Close Doesn’t Count€¦ · Contents October 2019 14 Close Doesn’t Count: Patient Matching...

OCTOBER 2019

OCTOBER2018

Close Doesn’t CountPatient Matching Challenges in HIEs

AHIMA’s

Coffee and Coding SeriesNot Your Average BrewIn the ever-changing environment of coding and government regulations, everyone needs a little pick-me-up. AHIMA is here to do just that with the Coffee and Coding webinar series. These 30-minute on-demand webinars take you through the more complicated or confusing cases presented to our coding subject matter experts.

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2019 Line-Up Laparoscopic MyomectomyShoulder ArthroplastyAmputation for Gangrene and OsteomyelitisLower Extremity AngioplastyOmmaya Reservoir and VP ShuntAnterolateral Lumbar FusionEloesser Window for EmpyemaInsertion of Antibiotic Delivery DeviceRepair of Aortic Coarctation Rotational Flap Graft for Tracheoesophageal FistulaStenting for Obstructive HydrocephalusWatchman Procedure

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* The American Health Information Management Association (AHIMA) is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.

282.19

The Inpatient and Outpatient CDI Academy offers best practices through real-life examples and exercises. Return to your organization with new insights and energy. At the Academy you will

• Review key coding guidelines of principal/primary and secondary diagnoses

• Examine opportunities for CDI in the outpatient setting

• Realize the impact of coded data on secondary data uses such as meaningful use incentives, quality measures, and public health reporting

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Contents October 2019

14

Close Doesn’t Count: Patient Matching Challenges in HIEsBy Lisa A. Eramo, MA

Cover

Features

18 Six Strategies to Build Outpatient Coding Accuracy and Quality By Keith Olenik, MA, RHIA, CHP

20 2019 AHIMA Triumph Awards

Departments

9 President’s MessageThree Ways Analytics Optimizes Health Outcomes

10 Bulletin Board

13 Inside LookA Time to Be Bold

41 A Look Ahead

41 Keep Informed

44 Addendum‘The Farewell’ Offers Insights into HIPAA’s Right to Access

pg. 18As healthcare services migrate toward outpatient settings, hospitals and health systems are struggling to ensure coding accuracy and quality for owned practices and clinics.

Contents October 2019 Vol. 90, no. 9

Working Smart

26 Anonymized EHRs Create Potential Liability for Google and HospitalBy Gail L. Gottehrer, JD and Ronald J. Hedges, JD

28 CAC Takes Coding Into the Future By Kristi Fahy, RHIA

30 Telehealth’s Popularity Puts New Emphasis on Privacy and Security By Lesley Clack, ScD, MS, CPH

32 NIST Privacy Framework: Protecting Privacy While Promoting InteroperabilityBy Karen Starling Greenhalgh, HCISPP, CHC, CHPC

Practice Brief

34 Clinical Documentation Improvement for Outpatient Care: Design and Implementation

Coding Notes

36 Evaluating Clinical Scenarios in Coding Clinic with Data Analytics By Anne Casto, RHIA, CCS

38 Coding Quality Improvement Plan Implementation for Hospital-Acquired Physician GroupsBy Karen Youmans, MPA, RHIA, CCS, and Vanessa Youmans, MA, RHIA, CCS, CPC

AHIMA members may earn continuing education credits by successfully completing the following quizzes at https://my.ahima.org/store

Quizzes

17 “Close Doesn’t Count: Patient Matching Challenges in HIEs”Domain: Clinical Data Management

19 “Six Strategies to Build Outpatient Coding Accuracy and Quality”Domain: Clinical Data Management

39 “Coding Quality Improvement Plan Implementation for Hospital-Acquired Physician Groups”Domain: Clinical Data Management

http://journal.ahima.org

Surviving the Tidal Wave of Change in Four EHR Go-LivesSharing lessons learned from critical culture and strategy transformation at Mayo Clinic.

Documentation DetectiveA recent post from the Journal’s CDI-focused online column discusses duplicate records, one of healthcare’s most vexing problems.

Podcast: CAC Time MachineKristi Fahy, RHIA, discusses the future of computer-assisted coding, artificial intelli-gence, and machine learning in healthcare.

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4 / Journal of AHIMA October 19

Journal of AHIMA (ISSN 1060-5487) is published monthly, except for the combined issues of July/August and November/December, by the American Health Information Management Association, 233 North Michigan Avenue, 21st Floor, Chicago, IL 60601-5800. Subscription Rates: Included in AHIMA membership dues is a subscription to the Journal. The annual member subscription rate is $22.00 for active and graduate members, and $10.00 for student members. Subscription for nonmembers is $100 (domestic), $110 (Canada), $120 (all other outside the U.S.). Postmaster: Send address changes to Journal of AHIMA, AHIMA, 233 North Michigan Avenue, 21st Floor, Chicago, IL 60601-5800. Notification of address change must be made six weeks in advance, including old and new address with zip code. Periodical’s postage is paid in Chicago, IL, and additional mailing offices.

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Please see additional Important Safety Information and accompanying Brief Summary of Prescribing Information

on the following pages.

IndicationLIBTAYO is indicated for the treatment of patients with metastatic cutaneous

squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates

for curative surgery or curative radiation.

Important Safety Information

Warnings and Precautions Severe and Fatal Immune-Mediated Adverse Reactions Immune-mediated adverse reactions, which may be severe or fatal, can occur in any

organ system or tissue and usually occur during treatment; however, they can also

occur after discontinuation. Early identification and management are essential to

ensuring safe use of PD-1–blocking antibodies. Monitor for symptoms and signs of

immune-mediated adverse reactions. Evaluate clinical chemistries, including liver

tests and thyroid function tests, at baseline and periodically during treatment.

Institute medical management promptly to include specialty consultation as

appropriate.

In general, withhold LIBTAYO for Grade 3 or 4 and certain Grade 2 immune-mediated

adverse reactions. Permanently discontinue LIBTAYO for Grade 4 and certain Grade 3

immune-mediated adverse reactions. For Grade 3 or 4 and certain Grade 2 immune-

mediated adverse reactions, administer corticosteroids (1 to 2 mg/kg/day prednisone

or equivalent) or other appropriate therapy until improvement to Grade 1 or less

followed by a corticosteroid taper over 1 month. Consider administration of other

systemic immunosuppressants in patients whose immune-mediated adverse

reaction is not controlled with corticosteroids. Institute hormone replacement therapy

for endocrinopathies as warranted.

Immune-mediated pneumonitis: Immune-mediated pneumonitis occurred in 2.4%

of 534 patients receiving LIBTAYO, including Grade 5 (0.2%), Grade 3 (0.7%), and

Grade 2 (1.3%). Pneumonitis led to permanent discontinuation of LIBTAYO in 1.3%

of patients. Systemic corticosteroids were required in all patients with pneumonitis,

including 85% who received prednisone ≥40 mg/day or equivalent. Pneumonitis

resolved in 62% of patients. Withhold LIBTAYO for Grade 2, and permanently

discontinue for Grade 3 or 4. Resume in patients with complete or partial resolution

(Grade 0 to 1) after corticosteroid taper.

Immune-mediated colitis: Immune-mediated colitis occurred in 0.9% of 534

patients receiving LIBTAYO, including Grade 3 (0.4%) and Grade 2 (0.6%). Colitis

led to permanent discontinuation of LIBTAYO in 0.2% of patients. Systemic

corticosteroids were required in all patients with colitis, including 60% who

received prednisone ≥40 mg/day or equivalent. Colitis resolved in 80% of patients.

Withhold LIBTAYO for Grade 2 or 3, and permanently discontinue for Grade 4.

Resume in patients with complete or partial resolution (Grade 0 to 1) after

corticosteroid taper.

Immune-mediated hepatitis: Immune-mediated hepatitis occurred in 2.1% of 534

patients receiving LIBTAYO, including Grade 5 (0.2%), Grade 4 (0.2%), and Grade 3

(1.7%). Hepatitis led to permanent discontinuation of LIBTAYO in 0.9% of patients.

Systemic corticosteroids were required in all patients with hepatitis, including 91%

who received prednisone ≥40 mg/day or equivalent. Hepatitis resolved in 64% of

patients. Withhold LIBTAYO if AST or ALT increases to more than 3 and up to 10

times the upper limit of normal (ULN) or if total bilirubin increases up to 3 times the

ULN. Permanently discontinue LIBTAYO if AST or ALT increases to more than 10

times the ULN or total bilirubin increases to more than 3 times the ULN. Resume in

patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper.

(Continued)

Warnings and Precautions (continued)Immune-mediated endocrinopathies: Withhold LIBTAYO if clinically necessary

for Grade 2, 3, or 4.

• Adrenal insufficiency: Adrenal insufficiency occurred in 0.4% of 534 patients

receiving LIBTAYO, including Grade 3 (0.2%) and Grade 2 (0.2%)

• Hypophysitis: Hypophysitis, which can result in hypopituitarism, occurred in

0.2% of 534 patients receiving LIBTAYO, which consisted of 1 patient with

Grade 3 hypophysitis

• Hypothyroidism: Hypothyroidism occurred in 6% of 534 patients receiving

LIBTAYO, including Grade 3 (0.2%) and Grade 2 (5.6%); no patients

discontinued hormone replacement therapy

• Hyperthyroidism: Hyperthyroidism occurred in 1.5% of 534 patients

receiving LIBTAYO, including Grade 3 (0.2%) and Grade 2 (0.4%);

hyperthyroidism resolved in 38% of patients

• Type 1 diabetes mellitus: Type 1 diabetes mellitus, which can present with

diabetic ketoacidosis, occurred in 0.7% of 534 patients, including Grade

4 (0.4%) and Grade 3 (0.4%); type 1 diabetes mellitus led to permanent

discontinuation of LIBTAYO in 0.2% of patients

Immune-mediated nephritis with renal dysfunction: Immune-mediated

nephritis occurred in 0.6% of 534 patients receiving LIBTAYO, including Grade 3

(0.4%) and Grade 2 (0.2%). Nephritis led to permanent discontinuation of LIBTAYO

in 0.2% of patients. Systemic corticosteroids were required in all patients with

nephritis, including 67% who received prednisone ≥40 mg/day or equivalent.

Nephritis resolved in all patients. Withhold LIBTAYO for Grade 3, and permanently

discontinue for Grade 4. Resume in patients with complete or partial resolution


Immune-mediated dermatologic adverse reactions: Immune-mediated

dermatologic reactions, including erythema multiforme and pemphigoid, occurred

in 1.7% of 534 patients receiving LIBTAYO, including Grade 3 (1.1%) and Grade 2

(0.6%). In addition, SJS and TEN have been observed with LIBTAYO and with other

products in this class. Systemic corticosteroids were required in all patients with

dermatologic reactions, including 89% who received prednisone ≥40 mg/day or

equivalent. Dermatologic reactions resolved in 33% of patients. Approximately

22% of patients had recurrence of dermatologic reactions after re-initiation of

LIBTAYO. Withhold LIBTAYO for Grade 3, and permanently discontinue for Grade 4.



Other immune-mediated adverse reactions: The following clinically

significant immune-mediated adverse reactions occurred at an incidence of <1%

in 534 patients who received LIBTAYO or were reported with the use of other

PD-1–blocking and PD-L1–blocking antibodies. Severe or fatal cases have been

reported for some of these adverse reactions. Withhold LIBTAYO for Grade 3, and

permanently discontinue for Grade 4. Resume in patients with complete or partial

resolution (Grade 0 to 1) after corticosteroid taper.

• Neurological: Meningitis, encephalitis, myelitis and demyelination,

myasthenic syndrome/myasthenia gravis, Guillain-Barré syndrome, nerve

paresis, and autoimmune neuropathy

• Cardiovascular: Myocarditis, pericarditis, and vasculitides

• Ocular: Uveitis, iritis, and other ocular inflammatory toxicities. Some

cases can be associated with retinal detachment. Various grades of visual

impairment to include blindness can occur. If uveitis occurs in combination

with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-

Harada–like syndrome, as this may require treatment with systemic

corticosteroids to reduce the risk of permanent vision loss

• Gastrointestinal: Pancreatitis to include increases in serum amylase and

lipase levels, gastritis, and duodenitis

• Musculoskeletal and connective tissue: Myositis, rhabdomyolysis,

and associated sequelae, including renal failure, arthritis, and

polymyalgia rheumatica

• Hematological and immunological: Hemolytic anemia, aplastic anemia,

hemophagocytic lymphohistiocytosis, systemic inflammatory response

syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis),

sarcoidosis, immune thrombocytopenic purpura, and solid organ

transplant rejection

Infusion-related reactions Severe infusion-related reactions (Grade 3) occurred in 0.2% of patients

receiving LIBTAYO. Monitor patients for signs and symptoms of infusion-

related reactions. Interrupt or slow the rate of infusion for Grade 1 or 2, and

permanently discontinue for Grade 3 or 4.

Embryo-fetal toxicity LIBTAYO can cause fetal harm when administered to a pregnant woman due to

an increased risk of immune-mediated rejection of the developing fetus resulting

in fetal death. Advise women of the potential risk to a fetus. Advise females

of reproductive potential to use effective contraception during treatment with

LIBTAYO and for at least 4 months after the last dose.

Adverse reactions• Serious adverse reactions occurred in 28% of patients. Serious adverse

reactions that occurred in ≥2% of patients were cellulitis, sepsis, pneumonia,

pneumonitis, and urinary tract infection. The most common Grade 3-4

adverse reactions (≥2%) were cellulitis, sepsis, hypertension, pneumonia,

musculoskeletal pain, skin infection, urinary tract infection, and fatigue

• LIBTAYO was permanently discontinued due to adverse reactions in 5%

of patients; adverse reactions resulting in permanent discontinuation were

pneumonitis, autoimmune myocarditis, hepatitis, aseptic meningitis, complex

regional pain syndrome, cough, and muscular weakness

• The most common adverse reactions (incidence ≥20%) were fatigue, rash,

and diarrhea

Use in specific populations• Lactation: Because of the potential for serious adverse reactions in

breastfed children, advise women not to breastfeed during treatment and for

at least 4 months after the last dose of LIBTAYO

• Females and males of reproductive potential: Verify pregnancy status in

females of reproductive potential prior to initiating LIBTAYO

Please see accompanying Brief Summary of

Prescribing Information on the following pages.

Reference: LIBTAYO (cemiplimab-rwlc) injection full U.S. prescribing information.

Regeneron Pharmaceuticals, Inc., and sanofi-aventis U.S. LLC.


© 2019 Regeneron Pharmaceuticals, Inc., and sanofi-aventis U.S. LLC.

All rights reserved. LIB.19.08.0027 08/19

ALT=alanine aminotransferase; AST=aspartate aminotransferase;

PD-1=programmed death receptor-1; NDC=National Drug Code.

Strength1

350 mg/7 mL (50 mg/mL)

NDC1

61755-008-01The Centers for Medicare & Medicaid Services assigned a 1 mg billing unit for LIBTAYO (1 mg of LIBTAYO = 1 unit).

Coding requirements may vary by payer; please verify coding requirements before submitting claims.

How supplied1

LIBTAYO is supplied in a carton containing 1 single-dose vial of 350 mg/7 mL

(50 mg/mL).

Recommended dosage1

The recommended dosage of LIBTAYO is 350 mg administered as an

intravenous infusion over 30 minutes every 3 weeks until disease progression

or unacceptable toxicity. Please see brief summary of prescribing information on

the following pages for additional dosing and administration information.

EFFECTIVE OCTOBER 1, 2019, THE FOLLOWING PERMANENT J-CODE CAN BE USED FOR BILLING AND OTHER ADMINISTRATIVE PURPOSES:

J9119, INJECTION, cemiplimab-rwlc, 1 mg














appropriate.




































(Continued)



















































































and diarrhea















Strength1

350 mg/7 mL (50 mg/mL)

NDC1



How supplied1


(50 mg/mL).

Recommended dosage1




















appropriate.




































(Continued)



















































































and diarrhea















Strength1

350 mg/7 mL (50 mg/mL)

NDC1



How supplied1


(50 mg/mL).

Recommended dosage1







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appropriate.




































(Continued)



















































































and diarrhea















Strength1

350 mg/7 mL (50 mg/mL)

NDC1



How supplied1


(50 mg/mL).

Recommended dosage1








LIBTAYO® (cemiplimab-rwlc) injections, for intravenous use

Brief Summary of Prescribing Information

1 INDICATIONS AND USAGELIBTAYO is indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC)

or locally advanced CSCC who are not candidates for curative surgery or curative radiation.

2 DOSAGE AND ADMINISTRATION2.1 Recommended Dosage The recommended dosage of LIBTAYO is 350 mg administered as an intravenous infusion over 30 minutes every

3 weeks until disease progression or unacceptable toxicity.

2.2 Dosage Modifications for Adverse ReactionsWithhold or discontinue LIBTAYO to manage adverse reactions as described in Table 1. No dose reduction of

LIBTAYO is recommended.

Table 1: Recommended Dosage Modifications for Adverse Reactions

Adverse Reaction Severity* LIBTAYO Dosage Modifications

Severe and Fatal Immune-Mediated Adverse Reactions [see Warnings and Precautions (5.1)]

PneumonitisGrade 2 Withhold†

Grades 3 or 4 Permanently discontinue

ColitisGrades 2 or 3 Withhold†

Grade 4 Permanently discontinue

Hepatitis

If AST or ALT increases to more than

3 and up to 10 times the upper limit

of normal (ULN) or if total bilirubin

increases up to 3 times the ULN.

Withhold†


10 times the ULN or total bilirubin

increases to more than 3 times

the ULN

Permanently discontinue

Endocrinopathies Grades 2, 3, or 4 Withhold if clinically necessary

Other immune-mediated

adverse reactions involving

a major organ

Grade 3 Withhold†


Recurrent or persistent

immune mediated adverse

reactions

• Recurrent Grade 3 or 4

• Grade 2 or 3 persistent for

12 weeks or longer after last

LIBTAYO dose

• Requirement for 10 mg per

day or greater prednisone or

equivalent lasting 12 weeks or

longer after last LIBTAYO dose


Other Adverse Reactions

Infusion-related reactions

[see Warnings and

Precautions (5.2)]

Grade 1 or 2 Interrupt or slow the rate of infusion

Grade 3 or 4 Permanently discontinue

*Toxicity graded per National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 †Resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper.

2.3 Preparation and Administration • Visually inspect for particulate matter and discoloration prior to administration. LIBTAYO is a clear to

slightly opalescent, colorless to pale yellow solution that may contain trace amounts of translucent to white

particles. Discard the vial if the solution is cloudy, discolored or contains extraneous particulate matter

other than trace amounts of translucent to white particles.

Preparation

• Do not shake.

• Withdraw 7 mL from a vial and dilute with 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection,

USP to a final concentration between 1 mg/mL to 20 mg/mL.

• Mix diluted solution by gentle inversion. Do not shake.

• Discard any unused medicinal product or waste material.

Storage and Infusion Solution

• Store at room temperature up to 25°C (77°F) for no more than 8 hours from the time of preparation to the

end of the infusion or at 2°C to 8°C (36°F to 46°F) for no more than 24 hours from the time of preparation to

the end of infusion.

• Allow the diluted solution to come to room temperature prior to administration.

• Do not freeze.

Administration

• Administer by intravenous infusion over 30 minutes through an intravenous line containing a sterile, in-line

or add-on 0.2-micron to 5-micron filter.

4 CONTRAINDICATIONSNone.

5 WARNINGS AND PRECAUTIONS5.1 Severe and Fatal Immune-Mediated Adverse ReactionsLIBTAYO is a monoclonal antibody that belongs to a class of drugs that binds to the programmed death

receptor-1 (PD-1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response with

the potential for breaking of peripheral tolerance and induction of immune-mediated adverse reactions.

Important immune-mediated adverse reactions listed under Warnings and Precautions may not be inclusive of

all possible immune-mediated reactions.

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue.

While immune-mediated adverse reactions usually manifest during treatment with PD-1/PD-L1 blocking

antibodies, immune-mediated adverse reactions can also manifest after discontinuation of PD-1/PD-L1

blocking antibodies.

Early identification and management are essential to ensure safe use of PD-1/PD-L1 blocking antibodies.

Monitor for symptoms and signs of immune-mediated adverse reactions. Evaluate clinical chemistries, including

liver tests and thyroid function tests, at baseline and periodically during treatment. Institute medical

management promptly to include specialty consultation as appropriate.

In general, withhold LIBTAYO for Grade 3 or 4 and certain Grade 2 immune-mediated adverse reactions.

Permanently discontinue LIBTAYO for Grade 4 and certain Grade 3 immune-mediated adverse reactions [see

Dosage and Administration (2.2)]. For Grade 3 or 4 and certain Grade 2 immune-mediated adverse reactions,

administer corticosteroids (1 to 2 mg/kg/day prednisone or equivalent) or other appropriate therapy until

improvement to Grade 1 or less followed by a corticosteroid taper over one month [see Dosage and Administration

(2.2)]. Consider administration of other systemic immunosuppressants in patients whose immune-mediated

adverse reaction is not controlled with corticosteroids. Institute hormone replacement therapy for

endocrinopathies as warranted.

Immune-Mediated Pneumonitis

Immune-mediated pneumonitis occurred in 2.4% of 534 patients receiving LIBTAYO, including Grade 5 (0.2%),

Grade 3 (0.7%) and Grade 2 (1.3%) [see Adverse Reactions (6.1)]. Pneumonitis led to permanent discontinuation

of LIBTAYO in 1.3% of patients. Systemic corticosteroids were required in all patients with pneumonitis,

including 85% who received prednisone ≥40 mg per day or equivalent. Pneumonitis resolved in 62% of patients.

Immune-Mediated Colitis

Immune-mediated colitis occurred in 0.9% of 534 patients receiving LIBTAYO, including Grade 3 (0.4%) and

Grade 2 (0.6%) [see Adverse Reactions (6.1)]. Colitis led to permanent discontinuation of LIBTAYO in 0.2% of

patients. Systemic corticosteroids were required in all patients with colitis, including 60% who received

prednisone ≥40 mg per day or equivalent. Colitis resolved in 80% of patients.

Immune-Mediated Hepatitis

Immune-mediated hepatitis occurred in 2.1% of 534 patients receiving LIBTAYO, including Grade 5 (0.2%),

Grade 4 (0.2%), and Grade 3 (1.7%) [see Adverse Reactions (6.1)]. Hepatitis led to permanent discontinuation of

LIBTAYO in 0.9% of patients. Systemic corticosteroids were required in all patients with hepatitis, including

91% who received prednisone ≥40 mg per day or equivalent. Hepatitis resolved in 64% of patients.

Immune-Mediated Endocrinopathies

Adrenal Insufficiency

Adrenal insufficiency occurred in 0.4% of 534 patients receiving LIBTAYO, including Grade 3 (0.2%), and Grade

2 (0.2%) [see Adverse Reactions (6.1)].

Hypophysitis

Hypophysitis, which can result in hypopituitarism, occurred in 0.2% of 534 patients receiving LIBTAYO, which

consisted of one patient with Grade 3 hypophysitis.

Hypothyroidism

Hypothyroidism occurred in 6% of 534 patients receiving LIBTAYO, including Grade 3 (0.2%) and Grade 2

(5.6%). No patients discontinued hormone replacement therapy.

Hyperthyroidism

Hyperthyroidism occurred in 1.5% of 534 patients receiving LIBTAYO, including Grade 3 (0.2%) and Grade 2

(0.4%). Hyperthyroidism resolved in 38% of patients.

Type 1 Diabetes Mellitus

Type 1 diabetes mellitus, which can present with diabetic ketoacidosis, occurred in 0.7% of 534 patients,

including Grade 4 (0.4%) and Grade 3 (0.4%). Type 1 diabetes mellitus led to permanent discontinuation of

LIBTAYO in 0.2% of patients.

Immune-Mediated Nephritis with Renal Dysfunction

Immune-mediated nephritis occurred in 0.6% of 534 patients receiving LIBTAYO, including Grade 3 (0.4%) and

Grade 2 (0.2%) [see Adverse Reactions (6.1)]. Nephritis led to permanent discontinuation of LIBTAYO in 0.2% of

patients. Systemic corticosteroids were required in all patients with nephritis, including 67% who received

prednisone ≥40 mg per day or equivalent. Nephritis resolved in all patients.

Immune-Mediated Dermatologic Adverse Reactions

Immune-mediated dermatologic reactions, including erythema multiforme and pemphigoid, occurred in 1.7% of

534 patients receiving LIBTAYO, including Grade 3 (1.1%) and Grade 2 (0.6%) [see Adverse Reactions (6.1)]. In

addition, SJS and TEN have been observed with LIBTAYO and with other products in this class. Systemic

corticosteroids were required in all patients with dermatologic reactions, including 89% who received

prednisone ≥40 mg per day or equivalent. Dermatologic reactions resolved in 33% of patients. Approximately

22% of patients had recurrence of dermatologic reactions after re-initiation of LIBTAYO.

Other Immune-Mediated Adverse Reactions

The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% in 534

patients who received LIBTAYO [see Adverse Reactions (6.1)] or were reported with the use of other

PD-1/PD-L1 blocking antibodies. Severe or fatal cases have been reported for some of these adverse reactions.

Neurological: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome / myasthenia gravis,

Guillain-Barre syndrome, nerve paresis, autoimmune neuropathy

Cardiovascular: Myocarditis, pericarditis, vasculitides

Ocular: Uveitis, iritis, and other ocular inflammatory toxicities. Some cases can be associated with retinal

detachment. Various grades of visual impairment to include blindness can occur. If uveitis occurs in

combination with other immune-mediated adverse reactions, consider a Vogt- Koyanagi-Harada like syndrome,

as this may require treatment with systemic corticosteroids to reduce the risk of permanent vision loss.

Gastrointestinal: Pancreatitis to include increases in serum amylase and lipase levels, gastritis, duodenitis

Musculoskeletal and Connective Tissue: Myositis, rhabdomyolysis and associated sequelae including renal

failure, arthritis, polymyalgia rheumatica

Hematological and Immunological: Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis,

systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis),

sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection.

5.2 Infusion-Related Reactions Severe infusion-related reactions (Grade 3) occurred in 0.2% of patients receiving LIBTAYO [see Adverse

Reactions (6.1)]. Monitor patients for signs and symptoms of infusion-related reactions. Interrupt or slow the

rate of infusion or permanently discontinue LIBTAYO based on severity of reaction [see Dosage and

Administration (2.2)].

5.3 Embryo-Fetal ToxicityBased on its mechanism of action, LIBTAYO can cause fetal harm when administered to a pregnant woman.

Animal studies have demonstrated that inhibition of the PD-1/PD-L1 pathway can lead to increased risk of

immune-mediated rejection of the developing fetus resulting in fetal death. Advise women of the potential risk

to a fetus. Advise females of reproductive potential to use effective contraception during treatment with

LIBTAYO and for at least 4 months after the last dose [see Use in Specific Populations (8.1, 8.3)].

6 ADVERSE REACTIONSThe following serious adverse reactions are described elsewhere in the labeling.

• Severe and Fatal Immune-Mediated Adverse Reactions [see Warnings and Precautions (5.1)]

• Infusion-Related Reactions [see Warnings and Precautions (5.2)]

6.1 Clinical Trials ExperienceBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the

clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not

reflect the rates observed in practice.

The data described in WARNINGS AND PRECAUTIONS reflect exposure to LIBTAYO in 534 patients in two

open-label, single-arm, multicohort studies (Study 1423 and Study 1540), including 98 patients with metastatic

(nodal or distant) CSCC, 65 patients with locally advanced CSCC, and 371 patients with other advanced solid

tumors. LIBTAYO as a single agent or in combination with chemotherapy or radiation was administered

intravenously at doses of 1 mg/kg every 2 weeks (n=27), 3 mg/kg every 2 weeks (n=446), 3 mg/kg every 3

weeks (n=12), 10 mg/kg every 2 weeks (n=6), 200 mg every 2 weeks (n=20) or 350 mg every 3 weeks (n=23).

Among the 534 patients, 38% were exposed for ≥6 months and 16% were exposed for ≥12 months.

The data described below reflect exposure to LIBTAYO in 163 patients with advanced CSCC (metastatic or

locally advanced disease) in Study 1423 and Study 1540. Patients received LIBTAYO 1 mg/kg every 2 weeks

(n=1), 3 mg/kg every 2 weeks (n=139) or 350 mg every 3 weeks (n=23) as an intravenous infusion until disease

progression, unacceptable toxicity, or completion of planned treatment. The median duration of exposure was 20

weeks (3 days to 1.4 years).

The safety population characteristics were: median age of 71 years (38 to 96 years), 85% male, 96% white, and

ECOG performance score (PS) of 0 (44%) or 1 (56%).

The most common adverse reactions reported in at least 20% of patients were fatigue, rash and diarrhea. The

most common Grade 3-4 adverse reactions (≥2%) were cellulitis, sepsis, hypertension, pneumonia,

musculoskeletal pain, skin infection, urinary tract infection and fatigue. LIBTAYO was permanently discontinued

due to adverse reactions in 5% of patients; adverse reactions resulting in permanent discontinuation were

pneumonitis, autoimmune myocarditis, hepatitis, aseptic meningitis, complex regional pain syndrome, cough,

and muscular weakness. Serious adverse reactions occurred in 28% of patients. Serious adverse reactions that

occurred in at least 2% of patients were cellulitis, sepsis, pneumonia, pneumonitis and urinary tract infection.

Table 2 summarizes the adverse reactions that occurred in ≥10% of patients and Table 3 summarizes Grade 3

and 4 laboratory abnormalities worsening from baseline in ≥1% of patients receiving LIBTAYO.

Table 2: Adverse Reactions in ≥10% of Patients with Advanced CSCC Receiving LIBTAYO in Study 1423 and

Study 1540

Adverse Reactions

LIBTAYO

N=163

All Grades

%

Grade 3-4

%

Skin and Subcutaneous Tissue

Rash* 25 1.2

Pruritus† 15 0

Gastrointestinal

Diarrhea‡ 22 0.6

Nausea 19 0

Constipation 12 0.6

General and Administration Site

Fatigue§ 29 2

Musculoskeletal and Connective Tissue

Musculoskeletal pain# 17 3

Metabolism and Nutrition

Decreased appetite 10 0

*Rash is a composite term that includes rash maculopapular, rash, dermatitis, rash generalized, dermatitis bullous, drug eruption,

erythema, rash erythematous, rash macular, rash pruritic, and skin reaction. †Pruritus is a composite term that includes pruritus and pruritus allergic. ‡Diarrhea is a composite term that inlcudes diarrhea and colitis. §Fatigue is a composite term that includes fatigue and asthenia.

#Musculoskeletal pain is a composite term that includes: musculoskeletal pain, back pain, myalgia, neck pain, pain in extremity.

Table 3: Grade 3 or 4 Laboratory Abnormalities Worsening from Baseline in ≥1% of Patients with Advanced

CSCC Receiving LIBTAYO in Study 1423 and Study 1540

Laboratory Abnormality Grade 3-4 (%)†

Chemistry

Increased aspartate aminotransferase 3

Increased INR 2

Hypoalbuminemia 1

Hematology

Lymphopenia 7

Anemia 2

Electrolytes

Hypophosphatemia 4

Hyponatremia 3

Hypercalcemia 1†Percentages are based on the number of patients with at least 1 post-baseline value available for that parameter.

6.2 ImmunogenicityAs with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is

highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody

(including neutralizing antibody) positivity in an assay may be influenced by several factors including assay

methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease.

For these reasons, comparison of the incidence of antibodies to cemiplimab-rwlc in the studies described below

with the incidence of antibodies in other studies or to other products may be misleading.

Anti-drug antibodies (ADA) were tested in 398 of 534 patients who received LIBTAYO and the incidence of

cemiplimab-rwlc treatment-emergent ADAs was 1.3% using an electrochemiluminescent (ECL) bridging

immunoassay; 0.3% were persistent ADA responses. In the patients who developed anti-cemiplimab-rwlc

antibodies, there was no evidence of an altered pharmacokinetic profile of cemiplimab-rwlc.

8 USE IN SPECIFIC POPULATIONS8.1 PregnancyRisk Summary

Based on its mechanism of action, LIBTAYO can cause fetal harm when administered to a pregnant woman.

There are no available data on the use of LIBTAYO in pregnant women. Animal studies have demonstrated that

inhibition of the PD -1/PD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing

fetus resulting in fetal death (see Data). Human IgG4 immunoglobulins (IgG4) are known to cross the placenta;

therefore, LIBTAYO has the potential to be transmitted from the mother to the developing fetus. Advise women of

the potential risk to a fetus.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically

recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data

Animal Data

Animal reproduction studies have not been conducted with LIBTAYO to evaluate its effect on reproduction and

fetal development. A central function of the PD-1/PD-L1 pathway is to preserve pregnancy by maintaining

maternal immune tolerance to the fetus. In murine models of pregnancy, blockade of PD-L1 signaling has been

shown to disrupt tolerance to the fetus and to result in an increase in fetal loss; therefore, potential risks of

administering LIBTAYO during pregnancy include increased rates of abortion or stillbirth. As reported in the

literature, there were no malformations related to the blockade of PD-1/PD-L1 signaling in the offspring of these

animals; however, immune-mediated disorders occurred in PD-1 and PD-L1 knockout mice. Based on its

mechanism of action, fetal exposure to cemiplimab-rwlc may increase the risk of developing immune-mediated

disorders or altering the normal immune response.

8.2 Lactation Risk Summary

There is no information regarding the presence of cemiplimab-rwlc in human milk, or its effects on the

breastfed child or on milk production. Because of the potential for serious adverse reactions in breastfed

children, advise women not to breastfeed during treatment and for at least 4 months after the last dose of

LIBTAYO.

8.3 Females and Males of Reproductive PotentialPregnancy Testing

Verify pregnancy status in females of reproductive potential prior to initiating LIBTAYO [see Use in Specific

Populations (8.1)].

Contraception

LIBTAYO can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)].

Females

Advise females of reproductive potential to use effective contraception during treatment with LIBTAYO and for

at least 4 months after the last dose.

8.4 Pediatric UseThe safety and effectiveness of LIBTAYO have not been established in pediatric patients.

8.5 Geriatric UseOf the 163 patients with metastatic and locally advanced CSCC who received LIBTAYO in clinical studies, 72%

were 65 years or older and 37% were 75 years or older. No overall differences in safety or effectiveness were

observed between these subjects and younger subjects.

17 PATIENT COUNSELING INFORMATIONAdvise the patient to read the FDA-approved patient labeling (Medication Guide).

Immune-Mediated Adverse Reactions

Advise patients that LIBTAYO can cause immune-mediated adverse reactions including the following [see

Warnings and Precautions (5.1)]:

• Pneumonitis: Advise patients to contact their healthcare provider immediately for signs or symptoms of

pneumonitis, including new or worsening symptoms of cough, chest pain, or shortness of breath.

• Colitis: Advise patients to contact their healthcare provider immediately for signs or symptoms of colitis,

including diarrhea, blood or mucus in stools, or severe abdominal pain.

• Hepatitis: Advise patients to contact their healthcare provider immediately for signs or symptoms of hepatitis.

• Endocrinopathies: Advise patients to contact their healthcare provider immediately for signs or symptoms of

hypothyroidism, hyperthyroidism, adrenal insufficiency, hypophysitis, or type 1 diabetes mellitus.

• Nephritis: Advise patients to contact their healthcare provider immediately for signs or symptoms of nephritis.

• Dermatologic Adverse Reactions: Advise patients to contact their healthcare provider immediately if they

develop a new rash.

Infusion-Related Reactions

Advise patients to contact their healthcare provider immediately for signs or symptoms of infusion-related

reactions [see Warnings and Precautions (5.2)].

Embryo-Fetal Toxicity

Advise females of reproductive potential that LIBTAYO can cause harm to a fetus and to inform their healthcare

provider of a known or suspected pregnancy [see Warnings and Precautions (5.3) and Use in Specific Populations

(8.1, 8.3)].

Advise females of reproductive potential to use effective contraception during treatment and for at least

4 months after the last dose of LIBTAYO [see Use in Specific Populations (8.3)].

Lactation

Advise female patients not to breastfeed while taking LIBTAYO and for at least 4 months after the last dose

[see Use in Specific Populations (8.2)].

© 2019 Regeneron Pharmaceuticals, Inc., and sanofi-aventis U.S. LLC. All rights reserved. US-LIB-1492 03/19


LIBTAYO® (cemiplimab-rwlc) injections, for intravenous use

Brief Summary of Prescribing Information

1 INDICATIONS AND USAGELIBTAYO is indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC)

or locally advanced CSCC who are not candidates for curative surgery or curative radiation.

2 DOSAGE AND ADMINISTRATION2.1 Recommended Dosage The recommended dosage of LIBTAYO is 350 mg administered as an intravenous infusion over 30 minutes every

3 weeks until disease progression or unacceptable toxicity.

2.2 Dosage Modifications for Adverse ReactionsWithhold or discontinue LIBTAYO to manage adverse reactions as described in Table 1. No dose reduction of

LIBTAYO is recommended.

Table 1: Recommended Dosage Modifications for Adverse Reactions

Adverse Reaction Severity* LIBTAYO Dosage Modifications

Severe and Fatal Immune-Mediated Adverse Reactions [see Warnings and Precautions (5.1)]

PneumonitisGrade 2 Withhold†

Grades 3 or 4 Permanently discontinue

ColitisGrades 2 or 3 Withhold†


Hepatitis


3 and up to 10 times the upper limit

of normal (ULN) or if total bilirubin

increases up to 3 times the ULN.

Withhold†


10 times the ULN or total bilirubin

increases to more than 3 times

the ULN


Endocrinopathies Grades 2, 3, or 4 Withhold if clinically necessary

Other immune-mediated

adverse reactions involving

a major organ

Grade 3 Withhold†


Recurrent or persistent

immune mediated adverse

reactions

• Recurrent Grade 3 or 4

• Grade 2 or 3 persistent for

12 weeks or longer after last

LIBTAYO dose

• Requirement for 10 mg per

day or greater prednisone or

equivalent lasting 12 weeks or

longer after last LIBTAYO dose


Other Adverse Reactions

Infusion-related reactions

[see Warnings and

Precautions (5.2)]

Grade 1 or 2 Interrupt or slow the rate of infusion

Grade 3 or 4 Permanently discontinue

*Toxicity graded per National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 †Resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper.

2.3 Preparation and Administration • Visually inspect for particulate matter and discoloration prior to administration. LIBTAYO is a clear to

slightly opalescent, colorless to pale yellow solution that may contain trace amounts of translucent to white

particles. Discard the vial if the solution is cloudy, discolored or contains extraneous particulate matter

other than trace amounts of translucent to white particles.

Preparation

• Do not shake.

• Withdraw 7 mL from a vial and dilute with 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection,

USP to a final concentration between 1 mg/mL to 20 mg/mL.

• Mix diluted solution by gentle inversion. Do not shake.

• Discard any unused medicinal product or waste material.

Storage and Infusion Solution

• Store at room temperature up to 25°C (77°F) for no more than 8 hours from the time of preparation to the

end of the infusion or at 2°C to 8°C (36°F to 46°F) for no more than 24 hours from the time of preparation to

the end of infusion.

• Allow the diluted solution to come to room temperature prior to administration.

• Do not freeze.

Administration

• Administer by intravenous infusion over 30 minutes through an intravenous line containing a sterile, in-line

or add-on 0.2-micron to 5-micron filter.

4 CONTRAINDICATIONSNone.

5 WARNINGS AND PRECAUTIONS5.1 Severe and Fatal Immune-Mediated Adverse ReactionsLIBTAYO is a monoclonal antibody that belongs to a class of drugs that binds to the programmed death

receptor-1 (PD-1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response with

the potential for breaking of peripheral tolerance and induction of immune-mediated adverse reactions.

Important immune-mediated adverse reactions listed under Warnings and Precautions may not be inclusive of

all possible immune-mediated reactions.

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue.

While immune-mediated adverse reactions usually manifest during treatment with PD-1/PD-L1 blocking

antibodies, immune-mediated adverse reactions can also manifest after discontinuation of PD-1/PD-L1

blocking antibodies.

Early identification and management are essential to ensure safe use of PD-1/PD-L1 blocking antibodies.

Monitor for symptoms and signs of immune-mediated adverse reactions. Evaluate clinical chemistries, including

liver tests and thyroid function tests, at baseline and periodically during treatment. Institute medical

management promptly to include specialty consultation as appropriate.

In general, withhold LIBTAYO for Grade 3 or 4 and certain Grade 2 immune-mediated adverse reactions.

Permanently discontinue LIBTAYO for Grade 4 and certain Grade 3 immune-mediated adverse reactions [see

Dosage and Administration (2.2)]. For Grade 3 or 4 and certain Grade 2 immune-mediated adverse reactions,

administer corticosteroids (1 to 2 mg/kg/day prednisone or equivalent) or other appropriate therapy until

improvement to Grade 1 or less followed by a corticosteroid taper over one month [see Dosage and Administration

(2.2)]. Consider administration of other systemic immunosuppressants in patients whose immune-mediated

adverse reaction is not controlled with corticosteroids. Institute hormone replacement therapy for

endocrinopathies as warranted.

Immune-Mediated Pneumonitis

Immune-mediated pneumonitis occurred in 2.4% of 534 patients receiving LIBTAYO, including Grade 5 (0.2%),

Grade 3 (0.7%) and Grade 2 (1.3%) [see Adverse Reactions (6.1)]. Pneumonitis led to permanent discontinuation

of LIBTAYO in 1.3% of patients. Systemic corticosteroids were required in all patients with pneumonitis,

including 85% who received prednisone ≥40 mg per day or equivalent. Pneumonitis resolved in 62% of patients.

Immune-Mediated Colitis

Immune-mediated colitis occurred in 0.9% of 534 patients receiving LIBTAYO, including Grade 3 (0.4%) and

Grade 2 (0.6%) [see Adverse Reactions (6.1)]. Colitis led to permanent discontinuation of LIBTAYO in 0.2% of

patients. Systemic corticosteroids were required in all patients with colitis, including 60% who received

prednisone ≥40 mg per day or equivalent. Colitis resolved in 80% of patients.

Immune-Mediated Hepatitis

Immune-mediated hepatitis occurred in 2.1% of 534 patients receiving LIBTAYO, including Grade 5 (0.2%),

Grade 4 (0.2%), and Grade 3 (1.7%) [see Adverse Reactions (6.1)]. Hepatitis led to permanent discontinuation of

LIBTAYO in 0.9% of patients. Systemic corticosteroids were required in all patients with hepatitis, including

91% who received prednisone ≥40 mg per day or equivalent. Hepatitis resolved in 64% of patients.

Immune-Mediated Endocrinopathies

Adrenal Insufficiency

Adrenal insufficiency occurred in 0.4% of 534 patients receiving LIBTAYO, including Grade 3 (0.2%), and Grade

2 (0.2%) [see Adverse Reactions (6.1)].

Hypophysitis

Hypophysitis, which can result in hypopituitarism, occurred in 0.2% of 534 patients receiving LIBTAYO, which

consisted of one patient with Grade 3 hypophysitis.

Hypothyroidism

Hypothyroidism occurred in 6% of 534 patients receiving LIBTAYO, including Grade 3 (0.2%) and Grade 2

(5.6%). No patients discontinued hormone replacement therapy.

Hyperthyroidism

Hyperthyroidism occurred in 1.5% of 534 patients receiving LIBTAYO, including Grade 3 (0.2%) and Grade 2

(0.4%). Hyperthyroidism resolved in 38% of patients.

Type 1 Diabetes Mellitus

Type 1 diabetes mellitus, which can present with diabetic ketoacidosis, occurred in 0.7% of 534 patients,

including Grade 4 (0.4%) and Grade 3 (0.4%). Type 1 diabetes mellitus led to permanent discontinuation of

LIBTAYO in 0.2% of patients.

Immune-Mediated Nephritis with Renal Dysfunction

Immune-mediated nephritis occurred in 0.6% of 534 patients receiving LIBTAYO, including Grade 3 (0.4%) and

Grade 2 (0.2%) [see Adverse Reactions (6.1)]. Nephritis led to permanent discontinuation of LIBTAYO in 0.2% of

patients. Systemic corticosteroids were required in all patients with nephritis, including 67% who received

prednisone ≥40 mg per day or equivalent. Nephritis resolved in all patients.

Immune-Mediated Dermatologic Adverse Reactions

Immune-mediated dermatologic reactions, including erythema multiforme and pemphigoid, occurred in 1.7% of

534 patients receiving LIBTAYO, including Grade 3 (1.1%) and Grade 2 (0.6%) [see Adverse Reactions (6.1)]. In

addition, SJS and TEN have been observed with LIBTAYO and with other products in this class. Systemic

corticosteroids were required in all patients with dermatologic reactions, including 89% who received

prednisone ≥40 mg per day or equivalent. Dermatologic reactions resolved in 33% of patients. Approximately

22% of patients had recurrence of dermatologic reactions after re-initiation of LIBTAYO.

Other Immune-Mediated Adverse Reactions

The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% in 534

patients who received LIBTAYO [see Adverse Reactions (6.1)] or were reported with the use of other

PD-1/PD-L1 blocking antibodies. Severe or fatal cases have been reported for some of these adverse reactions.

Neurological: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome / myasthenia gravis,

Guillain-Barre syndrome, nerve paresis, autoimmune neuropathy

Cardiovascular: Myocarditis, pericarditis, vasculitides

Ocular: Uveitis, iritis, and other ocular inflammatory toxicities. Some cases can be associated with retinal

detachment. Various grades of visual impairment to include blindness can occur. If uveitis occurs in

combination with other immune-mediated adverse reactions, consider a Vogt- Koyanagi-Harada like syndrome,

as this may require treatment with systemic corticosteroids to reduce the risk of permanent vision loss.

Gastrointestinal: Pancreatitis to include increases in serum amylase and lipase levels, gastritis, duodenitis

Musculoskeletal and Connective Tissue: Myositis, rhabdomyolysis and associated sequelae including renal

failure, arthritis, polymyalgia rheumatica

Hematological and Immunological: Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis,

systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis),

sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection.

5.2 Infusion-Related Reactions Severe infusion-related reactions (Grade 3) occurred in 0.2% of patients receiving LIBTAYO [see Adverse

Reactions (6.1)]. Monitor patients for signs and symptoms of infusion-related reactions. Interrupt or slow the

rate of infusion or permanently discontinue LIBTAYO based on severity of reaction [see Dosage and

Administration (2.2)].

5.3 Embryo-Fetal ToxicityBased on its mechanism of action, LIBTAYO can cause fetal harm when administered to a pregnant woman.

Animal studies have demonstrated that inhibition of the PD-1/PD-L1 pathway can lead to increased risk of

immune-mediated rejection of the developing fetus resulting in fetal death. Advise women of the potential risk

to a fetus. Advise females of reproductive potential to use effective contraception during treatment with

LIBTAYO and for at least 4 months after the last dose [see Use in Specific Populations (8.1, 8.3)].

6 ADVERSE REACTIONSThe following serious adverse reactions are described elsewhere in the labeling.

• Severe and Fatal Immune-Mediated Adverse Reactions [see Warnings and Precautions (5.1)]

• Infusion-Related Reactions [see Warnings and Precautions (5.2)]

6.1 Clinical Trials ExperienceBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the

clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not

reflect the rates observed in practice.

The data described in WARNINGS AND PRECAUTIONS reflect exposure to LIBTAYO in 534 patients in two

open-label, single-arm, multicohort studies (Study 1423 and Study 1540), including 98 patients with metastatic

(nodal or distant) CSCC, 65 patients with locally advanced CSCC, and 371 patients with other advanced solid

tumors. LIBTAYO as a single agent or in combination with chemotherapy or radiation was administered

intravenously at doses of 1 mg/kg every 2 weeks (n=27), 3 mg/kg every 2 weeks (n=446), 3 mg/kg every 3

weeks (n=12), 10 mg/kg every 2 weeks (n=6), 200 mg every 2 weeks (n=20) or 350 mg every 3 weeks (n=23).

Among the 534 patients, 38% were exposed for ≥6 months and 16% were exposed for ≥12 months.

The data described below reflect exposure to LIBTAYO in 163 patients with advanced CSCC (metastatic or

locally advanced disease) in Study 1423 and Study 1540. Patients received LIBTAYO 1 mg/kg every 2 weeks

(n=1), 3 mg/kg every 2 weeks (n=139) or 350 mg every 3 weeks (n=23) as an intravenous infusion until disease

progression, unacceptable toxicity, or completion of planned treatment. The median duration of exposure was 20

weeks (3 days to 1.4 years).

The safety population characteristics were: median age of 71 years (38 to 96 years), 85% male, 96% white, and

ECOG performance score (PS) of 0 (44%) or 1 (56%).

The most common adverse reactions reported in at least 20% of patients were fatigue, rash and diarrhea. The

most common Grade 3-4 adverse reactions (≥2%) were cellulitis, sepsis, hypertension, pneumonia,

musculoskeletal pain, skin infection, urinary tract infection and fatigue. LIBTAYO was permanently discontinued

due to adverse reactions in 5% of patients; adverse reactions resulting in permanent discontinuation were

pneumonitis, autoimmune myocarditis, hepatitis, aseptic meningitis, complex regional pain syndrome, cough,

and muscular weakness. Serious adverse reactions occurred in 28% of patients. Serious adverse reactions that

occurred in at least 2% of patients were cellulitis, sepsis, pneumonia, pneumonitis and urinary tract infection.

Table 2 summarizes the adverse reactions that occurred in ≥10% of patients and Table 3 summarizes Grade 3

and 4 laboratory abnormalities worsening from baseline in ≥1% of patients receiving LIBTAYO.

Table 2: Adverse Reactions in ≥10% of Patients with Advanced CSCC Receiving LIBTAYO in Study 1423 and

Study 1540

Adverse Reactions

LIBTAYO

N=163

All Grades

%

Grade 3-4

%

Skin and Subcutaneous Tissue

Rash* 25 1.2

Pruritus† 15 0

Gastrointestinal

Diarrhea‡ 22 0.6

Nausea 19 0

Constipation 12 0.6

General and Administration Site

Fatigue§ 29 2

Musculoskeletal and Connective Tissue

Musculoskeletal pain# 17 3

Metabolism and Nutrition

Decreased appetite 10 0

*Rash is a composite term that includes rash maculopapular, rash, dermatitis, rash generalized, dermatitis bullous, drug eruption,

erythema, rash erythematous, rash macular, rash pruritic, and skin reaction. †Pruritus is a composite term that includes pruritus and pruritus allergic. ‡Diarrhea is a composite term that inlcudes diarrhea and colitis. §Fatigue is a composite term that includes fatigue and asthenia.

#Musculoskeletal pain is a composite term that includes: musculoskeletal pain, back pain, myalgia, neck pain, pain in extremity.

Table 3: Grade 3 or 4 Laboratory Abnormalities Worsening from Baseline in ≥1% of Patients with Advanced

CSCC Receiving LIBTAYO in Study 1423 and Study 1540

Laboratory Abnormality Grade 3-4 (%)†

Chemistry

Increased aspartate aminotransferase 3

Increased INR 2

Hypoalbuminemia 1

Hematology

Lymphopenia 7

Anemia 2

Electrolytes

Hypophosphatemia 4

Hyponatremia 3

Hypercalcemia 1†Percentages are based on the number of patients with at least 1 post-baseline value available for that parameter.

6.2 ImmunogenicityAs with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is

highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody

(including neutralizing antibody) positivity in an assay may be influenced by several factors including assay

methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease.

For these reasons, comparison of the incidence of antibodies to cemiplimab-rwlc in the studies described below

with the incidence of antibodies in other studies or to other products may be misleading.

Anti-drug antibodies (ADA) were tested in 398 of 534 patients who received LIBTAYO and the incidence of

cemiplimab-rwlc treatment-emergent ADAs was 1.3% using an electrochemiluminescent (ECL) bridging

immunoassay; 0.3% were persistent ADA responses. In the patients who developed anti-cemiplimab-rwlc

antibodies, there was no evidence of an altered pharmacokinetic profile of cemiplimab-rwlc.

8 USE IN SPECIFIC POPULATIONS8.1 PregnancyRisk Summary

Based on its mechanism of action, LIBTAYO can cause fetal harm when administered to a pregnant woman.

There are no available data on the use of LIBTAYO in pregnant women. Animal studies have demonstrated that

inhibition of the PD -1/PD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing

fetus resulting in fetal death (see Data). Human IgG4 immunoglobulins (IgG4) are known to cross the placenta;

therefore, LIBTAYO has the potential to be transmitted from the mother to the developing fetus. Advise women of

the potential risk to a fetus.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically

recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data

Animal Data

Animal reproduction studies have not been conducted with LIBTAYO to evaluate its effect on reproduction and

fetal development. A central function of the PD-1/PD-L1 pathway is to preserve pregnancy by maintaining

maternal immune tolerance to the fetus. In murine models of pregnancy, blockade of PD-L1 signaling has been

shown to disrupt tolerance to the fetus and to result in an increase in fetal loss; therefore, potential risks of

administering LIBTAYO during pregnancy include increased rates of abortion or stillbirth. As reported in the

literature, there were no malformations related to the blockade of PD-1/PD-L1 signaling in the offspring of these

animals; however, immune-mediated disorders occurred in PD-1 and PD-L1 knockout mice. Based on its

mechanism of action, fetal exposure to cemiplimab-rwlc may increase the risk of developing immune-mediated

disorders or altering the normal immune response.

8.2 Lactation Risk Summary

There is no information regarding the presence of cemiplimab-rwlc in human milk, or its effects on the

breastfed child or on milk production. Because of the potential for serious adverse reactions in breastfed

children, advise women not to breastfeed during treatment and for at least 4 months after the last dose of

LIBTAYO.

8.3 Females and Males of Reproductive PotentialPregnancy Testing

Verify pregnancy status in females of reproductive potential prior to initiating LIBTAYO [see Use in Specific

Populations (8.1)].

Contraception

LIBTAYO can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)].

Females

Advise females of reproductive potential to use effective contraception during treatment with LIBTAYO and for

at least 4 months after the last dose.

8.4 Pediatric UseThe safety and effectiveness of LIBTAYO have not been established in pediatric patients.

8.5 Geriatric UseOf the 163 patients with metastatic and locally advanced CSCC who received LIBTAYO in clinical studies, 72%

were 65 years or older and 37% were 75 years or older. No overall differences in safety or effectiveness were

observed between these subjects and younger subjects.

17 PATIENT COUNSELING INFORMATIONAdvise the patient to read the FDA-approved patient labeling (Medication Guide).

Immune-Mediated Adverse Reactions

Advise patients that LIBTAYO can cause immune-mediated adverse reactions including the following [see

Warnings and Precautions (5.1)]:

• Pneumonitis: Advise patients to contact their healthcare provider immediately for signs or symptoms of

pneumonitis, including new or worsening symptoms of cough, chest pain, or shortness of breath.

• Colitis: Advise patients to contact their healthcare provider immediately for signs or symptoms of colitis,

including diarrhea, blood or mucus in stools, or severe abdominal pain.

• Hepatitis: Advise patients to contact their healthcare provider immediately for signs or symptoms of hepatitis.

• Endocrinopathies: Advise patients to contact their healthcare provider immediately for signs or symptoms of

hypothyroidism, hyperthyroidism, adrenal insufficiency, hypophysitis, or type 1 diabetes mellitus.

• Nephritis: Advise patients to contact their healthcare provider immediately for signs or symptoms of nephritis.

• Dermatologic Adverse Reactions: Advise patients to contact their healthcare provider immediately if they

develop a new rash.

Infusion-Related Reactions

Advise patients to contact their healthcare provider immediately for signs or symptoms of infusion-related

reactions [see Warnings and Precautions (5.2)].

Embryo-Fetal Toxicity

Advise females of reproductive potential that LIBTAYO can cause harm to a fetus and to inform their healthcare

provider of a known or suspected pregnancy [see Warnings and Precautions (5.3) and Use in Specific Populations

(8.1, 8.3)].

Advise females of reproductive potential to use effective contraception during treatment and for at least

4 months after the last dose of LIBTAYO [see Use in Specific Populations (8.3)].

Lactation

Advise female patients not to breastfeed while taking LIBTAYO and for at least 4 months after the last dose

[see Use in Specific Populations (8.2)].

© 2019 Regeneron Pharmaceuticals, Inc., and sanofi-aventis U.S. LLC. All rights reserved. US-LIB-1492 03/19


Journal of AHIMA October 19 / 9

President’s Message

OVER THE SUMMER I was fortunate to participate in several conferences. I was both honored to be involved and en-thralled at the expertise of all of the indi-viduals who participated and presented.

Data is powerful. Data literacy is also powerful. To collect, read, and commu-nicate data in ways that bring value to your organization is so important.

At the National Library of Medicine’s “Creating Connections: Advances in the Research Use of EHRs” panel, the pre-senters demonstrated how powerful data analytics tools have improved research in areas where progress has been stymied, such as pancreatic cancer. It was amaz-ing to see how the results changed and how progress can be made for chronic disease management when many large data sets are brought together.

At AHIMA’s Assembly on Education Symposium, the expert panel “Data Ana-lytics: It’s All About Integrity” focused on the integrity of data with a proposed defi-nition on health information integrity and how health information professionals “ensure the knowledgeable, contextual, secure, and appropriate use of health data obtained from many, disparate sources across the health eco-system.”

At the National Committee on Vital and Health Statistics roundtable on ICD-11, we focused on developing research questions that will be important to ad-dress before we move toward ICD-11.

Data analytics tools are used in so many ways to make a difference in health outcomes. For example:

1. Patients: Being able to connect large data sets together to make ad-vances in health outcomes and make sure that the data is of high integrity is vital. ICD-11 may be one tool that gets us there. We need to make sure we are ready for these changes and are able to use this classification system effectively.

Other tools to know and use to make im-provements in patient health outcomes include SQL, Tableau, R, Python, SPSS, SAS, and advanced analytics in Excel.

2. Prediction: The use of analytical methods such as regression models can predict the effects of health outcomes when using certain interventions. It can also predict coding productivity when using a regression model, with a certain case mix index and length of stay. Could we then predict whether ICD-11 will be as productive and accurate as ICD-10 if we have large, accurate data sets with coded data in both ICD-10 and 11? This could help with implementation and training with ICD-11.

3. Precision: The ability to use bio-logical, behavioral, and environmental factors or social determinants of health makes predictive analytics possible. The precision comes in when we are able to apply this to individuals and see how a certain medication or treatment can be specifically targeted for the individual based on this data. Precision type data makes predictive analytics possible.

This summer was filled with a focus on data analytics. Let’s make sure we chal-lenge ourselves to be experts in health information integrity as well as knowing and using the expert data analytic tools that can get us there. ¢

Valerie Watzlaf ([email protected]) is

vice chair of education and associate professor at

University of Pittsburgh.

Three Ways Analytics Optimizes Health Outcomes

By Valerie Watzlaf, PhD, MPH, RHIA, FAHIMA

Let's challenge ourselves to be experts in health information integrity.

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FROM THE WEB

AHIMA Participates in ICD-11 Expert RoundtableBy Sue Bowman, MJ, RHIA, CCS, FAHIMA

The National Committee on Vital and Health Statistics (NCVHS) Subcommittee on Standards convened an expert roundtable in August 2019 to develop a set of questions to help guide HHS in developing research about a future tran-sition to ICD-11. Roundtable participants included terminol-ogy experts, economists, and health researchers. The objectives for the ICD-11 Expert Roundtable were to:

� Develop a shared understanding of lessons from the ICD-10 planning process/transition and the differences between ICD-10 and ICD-11

� Reach consensus on research questions to help evalu-ate the cost and benefit of the transition from ICD-10 to ICD-11 for mortality and morbidity, and to identify im-pacts of not moving to ICD-11 for morbidity

� Identify key topics and messages to foster early stake-holder engagement and preparation for the transition to ICD-11

Potential research topics included: � Identification of use cases for ICD-11 � Assessment of whether a US clinical modification of

ICD-11 will need to be developed � Evaluation of costs and benefits of transitioning to ICD-

11, considering different use cases and alternative tran-sition timelines

� Evaluation of the fitness of ICD-11 to support the conver-

gence of clinical, social, and administrative standards � Analysis of the impact on clinician burden, quality of

care, and value of healthcare data � Analysis of the impact on different models of care � Assessment of the tools needed to reduce workflow

burden and improve documentation quality � Evaluate alternative and innovative approaches to ICD-

11 training and ongoing support � Assess the impact of ICD-11 on the coding workforce

and potential job role changes

The roundtable also raised questions about how related ter-minologies for domain-specific concepts (like medications, toxins, and devices) could be leveraged to complement ICD-11.

The group recommended that HHS provide leadership on strategic outreach and communication about the ICD-11 transition. Both NCVHS members and roundtable par-ticipants felt it was important to convey a sense of urgency to get started on securing research funding and conducting the necessary research.

For more information about ICD-11 and the tools and re-sources WHO has developed, visit the ICD-11 website.

This is an excerpt from “Under the Dome,” an online col-umn from AHIMA’s Policy and Government Affairs team published by Journal of AHIMA. Read the full article and get more legislative insights at journal.ahima.org. ¢

Bulletin Board what’s happening in healthcare

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FROM THE WEB

Half of Providers Not Compliant with Right to Access By Mary Butler

More than half of US healthcare providers are out of compli-ance with HIPAA’s right of access provision, and patient access to their complete clinical records via electronic health records (EHRs) is still years away. Those are two of the more alarming conclusions of research published by health IT startup Citizen.

Citizen researchers, led by Deven McGraw, the former deputy director for health information privacy at the US Department of Health and Human Services Office for Civil Rights, submitted HIPAA medical requests for records to 51 healthcare providers on behalf of 30 cancer patient beta users of the Citizen plat-form—an average of 2.3 medical requests per patient. They then scored the experiences in comparison to both what is required by the HIPAA right of access and whether any providers went above and beyond to get patients their records more promptly, according to the white paper.

Citizen found that “over 50 percent of these providers were either not compliant with the HIPAA right of access or needed multiple phone calls to supervisors or privacy officials to get compliant.” McGraw and her team encountered so many road-blocks to retrieving patient records that they published multiple blog posts about the most frustrating hurdles, such as:

� Not receiving requested information within 30 days � Not receiving records in the format requested

� Providers’ refusal to send images to a patient or designee � Refusal to accept requests by email � Providers imposing fees not compliant with HIPAA guidance

The findings published in the white paper are consistent with previous studies and anecdotal reports from health information management (HIM) professionals.

“We know from the questions we receive from the public that requesting and obtaining one’s health information is among the most frustrating experiences for patients and their families dur-ing their encounters within a healthcare setting,” said AHIMA’s Chief Knowledge Officer Cheryl D. Martin, MA, RHIA. “AHIMA has long advocated that patients have the right to receive infor-mation in the format of their choosing. As HIM professionals, we have the responsibility to provide patients with easy access to their records. These results show that there is still more work to be done to remove barriers to patient access and ensure com-pliance with federal regulations.”

Citizen investigators say healthcare providers need to redou-ble their focus on HIPAA’s right to access provisions, including giving staff more training on HIPAA.

“Greater enforcement of the law will help motivate providers to prioritize this issue,” they write. ¢


Reader Poll: How Has CAC Helped Your Organization?

How has computer-assisted coding for ICD-10 helped in your organization?

This reader poll, posted to AHIMA’s Facebook account, was inspired by the cover story from the June 2019 issue of Journal of AHIMA, “Computer-Assisted Coding Reality Check.” Users were asked to leave a comment if their answer was “Neither” or “Both.” Watch AHIMA’s social media accounts for the chance to weigh in on discussions and polls about articles in this and future issues of Journal of AHIMA.

0% 25% 50% 75% 100%

47% Improved productivity

53% Improved coding accuracy

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BACK BYPOPULAR DEMAND:ICD-10-CM/PCS Trainer Academies 2.0

October 28–30 | Chicago, IL • November 13–15, 2019 | Baltimore, MD • December 2–4 | Long Beach, CA

What is 2.0? It is a designation for improvement. It is the next level up.And that’s exactly what we’ve done here with our completly renovated ICD-10 Trainer Academy.

AHIMA’s ICD-10 Trainer Academy 2.0 o� ers expanded content where coding experts learn to train others to collectively raise quality standards within an organization. Confi dently walk colleagues through almost any coding scenario, whether that’s updated basic cases to advanced code-sets.

Our 2.0 curriculum also treats you to new content: Computer-Assisted Coding (CAC) Mapping Clinical Document Integrity (CDI) Auditing ICD-11

Candidates further learn how to apply proven adult learning principles, which includes an opportunity for a teaching demonstration with valuable feedback.

ICD-10-CM/PCS Trainer Academy attendees receive: 3 days of interactive, face-to-face instruction with expert AHIMA trainers Pre-Academy online course material to test your current knowledge Recently updated ICD-10-CM and ICD-10-PCS codebooks and a student

workbook Online assessment to validate ICD-10-CM/PCS competency 24 CEUS AHIMA-Approved Trainer Badge to display in emails, on digital resumes and via social media

Build a team you can trust. Get trained and get going!AHIMA.org/Education/TrainTrainer

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Inside Look

HIM PROFESSIONALS ARE well aware of the work involved in matching patients to their unique records. Mismatched re-cords can cost us time, lead to frustra-tion, and cause headaches and dissatis-faction for patients and providers. Most importantly, they can lead to serious pa-tient safety events as well as unneces-sary costs.

That’s why AHIMA celebrated earlier this summer when Congress passed an amendment to an appropriations bill that would remove language prohibiting the Department of Health and Human Ser-vices from spending any federal dollars to promulgate or adopt a national patient identifier. The removal of this language, which has been included in appropria-tions bills for 20 years, represented a small but significant victory on the road to solving the patient matching problem. It’s not the whole answer to the problem, but it’s a start.

AHIMA’s work in patient matching connects directly to the “trusted infor-mation” named in our vision of “A world where trusted information transforms health and healthcare by connecting people, systems, and ideas.” But it’s not enough to talk about our vision; we need to take bold action to make it happen.

Our strategic plan, which defines the work we will be doing in 2020 and be-yond to advance the profession and association, includes a robust thought leadership strategy. That means AHIMA will be leading the way to help the indus-try solve problems like patient matching.

AHIMA will be bold. But we can’t do it alone; we’ll need your expertise and your voice.

This month’s Journal looks at the tricky operational issues HIM professionals face in the workplace. Our cover story, “Close Doesn’t Count: Patient Match-

ing in HIEs,” examines patient matching in the health information exchange (HIE) context, including best practices for en-suring data integrity for patient identity and understanding the role HIEs play in protecting patient identity.

With the increasing migration of care toward outpatient settings, there is an opportunity for HIM to step in and lead the effort to ensure outpatient services are properly captured, billed, and re-ported. Keeping revenue integrity in the forefront, Keith Olenik, MA, RHIA, CHP, outlines “Six Strategies to Build Outpa-tient Coding Accuracy and Quality.”

AHIMA honors those who have worked to enrich the HIM field with this year’s Triumph Awards. National awards designed to recognize those who have made a difference in the HIM profession, the Triumph Awards honor leaders in the industry and recognize these efforts to build our knowledge base and prepare future leaders of the profession. In this time to be bold, this year’s recipients are leading the way forward.

This is a time of great opportunity for AHIMA and the HIM profession. It’s a time to ask questions and look for solu-tions, all with an eye to the future. Read more about AHIMA’s 2020-2023 stra-tegic plan in the AHIMA membership community on Engage. Be bold and join us in this work to transform health-care. ¢

A Time to Be Bold

By Wylecia Wiggs Harris, PhD, CAE, chief executive officer

AHIMA will be bold. But we can’t do it alone; we’ll need your expertise and your voice.

Close Doesn’t CountPatient Matching Challenges in HIEsBy Lisa A. Eramo, MA



THE MORE WE know about patients, the easier it is to match them. Or at least that’s the theory. Clinical data, patient-gener-ated data, biometrics, social determinants of health: all of this should make patient matching in health information exchanges (HIE) a breeze, right?

Not exactly. “As the volume of data grows, the matching burden grows as

well,” says Shaun Grannis, MD, MS, FAAFP, director of the Cen-ter for Biomedical Informatics at the Regenstrief Institute, a col-laborative research and learning organization that develops and evaluates innovative solutions for improving patient care. HIEs are caught in the crossfire, trying to make sense of the data and ulti-mately provide accurate information to its participating providers, according to Grannis.

Experts agree that challenges related to data quality and com-pleteness as well as a lack of data standardization make patient matching in HIEs more difficult today than ever before. How-ever, these challenges present unique opportunities for health information management (HIM) professionals to advocate for solutions that improve patient identity management.

Data Challenges PersistOne challenge is that healthcare providers feeding information into the HIE don’t collect the same data, nor do they collect that data in a consistent format, says Kelly Thompson, CEO at the Strategic Health Information Exchange Collaborative (SHIEC). Some provider organizations, for example, collect data for legal names while others use nicknames (e.g., Jim instead of James). Some electronic health record (EHR) vendors enable registra-tion staff to capture the middle initial only, while others can ac-commodate the entire middle name.

There’s also no data standardization among other entities—departments of health, departments of transportation, Medic-aid, and other agencies—upon which some HIEs rely for match-ing purposes. For example, some states only permit the choice of male or female for gender on their driver's licenses, while others allow additional options.

These differences that make it difficult to match patients with-in a single organization or health system are only magnified at the HIE level, says Thompson.

Dan Cidon, chief technology officer at NextGate, an identity management vendor, agrees. “Having to arbitrate these differ-ent internal and external sources to determine the source of truth—that’s the challenge,” he says.

Emerging Best Practices for Patient MatchingDeciding to join an HIE is the easy part. Providing that HIE with accurate and complete data? Not so much.

“HIEs complain that the data they receive is so horrendous,” says Cidon. “If an organization is looking for an HIE to magically solve all of its identity problems internally, well, it’s not going to do that.” Instead, he argues, organizations must establish best practices before joining an HIE—and continue to follow those practices after becoming a participating provider.

Consider the following:1. Make identity management a priority within the organi-

zation. “Few organizations think about patient matching until their accounts receivable goes past 90 days, and they start to re-alize they have bad patient demographic data because bills are being sent to the wrong address,” says Grannis.

Organizations may be tempted to solve the problem of iden-tity management by building their own rudimentary matching algorithm, says Cidon; however, this strategy will only achieve a modest matching rate. It also won’t provide the added data management tools of a commercial enterprise-wide master patient index (EMPI) that can include a variety of internal and external sources to construct a single high-quality best record from the data streams, he adds.

Anything organizations can do to clean up their data before join-ing the HIE is helpful, says Kim Chaundy, senior director of opera-tions at Keystone Health Information Exchange (KeyHIE), which uses an EMPI to link more than 10 million EHR records across 59 counties in Pennsylvania and New Jersey. The EMPI helped the HIE reduce its duplicate record rate to less than one percent.

All participating providers focus on registration performance improvement during the development and testing phase of KeyHIE integration. “We call upon the HIM department to con-stantly increase the quality of the data,” says Chaundy. “They need to understand the importance of certain data elements be-cause that’s what enables us to match patients correctly.” Even after joining the HIE, participating providers continue to moni-tor data quality and foster performance improvement, she adds.

2. Standardize data collection. For example, Neysa Noreen, MS, RHIA, inpatient coding and CDI manager at Children’s Min-nesota in Minneapolis, MN, says her organization implemented standard formatting for patient names and suffixes (e.g., Jr. vs. II or two separate last names vs. one name with hyphens), but hasn’t joined an HIE yet because it wants to focus on internal data quality and standardization first.

In addition, health systems using multiple EHRs should also ask their vendors to alter or add registration data fields, if nec-essary, to ensure consistent data collection—again for the ben-efit of the organization as well as any HIE to which the health system belongs, says Noreen. For example, one EHR may use “street” in the address field while another abbreviates it as “St.”

Standardizing addresses systemwide can also greatly help with patient matching. One recent study conducted by Indiana University and supported by Pew Charitable Trusts, found that standardizing addresses using the US Postal Services standard can improve match rates by up to three percent, translating to correct matches for tens of thousands of records or more per day.1 When standardizing addresses and last names, match rates improve by up to eight percent.

Such standardization would be critical in HIEs. The Office of the National Coordinator for Health Information Technology (ONC) recently issued draft regulations that propose to remove the Common Clinical Data Set definition from the 2015 certifi-cation criteria and replace it with the United States Core Data for Interoperability standard that requires patient address and phone number as part of the demographic information that’s exchanged.2 Address standardization would enable HIEs to match patients more easily.

Close Doesn’t Count: Patient Matching Challenges in HIEs

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Another option is to consider a centralized registration and/or scheduling model to reduce variation in how staff collect and enter data. Registration scripts may also be helpful. Children’s Minnesota developed these scripts when it initially imple-mented an EHR in the early 90s. “Over time, departments had morphed these documents into their own materials,” says Nor-een. “Now, we’re taking a step back and saying, ‘OK, everyone needs to capture the same information.’”

Departments using a “quick registration” (i.e., only asking for patient name, date of birth, and city/state) may also need to re-consider their workflows so that staff capture and/or validate complete demographic information, says Chaundy, adding that contracted labs should be at the top of the list.

3. Collect the right type of data. Children’s Minnesota no longer collects the Social Security Number (SSN). Noreen says it’s because patients sometimes don’t know their own SSN—prompting staff to enter a dummy number to bypass that por-tion of the registration—or staff accidentally transpose numbers or enter the wrong numbers, compromising data integrity.

Many organizations are moving away from the SSN to prevent medical identity theft, says Chaundy. “Cell phone numbers are really starting to be a great identifier,” she adds. “You know no-body wants to change their cell phone number.” Email address may also be helpful in terms of matching patients, she adds.

In some cases, organizations may need to look beyond basic demographic data. Children’s Minnesota can’t necessarily rely on phone number or address because these identifiers are not

unique to each patient. That’s because the address and phone numbers of the patient are those of their parents and are often the same for siblings. Even patient name can be tricky when there are multiples because parents sometimes name their children a vari-ation of the same name (e.g., twins named Jaime and Jayme). To match patients with more confidence, Children’s Minnesota has started to collect information such as birth order, birthplace (city and state), mother’s maiden name, and multiple birth indicator.

4. Educate registration personnel. “This is probably the best thing organizations can do,” says Grannis. “If you can start with high-quality data at the point of registration, you have gone a long way in terms of dramatically improving your data quality and, subsequently, your matching process.”

Organizations may also want to consider requiring registra-tion staff to meet a quality threshold and provide additional training if they don’t meet it, says Chaundy.

Education should also include individuals who perform the registration function as a secondary job responsibility. At Kansas Heart Hospital in Wichita, Kansas, for instance, unit clerks (not HIM staff) register patients between 6:00 p.m. and 6:00 a.m. It’s important to ensure that these individuals understand the down-stream effects of the data they capture, says Stephanie Costello, MS, RHIA, coding and reimbursement specialist at Kansas Heart Hospital.

5. Engage patients. Ask patients to validate demographic infor-mation on the computer screen or input information using a key-pad to avoid errors and omissions, says Grannis. Enabling patients to complete mobile intakes in advance can also reduce errors.

How HIEs Can HelpFortunately, the burden of patient identity management doesn’t lie solely with healthcare organizations. Experts say HIEs them-selves can also improve identity management in a variety of ways.

For example, many HIEs differentiate between authorita-tive and nonauthoritative sources, depending on the quality and completeness of a participating provider’s admission, dis-charge, and transfer data, says Grannis. Authoritative sources can create and update identities while nonauthoritative sources can only link to existing identities. This distinction helps main-tain data integrity throughout the HIE, he adds.

KeyHIE employs a group of individuals whose sole responsi-bility is to help organizations improve and validate their data, says Chaundy. “We view ourselves as an extended member of the team at each organization to make sure we’re constantly scrubbing the data.”

HIEs can—and should—educate providers, says Thompson. “HIEs are leaders in patient matching, They’re very skilled at this and can offer insights into best practices and lessons learned.”

Jaime Bland, CEO of the Nebraska Health Information Initia-tive (NEHII), agrees, adding that all HIEs must look beyond data query and retrieval to focus on data quality and provider educa-tion. “We see all kinds of challenges with using different EHRs and different EMPI solutions,” she says. “The more diverse your data sources, the more challenges there are from a comprehen-siveness perspective. HIEs are uniquely positioned to inform providers about this.”


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Journal of AHIMA Continuing Education QuizQuiz ID: Q1919009 | EXPIRATION DATE: OCTOBER 1, 2020HIM Domain Area: Clinical Data ManagementArticle—“Close Doesn't Count: Patient Matching Challenges in HIEs”

Review Quiz Questions and Take the Quiz Based on this Article Online at https://my.ahima.org/store

Note: AHIMA CE quizzes have moved to an online-only format.

NEHII helps organizations prioritize performance improve-ment initiatives based on recurring errors and omissions. It also helps them merge and manage duplicates as well as educate registration staff.

The feedback and assistance that HIEs provide is especially helpful for smaller specialty hospitals where HIM professionals wear many hats, making it difficult for them to focus on identity management, says Costello.

HIEs may even be able to establish an HIE-level patient identi-fier that would ease the matching burden on a state or regional level, says Bland.

SHIEC recently launched a patient matching workgroup that includes HIE representatives as well as technology vendors to discuss quality standards and best practices for developing in-take forms, resolving identity conflicts, and more. SHIEC is also exploring partnerships with various federal agencies to deploy predictive analytics for population health. “There’s a genuine interest to make healthcare better one community at a time,” says Thompson. “It’s not enough to share information. It needs to be good-quality data.” ¢

Notes 1. Grannis, Shaun et al. “Evaluating the effect of data stan-

dardization and validation on patient matching accuracy.”

Journal of the American Medical Informatics Association 26, no. 5 (May 2019): pgs. 447–456. https://academic.oup.com/jamia/article-abstract/26/5/447/5372371.

2. Office of the National Coordinator for Health IT. Notice of Proposed Rulemaking to Improve the Interoperability of Health Information. June 2019. https://www.healthit.gov/topic/laws-regulation-and-policy/notice-proposed-rulemaking-improve-interoperability-health.

Lisa Eramo ([email protected]) is a freelance writer and editor in Cran-

ston, RI, who specializes in healthcare regulatory topics, health information

management, and medical coding.

Vetting the National Patient Identifier

EXPERTS HAVE LONG touted a National Patient Identifier (NPI)—a unique number assigned to each patient that would travel with them throughout the healthcare ecosystem—as a panacea for patient matching challenges; however, the jury’s still out as to whether the NPI will ultimately solve the problem.

“There’s no doubt the NPI would improve matching accura-cy,” says Grannis. “The question is, by how much and at what cost?”

The Regenstrief Institute analyzed data from the Indiana Network for Patient Care and found that a statewide NPI would yield relatively nominal improvements in data quality even though it would cost $250 million to implement.

Even if adopted, the NPI wouldn’t be a perfect solution, says Grannis. Matching algorithms will continue to play an important role in emergency scenarios where patients are un-able to provide any identifying information.

There could also be duplicates and typographical errors at the national level when NPIs are initially assigned, necessitat-ing the need for matching algorithms at the provider and HIE levels, says Chaundy.

“An identifier is certainly one way to incrementally improve the accuracy of matching,” adds NextGate’s Cidon. “It’s a lot easier to match one number with another number.”

However, Cidon says even England and Scotland, both of which have used a unique identifier for more than a decade, continue to have problems with matching patients, most notably the resource-intensive process of enriching exist-ing registrations with the unique identifier and matching that

number to the right patient internally. There’s also a massive onboarding process in terms of

creating the identifiers at a national level that takes time, he adds. “Don’t hang your hat on this,” he says. “We’re talking about a decades-long process before you can rely on this single identifier, and even then, I’d be hesitant.”

When asked whether using biometrics is a reasonable al-ternative to the NPI, Cidon says implementing fingerprint or iris scanners at every place of service also takes time. “There have always been practical reasons why we continue to come back to this lowest common denominator approach of taking in the data streams, looking at demographics, and making the best match we can safely make,” he adds.

Decentralized identity management (i.e., allowing patients to manage their own identity and present it to various pro-viders) is a potential solution but one that wouldn’t yield im-mediate results, says Cidon. “This, to me, is the only solution that’s substantially different as a model that may succeed,” he adds. “But it will take a lot of time to get to that point.”

The healthcare industry may have the opportunity to ex-plore the NPI as a potential solution if the Senate joins the US House of Representatives in repealing a ban on federal funds to adopt a unique patient identifier. Using federal funds to create this identifier was originally banned out of privacy con-cerns; however, repealing the ban would allow collaboration between the US Department of Health and Human Services and the private sector to identify solutions for reducing medi-cal errors and protecting patient privacy.








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AS HEALTHCARE SERVICES migrate toward outpatient set-tings, hospitals and health systems are struggling to ensure coding accuracy and quality for owned practices and clinics. With the steady increase in outpatient services, revenue integ-rity challenges are more complex than ever. And the expansion of those services is further complicated by the rising volume of mergers and acquisitions.

Earlier this year, Definitive Healthcare released its 2019 Healthcare Trends Survey, which tracked 803 mergers and ac-quisitions as well as 858 affiliation and partnership announce-ments. The healthcare analytics firm predicted the consolida-tion trend would accelerate in 2019 and beyond. As mergers increase, health systems must integrate coding from physician practices, emergency departments, radiology, pathology, anes-thesia, and more, meaning revenue integrity on the outpatient side is now susceptible to chargemaster errors, missing codes, and documentation gaps, which are increasingly difficult to identify, track, manage, and improve.

Today’s Outpatient Revenue Integrity Challenges � Managing the claims editing process: The claims edit-

ing process on the outpatient side has become a part of the coding process to address edits such as missing docu-mentation, multiple codes, and charges on the account. To resolve issues, coders need access to the Centers for Medi-care and Medicaid Services (CMS) website at https://www.cms.gov, where they’ll find resources and tools—including claims-scrubbing software, analytics programs, and other applications—to help them pull together the necessary pieces of information to ensure that claims are properly submitted. The claims editing process has become in-creasingly difficult as organizations struggle to maintain skilled, knowledgeable staff at levels sufficient enough to complete the continuing increase of complex work.

� Merging professional fee and hospital outpatient cod-ing: When physician practices are integrated with health-care systems, professional fee services coding and billing

Six Strategies to Build Outpatient Coding Accuracy

and Quality By Keith Olenik, MA, RHIA, CHP


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must be merged with hospital-based outpatient coding and billing. Coders who have primarily performed pro-fessional coding now must collaborate with the hospital-based outpatient coders. Merging the two can be tricky because each group has had distinct training and has its own specialized knowledge. It is important to determine the hospital coders’ level of expertise with professional fee coding.

� Keeping up with coding changes: Coding changes can occur on an annual basis and should be updated and reviewed routinely to ensure accuracy. Use of outdated codes is a root cause of inappropriate charges, increased denials, time-consuming appeals, and delayed reim-bursement.

� Meeting medical necessity: The concept of medical ne-cessity is a major factor on the outpatient side, more so for hospitals. Without an effective process for checking medical necessity on the front end and without proper documentation and coding to support a valid diagnosis, hospitals sometimes write off the low-dollar cost of outpa-tient diagnostic tests rather than attempt to fix the prob-lem or resubmit claims. A recent Advisory Board update shows a surge in medical necessity denials, indicating the challenge many facilities face, particularly those without a clinical defense infrastructure.

� Shifting to value-based care: The shift from volume to value requires outpatient physician practices to prioritize wellness and preventive care, which means a shift in how information is captured. For example, consider chronical-ly ill patients who need greater attention to keep them well and out of the hospital. Documentation and coding must be completed properly to ensure chronic conditions and preventive treatments are captured according to value-based purchasing criteria. Some quality initiatives have specific requirements for certain treatments and condi-tions. Failure to check the right boxes and provide the right documentation can potentially reduce payments.

Six Strategies to Improve Outpatient Revenue IntegrityHow can providers build quality to ensure optimal outpatient coding, documentation, and revenue integrity? Consider the following proven strategies:

1. Build a multidisciplinary team: Include members from health information management (HIM), coding, clinical documentation improvement (CDI), physician practices, managed care contracts, revenue cycle, legal, IT, finan-cial, denial management, audits, and compliance. Meet on a regular basis to identify issues, develop strategies, and assess outcomes.

2. Conduct chargemaster review and maintenance: Rou-tine chargemaster cleanup helps eliminate claims ed-its and denials by ensuring all codes, supplies, and rev-enue codes are current and accurate. The main focus of a chargemaster review is to confirm accuracy of CPT and HCPCS codes. Because these codes are hard coded in the

chargemaster for most ancillary departments, an annual review for new, revised, and deleted codes is recommend-ed to ensure accurate payment.

3. Provide ongoing coder training and education: Ongoing education for outpatient coders is critical to compliance with quality-based reimbursement initiatives, so be sure to assess the skills, knowledge, and experience of profes-sional fee coders and hospital-based outpatient coders. Acknowledge differences and develop a training and edu-cation program that builds competencies and encourages collaboration.

4. Consider a single-path coding model: Some organiza-tions have successfully transitioned to hospital and phy-sician coding performed by one coder. With proper edu-cation and cohesive teamwork, single-path coding is an effective way to streamline workflow, reduce costs, and ensure greater integrity and consistency.

5. Ensure medical necessity up front to avoid issues with claims edits and denials: The clinical documentation must clearly state the reason for outpatient services, such as CT scans, MRIs, lab tests, or same-day surgery. Coding, CDI, and physicians should work together to ensure that complete and accurate clinical support is provided for re-viewers to acknowledge medical necessity. Though medi-cal necessity software built into the EHR can be useful, technology is not a standalone solution.

6. Promote communication among all areas involved in the denial and appeal process. Work collaboratively to create a denial management process from a root-cause perspective aimed at denial prevention to support timely, accurate reimbursement.

It’s All About People, Process, and TechnologyAddressing the complexities of outpatient services and the im-pact on revenue cycle outcomes requires strategies to assess risk, evaluate IT assets, streamline processes, manage human resources, and more. HIM professionals have an opportunity to lead efforts that ensure outpatient services are properly cap-tured, billed, and reported. Their expertise is essential to achiev-ing outpatient revenue integrity. ¢

Keith Olenik ([email protected]) serves as a health infor-

mation management subject matter expert at Pivot Point Consulting.

Journal of AHIMA Continuing Education QuizQuiz ID: Q1929009 | EXPIRATION DATE: OCTOBER 1, 2020HIM Domain Area: Clinical Data ManagementArticle—“Six Strategies to Build Outpatient Coding Accuracy and Quality”



Six Strategies to Improve Outpatient Coding

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Honoring Those Who Make a Difference

Honoring Those Who Make a Difference

2019



Distinguished Member AwardThe DISTINGUISHED MEMBER AWARD celebrates the individu-al who has an extensive history of exceptional contributions to HIM. The Distinguished Mem-ber is awarded to an outstand-ing member who has made sig-nificant contributions to the field

through dedicated volunteer service, innovative professional practice, education, research, presentation, or publishing.

AHIMA presents Cassi L. Birnbaum, MS, RHIA, CPHQ, FA-HIMA, with the 2019 Distinguished Member Triumph Award. Birnbaum is the system-wide director of HIM/revenue integrity at University of California San Diego Health.

Throughout her career, Birnbaum has demonstrated exceptional leadership, volunteerism, and talent. Birnbaum’s use of contempo-rary methods and technology highlight her invaluable contribu-tions to the profession and to AHIMA. She was an early proponent of e-HIM, leveraging healthcare technology, revenue integrity, data governance, CDI and HIM strategy development, and innovation.

A dedicated and exceptional volunteer for over 30 years, Birnbaum rarely says no when asked by AHIMA, the California Health Information Association (CHIA) and its local associa-tions, or other groups and organizations to write articles or par-ticipate in various committees and task forces. As board presi-dent/chair of AHIMA, Birnbaum was a tireless leader, guiding its members, the profession, and the industry to realize AHIMA’s vision of a successful transition to ICD-10, information gover-nance, analytics, informatics, and CDI strategies. As an AHIMA director from 2011 to 2013, Birnbaum chaired the Governance Committee and the Advocacy and Alliance Task Groups.

During her tenure as president and board member of CHIA, Birnbaum led the way in increasing membership and aligning CHIA’s strategies with AHIMA’s stated goals. Birnbaum received CHIA’s prestigious Distinguished Member Award in 2009 and Professional Achievement Award in 2002. She continues to serve on various committees at the national, state, and local levels and in IFHIMA. She has received numerous awards for her leadership, business experience, and broad understanding of the profession and industry at large, including 3M’s Innovator of the Year Award, the Distinguished Health Professions Alumna Recipient for the University of Kansas, the Outstanding Member Award from the San Diego Health Information Association, and the YWCA’s Trib-ute to Women and Industry (TWIN) Award.

Birnbaum is an adjunct faculty member for San Diego Mesa College and UCSD Extension academic programs, teaching strategic planning and leadership, human resources, and proj-ect management for HIM professionals. She assisted in estab-lishing the first bachelor’s program for HIM at a community college in California, where she also taught. She also actively mentors those pursuing future careers in HIM at all levels.

AHIMA congratulates Cassi L. Birnbaum on her 2019 AHIMA Dis-tinguished Member Triumph Award and thanks her for her work to advance the HIM profession.

AHIMA has a long and cherished tradition of honoring the excellence, dedication, and service of those professionals whose steadfast efforts have enriched the health information management (HIM) field. This time-honored celebration of outstanding accomplishments continues with the 2019 AHIMA Triumph Awards.

The AHIMA Triumph Awards are national awards designed to recognize those special individuals who have made a difference in the HIM profession. The AHIMA Triumph Awards honor today’s HIM leaders, rewarding those contributors who build our knowledge base, recognize excellence in preparing future HIM professionals, and encourage the development of fresh talent and new leadership.

Congratulations to the 2019 AHIMA Triumph Awards recipients!

2019 AHIMA Triumph Awards


Educator AwardThe EDUCATOR AWARD hon-ors those who demonstrate ex-cellence in preparing the next generation of professionals for careers in HIM.

AHIMA presents Marquetta M. Massey, MBA, RHIA, with the 2019 Educator Triumph Award. Massey is the chair of the health

information technology department at Central Piedmont Com-munity College (CPCC) in Charlotte, NC. She began teaching there in 2012 and was named chair in 2015. During Massey’s time at CPCC, she has worked tirelessly to incorporate technol-ogy into her courses to help enhance the online learning expe-rience for her students.

In 2018, Massey received an award at CPCC for “Best Instruc-tional Video,” based on her use of creative teaching tools and methods in her online courses. She has created informational lecture videos to define key practices and to further explain com-plex concepts that are essential knowledge for those in the field. Massey also used other technology-driven learning methods in her courses, including avatars in presentations, the AHIMA Vir-tual Lab Software Suite, and various technology resources used in tandem with course textbooks.

Massey continually strives to improve her teaching techniques to engage learners and provide inventive solutions to complex problems. She takes a collaborative approach with her students yet holds them accountable for their work. Massey has created a positive environment of care and compassion to facilitate learning and is recognized for her “student first” approach.

Massey is described as bringing “an infectious level of energy and enthusiasm to her students and fellow colleagues.” She is a positive role model who shares her broad knowledge of the health IT field and provides inspiring communications to her students. She motivates them to learn in ways that positively influence how they think, act, and feel. Massey is dedicated to ensuring students are prepared for a professional workplace.

Massey is known for mentoring students at various stages in their lives and careers. As a mentor and active member herself, she encourages students to be involved with AHIMA and their local state association as active members and volunteers. AHI-MA congratulates Marquetta M. Massey on her 2019 AHIMA Educator Triumph Award, and thanks her for making a positive difference as a leader, role model, and mentor in HIM educa-tion and the professional community.


Advocacy AwardThe ADVOCACY AWARD honors those who have exhibited long-standing and enthusiastic support of policy advocacy for the purpose of advancing the HIM profession and

practices.AHIMA presents the Ohio Health Information Management

Association (OHIMA) with the 2019 AHIMA Advocacy Triumph Award. The Advocacy Award’s nominators made a compelling case in describing how OHIMA used creativity to advocate for the HIM profession by creating a short animated video that showcased the diverse job settings, skills, and functions that make up the HIM profession. The video presented an entertaining, informative an-swer to that question we often hear: “What exactly is health infor-mation management?”

OHIMA’s board of directors created the video to help poten-tial students, human resource departments, and HIM practi-tioners communicate the HIM profession to others. The video, which debuted at the OHIMA 2019 Annual Meeting and Trade Show, was shared with OHIMA members who were encouraged to share it broadly with employers, human resource depart-ments, and HIM colleagues. Thanks to OHIMA members and other CSAs, the video received nearly 2,000 views within a few months of its release. Kristin M. Nelson, MS, RHIA; Lauren W. Manson, RHIA; and the OHIMA Board are credited with lead-ing this strategic advocacy project. The video can be viewed on the OHIMA website under the “What Is HIM?” link.

AHIMA congratulates OHIMA on the 2019 AHIMA Advocacy Triumph Award and recognizes its efforts for successfully advo-cating for the profession, explaining exactly what HIM profes-sionals do, and encouraging others to join OHIMA to showcase the talent and importance of the HIM professional.


Innovation AwardThe INNOVATION AWARD hon-ors those individuals, groups, or organizations focused on moving HIM into the future of the health-care and wellness industries. The Innovation Award honors individuals or groups who have promoted important advances in areas related to HIM practice,

quality data, patient safety, systems development, and any do-main where visionary thinking has made a difference.

AHIMA presents Patricia S. Coffey, RHIA, CPHIMS, CPHI, with the 2019 AHIMA Innovation Triumph Award. Coffey, chief of the HIM department in the Clinical Center for the National Institutes of Health (NIH), has an innovative and expansive view of the role of HIM. She is a collaborative and active leader for the NIH’s strategic improvement initiatives, embracing the role of “early influence” in the NIH gender identity efforts, ini-tiating and leading the NIH “Open Notes Revolution” to sup-port cutting-edge patient engagement, and collaborating with NIH research investigators to develop strategies and tools to facilitate the collection and management of critical research data while ensuring the integrity of clinical data and patient information. For her efforts on the gender identity initiative, Coffey was invited to speak at the 2018 AHIMA Conference and received the NIH 2019 Sexual and Gender Minority Community and Ally Leader Award from the NIH Office of Equity, Diversity and Inclusion. Long before the transition to electronic health records (EHRs) was a national initiative, Coffey positioned the NIH’s HIM department to transition to a paperless medical re-cord. She received the NIH Director’s Award for shepherding the path toward an entirely electronic patient record for her strategic use of technology, for improving patient access to their medical information, and for realizing significant cost savings. A fierce advocate for patients’ rights to access their medical records in the patient portal and in accordance with the Open Notes movement, Coffey is a sought-after colleague and leader regarding her innovative approaches to patient-centered care.

Coffey’s professional affiliations demonstrate her commit-ment to HIM. She is a member of AHIMA, president-elect of the Maryland Health Information Management Association, a member of the Health Information and Management Systems Society, and past member of the AHIMA Health Informatics Practice Council. She is a co-author of several AHIMA-pub-lished articles, including “The Role of Information Governance in the Implementation of Patient Portals.”

AHIMA congratulates Patricia S. Coffey on her 2019 AHIMA Innovation Triumph Award. Her innovative thinking has posi-tively impacted the quality and safety of the delivery of health-care.

Emerging Leader AwardThe EMERGING LEADER AWARD honors those individu-als who have made great strides and contributions to the HIM field and have been employed for over five years but fewer than 10 years from the date of entry into the HIM profession.

AHIMA presents Kenneth H. Lugo-Morales, MS, RHIA, with the 2019 AHIMA Emerging Leader Triumph Award winner, recognizing his career accom-plishments and unique attributes.

Lugo-Morales currently directs the HIM department at the San Jorge Children and Women’s Hospital in San Juan, Puerto Rico, where he successfully implemented the Revenue Cycle Committee, resulting in greater chargemaster accuracy, im-proved documentation, and improved coding outcomes. Pre-viously, Lugo-Morales served as a consultant, supervisor, and director of the HIM department at three other hospitals, in-cluding the Hospital UPR Dr. Federico Trilla, Hospital Buen Samaritano, and the PR Health Services Administration. As a young graduate, Lugo-Morales served as project manager for the ICD-10 transition in the PR Health Department and its eight government-owned hospitals.

His leadership contribution also extends to his volunteer roles within the Puerto Rico Health Information Management Asso-ciation (PRHIMA) where he has become an active and dedicated member of the CSA leadership, first as the nominating committee chair, then as president-elect in 2016. He served as president from 2017-2018. As the current past president, Lugo-Morales actively collaborates on several committees and is a CSA delegate to the AHIMA House of Delegates. As PRHIMA president, he was in-strumental in implementing new technological applications that greatly streamlined and improved the registration process and marketing of PRHIMA events. He also developed an educational resource bank of HIM-related professionals to offer trainings.

By exhibiting a passionate approach to his job, Lugo-Morales has set a positive example for his students and young graduates and has served as a true mentor and leader. Lugo-Morales has been a member of the HIM Advisory Board for the HIM Gradu-ate Program and has served as a clinical practice instructor in the professional practice experience (PPE), which he enjoys im-mensely. His charisma, enthusiasm, and can-do attitude serve as an inspiration to others within the profession.

Lugo-Morales’s peers praise him for his ability to quickly ad-just to any situation and his capacity to work under extreme circumstances while attaining outstanding results—skills that were demonstrated during Hurricane Maria coverage.

AHIMA congratulates Kenneth H. Lugo-Morales on his 2019 AHIMA Emerging Leader Triumph Award and recognzies him for his outstanding commitment to his profession and his pas-sion for passing on that commitment to others.



Mentor AwardThe MENTOR AWARD honors individuals or groups with ex-tensive records of encouraging individuals to realize their full potential and help them find ways to achieve their best.

AHIMA presents Tressa A. Lyon, RHIT, with the 2019 AHI-MA Mentor Triumph Award.

Lyon is the HIM manager at Norman Regional Hospital in Nor-man, OK, and is a member of the executive board for the Okla-homa Health Information Management Association (OkHIMA).

A 12-year veteran in the HIM field, Lyon has inspired count-less students and peers to better themselves both personally and professionally. Serving on multiple committees through-out her career, Lyon has touched many lives with her cheer-ful personality and willingness to share skills, knowledge, and expertise. Lyon has been involved in numerous OkHIMA com-mittees, including the Medical Decision-Making Committee, Documentation Management (as chair of the committee), Pa-tient Portal Committee, ICD-10 Project Manager, and Outcomes and Efficiencies Team. Her level of engagement with those she mentors led to recognition as the Norman Regional Health Sys-tem Employee of the Month in January 2014.

Lyon also serves as a mentor for many colleges and universities in Oklahoma and through OkHIMA. Active with the OkHIMA convention planning committee for numerous years, Lyon has mentored many students and has coached them to become suc-cessful leaders at the state and national level. Colleagues praise Lyon’s infectious love for HIM and former students credit her with broadening their understanding of the potential impact of HIM and empowering them to be part of the HIM process.

Lyon is a valuable team member regardless of her level of in-volvement and demonstrates great respect for the learning pro-cess. She is an inspiration to those around her and has a positive impact on all those whose paths she crosses—both within HIM and outside the field. A highly respected and sought-after men-tor, Lyon’s contributions will be felt in the HIM community for many years.

AHIMA congratulates Tressa A. Lyon on her 2019 AHIMA Mentor Triumph Award.

Leadership AwardThe LEADERSHIP AWARD hon-ors those individuals or groups who have provided outstanding service as a leader(s) for a mini-mum of 10 years; demonstrated ongoing leadership competency with the Association and the HIM profession; adhered to and ad-vocated for the AHIMA Code of

Ethics and any other appropriate codes of conduct; valued hon-esty, integrity, and transparency; worked as team players and collaborators; are recognized as a qualified authority in the HIM profession; and present a positive professional image for the As-sociation and the profession.

AHIMA presents Chrisann K. Lemery, MSE, RHIA, CHPS, FAHIMA, with the 2019 AHIMA Leadership Triumph Award. Lemery has been an AHIMA member for over 30 years and pas-sionately promotes the field of HIM through volunteering, vi-sionary leadership, and speaking engagements.

Lemery has served in numerous leadership capacities, includ-ing president, past-president, and board member for the Wis-consin Health Information Management Association (WHIMA). She has also served as secretary of the AHIMA Board of Direc-tors and Speaker of the House of Delegates. Lemery’s volunteer activities related to advocacy and legislation are iconic, includ-ing serving on the award-winning HIPAA Collaborative of Wis-consin (HIPAA COW) Board of Directors, participating in state and national Hill Days, and serving on government-appointed committees addressing EHRs and medical record copy fees. Her participation has aided numerous committees at the na-tional and state level, including AHIMA Privacy and Security and Enterprise Information Management Practice Councils, the Advocacy and Policy Council, and the Professional Ethics Com-mittee. Previously, she was awarded the prestigious fellowship designation by her AHIMA peers.

As a result of her experience in all sectors of the healthcare industry, Lemery always keeps a watchful eye for new regula-tions and healthcare industry information and helps others share what she has learned. Lemery is a true HIM leader who has a tremendous amount of knowledge, understanding, vision, and passion. She has shared invaluable insights with AHIMA, WHIMA, HIPAA COW, and numerous colleagues.

Lemery is a well-known author and speaker on a variety of HIM-related topics and is the go-to person for many different subjects. She has given more than 70 presentations demonstrat-ing her compassion for sharing her knowledge. She is active in academia, serving on college advisory boards and sharing her knowledge as a mentor to future HIM professionals.

A highly respected colleague and friend, Emery’s leadership is felt throughout the HIM community. AHIMA congratulates Chrisann K. Lemery on her 2019 AHIMA Leadership Triumph Award.



Rising Star AwardThe RISING STAR AWARD hon-ors those individuals who are up and coming in the HIM field and have been employed for five years or less from the date of en-try in the HIM profession.

AHIMA presents Laura Ann Shue, MPA, CHDA, CPHIMS, with the 2019 Rising Star Tri-

umph Award. Shue was chosen for this award because of her demonstrated commitment to the HIM profession and her lead-ership roles both in the workplace and her state association.

Shue graduated from Eastern Michigan University in 2011 with a master’s in public administration (MPA) and a concen-tration in healthcare administration. She subsequently earned her CHDA in 2012 and CPHIMS in 2016. Since 2014, she has served as the HIM operations director for Michigan Medicine (University of Michigan Health System). In this role, Shue suc-cessfully engaged in wide-scale efforts to reduce medical record delinquencies and improve EHR functionality within the orga-nization while advocating for quality, data management, data analytics, and management development. She has held a variety of leadership roles and demonstrated a capacity to adapt and lead change within her organization by bringing together clini-cal, IT, and HIM resources to collaborate on various strategic initiatives.

In addition to her professional commitments, Shue is an ac-tive member and president-elect of the Michigan Health Infor-mation Management Association (MHIMA). She has served on the MHIMA board of directors since 2016 and helped kickstart the MHIMA Student Concierge Program, an initiative that in-troduces students to the importance of volunteerism and helps them develop their professionalism and project management skills. Shue also represents the HIM profession at local colle-giate events, where she regularly engages with HIM and health IT students to mentor and develop new HIM professionals.

A Michigan Medicine colleague praises Shue for changing the institution’s perception of HIM staff, crediting her for the de-partment’s current status as a necessary and welcome partner for other Michigan Medicine groups. For her efforts toward en-larging the circle of HIM professionals and her dedication to the profession, AHIMA congratulates Laura Ann Shue on her 2019 AHIMA Rising Star Triumph Award.

Special thanks to the 2019 AHIMA Triumph Awards Committee:

CHAIRRenae L. Spohn, MBA, RHIA, CPHQ, CPHI, FNAHQ, FAHIMA

MEMBERSMarie T. Conde, MPA, RHIA, CCS, FAHIMATheresa A. Eichelmann, MBA, RHIADiana M. Flood, MS, RHIAMarques Edgar Grant, RHIAVaradraj Prabhu Gurupur, PhD, MS, RHIAMegan A. McDougal, MS, RHIA, CHTS-IMGrissel Pabon, MS, RHIA, CDIP, CCS, CCS-PIsabel Quintana, MA, RHIA, CCA

STAFF LIAISONSJoAnn V. Coleman, MPA, CAEMarilyn K. Render



AA RECENTLY FILED class action highlights the risk that the proliferation of health-related smartphone apps, fitness trackers, and the data these programs collect, may enable the re-identification of purportedly de-identified electronic health records (EHRs). The action raises questions about the need to examine existing de-identification requirements and processes to ensure that these keep pace with developments in technology, such as artificial intelligence (AI) and machine learning. It also presents questions of whether those requirements and processes are sufficient to protect patient privacy and confidentiality.

The AllegationsIn the class action complaint against Google, the University of Chicago Medical Center, and the University of Chicago (the latter two entities referred to here as the “University”),1 former University patient Matt Dinerstein alleged that in 2017 the University transferred its EHR consisting of thousands of patient medical records to Google without the express consent of those patients. Dinerstein asserted claims arising out of alleged violation of the Illinois Consumer Fraud and Deceptive Business Practices Act as well as claims for breach of contract, tortious interference with contract, intrusion upon seclusion, and unjust enrichment.

While Google explained that it was partnering with the University to enable it to “research ways to use machine learning to predict medical events,” according to the lawsuit, Dinerstein contended that Google’s actual motivation was financial—namely, to obtain patient health data that could be used by DeepMind Health, an AI and machine learning

entity that Google acquired. This acquisition was allegedly part of Google’s decade-long focus on the healthcare market. In recent years Google has worked on creating apps and cloud services such as G Suite for healthcare businesses and Google Cloud for HIPAA-compliant workloads. The company also has launched fitness-tracking products such as Google Fit, and has added features to Google Search to make it easier for consumers to research health-related questions.

In addition to failing to obtain consent from patients to provide these records to Google, Dinerstein alleged that although Google and the University represented that the patient data had been de-identified, the records “were not sufficiently anonymized and put the patients’ privacy at grave risk.” An article published by Google and the University in 20182 revealed that datestamps from University patients’ records were maintained, as were “de-identified free-text medical notes.” Other data included patient demographics, provider orders, diagnoses, procedures, medications, lab values, vital signs, and flowsheet data.

Underscoring the importance of effective de-identification of medical data, Dinerstein’s lawsuit cites two examples of “researchers with limited access to public data sets and supposedly de-identified medical records [who] have been able to re-identify patients.” The first was an instance where, using only publicly available data they bought for $50, researchers at Harvard’s Data Privacy Lab re-identified 43 percent of de-identified medical discharge records. In the other example, using AI and machine learning tools to analyze data from fitness trackers and information such as age, gender, education level, income, race, and country of birth, researchers were able to re-identify 95 percent of

Working Smart a professional practice forum

Anonymized EHRs Create Potential Liability for Google and HospitalBy Gail L. Gottehrer, JD, and Ronald J. Hedges, JD

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a data set from medical records. One of the authors of that study opined that the results show that “machine learning can successfully re-identify the de-identified physical activity data of a large percentage of individuals, and this indicates that our current practices for de-identifying physical activity data are insufficient for privacy,” according to the lawsuit. He went on to caution that, “[m]ore broadly it suggests that other types of health data that have been thought to be nonidentifying could potentially be matched to individuals by using machine learning and other artificial intelligence technologies.”7

Using these examples as guides, Dinerstein concluded that, when medical records that contain datestamps and free-text notes are shared, there is a high probability that the shared data can be re-identified. Moreover, “when the transfer of medical records is made to Google, the ability to re-identify those records becomes a certainty” because “Google is one of the largest and most comprehensive data mining companies in the world.”

As the lawsuit alleges, “Google has access to public and nonpublic information that could easily lead to the re-identification of the medical records it received from the University.” That information includes geolocation data from Google Maps, and when combined with data from Google email apps, could identify when an individual entered the hospital for treatment, which buildings they entered and exited, and the amount of time spent at each location.

The fact that Google has access to all this information increases the chances that medical records provided by the University could be used to re-identify an individual by name and compromise patient privacy.

The Causes of ActionDinerstein filed his class action complaint in the US District Court for the Northern District of Ilinois. He alleged that subject matter jurisdiction, which gives the court the authority to adjudicate the claims in issue, arises out of 28 U.S.C. Section 1332 (d)(2). That statute gives district courts subject matter jurisdiction over “any civil action in which the matter in controversy exceeds the sum or value of $5,000,000, exclusive of interest and costs, and is a class action.” Dinerstein alleged no claims under federal law. Instead, he asserted claims under Illinois statutory and common law. With that as a very basic background, the first defense that Google and the University might assert is a lack of standing.

Article III of the US Constitution allows federal courts to decide “cases or controversies.” To establish Article III standing, a plaintiff must have suffered an “injury in fact,” which the US Supreme Court has defined to be “an invasion of a legally protected interest” that is concrete and particularized and actual or imminent, not conjectural or hypothetical, Patel v. Facebook, Inc., No. 18-15982 (9th Cir. Aug. 8, 2019), quoting Lujan v. Defs. of Wildlife, 504 U.S. 555, 560 (1992). Standing

may be particularly difficult to allege when a plaintiff asserts a claim under a statute—such as the Illinois statute identified in the class action complaint—which sets forth a statutory requirement. The mere failure to comply with that requirement does not establish standing absent a real risk of harm. This has proved to be a stumbling block for plaintiffs who have sought to recover damages for “mere” data breaches without tangible harm since the Supreme Court decided Spokeo, Inc. v. Robins, 136 S.Ct. 1540 (2016).

The standing defense is complicated by a decision of the Illinois Supreme Court, Rosenbach v. Six Flags Entertainment Corp., 2019 IL 123186 (Ill. 2019), which interpreted an Illinois statute, the Biometric Information Privacy Act (BIPA), to allow a claim for damages arising out of BIPA to proceed without any allegation of actual damage. The court held that the violation of the statute was enough to state a claim. Rosenbach was “featured” in the Ninth Circuit Court of Appeals’ Facebook decision, cited above. Based on Rosenbach, that court held that allegations that Facebook violated BIPA were sufficient to confer standing. In other words, standing can be complicated.

Points to ConsiderThe Dinerstein case raises many important issues for health information management (HIM) professionals, not covered in the scope of this article. Looking at the lawsuit from the perspective of an HIM professional, some points to consider include:

� When might the duty to preserve relevant health records arise?

� What might the scope of any duty be? � How might electronically stored information—or physical

things such as paper records—be located and in what form should different information be preserved?

These and other topics are certain to be discussed as Google and the University defend against the claims asserted in the class action complaint. ¢

Note 1. Matt Dinerstein v. The University of Chicago, Google LLC,

and The University of Chicago Medical Center. https://edelson.com/wp-content/uploads/2016/05/Dinerstein-Google-DKT-001-Complaint.pdf.

2. Alvin Rajkomar et al. “Scalable and accurate deep learning with electronic health records.” Digital Medicine. May 9, 2018. https://www.nature.com/articles/s41746-018-0029-1.

Gail Gottehrer ([email protected]) is the founder of the Law Office

of Gail Gottehrer LLC, a lawfirm focused on emerging technologies. Ron

Hedges ([email protected]) is a former US Magistrate Judge in the District

of New Jersey and is a writer, lecturer, and consultant on topics related to

electronic information. He is a senior counsel with Dentons US LLP.




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CAC Takes Coding Into the FutureBy Kristi Fahy, RHIA

TECHNOLOGY IS THE segue to the future. It is the very thing that will transform the landscape of today’s world into one with endless possibilities. In healthcare, that transforma-tion is being accelerated by the transition to electronic health records (EHRs), which has helped providers to digitize and drive the organization with data every day. Technology is the catalyst to unlocking new opportunities, many of which will help push healthcare organizations to a more effective future. Companies that embrace technology will surpass their com-petitors and stay ahead in the marketplace. Meanwhile, com-panies that are content to wait will be left behind.

Improving CodingGiven today’s shift to value-based reimbursement method-ologies, both clinical documentation improvement (CDI) and coding accuracy are more important than ever. These special-ties are necessary for improving patient outcomes, ensuring continuity of care, and attaining appropriate reimbursement. The availability and quality of clinical documentation directly impacts which codes can be assigned. Additionally, the codes assigned for each patient encounter directly impact reim-bursement—a sentiment often expressed in the coding man-tra: “if it isn’t documented, it didn’t happen.” That’s why many healthcare organizations have sought to streamline their cod-ing and CDI processes with technology through computer-assisted coding (CAC).

AHIMA defines CAC as the “use of computer software that automatically generates a set of medical codes for review, vali-dation, and use based upon clinical documentation provided by healthcare practitioners.”1

CAC technologies, designed to be a productivity tool, have

come a long way since they first made their debut in the ear-ly 1990s. In more recent years, before CAC programs were broadly adopted in the mid-2000s, many organizations be-gan to fear what was to come from the long-anticipated shift to ICD-10. Although the transition was still several years away—ICD-10-CM/PCS was implemented in 2015—health information management (HIM) professionals questioned how they were going to manage the new complexity of ICD-10. With over 75,000 additional ICD-10-CM codes and increased specificity requirements for ICD-10-PCS codes, healthcare organizations needed an approach that would consistently capture accurate codes without hindering pro-ductivity. For many, that approach was CAC.

AI Meets CodingTraditional CAC technologies utilize natural language pro-cessing (NLP) to gain insights from large amounts of plain text data extracted from the EHR. NLP is used to scan docu-ments and provide code suggestions for coders to review and validate. The power of NLP lies in its ability to help coders quickly find key words or phrases and suggest affiliated codes within the documentation for more efficient coding.

Still, as a rules-based algorithm that is dependent on the context of the documentation, NLP has its limitations. If the rules don’t accommodate the variances in the way the docu-mentation is written—“left ankle fracture” vs. “the patient has a fracture of their left ankle”—NLP may suggest unspecified codes. In addition, clinical findings can be written across sev-eral sentences, paragraphs, and documents due to NLP’s re-liance on consistent patterns. When patterns change, the en-gine needs a human to program new rules.




Many HIM professionals caught on to the limitations of NLP and demanded more. They needed a tool comprehensive enough to improve accuracy, enhance efficiency, and redefine their current coding workflow so that it could be consolidated into a unified workspace.

As a result, CAC’s evolution continued by taking NLP a few steps further. Now, sophisticated CAC technologies utilize artificial intelligence (AI) and machine learning to enable far more accurate code suggestions. Essentially, the AI analyzes the electronic documentation and uses what it has learned to apply coding rules and guidelines. The AI considers all writ-ten documentation within a patient record to build out codes. It can understand when it is appropriate to combine codes, how to comprehend negations, and more. The machine learn-ing then learns code suggestion patterns from each action performed by a coder within CAC and will overlay what it has learned from those actions to consistently suggest accurate codes. The more data and information that is fed through CAC, the more it will learn, and the more accurate it will be for cod-ers to review and validate.

These innovations are driving improved revenue cycle outcomes every day. But how else will CAC technology be leveraged to unlock new opportunities and applications of its data? While many answers have yet to emerge and will evolve over time, other opportunities have already come to the forefront.

Better Workspace OrganizationMany organizations are beginning to use CAC not only for coding, but also for CDI, quality, case management, auditing, management reporting, and more. It is important that CAC systems be tailored to address specific roles and workflows. As a result, the AI can be configured to automate workflows within the application

In other words, when AI is incorporated into the workflow organizations can ask such questions as: How does an or-ganization prioritize which charts hit which coder’s queue? Are these priorities based on payer, coder specialty, patient type, or other factors? What is AI’s role in CDI? How do or-ganizations prioritize which cases should be reviewed by a CDI specialist each day? Is this based on possible query op-portunities that are generated from target reasons or events that occurred during the patient stay—perhaps patients with congestive heart failure lacking specificity or patients with clinical indicators of sepsis? These custom workflows can and should be configured, enhanced, and automated by AI to enable a streamlined and collaborative approach.

A unified, collaborative workspace also provides many benefits. Abstracting, querying, and other customary coder tasks can be performed within newer CAC technologies, eliminating the need to toggle between multiple systems. Because CDI is also commonly integrated within CAC, cod-ers have the benefit of knowing what the CDI specialist did

while the patient was present. In addition, coders and CDI specialists can communicate by leaving notes or book-marks for each other or for other end users such as auditors or management. These features, in addition to those result-ing from other innovative tools, go beyond the traditional functions of CAC. They have allowed end-users to signifi-cantly increase their productivity and to achieve greater revenue cycle outcomes.

Data-driven organizations can leverage CAC to gain new insights into their data—and determine areas for opportu-nity. In-depth reporting capabilities allow management to track and monitor productivity, query impact, query turn-around times and response rates, and monitor case mix index trends, just to name a few. Organizations also are looking to track and monitor hospital-acquired conditions, patient safety indicators, hospital readmissions within 30 days, and patients with current or previous hierarchal con-dition categories. The ability to extract these insights from CAC will help to paint a picture of an organization’s current state, processes, outcomes, patient population, and other key factors that will allow them to determine where they need improvement.

ConclusionNew industry demands will surface, further expanding fu-ture needs and uses for CAC. AI and machine learning in these technologies will continue to get smarter and will learn new mechanisms for problem-solving in ways previ-ously unimaginable.

Organizations looking to position themselves for future success should seek CAC solutions from vendors who values artificial intelligence and machine learning, enabling them to provide more accurate code suggestions, logical work-flows, and the ability to adapt to the ever-changing needs of the healthcare industry. ¢

Notes: 1. AHIMA e-HIM Work Group on Computer-Assisted Cod-

ing. “Delving into Computer-assisted Coding” (AHIMA Practice Brief). Journal of AHIMA 75, no.10 (Nov-Dec 2004): 48A-H.

Kristi Fahy ([email protected]) is an account executive at DVS, a

premier partner of Dolbey.

CAC technologies, designed to be a productivity tool, have come a long way since they first made their debut in the early 1990s.

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Telehealth’s Popularity Puts New Emphasis on Privacy and SecurityBy Lesley Clack, ScD, MS, CPH

TELEHEALTH, WHICH REFERS to healthcare services facilitated remotely through electronic information and telecommunications technology, is on the rise. In 2010, 35 percent of hospitals had partially or fully implemented computerized telehealth systems, compared to 76 percent of hospitals in 2017.1 Telehealth’s popularity also is increas-ing with patients, with 74 percent reporting that they would be comfortable using telehealth technologies, which can include the internet, videoconferencing, store-and-forward telecommunication techniques, mobile health applica-tions, remote monitoring, electronic consults, and wireless communication.

While there are many benefits to using telehealth, including convenience, cost-effectiveness, and improved access to ser-vices, the increase in popularity comes with new privacy and security concerns for patient data.

The Centers for Medicare and Medicaid Services (CMS) ex-panded reimbursement for telehealth services in the 2019 Physician Fee Schedule by adding new applicable codes.2 CMS also increased coverage for the use of equipment for remote monitoring, including setup, patient education, initial supply, daily recording or programmed alert transmissions, and staff time for interactive remote communication with patients or caregivers.

Privacy and Security ConcernsWhile telehealth services are cost-effective and convenient, they also create issues with privacy of patient information. The HIPAA Privacy Rule governs the use and disclosure of individuals’ health information and provides standards for patient privacy rights. The Privacy Rule requires that pa-

tient messaging is through a secure connection and that services provided through telehealth equipment are en-crypted. The HIPAA Security Rule refers to the protection of electronic protected health information and sets the stan-dards for securing patient data that is stored or transferred by electronic methods. It requires covered entities (CEs) to put technical safeguards in place to protect against unau-thorized access to protected health information (PHI) when transmitting information electronically. HIPAA guidelines for telemedicine are contained within the Security Rule and state that:

� Only authorized users should have access to electronic protected health information (ePHI)

� A system of secure communications should be imple-mented to protect the integrity of ePHI

� A system of monitoring communications containing ePHI should be implemented to prevent accidental or mali-cious breaches

Increased telehealth services also place an expanded em-phasis on cybersecurity, including monitoring telehealth sys-tems for unusual activity, encrypting confidential records, backing up sensitive healthcare information, establishing protocols for retrieving lost data, and restarting systems in case of a cyberattack or blackout. Research shows that 87 per-cent of healthcare executives expected to increase spending on cybersecurity in 2019.3

Patient Education and SupportWhile telehealth is growing in popularity with patients, it is important for providers to ensure that patients are aware of




potential privacy and security issues as well as other risks that can occur with the transmission of electronic information.

In 2016, the American Medical Association approved a set of guidelines4 for ethical guidance on telehealth and telemedi-cine in support of policies and initiatives that promote ac-cess to telehealth or telemedicine services for all patients who could benefit from receiving care electronically. These guide-lines recommended that:

� Physicians inform patients that telehealth technology has certain limitations

� Patients be advised how to arrange for follow-up care � Patients be advised to let their primary care physician

know when they’ve used a telehealth service

Because telehealth interactions involve communication with patients who are not physically in a room with the provid-er, there is an increased risk of disclosing information to the wrong person. To maintain patients’ privacy, providers should have processes in place for verifying the identities of patients receiving telehealth services.

Legal and State ProtectionsThe Health Insurance Portability and Accountability Act (HIPAA) was passed in 1996 to protect PHI. It required the Sec-retary of the US Department of Health and Human Services (HHS) to develop regulations protecting the privacy and secu-rity of PHI. As a result, HHS published the HIPAA Privacy Rule and the HIPAA Security Rule. The Privacy Rule, or Standards for Privacy of Individually Identifiable Health Information, establishes national standards for the protection of certain health information. The Security Rule, or Security Standards for the Protection of Electronic Protected Health Information, establishes a national set of security standards for protecting certain health information that is held or transferred in elec-tronic form.

These regulations, enforced by HIPAA, protect identifi-able health information when it is collected and shared by CEs. CEs are defined as healthcare providers that trans-mit patient information electronically, including provid-ers, health plans, and healthcare clearinghouses.5 Prior to HIPAA, a generally accepted set of security standards or general requirements for protecting health information did not exist in the healthcare industry. As new technolo-

gies have evolved, healthcare has relied more heavily on the use of electronic information systems to pay claims, answer eligibility questions, provide health information, and conduct a host of other administrative and clinically based functions.

In terms of reimbursement, the American Telemedicine Association’s 2019 State of the States Report: Coverage and Reimbursement publication notes that 40 states and the District of Columbia have adopted substantial policies to improve telehealth rules since 2017. In addition, over 21 states now mandate that Medicaid offer coverage for tele-health services as they would for in-person services. Thirty-six states regulate private payer coverage for telehealth.

Telehealth on the RiseThe use of telehealth services is increasing in popularity and gaining support from major stakeholders. In addition, both the federal government and individual states have made strides in improving reimbursement for telehealth services in 2019. This increase in popularity and reimbursement has elevated the need for private and secure telehealth services. Providers have a responsibility to ensure that patients are aware of the privacy and security risks involved and the legal protections provided for telehealth services. ¢

Notes 1. The American Hospital Association. “Fact Sheet: Tele-

health.” February 4, 2019. https://www.aha.org/system/files/2019-02/fact-sheet-telehealth-2-4-19.pdf.

2. The Centers for Medicare and Medicaid Services. “Phy-sician Fee Schedule.” 2018. https://www.cms.gov/medi-care/medicare-fee-for-service-payment/physicianfee-sched/.

3. In Touch Health. “What To Expect From Telehealth in 2019.” https://intouchhealth.com/what-to-expect-from-telehealth-in-2019/.

4. The American Medical Association. “AMA Adopts New Guidance for Ethical Practice in Telemedicine.” June 13, 2016. https://www.ama-assn.org/press-center/press-releases/ama-adopts-new-guidance-ethical-practice-telemedicine.

5. Hall, L. Joseph and Deven McGraw. “For Telehealth to Succeed, Privacy & Security Risks Must Be Identified and Addressed.” Health Affairs 33, no. 2. (February 2014). https://doi.org/10.1377/hlthaff.2013.0997.

6. The American Telehealth Association. “2019 State of the States Report: Coverage and Reimbursement.” https://www.americantelemed.org/initiatives/2019-state-of-the-states-report-coverage-and-reimbursement/.

Lesley Clack ([email protected]) is an assistant professor and coordi-

nator of the master of health administration program at the University of

Georgia.

While there are many benefits to using telehealth, the increase in popularity comes with new privacy and security concerns for patient data.

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NIST Privacy Framework: Protecting Privacy While Promoting InteroperabilityBy Karen Starling Greenhalgh, HCISPP, CHC, CHPC

PRIVACY IS OFTEN seen as a barrier to electronic health in-formation exchange (HIE). To help address those concerns and meld core privacy principles with proven oversight and accountability mechanisms, the National Institute of Stan-dards and Technology (NIST) is scheduled to release the Privacy Framework: An Enterprise Risk Management Tool this month. Draft versions are also available for review.1

Designed with collaboration between NIST, healthcare industry leaders, and privacy experts, the NIST Privacy Framework provides healthcare providers with an effective approach to protecting the privacy of the individual while implementing complex new interoperability and patient ac-cess programs.

Because HIE is a such a high priority, the Centers for Medi-care and Medicaid Services (CMS) encouraged implementa-tion of electronic health record (EHR) technology throughout the US healthcare delivery system by instituting the mean-ingful use (MU) EHR Incentive Program.2 While MU was successful with respect to industry-wide adoption of EHRs, it opened the door to unexpected security risks. In 2018, CMS revamped MU by renaming it the Promoting Interoperabil-ity (PI) program, emphasizing a broader focus on interoper-ability and improving patient access to health information.3

However, the privacy and security issues remain.

Privacy in HealthcareIndividuals’ privacy is of particular importance to healthcare providers because their patients’ well-being depends upon their ability to share personal data. Loss of trust could make a patient hesitant to share critical information or reluctant to pursue necessary medical care.

There have been numerous attempts to address privacy is-sues in healthcare that are of interest to health information management (HIM) professionals. For example, the govern-ment defined Fair Information Practice Principles (FIPPs) as part of the Privacy Act of 1974.4 FIPPs set forth eight key principles that formed the backbone of privacy law in the United States and are recognized by healthcare privacy pro-fessionals.

In 2008, the Nationwide Privacy and Security Framework for Electronic Exchange of Individually Identifiable Health Infor-mation (Privacy and Security Framework) was released by the Department of Health and Human Services’ Office of the Na-tional Coordinator for Health Information Technology (ONC).5

The ONC’s Privacy and Security Framework also comprises eight principles that are derived from FIPPs.

Figure 1 on page 33 exhibits the privacy principles stated in the FIPPs and ONC’s framework. These are similar and pro-vide a good foundation, but as value statements they are dif-ficult to operationalize.

In 2015 ONC issued the Guide to Privacy and Security of Electronic Health Information.6 This guide refers to the impor-tance of privacy and security and offers guidance on imple-menting the Health Insurance Portability and Accountability Act (HIPAA) Security Rule, but does not address the Privacy Rule. Security is necessary to protect the privacy of individu-als, but security alone cannot address all privacy issues.

The Privacy and Security ConnectionPrivacy professionals understand the importance of protect-ing privacy, but many in the healthcare industry are confused when differentiating between privacy and cybersecurity. As




cybersecurity becomes more established, privacy is often sim-plified to an outcome of an effective cybersecurity program. In order to promote interoperability and access while protect-ing the privacy of individuals, the differences between privacy and cybersecurity must be clearly defined.

While the term “privacy” is frequently used, there is no universally accepted definition of the word. Privacy’s scope, meaning, and value can be complex and confusing. To help understand privacy, consider that it is primarily used to an-swer the following questions:

� Who has access to personal information and under what conditions?

� Which data can be collected? � How is personal information collected, stored, and used? � What are the justifications, if any, for data collected for

one purpose and then reused for a second purpose? � Has an individual authorized particular use of his or her

personal information?

The term “security” is more tangible and therefore more eas-ily understood. It can be defined as the procedural and techni-cal measures required to:

� Prevent unauthorized access, modification, use, or dis-semination of data stored or processed in a computer system

� Prevent any deliberate denial of service � Protect the system in its entirety from physical harm

When someone hacks into a computer system, there is a breach of security and, potentially, a breach of privacy. No se-curity measure, however, can prevent invasion of privacy by those who have authority to access the record. Comprehensive data security requires mitigation of both security risks and privacy risks, as illustrated in Figure 2 (above).

Privacy and Security RiskThe new NIST Privacy Framework offers a fresh approach to privacy management. By applying an outcome-based meth-

odology to recognized privacy value statements, the NIST framework approaches privacy as a manageable risk. This approach, based on the widely accepted NIST Cybersecu-rity Framework (CSF),7 enables privacy compliance practi-tioners to state goals and achieve a measurable outcome for individuals’ privacy. Approaching privacy as a risk, NIST applied their proven standards for identifying and manag-ing security risks to develop guidelines for risk-based pri-vacy management.

Aligning privacy risk and security risk to increase protection of health information systems will bolster trust in such sys-tems and promote their adoption. While the NIST framework is designed to function as a standalone tool or in conjunction with any cybersecurity program, it is also specifically de-signed to work with the CSF. Both NIST frameworks are based on risk models that define the risk factors to be assessed, and the relationships among those factors.

Security Risk ModelThe NIST Security Risk Model, based on the widely known CIA Security Triad, is focused on unauthorized activity creating a se-curity risk, impacting confidentiality, integrity, or availability of information or systems.

The key aspects of the CIA Security Triad are confidentiality, integrity, and availability:

� Confidentiality: preserving authorized restrictions on in-formation access and disclosure, including means for pro-tecting personal privacy and proprietary information

� Integrity: guarding against improper information modifi-cation or destruction; includes ensuring information non-repudiation and authenticity

� Availability: ensuring timely and reliable access to and use of information

Figure 1: Privacy Principles

FIPPs ONC Privacy and Security Framework

1. Transparency2. Individual participation3. Purpose specification4. Data minimization5. Use limitation6. Data quality and integrity7. Security8. Accountability

1. Individual access2. Correction3. Openness and transparency4. Individual choice5. Collection, use, and disclosure limitation6. Data quality and integrity7. Safeguards8. Accountability

Figure 2: Cybersecurity and Privacy Risk Relationship

PRIVACY RISKSarise as a byproduct of authorized data

processing

data security

CYBERSECURITY RISKS

arise from unauthorized activity

Continued on page 43


Tpractice guidelines for managing health information

PRACTICE BRIEF

THE AHIMA FOUNDATION has established competencies for health information management (HIM) professionals, includ-ing clinical documentation improvement (CDI) practice, as part of an effort to establish new curricula and teaching methods for college and university HIM programs throughout the United States.1 For example, as HIM programs become increasingly so-phisticated, educators can use “unfolding” case studies, which can foster “a learner-centered classroom, where the student is actively engaged in the learning process. In this format, infor-mation is presented in several stages. At each stage, the student engages in critical thinking and problem solving.”2

Critical Thinking DefinedCritical thinking involves the following key tasks:2

� Validating information � Identifying exceptions � Analyzing trends � Considering what is not there � Thinking “outside the box” � Being creative

To accomplish these tasks, the critical thinker must be open to new information, alternative explanations, and unbiased consid-eration of what one presumes to be true about a given situation or problem before a conclusion is reached. “The primary difference between thinking and thinking critically is the added dynamic of having a purpose and control for the thought process.”4

Thinking critically requires more than criticism of the current state of affairs. Rather than a negative activity, it is a positive process developed to identify effective solutions to complex is-sues. Potential steps to critically consider a positive solution to a complex problem include:

� Gather and analyze information. � Develop a set of assumptions as a basis for the thought process. � Use scientific methods to develop conclusions. � Discern the validity of knowledge sources using questions

and judgment. � Apply a creative thought process to develop possible solutions. � Analyze the feasibility, advantages, and disadvantages of

possible solutions. � Determine necessary action. � Positively communicate a proposal to stakeholders. � Implement best-practice solutions.

The use of critical thinking allows for confidence through suc-cess, independent action, collaboration when needed, and ef-fective, creative solutions that improve job satisfaction.5

Why Is Critical Thinking Necessary in Healthcare?Critical thinking skills are necessary in today’s healthcare en-vironment because of the complexity of the industry. Health-care professionals must apply analytical skills to make complex decisions for high-quality patient care delivery. The intricacies of the electronic health record (EHR) and associated interop-erability issues have added a layer of complexity for providers and healthcare workers. The internet has exponentially in-creased the amount of information on any subject, resulting in the specialization and subspecialization of today’s providers, clinicians, and nonclinicians. Historically, there may have been one professional performing a combination of functions such as HIM management, quality assurance, utilization review, and CDI activities; today, however, each of these functions is typi-cally performed by a specialist in that area.

Critical thinking skills are an area of focus for many health-care managers as they encourage their staff to think through problem solving at a higher level. Traditionally, clinical docu-mentation specialists (CDSs) may have been selected for CDI positions based on their clinical expertise. Today’s CDI team members must be competent in many other areas. CDI manag-ers are calling for more highly skilled thought leaders who not only learn their specific area of expertise but also keep abreast of current research in interrelated areas in order to tie together a bigger picture of issues they face on a daily basis. The outpatient CDS should therefore learn about the organizational goals and objectives, budget issues, staffing constraints, key performance indicators, and strategic plans that affect the outpatient CDI ar-eas during the day-to-day problem-solving process.

Critical thinking skills allow the CDS to become a transforma-tional leader who can do the following:

� Challenge preliminary solutions. Example: The outpa-tient CDS has been the key CDI staff member on the new outpatient CDI pilot clinic implementation. They under-stand that the hospital has been closely monitoring budgets because of a downturn in revenue related to the increase in risk-based payer plans. The initial plan for the CDI pro-gram rollout to additional clinics involved adding one out-patient CDS to each site. After working on the initial clinic

Clinical Documentation Improvement for Outpatient Care: Design and Implementation Editor’s Note: This Practice Brief is based on an excerpt from the AHIMA Press publication Clinical Documentation Improvement for Outpatient Care: Design and Implementation by Pamela Carroll Hess, MA, RHIA, CCS, CDIP, CPC.


Practice Brief

implementation, the outpatient CDS streamlines some of the workflows to decrease time requirements and allow for remote CDSs to cover multiple clinics. The outpatient CDS presents this new process to the CDI taskforce. The CDI manager compliments the outpatient CDS for their critical thinking skills and for saving the health system money.

� Expand root cause analysis. Example: The outpatient CDS reviews the response and agreement rates for her clinics on a weekly basis. She notices that the response and agreement rates for Dr. Smith are much lower than those for the other providers in the internal medicine clinic. After collaboratively discussing the issue with Dr. Smith, the CDS learns that he travels to several of the out-lying clinics because his subspecialty is endocrinology. Because of his travel schedule, he misses out on the onsite benefit of having a nonprovider clinician help during the query process by notifying the physician of any outstand-ing queries for the case just before the patient encounter. To ensure that Dr. Smith also gets previsit notification of que-ries, the outpatient CDS and Dr. Smith agree to a revised workflow that would include the use of an EHR alert on the patient’s record. This alert will allow Dr. Smith to see the query prior to the patient encounter or as he is opening the case while in the patient room. The new process results in a significant increase in query responses and agreements by Dr. Smith.

� Use critical thinking to identify more streamlined solu-tions and workflows. Example: The outpatient CDS notices that the MIPS measure that includes a diabetic eye exam is not being captured by the primary care providers. Provider education has been conducted on several occasions, but the capture rate has not improved. During a recent meet-ing with the new EHR vendor, the outpatient CDS learns of enhancements to the system that include in-line documen-tation prompts that could be used to query providers about the need for a diabetic eye exam on diabetic patients. The outpatient CDS creates the wording for the prompt and the exact point in the documentation process where the prompt should occur. She then sets up a meeting with the CDI man-ager and EHR vendor to discuss the possibility of including this prompt during the new system implementation.

The outpatient CDS should always be on the lookout for op-portunities to use critical thinking skills to improve workflow, provider-communication process, and stakeholder collabora-tion. The issue at hand is not always obvious after a high-level investigation. A more in-depth root cause analysis, although more time-consuming, may lead to more cost-effective pro-cesses, improved key performance indicators (KPIs), and better collaboration among stakeholders.

Critical Thinking and the Learning ProcessTo improve one’s critical thinking skills, one must focus on learn-ing and be open to new ways of doing things. Research has shown that traditional learning occurs when a student reads a textbook and listens to lectures focused on the instructor rather than the student.6 This is an example of passive learning. Also, in passive

learning, the student is required to read specific chapters and research articles in preparation for a quiz. In contrast, using the assigned materials as the starting point for a research project is an active form of learning that helps solidify the information studied. Active learning methods are more successful than pas-sive methods. Learning environments in all disciplines, including medical education, are moving toward active learning models.7

Bloom’s taxonomy categorizes levels of learning from low to high. The active learning model aims to move learning from recall, un-derstanding, and application—forms of lower-order thinking—to analysis, evaluation, and creation—higher-order thinking. The typ-ical CDI trainee may begin practicing at the knowledge level, learn-ing and recalling the basic concepts of CDI as they are introduced by managers and during training. The trainee may enter the job from a college or university program or from another healthcare job within the current facility. Understanding, the next step, oc-curs as the CDI trainee begins the case review process while being shadowed by the trainer. The CDI trainee moves to the application level as he or she applies the knowledge of CDI and the case re-view process to identify opportunities for queries based on clinical indicators, knowledge, or medical necessity guidelines and quality measures. The analysis step occurs when the CDI trainee reviews metrics on query, response, and agreement rates to determine gaps for specific providers. Evaluation is demonstrated when the CDI trainee reviews the clinical documentation process for pro-viders with response and agreement gaps. During this root cause analysis, the CDI trainee determines the reason why the provider has not responded or agreed at the expected rate. During the eval-uation stage, the CDI trainee must collaborate with the providers and staff to develop a new workflow that corrects the problem. The highest level of thinking, which occurs during the creation state, takes place when the CDI practitioner, who is no longer a trainee, has become a subject matter expert and presents findings and so-lutions to the CDI manager and taskforce. These solutions typically can be used to assist other practitioners to improve KPI metrics, provider adoption, and provider collaboration. ¢

Notes 1. Tyczkowski, Brenda. “New Health Information Management

(HIM) Competencies? Teaching Critical Thinking Using An Unfolding Case Study.” Educational Perspectives In Health Information Management, 1-8. 2015.

2. Ibid. 3. Hess, Pamela Carroll. Clinical Documentation Improve-

ment: Principles and Practice. Chicago: AHIMA Press, 2017. 4. Alfaro-LeFevre, Rosalinda. “What Are Critical Thinking,

Clinical Reasoning, and Clinical Judgment?” In Critical Thinking, Clinical Reasoning, and Clinical Judgment: A Practical Approach, 1-22. St. Louis, MO: Elsevier, 2016.

5. Ibid. 6. Tyczkowski, Brenda. “New Health Information Management

(HIM) Competencies? Teaching Critical Thinking Using An Unfolding Case Study.”

7. Frieden, J. “Changing Face of Medical Education: It’s All About the System.” Medpage Today. https://www.med-pagetoday.com/PublicHealthPolicy/MedicalEduca-tion/52990.

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TTHE AMERICAN HOSPITAL Association’s Coding Clinic pub-lishes valuable advice and guidance for coding professionals, but can coding professionals learn even more from this publication? What could coding professionals gain if Coding Clinic entries were summarized over a period of time? Using a data analytics approach to evaluate the advice published in Coding Clinic can provide actionable information for coding professionals.

In preparation for the transition to ICD-10-PCS, Coding Clinic began including ICD-10-PCS advice in the Fourth Quarter 2012 issue. Since then, there have been numerous “Ask the Editor” questions about PCS coding. For the purposes of this article, all clinical scenarios published in Coding Clinic from the Fourth Quarter 2012 issue to the Fourth Quarter 2018 issue that con-tained ICD-10-PCS codes were cataloged. Data was cataloged by PCS section, body system, root operation, and PCS code. Our study included codes in the Medical and Surgical section of ICD-10-PCS.

Coding scenario topics published in Coding Clinic tend to be sit-uations that require advanced advice or situations that have been queried by multiple coding professionals. These complex queries represent challenging coding cases. In order to compare topics and coding scenarios presented in Coding Clinic to actual procedure reporting, the author utilized the 2016 Medicare Claims Data IPPS Standard Analytical File. This data set contains Medicare inpatient claims data from January 2016 to December 2016. Using claims data helps to determine if the codes included in Coding Clinic also have significant volume in actual coding practice.

The top five body systems included in Coding Clinic coding scenarios are:

1. Heart and Great Vessels (02)2. Subcutaneous Tissue and Fascia (0J)3. Gastrointestinal System (0D)4. Lower Arteries (04)5. Central Nervous System and Cranial Nerves (00)

Two out of the five top Coding Clinic body systems are also in-cluded in the top five body systems in claims data, which include:

1. Gastrointestinal System (0D)2. Heart and Great Vessels (02)3. Lower Joints (0S)4. Respiratory System (0B)5. General Anatomical Regions (0W)

Correlation was used to examine the relationship between claim volume and Coding Clinic scenario volume, with the assistance of the Spearman Rank Correlation Coefficient, which is based on the rank of the body system volume in both the claims and scenario data. Rank is a robust data tool that eliminates the influence of high and low outliers. The correlation for this study is 0.73, which is a very strong result as shown in Figure 1 on page 37.

Correlation ranges from -1 to +1. A result of +1 means that all points line up on the trend line with a positive slope (uphill). A result of -1 means that all points line up on the trend line with a negative slope (downhill). In Figure 1, the Anatomical Regions, General body system (0W) is directly on the trend line. This is the body system with the greatest correlation between Cod-ing Clinic and claim volume. The Central Nervous System and

Evaluating Clinical Scenarios in Coding Clinic with Data Analytics By Anne Casto, RHIA, CCS

Coding Notes

Continued on page 42


Coding Notes

Figure 1: Relationship Between Claim Rank and Coding Clinic Rank

Table 1: Top Root Operations for Gastrointestinal System (0D)

Table 1: Top Root Operations for Heart and Great Vessels (02)

Gastrointestinal System Rank in Claims Data

Root Operation in Gastroin-testinal System Claims Data



1 Excision 40%

2 Inspection 20%

3 Insertion 8%

4 Resection 7%

5 Release 6%

Percent of Total Body System Codes 81%

Heart and Great Vessels Rank in Claims Data

Root Operation in Heart and Great Vessels Claims Data

% of Body System Codes Root Operation in AHA Coding Clinic®

1 Insertion 59%

2 Dilation 14%

3 Replacement 10%

4 Bypass 5%

5 Destruction 2%

Percent of Total Body System Codes 90%


AAS HEALTHCARE ORGANIZATIONS strive for continuous ef-ficiency and sustainability, mergers and acquisitions (M&A)among diverse medical facilities provides organizations new opportunities to reduce costs and generate a larger footprint in both current and new markets. The trend of consolidation be-tween healthcare systems and physician practices is continuing at a rapid pace. According to recent data compiled by Avalere Health and the Physicians Advocacy Institute (PAI), hospitals acquired 8,000 medical practices from July 2016 to January 2018 while 14,000 physicians left private practice to enter into em-ployment agreements with hospitals during that time.

As this trend continues, health information management (HIM) departments continue to acquire new coding professionals and additional coding responsibilities. However, some healthcare sys-tems may lack resources to take over additional workloads that re-sult from an acquisition. Such a transition may necessitate profes-sional pro-fee coding, which is significantly different than facility coding. In addition, it is important to implement a coding quality improvement plan for the pro-fee side of newly acquired responsi-bilities as a result of M&A activities.

The coding quality improvement plan consists of five main pillars: � Quality audits � Coder mentoring � Coding support � Coding education programs � Coding policies and guidelines standardization

Quality AuditsOnce an acquisition has occurred, it is vital to conduct an ini-

tial and subsequent periodic quality audits for coding accuracy. While each organization conducts quality audits in different in-tervals, it is recommended that the coding professionals’ accura-cy information be captured, measured, and analyzed as soon as possible after the acquisition and then on a quarterly basis. Doc-umentation must be reviewed to ensure adequate support for the reported ICD-10-CM diagnosis codes and CPT procedure codes. Detailed reports need to be provided with individual encounters per coder or provider as well as accuracy rates. These reports should include any recommended code changes for coder, pro-vider, and supervisor vetting. Meetings with the physician group managers to discuss trends for action plans, including potential physician education regarding documentation, additional tools needed for coding professional support, transition of products for edits, coding policy documentation, and more are essential to this process. It is important to note that the pro-fee coders may never have experienced a coding audit, so taking the time to ex-plain the entire plan to them is essential to success.

Coder MentoringIf any of the coding professionals do not meet the 95 percent accuracy rate on the quality audit, then progressing quickly to the coding professional mentoring program is a valuable piece of a coding quality improvement plan. The main objective is to perform concurrent secondary reviews to enhance the physician group pro-fee coders’ knowledge, according to pre-approved criteria, in order to correctly code/bill the encounter. This pro-cess also will identify cases that need further training, education, one-on-one coaching, additional tools, and support from coding

Coding Quality Improvement Plan Implementation for Hospital-Acquired Physician GroupsBy Karen Youmans, MPA, RHIA, CCS, and Vanessa Youmans, MA, RHIA, CCS, CPC

Coding Notes


Coding Notes

professionals. Pro-fee coders may not have been provided with constructive feedback in the past, so providing them some men-toring time will be essential to the success of both the pro-fee coder and the merged healthcare system. In addition, training on various coding tools (e.g., encoders, NCCI manual, NCCI ed-its, coding references, etc.) may be needed.

Coding SupportThe coding support pillar of a coding quality improvement plan should include a question queue serving physician group pro-fee coders for questions that may arise during their day-to-day operations. Results from coding support can be gathered and implemented in tailored education programs and one-on-one coaching meetings for the physician group pro-fee coders. More complex providers or specialty groups may need to be transitioned to a more experienced pro-fee coder until a transi-tion plan can be developed to bring that complex specialty cod-ing back to a physician group pro-fee coder. This transition plan can include additional education and training for the selected pro-fee coders. Coding support may also include ongoing dia-logue discussions with physicians and surgeons. This should encompass coding management involvement to answer any questions from physicians and pro-fee coders. Conference calls may need to be scheduled for continual physician and coding professional feedback.

Coding Education ProgramsThe fourth pillar is implementing a coding education program. Many of the pro-fee coders may not have had the previous op-portunity to be cross-trained in various specialties. They may not have any formal training in the specialty they currently code. In addition, provider specialty-specific coding educational pro-grams may need to be developed. The educational program takes the physician group pro-fee coders through a re-review of medi-cal terminology, anatomy and physiology, ICD-10-CM diagnoses, and CPT procedural coding for each specialty (e.g., orthopedics, neurosurgery, cardiovascular, general surgery, etc.). A compre-hensive education program should include lectures, conference calls, webinars, homework assignments, periodic review of ICD-10-CM and CPT coding guidelines, example exercise completion, online quizzes, comprehension testing, and a final exam.

Coding Policies and Guidelines Standardization It is not uncommon to find that there are very few, if any, writ-ten coding policies for acquired physician groups or that the cod-ing policies differ from specialty to specialty. When a healthcare system acquires new pro-fee coders and additional coding re-sponsibilities, coding managers should begin to gather any and all formal and informal written coding policies and guidelines. Within the coding quality improvement plan, it is imperative to standardize the coding policies and to align them with all official coding guidelines and your internal healthcare system compliant coding guidelines and policies. For example, for pro-fee coding, is it appropriate to code diagnoses from the admitting history and physical performed the day before the actual surgery? Or are the diagnoses codes for the pro-fee surgery only to be taken from the

operative report and pathology report? A standardization of the coding policies and guidelines will be crucial for both the pro-fee coder and the auditors. One important tool resulting from a cod-ing quality improvement plan could be the implementation of a pro-fee coding handbook. A transition plan can be created by the coding management team with the objective of presenting a documented structure for the physician group pro-fee coders to benefit from a successful knowledge transfer and more consistent coding practices, while maintaining high coding accuracy rates.

Addressing Unique ChallengesM&A activity in physician groups will continue to increase. This can expand a provider's footprint in the market. Identifying the new, unique challenges that result from all this change, and then tailoring steps to address them, is imperative to the qual-ity of medical coding and its impact on a healthcare facility’s bottom line.

The best approach to addressing these challenges involves assessing and developing a plan with a holistic approach that positively impacts coding quality on an enterprise level. This ap-proach requires an objective team with high accuracy rates and a high level of expertise in the pro-fee coding, and proven experi-ence in coder mentoring and education. A few recommendations and considerations on the practical side are also important:

� Recognize the differences between facility CPT coding versus pro-fee CPT coding

� Acknowledge the importance of interaction between cod-ers and providers

� Assess pro-fee coders’ experience and expertise � Provide education to providers and coders � Standardize guidelines and procedures � Measure performance for continuous improvement ¢

ReferencesPhysicians Advocacy Institute. “Updated Physician Practice

Acquisition Study: National and Regional Changes in Physician Employment 2012-2018.” February 2019.http://www.physiciansadvocacyinstitute.org/Portals/0/assets/docs/021919-Avalere-PAI-Physician-Employment-Trends-Study-2018-Update.pdf?ver=2019-02-19-162735-117.

Karen Youmans (kyoumans@yes-himconsulting,com) is president/CEO,

and Vanessa Youmans ([email protected]) is director

OP/ProFee coding and auditing division of YES HIM Consulting, Inc.

Journal of AHIMA Continuing Education QuizQuiz ID: Q1939009 | EXPIRATION DATE: OCTOBER 1, 2020HIM Domain Area: Clinical Data Management Article—“Coding Quality Improvement Plan Implementation for Hospital-Acquired Physician Groups”



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ahima.org/grace1108.18© 2019 AHIMA

Congratulations!Hospital SistersHealth System

Eastern Wisconsin Division

G W MAWARD WINNER

2019

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AHIMA Annual Conference

Keep Informed Resources and News from AHIMA

Learn Clinical Documentation Improvement Best PracticesDecember 2-4, Long Beach, CAThe Inpatient and Outpatient Clinical Documenta-tion Improvement (CDI) Academy offers best prac-tices through real-life examples and exercises. The CDI Academy reviews key coding guidelines of prin-cipal/primary and secondary diagnoses, examines opportunities for CDI in the outpatient setting, and highlights the impact of coded data on secondary data uses such as meaningful use incentives, qual-ity measures, and public health reporting. Register at ahima.org/cdiacademy.

Privacy and Security Training and CHPS Exam PrepDecember 2-4, Long Beach, CAThe Privacy and Security Training and CHPS Exam Prep offers an in-depth review of HIPAA and HI-TECH omnibus rules and helps attendees prepare to sit for the CHPS exam. Register at ahima.org/ events/2019privacysecuritytrainingchpsexamprep.

OCTOBER28–30 ICD-10-CM/PCS Trainer Academy 2.0, Chicago, IL

UPCOMING INSTITUTES, SEMINARS, WORKSHOPS, AND WEBINARSNovember 13–15

ICD-10-CM/PCS Trainer Academy 2.0, Baltimore, MD

December 2–4

Inpatient and Outpatient Clinical Documentation Improvement (CDI) Academy, Long Beach, CA

December 2–4

Privacy and Security Training with CHPS Exam Prep, Long Beach, CA

December 2–4

ICD-10-CM/PCS Trainer Academy 2.0, Long Beach, CA

Check www.ahima.org/events for the latest schedule of institutes, seminars, and workshops.

A Look AheadUpcoming AHIMA Institutes, Seminars, Workshops, and Webinars

2021 Houston, TXSeptember 18-22

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AHIMA ...... inside front cover, 1, 12, 40, inside back cover

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Advertising IndexAHIMA Thanks Its Loyalty Program Members

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The AHIMA Loyalty Program offers organizations the opportu-nity to better align their marketing outreach with AHIMA’s print, content, and information channels while delivering year-long ex-posure to AHIMA’s 103,000+ health information professionals.

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Jeff Rhodes, 410-584-1940, [email protected]

Cranial Nerves body system (00) does not have much correla-tion—though it is heavily represented in Coding Clinic, it does not have a high volume of claims data. Overall, the correlation value of 0.73 for this study reveals that the coding scenarios published in Coding Clinic are not obscure scenarios that are unlikely to appear in “real life.” Rather, the advice is relevant to coding professionals’ performance because there is also signifi-cant volume in the claims data.

The next step in the analysis was to drill down to the root oper-ation level. Table 1 and Table 2 on page 37 show the top root op-erations for Gastrointestinal System (0D) and Heart and Great Vessels (02) as reported in Medicare claims data.

There are a few interesting data points in this analysis. First, the top five root operations account for 81 percent of all Gas-trointestinal System procedures and 90 percent of all Heart and Great Vessels procedures. This means that coding professionals are often using these root operations in practice. Second, for each body system, three of the five root operations have significant vol-ume in the Coding Clinic scenarios. Coding professionals should review past issues of Coding Clinic and ensure they fully under-stand the advice provided for these body systems and root opera-tions. Additionally, coding managers should consider monitoring and auditing PCS coding in these areas as they could be high-vol-ume, high-risk areas at their facility. Likewise, managers should provide coding professionals with continuing education hours for these root operations. Lastly, educators must ensure that stu-dents are given ample opportunities to practice coding these root operations in ICD-10-PCS courses.

The other top three body systems showed similar results as noted in the Gastrointestinal System and Heart and Great Ves-sels. Three to four of the top root operations for each body sys-tem also had significant presence in Coding Clinic. This analysis is merely the tip of the iceberg. Overall, this study shows that Coding Clinic provides a rich data set that can be used to iden-tify areas of coding risk, beginner and advanced education, and professional development.

Anne Casto ([email protected]) is lecturer, HIMS division, School of Health

and Rehabilitation Sciences at Ohio State University.

Continued from page 36 (“Evaluating Clinical Scenarios in Coding Clinic with Data Analytics ”)

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Security risk factors to take into account when developing se-curity risk models include:

� Threat � Vulnerability � Likelihood � Impact

Privacy Risk Model The NIST Privacy Risk Model is focused on authorized pro-cessing (planned and permissable) of personally identifiable information (PII) and protected health information (PHI) that creates a privacy risk, which impacts predictability, manage-ability, and disassociability. NIST introduced the concept of privacy risk in a report titled “An Introduction to Privacy En-gineering and Risk Management in Federal Systems.”8 The re-port proposes the idea of a “PMD” Privacy Triad focusing on predictability, manageability, and disassociability:

� Predictability: Enabling reliable assumptions by indi-viduals, owners, and operators about PII/PHI and its pro-cessing by an information system

� Manageability: Providing the capability for granular ad-ministration of PII including alteration, deletion, and se-lective disclosure

� Disassociability: Enabling the processing of PII or events without association to individuals or devices beyond the operations requirements of the system

Privacy risk factors to take into account when developing pri-vacy risk models include:

� Likelihood � Problematic data action � Impact

Problematic data actions are issues caused by authorized processing of PII/PHI. These problems may be less visible than a security event or not as well understood but can re-sult in real consequences. NIST describes them as rang-ing from dignity-type losses—embarrassment, stigmas, or discrimination—to more tangible harms such as economic loss or physical harm.9 The Privacy Framework identifies nine problematic data actions:

1. Appropriation2. Distortion3. Induced disclosure4. Insecurity5. Reidentification6. Stigmatization7. Surveillance8. Unanticipated revelation9. Unwarranted restriction

A Powerful Tool for HIMApplication of NIST’s extensive work concerning security

and privacy risk management into the Privacy Framework has created a powerful tool for health information manage-ment. Privacy experts understand data security and data privacy are not the same but share many objectives. Both are required for comprehensive data security. The NIST Pri-vacy Framework methodology of assessing privacy with a risk-based and outcome-based approach, in alignment with the NIST CSF, will allow healthcare entities to align privacy and security while incorporating interoperability and pa-tient access requirements. ¢

Notes 1. National Institute of Standards and Technology. Privacy

Framework. https://www.nist.gov/privacy-framework. 2. Centers for Disease Control and Prevention. “Public

Health and Promoting Interoperability Programs (former-ly known as Electronic Health Records Meaningful Use).” Last accessed 8/9/19. https://www.cdc.gov/ehrmeaning-fuluse/introduction.html.

3. Centers for Medicare and Medicaid Services. “Promoting Interoperability (PI).” Last accessed 8/9/19. https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIn-centivePrograms/index.html.

4. Department of Homeland Security. “Privacy Policy Guid-ance Memorandum.” Last accessed 8/10/19. https://www.dhs.gov/sites/default/files/publications/privacy_poli-cyguide_2008-01_0.pdf.

5. Office of the National Coordinator for Health Informa-tion Technology, U.S. Department of Health and Human Services. “Nationwide Privacy and Security Framework for Electronic Exchange of Individually Identifiable Health Information.” Last accessed 8/10/19. https://www.healthit.gov/sites/default/files/nationwide-ps-framework-5.pdf.

6. Office of the National Coordinator for Health Information Technology, “Guide to Privacy and Security of Electronic Health Information.” Last accessed 8/10/19. https://www.healthit.gov/sites/default/files/pdf/privacy/privacy-and-security-guide.pdf.

7. National Institute of Standards and Technology. “Frame-work for Improving Critical Infrastructure Cybersecurity Version 1.1.” Last accessed 8/10/19. https://nvlpubs.nist.gov/nistpubs/CSWP/NIST.CSWP.04162018.pdf.

8. National Institute of Standards and Technology. “NISTIR 8062, An Introduction to Privacy Engineering and Risk Man-agement in Federal Systems.” Last accessed 8/10/19. https://nvlpubs.nist.gov/nistpubs/ir/2017/NIST.IR.8062.pdf.

9. National Institute of Standards and Technology. “Privacy Risk Assessment Methodology (PRAM), update released 2019, Catalog of Problematic Data Actions and Problems.” ZIP file download. Last accessed 8/10/19.https://www.nist.gov/itl/applied-cybersecurity/privacy-engineering/resources.

Karen Starling Greenhalgh ([email protected]) is founder and man-

aging principal of Cyber Tygr.

Continued from page 33 (“NIST Privacy Framework: Protecting Privacy While Promoting Interoperability”)

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IN THE FILM THE Farewell, Chinese-American actress and comedian Awkwafina plays a woman torn between two cultural approaches to death and dying when her character, Billi, learns that her grandmother has terminal lung can-cer. Billi's grief is compounded when she learns that her family does not intend to tell her grandmother Nai Nai about the diagnosis—a common practice in China, where frank discussions about death are still taboo.

The film is based on a true story from director Lulu Wang’s own experience, which she described on episode 585 of the NPR program This American Life. Like Billi, Wang moved with her parents to the United States from China as a young child and grew to embrace the American healthcare norm of giving patients complete information about their medical condition. In the film, Nai Nai’s doctors perpetuate the cycle of misinformation, telling her that she’s suffering the effects of pneumonia, while sharing the true information with her family members. In one scene, Nai Nai’s extended family races to intercept the release of a damning CT scan report and convinces the radiologist to change mentions of “malignant tumors” to “benign shadows.”

Billi and other more Westernized family members in the movie acknowledge that what they’re asking doctors to do would be illegal in the US, which further advances Billi’s perception that she’s complicit in deception. Indeed, HIPAA’s right to access clause would require that Nai Nai be the only one to read her test results unless otherwise designated—and no ethical physician would knowingly change his or her diagnosis at a family member’s request. Access to one’s own medical information and the empowerment that comes with that was one of the driving fac-tors behind HIPAA’s creation and is one of the cornerstones of the HIM profession. Yet, as recent analyses on this part of the law have revealed, providers still struggle with right of access compliance.

The Farewell smartly avoids judgment about which response to death is morally right or wrong. Instead, it em-phasizes the different ways love is expressed and how that transcends borders and culture. ¢

‘The Farewell’ Offers Insights into HIPAA’s Right to AccessBy Mary Butler

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Privacy and Security Training with CHPS Exam Prep Workshop

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Reputation is everything. That’s why HIM leaders across the nation’s best health systems trust and rely on MRO’s

KLAS-rated #1 Release of Information services and team of renowned experts. Not only do we have a superior

reputation for personalized service and quality, we also work closely with clients to make sure they do too.

Together, we respond to increasing PHI disclosure volume and compliance demands. Through a combination of

the right people and innovative technology solutions, MRO enables clients to deliver high levels of quality, fast

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Gain peace of mind and more time back in your day by partnering with the team that has a proven track record for

excellence. Moira Washington is just one of the many expert resources you get when partnering with MRO.

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Operations. She is one of MRO’s exceptional leaders

overseeing operations at MRO-staffed client sites.

With a passion for delivering high levels of quality

and superior customer service to clients, patients and

other requesters of medical records, Moira and our

Client Operations leadership team manage highly

vetted, trained and professional ROI specialists in HIM

departments across the nation.

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Close Doesn’t Count€¦ · Contents October 2019 14 Close Doesn’t Count: Patient Matching...

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