youarewithinthenorms.com
NORMAN J CLEMENT RPH., DDS, NORMAN L. CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, BELINDA BROWN-PARKER, IN THE SPIRIT OF JOSEPH SOLVO ESQ., INC., SPIRIT OF REV. IN THE SPIRIT OF WALTER R. CLEMENT BS., MS, MBA. HARVEY JENKINS, MD, PH.D., IN THE SPIRIT OF C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., M.B.A., IN THE SPIRIT OF THE HON. PATRICE LUMUMBA, IN THE SPIRIT OF ERLIN CLEMENT SR., EVELYN J. CLEMENT, IN THE SPIRIT OF WALTER F. WRENN III., MD., JULIE KILLINGSWORTH, RENEE BLARE, RPH, DR. TERENCE SASAKI, MD LESLY POMPY MD., CHRISTOPHER RUSSO, MD., NANCY SEEFELDT, IN THE SPIRIT OF WILLIE GUINYARD BS., JOSEPH WEBSTER MD., MBA, BEVERLY C. PRINCE MD., FACS., NEIL ARNAND, MD., RICHARD KAUL, MD., IN THE SPIRIT OF LEROY BAYLOR, JAY K. JOSHI MD., MBA, AISHA GARDNER, ADRIENNE EDMUNDSON, ESTER HYATT PH.D., WALTER L. SMITH BS., IN THE SPIRIT OF BRAHM FISHER ESQ., MICHELE ALEXANDER MD., CUDJOE WILDING BS, MARTIN NJOKU, BS., RPH., IN THE SPIRIT OF DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS
🕷️🕷️🕷️
MEDICINE OF TRIAL
THE TARGETING OF MEDICAL PROFESSIONAL
Dr. Muhamad Aly Rifai’s article explores the growing trend of legal systems targeting medical professionals. In this critical examination of the American legal system, Dr. Muhamad Aly Rifai argues that the government has undergone a dangerous shift toward the criminalization of physician care, transforming healers into targets of aggressive federal pursuit.
Rifai’s work further highlights how complex medical decisions are increasingly misinterpreted as criminal intent, leading to an environment where prosecutorial overreach and a presumption of guilt devastate the lives of innocent practitioners.
By detailing the ruinous impact on both doctors and the patients they serve, the author illustrates how weaponized regulations and biased statistics force physicians into submission, regardless of their actual guilt.
THE PLIGHT OF Dr. Sanjeev Kumar
Supporters of Dr. Kumar contend that he provided essential, life-saving care to underserved populations and that his use of office hysteroscopy followed medical standards.
A judge granted a Remmer Hearing for Memphis gynecologist Sanjeev Kumar, who was found guilty on 40 of 46 charges. This judicial inquiry into potential jury tampering has effectively postponed the legal proceedings, potentially invalidating the guilty findings and pushing the defendant’s sentencing into late May.
The hearing, initially set for April 9, was reset for April 23, potentially invalidating the jury’s verdict and delaying Kumar’s sentencing to May 29.
DISINFECTION OR STERILIZATION
This judicial inquiry into potential jury tampering has effectively postponed the legal proceedings, potentially invalidating the guilty findings. Through this specialized hearing, the court aims to ensure the trial’s fairness by determining if outside contacts compromised the jury’s impartiality.
Following allegations of improper external influence on the jury during deliberations, a judge has authorized a Remmer Hearing to investigate the integrity of the original verdict.
THE HEARING REMMMER & RULE 33
In his legal filing request for a new trial, filed on behalf of Dr. Sanjeev Kumar, who argues that his criminal convictions were based on false and misleading expert testimony provided by the government.
BACKGROUND
HYSTEROSCOPY OFFICE PROCEDURE
SUMMARY OF THE LEGAL DOCUMENT FILE BY DR. SANJEEC KUMAR
This legal document is a consolidated motion filed by Dr. Sanjeev Kumar requesting either a judgment of acquittal or a new trial following his conviction for health care fraud and violations of the Food, Drug, and Cosmetics Act.
The document seeks to overturn the verdict by demonstrating that Dr. Kumar followed officially recognized protocols by asserting that the court’s jury instructions unconstitutionally criminalized mere intent and ignored established medical guidelines that would have vindicated the defendant’s sterilization practices that the prosecution erroneously characterized as criminal.
The defense presents newly discovered evidence consisting of correspondence from the FDA confirming that a medical device’s Instructions for Use (IFU) serve as the authoritative guide for doctors, contradicting a trial expert’s claim that only sterilization—and not high-level disinfection—was legally permissible.
What Is an IFU for Medical Devices?
When it comes to medical devices, ensuring safety, compliance, and correct usage is crucial. One key document that supports these aspects is the Instructions for Use (IFU).
An IFU (Instructions for Use) is a mandatory document that provides detailed guidance on how to properly use a medical device. This includes safety instructions, intended use, and regulatory compliance requirements. Every medical device manufacturer must develop an IFU that complies with the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) standards. This ensures that healthcare professionals and end users can safely and effectively operate the device.
By highlighting this discrepancy, the motion asserts that the government’s case was built on a legally debunked theory of device adulteration that unfairly prejudiced the jury.
The defense argues that the government failed to provide objective evidence of medical necessity for the procedures performed and neglected to prove that specific illegal acts occurred on the dates alleged in the indictment.
Furthermore, the motion emphasizes serious procedural errors and government misconduct, including evidence destruction by a federal agent and inflammatory pretrial statements that could have biased the jury. It aims to overturn the verdict by arguing that the court’s jury instructions unconstitutionally criminalized mere intent and overlooked established medical guidelines that would have supported the defendant’s sterilization practices.
Dr. Sanjeev Kumar, a highly trained gynecologic oncologist accused by federal prosecutors of healthcare fraud and medical misconduct. The article published on youarewithinthenorms.com argues that the government converted routine billing disputes and sterilization questions into sensationalized allegations of sexual assault and human trafficking. These charges were dropped due to an erroneous overreach by the government prosecutors.
The documents further claimed that the prosecution engaged in malicious overreach, ignored exonerating evidence from medical boards, and used inflammatory rhetoric to bias the public.
DEFINING THE METHODOLOGY OF HYSTERSCOPY PROCEDURES SAFELY AND EFFECTIVEL
BY
Salazar CA, Isaacson KB. Office Operative Hysteroscopy: An Update. JMIG August 2017
Wong M, Miller V. Why you should be performing office hysteroscopy …now. Contemporary OB/GYN.net Sept 27, 2017
Let’s define what is meant by a simple approach. Simple is defined by performing hysteroscopy safely and effectively in an office setting without the need for general, regional, or intravenous anesthesia.
Simple means a patient can potentially have the procedure performed during her initial visit, without the need to further disrupt her life with a second visit. Simple means that when the patient leaves the office, she can go back to normal activities and work the same day.
Simple means there is minimal need to invest in high-cost equipment or high-cost “procedure rooms” to perform office hysteroscopy. Simple means that no special schedule is needed to perform office hysteroscopy. The exam should not take longer than a typical well visit annual exam, and it fits in easily to a typical schedule.
Simple means that office hysteroscopy can be performed by a single provider and a medical assistant. Simple means there should be standards in place to efficiently clean and sterilize reusable equipment within 20-30 minutes. Simple means having crisis checklists on-site that can be rehearsed should a rare medical complication arise during the procedure. Simple means that office hysteroscopy should be rewarding both professionally and financially for the office-based practice. Figure 2. Specially designed office pump and suction.
To achieve simplicity, I have the following recommendations:
Define your mission. In my practice, I routinely perform diagnostic hysteroscopy as well as any procedure I can do with no anesthesia except oral NSAIDs and a very rare paracervical block. These are vaginoscopic procedures that include polypectomy, small myomectomy, metroplasty, and lysis of adhesions.
These are procedures that can be performed with a continuous-flow 5mm OD hysteroscope with a 5 Fr working channel for reusable scissors and a tenaculum. Make office hysteroscopy convenient for you and your staff. Standardize the setup and use of exam rooms within the practice suite.
While there is no need for a designated procedure room, a standardized setup for any exam room with a hysteroscope, light source, camera, and monitor is helpful. In our practice, we use 4 different standard exam rooms.
We have two rooms where the hardware is housed and a mobile cart for the other rooms. All we need to perform the procedure is a commercially available packet that contains a collection drape and inflow and outflow tubing as well as a designated pump to provide distention pressure and suction if needed. The drape system is key to our efficiency because no fluid goes on the floor or table, and room turnover takes minimal time. Cleaning and sterilization of equipment are performed using enzymatic soap and Cidex OPA, allowing sterilization to be complete within 30 minutes (Figure 3).
Minimize frustration.
Learn vaginoscopic techniques via online videos and attend regional, national, and international hysteroscopic conferences. Practice in the operating room when the patient is under anesthesia. When you master the technique of performing office hysteroscopy with no speculum, tenaculum, or paracervical anesthesia, it is hugely rewarding and fun.
You will soon realize that the speculum initiates anxiety that heightens pain sensation. Most often, there is zero discomfort to the patient until the scope passes through the internal cervical os, and by that time, you are over halfway done with the diagnostic procedure.
Keep the equipment simple.
Reimbursement for office hysteroscopy varies widely across regions of the country and around the world. In the U.S., I believe I practice in an area with some of the lowest reimbursement in the country, and still, office hysteroscopy is extremely productive for our practice. We accomplish this by using as much reusable equipment as possible while paying for disposable items that maximize our efficiency.
Our telescopes are rod/lens scopes that have lasted over 15 years. The same holds true for our camera and light source. We have upgraded our monitors to flat screens, but HD is not necessary. We use reusable 5Fr instruments, but we only get 10-15 uses out of the scissors before they become too dull to cut. Including our disposable drapes, tubing, and fluids, our simple setup costs approximately $25–$30 per case.
Depending on the procedure, our reimbursement ranges from $275 to $ 1,400. If one were to lease equipment, one would need to perform only 2 cases per month to cover the lease cost. Every case beyond that is productive to the practice. My two partners and I perform 15-20 office hysteroscopies a week in our simple office.
In summary, a simple, efficient office setup removes many of the barriers that discourage physicians from providing office hysteroscopy for their patients. A simple set up saves costs while maintaining safety and productivity. Several endoscopic companies have expressed interest in developing products specifically designed for office hysteroscopy. If we had a company that could provide one-stop shopping for disposable and reusable equipment and help with physician and patient education, it would enhance the simplicity even further. A doc can only dream!
SUMMARY
These narratives highlight the dilemmas faced by Dr. Sanjay Kumar, Dr. Walter F. Wrenn III, MD, Dr. Neil K. Anand, MD, Dr. Shiva Akula, MD, Dr. Christopher Russo, MD, Dr. Raj Bothra, MD, Dr. Joseph Webster, MD, et al., committed physicians unfairly targeted by a legal system that criminalizes standard clinical practices.
In Angela Green’s upcoming book, “Legal Extortion,” a must-read for medical, dental, law, and pharmacy students, as well as licensed providers in America and around the world, exposes a hidden injustice—one that has cost the lives of millions.
THE BOXES
Ms. Green vividly explores the lives of some of America’s most talented medical professionals and their families, illustrating how careers can be derailed and how the effort to save others can be compromised by exposing these injustices.
Dr. Muhamad Aly Rifai, MD, was acquitted. The government prosecutor had added a litany of creative, erroneous, misleading, scandalous, and headline-grabbing analytics suggesting that, on some days in 2015, services were billed for more than 24 hours of work and that my practice sent bills to deceased Medicare beneficiaries after their deaths.
The government investigators and prosecutor believed that this minority Muslim physician of Syrian origin, who is solo practicing, would quickly relent and submit to a plea agreement; they were wrong, for they had completely underestimated his resolve.
In his filing before the Third Circuit Court of Appeals, he highlights the points following the dismissal of his lawsuit againstof Justice and the DEA. At its core, the document challenges the adjudicatory authority of the DEA, arguing that the agency’s process for revoking medical registrations is structurally unconstitutional due to the improper removal protections granted to Administrative Law Judges.
Dr. Rifai contends that the District Court erred by claiming it lacked subject-matter jurisdiction, asserting instead that he suffered a “here-and-now” injury by being forced to participate in an illegitimate legal forum.
The brief relies heavily on recent Supreme Court precedents, such as Axon Enterprise, Inc. v. FTC, to argue that collateral constitutional claims should be heard immediately in federal court rather than delayed until after a final agency decision. The text seeks to reverse the lower court’s dismissal to ensure meaningful judicial review of the executive branch’s administrative power.
Dr. Rifia…. “struggle reveal that these agencies’ intrusions and overreaches are built on half-truths that support their foundation of Judicial Architectural Deception to imprison more medical providers with the utmost efficiency.”
🔓 🔓 🔓
ALL WATCHED OVER BY MACHINES OF LOVING GRACE
BE SURE TO DONATE TO THE MARK IBSEN GOFUNDME DEFENSE FUND, WHERE THE SON ALWAYS RISES!!!
OUR TREE OF KNOWLEDGE SHALL NEVER BE SUPPRESSED
FOR NOW, YOU ARE WITHIN
THE NORMS
REFERENCE:
