The Heartaches Associated with Billing for Cardiac Devices

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Georgia Chapter Healthcare Financial Management Association Tuesday, December 6, 20161:00pm ESTAt the Heart of the Matter: Medical Necessity

Prepared for Georgia Chapter Healthcare Financial Management Association Page #About the SpeakersDenise Hall-Gaulin, RN, BSN Principal, Healthcare ConsultingDenise manages the Firms Hospital and Physician Compliance Advisory Services. With more than 25 years of experience in the healthcare industry, Denise has provided business advisory services to a variety of organizations, including hospitals, health systems, physicians, and both behavioral health and post-acute organizations. Denise has extensive experience in compliance-related matters, including oversight of numerous engagements where PYA has served its clients as an Independent Review Organization (IRO). In addition, Denise has in-depth knowledge of quality, case management, health information management, chargemaster, and patient accounting matters. Denise has served as expert witness in compliance litigation matters as well as self-disclosure recoupments. She speaks frequently on these topics at various national and regional conferences.Joanna Malcolm, RN, BSN, CCM Manager, Healthcare ConsultingWith more than two decades of healthcare experience, Joanna is a manager of the Clinical Advisory Services team. Since joining PYA in 2007, Joanna has been instrumental in developing the Firms Case Management and Medical Necessity Compliance service line. In this role, she has provided denials and appeals services for Recovery Audit Contractors, Office of Inspector General (OIG), U.S. attorney, and Zone Program Integrity Contract cases; annual compliance plan reviews; and project oversight for federal- and state-focused reviews. Additional areas of focus and expertise include analysis and consultation services for inpatient, outpatient, rehab therapy, skilled nursing facilities, and psychiatric facilities. Joanna serves as an active resource in her field and has provided interviews and quotes to several publications specializing in the aforementioned areas.

Prepared for Georgia Chapter Healthcare Financial Management Association Page #Amanda Fanning (AF) - Per GA HFMA Instructions:

Please include a slide at the beginning of your presentation that includes the name of your company, brief overview of your products/services, and brief bio of the speaker. Although we ask that you do not do a sales pitch, it is certainly acceptable to spend a few minutes at the beginning of the presentation talking about yourself and your company.Firm Overview

Prepared for Georgia Chapter Healthcare Financial Management Association Page #

AgendaRecent cases and legal actionsUnderstanding the impact of medical necessity when interpreting the regulations and guidelines for:StentsPacemakersAutomatic Implantable Cardiac Defibrillators (AICD)Electrophysiology Studies (EPS) and AblationsA discussion of common areas of risk in applying Local Coverage Determination (LCD)/National Coverage Determination (NCD) guidance to cardiac procedures: how to identify risks and avoid vulnerabilityHow bundled payment models affect quality and costsDiscussion of best practices for ensuring compliance with regulations

Prepared for Georgia Chapter Healthcare Financial Management Association Page #In the News

Prepared for Georgia Chapter Healthcare Financial Management Association Page #DOJ National ProbeResults:Over 500 hospitals agreed to pay back nearly $500 million to the government to resolve allegations that they charged Medicare for procedures that did not comply with NCD 20.4 for implantable cardiac defibrillators (ICDs). Providers are now keenly aware of the technical guideline that specifically requires a waiting period for device placement following certain cardiac events or procedures.It brought attention to the fact that the NCD also contains many other frequently overlooked indications, exclusions, and documentation requirements to support medical necessity. It showed that 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.

Prepared for Georgia Chapter Healthcare Financial Management Association Page #Medicare Coverage/DeterminationCardiac devices (pacemakers, ICDs, cardiac resynchronization devices) cost between $25,000 and $40,000 each for the initial implantation procedure. Medicare coverage for these procedures is limited to items and services that are reasonable and necessary for the diagnosis or treatment of an illness or injury, and within the scope of a Medicare benefit category. Determination of reasonable and necessary is decided through the Medicare National Coverage Process that is performed over a nine month period. This process either results in an NCD, or a reconsideration in which the process begins anew.

Prepared for Georgia Chapter Healthcare Financial Management Association Page #Medicare Coverage Determination Process

Prepared for Georgia Chapter Healthcare Financial Management Association Page #Medical NecessityThe AMA defines medical necessity as healthcare services or products that a prudent physician would provide to a patient for the purpose of preventing, diagnosing, or treating an illness, injury, disease, or its symptoms in a manner that is: In accordance with generally accepted standards of medical practice.Clinically appropriate in terms of type, frequency, extent, site, and duration.Not primarily for the convenience of the patient, physician, or other healthcare provider.Usage of the term "medical necessity" must be consistent between the medical profession and the insurance industry.Carrier denials for non-covered services should state so explicitly and not confound this with a determination of lack of "medical necessity."

Source: American Medical Association, H-320.953 Definitions of "Screening" and "Medical Necessity, https://www.ama-assn.org/ssl3/ecomm/PolicyFinderForm.pl?site=www.ama-assn.org&uri=/resources/html/PolicyFinder/policyfiles/HnE/H-320.953.HTM

Prepared for Georgia Chapter Healthcare Financial Management Association Page #No payment may be made... for any expenses incurred for items or services, which ... are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. Sec. 1862(a) of the Social Security Act

The Shared Responsibility of Medical Necessity

Prepared for Georgia Chapter Healthcare Financial Management Association Page #Physicians bear the responsibility of ordering the treatments that they believe are the most appropriate for each individual patients diagnosis and symptoms based on their experience, knowledge of the patient, and current medical treatment guidelines. Physicians are also expected to consider and follow the various complex standards of what is medically necessary as outlined by government and private payers. Further complicating the process is that hospitals are prohibited from billing for services ordered and performed by physicians that are not medically necessary, even when the diagnosis or decision of what the most appropriate service or treatment was for the patient was not the responsibility of the hospital. This shared responsibility is based on the theory that the hospital knew, or should have known, that unnecessary procedures were being performed.

The Shared Responsibility of Medical Necessity

Prepared for Georgia Chapter Healthcare Financial Management Association Page #Both the physician and hospital are responsible for knowing the multitude of complex medical necessity determinations and payer guidelines for every service they provide. Physicians have to balance the presentation of the patient in front of them with the most current clinical guidelines and medical necessity determinations, which are frequently conflicting. Hospitals have to balance the presentation of the patient, as described by the physician who orders the service, with the medical necessity determinations. Frequently, the hospitals responsibility is greater because they have the burden of gathering the documentation that supports the service was reasonable and necessary. The hospital has to confirm that supporting documentation is included in the hospital record, and that it complies with the coverage guidance. Frequently, that documentation is incomplete, conflicting, or missing. The hospital must then decide whether the service is reasonable and necessary based on available physician documentation alone.

Documentation Is Important!Physicians may, knowingly or unknowingly, practice outside of the payer guidelines, but are also using the most up-to-date patient care guidelines. Example: the most recent clinical guidelines and AUC for ICDs were issued in 2013, whereas the most recent update to NCD 20.4 was in 2005. Physicians documentation should be detailed as to what criteria or guidelines they are using to make treatment decisions.

Prepared for Georgia Chapter Healthcare Financial Management Association Page #Documentation Is Important!Documentation should very specifically answer the following questions:What are the patients specific signs and symptoms?What are the diagnostic tests that support the diagnosis?What are the patient comorbidities that contribute to the clinical picture?How can the treatment improve the patients expected long-term mortality?How can the procedure potentially improve the patients quality of life?In what way will the limitations of the current coverage guidelines restrict the patient from the most appropriate treatment currently available?

Prepared for Georgia Chapter Healthcare Financial Management Association Page #Documentation Pitfalls for NCD 20.4NCD 20.4 Implantable Automatic DefibrillatorsDocumented prior Myocardial Infarction (MI)Of the eight covered indications for an ICD, five require the documentation of a prior MI. Frequently, a physician will document the diagnosis of ischemic dilated cardiomyopathy as the indication for the placement of an ICD. Inferred in the diagnosis is that the ischemia is related to an MI. However, ischemia can result from an MI or chronically narrowed arteries, without an MI. The guidelines also list the criteria for the definition of an MI. There are many ways to document a prior MI, but a physician statement is the minimumLeft Ventricular Ejection Fraction (EF) Indications 3-8 require an EF of 35%.Many times, the LVEF is either not documented at all, or is documented as 35-40%. ICDs are virtually never placed without a measurement of LVEF by echocardiogram or radionuclide scanning; locating the study and ensuring that it is in the medical record is usually responsible for this deficiency.ICDs are never indicated for LVEF of >35%. The statement of 35-40% will be denied as not necessary every time. Ventricular Tachycardia (VT) or Ventricular Fibrillation (VF) Indications 1 and 2 allow ICD for the documented presence of VT or VF not associated with an MI or transient or reversible cause.Often missing in the documentation to support this, is 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 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. Documentation should state when the MI or procedure was performed, when the arrhythmia was induced, and how long it lasted to support the necessity and timing requirements. Of note, this technical requirement is different than what the DOJ investigation focused on, which was the timing of the placement of the device. This requirement is directed at proving an arrhythmia still exists outside of those time requirements.

Prepared for Georgia Chapter Healthcare Financial Management Association Page #Documentation Pitfalls for NCD 20.8.3NCD 20.8.3 for Single and Dual Chamber Cardiac PacemakersBradycardiaBoth indications for coverage of pacemakers are for documented symptomatic bradycardia, which is defined as a heart rate less than 60 beats per minute. This is very specific, yet frequently the physician documents only bradycardia, without specifying the rate. Further, there may be documentation of an EKG that shows a rate higher than 60 beats per minute. This is usually a result of insufficient documentation and easily avoidable by more thorough documentation of the rate and what study was used to confirm the diagnosis. Without documented bradycardia of less than 60 beats per minute, a pacemaker will be deemed not medically necessary.SymptomaticAlso specified for both indications is the presence of symptoms directly attributable to a heart rate of less than 60 beats per minute. The examples given are syncope, seizures, congestive heart failure, dizziness, or confusion. Again, frequently missing from documentation are the clinical symptoms that support the need for a pacemaker to correct the bradycardia. Without support for symptoms, such as a brief statement by the physician in the history and physical, a pacemaker will not be deemed medically necessary.Atrial FibrillationThe diagnosis of Atrial Fibrillation (AF) is a non-covered indication for a pacemaker unless there is also symptomatic bradycardia or a future plan to perform AV node ablation, which eliminates the hearts ability to pace itself. Many times a physician states AF as the indication for a pacemaker without any documentation to support symptoms related to bradycardia. Most frequently this symptom is congestive heart failure due to medications used to slow the heart rate, but is never tied together in the documentation. Most physicians are just unaware of this exclusion, and need to be educated about the requirements for more detailed documentation to support pacemakers in patients with AF.

Prepared for Georgia Chapter Healthcare Financial Management Association Page #Why Does It Matter?DRG PaymentDRGDescription2016 Payment226ICD Implant w/MCC$41,178227ICD Implant w/o MCC$32,367242PM Implant w/MCC$22,341243PM Implant w/CC$15,614244PM Implant w/o CC$12,633245ICD Replacement$27,300258PM Replacement$16,882260PM Revision$21,997265ICD Lead Revision$17,526

APC PaymentAPCDescription2016 Payment5223Level 3 Pacemaker $9,2835224Level 4 Pacemaker$16,9145231Level 1 ICD$21,9305232Level 2 ICD$30,490

Physician PaymentCPTProcedure2016 Payment33208Pacemaker$553.6333249ICD$962.42

Prepared for Georgia Chapter Healthcare Financial Management Association Page #I would like to add another table below APC. Is that possible?15

Cardiovascular Procedures NCDsNCD TitleMost Recent Revision20.4Implantable Automatic Defibrillators3-4-200520.7Percutaneous Transluminal Angioplasty9-4-201420.8.3Single and Dual Chamber Pacemakers8-13-201320.9.1Ventricular Assist Devices8-29-2014

Notably absent: Catheter Ablation, Electrophysiology, CABG

Prepared for Georgia Chapter Healthcare Financial Management Association Page #Selected LCD ExamplesLCDTitleStates CoveredLast Revision DateL33271Cardiac Resynchronization TherapyFL, PR, USVI3-21-2014L33557Cardiac Catheterization & Coronary AngiographyIL, MN, WI, CT, NY, ME, MA, NH, RI, VT7-1-2011L33959Cardiac Catheterization & Coronary AngiographyKY, OH4-30-2011L33623*Percutaneous Coronary InterventionIL, MN, WI, CT, NY, ME, MA, NH, RI, VT10-1-2015L34761*Percutaneous Coronary Intervention38 States04-15-2015L34598Cardiovascular Stress Testing48 states12-1-2009L34324Cardiovascular Stress TestingCA, HI, NV9-16-2013

Prepared for Georgia Chapter Healthcare Financial Management Association Page #* Supplements NCD 20.717

Medical Necessity AuditsOIG: Office of the Inspector GeneralDOJ: Department of JusticeRAC: Recovery Audit ContractorsMAC: Medicare Administrative ContractorsHEAT: Healthcare Fraud Prevention and Enforcement TeamZPIC: Zone Program Integrity ContractorsMIC: Medicaid Integrity Contractors QIO: Quality Improvement Organizations

Prepared for Georgia Chapter Healthcare Financial Management Association Page #FCSO MAC Prepayment ReviewsSource: http://medicare.fcso.com/wrapped/231916.asp


NGS Post-Payment ReviewsSource: National Government Services, http://bit.ly/22vqJXT

Prepared for Georgia Chapter Healthcare Financial Management Association Page #* There are no new changes to the 2017 Plan.

Source: http://oig.hhs.gov/reports-and-publications/archives/workplan/2016/oig-work-plan-2016.pdf

OIG Work Plan 2016*

Prepared for Georgia Chapter Healthcare Financial Management Association Page #Bundled PaymentsProposed Rule for patients with myocardial infarction who undergo percutaneous coronary intervention (PCI) with or without stenting and coronary bypass graft surgery

July 1, 2017 - 98 randomly selected metropolitan statistical areas (MSA) will begin the five-year cardiac bundled payment demonstration project

Hospital payment will be a fixed target price per episode based on a quality-adjusted price

Prepared for Georgia Chapter Healthcare Financial Management Association Page #Sample Checklist (1 of 3)

Secondary Prevention: Patient has already experienced a life threatening arrhythmia.


Primary Prevention: The patient has not experienced an arrhythmia, but is at high risk of Spontaneous Cardiac Death (SCD) due to other cardiac conditions.All indications for Primary Prevention require ICD Registry data collection and reporting


Prepared for Georgia Chapter Healthcare Financial Management Association Page #Best PracticesDevelop required training for all physicians with hospital privileges that include education regarding NCDs, specific requirements, and practice responsibility to provide the supporting documentation.Develop a process and delegate responsibility for collecting and maintaining the NCDs within each specialty department.Implement a specific checklist for ordering cardiac device procedures that includes the documentation to support medical necessity before the procedure can be scheduled. (see attached example)Implement a specific checklist to be used within the hospital department that must be complete prior to performing the procedure. (see attached example)Develop a process for pre-billing monitoring and regular post-payment auditing for all cardiac device placements.Assign a Physician Champion who is knowledgeable of the NCD coverage requirements that can serve as a resource when physicians order treatments outside of coverage guidelines.

Prepared for Georgia Chapter Healthcare Financial Management Association Page #Questions


Denise Hall-Gaulin, RN, BSN [email protected]

Joanna Malcolm, RN, BSN, [email protected]

PERSHING YOAKLEY & ASSOCIATES, P.C.800.270.9629 | www.pyapc.com
