23Cultivating

young compliance

professionals

Natalie Bulger

26Advocating for an annual compliance

program review

Ryan Burt and Mai Lee Yang

38HIPAA Privacy:

Follow proper steps to avoid becoming a

news headline

Lina Pacelli

30An in-depth

interview with Robert K. DeConti,

Part 2

Gabriel Imperato

a publication of the health care compliance association www.hcca-info.org

ComplianceTODAY January 2017

Improving the Medicare audit processan interview with Gerard (Jerry) Mulcahy

Former Director, Medicare Parts C and D Oversight and Enforcement Group

Centers for Medicare and Medicaid ServicesBaltimore, MD

See page 16

Improving the Medicare audit processan interview with Gerard (Jerry) Mulcahy

Former Director, Medicare Parts C and D Oversight and Enforcement Group

Centers for Medicare and Medicaid ServicesBaltimore, MD

See page 16

This article, published in Compliance Today, appears here with permission from the Health Care Compliance Association. Call HCCA at 888-580-8373 with reprint requests.

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The Department of Justice (DOJ) recently concluded a national probe of hospitals that allegedly billed for implanting

cardiac defibrillators that were not medically necessary. As a result of the settlement, more than 500 hospitals agreed to reimburse the government nearly $500 million to resolve alle-gations they charged Medicare for procedures that did not comply with National Coverage Determination (NCD) 20.4 for implantable cardiac defibrillators (ICDs).1

The DOJ investigation used data mining, claims denials, and whistleblower actions to isolate procedures that potentially violated the required waiting period for device placement under NCDs. As a result, most providers are now keenly aware of this technical guideline; however, the NCD also contains many other frequently overlooked indications, exclusions, and documentation requirements to support medical necessity. Additionally, the risk for non-compliance is not isolated to ICDs; other cardiac procedures and devices have coverage

determinations that explicitly cover or exclude certain indications.

The completion of the DOJ investigation does not mean the scru-tiny has ended, or that the risk has receded. Providers — both physicians and hospitals — still face significant risk if they fail to adhere to NCD requirements. The recent DOJ probe demonstrates the need for focused education for physicians and staff, and implementation of policies and procedures to ensure compliance with the NCD. In doing so, providers can get to the heart of the matter: ensuring compliance with medical necessity standards.

BackgroundImplantable cardiac devices are used to treat cardiac arrhythmia, which is any disorder of the rate or rhythm of the heart (e.g., beating too quickly, too slowly, or with an irregular pattern).2 ICDs are small, battery-powered devices implanted in the chest or abdomen during a minor surgical procedure, at a cost between $25,000 and $40,000.3

The cardiac devices used to treat arrhyth-mias include pacemakers, ICDs, and cardiac

by Joanna Malcolm, RN, CCM, BSN and Sherry E. Daugherty, RN, COC

Medical necessity for cardiac procedures and devices

» Hospitals and physicians face increasing scrutiny over compliance with National Coverage Determinations (NCDs).

» A disconnect exists between NCDs and advances in evidence-based medicine.

» Missing, incomplete, or conflicting documentation creates denial risk for procedures.

» Physicians and hospitals must share the responsibility of medical necessity.

» Providers must develop effective education initiatives and compliance processes.

Malcolm

Daugherty

Joanna Malcolm (jmalcolm@pyapc.com) is a Nurse Analyst & Consulting

Manager and Sherry E. Daugherty (sdaugherty@pyapc.com) is a Nurse

Analyst & Consulting Senior with PYA- Healthcare Management & Consulting

Firm in Atlanta. bit.ly/in-JoannaMalcolm @Joanna_malcolm2

bit.ly/in-SherryDaugherty

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resynchronization therapy devices (CRTs). Pacemakers help control abnormal heart rhythms by speeding up a slow rhythm, con-trolling a fast rhythm, or coordinating the chambers of the heart to beat in synchrony. ICDs can be single or dual chamber, or CRT devices that work in three chambers.

An ICD monitors heart rhythms and will deliver a shock called “defibrillation” if it senses an abnormal rhythm. ICDs treat life-threatening arrhythmias that can lead to

sudden cardiac death. Most ICDs can act as both pacemaker and defibrillator.

Medicare coverage for these procedures and devices is limited to items and services that are reasonable and necessary for the diagnosis or treatment of an illness or injury, and also are within the scope of a Medicare benefit category. The “not reasonable and nec-essary” coverage exclusion is based on Title XVIII § 1862(a) (1) of the Social Security Act. The Centers for Medicare & Medicaid Services (CMS) determines what is “reasonable and

necessary” through the Medicare National Coverage Process.

The process is long and ardu-ous, and frequently results in out-of-date coverage rules that conflict with the most recent technol-ogy and medical guidelines. As illus-trated in Figure 1, the process takes a minimum of nine months. However, if the process results in reconsideration, which causes the process to begin anew, the process can take significantly longer.

Assuming the process generates an NCD, CMS incor-porates it into the National Coverage Determinations Manual (NCDs Manual). The NCDs

Phase I (6 months)

Phase II (3 months)

Phase III (Possible)

Phase III (Possible)

OR

Final Decision Memorandum and

Implementation Instructions

(60 Days)

Final Decision Memorandum and

Implementation Instructions

External Technology Assessment and/or Medicare Coverage Advisory Committee

Staff Review

Public Comments (30 Days)

Department Appeals Board

Staff Review

Draft Decision Memorandum

Posted

Draft Decision Memorandum

Posted

External Technology Assessment and/or Medicare Coverage Advisory Committee

Preliminary Discussions Category

National Coverage Request

Staff ReviewBenefit

Medicare Coverage Determination ProcessFigure 1: Medicare Coverage Determination Process

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in this manual describe whether specific medi-cal items, services, treatments, procedures, or technologies are paid for by Medicare and also may state that certain items are not covered.

Three NCDs address device placement, and these NCDs contain 33 determinations. All three are located in Section 20 of the Medicare NCDs Manual.4 To restrict coverage, the NCD must contain a statement that explic-itly excludes the item or service from coverage. If the NCD fails to mention an indication or service (which includes providing cover-age for specified indications or services, but remaining silent about its application in other circumstances), or fails to mention whether it is necessary in a particular circumstance, the local Medicare Administrative Contractor (MAC) has the discretion to make coverage decisions.5

Local MACs also can develop coverage determinations to further clarify NCDs, or make their own Local Coverage Determinations (LCDs) for services or items that are not addressed in the NCDs Manual. Often, LCDs contain greater coding details, such as specific diagnosis codes that must be present for payment.

The shared responsibility of medical necessityPhysicians and hospitals share the responsi-bility of ensuring that items and services are reasonable and necessary for a diagnosis or treatment and comply with the standards and rules required by the government and private payers.6 Physicians bear the responsibility of ordering the treatments they believe are the most appropriate for each patient’s diagnosis and symptoms, based on their experience, knowledge of the patient, and current medical treatment guidelines, as well as payers’ com-plex standards of what is medically necessary.

Hospitals also are prohibited from billing for services that are not medically necessary, but which are ordered and performed by

physicians. This shared responsibility is based on the theory that the hospital knew, or should have known, that unnecessary procedures were performed.7

Therefore, both the physician and hospital must know and apply the multitude of com-plex medical necessity determinations and payer guidelines for every service they pro-vide. Physicians must balance the presentation of the patient in front of them with the most current clinical guidelines and medical neces-sity determinations, which frequently conflict with one another.

Hospitals must balance the presentation of the patient, as described by the physician who orders the service, with the medical necessity determinations. The hospital also must document that the service was reason-able and necessary. The hospital is responsible for collecting the necessary documents from the physician’s office, ensuring that these documents are included in the hospital’s medical record, and that they comply with the coverage guidance. If the documentation is incomplete, conflicting, or missing, the hos-pital must then decide whether the service is reasonable and necessary based on the avail-able documentation.

As evidenced by the DOJ investigation, some hospitals have performed procedures that are inconsistent with Medicare’s cover-age and clinical guidelines. Although most cases investigated by the DOJ were based on violating technical timing requirements (e.g., inserting an ICD within 40 days of an acute myocardial infarction [MI] or within 3 months of revascularization [percutaneous coronary intervention or coronary artery bypass graft-ing]), other requirements found in the NCD and LCD could pose bigger risks for physi-cians and hospitals. Even if the majority of performed procedures are clinically justified, the issue of missing, incomplete, or conflicting documentation (between the physician’s office

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and hospital) puts the procedure at greatest risk for denial.

Documenting to support medical necessityWith the increased scrutiny surrounding the appropriateness of cardiac procedures,

detailed clinical and hospital record documen-tation that supports the specific requirements of the NCDs and LCDs is the best defense against risk. Each coverage determination has indications that either are covered or not covered. All providers must be aware of and regularly document these requirements. In instances where current guidelines and

appropriate-use rec-ommendations may support treatment outside of the cover-age requirements, physicians should include detailed documentation and reasoning for treat-ment decisions to alleviate regulatory pushback.

Figures 2 and 3 show examples of the most frequently avoidable documenta-tion issues for ICDs and pacemakers.

Clinical guidelinesRegulations and coverage determina-tions can be slow in integrating new information about advances in medicine. There often is a dis-connect between the coverage determina-tions and the most current advances in evidence-based medi-cine. For example, the American College of Cardiology (ACC) issues appropriate-use

• Five of the eight covered indications for an ICD require the documentation of a prior MI.

• There are numerous ways to document a prior MI, but an explicit physician statement is the minimum requirement. Frequently, a physician will document the diagnosis of “ischemic dilated cardiomyopathy” as the indication for ICD placement. This diagnosis alone is insufficient since ischemia can result from an MI or it can result from chronically narrowed arteries when an MI has not occurred.

• Indications 3-8 require an LVEF of ≤ 35%.• The LVEF frequently is either not documented at

all, or documented as 35-40%. • ICDs virtually are never placed without a

measurement of LVEF by echocardiogram or radionuclide scanning; the study must be included in the medical record.

• ICDs are never indicated for LVEF of >35%. A statement of 35-40% will result in denial as not necessary.

• Indications 1 and 2 allow ICD for the documented presence of VT or VF not associated with an MI or transient or reversible cause. Documentation must show that the arrhythmia is still present and poses a risk outside the immediate timing of an MI and that the revascularization procedure did not remove the risk.

• The record often fails to include documentation that the VT or VF was sustained (lasting longer than 30 seconds) and induced in an electrophysiology study that was performed more than 40 days following an MI, or more than 3 months following revascularization.

• Documentation should state when the MI or procedure was performed, when the arrhythmia was induced, and how long it lasted.

• Indications 5-8 require the documentation of NYHA class of heart failure between II-IV.

• Symptoms frequently are documented, but the actual class is not stated in the medical record as required.

Documented Prior MI

Left Ventricular Ejection Fraction

(LVEF)

Ventricular Tachycardia (VT) or

Ventricular Fibrillation (VF)

New York Heart Association (NYHA) class of heart failure

Avoidable Documentation Pitfalls for NCD 20.4Implantable Automatic DefibrillatorsFigure 2: Avoidable Documentation Pitfalls for

NCD 20.4 Implantable Automatic Defibrillators

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criteria (AUC) documents that help define when it is or is not reasonable to perform a procedure.

The ACC also issues clinical practice guidelines that review and consider the most current medical literature to advise physicians in clinical decision making by describing a broad range of generally acceptable approaches for the diagnosis, management, or prevention of certain dis-eases or conditions. Both of these types of documents represent the most current evidence-based treatments for car-diovascular care and routinely are used by physicians to guide their care. The most recent clinical guide-lines and AUC for ICDs were issued in 2013; the most recent update to NCD 20.4 was in 2005.

This discon-nect creates an environment where physicians may, knowingly or unknowingly, practice outside of the payer guide-lines, even though they also are using the most up-to-date patient care guidelines. In these instances, phy-sician documentation should be detailed as to what criteria or guidelines are used to make treat-ment decisions.

Additionally, documentation should specifi-cally answer the following questions:1. What are the patient’s specific signs and

symptoms?2. What are the diagnostic tests that support

the diagnosis?3. What are the patient comorbidities that

contribute to the clinical picture?4. How can the treatment improve the

patient’s expected long-term mortality?

• Both indications for coverage of pacemakers are for documented symptomatic bradycardia, which is defined as a heart rate less than 60 beats per minute. The physician frequently documents only “bradycardia,” without specifying the rate. Further, there may be documentation of an electrocardiogram that shows a rate higher than 60 beats per minute. This is easily avoidable through exhaustive documentation of the rate and determination of the particular study used to confirm the diagnosis. Without documented bradycardia of less than 60 beats per minute, a pacemaker will be deemed not medically necessary.

• Both indications require the presence of symptoms directly attributable to a heart rate of less than 60 beats per minute. These symptoms could include syncope, seizures, congestive heart failure, dizziness, or confusion. The documentation frequently fails to include the clinical symptoms that support the need for a pacemaker. Without documentation of the symptoms, such as a brief physician statement in the patient’s history and physical notes, a pacemaker will not be deemed medically necessary.

• The diagnosis of Atrial Fibrillation (AF) is a non-covered indication for a pacemaker unless there also is symptomatic bradycardia or a plan to perform AV node ablation, which eliminates the heart’s ability to pace itself. Many times a physician states AF as the indication for a pacemaker without any documentation of symptoms related to bradycardia. Many physicians are unaware of this exclusion, and need to include more detailed documentation to support pacemakers in patients with AF.

Bradycardia

Symptomatic

Atrial Fibrillation

Avoidable Documentation Pitfalls of NCD 20.8.3 for Single and Dual Chamber Cardiac PacemakerFigure 3: Avoidable Documentation Pitfalls for NCD 20.8.3 for Single

and Dual Chamber Cardiac Pacemaker

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5. How can the procedure potentially improve the patient’s quality of life?

6. In what way will the limitations of the current coverage guidelines restrict the patient from the most appropriate treat-ment currently available?

Practical steps to mitigate the riskAs hospitals and physicians face greater scru-tiny over their compliance with the NCDs, there will be a greater need to ensure that all healthcare providers understand the specif-ics of the coverage guidelines. Hospitals, as well as physician groups, need to develop an effective education initiative and compliance process for their providers and staff. The fol-lowing checklist is a basic outline for building a compliance process that begins with the physician and ends with the hospital:

D Develop required training that addresses NCDs, specific requirements under the NCDs, and adequate compliance documentation for all physicians with hospital privileges.

D Develop a process and delegate respon-sibility for collecting, maintaining, and disseminating the NCDs within each spe-cialty department.

D Develop and implement a specific check-list for ordering cardiac device procedures. The checklist should include producing the documentation to support medical necessity before the procedure can be scheduled.

D Develop and implement a specific check-list that must be completed within the hospital department prior to performing the procedure.

D Develop and implement a process for pre-billing monitoring and regular post-payment auditing for all cardiac device placements.

D Assign a physician champion who is knowledgeable of the NCD coverage

requirements and who can serve as a resource when physicians order treatments outside of coverage guidelines.

1. Department of Justice, press release: “Fifty-One Hospitals Pay United States More Than $23 Million to Resolve False Claims Act Allegations Related to Implantation of Cardiac Devices” February 17, 2016. Available at http://bit.ly/2foz4J2

2. U.S National Library of Medicine: “Pacemakers and Implantable Defibrillators” Available at http://bit.ly/2g0CYqb

3. Centers for Medicare & Medicaid Services: Inpatient Prospective Payment System Final Rule FY 2016. Available at http://go.cms.gov/2fCV2pm

4 CMS: Medicare National Coverage Determinations Manual, revised December 10, 2015. Available at http://go.cms.gov/2gz7QS1

5 Idem.6 42 U.S.C. § 1395y(a)(1)(a)7. Department of Health and Human Services: OIG Compliance

Program Guidelines for Hospitals. 63 Federal Register 8987, 8992. February 23, 1998. Available at http://1.usa.gov/1m8YBqk

False Claims

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