at the heart of the matter: medical necessity
TRANSCRIPT
AHLA INSTITUTE ON MEDICARE AND MEDICAID PAYMENT ISSUES
Wednesday, April 13, 2016 Thursday, April 14, 2016
At the Heart of the Matter: Medical Necessity
Prepared for AHLA Institute on Medicare and Medicaid Payment Issues Page 2
Agenda
Recent cases and legal actions Understanding the impact of medical necessity when
interpreting the regulations and guidelines for: Stents Pacemakers Automatic Implantable Cardiac Defibrillators (AICD) Electrophysiology Studies (EPS) and Ablations
A 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 vulnerability
Discussion of best practices for ensuring compliance with regulations
Prepared for AHLA Institute on Medicare and Medicaid Payment Issues Page 3
In the News
Prepared for AHLA Institute on Medicare and Medicaid Payment Issues Page 4
DOJ National Probe Results:
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 indications, exclusions, and documentation requirements to support medical necessity that are frequently overlooked.
It highlighted 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 AHLA Institute on Medicare and Medicaid Payment Issues Page 5
Medicare Coverage/Determination Cardiac 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 AHLA Institute on Medicare and Medicaid Payment Issues Page 6
Medicare Coverage Determination Process
Prepared for AHLA Institute on Medicare and Medicaid Payment Issues Page 7
Medical Necessity
The 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 AHLA Institute on Medicare and Medicaid Payment Issues Page 8
The Shared Responsibility of Medical Necessity
Physicians• Order appropriate
treatments for the patient
• Consider complex medical necessity standards as outlined by government and private payers
Hospitals• Prohibited from
billing for services ordered and performed by physicians that are not medically necessary
Prepared for AHLA Institute on Medicare and Medicaid Payment Issues Page 9
The Shared Responsibility of Medical Necessity
Physicians Hospitals
Incomplete, conflicting, or missing documentation
Gather documentation from Physician
Complex medical necessity determinations
Payer guidelines
Complex medical necessity determinations
Payer guidelines
Prepared for AHLA Institute on Medicare and Medicaid Payment Issues Page 10
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.
Physician documentation should be detailed as to what criteria or guidelines they are using to make treatment decisions.
Prepared for AHLA Institute on Medicare and Medicaid Payment Issues Page 11
Documentation is Important! Documentation should very specifically answer the
following questions: What are the patient’s 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 patient’s expected long-term
mortality? How can the procedure potentially improve the patient’s 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 AHLA Institute on Medicare and Medicaid Payment Issues Page 12
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 minimum
Left 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 AHLA Institute on Medicare and Medicaid Payment Issues Page 13
Documentation Pitfalls for NCD 20.8.3NCD 20.8.3 for Single and Dual Chamber Cardiac PacemakersBradycardia Both 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.
Symptomatic
Also 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 Fibrillation The 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 AHLA Institute on Medicare and Medicaid Payment Issues Page 14
Why Does It Matter?
DRG PaymentDRG Description 2016
Payment
226 ICD Implant w/MCC $41,178
227 ICD Implant w/o MCC $32,367
242 PM Implant w/MCC $22,341
243 PM Implant w/CC $15,614
244 PM Implant w/o CC $12,633
245 ICD Replacement $27,300
258 PM Replacement $16,882
260 PM Revision $21,997
265 ICD Lead Revision $17,526
APC PaymentAPC Description 2016
Payment5223 Level 3 Pacemaker $9,283
5224 Level 4 Pacemaker $16,914
5231 Level 1 ICD $21,930
5232 Level 2 ICD $30,490
Physician PaymentCPT Procedure 2016
Payment
33208 Pacemaker $553.63
33249 ICD $962.42
Prepared for AHLA Institute on Medicare and Medicaid Payment Issues Page 15
Cardiovascular Procedures NCDsNCD Title Most Recent Revision20.4 Implantable Automatic Defibrillators 3-4-2005
20.7 Percutaneous Transluminal Angioplasty 9-4-2014
20.8.3 Single and Dual Chamber Pacemakers 8-13-2013
20.9.1 Ventricular Assist Devices 8-29-2014
Notably absent: Catheter Ablation, Electrophysiology, CABG
Prepared for AHLA Institute on Medicare and Medicaid Payment Issues Page 16
Selected LCD Examples
LCD Title States CoveredLast Revision Date
L33271 Cardiac Resynchronization Therapy FL, PR, USVI 3-21-2014
L33557 Cardiac Catheterization & Coronary Angiography
IL, MN, WI, CT, NY, ME, MA, NH, RI, VT 7-1-2011
L33959 Cardiac Catheterization & Coronary Angiography KY, OH 4-30-2011
L33623* Percutaneous Coronary Intervention
IL, MN, WI, CT, NY, ME, MA, NH, RI, VT 10-1-2015
L34761* Percutaneous Coronary Intervention 38 States 04-15-2015
L34598 Cardiovascular Stress Testing 48 states 12-1-2009
L34324 Cardiovascular Stress Testing CA, HI, NV 9-16-2013
Prepared for AHLA Institute on Medicare and Medicaid Payment Issues Page 17
Medical Necessity Audits OIG: Office of the Inspector General DOJ: Department of Justice RAC: Recovery Audit Contractors MAC: Medicare Administrative Contractors HEAT: Healthcare Fraud Prevention and Enforcement
Team ZPIC: Zone Program Integrity Contractors MIC: Medicaid Integrity Contractors QIO: Quality Improvement Organizations
Prepared for AHLA Institute on Medicare and Medicaid Payment Issues Page 18
FCSO MAC Prepayment Reviews
Source: http://medicare.fcso.com/wrapped/231916.asp
Prepared for AHLA Institute on Medicare and Medicaid Payment Issues Page 19
NGS Post-Payment Reviews
Source: National Government Services, http://bit.ly/22vqJXT
Prepared for AHLA Institute on Medicare and Medicaid Payment Issues Page 20
Source: http://oig.hhs.gov/reports-and-publications/archives/workplan/2016/oig-work-plan-2016.pdf
OIG Work Plan 2016
Prepared for AHLA Institute on Medicare and Medicaid Payment Issues Page 21
Sample Checklist (1 of 3)
Secondary Prevention: Patient has already experienced a life threatening arrhythmia
Prepared for AHLA Institute on Medicare and Medicaid Payment Issues Page 22
Sample Checklist (2 of 3)
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 AHLA Institute on Medicare and Medicaid Payment Issues Page 23
Sample Checklist (3 of 3)
Prepared for AHLA Institute on Medicare and Medicaid Payment Issues Page 24
Best Practices Develop 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 AHLA Institute on Medicare and Medicaid Payment Issues Page 25
Case Studies Generated by internal compliance risk
assessment
Generated by hotline or department communications
Generated by external communications (MAC, OIG, RAC)
Prepared for AHLA Institute on Medicare and Medicaid Payment Issues Page 26
Questions
Prepared for AHLA Institute on Medicare and Medicaid Payment Issues Page 27
Contact Information
Denise Hall, RNPrincipal
Michael Spake, MHA, JDVice President of External Affairs and Chief Compliance & Integrity Officer
Lakeland Regional [email protected]