies5.

Context of Enforcement

  • The DOJ does actively enforce other provisions within 42 USC 1395, such as the Stark Law (physician self-referral law, 42 USC 1395nn), particularly in False Claims Act cases related to Medicare fraud2. However, this is a different section and context.

  • The DEA and DOJ enforce the Controlled Substances Act (CSA), which regulates controlled substances and the registration of practitioners, but these enforcement actions are not typically challenged or limited by 42 USC 1395 in practice46.

Relationship Between 42 USC 1395 and the Controlled Substances Act (CSA)

  • The CSA (enacted in 1970) gives the DEA authority to regulate and enforce laws regarding controlled substances, including the ability to suspend or revoke practitioners’ registrations and prosecute violations346.

  • While 42 USC 1395 predates the CSA, there is no clear legal precedent or regular practice where this Medicare provision has been used to shield practitioners from DEA or DOJ enforcement under the CSA.

  • The courts have generally upheld the DEA’s authority to regulate controlled substances, even when such actions may indirectly affect the practice of medicine, as long as the federal government is not directly dictating clinical decisions46.

  • 42 USC 1395 is often cited in legal arguments to assert the independence of medical judgment, but it does not create a private right of action or a direct bar to federal enforcement of drug laws5.

  • The DEA’s Practitioner’s Manual and federal case law emphasize that, while clinical judgment is respected, prescriptions for controlled substances must comply with federal law and be for a legitimate medical purpose6.

  • In practice, no known case exists where DOJ or DEA actions under the CSA were successfully stopped or reversed solely on the basis of 42 USC 1395.

Conclusion

  • 42 USC 1395 has not been directly enforced by law enforcement or the DOJ as a shield against federal action under the CSA or other federal drug laws.

  • The DOJ and DEA continue to enforce the CSA, and courts have not interpreted 42 USC 1395 as a substantive limit on those enforcement powers46.

  • The law serves as a policy statement limiting federal supervision of medical practice under Medicare, but it does not override other federal statutes or provide a defense against CSA enforcement56.

Citations:

  1. https://www.govinfo.gov/content/pkg/USCODE-2011-title42/html/USCODE-2011-title42-chap7-subchapXVIII.htm
  2. https://www.arnoldporter.com/en/perspectives/blogs/fca-qui-notes/posts/2024/04/doj-renewed-focus-on-standalone-stark-law-violations
  3. https://www.dea.gov/drug-information/csa
  4. https://sgp.fas.org/crs/misc/R45948.pdf
  5. https://uscode.house.gov/view.xhtml?req=%28title%3A42+section%3A1395+edition%3Aprelim%29
  6. https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-071)(EO-DEA226)_Practitioner’s_Manual_(final).pdf
  7. https://frostbrowntodd.com/stark-law-and-anti-kickback-statute-enforcement-eased-during-covid-19-crisis/
  8. https://www.hhs.gov/guidance/document/physician-self-referral
  9. https://www.congress.gov/crs-product/R45948
  10. https://oig.hhs.gov/compliance/physician-education/fraud-abuse-laws/
  11. https://www.law.cornell.edu/uscode/text/42/1395mm
  12. https://uscode.house.gov/view.xhtml?req=%28title%3A42+section%3A1395y+edition%3Aprelim%29
  13. https://www.law.cornell.edu/uscode/text/42/1395y
  14. https://www.govregs.com/uscode/expand/title42_chapter7_subchapterXVIII_section1395
  15. https://www.justice.gov/osg/media/199181/dl?inline
  16. https://uscode.house.gov/view.xhtml?path=%2Fprelim%40title21%2Fchapter13%2Fsubchapter1&edition=prelim
  17. https://www.law.cornell.edu/uscode/text/21/802
  18. https://public-inspection.federalregister.gov/2025-01044.pdf
  19. https://www.govinfo.gov/content/pkg/USCODE-2011-title21/html/USCODE-2011-title21-chap13.htm
  20. https://chicagounbound.uchicago.edu/cgi/viewcontent.cgi?article=6214&context=uclrev

SO I ASKED: Is it more appropriate for a practitioner to determine what is a legitimate medical purpose as opposed to a federal prosecutor – with no medical training – mostly functioning on some arbitrary limits on mgs/day that is less than the FDA’s dosing guidelines?

The question of whether medical practitioners or federal prosecutors should determine “legitimate medical purpose” under the Controlled Substances Act (CSA) involves balancing clinical judgment, legal standards, and evolving medical evidence. Here’s the breakdown:

Legal Framework for Prescribing Controlled Substances

  • The CSA mandates that prescriptions for controlled substances must be “for a legitimate medical purpose” and issued “in the usual course of professional practice”138.

  • Federal prosecutors rely on expert testimony and circumstantial evidence (e.g., patient travel patterns, drug-seeking behavior) to argue that prescriptions violate these standards25.

Role of Medical Practitioners

  1. Clinical Expertise:

    • Physicians are trained to tailor treatments to individual patient needs, including adjusting dosages based on factors like tolerance, comorbidities, and treatment response9.

    • The FDA recently clarified that buprenorphine dosing should not have rigid upper limits, emphasizing individualized care9.

  2. Legal Precedent:

    • In Gonzales v. Oregon (2006), the Supreme Court ruled that the federal government cannot override state-authorized medical practices, affirming that medical standards are determined by clinicians, not prosecutors7.

    • The Ruan v. United States (2022) decision requires prosecutors to prove subjective intent (knowing or intentional misuse) by prescribers, raising the burden of proof for criminal charges10.

Federal Prosecutors’ Limitations

  • Lack of Medical Training: Prosecutors often rely on arbitrary dosage thresholds (e.g., milligrams/day) or outdated FDA labels, which may conflict with modern clinical guidelines9.

  • Circumstantial Evidence: Prosecutions frequently hinge on non-clinical factors (e.g., cash payments, geographic patterns)25, which can misrepresent legitimate care.

  • Conflict with FDA Guidance: For example, while the FDA now supports higher buprenorphine doses for opioid-use disorder, some prosecutors and payers still enforce outdated limits9.

Key Conflicts and Resolutions

Issue Practitioner’s Role Prosecutorial Approach
Dosage Limits Individualized dosing based on patient needs9. May use rigid thresholds (e.g., 24 mg/day)9.
Medical Necessity Determined via clinical evaluation710. Relies on expert witnesses and red flags25.
Regulatory Updates Follows FDA and clinical guidelines9. Often lags behind evolving standards9.

Conclusion

  • Practitioners are better positioned to determine “legitimate medical purpose” due to their clinical training and patient-specific knowledge. Courts have repeatedly affirmed that medical judgments should not be second-guessed by prosecutors without clear evidence of intent to violate the CSA710.

  • However, prosecutors retain authority to challenge prescriptions when objective evidence of diversion or abuse exists, provided they meet the heightened Ruan standard of proving intent10.

  • Arbitrary dosing limits below FDA guidelines are increasingly seen as medically unsound, and advocacy efforts (e.g., AMA, FDA updates) aim to align legal enforcement with evidence-based practice9.

In short, while prosecutors play a role in preventing CSA violations, clinical expertise should guide prescribing decisions unless there is demonstrable criminal intent.

Citations:

  1. https://pmc.ncbi.nlm.nih.gov/articles/PMC3847977/
  2. https://www.burnhamgorokhov.com/criminal-defense-resources/federal-crimes/csa-prosecutions-against-physicians/
  3. https://www.pharmacy.texas.gov/files_pdf/Corresponding_Responsibility_Brochure.pdf
  4. https://www.ncbi.nlm.nih.gov/books/NBK582130/
  5. https://pmc.ncbi.nlm.nih.gov/articles/PMC4773337/
  6. https://dash.harvard.edu/server/api/core/bitstreams/7312037c-8e07-6bd4-e053-0100007fdf3b/content
  7. https://pmc.ncbi.nlm.nih.gov/articles/PMC1802109/
  8. https://www.ecfr.gov/current/title-21/chapter-II/part-1300/section-1300.04
  9. https://www.ama-assn.org/delivering-care/nation-s-overdose-epidemic/fda-moves-change-labeling-buprenorphine-dosing
  10. https://www.uspharmacist.com/article/dea-must-prove-knowing-and-intentional-violations-of-the-controlled-substances-act
  11. https://www.quarles.com/newsroom/publications/high-court-rules-state-of-mind-relevant-in-prosecuting-prescribers-under-the-controlled-substance-act
  12. https://www.ecfr.gov/current/title-21/chapter-II/part-1306/subject-group-ECFR1eb5bb3a23fddd0/section-1306.04
  13. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dosage-and-administration-section-labeling-human-prescription-drug-and-biological-products-content
  14. https://en.wikipedia.org/wiki/Controlled_Substances_Act
  15. https://www.uspharmacist.com/article/dea-must-prove-knowing-and-intentional-violations-of-the-controlled-substances-act
  16. https://www.scotusblog.com/2022/02/amid-overdose-crisis-court-will-weigh-physician-intent-in-pill-mill-prosecutions-and-more-under-the-controlled-substances-act/
  17. https://www.dea.gov/drug-information/csa
  18. https://www.deadiversion.usdoj.gov/faq/prescriptions-faq.html
  19. https://sgp.fas.org/crs/misc/R45948.pdf
  20. https://www.dea.gov/drug-information/drug-scheduling
  21. https://www.samhsa.gov/substance-use/treatment/statutes-regulations-guidelines
  22. https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-071)(EO-DEA226)_Practitioner’s_Manual_(final).pdf
  23. https://www.fda.gov/about-fda/cder-offices-and-divisions/controlled-substances-program
  24. https://uscode.house.gov/view.xhtml?req=38&f=treesort&num=5465
  25. https://www.fda.gov/media/72142/download
  26. https://www.bowlesrice.com/under-the-collar/physicians-improper-prescribing
  27. https://www.clemetrobar.org/?pg=CMBABlog&blAction=showEntry&blogEntry=67902
  28. https://www.thefederalcriminalattorneys.com/defending-doctors-against-federal-prosecution
  29. https://journalofethics.ama-assn.org/article/what-counts-expert-medical-testimony/2004-12
  30. https://www.law.cornell.edu/rules/fre/rule_702

SO I ASKED: can you document that federal prosecutors routinely use the same “experts” to testify for the prosecution

Federal prosecutors routinely rely on a small, recurring group of expert witnesses-often law enforcement officers or government-paid medical experts-to testify for the prosecution in drug and controlled substance cases.

  • In federal prosecutions against physicians under the Controlled Substances Act, prosecutors typically consult and use government-paid medical experts to review prescribing behavior and testify at trial if their opinions support prosecution1.

  • In many jurisdictions, especially in drug distribution cases, the prosecution’s “expert” is almost always a salaried, on-duty police officer who testifies exclusively for the government, often as part of their full-time job3. These officers are not independent and are frequently used across multiple cases, raising concerns about bias and lack of objectivity34.

  • Academic and legal commentary notes that the same law enforcement experts are regularly admitted to testify on patterns of drug trafficking or prescribing, sometimes without a strong empirical basis4. This practice has been criticized for creating unfair prejudice and for potentially usurping the jury’s role in determining the facts of the case4.

  • There is also documented concern, even among federal judges, that jurors may give disproportionate weight to testimony from law enforcement agents who frequently serve as prosecution experts, compared to independent experts called by the defense2.

In summary:
Yes, it is well-documented that federal prosecutors routinely use the same experts-often law enforcement officers or government-paid medical professionals-to testify for the prosecution in drug-related cases. This practice is widespread, has been subject to criticism for potential bias, and is recognized in both legal scholarship and court commentary134.

Citations:

  1. https://www.burnhamgorokhov.com/criminal-defense-resources/federal-crimes/csa-prosecutions-against-physicians/
  2. https://www.bracewell.com/resources/diaz-and-gorsuchs-dissent-seeking-other-provisions-to-bar-expert-testimony-on-criminal-defendants-mental-state/
  3. https://goldsteinmehta.com/blog/expert-witnesses-drug-cases
  4. https://www.johntfloyd.com/profiling-experts-in-federal-drug-cases/
  5. https://www.courthousenews.com/expert-testimony-in-drug-cases-will-undergo-supreme-court-review/
  6. https://goldsteinmehta.com/blog/expert-witnesses-drug-cases
  7. https://leppardlaw.com/federal/motions/expert-witness-disclosures-in-us-federal-criminal-discovery/
  8. https://themanitobalawjournal.com/wp-content/uploads/articles/MLJ_42.4/42.4_Chin.pdf
  9. https://dlglearningcenter.com/testifying-on-trial-guiding-law-enforcement-through-expert-testimony-in-diaz-v-united-states/
  10. https://digitalcommons.molloy.edu/cgi/viewcontent.cgi?article=1003&context=crj_fac
  11. https://www.bracewell.com/resources/diaz-and-gorsuchs-dissent-seeking-other-provisions-to-bar-expert-testimony-on-criminal-defendants-mental-state/
  12. https://www.jurist.org/news/2023/11/us-supreme-court-agrees-to-consider-evidentiary-scope-of-expert-witness-testimony-in-drug-trafficking-case/
  13. https://dc.fd.org/motions/alaska/exclude/drugid.htm
  14. https://www.justice.gov/jm/jm-9-5000-issues-related-trials-and-other-court-proceedings
  15. https://www.law.cornell.edu/rules/fre/rule_702
  16. https://www.washingtonpost.com/local/public-safety/defense-says-federal-prosecutor-tried-to-co-opt-witness-in-physicians-opioid-trial/2018/01/22/1ab5477a-ff94-11e7-bb03-722769454f82_story.html
  17. https://www.druganddevicelawblog.com/2024/04/the-state-of-state-of-mind-testimony-by-experts.html
  18. https://www.supremecourt.gov/opinions/23pdf/23-14_d1o2.pdf
  19. https://www.selendygay.com/news/publications/2024-06-25-scotus-changes-admissibility-of-expert-testimony-in-criminal-cases

SO I ASKED: Didn’t the SCOTUS overturning the Chevron Doctrine cleared up the fact that federal agencies should not create new interpretations of the federal laws they are in charge of enforcing – such things as all the DEA’s RED FLAGS, which prosecutors use to determine that the patient was acting as a addict or diverter?

Yes, the Supreme Court’s recent decision overturning the Chevron doctrine fundamentally changes how courts review federal agency interpretations of law-including the DEA’s use of “red flags” to judge whether a prescription was written for a legitimate medical purpose.

What Did the Supreme Court Decide?

  • On June 28, 2024, the Supreme Court overruled the Chevron doctrine, which for 40 years required courts to defer to federal agencies’ reasonable interpretations of ambiguous statutes146.

  • Now, courts must exercise their own independent judgment in interpreting federal laws and are not required to defer to agency interpretations, even in technical or complex areas1245.

How Does This Affect DEA “Red Flags” and Agency Rules?

  • The DEA’s “red flags” (such as dosage limits, combinations of drugs, or patient travel distances) were often justified under the Chevron doctrine as reasonable interpretations of ambiguous statutory language in the Controlled Substances Act3.

  • Courts previously upheld DEA enforcement actions and rules-even if challenged-by deferring to the agency’s expertise and interpretation of what constitutes a violation or “legitimate medical purpose”3.

  • With Chevron overturned, courts will now scrutinize the legal basis for the DEA’s rules and enforcement actions-including “red flags”-without giving them automatic deference134.

  • This means that if a practitioner or pharmacy is prosecuted or sanctioned for allegedly ignoring “red flags,” the DEA must now justify its interpretation of the law in court, and the judge will make an independent decision about whether the agency’s standards are consistent with the statute3.

Implications for Practitioners and Prosecutors

  • Practitioners and their attorneys will have greater ability to challenge the legal validity of DEA-created rules and “red flags” in court235.

  • Prosecutors can no longer rely solely on the DEA’s interpretations or guidance as legally binding; they must persuade courts that these interpretations are correct under the law itself13.

  • As a result, agency-created standards that go beyond the plain text of the statute-such as arbitrary dose limits below FDA guidelines-are more vulnerable to being overturned by courts357.

Conclusion

The Supreme Court’s rejection of Chevron deference means that federal agencies like the DEA can no longer unilaterally create new interpretations of the laws they enforce and expect courts to uphold them automatically. Instead, courts will independently decide whether agency-created rules-such as “red flags” used to infer addiction or diversion-are consistent with the law. This shift provides practitioners with a stronger legal basis to challenge agency overreach and arbitrary enforcement standards in court1234567.

Citations:

  1. https://www.scotusblog.com/2024/06/supreme-court-strikes-down-chevron-curtailing-power-of-federal-agencies/
  2. https://www.bhfs.com/insights/alerts-articles/2024/health-care-impacts-following-chevron-decision
  3. https://ronaldwchapman.com/understanding-chevron-deference-impact-dea-physicians
  4. https://www.dentons.com/en/insights/articles/2024/july/3/us-supreme-court-overrules-chevron-doctrine-implications-for-employers
  5. https://www.sts.org/blog/implications-supreme-court-overturning-chevron-deference
  6. https://www.ncsl.org/resources/details/supreme-court-throws-out-chevron-decision-weakening-federal-regulators
  7. https://www.ajmc.com/view/how-chevron-s-overturn-could-complicate-the-health-policy-environment
  8. https://www.ppic.org/blog/unpacking-the-supreme-courts-recent-ruling-on-the-chevron-doctrine/
  9. https://www.hklaw.com/en/insights/publications/2024/06/supreme-court-overrules-chevron-deference
  10. https://ronaldwchapman.com/blog/suntree-v-dea
  11. https://www.ncsl.org/events/details/supreme-court-throws-out-chevron-decision-weakening-federal-regulators
  12. https://www.supremecourt.gov/opinions/23pdf/22-451_7m58.pdf
  13. https://www.naco.org/news/us-supreme-court-overturns-chevron-doctrine-reshape-federal-administrative-state
  14. https://www.whitecase.com/insight-alert/us-supreme-court-strikes-down-chevron-doctrine-what-you-need-know
  15. https://www.wiley.law/alert-Supreme-Court-Overturns-Chevron-Deference-in-Loper-Bright-Decision
  16. https://www.bu.edu/sph/news/articles/2024/with-supreme-courts-chevron-ruling-big-business-won-another-round/
  17. https://www.ccghealthcare.com/resource-library/chevrondeference
  18. https://regulatorystudies.columbian.gwu.edu/regulation-adjudication
  19. https://www.lastprisonerproject.org/implications-for-cannabis-justice-could-the-supreme-court-s-chevron-decision-rollback-rescheduling

Answer from Perplexity: pplx.ai/share

 

Legal/Regulatory Pressures Outweigh Scientific Rationale – when dosing, prescribing opioids to chronic pain pts

If a chronic pain pt’s practitioner’s office is raided by DOJ/DEA and shut down, what percentage of the chronic pain pts are able to find a new practitioner that will continue the pt’s pain management at the dose level the pt was stable on?

When a chronic pain patient’s practitioner is raided and shut down by the DEA/DOJ, finding a new provider willing to continue the same opioid dose is extremely challenging. While no study provides an exact percentage, evidence suggests **most patients face abrupt discontinuation, forced tapering, or difficulty securing care** due to systemic barriers and provider reluctance[1][5][6][7][8].

### Key Factors Impacting Patient Outcomes:
**1. Provider Fear of Legal/Regulatory Scrutiny**
– Many clinicians avoid accepting these patients due to perceived liability risks, even if they believe opioid therapy is appropriate[8].
– Primary care providers (PCPs) often refuse to continue existing regimens, opting instead to taper doses or discontinue opioids entirely[2][4][6].

**2. Systemic Barriers to Care**
– **Insurance constraints** and **pharmacy restrictions** limit access to opioids, even with a valid prescription[3][7].
– **Stigma** against chronic pain patients exacerbates difficulties finding new providers[7][8].

**3. Clinical Decision-Making Trends**
– PCPs managing displaced patients frequently:
– Taper doses due to unfamiliarity with high-dose protocols[2][4].
– Switch to non-opioid alternatives (e.g., gabapentin, antidepressants) despite lower efficacy[3][7].
– Require new pain contracts, drug testing, or specialist referrals before continuing treatment[4][8].

### Documented Patient Experiences:
– A 2015 survey found **71% of patients** were switched to less effective medications after regulatory changes[7].
– Case reports describe patients becoming bedridden or suicidal after losing access to opioids[7][8].
– Primary care clinics often lack capacity or expertise to manage complex, high-dose opioid regimens[2][3][4].

### Legal and Ethical Considerations:
– Abandonment risks exist if providers fail to offer tapering support or referrals[4].
– Guidelines recommend “bridging prescriptions” during transitions, but these are inconsistently provided[4][8].

In summary, while a small subset of patients may find new providers willing to continue their regimen-often through extensive advocacy or cash-based clinics-**the majority face dose reductions or discontinuation**. Systemic fear, fragmented care networks, and regulatory pressures create a healthcare environment where stable opioid maintenance becomes exceptionally rare post-closure[1][5][6][8].

Citations:
[1] https://www.cato.org/white-paper/cops-practicing-medicine
[2] https://jamespmurphymd.com/2018/08/01/pain-clinic-closure-survival-guide-for-patients-clinicians/
[3] https://pmc.ncbi.nlm.nih.gov/articles/PMC7301400/
[4] https://www.mbc.ca.gov/Download/Publications/pain-guidelines.pdf
[5] https://lynnwebstermd.com/2017/11/18/dea-raids-offices-friend-colleague-dr-tennant/
[6] https://www.kolmac.com/blog/patients-chronic-pain-collateral-dea-damage/
[7] https://lynnwebstermd.com/2015/04/06/dea-inflicts-harm-on-chronic-pain-patients/
[8] https://www.hrw.org/report/2018/12/18/not-allowed-be-compassionate/chronic-pain-overdose-crisis-and-unintended-harms-us
[9] https://scholarworks.waldenu.edu/cgi/viewcontent.cgi?article=9966&context=dissertations
[10] https://news.wttw.com/2024/03/12/chronic-pain-patients-suffer-opioid-epidemic-overcorrection
[11] https://www.painnewsnetwork.org/stories/2017/11/25/dea-tactics-questioned-in-raid-on-tennant
[12] https://pmc.ncbi.nlm.nih.gov/articles/PMC3104828/
[13] https://www.vice.com/en/article/dea-raided-chronic-pain-doctor-forest-tennant/
[14] https://meridian.allenpress.com/jmr/article/106/3/6/447314/Demanding-Better-A-Case-for-Increased-Funding-and
[15] https://www.painscale.com/article/what-to-do-if-the-pain-clinic-suddenly-closes
[16] https://www.dea.gov/press-releases/2020/10/15/local-pain-management-doctor-going-prison-for-70-months-for-conspiring
[17] https://federal-lawyer.com/dea-opioid-investigations-100-faqs/
[18] https://creyos.com/blog/continuity-of-care
[19] https://journalofethics.ama-assn.org/article/addressing-obstacles-evidence-informed-pain-care/2020-08
[20] https://www.ncbi.nlm.nih.gov/books/NBK569979/
[21] https://www.aafp.org/pubs/afp/issues/2020/0915/p335.html
[22] https://www.frontiersin.org/journals/pain-research/articles/10.3389/fpain.2024.1376462/full
[23] https://www.medcentral.com/pain/chronic/dea-doctors-working-together
[24] https://www.azdhs.gov/documents/prevention/womens-childrens-health/injury-prevention/opioid-prevention/appendix-b-state-by-state-summary.pdf
[25] https://pmc.ncbi.nlm.nih.gov/articles/PMC5632690/
[26] https://www.cdc.gov/mmwr/volumes/71/rr/rr7103a1.htm
[27] https://www.atrainceu.com/content/17-barriers-effective-pain-management
[28] https://pmc.ncbi.nlm.nih.gov/articles/PMC4548284/
[29] https://academic.oup.com/painmedicine/article/21/11/2913/5812909
[30] https://www.acpjournals.org/doi/10.7326/M14-2559
[31] https://www.mdpi.com/2227-9032/12/17/1765
[32] https://digitalcommons.wcl.american.edu/cgi/viewcontent.cgi?article=1071&context=lpb
[33] https://medicare-lawyer.com/dea-raids-doctors-office-in-one-of-the-biggest-opioid-cases-ever-with-essentially-no-evidence/
[34] https://pubmed.ncbi.nlm.nih.gov/16886030/
[35] https://pubmed.ncbi.nlm.nih.gov/31907245/
[36] https://pmc.ncbi.nlm.nih.gov/articles/PMC10588239/


Answer from Perplexity: pplx.ai/share

If the pt has pharmacogenomic tests that support/justified the pt’s need for higher doses does that make any difference in the pt being able to keep their pain therapy when the pt’s PCP is raided/shutdown by the DOJ/DEA

While pharmacogenomic (PGx) testing provides objective data to justify individualized opioid dosing, **it does not meaningfully improve most patients’ ability to maintain their original dose** when displaced by clinic closures. Systemic barriers and prescriber hesitancy often override genetic evidence.

### Key Limitations of PGx Testing in This Scenario:
**1. Legal/Regulatory Pressures Outweigh Scientific Rationale**
– New providers often prioritize DEA scrutiny avoidance over PGx results, even when tests explain dose requirements[1][4].

– PGx-guided dosing (e.g., *CYP2D6* phenotypes) may reduce opioid needs in some patients[2], but this doesn’t protect providers prescribing higher doses to ultra-rapid metabolizers.

**2. Clinical Implementation Gaps**
– Only 24% of PCPs routinely use PGx testing for pain management[3], limiting its utility during care transitions.
– Guidelines explicitly warn against using PGx results alone to justify therapy changes without physician oversight[3][4].

**3. Documentation Challenges**
– PGx reports from shuttered clinics may be dismissed as “pill mill” artifacts by new providers.
– Pharmacy benefit managers often deny prior authorizations regardless of genetic data during clinic transitions[4].

### Potential Niche Benefits:
– **Specialist Referrals**: Pain management specialists may be more likely to consider PGx data when accepting transferred patients[2][4].
– **Litigation Support**: PGx records could help patients prove medical necessity in malpractice/abandonment lawsuits[1].

A 2023 RCT showed PGx-guided prescribing **reduced opioid doses by 42%** while maintaining pain control[2], suggesting genetic testing might help *lower* rather than preserve doses post-closure. In practice, displaced patients with PGx documentation still face **>80% forced tapering rates** due to systemic risk aversion[4].

Citations:
[1] https://www.uspharmacist.com/article/pharmacogenomic-considerations-in-opioid-therapy
[2] https://pmc.ncbi.nlm.nih.gov/articles/PMC10341655/
[3] https://www.pharmacytimes.com/view/unlocking-pain-relief-the-role-of-pharmacogenomics-in-optimizing-opioid-therapy
[4] https://www.pharmacypracticenews.com/Clinical/Pharmacogenomics/Article/09-24/PGx-May-Take-Edge-Off-Pain-Management/74743
[5] https://www.ahdbonline.com/articles/2069-utilizing-pharmacogenomics-when-selecting-personalized-medicine-for-patients-with-chronic-pain
[6] https://onlinelibrary.wiley.com/doi/10.1111/bcpt.13155
[7] https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2793293
[8] https://www.sciencedirect.com/science/article/pii/S075333222100843X
[9] https://www.sciencedirect.com/science/article/abs/pii/S0090825824001409
[10] https://www.pa.gov/content/dam/copapwp-pagov/en/dli/documents/businesses/compensation/wc/conferences/documents/2023-handouts/genetic-testing-for-pharma-effectiveness-presentation.pdf
[11] https://academic.oup.com/oncolo/article/28/3/189/7010651
[12] https://www.ccjm.org/content/87/2/91
[13] https://www.va.gov/painmanagement/docs/cpg_opioidtherapy_summary.pdf
[14] https://www.sciencedirect.com/science/article/pii/S0009912014003890
[15] https://www.bps.ac.uk/getmedia/b43a3dca-1bbf-4bff-9379-20bef9349a8c/Personalised-prescribing-full-report.pdf.aspx
[16] https://www.frontiersin.org/journals/pain-research/articles/10.3389/fpain.2021.721357/full
[17] https://scholarworks.indianapolis.iu.edu/bitstreams/a97b8ad1-8479-43ce-b617-5e858307088b/download
[18] https://pmc.ncbi.nlm.nih.gov/articles/PMC10020807/
[19] https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2814995
[20] https://cpicpgx.org/guidelines/
[21] https://pmc.ncbi.nlm.nih.gov/articles/PMC5935553/
[22] https://www.pharmgkb.org/combination/PA128,PA450741/literature
[23] https://accpjournals.onlinelibrary.wiley.com/doi/10.1002/jac5.1958
[24] https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2797036
[25] https://www.cdc.gov/mmwr/volumes/71/rr/rr7103a1.htm
[26] https://scitechdaily.com/new-research-reveals-dangerous-consequences-of-stopping-opioid-treatment-for-chronic-pain/
[27] https://pmc.ncbi.nlm.nih.gov/articles/PMC10805517/
[28] https://www.bluecrossnc.com/providers/policies-guidelines-codes/commercial/laboratory/updates/pharmacogenetics-testing
[29] https://www.wolterskluwer.com/en/expert-insights/pharmacogenomics-effect-of-gene-variability-on-pain-management
[30] https://www.southcarolinablues.com/web/public/brands/medicalpolicy/external-policies/pharmacogenetic-testing/
[31] https://www.southcarolinablues.com/web/public/brands/medicalpolicyhb/external-policies/pharmacogenetic-testing/
[32] https://pmc.ncbi.nlm.nih.gov/articles/PMC6789586/


Answer from Perplexity: pplx.ai/share

PHARMACOGENOMICS the foundation of PRECISION MEDICINE

PHARMACOGENOMICS

This test was not even around when I was in pharmacy school, nor when I graduated from pharmacy school in 1970. In fact, it is based on our DNA system,m and our DNA was not fully mapped until around 2000. In 2000, I was already 4 years into my FIRST RETIREMENT. By the time that PGx was really starting to gain some serious traction 10-15 yrs ago. I had decided to retire again, which ended up being my FINAL RETIREMENT.  I had no real incentive to wade into the “weeds” of PGx, but I picked up enough knowledge to be “dangerous” concerning PGx.

I learned that there are some 50+ enzymes in our livers that metabolize substances we consume, and not everyone’s enzymes metabolize at the same rate.  We have slow, normal, fast, and ultra-fast metabolizers.

You get a pt dealing with CRPS that is a ultra-fast metabolizer and you got a pt that will need much higher single doses and typically also more frequent doses. And CRPS pts use the McGill pain scale, which is 1 to 50, not the normal 1-10 pain scale.

I ran across this type of exception to the pt’s metabolism. In this example, the pt was a NORMAL METABOLIZER 

OxyCODONE

  • Genotype: CYP2D6 *1/*2 (normal metabolizer), OPRM1 A118G (A/A, normal function)

  • Implication: The patient should have a typical response to oxyCODONE, with no increased risk of poor pain control or opioid toxicity due to metabolism issues

The COMT Val158Met G/G genotype (Val/Val) in this patient indicates high/normal catechol-O-methyltransferase (COMT) enzyme activity, which has implications for pain perception and neurotransmitter regulation. Here’s a detailed analysis:

Biological Mechanism

  • Gene: COMT (chromosome 22q11)

  • Polymorphism: Val158Met (rs4680, G>A substitution)

  • Enzyme Activity:

    • Val/Val (G/G): ~38% higher COMT activity compared to Met/Met (A/A), leading to faster dopamine catabolism in the prefrontal cortex

  • Dopamine modulates pain processing via cortico-subcortical pathways, including the endogenous opioid system.

Impact on Pain Perception

  1. Cognitive Pain Modulation

    • Val/Val carriers show increased activation in dorsolateral prefrontal cortex (DLPFC) during pain processing, linked to cognitive control of pain

  • Higher COMT activity may reduce dopamine availability, potentially diminishing top-down pain inhibition.

  • Opioid Response

    • Val/Val genotype is associated with higher postoperative opioid consumption, possibly due to reduced endogenous opioid signaling

  • Interaction with OPRM1 (mu-opioid receptor gene): Patients with Val/Val + OPRM1 AG/GG genotypes may require larger opioid doses

Imagine having a CRPS pt who is an ultra-fast metabolizer and also has reduced dopamine levels, how many MME/day would they need to have at least a minimum of pain management?


.

what is pharmacogenomics testing?

Pharmacogenomics testing, also known as pharmacogenetic testing, is a type of genetic test that analyzes a person’s DNA to determine how their genes may affect their response to specific medications125. This testing is part of the broader field of precision medicine, which aims to tailor medical treatment to individual characteristics, including genetic makeup, environment, and lifestyle15.

How Pharmacogenomics Testing Works

  • Sample Collection: The test typically uses a sample of saliva, blood, or a cheek (buccal) swab125.

  • Genetic Analysis: The sample is analyzed in a laboratory to identify specific genetic variants-often in genes that encode drug-metabolizing enzymes, drug transporters, or drug targets36.

  • Interpretation: Results indicate whether a person may metabolize certain medications faster, slower, or at an average rate, and whether they are at increased risk for side effects or therapeutic failure235.

  • Clinical Application: Healthcare providers use this information to help choose the most appropriate medication and dosage, aiming to maximize effectiveness and minimize adverse effects125.

Why Pharmacogenomics Testing Is Used

  • Personalized Medication Selection: Helps predict which medications are likely to be most effective or cause fewer side effects for an individual15.

  • Dose Optimization: Assists in determining the safest and most effective dose for a patient15.

  • Adverse Reaction Prevention: Identifies patients at risk for serious side effects from certain medications, allowing for alternative therapies to be considered127.

Examples of Medications with Pharmacogenomics Guidance

Pharmacogenomics testing is available for a growing list of medications, including:

  • Blood thinners (e.g., warfarin, clopidogrel)

  • Certain antidepressants and antipsychotics

  • Cancer therapies (e.g., tamoxifen)

  • HIV treatments (e.g., abacavir)

  • Epilepsy medications (e.g., carbamazepine)137

Key Points

  • Not everyone responds to medications the same way due to genetic differences157.

  • Pharmacogenomics testing can improve treatment outcomes by guiding drug and dose selection125.

  • The test is usually performed before starting a new medication or when a patient has had problems with standard treatments17.

  • Testing is not available for all medications, and its integration into routine clinical practice is still evolving3.

Summary Table

Aspect Description
What is tested? Genetic variants affecting drug metabolism and response
Sample type Saliva, blood, or cheek swab
Purpose Guide medication and dosage selection; reduce side effects
Clinical use Before starting new meds, after adverse reactions, or lack of efficacy
Common drug classes tested Antidepressants, antipsychotics, blood thinners, cancer drugs, HIV meds

Pharmacogenomics testing represents a significant advance in personalized medicine, offering the potential for safer, more effective drug therapy tailored to each individual’s genetic profile125.

Citations:

  1. https://medlineplus.gov/lab-tests/pharmacogenetic-tests/
  2. https://my.clevelandclinic.org/health/articles/pharmacogenomics
  3. https://www.ncbi.nlm.nih.gov/books/NBK595332/
  4. https://www.mayo.edu/research/centers-programs/center-individualized-medicine/patient-care/pharmacogenomics
  5. https://www.genome.gov/about-genomics/educational-resources/fact-sheets/pharmacogenomics
  6. https://www.southcarolinablues.com/web/public/brands/medicalpolicyhb/external-policies/pharmacogenetic-testing/
  7. https://kidshealth.org/en/parents/pharmacogenomics.html
  8. https://www.cdc.gov/genomics-and-health/pharmacogenomics/index.html
  9. https://genomind.com/solutions/pharmacogenetic-testing/
  10. https://med.stanford.edu/cvi/mission/news_center/articles_announcements/2021/the-problem-with-pharmacogenetic-testing.html

Answer from Perplexity: pplx.ai/share

FDA sends warning letters to Amazon, three OTC drugmakers, and a drug compounder

FDA sends warning letters to Amazon, three OTC drugmakers, and a drug compounder

https://www.raps.org/News-and-Articles/News-Articles/2025/4/FDA-sends-warning-letters-to-Amazon,-three-OTC-dru

The US Food and Drug Administration (FDA) has sent another warning letter to online retail giant Amazon for distributing unapproved new drugs. Additionally, three manufacturers of over-the-counter (OTC) medications received warnings for good manufacturing practice (GMP) violations, and a drug compounding pharmacy was warned for making sterile drugs under unsanitary conditions.
 
All five warning letters were posted on April 29, and all were sent to manufacturers or distributors in the United States.
 
Amazon cited for distributing unapproved new drugs
 
FDA’s warning letter to Amazon cited the company for distributing unapproved new drugs intended for use as external analgesics on the skin during or after tattooing, piercing, or laser hair removal.
 
The letter states that “your firm is responsible for introducing or delivering for introduction into interstate commerce these products, which are unapproved new drugs under section 505(a) of the [Federal Food, Drug, and Cosmetic Act] FD&C Act, 21 U.S.C. 355(a).” It further noted that “introducing or delivering these products for introduction into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act, 21 U.S.C. 331(a) and (d).”
 
FDA said it purchased seven offending products via Amazon’s website, including “Painless Tattoo: Tattoo Numbing Cream,” “Ink Scribd: Numbing Cream,” “Nupharmisto: Tattoo Numbing Cream,” “QWP: Painless Tattoo,” “Kaisasa: Tattoo Numbing Cream,” “Painless Tattoo: Tattoo Triple Numb,” and “TKTX 40%.”
 
“FDA has safety concerns about external analgesic drug products formulated with active ingredients at concentrations that exceed levels currently permitted for nonprescription external analgesic products, because they are intended to be used before or during certain cosmetic procedures in ways that could lead to increased absorption of the drug product through the skin,” the agency wrote.
 
The products also do not conform to the OTC Monograph M017 governing external analgesics for OTC use, FDA said.
 
FDA has been cracking down on online retailers for selling unapproved drug products.  Amazon was also cited in two other recent warning letters for similar violations.
 
Other recent actions against the company include a warning letter sent in March 2025 for distributing injectable products used to dissolve fat and a warning letter in 2023 for selling unapproved drugs to treat a viral skin condition. (RELATED: FDA warns Amazon, Walmart and others for selling unapproved drugs for viral skin infection, Regulatory Focus 22 August 2023)
 
Cosco International failed to validate manufacturing processes
 
FDA also cited Cosco International for numerous GMP violations for its (OTC) products Berberex Wound Gel, Asystem Pain Roll On, Forticept Antimicrobial Gel, and Forticept Antiseptic Ear Flush.
 
FDA inspected the Marietta, GA-based firm in October 2024 and cited it for failing to validate its manufacturing processes for OTC drugs, including topical drugs intended for wound treatment in children.
 
“You failed to adequately validate your manufacturing processes to demonstrate that your processes are reproducible and controlled to consistently yield drug products of uniform character and quality. For example, your OTC drug products, Berberex Wound Gel, Asystem Pain Roll On, Forticept Antimicrobial Gel, and Forticept Antiseptic Ear Flush, were manufactured without adequate process qualification studies,” said FDA.
 
The company failed to conduct cleaning validation studies for making products produced on shared equipment. These products contain active ingredients such as menthol, benzalkonium chloride, lidocaine, or ketoconazole, in addition to manufacturing cosmetic items. FDA said that the company “failed to demonstrate that your cleaning procedures can prevent potential cross-contamination between the various drug and cosmetic products mixed and filled on the same shared equipment.”
 
The firm also lacked stability data to show that the product met specified standards. The company distributed drugs intended for wound treatment without conducting accelerated or long-term stability studies.
 
Additionally, the company failed to test its products for bacteria, fungi, and objectionable microorganisms, such as Burkholderia cepacia complex (BCC), and Pseudomonas species in its water testing.
 
Dyno International did not test components
 
Dyno Manufacturing was also cited for violations concerning component testing and failing to have a stability testing program for its OTC hand sanitizers and antibacterial hand soap products.  
 
The company, based in Madison, IL, failed to adequately test incoming raw materials, including identity testing of each shipment of each component lot for ethanol, glycerin, or propylene glycol. The firm accepted the at-risk components based on their suppliers’ certificate of analysis (COA).
 
The company also lacked a stability testing program to support the expiration date of drug products. The FDA said the company did not perform any stability studies for your OTC hand sanitizer and antibacterial hand soap drug products to support their assigned expiration dates.
 
BEO Pharma lambasted for failure to test components
 
Another company, BEO Pharmaceuticals Inc. of Brooksville, FL, was also cited for failing to test incoming components used in its OTC liquid drug products. The company makes shampoos, hair serums, and skin lighteners.
 
The company failed to adequately test each lot of active pharmaceutical ingredient (API) for identity prior to use in your OTC drug products and relied on their suppliers’ certificate of analysis (COA) without establishing the reliability of your component suppliers’ test analyses at appropriate intervals.
 
The company also failed to adequately test each shipment or lot for components contaminated with high-risk diethylene glycol (DEG) or ethylene glycol (EG).
 
FDA also warned the company for failing to demonstrate that its microbiological test methods could ensure the product conformed to “appropriate standards of identity, strength, quality, and purity.”
 
Lastly, the company was faulted for failing to retain reserve samples of incoming raw materials, including APIs and high-risk components, in accordance with their written procedures.
 
Compounding pharmacy cited for unsanitary conditions
 
Drug compounding pharmacy Empower Pharmacy, based in Houston, TX, was cited for making drug under unsanitary conditions and failing to produce drugs in a sterile environment.
 
During the inspection, FDA “noted serious deficiencies in your practices for producing drug products, which put patients at risk.”
 
FDA investigators found that drug products intended to be sterile were prepared under insanitary conditions, “Whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501(a)(2)(A) of the FDCA.”
 
The firm failed to perform routine environmental monitoring, and media fills were not performed under challenging or stressful conditions. FDA said that “there is a lack of assurance that your firm can aseptically produce drug products within your facility.”
 
The firm also failed to sterilize equipment located in the ISO 5 area. For example, the firm did not sterilize the stopper sorting bowl, supply hopper, and insertion station that come into contact with stoppers used to produce injectable drug products.
 
Empower was previously warned by FDA in a similar letter issued in 2021.
 
All of the companies were given 15 days to respond to the warning letters.
 
Amazon, Cosco, Dyno, BEO Pharmaceuticals, Empower

If a practitioner falsifies a pt’s medical records – what could be the consequences?

A pt made a statement to me about a practitioner falsifying their blood pressure in the pt’s medical records, The pt claimed that the practitioner put the BP as LOWER than the practitioner measured it during an office visit. This was just another chronic pain pts who had their opioid reduced and their blood pressure SPIKED, and as typical, the practitioner could not see the relationship of reducing the pt’s opioids and the SPIKE in the pt’s blood pressure.

I knew such actions by a practitioner were at least unprofessional, so I went out to www.perplexity.ai and asked the question:

Falsifying a patient’s medical record-such as entering a lower blood pressure reading than what was actually measured during an office visit-is both illegal and unethical.

We all have to keep in mind what we are often told by politicians and bureaucrats: “NO ONE IS ABOVE THE LAW ..” but it seems like that is only half of an accurate saying, it should be finished with “.. except for those who are in charge of enforcing our laws…”

Of course, I am not going to “bet the farm” on some oversight entity – medical licensing board, insurance company, Joint Commission, or corporate employer to take action against a practitioner who is caught falsifying a pt’s medical records, but one can only hope!

  • Falsification Defined: Falsifying medical records involves intentionally altering, fabricating, or omitting information in a patient’s health documentation with the intent to deceive or mislead. This includes inaccurately noting vital signs like blood pressure14.

  • Criminal Offense: Such actions are considered a crime in most jurisdictions. Penalties can include fines, imprisonment, and loss of professional licensure. For example, in some states, falsifying medical records can be prosecuted as a felony, carrying potential jail time and significant fines245.

  • Professional Consequences: Healthcare providers who falsify records risk disciplinary action by licensing boards, including suspension or revocation of their license to practice124.

Ethical and Professional Implications

  • Breach of Trust: Falsifying records undermines the trust between patients and healthcare providers and can compromise patient safety, leading to inappropriate or harmful medical decisions14.

  • Malpractice Liability: If falsification is discovered, it can severely undermine the credibility of the provider and may increase liability in malpractice claims, as altered records are often used as evidence in legal proceedings12.

Case Example

A federal investigation found that a provider knowingly entered false blood pressure readings (e.g., 120/80) into patient records during virtual visits. This was determined to be a violation of ethical standards and documentation policy, creating a potential threat to patient care, even if no immediate harm was identified3.

Summary Table

Action Legal Status Potential Penalties
Falsifying blood pressure in records Illegal & unethical Fines, imprisonment, license loss
Omitting or altering other vital signs Illegal & unethical Same as above

In summary: Intentionally entering a lower blood pressure reading than was actually taken is illegal, unethical, and can result in criminal charges, civil liability, and professional discipline1245. Accurate documentation is a legal and ethical obligation for all healthcare professionals.

Citations:

  1. https://www.nicholllaw.com/blog/falsifying-medical-records-and-medical-malpractice-claims/
  2. https://www.lezdotechmed.com/blog/consequences-of-medical-record-tampering-in-medical-malpractice-claim/
  3. https://www.vaoig.gov/sites/default/files/reports/2023-01/VAOIG-22-00707-44.pdf
  4. https://www.ifaxapp.com/hipaa/falsifying-medical-records/
  5. https://www.reddit.com/r/legaladvice/comments/c4p8jq/nurse_falsified_my_medical_records_illegal_or/
  6. https://chartrequest.com/falsification-medical-records/
  7. https://www.vaoig.gov/sites/default/files/reports/2019-01/VAOIG-18-05410-62.pdf
  8. https://whistleblowerlaw.com/falsifying-medical-records/
  9. https://www.ama-assn.org/delivering-care/hypertension/4-big-ways-bp-measurement-goes-wrong-and-how-tackle-them
  10. https://www.stanleyfriedmanlaw.com/falsifying-medical-records-defense/
  11. https://www.ems1.com/ems-products/medical-monitoring/articles/5-errors-that-are-giving-you-incorrect-blood-pressure-readings-zJNOHnFJZOocufoS/
  12. https://www.millerandzois.com/medical-malpractice/maryland-medical-malpractice-laws/doctor-alter-records/
  13. https://www.heart.org/en/news/2024/06/25/the-rules-for-measuring-blood-pressure-and-why-they-exist
  14. https://www.flsenate.gov/Laws/Statutes/2011/0395.302
  15. https://journalofethics.ama-assn.org/article/disclosing-error-patient-physician-patient-communication/2005-08
  16. https://www.ama-assn.org/practice-management/hipaa/hipaa-violations-enforcement
  17. https://www.uabmedicine.org/news/anxiety-or-calm-can-cause-false-blood-pressure-readings/
  18. https://journals.lww.com/nursing/fulltext/2005/12000/when_a_colleague_falsifies_the_record.60.aspx
  19. https://www.reddit.com/r/nursing/comments/1du9sra/nurse_encouraged_to_falsify_medical_records_by/
  20. https://oig.hhs.gov/compliance/physician-education/fraud-abuse-laws/

Answer from Perplexity: pplx.ai/share

Why is the PBM industry all of a sudden running a lot of TV ads on how much money they save pts

It is obvious that the PBM industry is feeling the pressure from bureaucrats, politicians, and those who pay premiums for healthcare.

It is interesting that in this advertisement, CHASE, who claims to be the Prescription Benefit Manager (PBM). States that the patient will pay ~ 50% less than what they would have paid cash for their prescription.

Which may be TRUE – HOWEVER – what he doesn’t mention is that the PBM may be demanding up to 75% discount, rebate, or kickback off of the Average Wholesale Price -from the pharma so that they don’t make the pharma’s med a non-formulary med and would require your doctor to file a prior authorization to get the medication that your doctor prescribed for you covered.

“CHASE” also didn’t say that the PBM would charge your insurance company and/or your employer if your insurance is an ERISA prgm – where the employer is self-funding all medical cost for their employees and their family, maybe something like 5 to 10 times what they SAVED THE PATIENT from paying cash.

Recently Arkansas passed a law HB1150 prohibits state permits to pharmacies owned by pharmacy benefit managers effective Jan. 1, 2026. Here is CVS’ response CVS may close stores in Arkansas following law banning PBMs from owning pharmacies  Because CVS owns Caremark, the largest PBM in the country and CVS has only 23 stores in Arkansas. Nationally CVS has about 9100 pharmacies in the USA. CVS has already scheduled to close 10% of its stores over the next 3 yrs.

CVS Will Close 900 Stores Over Next 3 Years, Convert to New Store Formats

Obviously, it is clear where CVS makes most of their profits. How many pharmacy deserts will closing those 900 pharmacies create?

The above TV is just one of many for the PBM industry – you just need to go to www.youtube.com and type in “prescription benefit manager tv ads” and see all the TV ads that come up for the PBM industry defending how they are saving you money.

FDA contemplating taking Long Acting Opioids off the market -how do we make American Healthy Again?

What does MAKE AMERICA HEALTHY AGAIN really mean? Is a person’s QOL (Quality of Life) part of a person being HEALTHY?

Technically, our President is the head of the LAW ENFORCEMENT branch of our government

The three branches of government are the legislative branch, which makes laws; the executive branch, which enforces laws; and the judicial branch, which interprets laws. This structure helps ensure a separation of powers and a system of checks and balances among the branches.

The president of the United States takes the following oath: “I do solemnly swear (or affirm) that I will faithfully execute the Office of President of the United States, and will to the best of my ability, preserve, protect and defend the Constitution of the United States.” This oath is specified in Article II, Section 1 of the U.S. Constitution.

42 USC 1395: Prohibition against any Federal interference

https://uscode.house.gov/view.xhtml?req=(title:42%20section:1395%20edition:prelim)

From Title 42-THE PUBLIC HEALTH AND WELFARE CHAPTER 7-SOCIAL SECURITY SUBCHAPTER XVIII-HEALTH INSURANCE FOR AGED AND DISABLED

§1395. Prohibition against any Federal interference

Nothing in this sub chapter shall be construed to authorize any Federal officer or employee to exercise any supervision or control over the practice of medicine or the manner in which medical services are provided, or over the selection, tenure, or compensation of any officer or employee of any institution, agency, or person providing health services; or to exercise any supervision or control over the administration or operation of any such institution, agency, or person.

(Aug. 14, 1935, ch. 531, title XVIII, §1801, as added Pub. L. 89–97, title I, §102(a), July 30, 1965, 79 Stat. 291 .)

Statutory Notes and Related Subsidiaries

Short Title

For short title of title I of Pub. L. 89–97, which enacted this subchapter as the “Health Insurance for the Aged Act”, see section 100 of Pub. L. 89–97, set out as a Short Title of 1965 Amendment note under section 1305 of this title.

Protecting and Improving Guaranteed Medicare Benefits

Pub. L. 111–148, title III, §3601, Mar. 23, 2010, 124 Stat. 538 , provided that:

“(a) Protecting Guaranteed Medicare Benefits.-Nothing in the provisions of, or amendments made by, this Act [see Short Title note set out under section 18001 of this title] shall result in a reduction of guaranteed benefits under title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.].

“(b) Ensuring That Medicare Savings Benefit the Medicare Program and Medicare Beneficiaries.-Savings generated for the Medicare program under title XVIII of the Social Security Act under the provisions of, and amendments made by, this Act shall extend the solvency of the Medicare trust funds, reduce Medicare premiums and other cost-sharing for beneficiaries, and improve or expand guaranteed Medicare benefits and protect access to Medicare providers.”

I remember when Biden was President and he made several EOs and the SCOTUS would declare that the EO was UNCONSTITUTIONAL, and Biden would state that the SCOTUS WAS WRONG and proceed, mostly by giving away some money like forgiving or paying off student loans. Since our President is the head of our executive branch that enforces our laws and our Fed AG basically serves at the pleasure of our President.

Maybe someone should point out to President Trump that the FDA is considering taking long-acting opioids off the market. About 30% of our population is dealing with chronic pain, and long-acting opioids can be the only answer for a chronic pain pt to get a full night of RESTORATIVE SLEEP. Without a full night of RESTORATIVE SLEEP, the chronic pain pt’s QOL (Quality of Life) may go into a spiral downhill.

The question is … that law mentioned above, that has been the law of our land since 1935, 35 years before the Controlled Substances Act was signed into law. If Trump is not interested, maybe Kennedy would be interested in bending some ears.

Many on Capitol Hill keep stating that “NO ONE IS ABOVE THE LAW…”, but they never seem to finish the sentence, “except those who are in charge of enforcing our laws..” This one law seems to be an excellent example of that saying.

How can 30% of the population be HEALTHY AGAIN if certain groups keep pushing for needed medicine to be restricted or taken off the market?

Trump Policies at Odds With ‘Make America Healthy Again’ Push

https://www.medpagetoday.com/publichealthpolicy/washington-watch/115460

The contradictions raise doubts about the sincerity of Trump’s support for the MAHA agenda

In his March address to Congress, President Trump honored a Texas boy diagnosed with brain cancer. Amid bipartisan applause, he vowed to drive down childhood cancer rates through his “Make America Healthy Again (MAHA)” initiative.

A few days later, the administration quietly dropped a lawsuit to cut emissions from a Louisiana chemical plant linked to cancer.

At first glance, Trump appears to have fully embraced the MAHA movement championed by HHS Secretary Robert F. Kennedy Jr. From proclaiming in his congressional speech a goal to “get toxins out of our environment” to launching a new commission to study cancer and other ailments, Trump has vowed to end what he calls an epidemic of chronic disease.

But even as he extols MAHA, Trump has unleashed a slew of policies likely to make Americans less healthy. He’s slashing 20,000 full time positions  from HHS and cutting more than $4 billion in indirect costs related to health research grants, including studies into treatment for Alzheimer’s and cancer. He also supported a GOP plan likely to kneecap Medicaid, a joint federal-state program that covers about 72 million Americans.

The contradictions raise doubts about the sincerity of Trump’s support for the MAHA agenda and his administration’s commitment to making a dent in chronic disease — conditions that afflict about 133 million Americans and account for roughly 90% of the $4.5 trillion  spent annually in the U.S. on healthcare.

The administration’s attention to chronic disease is also notable for its lack of focus on expanding health insurance. Research shows people with coverage have lower death rates; insurance provides free or low-cost preventive care that can help manage chronic disease and reduce risks of serious complications.

“The layoffs at HHS, cuts to Medicaid, and reduction in research could all end up resulting in less healthy Americans,” said Larry Levitt, executive vice president for health policy at KFF. “They’re talking about getting at the root causes of chronic disease. Less research and protections will undermine that goal.” KFF is a health information nonprofit that includes KFF Health News.

HHS leaders have said that they focused personnel cuts at agencies on redundant or unnecessary administrative positions. The administration has said the job cuts will save money and make HHS more responsive.

“Streamlining bureaucracy and eliminating redundancies is how we deliver on the mission of Making America Healthy Again — not by preserving a bloated system that’s failed to improve outcomes despite record spending,” HHS spokesperson Vianca Rodriguez Feliciano said in an email.

Public health advocates say the staffing cuts run counter to the promise of a MAHA agenda dedicated to reducing chronic disease.

“HHS declared that their mission is to Make America Healthy Again,” said Sharon Gilmartin, MPH, executive director of Safe States Alliance, on a press call. The alliance is a nonprofit focused on preventing injury and violence. “How can we do that when the people who have spent decades of their life combating the health issues of our nation are being tossed out with no notice?”

The HHS workforce reductions decimated divisions focused on chronic disease.

Gone is most of the CDC’s population health division, which conducted research and developed public health programs on chronic disease. Gone, too, are staffers at the NIH who focused on Alzheimer’s research. After HHS staffers working on Alzheimer’s projects were put on administrative leave, the Alzheimer’s Association sounded the alarm about the cuts, saying in an April 1 statement that the reductions “could cause irreversible damage.”

And gone is the CDC’s Office on Smoking and Health which worked to protect the public from the harmful effects of tobacco use. The administration also gutted the FDA’s Center for Tobacco Products, which enforces advertising restrictions. Tobacco use is the leading preventable cause of disease, disability, and death in the country.

“Cuts to CDC and FDA tobacco control programs are devastating,” Tom Frieden, MD, MPH, who served as director of the CDC from 2009 to 2017, said April 18  on the social media platform Bluesky.

According to administration fact sheets and press releases, the staffing cuts will save $1.8 billion a year and shrink HHS’ workforce from 82,000 to 62,000 full-time employees. HHS will be retooled to focus on “safe, wholesome food, clean water, and the elimination of environmental toxins,” according to a March 27 press statement  The restructuring will improve Americans’ experience with HHS by making the agency more responsive and efficient, the statement said.

Roger Severino, a lawyer who led the HHS Office for Civil Rights during the previous Trump administration, said the job cuts are necessary because the HHS budget has grown while American health has declined.

“If you want to Make America Healthy Again, you have to make HHS healthy again. You have to trim the bureaucratic fat,” said Severino, who is now vice president of domestic policy at the Heritage Foundation, a conservative policy group. “We haven’t seen chronic disease go down or obesity go down, while autism rates are up. If this were a private company, it would have gone bankrupt years ago.”

But many public health experts question how the federal government will be able to respond to existing problems, as well as new health issues, with fewer employees and resources.

Infectious diseases are one area of concern.

Trump, on the first day of his second term in office, withdrew the nation from the World Health Organization (WHO), which detects, monitors, and responds to emerging health threats. The U.S. has been the largest financial contributor to the organization.

Without membership, the U.S. may remain in the dark if the WHO identifies an emerging threat that could ultimately spread and become global. Spillover can happen: In 2014, an Ebola outbreak in West Africa led to 11 reported cases in the U.S. The WHO played a central role in developing infection-prevention protocols and provided logistical support to affected countries.

The evisceration of the U.S. Agency for International Development could also leave the nation more vulnerable because the agency worked with countries such as Vietnam on early detection of diseases including bird flu. The agency typically would have aided in the response to a current Ebola outbreak in Uganda, providing support that doctors say helped prevent spread in past outbreaks.

The staffing reductions and frozen or canceled grants are having an immediate impact on the ability to respond to infectious outbreaks . Right now, for instance, Texas is in the throes of a measles outbreak, with more than 500 confirmed cases.

But the administration’s funding cuts forced the Dallas County health department to lay off 11 full-time workers and 10 part-time staffers responsible for responding to such outbreaks, Philip Huang, MD, MPH, director and health authority for the Dallas County Health and Human Services Department, said at a press event.

The administration has also imperiled ongoing research, including studies and trials related to chronic disease.

Trump ended hundreds of research projects at the NIH totaling more than $2 billion, including projects on HIV prevention drugs and Alzheimer’s disease research.

“Patients enrolled in NIH studies led by Plaintiffs face abrupt cancellations of treatment in which they have invested months of time with no explanation or plan for how to mitigate the harm,” according to a federal lawsuit filed in Massachusetts by scientists and researchers.

The research being cut could potentially have supported Trump’s pledge, when he honored the boy with brain cancer, to drive down rates of the disease. In the weeks since, however, Trump’s administration announced plans to weaken  automobile tailpipe emission standards. Trump slashed more than 400 grants to Columbia University, including millions earmarked for a cancer center.

“It’s making people sicker again. Now that would be a more honest bumper sticker,” said Leslie Dach, a former Obama administration official who is the executive chair of Protect Our Care, which advocates for the Affordable Care Act. “They’re stopping research on vaccines and gutting healthcare programs that keep 100 million Americans healthy. It’s all show. It’s a bunch of junk.”

Just another DEAD PT WALKING?

Last night I was contacted by a chronic pain pt. This pt is a chronic pain pt, but what she described to me was that she had a shattered patella.

In seeing her PCP, her BP was 220/110 and her PCP told the pt that he could not prescribe any more pain meds. He was at the “LIMIT” that he could prescribe.

The PCP called the pt’s pain clinic and that clinic was SO CONCERNED that they moved the pt’s appt UP ONE WEEK, so that made the pt’s appt at the pain clinic ONLY TWO WEEKS AWAY.

What I find interesting, both the PCP & the pain doc are EMPLOYEES OF THE SAME LARGE HOSPITAL SYSTEM.

In fact the hospital claims – on their website – to be the LARGEST HOSPITAL IN OHIO – 1,059-bed, teaching hospital , whose mission “to improve the health of those we serve.” Our caring and compassionate teams do this through providing the best patient experience possible, and  is a Level II trauma center.

This is the chart from the American Heart Assoc on the various levels of blood pressure and classification, and this pt’s blood pressure falls in the HYPERTENSIVE CRISIS LEVEL (consult your doctor immediately)

I told the pt that I would contact both of the practitioners but the pt declined.

When is AG Bondi going to enforce 42 USC 1395 and quit discriminating against disabled Seniors

It is FED AG Pam Bondi who is in charge of seeing that all of our laws are enforced.  RFK Jr wants to make America Healthy Again. Yet Bondi seems to be out of step with MAHA. Can anyone be HEALTHY and have their QOL that is in the gutter and/or circling the drain?

This law has been on the books since 1935, 35 yrs before the Controlled Substances Act was signed into law.

42 USC 1395: Prohibition against any Federal interference

https://uscode.house.gov/view.xhtml?req=(title:42%20section:1395%20edition:prelim)

From Title 42-THE PUBLIC HEALTH AND WELFARE CHAPTER 7-SOCIAL SECURITY SUBCHAPTER XVIII-HEALTH INSURANCE FOR AGED AND DISABLED

§1395. Prohibition against any Federal interference

Nothing in this sub chapter shall be construed to authorize any Federal officer or employee to exercise any supervision or control over the practice of medicine or the manner in which medical services are provided, or over the selection, tenure, or compensation of any officer or employee of any institution, agency, or person providing health services; or to exercise any supervision or control over the administration or operation of any such institution, agency, or person.

(Aug. 14, 1935, ch. 531, title XVIII, §1801, as added Pub. L. 89–97, title I, §102(a), July 30, 1965, 79 Stat. 291 .)

Statutory Notes and Related Subsidiaries

Short Title

For short title of title I of Pub. L. 89–97, which enacted this subchapter as the “Health Insurance for the Aged Act”, see section 100 of Pub. L. 89–97, set out as a Short Title of 1965 Amendment note under section 1305 of this title.

Protecting and Improving Guaranteed Medicare Benefits

Pub. L. 111–148, title III, §3601, Mar. 23, 2010, 124 Stat. 538 , provided that:

“(a) Protecting Guaranteed Medicare Benefits.-Nothing in the provisions of, or amendments made by, this Act [see Short Title note set out under section 18001 of this title] shall result in a reduction of guaranteed benefits under title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.].

“(b) Ensuring That Medicare Savings Benefit the Medicare Program and Medicare Beneficiaries.-Savings generated for the Medicare program under title XVIII of the Social Security Act under the provisions of, and amendments made by, this Act shall extend the solvency of the Medicare trust funds, reduce Medicare premiums and other cost-sharing for beneficiaries, and improve or expand guaranteed Medicare benefits and protect access to Medicare providers.”

AI answers are not infallible and incorrect information can be challenged to make them look again

Here are two inquiries and responses from Grok, which can be found within the X/Twitter website. The first was fairly factual. IMO, most of the opioid deaths were from Pharma opioids that were diverted. People would go to a “Oxy doc” and get some meds and sell half of what they got, to help pay for their half and what they had to pay to travel over several states to get to a “oxy doc’s office” to get a Rx.
1-An overview of my conversation with @Grok, on how the ‘opioid crisis’ scam is harming vulnerable patients/ a scam that’s led to policies which severely limit access to opioids, benzodiazepines, and ADHD medications, devastating patients who rely on them.
2-“Overprescribing” lacks a clear legal or medical definition. It is a made up term that emerged in the late 1990s and 2000s as a catch-all term to describe high prescription opioid volumes based on a medically baseless maximum ‘morphine milligram equivalent’, or MME.
3-The made up term was popularized by media, advocacy groups, and regulators to frame prescription opioids as the primary driver of rising overdose deaths, despite limited evidence isolating their impact from illicit drugs.
4-The rx litigation narrative gained traction with reports like the CDC’s 2011 claim that prescription opioid overdoses drove the crisis, ignoring that death certificates often listed “opioids” without distinguishing between prescription and illicit sources.
5-This conflation was exacerbated by the lack of routine testing for IMF until the mid-2000s, when forensic labs began widely adopting mass spectrometry to detect fentanyl analogs.
6-Illicitly manufactured fentanyl (IMF) has been documented since the 1970s, with early outbreaks like the 1980s “China White” epidemic in California. However, until the mid-2000s, most coroners’ offices lacked the capability to test for fentanyl or its analogs,
7-Instead, reports on cause of death relied on basic toxicology panels that flagged “opioids” generically. A 2006 Journal of Analytical Toxicology study noted that fentanyl-related deaths were likely underreported due to testing limitations, skewing data toward Rx opioids.
8-By the time testing improved (post-2005), IMF was already surging, but the “overprescribing” narrative was entrenched. CDC data shows prescription opioid deaths peaked around 2011 (~17,000 annually), while fentanyl-driven deaths skyrocketed after 2013…
9- (street fentanyl deaths) reaching 82,000 of 108,000 total overdose deaths in 2022. The early absence of IMF testing falsely inflated the perceived role of prescription opioids, justifying restrictive policies.
10-Access Denied: The CDC’s 2016 opioid prescribing guidelines, rooted in the hyperbolic “overprescribing” narrative, set arbitrary dose limits (e.g., 90 morphine milligram equivalents), leading doctors and pharmacies to refuse or taper patients with chronic pain conditions…
11-People with conditions like neuropathy, rheumatoid arthritis, EDS, Fibromyalgia, severe injuries, even terminal cancer. A 2021 Pain Medicine study found 25–50% of pain patients lost access to opioids post-2016, with many reporting untreated pain and reduced quality of life.

This response seems to be Grok giving a summary of mostly “fake news” headlines. It seem to flip back and forth between talking about Fentanyl and illicit Fentanyl or Fentanyl mostly sourced illegally. The time frame mentioned was a period when during the Decade of Pain Law was in effect.
I presume that the numbers stated were from the CDC. It mentioned so many prescriptions per 100,000 people. Which is mostly meaningless, since the prescriptions could be for Oxycontin/Oxycodone 5mg to 30 mg IR and Oxycontin/Oxycodone 10mg to 80 mg ER. Likewise, the number of doses per prescription could be anywhere up to 90 days supply.
Who believes that prescribed opioids dropped 55%, and yet the reported pharma opioids OD/poisoning dropped ~ 1%.
From Grok: Opioid overdoses stem from both illegal street drugs and overprescribing by doctors, but the balance has shifted over time. Data from the CDC shows that from 1999 to 2011, overdoses were heavily driven by prescription opioids, with deaths linked to drugs like oxycodone and hydrocodone peaking due to widespread prescribing. By 2010, the U.S. saw about 1.8 million prescriptions per 100,000 people, and prescription opioid deaths reached 16,917 in 2011. Since then, illegal street drugs, particularly illicit fentanyl, have become the dominant driver. By 2021, of the 106,699 total drug overdose deaths, over 70,000 involved synthetic opioids like fentanyl, mostly sourced illegally. Fentanyl’s rise is tied to its potency and infiltration into heroin, cocaine, and counterfeit pills. Prescription opioid deaths, while still significant, dropped to around 16,706 by 2021 as prescribing rates fell—down to about 0.8 million per 100,000 people by 2020 due to tighter regulations and monitoring. Both factors interplay: overprescribing initially fueled addiction, pushing some users to street drugs when prescriptions became harder to obtain. Now, illegal fentanyl’s accessibility and lethality overshadow prescription-related deaths, though the latter remains a persistent issue.

Normally, I use www.perplexity.ai and I learned early on that these AI programs can be biased or use the most frequently stated information in the various media. Which should not be a surprise since a few companies own/manage a large segment of the news media. I did find out when the AI was incorrect or “off base” that I could tell it to go back out and “dig a little deeper for the truth” and they will come back and give more correct information. Now if they continue to use the new information if others ask similar questions they use that or fall back to the information that they provided me?