Point-Of-Care Testing in

Primary Care Kent Lewandrowski MD

Associate Chief Pathology

Director of Clinical Laboratories and Molecular Medicine)

Massachusetts General Hospital

Professor

Harvard Medical School

Laboratory Testing

On Airline Flights

Conventional Wisdom

POCT is:

• More expensive than central laboratory testing

• Is difficult to manage quality and documentation

• Is difficult to comply with regulatory requirements

For these reasons POCT should only be

performed if there is a demonstrable benefit

(e.g. outcomes)

Objectives

• Describe the classification of outcomes including

medical, financial and outcomes relating to

hospital operations

• Analyze different models for performing

laboratory testing in primary care

• Evaluate different tests that have been shown to

improve outcomes and practice efficiency in

primary care

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Types Of Outcomes

• Medical outcomes: Live longer, better

– Very difficult to document

• Financial outcomes: Save money, more cost effective

– Complex and difficult to document

• Operations outcomes: Improve length of stay, improve efficiency, streamline processes

– Easier to document

Options for Obtaining Laboratory

Testing in Primary Care 1. Sending the patient to a central laboratory after the

office visit: Inconvenient for the patient.

Patient may never show up at the laboratory.

Prevents test results from being reviewed with the patient at the time of the office visit.

Follow-up letters and phone calls and follow-up office visits may be required.

2. Sending the patient to a central laboratory several days before the office visit:

Assumes the required tests can be anticipated in advance.

Patient may never show up at the laboratory.

Allows test results to be reviewed with the patient during the office visit.

Requires an extra trip to the laboratory which may be inconvenient and may incur costs including travel, parking and potentially lost wages.

Options for Obtaining Laboratory

Testing in Primary Care

3. Performing testing in the physician’s office

at the time of the patients visit using rapid POCT

devices:

Individual tests do not need to be anticipated in advance

Results can be reviewed directly with the patient.

Follow-up letters and phone calls may be reduced and revisits for abnormal

test results potentially eliminated.

Which choice would you prefer?

A Relative of Mine

• Saw physician for a chronic complaint

• Tests ordered and the patient was told to

go to a phlebotomy site 15 miles away

• Round trip would require several hours

away from work

• Due to inconvenience the patient never

went

Sample Acquisition: A Key Issue With Point-

of-Care Testing

• Most practices do not have on-site

phlebotomy

• Finger-stick tests therefore highly

desirable

• Alternate sample types useful in some

cases (e.g. salivary samples, urine)

• New technologies coming on the horizon

One New Technology

Place device on skin

Collects 20 uL of blood essentially without

pain

Future devices planned to collect a larger

sample

Key Factors Impacting POCT in

Primary Care

• Accuracy of the test

• Cost of testing supplies

• Labor cost

• Space

• Ease of use

• Need for finger stick or phlebotomy on-site

• Billing revenues

• Clinical impact of the test on patient care

• Clinical impact of the test on the practice

The All Important CLIA Waiver

Status In Primary Care

Office practice using only CLIA waived tests

• Requires certificate of waiver

• No routine inspections by regulators

• No proficiency testing required

Office practice using moderately complex tests

• Requires certificate of compliance

• Routine inspections by regulators

• Proficiency testing required

What Type of Practice is it?

• Private practice

Basically functions as a small business

Very sensitive to cost and revenue

• Hospital affiliated practice

Functions as a business unit in the larger organization

Very sensitive to annual budget

• Salaried staff physician

Functions as an employee of the organization

Sensitive to the overall organizational cost

Selected Traditional POCT Tests in

Primary Care Rapid Strep A

Influenza

Sexually transmitted diseases

Rapid HIV

Dipstick urinalysis

Pregnancy testing

HbA1c

Glucose

Fecal occult blood

PT-INR

Lipid panel

Examples of Missing Tests and Potentially

Emerging Tests

• CBC: No viable current options. A major missing piece in POCT

• Chemistry panels (CMP/BMP): Some options available but all require phlebotomy

• Thyroid screen: A common rule out for many patient presentations

• BNP/NT proBNP: Manage patients with heart failure: Some options available but all require phlebotomy

• Salivary DOA: Eliminates observation of urine sample collection

• Lyme serology: CDC estimates 300,000 cases annually

Case Example: HIV Testing

Over 1 million people in US infected with HIV

Over 250,000 unaware of their infection

CDC Guidelines

• Screen all people 13-64 years old

• Identify HIV infected patients and connect them

to early care

• Educate patients of risk factors

• Three quarters will modify at-risk behaviors

when they know their HIV status

The Problem

• Many at-risk patients have poor access to the health care system and are easily lost to follow-up

• Many never return to learn their results

• Kassler et al. AIDS 1997;11:1045-1051

Compared rapid testing to central laboratory testing

Rapid testing resulted in a 210% increase in patients learning their HIV status for uninfected and a 23% increase for infected patients

• Rapid in-office HIV tests result in more patients being tested and connected to follow-up care and education

Case Example: HbA1c for Diabetes Care

Clinical Utility of HbA1c

Traditional use:

Monitoring diabetic therapy

Requires reproducible assay

New uses (utilize fixed cut-points thus

assays must be accurate, reproducible

and free from bias)

Screening for diabetes

Diagnosis of diabetes

First Order of Business

The Test Has to Work

y = 1.0005x - 0.0668

R2 = 0.9876

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Main Laboratory

P

O

C

T

Note: Not all POCT

HbA1c

assays perform with

acceptable

accuracy

and precision

A Word Of Caution On Some POCT Devices

Clin Chem 2010 Jan;56(1):44-52. Six of eight

hemoglobin A1c point-of-care instruments do not meet

the general accepted analytical performance criteria.

Lenters E and Slingerland

HbA1c devices should conform to standards of the

National Glycohemoglobin Standardization Program

Only 2 of eight POCT devices for HbA1c passed NGSP

criteria

POCT Outcomes: Glycemic Control

Some (but not all) studies of POCT for HbA1c

have shown an improvement in glycemic control

Cagliero et al, Diabetes Care 1999;22:1785-1789

Randomized controlled trial in 201 diabetic

patients

• HbA1c levels decreased over 6 and 12 months

with POCT by 0.57% and 0.40%

• No change in HbA1c in controls

Case Example: Rapid testing For

Strep A

Culture requires 18-24 hours: This delay leads to

over diagnosis and unnecessary preemptive

antibiotic usage

Clinical diagnosis is unreliable

One study: 48% of patients with pharyngitis

received antibiotics

Only 28% were positive by culture

Rapid strep A tests are highly specific but will

miss some cases of Strep A pharyngitis

Clinical evaluation

Two pharynx swabs

History of rheumatic fever and classic

clinical findings or rash or scarlet

fever

No: Rapid strep test Yes: Culture and

treat

Positive: Treat

Negative: Send second swab

for culture, write prescription to

be filled only if culture is positive

Case Example: POCT PT-INR For Managing

Anticoagulation: Frank et al. Ann Fam Med

2008;6:s28-s32

Evaluated POCT for PT-INR in combination with

a Coumadin dosing guideline

Results

Baseline control

32.1 % of patients within the INR goal

With POCT-INR

45.9 % of patients within INR goal

Reimbursement Models

• Traditional fee for service

• Global reimbursement or capitation

• Risk sharing reimbursement model

Each reimbursement model creates its own incentives and disincentives with regards to: – Practice costs

– Revenues

– Practice efficiency metrics

– System wide costs

Traditional Fee-For-Service

• Practice gets paid for each billable unit of

service it produces

• Outpatient labs often profitable

• Favors POCT assuming there are easy to

use devices that don’t require phlebotomy

Global Reimbursement or

Capitation

• Practice gets paid a fixed amount to provide all needed services

• Many carve-outs can create perverse incentives (e.g. lab carve-out)

• Strongly discourages POCT unless there is a carve-out

• Accountable Care Organizations (ACO’s) will introduce a global fee for all services to a healthcare organization (not an isolated practice)

The Basic Accountable Care Model

Doctors

Hospitals

Ancillary Services

Pharmacy

Other stakeholders

Risk Sharing Reimbursement

Contracts: Pay for Performance

The physician is typically subject to a

payment withhold pending performance of:

• Quality metrics

• Utilization metrics

• Financial metrics

Risk Sharing Reimbursement Contracts: An

Example for Patients With Diabetes

For Diabetes Care to be paid the withhold the

practice must perform

1. HbA1c twice a year

2. Annual urinary microalbumin

3. Annual lipid profile

4. Annual eye examination

Note 3 of 4 are laboratory tests

How often does the patient not go to the lab to get

the tests (especially less reliable patients)

A Key Element for the Future of POCT

in Primary Care

Reimbursement will progressively move towards global payments to the healthcare system including elements of:

• Capitation

• Risk sharing

• Pay for performance

The future of POCT in this new world will depend on:

• Reimbursement (or lack thereof)

• Demonstration of cost saving outcomes

• Dollars at risk in pay for performance contracts

MGH Study Patient Satisfaction With POCT

in Primary Care: Clin Chem Acta

2013;424:8-11

150 patients who received POCT were given an anonymous patient satisfaction survey at the end of their clinic visit.

Satisfaction scores were rated 1 to 4 (4 being the most satisfied). The surveys identified the tests that were performed and asked for additional comments.

Completed surveys were deposited in an anonymous collection

Patient Satisfaction Study Questionnaire

Compared with your past experiences of physician

office visits that did not have on-site testing please

rank your overall level of satisfaction with today’s

office visit:

Circle one:

1= poor (today was less satisfactory)

2= acceptable (today was about the same)

3= good (today was generally better

4= excellent (today was a much better experience)

Other comments:

Patient Satisfaction Survey At An

MGH Primary Care Practice

Results

Overall the mean satisfaction score on a scale of 1 (poor) to 4 (excellent) was 3.96.

Selected comments:

• Wonderful to have the results and directions for medications while I was here. It made the plan clear. Also a true time saver- not only a lab visit but follow-up phone calls

• It is so much easier to do it at the office while I am here.

• It was great to be able to consult immediately with the doctor having the results in front of us.

• I thinks it good to get the results while still talking to the doctor.

POCT may offer some advantages over centralized laboratory

testing including

• Reducing follow-up visits

• Eliminating letters and phone calls to patients regarding test

results

• Improved patient management by having the test results

available at the time of the office visit.

However, POCT must be financially viable to cover the

cost of the testing supplies and labor in the practice.

MGH Outcomes Study on POCT Cost and

Practice Efficiency Metrics

Implemented POCT for hemoglobin A1c (Siemens

Diagnostics), lipid panel and comprehensive metabolic panel

(Abaxis)

The cost of performing the testing was calculated using:

Cost of the reagents

Consumables (including phlebotomy)

Labor required for practice assistants to perform the testing.

Potential revenues were estimated using Medicare fee

schedules including a phlebotomy charge of $3.00.

Cost Analysis for POCT in Primary

Care

The average cost for testing was $25.25 per patient.

Estimated revenues were $31.87.

The per patient margin $6.62.

The revenues actually collected would depend on the payer

mix of the practice.

Using a margin of $6.62 per patient it would take

approximately 2266 patients to cover the cost of the capital

equipment.

Financial Analysis

Financial Analysis

Other cost reductions in the practice would add to the potential financial benefits of the POCT program including:

1. Costs incurred for writing and processing letters:

– A simple letter detailing normal findings costs $ 7.03 to the practice,

– A letter with minor abnormal findings costs $ 15.52

– A letter with major abnormal findings costs $ 29.67.

2. The cost of a typical phone call was estimated to be

$ 28.30

3. Costs incurred for follow-up visits are approximately $ 3.24 per minute including physician and office support staff labor.

Practice Metrics for Control Patients and Those That

Received POCT (all numbers in table rounded)

Metric Visit Type Control POCT % Reduction Significant

Tests New Pt 2.45 2.35 4 N

Annual 2.59 1.88 28 Y

Follow-up 2.00 1.32 34 Y

Total 2.35 1.85 21 Y

Calls New Pt 0.10 0.00 100 Y

Annual 0.22 0.00 100 Y

Follow-up 0.48 0.08 84 Y

Total 0.24 0.03 89 Y

Letters New Pt 0.86 0.18 78 Y

Annual 0.88 0.09 89 Y

Follow-up 0.63 0.06 90 Y

Total 0.79 0.06 91 Y

Additional New Pt 0.39 0.22 44 Y

Visit Annual 0.38 0.09 75 Y

Follow-up 0.43 0.09 78 Y

Total 0.40 0.14 65 Y

Metrics of Practice Efficiency

For each patient the improvement in practice efficiency

was a reduction of 0.54 tests (24.2%), 0.21 telephone

calls, 0.73 letters and 0.26 revisits .

Assuming:

Most letters to patients are of the “simple” variety ($7.03 per letter)

A per phone call cost of $28.30

A typical revisit time of 30 minutes (at $3.24 per minute)

Estimate of the potential cost savings to the practice would be (0.73 letters X

$7.03/letter) + (0.21 calls X $28.30/call) + (30 minutes/revist X $3.24/minute X

0.26) = $36.34.

This amount exceeds the per patient testing cost of $25.25 and does not

include any savings from reduction in the total number of tests ordered.

Metrics of Practice Efficiency

Overall Financial Impact Per Patient

Cost: Labor and consumables: $25.25

Estimated revenues: $ 31.87

Practice efficiency savings: $ 36.34

Overall financial benefit: $ 42.96/patient

Home Testing

(Analogous to over the counter medications)

• Blood Glucose

• Pregnancy

• Ovulation Testing

• Cholesterol

• Drugs of abuse

• HIV

• Coagulation (PT-INR)

• Occult blood

• Many Others

Includes at home test kits and specimen “mail in” testing

Who Wins With Home Testing

• Insurance carrier: Patient pays for all tests

and treatment (if any)

• Capitated physician practices

• The patient: Assuming they can afford the

tests and didn’t make a mistake

Remember When…..

• Motrin required a prescription

• The were no OTC drugs for yeast vaginitis

• OTC pregnancy tests did not exist

An example of the future trend: Recent FDA approval of an OTC salivary HIV test

As new products become available patients will take more of their care into their own hands

Conclusions: POCT in Primary

Care Can

• Improve patient satisfaction

• Improve practice efficiency

• May in selected cases improve outcomes

Conclusions: But…….

• More and improved technologies will be

required (e.g. CBC)

• More studies will be needed to

demonstrate improved outcomes

(financial, medical, or operations)

• Reimbursement models cannot create

disincentives

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