CMS Pulls The Trigger on COPD

In Fiscal Year 2015

Patrick J. Dunne, MEd, RRT, FAARC

HealthCare Productions, Inc.

Fullerton, CA 92838

pjdunne@sbcglobal.net

2014 Annual Conference & Exhibits March 3-4, 2014 Birmingham AL

Disclosure

I have a professional relationship with

Monaghan Medical Corporation

Mylan LP

Ohio Medical Corporation

Objectives

Review the provisions / timelines of Medicare’s Hospital Readmission Reduction Program;

List the clinical and economic impact of COPD and associated comorbidities;

List the evidence-based care guidelines for the inpatient treatment of a COPD exacerbation, and

Describe potential strategies to help reduce all-cause 30-day COPD readmissions.

Hospital Readmission Reduction ProgramSection 3025 Affordable Care Act

Effective FY 2013 (10/1/12 - 9/30/13)

2nd of 2 new payment policies

Financial penalties for excessive 30-day readmissions

3 Targeted conditions Acute MI (19.9%); CHF (24.5%); Pneumonia (18.2%)

Additional conditions to be added in FY 2015

Hospitals identified nationwide

FY 2013 - - 2,213 hospitals w/ $280 million in penalties (up to 1%)

FY 2014 - - 2,225 hospitals w/ $227 million in penalties (up to 2%)

FY 2015 - - Penalty up to 3% of total Medicare payments

Page 113: “We believe the COPD

measure warrants inclusion in

the Hospital Readmission

Reduction Program for FY 2015”

Fiscal Year 2015

October 1, 2014 – September 30, 2015

Index Years:

July 1, 2010 – June 30, 2011

July 1, 2011 – June 30, 2012

July 1, 2012 – June 30, 2013

Penalty in FY 2015:

Up to 3% of Medicare payments

Now, About COPD . . . .

Definition: A progressive, inflammatory chronic disease characterized by

increasing airflow obstruction coupled with destruction of

pulmonary gas exchange areas. There are clinically relevant

extra-pulmonary effects secondary to systemic inflammation

Prevalence is increasing; 3rd Leading cause of death

Airflow obstruction/alveolar destruction largely irreversible

Primary cause: Long-term exposure to noxious inhalants

A largely preventable disease

Fourth leading cause of recidivism

Risk Factors for COPD

Socio-economic status

© 2013 Global Initiative for Chronic Obstructive Lung Disease

Genes

Infections

Aging Populations

Cardiovascular Disease

Lung Cancer

Anxiety, Depression, Addiction

Peripheral Muscle Wasting & Dysfunction

Osteoporosis

Cachexia

Peptic UlcersGI Complications

Anemia

Pulmonary Hypertension

DiabetesMetabolic Syndrome

Adapted from Kao C, Hanania NA. Atlas of COPD. 2008.

COPD is a Multisystem Disease

COPD Comorbidities

COPDOpportunities for Improvement

Unplanned re-admissions are costly

30 day re-admits largely preventable

COPD evidence-based care guidelines exist

For both in-patient (exacerbation) and out-patient (Sx control)

Use of evidence-based care guidelines is low

Currently, care outcomes less than optimal

Growing concern over high recidivism rate

Under-treatment of COPD

Record review: 553 pts. discharged with Dx of COPD Darmella W, et al. Respir Care; October 2006

Only 31% had confirmatory spirometry

We must raise awareness of the need to confirm the diagnosis of COPD and it’s severity with spirometry

Record review: 169 pts. with 1,664 care events

Mularski RW, et al. Chest; December 2006

Subjects received 55% of recommended care; Only 30% with base-line hypoxemia received LTOT

The deficits and variability in processes of care for patients with obstructive lung disease presents ample opportunity

for improvement

Inpatient COPD Care: The EvidenceMcCrory DC, et al. Chest; 2001

EFFICACY EVIDENCE EXISTS EFFICACY EVIDENCE LACKING

Chest radiography/ABGs Sputum analysis

Oxygen therapy Acute spirometry

Bronchodilator therapy Mucolytic agents

Systemic steroids Chest physiotherapy

Antibiotics Methylxanthine bronchodilators

Ventilatory support (as required) Leukotrine modifiers; Mast cell stablizers

Level 1-2 evidence of efficacy = Recommended care

Insufficient efficacy evidence = Non-recommended care

Non-recommended care = Unnecessary care

Under-treatment of COPD

Record review: 69,820 records from 360 hospitals Lindenauer PK, et al. Ann Intern Med; June 2006

66% received all of recommended care; 45% received at least one non-recommended care; Only 30% received Ideal Care

We identified widespread opportunities to improve quality of care and to reduce costs by addressing problems of underuse, overuse and

misuse of resources, and by reducing variation in practice

Claims data review: 42,565 commercial, 8,507 Medicare Make B, et al. Int J Chron Obstruct Pulmon Dis; January 2012

No pharmacotherapy – 60% commercial, 70% Medicare No smoking cessation – 82% commercial, 90% Medicare No influenza vaccination – 83% commercial, 76% Medicare

This study highlights a high degree of undertreatment of COPD, with most patients receiving no maintenance pharmacotherapy

or influenza vaccination

Under-treatment of COPD: Summary

COPD - an expensive, chronic condition

Incidence is increasing

Financial liability is escalating

Diagnostic spirometry is woefully under-used

Use of evidence-based treatment guidelines is low

Failure to control symptoms a precursor to exacerbations

COPD hospital re-admissions are largely preventable

Chronic disease management strategies a necessity

• FEV1/FVC < 0.70

• FEV1 ≥ 80% predicted

• FEV1/FVC < 0.70

• 50% ≤ FEV1 < 80% predicted

• FEV1/FVC < 0.70

• 30% ≤ FEV1 < 50% predicted

• FEV1/FVC < 0.70

• FEV1 < 30% predicted or FEV1 < 50% predicted plus chronic respiratory failure

Add regular treatment with long-acting bronchodilators; Begin Pulmonary Rehabilitation

Add inhaled glucocorticosteroids if repeated acute exacerbations

Add LTOT for chronic hypoxemia.Consider surgical options

III: Severe

I: MildII: Moderate

IV: Very Severe

Active reduction of risk factor(s); smoking cessation, flu vaccination

Add short-acting bronchodilator (as needed)

GOLD GuidelinesPre-2013

Combined Assessment of COPDGOLD Guidelines (2013)

Risk

GOLD Classification of Airflow Limitation

Risk

Exacerbation history

≥ 2

1

0

(C) (D)

(A) (B)

mMRC 0-1 (or) CAT < 10

4

3

2

1

mMRC > 2 (or) CAT > 10

Symptoms(mMRC or CAT score)

Left (or) Right - - - Up (or) Down

Fewer MoreSymptoms Symptoms

> 2 exacerbations

0-1 exacerbations

Combined Assessment of COPDGOLD Guidelines (2013)

Risk

GOLD Classification of Airflow Limitation

Risk

Exacerbation history

≥ 2

1

0

(C) (D)

(A) (B)

mMRC 0-1 (or) CAT < 10

4

3

2

1

mMRC > 2 (or) CAT > 10

Symptoms(mMRC or CAT score)

Modified British Medical Research Council (mMRC) Dyspnea Questionnaire:

A 5-item measure of perceived dyspneaSelf-report on grade 0 – 5

(or)

COPD Assessment Test (CAT):

An 8-item measure of health status impairment in COPDSelf-report on scale 0 – 5

Assessment of SymptomsGOLD Guidelines (2013)

Both have been validated and relate well to other measures of

health status and predict future mortality risk.

Modified MRC (mMRC) QuestionnaireGOLD Guidelines (2013)

COPD Assessment Test (CAT)GOLD Guidelines (2013)

COPD Assessment Test (CAT)GOLD Guidelines (2013)

Combined Assessment of COPDGlobal Strategy for Diagnosis, Management and Prevention of COPD

Risk Pre-2013 GOLD Classification of

Airflow Limitation

Risk

Exacerbation history

≥ 2

1

0

(C) (D)

(A) (B)

mMRC 0-1 (or) CAT < 10

4<30%

3 30-50%

1≥ 80%

mMRC > 2 (or) CAT > 10

Symptoms(mMRC or CAT score)

2 50-80%

Patient Characteristics Spirometric Classification

Exacerbations per year

mMRC CAT

ALess Symptoms

Low RiskGOLD 1-2 0-1 0-1 < 10

BMore Symptoms

Low RiskGOLD 1-2 0-1 ≥ 2 ≥ 10

CLess Symptoms

High RiskGOLD 3-4 ≥ 2 0-1 < 10

DMore Symptoms

High RiskGOLD 3-4 ≥ 2 ≥ 2 ≥ 10

Combined Assessment of COPDGOLD Guidelines (2013)

When assessing risk, choose the highest risk according to GOLD grade or

exacerbation history

COPD Maintenance Treatment by Airflow Limitation/RiskGOLD Guidelines (2013)

Inpatient COPD Care: The EvidenceMcCrory DC, et al. Chest; 2001

EFFICACY EVIDENCE EXISTS EFFICACY EVIDENCE LACKING

Chest radiography/ABGs Sputum analysis

Oxygen therapy Acute spirometry

Bronchodilator therapy Mucolytic agents

Systemic steroids Chest physiotherapy

Antibiotics Methylxanthine bronchodilators

Ventilatory support (as required) Leukotrine modifiers; Mast cell stablizers

Acute Spirometry with COPD Exacerbation Isn’t spirometry needed to Confirm Dx and Grade Airflow Limitation?

Acute spirometry

Hospitalized patients not ready for full PFT studies

Unable to exert maximal effort; Repeat maneuvers Pre-post bronchodilator response of limited value

Make appointment for 4-6 weeks post recovery

What about peak inspiratory flow?

Not a demanding test but insightful Ability to use a DPI

Generate ≥ 40 L/min PIF

Secretion Retention with COPD ExacerbationCan Contribute to Airflow Obstruction; WOB

Chest physiotherapy

An airway clearance technique (ACT)

Secretion retention, ineffective cough problematic

Trendelenburg position contraindicated in COPD

Proven alternate ACT techniques in use for CF

ACBT, AD, HFCWO, IPV, OPEP

Which to consider for COPD? OPEP Rx a viable regimen

Inexpensive, non-invasive Alone or in combo with SVN

Airway Clearance Therapy: The EvidenceRESPIRATORY CARE: December 2013

ACT is not recommended for routine use in COPD.

ACT may be considered in COPD patients with symptomatic secretion retention.

Medication NebulizersNot all jet-nebulizers are created equal!

Higher respirable dose = Quicker onset of action!

Higher respirable dose = Shorter treatment times!

Quicker onset/less time = Better RT deployment!

Respirable Dose 10% Respirable Dose 30%Respirable Dose 15%

Dynamichyperinflation

Dynamic Hyperinflation

Breath Actuated Nebulizer in COPDHaynes J. Respir Care; Sept 2012

Prospective, randomized controlled trial

Objective: compare bronchodilator response w/ BAN to standard SVN

Patients admitted w/ COPD exacerbation N = 40 of 46; Similar baseline characteristics

Dyspnea secondary to dynamic hyperinflation

Medication regimen 2.5 mg albuterol/0.5 mg ipratropium (3 mL) Q4H

2.5 albuterol Q2H prn

Common adverse effects monitored during/after each Rx

Data collected 2 hrs post 6th scheduled Rx (collector blinded) Inspiratory capacity; dyspnea; RR

Breath Actuated Nebulizer in COPDHaynes J. Respir Care; Sept 2012

Findings: Both groups received same # Rxs (6.25; 6.20)

IC higher in BAN v. SVN (1.83 L v. 1.42 L; P .03) Change in IC greater BAN v. SVN

RR lower in BAN v. SVN (19/min v. 22/min; P = .03)

No difference in BORG or LOS

Breath Actuated Nebulizer in COPDHaynes J. Respir Care; Sept 2012

Conclusions:

In this cohort of patients with ECOPD, the AeroEclipse II BAN was

more effective in reducing lung hyperinflation and respiratory rate

than traditional SVN.

It may be that the BAN group simply received more medication

because of the breath activated mode…Aerosols with MMAD of

3.0 μm produce the highest physiological response in terms of

FEV1 and airway conductance.

Role of Nebulized Therapy in COPDDhand R, et al. COPD; Feb 2012

RECOMMENDATION: Many patients, especially elderly patients

with COPD, are unable to use their pMDIs and DPIs in an optimal

manner. For such patients, nebulizers should be employed on

a domiciliary basis. . .

Nebulizers are more forgiving to poor inhalation technique,

especially poor coordination with pMDIs and the requirement to

generate adequate peak inspiratory flows with DPIs.

Ease of use; simple technique

Addresses inconvenience issue

Effective and reliable drug delivery

Use not limited by disease severity or mental acuity

Device & medications covered under Medicare Part B

Nebulized Therapy at Home

Managing Stable COPD Goals of Therapy

Relieve airflow obstruction

Improve exercise tolerance Reduce symptoms

Improve health status

Prevent disease progression

Prevent & treat exacerbations Reduce risk

Reduce mortality

Reduced symptoms + Reduced risk = Successful disease management

Improving COPD Care OutcomesSummary

A new COPD care pathway essential COPD patients will impact hospital’s revenue Patient volume will vary by institution (1-2/month to 6-8/month)

Advocate evidence-base care Re-design current workload Allocate resources accordingly

Start small; Expand as necessary Appoint, anoint, elect one departmental COPD Guru Let patient volume drive program development

Determine risk grade per 2013 GOLD Guidelines Use CAT (or) mMRC Ensure proper controller medications prescribed Recommend follow-up MD appointment within 5-7 days

New CMS Payment ModelsSummary

Two distinct programs Value-based Purchasing Program (VBP)

Bonus payment (or) penalty Based on Core Performance Measures reported for:

• AMI, CHF, Pneumonia

Hospital Readmission Reduction Program (HRRP) Penalty only Based on historic readmission rates for:

• AMI, CHF, Pneumonia

Additional conditions to be added in FY 2015 COPD for HRRP COPD Core Performance Measures coming for VBP?

Domain of Likely COPD Performance MeasuresTimely and Effective Care

Documented evidence in medical record of:

Smoking cessation (discussed at every visit)

Spirometry (within past 2-3 yrs.)

Bronchodilator therapy (LABA vs. SABA-only)

Immunizations (pneumococcal, influenza)

Performance measures tied to bonus or penalty payments

Already required under Physician Quality Reporting System (PQRS)

Demonstrate your value Help your hospital achieve bonus payments!!!!

AARC Resources

CMS Pulls The Trigger on COPD

In Fiscal Year 2015

Patrick J. Dunne, MEd, RRT, FAARC

HealthCare Productions, Inc.

Fullerton, CA 92838

pjdunne@sbcglobal.net

2014 Annual Conference & Exhibits March 3-4 2014 Birmingham AL