(Medicare National Coverage Determinations Manual)

The CMS has created a list of minimum standards modeled in part on professional society statements on competency. All facilities must at least meet CMSs standards in order to receive coverage for CAS for high- risk patients.    Facilities must have necessary imaging equipment, device inventory, staffing, and infrastructure to support a dedicated carotid stent program. Specifically, high-quality x- ray imaging equipment is a critical component of any carotid interventional suite, such as high- resolution digital imaging systems with the capability of subtraction, magnification, road mapping, and orthogonal angulation.   Advanced physiologic monitoring must be available in t he interventional suite. This includes real time and archived physiologic, hemodynamic, and cardiac rhythm monitoring equipment, as well as support staff who are capable of interpreting the findings and responding appropriately.   Emergency management equipment and systems must be readily available in the interventional suite such as resuscitation equipment, a defibrillator, vasoactive and antiarrhythmic drugs, endotracheal intubation capability, and anesthesia support.   Each institution shall have a clearly delineated program for granting carotid stent privileges and for monitoring the quality of the individual interventionalists and the program as a whole. The oversight committee for this program shall be empowered to identify the minimum case volume for an operator to maintain privileges, as well as the (risk -adjusted) threshold for complications that the institution will allow before suspending privileges or instituting measures for remediation. Committees are encouraged to apply published standards from national specialty societies recognized by the American Board of Medical Specialties to determine appropriate physician qualifications. Examples of standards and clinical competence guidelines include those published in the December 2004 edition of the American Journal of Neuroradiology, and those published in the August 18, 2004, Journal of the American College of Cardiology.   To continue to receive Medicare payment for CAS under this decision, the facility or a contract or to the facility must collect data on all CAS procedures done at that particular facility.  This data must be analyzed routinely to ensure patient safety. This data must be made available to CMS upon request. The interval for data analysis will be determined by the facility but shall not be less frequent than every 6 months.  Since there currently is no recognized entity that evaluates CAS facilities, CMS has established a mechanism for evaluating facilities. Facilities must provide written documentation to CMS that the facility meets one of the following:   1. The facility was an FDA -approved site that enrolled patients in prior CAS IDE trials, such as SAPPHIRE, and ARCHER;   2. The facility is an FDA -approved site that is participating and enrolling pati ents in ongoing CAS IDE trials, such as CREST;   3. The facility is an FDA -approved site for one or more FDA post approval studies; or,   4.  The facility has provided a written affidavit to CMS attesting that the facility has met the minimum facility stan dards. This should be sent to:   Director, Coverage and Analysis Group  7500 Security Boulevard, Mailstop S3- 02-01 Baltimore, MD 21244  The letter must include the following information:    Facility's name and complete address;   Facility's national provider identifier (formerly referred to as the Medicare provider number);   Point -of-contact for questions with telephone number;   Discussion of how each standard has been met by the hospital;   Mechanism of data collection of CAS procedures; and,   Signature of a senior facility administrative official.   A list of certified facilities will be made available and viewable at: http://www.cms.hhs.gov/coverage/carotid- stent -facilities.as p.  In addition, CMS will publish a list of approved facilities in the Federal  Register .  Facilities must recertify every two (2) years in order to maintain Medicare coverage of CAS procedures. Recertification will occur  when the facility documents that and describes how it continues to meet the CMS standards.   The process for recertification is as follows:   1. At 23 months after initial certification:   Submission of a letter to CMS stating how the facility continues to meet the minimum facility standards as listed above.   2. At 27 months after initial certification:   Submission of required data elements for all CAS procedures performed on patients during the previous two (2) years of certification.   Data elements:   a. Patients Medicare beneficiary identifier if a Medicare beneficiary;  b. Patients date of birth;  c. Date of procedure;  d. Does the patient meet high surgical risk criteria (defined below)?    Age 80;   Recent (<30 days) MI;   LVEF <30%;   Contralate ral carotid occlusion;   New York Heart Association (NYHA) Class III or IV congestive heart failure;   Unstable angina: Canadian Cardiovascular Society (CCS) Class III/IV;   Renal failure: end -stage renal disease on dialysis;   Common Carotid Artery (CCA) lesion(s) below clavicle;   Severe chronic lung disease;   Previous neck radiation;   High cervical Internal Carotid Artery (ICA) lesion(s);  Restenosis of prior CEA;   Tracheostomy;   Contralateral laryngeal nerve palsy.   e. Is the patien t symptomatic (defined below)?    Carotid Transient Ischemic Attack (TIA) persisting less than 24 hours;   Non-disabling stroke: Modified Rankin Scale   Transient monocular blindness: amaurosis fugax.   f.  Modified Rankin Scale score if the patient experienced a stroke.  g.  Percent of stenosis of stented lesion(s) by angiography. h. Was embolic protection used?  i. Were there any complications during hospitalization (defined below)?   o All stroke: an ischemic neurologic deficit that persisted more than 24 hours;  o MI;  o All death.   Recertification is effective for two (2) additional years during which facilities will be required to submit the requested data every April 1 and October 1.   The CMS will consider the approval of national CAS registries that provide CMS with a comprehensive overview of the registry and its capabilities, and the manner in which the registry meets CMS data collection and evaluation requirements. Specific standards f or CMS approval are listed below. Facilities enrolled in a CMS -approved national CAS registry will automatically meet the data collection standards required for initial and continued facility certification. Hospitals contracts with an approved registry ma y include authority for the registry to submit required data to CMS for the hospital. A list of approved registries will be available on the CMS Coverage Web site.   National Registries   As noted above, CMS will approve national registries developed by prof essional societies and other organizations and allow these entities to collect and submit data to CMS on behalf of participating facilities to meet facility certification and recertification requirements. To be eligible to perform these functions and becom e a CMS -approved registry, the national registry, at a minimum, must be able to:   1. Enroll facilities in every U.S. state and territory;  2. Assure data confidentiality and compliance with HIPPA;  3. Collect the required CMS data elements as listed in the above section;  4. Assure data quality and data completeness;  5. Address deficiencies in the facility data collection, quality, and submission;  6. Validate the data submitted by facilities as needed;  7. Track long term outcomes such as stroke and death;  8. Conduct data analyses and produce facility specific data reports and summaries;  9. Submit data to CMS on behalf of the individual facilities; and  10. Provide quarterly reports to CMS on facilities that do not meet or no longer meet the CMS facility certification and recertification requirements pertaining to data collection and analysis.   Registries wishing to receive this designation from CMS must submit evidence that they meet or exceed our standards.  Though the registry requirements pertain to CAS, CMS strongly encourages all national registries to establish a similar mechanism to collect comparable data on CEA.  Having both CAS and CEA data will help answer questions about carotid revascularization, in general, in the Medicare population.  The CAS for patients who are not at high risk for CEA remains covered only in FDA -approved Category B IDE clinical trials under 42 CFR 405.201.  The CMS has determined that PTA of the carotid artery concurrent with the placement of an FDA -approved carotid stent and an FDA -approved or cleared embolic protection device is not reasonable and necessary for all other patients.  5. Concurrent with Intracranial Stent Placement in FDA -Approved Category B IDE Clinical Trials   Effective November 6, 2006, Medicare covers PTA and stenting of intracranial arteries for the treatment of cerebral artery stenosis 50% in patients with intracranial atherosclerotic disease when furnished in accordance with the FDA -approved protocols governing Category B IDE clinical trials.  CMS determines that coverage of intracranial PTA and stenting is reasonable and necessary under these circumstances.   C. Nationally Non -Covered Indications   All other indications for PTA with or without stenting to  treat obstructive lesions of the vertebral and cerebral arteries remain non -covered.   All other indications for PTA without stenting for which CMS has not specifically indicated coverage remain non- covered.   D. Other  Coverage of PTA with stenting not specifically addressed or discussed in this NCD is at local A/B MAC discretion.    20.8 - Cardiac Pacemakers (Various Effective Dates Below)  (Rev. 173, Issued: 09- 04-14, Effective: Upon Implementation: of ICD -10, Implementation: Upon Implementation of ICD -10)  Cardiac pacemakers are self -contained, battery -operated units that send electrical stimulation to the heart.  They are generally implanted to alleviate symptoms of decreased cardiac output related to abnormal heart rate and/or rh ythm.  Pacemakers are generally used for persistent, symptomatic second - or third -degree atrioventricular (AV) block and symptomatic sinus bradycardia.   Cardiac pacemakers are covered as prosthetic devices under the Medicare program, subject to the followi ng conditions and limitations.  While cardiac pacemakers have been covered under Medicare for many years, there were no specific guidelines for their use other than the general Medicare requirement that covered services be reasonable and necessary for the treatment of the condition.  Services rendered for cardiac pacing on or after the effective dates of this instruction are subject to these guidelines, which are based on certain assumptions regarding the clinical goals of cardiac pacing.  While some uses of pacemakers are relatively certain or unambiguous, many other uses require considerable expertise and judgment.  Consequently, the medical necessity for permanent cardiac pacing must be viewed in the context of overall patient management.  The appropriate ness of such pacing may be conditional on other diagnostic or therapeutic modalities having been undertaken.  Although significant complications and adverse side effects of pacemaker use are relatively rare, they cannot be ignored when considering the use of pacemakers for dubious medical conditions, or marginal clinical benefit.   These guidelines represent current concepts regarding medical circumstances in which permanent cardiac pacing may be appropriate or necessary.  As with other areas of medicine, ad vances in knowledge and techniques in cardiology are expected. Consequently, judgments about the medical necessity and acceptability of new uses for cardiac pacing in new classes of patients may change as more conclusive evidence becomes available.  This i nstruction applies only to permanent cardiac pacemakers, and does not address the use of temporary, non -implanted pacemakers.   The two groups of conditions outlined below deal with the necessity for cardiac pacing for patients in general.  These are intended as guidelines in assessing the medical necessity for pacing therapies, taking into account the particular circumstances in each case.  However, as a general rule, the two groups of current medical concepts may be viewed as representing:   Group I :  Singl e-Chamber Cardiac Pacemakers  a) conditions under which single chamber pacemaker claims may be considered covered without further claims development; and b) conditions under which single -chamber pacemaker claims would be denied unless further claims devel opment shows that they fall into the covered category, or special medical circumstances exist of the sufficiency to convince the A/B MAC that the claim should be paid.   Group II :  Dual -Chamber Cardiac Pacemakers -  a) conditions under which dual -chamber pacemaker claims may be considered covered without further claims development, and b) conditions under which dual -chamber pacemaker claims would be denied unless further claims development shows that they fall into the covered categories for single - and dual -chamber pacemakers, or special medical circumstances exist sufficient to convince the A/B MAC that the claim should be paid.  The Centers for Medicare & Medicaid Services (CMS) opened the National Coverage Determination (NCD) on Cardiac Pacemakers to afford the public an opportunity to comment on the proposal to revise the language contained in the instruction.  The revisions transfer the focus of the NCD from the actual pacemaker implantation procedure itself to the reasonable and necess ary medical indications that justify cardiac pacing.  This is consistent with our findings that pacemaker implantation is no longer considered routinely harmful or an experimental procedure.   Group I :  Single -Chamber Cardiac Pacemakers (Effective March 16,  1983)