Federal Indictment Against NJ Doctor Collapses in Stunning DOJ Reversal

https://www.healthlawalliance.com/blog/federal-indictment-against-nj-doctor-collapses-in-stunning-doj-reversal

Anthony Mahajan Obtains Dismissal of All Charges Involving Speaker Program Kickbacks and Violations of the Controlled Substances Act

In a dramatic and virtually unprecedented move, the U.S. Department of Justice has dismissed its entire criminal case against New Jersey urologist Dr. Mukaram Gazi, who had faced federal charges for allegedly accepting more than $130,000 in bribes from Insys Therapeutics for “sham” speaker program engagements and for unlawful drug distribution of fentanyl and Adderall, Schedule II controlled substances.

The four-count indictment—once part of a national crackdown on opioid-related misconduct—was dismissed by the court in full, with no plea deal, no fine, and no admission of guilt. All charges were dropped, including Anti-Kickback Statute violations, healthcare fraud, conspiracy to defraud the United States, and violations of the Controlled Substances Act.

With this sweeping dismissal, Dr. Gazi stands alone as the only individual in the Nation indicted over Insys-related charges to defeat the case entirely and emerge fully exonerated. Since 2014, thirty-five (35) individuals, including Insys’ founder John Kapoor, have been prosecuted for their roles in various Insys-related schemes, with some receiving sentences of over 20 years.

The victory was secured by Anthony Mahajan, a former federal prosecutor and now founding partner of Health Law Alliance, a national healthcare law firm based in Short Hills, New Jersey.

“This is the type of outcome you almost never see,” said one legal observer familiar with federal healthcare prosecutions. “Once the DOJ indicts, especially in the District of New Jersey, dismissals just don’t happen.”

The case against Dr. Gazi had been announced with fanfare in November 2021, linking him to the now-defunct Insys Therapeutics—the pharmaceutical company whose executives were convicted in one of the most high-profile opioid prosecutions in U.S. history. Central to Dr. Gazi’s defense, however, was that the law permits, and even encourages, physicians to prescribe medication “off-label” for the advancement of medicine. Similarly, the law permits physicians to receive compensation from drug manufacturers to promote their products, typically referred to as “speaker program” fees.

Health Law Alliance has positioned itself at the forefront of defending healthcare professionals in high-stakes legal battles. The firm’s decisive handling of this case suggests that, despite the public condemnation of fentanyl, physicians should not be intimidated against prescribing the medication that they deem most suitable for their patients. Health Law Alliance will defend physicians’ professional expertise and judgment against challenge by government regulators.

For further information, contact us.

Frequently Asked Questions

Q: What was the outcome of the federal indictment against Dr. Mukaram Gazi?

A: Dr. Mukaram Gazi, a New Jersey urologist, had all federal charges against him dismissed by the U.S. Department of Justice. The dismissal included allegations of Anti-Kickback Statute violations, healthcare fraud, conspiracy to defraud the U.S., and unlawful Adderall distribution. Health Law Alliance successfully secured a complete dismissal with no plea deal, no fine, and no admission of guilt.

Q: Why was Dr. Gazi facing federal charges?

A: Dr. Gazi was accused of accepting payments from Insys Therapeutics to prescribe a fentanyl-based spray manufactured by Insys. The DOJ alleged that these payments were illegal kickbacks, but Health Law Alliance argued that such payments were permissible under speaker program arrangements commonly used in the pharmaceutical industry.

Q: What makes the dismissal of Dr. Gazi’s case significant?

A: The dismissal of Dr. Gazi’s case is highly unusual, particularly given the DOJ’s aggressive stance against opioid-related misconduct and fentanyl in particular. He is the only person out of 35 charged in Insys-related cases to be acquitted.

Q: How does Health Law Alliance approach Medicare fraud and kickback defense?

A: Health Law Alliance employs a strategic, evidence-based defense, focusing on legal precedents and the proper interpretation of federal statutes like the Anti-Kickback Statute. In Dr. Gazi’s case, the firm emphasized that the law permits off-label prescribing and speaker program payments when conducted within legal boundaries.

Q: What was Insys Therapeutics accused of?

A: Insys Therapeutics was implicated in a nationwide opioid kickback scheme involving a fentanyl-based spray approved for cancer pain. The company’s executives, including founder John Kapoor, were convicted of marketing the drug for off-label uses. However, Health Law Alliance successfully demonstrated that Dr. Gazi’s actions fell within legal boundaries for off-label prescribing and speaker fees.

Q: How can healthcare providers facing similar charges contact Health Law Alliance?

A: Healthcare professionals facing allegations of healthcare fraud, Medicare audits, or kickback violations can contact Health Law Alliance for a consultation. The firm specializes in defending physicians and healthcare organizations in complex federal cases.

 

Class Action Lawsuits Against CVS, Walgreens & Costco Over Refusal to Fill Pain Medication

What happened to people entitled to a “speedy trial”?

 https://seekingjusticeforpainpatients.com/

Speedy Trial Rights: Criminal vs. Civil (Class Action) Cases

Criminal Cases:

  • The right to a “speedy trial” is a constitutional protection under the Sixth Amendment of the U.S. Constitution and is reinforced by statutes like the federal Speedy Trial Act125.

  • This right is specifically designed to protect criminal defendants from undue delays that could result in oppressive pretrial incarceration, anxiety, and impairment of the defense15.

  • Courts use a balancing test (from Barker v. Wingo) to determine if a criminal defendant’s speedy trial rights have been violated, considering factors such as the length and reason for delay, the defendant’s assertion of the right, and prejudice to the defendant125.

Civil Cases and Class Actions:

  • Class action lawsuits are a form of civil litigation, not criminal prosecution6710.

  • The right to a speedy trial does not apply to civil cases, including class actions. The Sixth Amendment and the Speedy Trial Act are limited to criminal proceedings125.

  • Civil cases, including class actions, are governed by different rules (such as the Federal Rules of Civil Procedure, Rule 23), which do not guarantee a speedy trial36.

  • While courts may manage their dockets to avoid unreasonable delays in civil cases, there is no constitutional or statutory right to a speedy trial for class action plaintiffs368.

Summary Table: Speedy Trial Rights

Type of Case Right to Speedy Trial? Legal Basis
Criminal Yes Sixth Amendment, Speedy Trial Act125
Civil (including class actions) No Federal Rules of Civil Procedure36

Conclusion

People who file class action lawsuits are not entitled to a speedy trial. The right to a speedy trial is a protection afforded only to criminal defendants and does not extend to plaintiffs or class members in civil litigation, including class actions12356. Civil cases may still be subject to general court rules against unreasonable delay, but there is no constitutional or statutory right equivalent to the speedy trial protections in criminal law.

Citations:

  1. https://www.strengthenthesixth.org/focus/Speedy-Trial
  2. https://www.justice.gov/archives/jm/criminal-resource-manual-628-speedy-trial-act-1974
  3. https://www.law.cornell.edu/rules/frcp/rule_23
  4. https://www.americanbar.org/groups/criminal_justice/resources/standards/speedy-trial/
  5. https://www.justia.com/criminal/procedure/right-to-a-speedy-trial/
  6. https://www.sarrafgentile.com/wp-content/uploads/pdf/An-Introduction-to-Class-Actions.pdf
  7. https://en.wikipedia.org/wiki/Class_action
  8. https://www.crowell.com/en/insights/publications/class-actions-rethinking-the-class-actions-strategy
  9. https://thenationaltriallawyers.org/article/class-action-lawsuit-checklist-do-you-have-a-claim/
  10. https://sanfordheisler.com/blog/2024/08/class-action-lawsuits-powerful-tools-for-advancing-the-public-interest/

Answer from Perplexity: pplx.ai/share

Class Action Lawsuits Against CVS, Walgreens & Costco Over Refusal to Fill Pain Medication

Overview of the Lawsuits

Two prominent class action lawsuits were filed by women in different states-Florida and California-against major pharmacy chains for refusing to fill opioid prescriptions for chronic pain:

  • Edith Fuog (Florida): Filed a class action lawsuit against CVS, alleging that CVS pharmacists repeatedly refused to fill her opioid prescriptions, which she used to manage chronic pain from multiple serious medical conditions. The refusals were reportedly based on the 2016 CDC opioid prescribing guidelines, particularly the 90 morphine milligram equivalents (MME) daily threshold1234.

  • Susan Smith (California): Filed a class action lawsuit against Walgreens and Costco in California, claiming that these pharmacies refused to fill her legitimate opioid prescriptions for severe chronic migraines and other conditions, despite her physician’s oversight and documentation345.

Both lawsuits allege violations of the Americans with Disabilities Act (ADA), the Rehabilitation Act, and the anti-discrimination provisions of the Affordable Care Act, arguing that the refusals amounted to discrimination against people with disabilities who require pain management34.

Status of the Lawsuits

Edith Fuog v. CVS (Florida)

  • The case was filed in federal court in Rhode Island, where CVS is headquartered.

  • In May 2022, a federal judge ruled that the lawsuit could proceed, rejecting CVS’s motion to dismiss. The court found that Fuog had presented plausible claims under the ADA, particularly because her need for higher opioid doses was directly related to her disabilities1.

  • The judge allowed the case to move forward as a potential class action, meaning other similarly affected patients could be included1.

  • As of the latest available updates, the case is ongoing, with Fuog indicating she would only settle if CVS adopts a clear public policy instructing pharmacists to fill all legitimate opioid prescriptions5.

Susan Smith v. Walgreens and Costco (California)

  • Smith’s lawsuit was filed in California and also seeks class action status. She alleges repeated refusals by Walgreens and Costco to fill her opioid prescriptions, despite extensive documentation and compliance with medical oversight345.

  • Like the CVS case, Smith’s lawsuit is based on alleged discrimination under federal disability and health laws34.

  • As of the latest reports, the case is ongoing. Attorneys have not publicly disclosed further developments or any settlements5.

Summary Table

Plaintiff State Defendant(s) Status (as of 2025)
Edith Fuog Florida CVS Class action moving forward; ongoing15
Susan Smith California Walgreens, Costco Class action filed; ongoing35

Key Points

  • Both lawsuits are among the first national class actions addressing pharmacy refusals to fill opioid prescriptions for chronic pain patients134.

  • The cases are still active, with no final rulings or settlements reported as of May 2025.

  • The outcomes may set important precedents regarding pharmacy obligations under disability and anti-discrimination laws.

If you need more recent updates or specifics about court dates or rulings, additional legal databases or news sources may need to be consulted.

Citations:

  1. https://www.painnewsnetwork.org/stories/2022/5/12/class-action-lawsuit-over-cvs-opioid-policy-moves-forward
  2. https://wpde.com/news/nation-world/chronic-pain-sufferer-sues-cvs-for-refusing-to-fill-opioid-prescription-05-30-2021
  3. https://floridaorthopaedicsociety.org/news/524004/Pharmacy-Chains-Face-Lawsuits-For-Refusing-To-Fill-Opioid-Prescriptions.htm
  4. https://www.beckershospitalreview.com/pharmacy/cvs-walgreens-costco-sued-for-not-filling-opioid-prescriptions.html
  5. https://www.painnewsnetwork.org/stories/2020/8/27/lawyers-may-not-expand-lawsuits-against-pharmacy-chains
  6. https://www.youtube.com/watch?v=YzDGZCyMIgI
  7. https://www.cvshealth.com/impact/healthy-community/our-opioid-response.html
  8. https://www.painnewsnetwork.org/stories/2020/8/11/class-action-lawsuits-filed-against-pharmacies-for-discrimination-against-pain-patients
  9. https://www.painnewsnetwork.org/stories/2024/12/20/cvs-pushes-back-against-latest-opioid-lawsuit
  10. https://wgxa.tv/news/nation-world/chronic-pain-sufferer-sues-cvs-for-refusing-to-fill-opioid-prescription
  11. https://drugfree.org/drug-and-alcohol-news/florida-doctor-sues-cvs-for-not-filling-his-prescriptions/
  12. https://www.youtube.com/watch?v=J6B9VLypoE0
  13. https://nwlc.org/wp-content/uploads/2024/06/2024.6.6-CVS-Demand-Letter.pdf
  14. https://centerforuspolicy.org/wp-content/uploads/2021/04/Patient-Access-to-Opioids-Litig-Tracker-20210913.pdf
  15. https://www.govinfo.gov/content/pkg/USCOURTS-rid-1_20-cv-00337/pdf/USCOURTS-rid-1_20-cv-00337-1.pdf
  16. https://ecf.rid.uscourts.gov/cgi-bin/show_public_doc?2020cv0337-46
  17. https://legislativeanalysis.org/wp-content/uploads/2022/01/October-2021-Case-Law-Monitor-FINAL.pdf
  18. https://abcnews.go.com/US/cvs-knowingly-dispensed-massive-amount-invalid-opioid-prescriptions/story?id=116927855

Answer from Perplexity: pplx.ai/share

Is the USA medical system starting to mirror other countries universal healthcare systems

Is the USA medical system starting to mirror what we hear about the universal healthcare system in places like Canada and England?

I asked a AI program:

A university hospital system in Philadelphia, PA, has recently announced the closure of its pain management practices. While specific details about this particular closure were not found in the search results, it is part of a broader trend where large hospital systems are shutting down specialty practices or entire departments focused on single diseases or services.

A university hospital system in Philadelphia, PA, has recently announced the closure of its pain management practices. While specific details about this particular closure were not found in the search results, it is part of a broader trend where large hospital systems are shutting down specialty practices or entire departments focused on single diseases or services.

According to Becker’s Hospital Review, since mid-2023, dozens of hospitals across the U.S. have announced closures or reductions in specialty departments or single-service units. These closures span a wide range of specialties including labor and delivery services, behavioral health units, pediatric units, dialysis clinics, urgent care centers, oncology services, and more. For example:

  • Multiple hospitals have closed or are closing labor and delivery departments due to declining birth rates and staffing shortages (e.g., ThedaCare Medical Center Waupaca in Wisconsin, MaineHealth Waldo Hospital, Mayo Clinic Health System in Minnesota, and others)23.

  • Behavioral health units have been shut down in some hospitals due to financial and operational challenges (e.g., Mercy Fitzgerald Hospital in Pennsylvania, St. Dominic Health Services in Mississippi)23.

  • Pediatric units and specialty clinics such as pediatric cardiology have also been closed in response to low patient volumes and workforce shortages (e.g., Sentara RMH Medical Center in Virginia, PeaceHealth in Washington)23.

  • Other specialty services like dialysis clinics, urgent care centers, and oncology/radiation therapy services have been terminated or scaled back in various health systems23.

Overall, Becker’s reported at least 41 department closures or service terminations since July 2023, and a total of 72 such closures or endings since early 2023. These closures are driven by factors including declining patient volumes, workforce shortages, financial pressures, shifting patient preferences (e.g., telehealth), and changes in community health needs23.

In 2025, hospital closures and service consolidations continue, with entire hospitals shutting down or converting to outpatient-only models, further impacting specialty care availability4.

In summary, the closure of a pain management specialty practice in Philadelphia fits into a larger national pattern where large hospital systems are shutting down or scaling back single-disease or specialty-focused practices due to evolving healthcare demands, financial challenges, and workforce issues. At least dozens of such specialty units have been closed or announced for closure across the U.S. in recent years, affecting a variety of specialties beyond pain management234.

Citations:

  1. https://www.pennmedicine.org/for-patients-and-visitors/find-a-program-or-service/pain-medicine/pain-medicine-center
  2. https://www.beckershospitalreview.com/finance/10-hospitals-closing-departments-or-ending-services-5
  3. https://www.beckershospitalreview.com/finance/61-hospitals-closing-departments-or-ending-services/
  4. https://www.beckershospitalreview.com/finance/2-hospital-closures-in-2025.html
  5. https://www.pennmedicine.org/for-patients-and-visitors/find-a-program-or-service/pain-medicine
  6. https://www.beckershospitalreview.com/finance/philadelphia-hospital-to-close-5-things-to-know.html
  7. https://www.newyorker.com/magazine/2021/06/07/the-death-of-hahnemann-hospital
  8. https://www.chiefhealthcareexecutive.com/view/-devastating-crozer-health-is-closing-shutting-down-two-pennsylvania-hospitals
  9. https://pmc.ncbi.nlm.nih.gov/articles/PMC11347414/
  10. https://www.templehealth.org/services/pain-management
  11. https://penntoday.upenn.edu/news/managing-pain-age-opioids
  12. https://whyy.org/articles/pa-issues-cease-and-desist-order-to-hahnemanns-owner-on-closure/
  13. https://www.medpagetoday.com/special-reports/exclusives/81023
  14. https://pmc.ncbi.nlm.nih.gov/articles/PMC11493740/
  15. https://www.jeffersonhealth.org/clinical-specialties/pain-management/locations
  16. https://www.kff.org/key-facts-about-hospitals/?entry=the-hospital-industry-openings-and-closings
  17. https://pmc.ncbi.nlm.nih.gov/articles/PMC9186448/
  18. https://www.renalandurologynews.com/features/doctors-leaving-private-practice-for-hospitals/
  19. https://www.frontiersin.org/journals/public-health/articles/10.3389/fpubh.2024.1415033/full
  20. https://www.ama-assn.org/practice-management/private-practices/3-top-reasons-why-doctors-are-selling-their-practices

Is it typical or untypical for a regional healthcare system to expand to care for the pts that are in need of these specialty care/services or are these pts just abandoned without much access to the care that they need?

It is not typical for regional healthcare systems to fully expand and seamlessly absorb all patients in need of specialty care after the closure of single-disease or specialty practices. Instead, the reality is often more complex, with significant gaps in access to care for affected patients.

What Usually Happens After Specialty Practice Closures

1. Increased Strain on Remaining Providers

  • When specialty services close, remaining hospitals and clinics-especially safety-net providers-often experience a surge in patient volume. This can overwhelm already strained resources, leading to longer wait times, delays in care, and in some cases, decreased quality of care49.

2. Limited Expansion by Regional Systems

  • While some regional healthcare systems attempt to adjust by taking on additional patients, this expansion is usually reactive and limited by capacity constraints. For example, after service reductions at a major hospital in Santa Clara County, local county hospitals anticipated significant strain and the need for major adjustments, but also expressed concern about being able to meet increased demand49.

3. Vulnerable Populations Are Disproportionately Affected

  • The negative effects of specialty care closures are most pronounced among low-income, uninsured, elderly, and rural populations. These groups face increased travel times, higher out-of-pocket costs, and may forego care entirely due to inconvenience or lack of access68.

4. Emerging Solutions-But Not Yet Widespread

  • Some health systems are piloting innovative approaches to expand specialty care access, such as:

    • Training primary care physicians (PCPs) to provide certain specialty services.

    • Using telemedicine to connect patients with distant specialists.

    • Coordinating specialist referral networks for underserved patients1.

  • However, these solutions are not universally adopted and often depend on local resources, disease burden, and institutional priorities1.

5. Fragmented and Delayed Care

  • Closures often result in more fragmented care, with patients shifting between providers and experiencing longer delays before receiving needed specialty services. This can lead to worse health outcomes, especially for those with complex or chronic conditions239.

Are Patients “Abandoned”?

While some regional systems make efforts to absorb displaced patients, many are left with reduced or delayed access to the specialty care they need. In practice, the transition is rarely seamless, and significant numbers of patients-especially in underserved communities-experience barriers to care, increased travel, and sometimes abandonment if no alternatives are available4689.

Summary Table

After Specialty Closure Typical Outcome
Regional system expansion Limited, often insufficient
Patient access to care Frequently reduced, especially for vulnerable
Wait times and delays Increase
Quality of care Can decrease due to system strain
Innovative solutions Emerging, but not widespread
Abandonment risk Real for some patients, especially underserved

In summary, while there are efforts to expand access after specialty practice closures, it is not typical for regional healthcare systems to fully and effectively absorb all affected patients. Many experience reduced access, longer wait times, and, in some cases, are left without the specialty care they need149.

Citations:

  1. https://www.fsg.org/wp-content/uploads/2021/08/Equity-in-Specialty-Series-Brief-2_FSG-Increasing-Specialty-Care-Availability.pdf
  2. https://www.kff.org/report-section/a-look-at-rural-hospital-closures-and-implications-for-access-to-care-three-case-studies-issue-brief/
  3. https://pubmed.ncbi.nlm.nih.gov/34046966/
  4. https://news.santaclaracounty.gov/deeply-concerning-board-supervisors-hear-report-impact-cuts-regional-medical-center
  5. https://www.hfmmagazine.com/specialty-hospital-growth-and-evolution
  6. https://pmc.ncbi.nlm.nih.gov/articles/PMC4193569/
  7. https://journalofethics.ama-assn.org/article/what-should-be-scope-health-networks-obligation-respond-after-hospital-closure/2019-03
  8. https://www.shepscenter.unc.edu/wp-content/uploads/2014/10/wor58.pdf
  9. https://pmc.ncbi.nlm.nih.gov/articles/PMC3252182/
  10. https://www.ncsl.org/events/details/new-medicare-designation-could-prevent-closure-of-struggling-rural-hospitals
  11. https://pmc.ncbi.nlm.nih.gov/articles/PMC10227999/
  12. https://rupri.public-health.uiowa.edu/publications/policybriefs/2020/hospital%20closure%20workforce.pdf
  13. https://www.cms.gov/blog/pathways-specialty-care-coordination-and-integration-population-based-models
  14. https://www.hrrmc.com/news/2017/june/hrrmc-answers-questions-about-expansion-plans/
  15. https://pmc.ncbi.nlm.nih.gov/articles/PMC6921587/
  16. https://www.medpro.com/documents/10502/2837997/Guideline_Closing+the+Practice.pdf
  17. https://www.fiercehealthcare.com/providers/carrum-health-expands-centers-excellence-network-specialty-care-service-lines
  18. https://rupri.public-health.uiowa.edu/publications/policypapers/Alternatives%20for%20Developing%20the%20High%20Performance%20Rural%20Health%20System.pdf

 

Reporter with The NEW YORK TIMES -looking for pts having trouble getting their meds

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.