Point-of-care Point of Care Billing: Yes You Can! Christopher FETTERS Senior Technical Manager, Connectivity Solutions © 2005. All Rights Reserved. Unauthorized duplication is a violation of applicable laws.

Goal Goal in Point of Care? Goal in the Laboratory? Goal in the Hospital? Golden Rule: Do unto others as you would have them do unto your mother.

44,000 – 98,000 patients killed each year by medical mistakes To Err is Human - Building a Safer Health System A Report From The National Academies of Science, Institute of Medicine 44,000 – 98,000 patients killed each year by medical mistakes Key Recommendations Center for patient safety National mandatory reporting Peer review protections Focus greater attention on patient safety FDA should increase attention to safe use of drugs

It is necessary to create a culture of change that embraces patient safety through shared accountability within a blameless culture. Rosina Jones, LHRM, CHRM

Causes of Medical Mistakes 15-20% is mechanical failure 60-80% is human error Active errors Latent errors

Three approaches to quality Remedial Alleviate the symptoms of the existing problem Corrective Eliminate the cause of existing problems or undesirable situation to prevent recurrence Preventative Eliminate the cause of potential problems

IDIOT Not this one Changing the process “er” – Season finale Romano’s accident Not this one IDIOT

hile point-of-care testing (POCT) has significantly improved the timely delivery of diagnostic information for clinical decision making, the wide range of settings and operators involved in POCT add a layer of complexity to an institution’s effort to ensure consistently high-quality results.” W Gerald J. Kost, MD, PhD. “Using operator lockout to improve the performance of point-of-care blood glucose monitoring.” 2000.

Is 99.9% Good Enough? 1 hour of unsafe drinking water every month; There will be no telephone, electricity or television for 15 minutes each day. 315 entries in Webster's Dictionary will be misspelled 114,500 mismatched pairs of shoes will be shipped/year 811,000 faulty rolls of 35MM film will be purchased this year. 880,000 credit cards in circulation will turn out to have incorrect cardholder information on their magnetic strips 2,488,200 books will be shipped in the next 12 months with the wrong cover. 5,517,200 cases of soft drinks produced in the next year will be flatter than a bad tire. 1,314 phone calls will be misplaced by telecommunications services every minute. 18,322 pieces of mail will be mishandled/hour 22,000 checks will be deducted from the wrong bank accounts in the next 60 minutes. 2,000,000 documents will be lost by the IRS this year Your heart fails to beat 32,000 times each year. Twelve babies will be given to the wrong parents each day. 2,500 newborn babies will be dropped in the next month. 107 incorrect medical procedures will be performed by the end of the day today. 500 incorrect surgical operations each week; 200,000 drug prescriptions will be filled incorrectly in the next 12 months. A typical day would be 24 hours long (give or take 86.4 seconds) Jeff Dewar

Quality Our healthcare delivery system is NOT safe for the patient Safety is part of quality Process changes ensure long-term benefit Labs have opportunity because of attention to quality issues Examine pre-analytical processes first Use technology to improve processes, address quality & examine data

82% of Patient Data Still Manually Recorded Source: 1999 EAC US Hospital POC Survey

Point of Care Errors Sensa v. Non-sensa Documentation of ACT Results MD Pocket Developer (distilled water) Timing urine dipsticks Bad Patient ID’s CHANGE THE PROCESS

You can’t manage what you can’t measure. Bill Hewlett

Three things you MUST DO! Christopher Fetters: Video of barcoding a patient. Video of instrument download, data management station, computer room, Bills printing off, money falling, patient accounting department Graphics with poof on previous, then diminishing graphic of current one Find a bite mark for these… Three things you MUST DO! Barcode your patients & operators 2. Install Connectivity 3. Bill for point of care testing

Objectives You should bill for point of care testing! Point of care billing is profitable! Billing for point of care improves patient care!

Why bill? Gives credit among admin to program Count workload (You get what you pay for) Count workload Ought to be paid for services Recoup costs Continue to upgrade technology Add FTE’s to improve control Good for patient care

We S-H-O-U-L-D bill for Point of Care Testing

We should bill for point of care testing. HOW? Q. WHY? The same way we do for all other laboratory testing. A. Because it is laboratory testing.

Point of Care Testing is Lab Testing Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88) American Medical Association (AMA) Medicare

CLIA ‘88 Certifies testing Human specimens • Based on complexity, not setting • Agents of the laboratory

CLIA’s View of In Vitro Testing CLIA requires all entities that perform even one test, including waived test on ‘... materials derived from the human body for the purpose of providing information for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of, human beings’ to meet certain Federal requirements. If an entity performs tests for these purposes, it is considered under CLIA to be a laboratory and must register with the CLIA program.” www.cms.gov/clia/cliaapp.asp

AMA’s CPT Codes Defines code for medical procedures Laboratory testing in the range: 80000 to 89399 CPT Codes for POC Waived Glucose – 82962 Urine dipstick – 81002 ACT – 85347 Fecal occult blood- 82270 • • •

Medicare Medicare Part A Medicare Part B Inpatient Reimbursed by Fiscal Intermediary Medicare Part B Outpatient/POL’s Reimbursed by Carrier Florida (Regional Office: Atlanta) Part A - First Coast Service Options, Inc. Mutual of Omaha Insurance Company Part B - First Coast Service Options, Inc.

Inpatient Medicare Billing Process Christopher Fetters: Set this up as an animation or video Inpatient Medicare Billing Process Patient discharged Physician discharge summary and diagnoses - 30,000 codes Standardized codes for diagnosis Formulated by the World Health Organization (WHO) ICD-10CM is coming… Medical Records Coder  ICD-9 codes - 500 codes - Clinically cohesive groups Similar consumption of hospital resources Similar length of stay patterns Grouper  DRG code Upload to Medicare Payment under Prospective Payment System (PPS) Upload hospital cost report

Use of the cost report Globally Locally PPS based on averages Christopher Fetters: Illustrate the averages going down because point of care testing is absent. Illustrate the cost to charge ratio Illustrate the lump sum payment at the end of the year. Illustrate the Part A to Part B Rollover Use of the cost report Globally PPS based on averages Set next year’s DRG reimbursement schedule Locally Cost to charge ratio

Example DRG Primary Diagnosis: Secondary Diagnoses: Christopher Fetters: Set this up as a flow chart. Get video of medical records, picture of discharge notes, doctor writing discharge notes Example DRG Primary Diagnosis: ICD-9 36.1 – “Bypass, aortocoronary” ICD-9 Secondary Diagnoses: Valvuloplasty, Atherectomy, Catheterization, Angiocardiogram, or Arteriogram ICD-9 DRG 106: “Coronary Bypass with Cardiac Catheterization” DRG Medicare Average Reimbursement: $37,000 $$

Medicare contractors 12 TRAILBLAZER CHISOLM BCBS “Waived Test” QUESTION Part A - Coverage Is CPT 82962 a covered service for inpatients? ANSWER Inpatient claims submitting for Glucose, blood by glucose monitoring device(s) cleared by the FDA (Food and Drug Administration) specifically for home use is a covered procedure and reimbursed DRG for hospitals or RUG for Skilled Nursing Facilities (SNF). [http://www.trailblazerhealth.com/faqs.asp?action=print&id=1561] QUESTION Part A - Coverage Is CPT 82962 a covered service for inpatients? ANSWER Inpatient claims submitting for Glucose, blood by glucose monitoring device(s) cleared by the FDA (Food and Drug Administration) specifically for home use is a covered procedure and reimbursed DRG for hospitals or RUG for Skilled Nursing Facilities (SNF). [http://www.trailblazerhealth.com/faqs.asp?action=print&id=1561] QUESTION Part A - Coverage Is CPT 82962 a covered service for inpatients? ANSWER Inpatient claims submitting for Glucose, blood by glucose monitoring device(s) cleared by the FDA (Food and Drug Administration) specifically for home use is a covered procedure and reimbursed DRG for hospitals or RUG for Skilled Nursing Facilities (SNF). [http://www.trailblazerhealth.com/faqs.asp?action=print&id=1561] “Waived Test” TRAILBLAZER QUESTION Is CPT 82962 a covered service for inpatient claims? ANSWER Inpatient claims submitted for Glucose, blood by glucose monitoring device(s) cleared by the FDA specifically for home use, is a covered procedure and reimbursed as a portion of the Prospective Payment System for Hospital and Skilled Nursing care inpatient services. [http://www.bcbsok.com/chisholm/frequently_asked_questions.html] CHISOLM BCBS 12

Medicare Clinical Laboratory Fee Schedule Covers procedures in CPT Range 80000-89399 Set reimbursement rate (Medicare Part B) Update yearly by Medicare (http://www.hcfa.gov/stats/pufiles.htm)

Setting charges for analytes X Using the Clinical Lab Fee Schedule DON’T Glucose (82962) $3.03 Use lab/hospital Charge Master Suggest NCCLS GP-11A “Basic Cost Accounting for Laboratories” Calculate using worksheets (Direct cost + Indirect cost) X Hospital multiplier

Medicare Payment Policies Local LMRP (Local Medical Review Policy) www.lmrp.net Administered by Carrier National National Coverage Decisions 23 lab analytes In effect Nov, 2002 Final Rule: Federal Register 11/23/2001 Administered by Federal Law

Medicare National Coverage Decision Christopher Fetters: Picture of someone putting a grey top on a core lab instrument Medicare National Coverage Decision Specifically addresses glucose testing Lists ICD-9 for medical necessity Lists reasons for denial Also covers CPT 82947

Who says I can bill for POCT? Christopher Fetters: Gradient picture of Consultant, Government building, Hospital Who says I can bill for POCT? Medicare • Compliance Consultants • Other hospitals

What hospitals? Cedars-Sinai, Mayo Clinic, Wellspan Health, Baystate Medical, Mercy Health, Henry Ford Hospital, Bay Medical Center (Panama City, FL), Merle West Medical Center, Emory University Hospital, Providence Alaska Medical Center, Hershey Medical Center, Methodist Medical Center, Geisinger Health System, Mobile Infirmary, Lancaster General, SSM Health Care, Lakeland Regional Medical Center, MCCG (Macon, GA), St. Vincent Hospital Santa Fe Regional Medical Center, Mercy Health Partners, Presbyterian Hospital of Plano, Concord Hospital (Concord, NH), PinnacleHealth System… Just to name a few!

AACC Conference Call Poll (2003) Q: For which POCT procedures does your institution receive reimbursement? Glucose only (22%) Coagulation (PT/INR) only (30%) Glucose and coagulation only (22%) All POCT charges are billed (26%)

What is required to bill lab tests? CLIA Number Physician order Reasonable and necessary (SSA 1862(a)(1)(A)) Physician must use to manage pt care (42 CFR 410.32, 411.15) Result to physician promptly (implicit)

Medicare National Coverage Decision Specifically addresses glucose testing CPT Codes ICD-9 for medical necessity Reasons for denial Absence of signs or symptoms Routine physical (such as employee physical or community health fair) Failure to provide medical necessity Not ordered by physician Failure to have CLIA certificate Testing performed on device not FDA approved

100% How do I bill? Manual Billing Data management Christopher Fetters: Video of someone filling out a lab card, video of someone docking each type of instrument, video of nurse with stickers on uniform, video of using a pyxis, video of using a data management workstation – Add slide to show increased revenue with data management. How do I bill? Manual Billing 20-40% Missed charges Data management 100%

AACC Conference Call Poll (2003) Q: What are your major stumbling blocks to POC billing? Too great an investment to set up infrastructure (24%) The lab director or finance department has told us we cannot bill (34%) Consultant told us we cannot bill (8%) We are waiting for connectivity (34%)

Why don’t hospitals bill? How did we get here? 15 years ago… 1988 1992 1995

“If you don’t do it excellently, don’t do it at all. Because if it’s not excellent, it won’t be profitable. If it is not excellent, it won’t be fun and if you’re not in business for fun or profit, what the hell are you doing here?” Robert Townsend

PROFITABLE! PROFITABLE! Point of Care Billing Point of Care Billing is Christopher Fetters: Add spice to all three major points… maybe Flash-animate these three screens Point of Care Billing is PROFITABLE! Point of Care Billing is PROFITABLE!

Laboratory Trends Profits Costs

Where have all the grey tubes gone? Christopher Fetters: Movie of racks of grey top tubes, putting grey tubes on core instrument. Poof Money leaves as point of care instruments are introduced. Lined up instruments on table being linearitead. Training nurses to perform point of care testing. Flash through glucose, ACT, urine dipstick, hemoccult and all other point of care testing. Where have all the grey tubes gone? Dade Behring Roche

Payor mix (typical) Medicare / Medicaid (45-60%) Managed care (20-40%) Fee for Service (15-25%) Other (remaining)

Billing can improve Patient Care! Christopher Fetters: Improve this with a sexy picture collage of nursing, operating room, etc… Billing can improve Patient Care! Billing can improve Patient Care!

Billing can improve patient care Christopher Fetters: Picture of a discontented nurse with her arms crossed. Picture of doctor signing patient chart. Illustrate data management Show form with clinical and financial justification request. Billing can improve patient care More FTE’s = Better quality More leverage with physicians and nurses Show ROI on Data Management Financial and clinical justification for new point of care analytes POC Billing creates more nursing positions

Your mission… POC Committee Create an impact worksheet Pt volumes X Charges = Gross Charges Gross Charges X Fee for service % = Net Revenue Potential Billing investigation committee (Ad hoc) POC Coordinator (& Staff) Medical Director Lab Manager / Administrative Director Lab Business Operations Mgr LIS Supervisor Patient Accounting Nursing Admin Managed Care Contracts Potential

You should bill for point of care testing! Christopher Fetters: Include montage of point of care, data management, money, instruments, downloading, nurse taking care of patients. Build the montage with lots of dissolved shots… Needs to create a picture of something as it builds. Like a dollar sign or fade into the face of a patient or something… Conclusion You should bill for point of care testing! Point of care billing is profitable! Billing for point of care improves patient care!

Questions? Christopher Fetters Christopher Fetters: Include stylized Nextivity Logo, Picture of me…etc. Questions? Christopher Fetters Nova Biomedical (781) 647-3700 x293 (781) 894-0585 Fax cfetters@novabiomedical.com www.nextivity.net

Frequently asked questions 1. DRG = No money \ Why bill? Medicare cost report Other payors 2. What CPT code for glucose? 82962 or 82948 82962: Glucose, blood by glucose monitoring device(s) cleared by the FDA specifically for home use 510K approval by the FDA 3. Venipuncture charge G0001? Example: http://hlunix.hl.state.ut.us/medicaid/april2002.pdf 4. “This procedure is just part of the nursing room charge” 5. Repeat testing? 22

FAQ – Nursing Room Charge "Routine services" as defined in Medicare regulations found at 42CFR 413.53(B) are: "Routine services means the regular room, dietary and nursing services, minor medical equipment and surgical supplies and the use of equipment and facilities for which a separate charge is not customarily made.“ The Provider Reimbursement Manual also defines routine services at section 2202.6 "Inpatient routine services in a hospital...generally are those services included by the provider in a daily service charge – sometimes referred to as the room and board charge. Routine services are composed of two broad components: (1) general routine services and (2) special care units, including coronary care units and intensive care units. Included in routine services are the regular room, dietary and nursing services, minor medical and surgical supplies, medical social services, psychiatric social services and the use of certain equipment and facilities for which a separate charge is not customarily made." The Provider Reimbursement Manual defines Ancillary Services at section 2202.8 as follows: "Ancillary services in a hospital...include laboratory, radiology, drugs, delivery room, operating room and therapy services. Ancillary services may also include other special items and services for which charges are customarily made in addition to a routine service charge." 23

FAQ – Repeat Glucose testing Question from ASF (AdminaStar Federal, Inc.) to CMS (Centers for Medicare and Medicaid Services, formerly HCFA) In November we spoke of CMS’s requirement that to be deemed “reasonable and necessary” a physician must use the result of a test in the management of a beneficiary’s specific problem (Program Memorandum AB-00-108). In the instance where a physician has ordered repeated tests—such as a glucose test ordered every half hour—we asked if ASF interprets the requirement to mean a lab or hospital must contact a physician with the results of each test and request another before a repeat test can be performed. ASF replied with a statement from its Local Medical Review Policy (LMRP) on glucose monitoring: “For purposes of this policy prompt physician notification means prior to the next blood glucose test or within eight hours, whichever is sooner”. We accept ASF’s assurance that this requirement is only applied to the outpatient setting, but there is still a problem with outpatient observation and emergency services, where the physician is often quite specific with his/her plan of care, and will order a series of glucose tests with precise instructions on how to proceed based on their results. Does ASF’s opinion about the need to personally contact a physician with the results of a repeat test before another test can be performed extend to emergency patients or to those who have been admitted to outpatient observation?. Answer from CMS: The intent of the policy was not that it be applied to Emergency Department patients or those in observation status, who would be receiving frequent attendance by the physician. [http://www.adminastar.com/anthem/affiliates/adminastar/meda/files/feb02.pdf] 24

Medicare Intermediary Manual All laboratory testing must be reimbursed under the Clinical Laboratory Fee Schedule Laboratory testing is an ancillary service (415.5) Laboratory services are covered under Medicare as a payable service (210.5) Transmittal AB-00-108 & AB-00-99 Laboratory test charges must be reflected on the cost report Laboratory test charges must be uploaded with department code 30x

Payment for glucose testing (Outpatient) Medicare Transmittal AB-00-108 CR 1362 (Dec 2000) When glucose meets the criteria… payment must be made. “Denial of payment for Part B covered laboratory service cannot be made on the basis that the service is routine care.”

Point of Care Billing Impact Christopher Fetters: Worksheet with places to fill in numbers and calculate impact for point of care program. Point of Care Billing Impact Glucose: Yearly Total Volume: 300,000 Yearly Patient Volume: 200,000 (2/3 of total, waste, QC, repeats) (Inpatient) Inpatient volume: 100,000 Charge per test: $14.60 (avg. $12-25) Yearly charges: $1.5 M REVENUE FROM PAYORS: Medicare/Medicaid (55%): $0 Managed Care (30%): $0 Fee-for-Service (15%): $219,000 TOTAL IP REVENUE: $219,000

Point of Care Billing Impact Christopher Fetters: Worksheet with places to fill in numbers and calculate impact for point of care program. Point of Care Billing Impact Glucose: Yearly Total Volume: 300,000 Yearly Patient Volume: 200,000 (2/3 of total, waste, QC, repeats) (Outpatient) Outpatient volume: 100,000 Charge per test: $14.60 (avg. $12-25) Yearly charges: $1.5 M REVENUE FROM PAYORS: Medicare/Medicaid (55%): $177,650 ($3.23 CLFS on 55,000 tests) Managed Care (30%): $0 Fee-for-Service (15%): $219,000 TOTAL IP REVENUE: $396,650

Point of Care Billing Impact Glucose: Inpatient: $219,000 Outpatient: $396,650 Revenue: $615,650 ACT: Volume: 48,000 pt tests Charge: $28.00 Billables: $1.3M Revenue: $195,000 Urine dipstick: Volume: 35,000 pt tests Charge: $9.00 Billables: $315,000 Revenue: $47,250 ABG: Volume: 11,000 pt tests Charge: $55.00 Billables: $605,000 Revenue: $90,750 Only 4 analytes: Hemoccult, Strep-A, Urine Pregnancy, Cardiac Markers, Drug Screens, h. pylori, Gastroccult, PT, pH, Hemoglobin, HbA1C, Provider Performed Microscopy

Total Impact (VERY CONSERVATIVE) Test Billables Revenue Glucose 2,900,000 615,650 ACT 1,300,000 195,000 Urine dip 315,000 47,250 ABG 605,000 90,750 Total 5,120,000 948,650

Profit Strip usage: 300,000 (total) Revenue: $615,650 Vial cost: $25 Strip cost: $.50 Total strip cost: $150,000 Gloves, gauze, alcohol, lancet: $.50 Total disposables: $150,000 FTE (POCC): $45,000 Data Management: $75,000

Payment for glucose testing (Outpatient) Medicare Transmittal AB-00-108 CR 1362 (Dec 2000) When glucose meets the criteria… payment must be made. “Denial of payment for Part B covered laboratory service cannot be made on the basis that the service is routine care.”