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The New World for Providers - American College of Physicians

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					                  Compliance 
                    2010:

          The New World for 
              Providers

American College of Physicians        Stephen W. Stair, MD, FACP
                                 Assistant Professor, Internal Medicine
  Alabama Chapter Meeting         Medical Compliance Officer, UAHSF
       May 30, 2010
             Map of our “New World”


                          Shift from Volume-Based
 Value-Based
Reimbursement           Physicians and hospitals paid 
                              for “quality care”

                      Evidence-based, outcome-driven

                     Incentives for Patient Access, EHR, 
                           Quality Reporting, etc.

                      Component of Health Care Reform
             Map of our “New World”


 Value-Based
Reimbursement
                          Services not reimbursed without
                            evidence of medical necessity

     Pre-Payment         CMS CERT requests are increasing
      Reviews by
        Payers                CMS – started late 2008

                         No documentation = No payment

                           No signed order = No payment
               Map of our “New World”


 Value-Based
Reimbursement




      Pre-Payment 
       Reviews by
         Payers



Public Reporting
 on Individual 
  Physicians
               Map of our “New World”


                          RACs and MICs:
 Value-Based               Overpayment 
Reimbursement               Collections




      Pre-Payment 
       Reviews by             Permanent Federal Program (2009)
         Payers
                          Review claims post-payment for recoupment

                            Contingency Fee to Recovery Contractors 
Public Reporting                  (Connelly, Health Integrity)
 on Individual 
  Physicians                   Target Hospital, Rehab, Physicians

                     UAB has received 700+ records request in past 6 months
               Map of our “New World”


                     RACs and MICs:
 Value-Based          Overpayment 
Reimbursement          Collections



                              •Effective January 2010 (Medicare only)
      Pre-Payment      Elimination of 
                                    Other payers likely to follow
       Reviews by    Consultation Services
         Payers
                               •“Budget-neutral” – slight increase in
                              RVUs for new and initial hospital codes

                                       •Huge operational issues
Public Reporting
 on Individual 
                                      •Decreased reimbursement
  Physicians
                                            for specialists
               Map of our “New World”


                          RACs and MICs:
 Value-Based               Overpayment 
        ARRA 2009:  Provider Incentives for “Meaningful Use” of EHR
                            Collections
Reimbursement (E-prescribing, CPOE, E-Summary of Visit, etc.)

                Medicare ($44,000) and Medicaid ($63,500) 
                       Incentives start January 2011 
      Pre-Payment            Elimination of 
       Reviews by          Penalties begin 2015
                          Consultation Services 
         Payers



Public Reporting        Mandatory Electronic 
 on Individual            Health Records
  Physicians
                 Map of our “New World”

                                                       Looming Medicare 
                             RACs and MICs:                 Fee Cuts
       Mandated for October 1, 2013
  Value-Based                 Overpayment               (21.2% in 2010)
 Reimbursement                 Collections
68,000 new codes (currently 13,500 in ICD-9)

Alpha-numeric with up to 7 characters per code          New ICD-10 Coding
        Pre-Payment                                          System 
                                  Elimination of 
 Example:  E09.52 – drug-induced diabetes                 October 2013
         Reviews by            Consultation Services
 mellitus with diabetic peripheral angiopathy
           Payers
                with gangrene

   Essentially forces change to an electronic
 billing system (no more paper charge tickets)
 Public Reporting           Mandatory Electronic 
   on Individual                Health Records
      Physicians
               Map of our “New World”

                                                 Looming Medicare 
                          RACs and MICs:              Fee Cuts
 Value-Based               Overpayment            (21.2% in 2010)
Reimbursement         Health Care Reform
                            Collections

(The Patient Protection and Affordable Care Act)
                                              New ICD-10 Coding
      Pre-Payment                                  System 
                           Elimination of 
       Expansion of Fraud and Abuse Investigation
       Reviews by       Consultation Services
                                                October 2013
           Quality Driving Reimbursement (VBP)
         Payers
                   More Patients, Less Physicians
                    Expansion of RACs, MICs Ramped-Up HIPAA
                                                   Privacy Laws
Public Reporting         Mandatory Electronic 
 on Individual             Health Records
  Physicians
                Map of our “New World”

                                  RACs and MICs:
                                   Overpayment 
          Value-Based               Collections
         Reimbursement                              Looming Medicare 
                                                        Fee Cuts


   Elimination of 
                              CODING, 
                              Health Care Reform
                 (The Patient Protection and Affordable CareNew ICD-10 Coding
                                                            Act)
Consultation ServicesDOCUMENTATION,                              System 
  “Budget-Neutral”
                Expansion of Scrutiny/Audits/Fraud Investigation
                                                               October 2013
                                   AND 
                      Quality Driving Reimbursement
                      More Patients, Less Physicians
     Pre-Payment    MEDICAL NECESSITY
      Reviews by                                          Ramped-Up HIPAA
        Payers                                              Privacy Laws
               Public Reporting
                on Individual        Mandatory Electronic 
                 Physicians            Health Records
                                                       Taking Care of Patients
          Today’s Workshop:
   Coding and Documentation:  Current Issues
    § E&M Essentials: Medical Necessity
    § Signed Orders for All Services
    § Observation Services

   New HIPAA Privacy Laws (ARRA 2009)

   Industry Relationships: Guidelines

   Compliance and EHRs: Be Careful
        Causes of Coding Illiteracy
n   No training in residency (until recently)

n   We just “wing it” when we start practice . . .
    It’s on-the-job training

n   We’re not all wired to think about financial
    implications, especially in academic centers

n   Don’t realize legal implications of improper
    coding
    Why does coding matter?
IT’S OUR AGREEMENT WITH MEDICARE AND
       OTHER INSURANCE COMPANIES

 CORRECT CODING PRACTICE IS PART OF GOOD
             MEDICAL CARE


 CIVIL AND CRIMINAL VIOLATIONS ARE HANDED
  DOWN EACH YEAR FOR FRAUDULENT CODING


MILLIONS OF DOLLARS ARE LOST EACH YEAR TO
          POOR CODING PRACTICES
     FINANCIAL IMPLICATIONS
n   Medicare Fee Schedule 2010
     n   Level 3 NEW visit -$98
     n   Level 4 NEW visit - $151       -   ($53 difference)

     n   Level 3 EST visit - $66
     n   Level 4 EST visit - $98    -       ($32 difference)
    If each physician in a group of five codes 360 visits/month,
    approx. 70% of these will be Level 3 or 4 . . .

    Just 25 undercoded visits/month (about one/day) per doctor
    per month amounts to a loss of $64,000 year
LEGAL IMPLICATIONS
Nuts and Bolts of E&M Coding:

  THE THREE KEY DOCUMENTATION
            ELEMENTS

MEDICAL DECISION-MAKING
          HISTORY

     PHYSICAL EXAM
                 IMPORTANT!

n   The Nature of the Presenting Problem determines the
      level of documentation necessary for the service

n   The level of care (E&M service) submitted must not exceed
           the level of care that is medically necessary

                           SO . . .

Medical Decision-Making and Medical Necessity related to
    the “NPP” determine the maximum E&M service.
    The amount of history and exam alone do NOT.
  MEDICAL DECISION-MAKING

                       •   Number of Diagnoses or
                             Treatment Options



    One or two stable problems?
                                                    LOWER
    No further workup required?       =
      Improved from last visit?               COMPLEXITY

     Multiple active problems?
                                                HIGHER
New problem with additional workup?   =
       Are problems worse?                   COMPLEXITY
MEDICAL DECISION-MAKING

          2. Amount/Complexity of Data




            Were lab/xray ordered or reviewed?
Were other more detailed studies ordered (Echo, PFTs, BMD,
                     EMG/NCV, etc.)?
               Did you review old records?
              Did you view images yourself?
            Discuss the patient with consultant?
MEDICAL DECISION-MAKING
                3. Table of Risk




       Is the presenting problem self-limited?
              Are procedures required?
      Is there exacerbation of chronic illness?
 Is surgery or complicated management indicated?
   Are prescription medications being managed?
                HISTORY
           FOUR ELEMENTS
1. Chief Complaint (CC:)

2. History of Present Illness (HPI)
   location/quality/severity/duration/timing/context/modifying
   factors/associated symptoms

3. Past/Family/Social History (PFSHx)

4. Review of Systems (ROS)
                               HISTORY
n   PEARLS FOR HISTORY DOCUMENTATION:

    n    Must have PAST/FAMILY/SOCIAL history for comprehensive
        history (ALL THREE)
         n   “Noncontributory” or “Unremarkable” should not be used


    n   Don’t forget 10-system review for comprehensive history

    n   You cannot charge higher than a level 3 new or consult visit for a
        higher-complexity patient without COMPREHENSIVE
        HISTORY

    n   Patient questionnaire may be referred to without repeating
       PHYSICAL EXAM

ORGAN SYSTEMS - 12 recognized
 Constitution/Eyes/ENMT/Resp/CV/GI/GU/
 Heme or Lymph/MSK/Neuro/Psych/Skin

BODY AREAS - 8 recognized
   Abdomen/Back/Breast and
  Axillae/Chest/Extremity(4)/Genitalia &
  Buttocks/Head &Face/Neck
         History/Exam Requirements
    New/Consult         History        Exam          MDM
n   99203/99243         Detailed      Detailed         Low
n   99204/99244     Comprehensive   Comprehensive    Moderate
n   99205/99245     Comprehensive   Comprehensive      High




Initial Hospital Care

     •   99221          Detailed      Detailed       Low
     •   99222      Comprehensive   Comprehensive   Moderate
     •   99223      Comprehensive   Comprehensive    High
                 CONSULTS*
n   What is a CONSULT? (The Three “R”s)

    n Requested by another physician


    n Reason for consultation must be documented


    n Report must be sent to requesting physician



    * CMS has just changed fee schedule to eliminate
      consultation services starting January 1, 2010
      (November 1, 2009)
                     CONSULTS
                   IMPORTANT !
    n   All three “R’s” must be documented to bill a consult
                   (unless shared medical record)

    n   Coding guidelines for consults are the same as a NEW
                               patient

n   BCBS, Medicaid, and most payers still recognize consults
           NEW PATIENTS

n   Patient selects you as his/her MD or is
    referred by a non-physician

n   Patient not seen by you or your group in
    past three years (as outpatient or inpatient)

n   Referred for primary care by specialist
        INPATIENT E&M CODING
n   Initial Hospital Care (First visit)
    n   Three levels of service: 99221, 99222, 99223

         n   Used by admitting physician ONLY

         n   99222 and 223 require comprehensive history and
             examination (detailed for 221)

         n   Distinguishing feature is Medical-Decision Making
              n   221 = Low Complexity
              n   222 = Moderate Complexity
              n   223 = High Complexity
        INPATIENT E&M CODING
    n   Subsequent Hospital Care
        n   Three levels of service: 99231, 99232, 99233

        n   231 - Stable, recovering, improving
                 n Problem focused history or exam


        n   232 - Not responding, minor complication
                 n Expanded problem focused history or exam


        n   233 - Very unstable, significant complications
                 n Detailed history or exam

REMEMBER - What is medically necessary to document for that day?
n   Subsequent Hospital Care 99231 – Examples


n   70 yo male admitted for lobar pneumonia with
    vomiting and dehydration, now afebrile and
    tolerating oral fluids

n   40yo female seen 3 days after asthma exacerbation,
    tapering steroids, changing to po antibiotics, d/c in
    a.m.
n   Subsequent Hospital Care 99232 – Examples


n   37 yo female hospitalized for endocarditis, still with
    low-grade fever

n   13 yo male admitted with LLQ abdominal pain and
    fever, not responding to initial antibiotics

n   73yo female recently diagnosed with lung cancer,
    now with unsteady gait
n   Subsequent Hospital Care 99233 – Examples


n   56yo male ESRD patient develops chest pain/dypnea
    while in hospital for cellulitis

n   67yo female in hospital for acute MI develops sudden
    pulmonary edema

n   46yo male with cirrhosis and peritonitis develops
    worsening encephalopathy and ascites
SUBSEQUENT HOSPITAL VISITS

Medical Necessity should drive your documentation for
                    each day’s visit:

              What’s wrong with this audit?

                      Day 1: 223
                      Day 2: 233
                      Day 3: 233
                      Day 4: 233
                      Day 5: 233
             Day 6: 239 (discharge to home)
           Critical Care Services
DEFINITION (CPT 2005):

n   Direct delivery by a physician of medical care for a
    critically ill or injured patient. . .

n   Illness acutely impairs one or more vital organ
    systems such that there is a high probability of
    imminent or life-threatening deterioration in patient’s
    condition . . .

n   Involves high-complexity decision-making to assess,
    manipulate, and support vital organ system function to
    prevent further deterioration
          Critical Care Services
      Documentation Requirements

1.   Organ system failure and nature of
               critical illness

n    Acute respiratory distress
n    Sepsis
n    Hypotension
n    Acute neurologic change
          Critical Care Services
      Documentation Requirements


2.   Attending physician’s highly complex
     decision-making and intervention

(Swan-Ganz interpretation, vent adjustments,
   lab interpretation, imaging studies, etc.)
        Critical Care Services
    Documentation Requirements
 3. Time spent in critical care of patient

99291 – First 30-74 minutes
99292 – Each additional 30 minutes

Must be attending time only in direct care of the
                      patient
       E&M Services Allowables
                 Critical Care Codes

 Critical
  Care         Medicaid    Medicare     BCBS
 (>6yo)

99291 (first
                $ 126.00     $ 202.05   $ 312.00
30-74 min)

99292 (ea.
 add’l 30         $63.00     $100.96    $107.00
   min)
CRITICAL CARE SERVICES –
       What counts?
 n Direct patient care
 n Time spent on the unit/nurses’ station

 n Discussion of patient with nurses/consultant

 n Writing progress notes/dictating

 n Review of labs/imaging studies/etc.

 n Time spent with family members when patient
   is unable to participate – must be necessary
   for proper care of patient (not just “daily
   updates”)
CRITICAL CARE SERVICES –
    What does not count?
 n   Time spent off the floor

 n   Time teaching residents in rounds outside the
     patient’s presence

 n   Linking to resident’s notes

 n   Time spent on procedures

 n   Routine telephone calls to family members
            Critical Care Services
                      Common Issues
- When does calendar day start for critical care services?
   Midnight to Midnight
       Critical Care Service from 11:15 – 12 MN – 99291
       Continued service from 12MN – 12:45 – 99291

– Can two providers bill critical care time on the same day?
   YES – must be different time periods
   NOTE – cannot bill regular E&M service AFTER critical care


– Does time spent on procedures count for critical care time?
   YES for bundled procedures only
   NO for other billable services
 Critical Care with Other Services
Ventilator management
  – Bundled into Critical Care – NO Modifier-25
     Cannot bill separately from 99291-292
  – CPT Codes:
     94002 Initial day ($81.27)
     94003 Subsequent day ($58.89)
     Must document vent settings, pt. response, revisions, plan


Other Bundled Services:
  – Cardiac OP, CXR, ABG, NGT, Temp. Pacing,
    Venipuncture, Arterial Puncture 
         Billable Services apart from
                 Critical Care
n   Endotracheal intubation
n   PA Catheter placement
n   CPR
n   CVL
n   Arterial Lines
n   Dialysis catheter
n   Swan-Ganz
      These should all have separate procedure notes!
                   MODIFIERS

 n   Indicate that a separate service or procedure has been
       performed by the same physician on the same day
                   (2 CPT codes submitted)


     Medicare is monitoring these codes!
Recent report from CMS: 35% of claims using modifier -
  25 did not meet requirements, resulting in $538 million
               dollars in improper payments
  You will be audited if you regularly use these codes!
      COMMON MODIFIERS

                 n   Modifier -25

     Signifies visit or consultation for a
 SIGNIFICANT, SEPARATE identifiable E/M
           service on the same day

Good Example - visit for HTN, DM follow-up/patient
          also receives injection in knee
        TIME-BASED CODING

n   Medicare will allow payment for face-to-
    face time counseling patient if documented
    correctly:

    n “I spent 40 minutes with the patient, of which
      >50 % were spent counseling on ________”
    n No other documentation necessary

    n MUST BE FACE-TO-FACE TIME WITH
      PATIENT OR FAMILY MEMBERS ONLY!!
           WHAT INITIATES A
           MEDICARE AUDIT?
n   Complaints from patients or “whistleblowers” -
    nurses, employees, etc
n   Disproportionate volumes of high level services
    (Level 4s and 5s)
n   Lack of documentation of medical necessity for
    services rendered
n   Unrelated specialty procedure billing
n   Uniform level coding (I.e. all Level 4s)
        Hospitalist Data




Admissions          Subsequent Visits
Rheumatology - Outpatient




 Consult           Established
Otolaryngology - Outpatient




 Consults            Established
The New World of . . . 

   Ordering Tests 
    Orders for Lab and Diagnostic 
               Testing
n   Requirements:

    n   The physician is solely responsible  for the 
        medical necessity of each test ordered

    n   A diagnosis must be linked to each test in 
        order for the service to be covered

    n   The correct diagnosis is the responsibility of 
        the physician (not the nurse or secretary)
    Orders for Lab and Diagnostic 
               Testing
n   Requirements:

    n    A signed order or note of physician’s 
        intention must exist for each lab and 
        diagnostic test (verbal  orders as well)

    n   Can be electronic or written and must be kept in the 
        patient’s medical record (no sticky notes)

    n   Patient must be informed if test or procedure is not 
        covered by insurance
New Signature Guidelines from 
    CMS (April 16, 2010)
n   All orders for services must be handwritten or electronic 
    (no stamps)

n   If signature is missing from an order the service will be 
    denied
    Compliant Signature Practices
                       (CMS April 2010)

n   Legible full signature; 
n   Legible first initial and last name; 
n   Illegible signature over a typed or printed name; 
n   Illegible signature accompanied by letterhead, addressograph or 
    other information on the page that indicates the author's identify; 
n   Illegible signature with documentation that is accompanied by a 
    signature log or an attestation statement; 
n   Initials over a typed or printed name; 
n   Initials not over a typed/printed name, but accompanied by a 
    signature log or an attestation statement; 
n   Unsigned handwritten note with other signed entries on the same 
    page, written in the same handwriting.   
    Non-Compliant Signature Practices
           (CMS April 2010)
                    

n   Illegible signature not over a typed/printed name and not on 
    letterhead, with no signature log or attestation statement 
    accompanying documentation; 

n   Initials not over a typed/printed name and not accompanied by a 
    signature log or attestation statement; 

n   Unsigned, typed note with provider's typed name; 

n   Unsigned, typed note without provider's typed/printed name; 

n   Unsigned handwritten note (the only entry on the page); and 

n   Statement such as "signature on file." 
    Orders for Lab and Diagnostic 
               Testing


n   Over 200 pre-payment requests received 
    in UAB Billing Office since December 
    2008
Observation Services
Hospital Observation Services
Admission/Discharge on different days:
99218:   Detailed history/exam, low-complexity MDM
99219:   Comprehensive history/exam, moderate MDM
99220:   Comprehensive history/exam, high MDM
99217:   Observation Discharge

Admission/Discharge on same day:
99234:   Detailed history/exam, low-complexity MDM
99235:   Comprehensive history/exam, moderate MDM
99236:   Comprehensive history/exam, high MDM
        What is Observation?
1. Evaluating a patient for possible inpatient admission.
2. Treating a patient expected to be stabilized and released
  in 24 hours (with appropriate documentation, patients can
  stay in observation more than 24 hours).
3. Extended recovery following a complication of an
  outpatient procedure, for example:
   • poor pain control
   • intractable vomiting
   • delayed recovery from anesthesia
   • abnormal postoperative bleeding
    What is NOT Observation?
1. A substitute for inpatient admission.
2. For continuous monitoring.
3. For medically stable patients who need diagnostic testing or
   outpatient procedures.
4. For patients who need therapeutic procedures (e.g., blood
   transfusion, chemotherapy, dialysis) that are routinely provided in an
   outpatient setting.
5. Patient awaiting placement in a facility.
6. To be used as a convenience to the patient, his or her family, the hospital,
or or the attending physician.
7. For routine prep or recovery prior to or following diagnostic or surgical
   services.
8. A routine “stop” between the Emergency Department and an inpatient
   admission.
  The New World of . . .
  Privacy and Security


(a.k.a. HIPAA on Steroids)
Medical Records Are a Key Target:
 Insiders and External Thieves
                                                                IDE
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               U nive tural          Proliferating HIPAA complaints and
                  a 'na
                                            medical record breaches
Health Information Privacy Complaints Received by Calendar Year
    Pre-ARRA HIPAA Privacy and 
      Security Rule Complaints
n   Complaint-driven enforcement
n   CMS criticized by OIG for lax compliance, 
    insufficient enforcement
n   OIG found significant violations at 8 hospitals 
    that it audited
n   March 5, 2007 – first CMS audit (Piedmont 
    Hospital) 
n   Reportedly auditing 50 hospitals per year – via 
    unannounced audits
      Congress Takes Action
n American Economic Recovery and 
 Reinvestment Act (“ARRA”) 
 n Significant changes to the US privacy and 
   security landscape (HIPAA)
 n Increasing scrutiny, enforcement on the way 
   (federal and state)
n
         Security Breach Notification
    We must notify patients, the government and, in some instances, local media, 
    of “security breaches” of “unsecured protected health information.” (Effective 
    9/09)

     n   What is a Security Breach?
          n   Unauthorized acquisition, access, use, or disclosure of “unsecured” health 
              information
          n   Compromises the security or privacy of the information

          n   Examples: 
               n   Theft of laptop with unencrypted patient health information
               n   Employee viewing electronic medical record with no business purpose.  

          n   Exceptions
               n   Any unintentional acquisition or access by an employee if made in good faith in course 
                   of employment and no further disclosure
               n   Any inadvertent disclosure from an individual who is authorized to access health 
                   information to another similarly situated individual and no further disclosure

     n   “Unsecured protected health information” is electronic or paper health 
         information that is not encrypted. 
         Security Breach Notification
n   For all security breaches of unsecure protected health information, 
    we must:
     n   Notify affected patients within 60 calendar days of discovery
          n Mail/email describing breach, types of health information involved, steps 
            patients should take to protect themselves, description of steps we’ve taken and 
            contact procedures (telephone number, email address, web site)

     n   Maintain log of breaches and submit annually to Department of Health & Human 
         Services



n   If more than 500 patients are affected, we must:
     n   Notify affected patients within 60 calendar days of discovery
     n   Notify the Department of Health & Human Services “immediately”
          n   Posted on public website
     n   Notify major media outlets in the area 
         Increased Enforcement and 
                  Penalties
n   State Attorneys General are authorized to bring civil actions in U.S. 
    District Court for HIPAA violations (effective 2/09).
     n   Injunction or damages of $100 per violation, not to exceed $25,000 
         aggregate for identical violations during a calendar year.  

n   Increased Civil Money Penalties – 3 tiers (effective 2/09)
     n   “Did Not Know of Violation” -- $100 per violation, not to exceed $25,000 
         for identical violations during a calendar year.
     n   “Reasonable cause but not willful neglect” -- $1,000 per violation not to 
         exceed $100,000 for identical violations during a calendar year.
     n   “Willful neglect” -- $10,000 per violation, not to exceed $250,000 for 
         identical violations during a calendar year. 

n   By February 2012, affected patients may be entitled to percentage of
    civil money penalties collected.  
           HIPAA Top Do’s and Don’ts
n   Do not discuss or share PHI with coworkers, family, or friends unless 
    they have a business/work-related need to know (TPO purposes). 

n   Limit PHI used or disclosed to the minimum necessary PHI to 
    accomplish the purpose. 

n   Do not share your user account, password, token, or other means of 
    system access with anyone. 

n   Do not use your access to the clinical systems to look up medical 
    information on your family, friends, or co-workers. 

n   Never take photographs of patients or their families with personal 
    devices.  Refrain from taking pictures in patient care areas. 
           HIPAA Top Do’s and Don’ts
           HIPAA
n   Log off a computer if it is to be left unattended or if a coworker needs 
    to use it. 

n   Do not email PHI unless it is encrypted and secure.

n   Do not use portable devices for storing or transporting ePHI without 
    appropriate administrative approval and mandated security 
    protections (encryption). 

n   Do not use your own personal portable devices for health care 
    business unless such use is specifically approved by senior 
    management and all established security guidelines are followed 
    (encryption).

n   Do not post PHI on social networking sites (Facebook, Twitter, 
    LinkedIn, YouTube).
   Conflicts of Interest:
Relationship with Industry
       The Company We Keep…
n   Stanford University
n   Cleveland Clinic
n   University of Pennsylvania
n   Vanderbilt University
n   Emory University
n   Harvard University
n   Johns Hopkins
n   Columbia University
n   UAB Medicine
         Conflict of Interest Policies
n   Academic Medical Centers adopting 
    new or revised Conflicts of Interest 
    Policies that prohibit and/or restrict 
    interactions between staff and the life 
    sciences industry
     n   Recent significant adverse news reports 
         regarding physician/industry 
         relationships and failure or inadequacy 
         of disclosures
n   UHC, AAMC, and IOM White Papers
n   Industry Action
     n   PhrMA and AdvaMed Guidelines
           Why All The Concern?
n   Skews clinical and research decisions
    n   Decisions not based on best interest of patient
n   Undermines integrity of drug formulary and 
    technology purchasing program
n   Increased/inappropriate utilization
    n   Back to patient’s best interest…
    n   Increased costs
n   Undermines pricing structure for government 
    programs
           Why All The Concern?

n   Conflicts of Interest “erode the public trust 
    while providing no meaningful benefits to 
    patients or society.”
    n   IOM Panel Chair Bernard Lo, MD, Professor 
        of Medicine and Director of the Program in 
        Medical Ethics at the University of California, 
        San Francisco
     Conflict of Interest Policy Examples
n   Conflict of Interest Policies
    n   Stanford
         n   “…interactions with industry should be conducted so as to avoid or 
             minimize conflicts of interest.  When conflicts do arise they must be 
             addressed appropriately…”
         n   Policy Summary
               n   Faculty research addressed in another policy
               n   Gifts and compensation
                     n All gifts are prohibited
                     n Compensation for sales pitches and attending CMEs are 
                       prohibited
               n   Restricted site access by sales and marketing representatives
               n   Limitations and requirements for scholarships and other educational 
                   funds for students and trainees
               n   Required disclosure of industry relationships
               n   Conflicts of interest training for students, trainees and staff
                     n “All students, residents, trainees, and staff shall receive training 
                       regarding potential conflicts of interest in interactions with 
                       industry.”
     Conflict of Interest Policy Examples
n   Conflict of Interest Policies
    n   University of Pennsylvania
         n   The purpose of this policy is to protect physician and other medical 
             staff and other health care providers’ efficiency and integrity and to 
             protect patient safety and privacy.”
         n   Policy Summary
               n   Prohibits gifts from both industries
               n   Requires pharma rep registration and an appointment
               n   Restricts meeting and detailing areas
               n   Prohibits pharma samples or vouchers
               n   Limitations on and requirements for education grants and programs
               n   Prohibition against food provided directly by pharma reps. 
                   Prohibits hospitality or subsidies from both industries
               n   Restrictions on consulting and research
               n   Requirements for scholarships for health care professionals in training
     Conflict of Interest Policy Examples
n   Guidelines for Relationships with Industry
    n   University of Alabama at Birmingham School of Medicine 
        and UAB Health System
         n “A primary goal of the UAB AMC is to provide 
           outstanding, state-of-the-art medical care. This care must 
           be as free as possible of both real and perceived conflict of 
           interest and competing interests. As conflicts are 
           identified, they must be managed in a transparent 
           fashion…”
    n   Policy Summary
            n   Prohibits gifts from industry 
            n   Requires industry rep registration and an appointment
            n   Restricts meeting and detailing areas
            n   Prohibits pharma samples or vouchers
            n   Limitations on and requirements for education grants and programs
            n   Prohibition against food provided directly by pharma reps. 
                Prohibits hospitality or subsidies from both industries
            n   Restrictions on consulting and speaking 
            n   Requires disclosure of relationships with industry
    The New World Order in the News
n   Prosecutors Plan Crackdown on Doctors who Accept Kickbacks
    n   “Federal health officials and prosecutors, frustrated that they have been 
        unable to stop illegal kickbacks to doctors from drug and device companies, 
        are investigating doctors who take money for using these products…”  
        “What we need to do is make examples of a couple of doctors so that their 
        colleagues see that this isn’t worth it,” said Lewis Morris, chief counsel to 
        the inspector general of the Department of Health and Human Services. 
        “We want to send the message to the physician community – particularly 
        surgeons – that you can’t do this.’”
         n   http://www.nytimes.com/2009/03/04/health/policy/04doctors.html?_r=1&sc
             p=2&sq=%2bMedicare&st=nyt

n   U.S. Probes Emory Doctor’s Glaxo Ties
    n   “Federal officials are investigating Emory University to determine if the 
        school misled the National Institutes of Health about its star psychiatrist’s 
        lucrative consulting work for big drug makers, people familiar with the 
        matter said.”
         n   http://online.wsj.com/article/SB123562069194979361.html
The New World Order in the News
n   Legislation and Regulation
    n   Proposed physician Payment Sunshine Act requires 
        disclosure of almost all items of value that pharma 
        and medical device companies provide to physicians
    n   [Massachusetts] bans drug firm gifts to doctors – 
        Disclosure of fees for consulting mandated”
         n   “State officials gave final approval yesterday to regulations 
             banning pharmaceutical and medical device companies from 
             providing gifts to physicians, limiting when companies can 
             pay for doctors’ meals, and requiring companies to publicly 
             disclose payments to doctors over $50 for certain types of 
             consulting and speaking engagements.”
     The New World Order In the News
n   Proposals for Limiting & Banning Industry Funding
    n   “Doctors Urge Limits on Drug Firm Money”
         n   “A group of leading doctors and researchers called on medical 
             associations to sharply limit the funding they receive from the drug 
             and device companies, the latest sign of the growing push to limit 
             industry’s influence on how medicine is practiced.”
    n   “Ban Urged on Gifts at Medical Schools”
         n   Drug and medical device companies should be banned from offering 
             free food, gifts, travel and ghost-writing services to doctors, staff and 
             students in all 129 of the nation’s medical colleges, an influential 
             college association has concluded.”
    The New World Order In the News
n   Professional Societies
    n   “U.S. psychiatrists to end drug company seminars”
         n   “The American Psychiatric Association said on  Wednesday it will end 
             medical education seminars and meals sponsored by drug companies at 
             its annual meetings to reduce chances for financial conflicts of interest.”
    n   “Spine Doctors are Adopting Strict Rules on Payments”
         n   “A medical society representing U.S. spine surgeons has taken the rare 
             step of requiring that researchers disclose not just the existence of 
             financial ties to medical-device companies, but the dollar amounts as 
             well…
         n   NASS…said the new disclosure policy will apply to doctors who present 
             studies at future medical conferences.”
    n   “Wisconsin Medical Society discourages gifts from drug firms”
         n   “The Wisconsin Medical society’s board has come out against doctors 
             accepting gifts, speaking fees and other payments from pharmaceutical 
             and medical device companies.”
     The New World Order In the News
n   Voluntary Industry Disclosure
    n “Medtronic to reveal consulting fees to doctors”
    n “Pfizer to Disclose Payments to Doctors”

    n “Edwards to Disclose Relationships with Doctors

    n “GSK to publish level of advisory fees for doctors”

    n “Lilly will disclose speaking, consulting fees paid to 
      doctors”
             New World Order – Physician 
                    Resistance
n   “Not me – Industry entertainment and funding do not affect my 
    medical judgment”
    n   Resident Survey
         n   60% did not think they were influenced by industry gifts
         n   But, only 16% thought other physicians were not affected by industry gifts
    n   Numerous studies have demonstrated that physician medical decisions 
        are influenced by meals, gifts, and other items of value provided by the 
        industry, even relatively minor meals or gifts.
         n   Influence may be unconscious
         n   Accepting gifts can lead to social relationships with real obligations (Chen, 
             Landefeld & Murray, Doctors, Drug companies and Gifts, 262 JAMA 2448 
             (1989))
               n   Natural reaction to reciprocate when receiving something
        New World Order – Physician 
               Resistance
n   Customer Expectations
    n   “Your competitors are doing it”
    n   “You want my business, I want a consulting 
        agreement”
    n   “What do you mean your company isn’t providing a 
        grant for my program – do you know how much 
        business I do with your company!”
    n   “What do you mean you cannot pay for my wife?”
    n   “If you want to meet with the doctors you have to 
        bring food for the entire staff”
    n   “We are such good customers of yours that we are 
        sure you will want to participate in our fundraiser.”
         n   Signed by or copied to physicians using vendor’s products
        Enforcement Environment
n   Application of the Laws
    n   Anti-Kickback Statute
    n   Federal False Claims Act
         n   Whistleblower Provision
n   Case Examples:
    n   Pfizer
    n   Merck
    n   Bristol Myers Squibb
    n   Schering-Plough
    n   Hips and Knees 
        Hips and Knees
  The New World of . . .

     Compliance and 
Electronic Health Records
So What’s the Big Deal?  It Works for 
                Us!




              COPY    PASTE
    Word on the Streets of our Medical 
                Centers:
n   Coding, HIM and Clinical Applications Professionals are saying:
     n   “How can I tell who the author-of-note is?”
     n   “All these physical exams look exactly the same!”
     n   What happens if an error is copied forward?”
     n   “How can I remove the button?”
     n   “Do I need to hire a full-time person to audit the appropriate use of this 
         feature?”

n   What Corporate Compliance, Payers, Regulatory and Governmental 
    Agencies are saying:
     n   “Unless the doctor credits the original author, this is fraudulent”’
     n   “Each entry must be attributed to the author.”
     n   “Cloned documentation does not meet medical necessity”
    Word on the Streets of Health Care:

n   What the Providers are Saying:
     n   “It took two painful years until the IPhone got it! Don’t take it 
         out of my EHR!”
     n   “It saves time if I can copy forward a note”;
     n   “I only use it for past medical history”;
     n   “If another provider can re-use my note, what is the harm?”


n   What the Vendors are Saying:
     n   “Copy/Paste is Windows Functionality that we cannot control”’
     n   “Providers are requesting it!”
     n   “This feature should be controlled and managed by policy”.
  Has Any Research Been Done of 
  Copy Paste Functionality (CPF)?
2008 MD Survey:
According to O’Donnell, et al,  out of 253 MDs who
document electronically, 225 (90%) use CPF:
n 70% used CPF most of the time when writing progress notes;

n 71% felt that inconsistencies and outdated information were more 
   common in copy and pasted notes;
n 19% felt that CPF had a negative impact on MD documentation;

n 24% felt it led to mistakes in patient care;

n 80% wanted to continue to use CPF.


O’Donnell HC, Kaushal R, Barron Y, et al. Physicians’ attitudes towards Copy and pasting
 in electronic note writing. J            Med. 2009: 24:63-68
 in electronic note writing. J Gen Intern Med. 2009: 24:63-68
    Risks Identified in Research of CPF 
                   (cont)
Weir, et al., examined 1,900 entries for input-
related error, identified:
n Common errors from copying
    n   Inconsistent text
    n   Inappropriate insertion
    n   Signature issues in the EHR
n   Findings
    n   6 out of 10 charts had > 1 input-related error,  average chart had over 7 
        errors
    n   Risk of error increased when copied from one clinician to another – 1 in 5 
        notes (avgeraging 1 error/note)

    Weir CR, Hurdle JF, Felgar MA, et al. Direct text entry in electronic progress notes: an evaluation of input 
    Errors. Methods     Med. 2003;42:61-67.[PubMed]
    Errors. Methods Int Med. 2003;42:61-67.[PubMed]
    Risks Identified in Research of CPF 
                   (cont)
Seigler and Adelman identified the following CPF hazards
in electronic documentation:
n   Reduced credibility of recorded findings;
n   Clouding clinical thinking;
n   Limiting proper coding;
n   Robbing the chart of its narrative flow and function;
n   Problem Lists never change:
       n    House staff recognize that if they organize problems by system they can copy and 
            paste the same problem list day after day even if new diagnoses appear or priorities 
            have changed – when added it is difficult to see the updated information
n    With each copy and paste iteration – notes lengthen and errors accumulate.
Seigler ES, Adelman, R..Copy and Paste: A Remedial Hazard of Electronic Health Records. American            Medicine. 2009;122:495-
Seigler ES, Adelman, R..Copy and Paste: A Remedial Hazard of Electronic Health Records. American Journal of Medicine. 2009;122:495-
      486.[PubMed]
    Risks Identified in Research of CPF 
                   (cont)
n   Embi, et al., performed a small study interviewing VA 
    Residents and Faculty identifying:

     n   Redundancy: same information and misinformation repeated over 
         and over again – difficult to identify where the misinformation 
         begins;
     n   Formatting: difficulty segregating out the useful information “stuff 
         you care about” from the endless notes;
     n   Decreased Confidence in the Material: “..the same physical exam 
         is the intern’s , resident’s, attending’s, and in subsequent 
         specialist’s progress notes.”

     Embi, P.J., T.R. Yackel, J.R. Logan, J.L. Bowen, T.G. Cooney, and P.N. Gorman. 2004. Impacts of computerized 
        physician documentation in a teaching hospital: Perceptions of faculty and resident physicians. Journal
        physician documentation in a teaching hospital: Perceptions of faculty and resident physicians. Journal of the
                                          Association: JAMIA 11, (4)(Jul-Aug): 300-9.
        American Medical Informatics Association: JAMIA 11, (4)(Jul-Aug): 300-9.
      Other Findings – Templates and 
     Cloning Impacting Compliance and 
              Reimbursement
1.       Templated documentation and Copy and Pasted notes 
         are also referred to as Cloning – identical entities for 
         the same patient over time or different patients may 
         have a reimbursement and compliance impact.

2.       First Coast Service Options, Inc. (A CMS Contracted 
         intermediary and Carrier stated according to Michael 
         Vigoda, MD, MBA:
     n     “Documentation is considered cloned when each entry in the 
           medical record is worded exactly like or similar to the previous 
           entries. Cloning also occurs when medical documentation is 
           exactly the same from beneficiary to beneficiary. It would not 
           be expected that every patient had the exact same problem, 
           symptoms, and required the exact same treatment.
     Other Findings – Templates and 
    Cloning Impacting Compliance and 
             Reimbursement
n   According to a 2006 Medicare Update:
     n   Cloned documentation does not meet medical necessity
         requirements for coverage due to the lack of specific, individual
         information.  All documentation in the record must be specific 
         to the patient and her/his situation at the time of the encounter.


     n   Cloning of documentation is considered a misrepresentation of 
         the medical necessity requirement for coverage of services. 
         Identification of this type of documentation will lead to denial of 
         recoupment of overpayments made.

     Medicare Update, First Coast Service Options Inc. (A CMS Contracted Intermediary and Carrier) 3 rd Quarter 2006 Vol.4,Num.3
      If We can’t Beat the Habit – Are 
         There Some Industry Best 
                 Practices?

n   Hammond, et al., concluded that disabling CPF 
    would have a crippling effect on electronic 
    documentation and, instead, recommended an 
    approach of:
    n   User education
    n   Enunciation of strong guidelines
    n   Effective monitoring systems and supervisory feedback
    Hammond KW, Helbig ST, Benson CC, Brathwaite-Sketoe BM. Are electronic medical records trustworthy?
    Observations on copying, pasting and duplication. AMIA           Proc. 2003;269-73
    Observations on copying, pasting and duplication. AMIA Annu Symp Proc. 2003;269-73
         Recommendations for Clinical 
        Documentation to Mitigate Risk
n   Hammond, et al. further proposed that institutions using EHRs 
    consider:
    n   Re-engineer templates to avoid unnecessary duplication artifact.
    n   Minimize inserting patient data available elsewhere into the narrative 
        record.
    n   Develop medical history and examination data objects that can be 
        reviewed, amended and re-used.
    n   Enhance the problem list function as a better alternative to copying text 
        lists.
    n   Enhance automated methods to more efficiently monitor for dangerous 
        and misleading copying.
    n   Caution clinical departments against excessive use of copying to boost 
        productivity.
    n   Teach practitioners and students that careless copying creates 
        untrustworthy records.
    n   Empower teachers to monitor the writings of trainees with automated 
        methods.
         Design Strategies for Your 
              Consideration
Organizational Considerations:

n   Are there alternatives to the use of copy 
    functionality?
n   How will we ensure user competency?
n   What copy functionality exists within the EHR-
    including the ability to make corrections?
n   What will be our process to mitigate and 
    identify unacceptable uses?
n   Who is going to enforce the policies?
          Design Strategies for Your 
               Consideration
Questions for your Vendor:

n   Does the system allow for “soft” copy forward?
n   How are chart errors identified and corrected?
n   What audit trails are available?
n   Is copied information easily identified?
n   Are blocks of content individually authenticated?
n   How is re-authenticated information identified?
n   How are source documents identified?
    Develop an Operational Strategy 
    for Data Replication Reduction
n   Investigation / Troubleshooting
    n   Consider Data Integrity Coordinator position 
        to oversee and manage EHR record integrity 
        functions, including chart corrections
n   Auditing
    n   Fold into existing functions 
        (coding/billing/compliance)
      Don’t Forget about Regulatory, 
             Accreditation and Payer 
                       Requirements
And Remember:

   The individual performing the copy/paste 
   is responsible for the documentation 
   regardless of who authored the original 
   information!
            Final Thoughts …


n   Document What You Did with Accuracy
n   Protect and Secure PHI
n   Be Transparent in our Relationships
n   Be Cautious With Your EHR “Shortcuts”



                QUESTIONS?

				
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