W VENTILATOR-ASSOCIATED EVENTS, A NEW SURVEILLANCE PROPOSAL · A NEW SURVEILLANCE PROPOSAL From the early stages of development of the Hospital Acquired Conditions (HAC) policy, the

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November 2012 www.namdrc.org VOLUME 22 No. 11

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VENTILATOR-ASSOCIATED EVENTS,

A NEW SURVEILLANCE PROPOSAL

From the early stages of development of the Hospital Acquired Conditions (HAC) policy, the Medicare administration has had Ventilator-Associated Pneumonia (VAP) high on its list of preventable complications. In the early years, for some very good reasons, our professional societies voiced opposition to adding this to the list of conditions for which hospitals would not receive additional reimbursement. As a result of subsequent cooperation between the Centers for Disease Control (CDC) and a number of professional societies, a new algorithm, Surveillance for Ventilator-Associated Events (VAE), will be implemented for use in the National Health Safety Network in January 2013. This algorithm culminates in criteria for defining VAP as a

reportable condition.

The federal policy of eliminating reimbursement for hospital acquired condi-tions was established as law in February 2006 when President Bush signed the Deficit Reduction Act of 2005. The law required the Secretary of Health and Human Services

to select at least two hospital acquired conditions by FY 2008 that were:

1. High cost or high volume or both

2. Assigned to a higher paying DRG when present as a secondary diagnosis.

3. Reasonably preventable through application of evidence based guidelines.

The law was fully implemented beginning FY 2009. Ventilator-Associated Pneumonia was identified early in the process of selecting conditions that would be included in this policy. Data from the CDC, while imprecise, suggested that this entity met the first criteria.

CDC reports that there are 250,205 ventilator-associated pneumonias per year. Be-cause there is not a unique ICD-9-CM code for ventilator-associated pneumonia, there is not accurate data for FY 2006 on the number of Medicare patients who had this condition as a secondary diagnosis. However, we did examine data for FY 2006 on the number of Medicare patients who listed pneumonia as a secondary diagnosis. There were 92,586 cases with a secondary diagnosis of pneumonia, with average

charges of $88,781.

November` 2012 VOLUME 22 NO 11 PAGE 2

The Society of Critical Care Medicine has also reported:

The incidence of VAP is estimated to be 22.8% in patients receiving mechanical ventilation. VAP is associated with increases in mor-bidity and mortality, hospital length of stay, and costs. The mortality rate attributable to VAP is 27% and has been as high as 43% when the causative agent was antibiotic resistant. Length of stay in the intensive care unit is increased 5 to 7 days and hospital length of stay two- to three-fold in patients with VAP. The cost of VAP is estimated to be an additional $40,000 per hospital admission per

patient and an estimated at $1.2 billion per year in the United States.

As CMS began to consider adding VAP to the list of hospital acquired conditions NAMDRC was invited to meet with Thomas B. Valuck, MD, JD Director, CMS -Special Program Office for Value-Based Purchasing and Joe Kelly, MD Medical Officer CMS -Center for Medicare Management. NAMDRC contacted our sister societies and invited them to send representatives to that meeting. The group emphasized several crucial points including the lack of a clear definition of VAP and the absence of a unique ICD-9-CM code that identified ventilator-associated pneumonia. We also pointed out that while ventilator management guidelines existed, it was not clear how effective they were in preventing VAP. In the final Inpatient Prospective Payment System (IPPS) rule for FY 2008 CMS decided against selecting ventilator-associated pneumonia as one of the initial hospital-acquired conditions, however, they indicated that they would reevaluate the selection of this condition for FY 2009. After experiencing the same resistance from our representative societies in discussions leading up to the final FY 2009 IPPS, CMS shifted the burden of resolving the conflicts surrounding the issue of ventilator-associated pneumonia to the Centers for Disease Control. Early in 2009 the CDC established the ICD-9-CM code 997.31

for Ventilator-Associated Pneumonia:

The new VAP code, 997.31, should be reported as a secondary diagnosis code, after the primary diagnosis code is listed.

(a) Documentation of Ventilator-Associated Pneumonia

As with all procedural or post procedural complications, code assignment is based on the provider’s documentation of the relationship between the condition and the procedure. Code 997.31, ventilator-associated pneumonia, should be assigned only when the provider has documented ventilator-associated pneumonia (VAP). An additional code to identify the organism (e.g., Pseudomonas aeruginosa,

code 041.7) should also be assigned.

(b) Patient admitted with pneumonia and develops VAP

A patient may be admitted with one type of pneumonia (e.g., code 481, pneumococcal pneumonia) and subsequently develop VAP. In this instance, the principal diagnosis would be the appropriate code from categories 480-484 for the pneumonia diagnosed at the time of admission. Code 997.31, ventilator associated pneumonia, would be assigned as an additional diagnosis when the provider has

also documented the presence of ventilator-associated pneumonia.

Shortly after establishing the code, the CDC began to collaborate with several professional societies as well as other federal agen-

cies. In 2011 CDC convened a VAP Surveillance Definition Working Group composed of members of several stakeholder organiza-tions to address the limitations of the National Healthcare Safety Network (NHSN) definitions of VAP and to propose a new approach to surveillance focused on Ventilator-Associated Events (VAE). The organizations represented in the Working Group included: the Critical Care Societies Collaborative (CCSC) comprised of the American Association of Critical-Care Nurses, the American College of Chest Physicians, the American Thoracic Society, and the Society for Critical Care Medicine; the American Association for Respira-tory Care; the Association of Professionals in Infection Control and Epidemiology; the Council of State and Territorial Epidemiologists; the Healthcare Infection Control Practices Advisory Committee’s Surveillance Working Group; the Infectious Diseases Society of America; and the Society for Healthcare Epidemiology of America. This new approach, surveillance for Ventilator-Associated Events (VAE) will be implemented for use in the National Healthcare Safety Network reporting in January 2013. It has been made clear that

the proposed algorithm was developed to be appropriate for the future uses of public reporting and pay-for-performance programs.

NQF #1861; National Healthcare Safety Network (NHSN) Ventilator-Associated Event (VAE) Outcome Measure. There are three definition tiers within the VAE algorithm: 1) Ventilator-Associated Condition (VAC); 2) Infection-related Ventilator-Associated Complication (IVAC); and 3) Possible and Probable VAP. At this time tiers one and two are for public reporting while tier

three is for internal quality improvement.

November 2012 VOLUME 22 NO 11 PAGE 3

There must be no evidence that the condition was present or incubating at the time of admission to the care setting. A patient must have been mechanically ventilated for at least four days to be able to meet the required VAE criteria. The patient must have a base-line period of stability or improvement on the ventilator, defined by >= 2 calendar days of stable or decreasing fraction of inspired oxy-gen (FiO2) or positive end expiratory pressure (PEEP). Baseline FiO2 and PEEP are defined by the minimum daily FiO2 or PEEP

measurement during the period of stability or improvement.

Tier One:

After a period of stability or improvement on the ventilator, the patient has at least one of the following indicators of worsening oxy-

genation:

-Minimum daily FiO2 values increase >= 0.20 (20 points) over baseline and remain at or above that increased level for >= 2 calendar

days

-Minimum daily PEEP values increase >= 3 cmH2O over baseline and remain at or above that increased level for >= 2 calendar days

A Ventilator-Associated Condition (VAC) has been detected.

Tier Two: On or after calendar day 3 of mechanical ventilation and within 2 calendar days before or after the onset of worsening oxygenation, the patient meets both of the following criteria:

- Temperature > 38 °C or < 36°C, OR white blood cell count >= 12,000 cells/mm3 or <= 4,000 cells/mm3

AND

- A new antimicrobial agent(s) is started, and is continued for >= 4 calendar days.

An Infection-related Ventilator-Associated Complication (IVAC) has been detected.

Tier Three:

On or after calendar day 3 of mechanical ventilation and within 2 calendar days before or after the onset of worsening oxygenation,

ONE of the following criteria is met:

-Purulent respiratory secretions (from one or more specimen collections) Defined as secretions from the lungs, bronchi, or trachea that contain >25 neutrophils and <10 squamous epithelial cells per low power field [lpf, x100]. If the laboratory reports semi-

quantitative results, those results must be equivalent to the above quantitative thresholds.

-Positive culture (qualitative, semi-quantitative or quantitative) of sputum, endotracheal aspirate, bronchoalveolar lavage, lung tissue,

or protected specimen brushing.

A possible VAP has been detected.

On or after calendar day 3 of mechanical ventilation and within 2 calendar days before or after the onset of worsening oxygenation,

ONE of the following criteria is met:

- Purulent respiratory secretions (from one or more specimen collections—and defined as for possible VAP)

AND one of the following:

Positive culture of endotracheal aspirate, ≥ 105 CFU/ml or equivalent semi-quantitative result

Positive culture of bronchoalveolar lavage, ≥ 104 CFU/ml or equivalent semi-quantitative result

Positive culture of lung tissue, ≥ 104 CFU/ml or equivalent semi-quantitative result

Positive culture of protected specimen brush, ≥ 103 CFU/ml or equivalent semi-quantitative result

November 2012 VOLUME 22 NO 11 PAGE 4

-One of the following (without requirement for purulent respiratory secretions):

Positive pleural fluid culture (where specimen was obtained during thoracentesis or initial placement of chest tube and NOT from

an indwelling chest tube)

Positive lung histopathology

Positive diagnostic test for Legionella spp.

Positive diagnostic test on respiratory secretions for influenza virus, respiratory syncytial virus, adenovirus, parainfluenza virus

A probable VAP has been detected.

While the National Quality Forum (NQF) has assigned a number to this algorithm, the measure has not been fully approved by NQF. At the May meeting the Committee viewed the algorithm favorably but felt the measure has not yet been adequately tested for reliabil-

ity and validity. The NQF will monitor the use of the algorithm and revisit the issue next year.

Reasonable preventable through application of evidence based guidelines?

While the focus has been on developing a reporting algorithm that our professional societies support and one that satisfies both federal regulators and public sector watchdogs, the big question remains unanswered. Can these complications be reduced or prevented through application of evidence based guidelines? Apparently CMS believes they can and has decided to apply the NQF-endorsed ventilator bundle (NQF #0302) developed by the Institute of Healthcare Improvement as a quality metric for Long Term Care Hospitals under the FY 2013 IPPS. On the other hand, The Critical Care Societies Collaborative has responded to a NQF re-quest to address perceived measure gaps in critical care medicine with a document that includes criticism of the Ventilator Bundle. The CCSC established a task force with a broad mandate to evaluate quality measure gaps in critical care. The task force felt that the VAP “care bundle” minimizes the importance of each individual component measure and neglects the fact that many elements of the existing VAP bundle are known to have important effects outside of VAP reduction, including improved patient survival. In a formal letter to NQF, the task force recommended emphasizing individual components of the ventilator bundle likely to affect the incidence of

VAP as independent performance measures. Specifically, they recommended that NQF:

(1) Dissolve the VAP care bundle and instead develop a new group of quality measures related to general evidence based practices for patients requiring mechanical ventilation. These potential measure gaps would include care processes known to reduce

morbidity and mortality in patients who are ventilated.

(2) Develop measures using the VAP specific measure gaps supported by recent guidelines. These may include measures

for the following evidenced based practices:

Orotracheal rather than nasotracheal intubation to prevent VAP;

Subglottic secretion drainage to prevent VAP;

Elevating the head of bed to 45 degrees to prevent VAP;

Oral antiseptic administration to prevent VAP;

When empiric antibiotics are used to treat VAP, initial treatment based on qualitative endotracheal aspirates rather than quantitative

bronchoscopic aspirates; and

No more than an 8 day course of antibiotics as treatment for uncomplicated VAP.

Surveillance and Reporting

There is no federal requirement to report Ventilator Associated Events at this time. VAE reporting is not currently included in the Centers for Medicare & Medicaid Services Hospital Inpatient Quality Reporting (IQR) program. The CDC has established a pro-gram for voluntary reporting under the National Healthcare Safety Network. The current CDC plan is applicable to acute care hospi-

tals, long term acute care hospitals, and inpatient rehabilitation facilities. The voluntary reporting would be on surveillance for VAE

2012-2013 EXECUTIVE COMMITTEE

AND BOARD OF DIRECTORS

OFFICERS Lynn T. Tanoue, MD President Dennis E. Doherty, MD President-Elect Timothy A. Morris, MD Secretary/Treasurer Steve G. Peters, MD Past President BOARD OF DIRECTORS Charles W. Atwood, MD Peter C. Gay, MD Nicholas S. Hill, MD James P. Lamberti, MD Thomas M. Siler, MD Maida V. Soghikian, MD PRESIDENT’S COUNCIL George G. Burton, MD John Lore, MD Louis W. Burgher, MD, Ph.D. Alan L. Plummer, MD E. Neil Schachter, MD Joel M. Seidman, MD Frederick A. Oldenburg, Jr., MD Paul A. Selecky, MD Neil R. MacIntyre, MD Steven M. Zimmet, MD Joseph W. Sokolowski, MD Peter C. Gay, MD Steve G. Peters, MD EXECUTIVE DIRECTOR Phillip Porte ASSOCIATE EXECUTIVE DIRECTOR Karen Lui, RN, MS DIRECTOR MEMBER SERVICES Vickie Parshall

November 2012 VOLUME 22 NO 11 PAGE 5

in at least one inpatient location in the healthcare institution for at least one calendar month. Spe-

cific instructions include:

Conducting in-plan VAE surveillance in 2013 means assessing patients for the presence of ALL events included in the algorithm—from VAC to IVAC to Possible and Probable VAP. At this time, a unit conducting in-plan VAE surveillance cannot decide, for example, that only

surveillance for VAC (and not for IVAC or possible or probable VAP) will be performed.

There is a hierarchy of definitions within VAE:

If a patient meets criteria for VAC and IVAC, report as IVAC.

If a patient meets criteria for VAC, IVAC and Possible VAP, report Possible VAP.

If a patient meets criteria for VAC, IVAC and Probable VAP, report Probable VAP.

If a patient meets criteria for VAC, IVAC, Possible VAP and Probable VAP, report Probable

VAP

While CMS has the most direct influence on our daily practice through its rules, regula-tions and financial incentives there are additional entities, focusing on hospital activities and pa-tient safety, with increasing influence. Both the Joint Commission and the Leapfrog Group have shown an interest in issues of safety and quality of care of patients on ventilator support. While CMS can dictate the surveillance and reporting requirements for federal reimbursement, the Leapfrog Group’s influence in the private sector is increasing. This healthcare-quality watchdog launched its public hospital report-card system, the “Hospital Safety Score,” June 6, 2012 to show healthcare consumers how their local hospitals measure up on various criteria for safety. As more employers join the Leapfrog Group and more insurers become associate members Leapfrog’s influence over hospital occupancy through its publically available grading scores will become sig-

nificant.

As the Ventilator-Associated Events algorithm matures and is fine tuned with the support of multiple professional societies and federal agencies, it is very likely that it will be adopted into the Hospital Inpatient Quality Reporting (IQR) program as well as Leapfrogs Safe Practices Score and the Joint Commission survey. The draft of the CDC algorithm and reporting checksheet is

available:

http://www.cdc.gov/nhsn/PDFs/vae/Draft-Ventilator-Associate-Event-Protocol_v6.pdf

******************************

The Early Bird Registration for the 36th Annual Meeting and Educational Conference at the US Grant Hotel in San Diego, CA March 21—23, 2013 is now open @ www.namdrc.org. Dues may also be renewed at: www.namdrc.org.

And be sure to check out the NAMDRC Pulmonary Medicine Health Policy Summit to be held April 8-9, 2013 in Washington, DC on our website as well at: www.namdrc.org.

PRODUCT AND TECHNOLOGY NEWS!

NAMDRC is providing this space to our benefactors and patrons who provide us with infor-

mation about new products and innovations related to pulmonary medicine. NAMDRC re-

serves the right to edit this copy as appropriate.

November 2012 VOLUME 22 NO 11 PAGE 6

ABOUT NAMDRC:

Established over three decades ago, the National Association for Medical Direction of Respiratory Care

(NAMDRC) is a national organization of physicians whose mission is to educate its members and address regula-

tory, legislative and payment issues that relate to the delivery of healthcare to patients with respiratory disor-

ders.

NAMDRC members, all physicians, work in close to 2,000 hospitals nationwide, primarily in respiratory

care departments and critical/intensive care units. They also have responsibilities for sleep labs, management of

blood gas laboratories, pulmonary rehabilitation services, and other respiratory related services.

NAMDRC MEMBERSHIP BENEFITS AT A GLANCE...

Monthly publication of the Washington Watchline, providing timely information for practicing

physicians;

Publication of Current Controversies focusing on one specific Pulmonary/Critical Care Issue in

each publication;

Regulatory updates;

Discounted Annual Meeting registration fees;

The Executive Office Staff as a resource on a wide range of clinical and management issues; and

The knowledge that NAMDRC is an advocate for you and your profession.

http://www.namdrc.org/coding.html

One of NAMDRC’s primary reasons for existence is to provide both clinicians and patients with the most up-to-date

information regarding pulmonary medicine. Bookmark this page!

The complexity of our nation’s health care system in general, and Medicare in particular, create a true challenge for

physicians and their office staffs. One of NAMDRC’s key strengths is to offer assistance on a myriad of coding, cover-

age and payment issues.

In fact, NAMDRC members indicate that their #1 reason for belonging to and continuing membership in the Associa-

tion is its voice before regulatory agencies and legislators. That effective voice is translated into providing members

with timely information, identifying important Federal Register announcements, pertinent statements and notices by

the Centers for Medicare and Medicaid Services, the Durable Medical Equipment Regional Carriers, and local medical

review policies.

November 2012 VOLUME 22 NO 11 PAGE 7

November 2012 VOLUME 22 NO 11 PAGE 8