David Antoon PREVENT MEDICAL HARM aka Patient 32 is the goal of - - PDF document

11/5/2015 1

“PREVENT MEDICAL HARM”

is the goal of every harmed patient

*A New, Evidence‐based Estimate of Patient Harms Associated with Hospital Care

By James, John T. PhD

*

David Antoon

aka “Patient 32”

Patient Advocate

25 Years Military Aviation 20 Years Commercial Aviation 8 Years Patient Advocate 53 Years Safety

DISCLAIMER: All views, representations, statements or slides presented are solely the opinion of the presenter and not those of HealthWatch USA or any other entity.

“Accidents Don’t Just Happen; They are Caused!”

THE GOAL OF EVERY HARMED PATIENT IS TO PREVENT HARM TO OTHERS

Non‐invasive da Vinci robotic Prostatectomy No Patient Consent Form – “Patient Fully Aware of this Risk”

My COMPLAINTS:

• False billing
• Medical harm to “staggering

number” of patients

• Fraudulent Credentials
• No Credentialing
• Alteration of Medical Records
• Insurance Fraud
• Ghost Surgery

WHO DOES THE DOCTOR/HOSPITAL HOLD RESPONSIBLE?

Deny and Defend ‐ Blame the Patient!

• Disgruntled Patient
• Attack Patient Credibility
• Informed Consent
• Expected Complication
• Standard of Care Met

Confidentiality! Confidentiality! Confidentiality!

• Prevent Discovery

The Patient is Responsible!

PATIENT INVESTIGATION

“What Happened to me?”

• Medical Records ‐ (Falsified, Altered, Withheld)
• Signed Informed Consent ‐ (disappeared)
• Op Note: Copy and Paste Boiler plate written in 3rd person not signed
• Significant blood loss and complications concealed
• All Progress notes written by 2nd year resident ‐‐ not cosigned
• OR Log and Audit Report show staff surgeon never present
• Attestation Blank
• Same day review of informed consent –blank
• Surgical Time Out –Staff surgeon not present
• Staff Surgeon performing “Concurrent Surgeries” beginning at the same time
• The Staff Surgeon
• Not Board Certified
• Not Credentialed
• Not Privileged
• Many fraudulent credentials (including Iowa Medical License)
• Consultant, Proctor, Lecturer for Intuitive Surgical
• Not present at any time during surgery and hospitalization (Audit Report and OR Log)
• The Hospital
• Marketed: “World Class Care” Ranked in Top 5 hospitals in the country
• Independent Reviews:
• Bottom 7% of all hospitals surveyed Kaiser Family Foundation Review of CMS “Hospital Acquired

Conditions”

• 98 out of 105 rated state hospitalsConsumer Reports
• first “D” rating ever issued by Leapfrog issued for patient safety

THE HARMED PATIENT Where do I go? Who can help me? Who will help me?

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OVERSIGHT AGENCIES

• Centers for Medicare and Medicaid Services (CMS)
• HHS/Office of Civil Rights (HIPAA)
• Courts
• State Department of Health
• Insurance Companies
• Ohio Insurance Commission
• State Medical Board
• American Board of Urology
• State Attorney General
• Accreditation Council for Graduate Medical Education (ACGME)
• Food and Drug Administration (FDA)
• Accrediting Organization (Joint Commission)
• Media – Investigative Reporters

CENTERS FOR MEDICARE MEDICAID SERVICES

• Medicare Surveys ‐‐ difficult to initiate
• Institutions can be Too Big To Fail and have

repeated violations and multiple extensions

• June 7, 2014 Modern Healthcare cover story “..Cases

Highlight Flaws in Safety Oversight” * by Joe Carlson

CENTER FOR MEDICARE AND MEDICAID SERVICES5

Do You Have A Right To Know If Your Hospital Is Unsafe?

The facility “was cited by CMS for violating Medicare rules more than three dozen times since 2010.”* Joe Carlson, Modern Healthcare, June 7, 2014

• Jan. 21, 2010 Complaint Survey (PDF)

April 30, 2010 Full Survey (PDF)

• Feb. 23, 2012 Complaint Survey (PDF)

July 30, 2012 Revisit Survey (PDF)

• Sept. 20, 2012 Complaint Survey (PDF)

May 17, 2013 Complaint Survey (PDF) July 25 2013 Complaint Survey (PDF)

• Sept. 26, 2013 Complaint Survey (PDF)
• Dec. 12, 2013 Complaint Survey (PDF)

*Links to Nine Selected inspection reports finding violations at the same institutions

CITED AS UNSAFE NO PUBLIC NOTICE ISSUED

CENTER FOR MEDICARE AND MEDICAID SERVICES7

CMS Citations at one facility 13 March 2015 Media Reports 12 September 2015

BREAKING NEWS: Media Reports CIVIL MONETARY PENALTY

• Clinic fined $600000 for blood lab violations ModernHealthcare.com

I facility in my treating hospital system was fined more than $600,000 for six serious violations by CMS.

• CMS report on the Hospital’s lab details systemic problems

A 300‐page report from the Centers for Medicare and Medicaid Services (CMS) released Friday reveals dozens of violations in procedure, training and

• The facility faces $650000 CMS fine Hospital lab violations, patients in ...

A 6‐month investigation of lab services by the Centers for Medicaid and Medicare Services has uncovered ..

• Federal report: Hospital patient blood lab tests filled with procedural errors

CMS officials said the facility is already facing more than $600,000 in fines, and must have all issues at the lab taken care of by Oct. 5, or face ...

• CMS fines hospital for lab deficiencies

A CMS inspection found six serious violations of procedures that rose to the level of immediate jeopardy IMMEDIATE JEAPARDY AND CONDITION LEVEL VIOLATIONS NO FEDERAL PUBLIC NOTICE OF UNSAFE CONDITIONS LACK OF INFORMED CONSENT

CITED AS UNSAFE NO PUBLIC NOTICE ISSUED

CMS Must Notify The Public

The public has the right to know when a termination notice has been issued.

• CFR 42 Section 489.53(d)(1):

Timing: basic rule. Except as provided in paragraphs (d)(2) and (d)(3) of this section, CMS gives the provider notice of termination at least 15 days before the effective date of termination of the provider agreement. Termination effective dates are normally issued 90 days before the effective date.

• CFR 42 Section 489.53(d)(1)

Notice to public. CMS concurrently gives notice of the termination to the public. Concurrent Public Notice is NECESSARY to have Informed Consent THIS DOES NOT HAPPEN!

HHS/OFFICE OF CIVIL RIGHTS

HIPAA

• COMPLAINT:
• Records requested by Patient 32 withheld by

Hospital

• RESPONSE:
• Please be advised that the Privacy Rule does not

include specific requirements for the retention of medical records.

• DESIGNATED RECORD SET is DEFINED BY THE

HOSPTAL – There is NO STANDARD

• The Privacy Rule does not regulate the accuracy
• r authenticity of medical records.

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COURTS

Statute of Limitations: One Year Statute of Repose: Four Years Damage Caps: Prevent Litigation Discovery: Obstructed by Confidentiality Imposed Legislation Lobbies: $500M per year by Medical Lobbies Cost of Expert Witnesses: Prevent Litigation Hospital Deep Legal Pockets: Unmatched by Injured Plaintiffs Anti Kick Back Act: Medicare & Medicaid Patient Protection Act Unenforced False Claims Act:

• Justice Department has limited resources
• “Triages” cases based upon threshold of financial recovery to the government
• Standing – plaintiff must have direct knowledge of false billing
• Must directly observe the surgeon’s presence or lack thereof during surgery
• Must directly observe the surgeon signing the CMS1500 request for reimbursement
• (Impossible Legal Bar to Meet for Unconscious Patient)

TORT REFORM

• Placed the cost of Medical Harm on the Patient and their families
• Reduces the Quality of Care
• Harmful/Deadly to the Public

Uncovering The Silent Victims Of The American Medical Liability System Caps on Damages are Potentially Ruining the Healthcare Industry Confidentiality agreements in lawsuit settlements can be harmful, even deadly, to the public

Tort Reform

STATE DEPARTMENT OF HEALTH

• Defer to State Medical Board
• Defer to CMS
• Ohio Department of Health Does NOT License Hospitals
• Ohio Department of Health Inspects Hospitals

Only When Directed by CMS Medical Oversight System

INSURANCE COMPANIES

(BCBS and HNFS/TRICARE)

• Post card response to complaint of medical harm and fraud
• “Thank you”
• Confidentiality ‐ You will receive no response
• Found on Preferred Provider List for all Insurance companies searched
• Even though patient investigation determined
• Not Credentialed
• Not Privileged
• Not Board Certified
• Fraudulent Credentials
• Preferred Provider List

(What does this mean?)

• “Unfortunately …we do not have access to the information that is used in credentialing

providers as Blue Cross and Blue Shield uses a third party vendor for this process called CAQH.”

• Nearly All Insurance Plans use CAQH
• CAQH (Council for Affordable Quality Healthcare)
• “Clearing House” for collecting provider information to give to Provider Hospitals
• Requires no primary source (or any source) verification of credentials presented by providers
• Only “attestation” by provider stating what has been presented is true

OHIO INSURANCE COMMISSION

ORC 3901.44 (B) states: (B) All documents, reports, and evidence in the possession of the superintendent or the superintendent's designee that pertain to an insurance fraud investigation are confidential law enforcement investigatory records under section 149.43 of the Revised Code. Notwithstanding such section, the superintendent shall not prohibit public inspection of such records that pertain to an insurance fraud investigation after the expiration of all

federal and state statutes of limitations applicable to

the particular offense to which the papers, documents, reports, and evidence relate.

STATE MEDICAL BOARDS

 MULTIPLE COMPLAINTS by large cluster of harmed patients:

• False billing
• Medical harm to “staggering number” of patients
• Fraudulent Credentials
• No Credentialing
• Alteration of Medical Records
• Insurance Fraud
• Ghost Surgery

 Response:

• Under investigation (January 2010 - March 2015)
• Hospital refused to provide patient records to Medical Board Medical
• Medical Board resorted to subpoena to obtain records in March 2010
• Some falsely claimed credentials removed from Hospital Website
• 2015 No Sanctions
• ALL FINDINGS CONFIDENTIAL

AMERICAN BOARD OF UROLOGY

 MULTIPLE COMPLAINTS by large cluster of harmed patients:

• False billing
• Medical harm to “staggering number” of patients
• Fraudulent Credentials
• No Credentialing
• Alteration of Medical Records
• Insurance Fraud
• Ghost Surgery

 2011 ABU RESPONSE:

• Surgeon was not Board Certified nor Board Eligible
• Executive session September 2011 denied Board Certification
• Requested all Complainants submit complaints to State Medical Board

 2014 ABU Change of Executive Board Leadership

• Surgeon Granted Board Certification

(while under State Medical Board Investigation)

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STATE ATTORNEY GENERAL

• COMPLAINT:
• False billing
• Insurance Fraud
• Alteration/Falsification of Medical Records
• RESPONSE:
• Defer to State Medical Board
• Defer to State Insurance Commission
• “CATCH 22”

ACCREDITATION COUNCIL for GRADUATE MEDICAL EDUCATION (ACGME)

• COMPLAINT:
• Unsupervised Residents performing complex major

surgeries

• Resident Progress notes not co‐signed
• False billing
• Medical harm to “staggering number” of patients
• Fraudulent Credentials and No Credentials of Resident

Supervisor

• Response
• ACGME appreciates the opportunity to have reviewed

your complaint

• “No Action”

FDA WHERE WAS THE FDA?

Da VINCI

• New Concerns on Robotic Surgeries ‐ The New York Times
• Robotic Surgery: Growing Sales, but Growing Concerns
• The rush to use new medical tech tied to patient harm ...
• Study: Da Vinci Robot Injuries Underreported
• Complications of Robotic Surgery Underreported, Study Says
• Counting the Problems of Robot‐Assisted Surgery
• Marty Makary: A Minimally Invasive Approach to Health ...
• Rush to Robotic Surgery Outpaces Medical Evidence ...
• FDA eyes increase in freak accidents during robotic surgeries
• Unreported Robot Surgery Injuries Open Questions for FDA

Peter Eisler (USA Today/Reuters) ‐‐ Duodenscopes Steve Tower, MD ‐‐ Hip Implants Hooman Norchasm, MD – Morcellators Joleen Chambers (President Failed Implant Device Association) Surgical Mesh

The Root of The Problem Is: 1) An Approval Process of New Devices which does not capture all problems 2) The 510K Approval Process of substantially similar devices which does not capture all problems. 3) Self Reporting of Adverse Events resulting in An Ineffective Post Market.

In the USA The Media Captures Most Device Problems

ACCREDITING ORGANIZATIONS

(i.e. JOINT COMMISSION)

 Accrediting organizations do not hold a high enough standard to assure an acceptable level of healthcare quality.  In the case of my institution, with all the CMS Findings and termination notices, they continued to hold the “Gold Seal of Accreditation  Response to my complaint “(The facility’s) response was accepted by the Joint Commission” “Please be aware our current Public Information Policy precludes us from providing you with the specific results of any complaint investigation”

• RESULT: “GOLD SEAL ACCREDITATION”

Despite violations over a number of years,

What Should We Do?

Everyone Passes The Buck It is someone else's responsibility

NPR: How Do You Stop Sea Captains From Killing Their Passengers?

By Alex Tabarrok of George Mason University

http://www.npr.org/sections/money/2010/09/09/129757852/pop‐quiz‐how‐do‐you‐stop‐sea‐ captains‐from‐killing‐their‐passengers

11/5/2015 5

How Do You Stop Sea Captains From Killing Their Passengers?

“Finally, an economist (who else?) had a new idea.”

“Instead of paying for each prisoner that walked on the ship in Great Britain, the government should only pay for each prisoner that walked off the ship in Australia. And in fact, this was the suggestion which in 1793 was adopted and implemented. And immediately, the survival rate shot up to 99%.”

http://www.npr.org/sections/money/2010/09/09/129757852/pop‐quiz‐how‐do‐you‐stop‐sea‐ captains‐from‐killing‐their‐passengers