CMS Pulls the Trigger on COPD in 2015

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2014 Annual Conference

&

Exhibits

March 3-4, 2014

Birmingham

AL

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

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 Program

Section 3025 Affordable Care Act

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

 2 nd 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; 3 rd 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

Genes

Infections

Socio-economic status

Aging Populations

© 2013 Global Initiative for Chronic Obstructive Lung Disease

COPD is a Multisystem Disease

Anxiety, Depression, Addiction

Lung Cancer

Pulmonary Hypertension

Anemia

Diabetes

Metabolic Syndrome

Cachexia

Cardiovascular Disease

Peripheral Muscle

Wasting & Dysfunction

Osteoporosis

Peptic Ulcers

GI Complications

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

COPD Comorbidities

COPD

Opportunities for Improvement

 Currently, care outcomes less than optimal

 Growing concern over high recidivism rate

 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

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 Evidence

McCrory DC, et al. Chest; 2001

EFFICACY EVIDENCE EXISTS

Chest radiography/ABGs

Oxygen therapy

Bronchodilator therapy

Systemic steroids

Antibiotics

Ventilatory support (as required)

EFFICACY EVIDENCE LACKING

Sputum analysis

Acute spirometry

Mucolytic agents

Chest physiotherapy

Methylxanthine bronchodilators

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

GOLD Guidelines

Pre-2013

IV: Very Severe

III: Severe

II: Moderate

I: Mild

FEV

1

/FVC < 0.70

• FEV

1

≥ 80% predicted

• FEV

1

/FVC < 0.70

• 50% ≤ FEV

1 predicted

< 80%

FEV

1

/FVC < 0.70

• 30% ≤ FEV

1 predicted

< 50%

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

Add short-acting bronchodilator (as needed)

FEV

1

/FVC < 0.70

FEV

1

< 30% predicted or FEV

1

< 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

Combined Assessment of COPD

GOLD Guidelines (2013)

4

3

Risk

GOLD Classification of Airflow Limitation 2

1

(C)

(A)

(D) ≥ 2

(B)

Risk

1

Exacerbation history

0 mMRC 0-1 (or) CAT < 10 mMRC > 2 (or) CAT >

10

Symptoms

(mMRC or CAT score )

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

Fewer

Symptoms

More

Symptoms

> 2 exacerbations

0-1 exacerbations

Combined Assessment of COPD

GOLD Guidelines (2013)

4

3

Risk

GOLD Classification of Airflow Limitation 2

1

(C)

(A)

(D) ≥ 2

(B)

Risk

1

Exacerbation history

0 mMRC 0-1 (or) CAT < 10 mMRC > 2 (or) CAT >

10

Symptoms

(mMRC or CAT score )

Assessment of Symptoms

GOLD Guidelines (2013)

 Modified British Medical Research Council (mMRC) Dyspnea

Questionnaire:

A 5-item measure of perceived dyspnea

Self-report on grade 0 – 5

(or)

 COPD Assessment Test (CAT):

An 8-item measure of health status impairment in COPD

Self-report on scale 0 – 5

Both have been validated and relate well to other measures of health status and predict future mortality risk.

Modified MRC (mMRC) Questionnaire

GOLD Guidelines (2013)

COPD Assessment Test (CAT)

GOLD Guidelines (2013)

COPD Assessment Test (CAT)

GOLD Guidelines (2013)

Combined Assessment of COPD

Global Strategy for Diagnosis, Management and Prevention of COPD

Risk

Pre-2013 GOLD

Classification of

Airflow Limitation

(C) (D) ≥ 2

3

30-50%

4

<30%

(A) (B)

1

≥ 80%

2

50-80% mMRC 0-1 (or) CAT < 10 mMRC > 2 (or) CAT > 10

Symptoms

(mMRC or CAT score )

0

Risk

1

Exacerbation history

Combined Assessment of COPD

GOLD Guidelines (2013)

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

A

B

C

D

Patient Characteristics

Less Symptoms

Low Risk

More Symptoms

Low Risk

Less Symptoms

High Risk

More Symptoms

High Risk

Spirometric

Classification

GOLD 1-2

GOLD 1-2

GOLD 3-4

Exacerbations per year mMRC

0-1

0-1

0-1

≥ 2

≥ 2 0-1

CAT

< 10

≥ 10

< 10

GOLD 3-4

≥ 2 ≥ 2 ≥ 10

COPD Maintenance Treatment by Airflow Limitation/Risk

GOLD Guidelines (2013)

FEV1

% PREDICTED

(AIRFLOW LIMITATION)

≥ 80%

50 – 80%

30 – 50%

≤ 30%

EXACERBATION

GRADE

(RISK)

LOW

MEDIUM

HIGH

VERY HIGH

TREATMENT

CONSIDERATIONS

Smoking cessation; Vaccinations; SABA prn

Add to above: Nebulized LABA-LAMA daily;

Pulm Rehab; Exacerbation action plan

Add to above: ICS for exacerbation prone;

Referral to pulmonologist

Add to above: long-term oxygen therapy;

Consider surgical options

Inpatient COPD Care: The Evidence

McCrory DC, et al. Chest; 2001

EFFICACY EVIDENCE EXISTS

Chest radiography/ABGs

Oxygen therapy

Bronchodilator therapy

Systemic steroids

Antibiotics

Ventilatory support (as required)

EFFICACY EVIDENCE LACKING

Sputum analysis

Acute spirometry

Mucolytic agents

Chest physiotherapy

Methylxanthine bronchodilators

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 valu e

 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 Exacerbation

Can 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 Evidence

R ESPIRATORY C ARE: December 2013

ACT is not recommended for routine use in COPD.

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

Medication Nebulizers

Not all jet-nebulizers are created equal!

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

Higher respirable dose = Quicker onset of action!

Higher respirable dose = Shorter treatment times!

Quicker onset/less time = Better RT deployment!

Dynamic Hyperinflation

Dynamic hyperinflation

Breath Actuated Nebulizer in COPD

Haynes 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 6 th scheduled Rx (collector blinded)

 Inspiratory capacity; dyspnea; RR

Breath Actuated Nebulizer in COPD

Haynes 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 COPD

Haynes 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

FEV

1 and airway conductance.

Role of Nebulized Therapy in COPD

Dhand R, et al. COPD; Feb 2012

RECOMMENDATION : Many patients, especially elderly patients with COPD , are unable to use their p MDIs 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 p MDIs and the requirement to generate adequate peak inspiratory flows with DPIs .

Nebulized Therapy at Home

 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

Managing Stable COPD

Goals of Therapy

 Relieve airflow obstruction

 Improve exercise tolerance

 Improve health status

Reduce symptoms

 Prevent disease progression

 Prevent & treat exacerbations Reduce risk

 Reduce mortality

Reduced symptoms + Reduced risk = Successful disease management

Improving COPD Care Outcomes

Summary

 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 Models

Summary

 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 Measures

Timely and Effective Care

 Performance measures tied to bonus or penalty payments

 Already required under Physician Quality Reporting System

(PQRS)

 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)

 Demonstrate your value

 Help your hospital achieve bonus payments!!!!

AARC Resources

2014 Annual Conference

&

Exhibits

March 3-4 2014

Birmingham

AL

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

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