evekhm/cms_iom_500 huggingface dataset:
(Medicare National Coverage Determinations Manual)
Medicare covers a variety of services for the post -implant follow -up and evaluation of implanted cardiac  pacemakers.  The following guidelines are designed to assist A/B MACs in identifying and processing claims for such services.  NOTE:  These new guidelines are limited to lithium battery -powered pacemakers, because mercury -zinc battery -powered pacemakers ar e no longer being manufactured and virtually all have been replaced by lithium units.  A/B MACs still receiving claims for monitoring such units should continue to apply the guidelines published in 1980 to those units until they are replaced.  There are tw o general types of pacemakers in current use -  single -chamber pacemakers which sense and pace the ventricles of the heart, and dual -chamber pacemakers which sense and pace both the atria and the ventricles.  These differences require different monitoring patterns over the expected life of the units involved.  One fact of which A/B MACs should be aware is that many dual -chamber units may be programmed to pace only the ventricles; this may be done either at the time the pacemaker is implanted or at some time afterward.  In such cases, a dual -chamber unit, when programmed or reprogrammed for ventricular pacing, should be treated as a single -chamber pacemaker in applying screening guidelines.  The decision as to how often any patients pacemaker should be monitored is the responsibility of the patients physician who is best able to take into account the condition and circumstances of the individual patient.  These may vary over time, requiring modifications of the frequency with which the patient should be monit ored.  In cases where monitoring is done by some entity other than the patients physician, such as a commercial monitoring service or hospital outpatient department, the physicians prescription for monitoring is required and should be periodically renewe d (at least annually) to assure that the frequency of monitoring is proper for the patient.  Where a patient is monitored both during clinic visits and transtelephonically, the A/B MAC should be sure to include frequency data on both types of monitoring in evaluating the reasonableness of the frequency of monitoring services received by the patient. Since there are over 200 pacemaker models in service at any given point, and a variety of patient conditions that give rise to the need for pacemakers, the question of the appropriate frequency of monitoring is a complex one.  Nevertheless, it is possible to develop guidelines within which the vast majority of
(Medicare National Coverage Determinations Manual)
in service at any given point, and a variety of patient conditions that give rise to the need for pacemakers, the question of the appropriate frequency of monitoring is a complex one.  Nevertheless, it is possible to develop guidelines within which the vast majority of pacemaker monitoring will fall and A/B MACs should do this, using their own data and experience, as well as the frequency guidelines which follow, in order to limit extensive claims development to those cases requiring special attention.  20.8.1.1 - Transtelephonic Monitoring of Cardiac Pacemakers  (Rev. 173, Issued: 09- 04-14, Effective: Upon Implementation: of ICD -10, Implementation: Upon Implementation of ICD -10)
(Medicare National Coverage Determinations Manual)
A.  General   Transtelephonic monitoring of pacemakers is furnished by commercial suppliers, hospital outpatient departments, and physicians offices.   Telephone monitoring of cardiac pacemakers as described below is medically efficacious in identifying early signs of possible pacemaker failure, thus reducing the number of sudden pacemaker failures requiring emergency replacement.  All systems that monitor the pacemaker rate (bpm) in both the free -running and/or magnetic mode are effective in detecting subclinical pacema ker failure due to battery depletion.  More sophisticated systems are also capable of detecting internal electronic problems within the pulse generator itself and other potential problems.  In the case of dual -chamber pacemakers in particular, such monitor ing may detect failure of synchronization of the atria and ventricles, and the need for adjustment and reprogramming of the device.   NOTE:  The transmitting device furnished to the patient is simply one component of the diagnostic system, and is not covered as durable medical equipment.  Those engaged in transtelephonic pacemaker monitoring should reflect the costs of the transmitters in setting their charges for monitoring.   B.  Definition of Transtelephonic Monitoring   In order for transtelephonic monitori ng services to be covered, the services must consist of the following elements:    A minimum 30 -second readable strip of the pacemaker in the free -running mode;    Unless contraindicated, a minimum 30- second readable strip of the pacemaker in the magnetic mode ; and,    A minimum 30 seconds of readable ECG strip.   C.  Frequency Guidelines for Transtelephonic Monitoring   The guidelines below constitute a system which A/B MACs should use, in conjunction with their knowledge of local medical practices, to screen clai ms for transtelephonic monitoring prior to payment. It is important to note that they are not recommendations with respect to a minimum frequency for such monitorings, but rather a maximum frequency (within which payment may be made without further claims development).  As with previous guidelines, more frequent monitorings may be covered in cases where A/B MACs are satisfied that such monitorings are medically necessary; e.g., based on the condition of the patient, or with respect to pacemakers exhibiting unexpected defects or premature failure.  A/B MACs should seek written justification for more frequent monitorings from the patients physician and/or any monitoring service involved.
(Medicare National Coverage Determinations Manual)
These guidelines are divided into two broad categories -  Guideline I which will apply to the majority of pacemakers now in use, and Guideline II which will apply only to pacemaker systems (pacemaker and leads) for which sufficient long -term clinical inform ation exists to assure that they meet the standards of the Inter -Society Commission for Heart Disease Resources (ICHD) for longevity and end- of-life decay.  (The ICHD standards are: (1) 90% cumulative survival at 5 years following implant; and (2) an end -of-life decay of less than a 50% drop of output voltage and less than 20% deviation of magnet rate, or a drop of 5 beats per minute or less, over a period of 3 months or more.)  A/B MACs should consult with their medical advisers and other appropriate individuals and organizations (such as the North American Society of Pacing and Electrophysiology which publishes product reliability information) should questions arise over whether a pacemaker system meets the ICHD standards.   The two groups of guidelines are  then further broken down into two general categories  single -chamber and dual -chamber pacemakers. A/B MACs should be aware that the frequency with which a patient is monitored may be changed from time -to-time for a number of reasons, such as a change in the patients overall condition, a reprogramming of the patients pacemaker, the development of better information on the pacemakers longevity or failure mode, etc.  Consequently, changes in the proper set of guidelines may be required. A/B MACs should inform physicians and monitoring services to alert A/B MACs to any changes in the patients monitoring prescription that might necessitate changes in the screening guidelines applied to that patient.  (Of particular importance is the reprogramming of a dual -chamber pacemaker to a single -chamber mode of operation. Such reprogramming would shift the patient from the appropriate dual -chamber guideline to the appropriate single -chamber guideline.)   Guideline I   1 - Single -chamber pacemakers  1st month -  every 2 we eks. 2nd through 36th month -  every 8 weeks.  37th month to failure -  every 4 weeks.   2 - Dual -chamber pacemaker  1st month -  every 2 weeks.  2nd through 6th month -  every 4 weeks.  7th through 36th month -  every 8 weeks.  37th month to failure -  every 4 weeks.   Guideline II
(Medicare National Coverage Determinations Manual)
2 - Dual -chamber pacemaker  1st month -  every 2 weeks.  2nd through 6th month -  every 4 weeks.  7th through 36th month -  every 8 weeks.  37th month to failure -  every 4 weeks.   Guideline II   1 - Single -chamber pacemakers  1st month -  every 2 weeks.  2nd through 48th month -  every 12 weeks.  49th through 72nd month -  every 8 weeks.  Thereafter - every 4 weeks.  2 - Dual -chamber pacemaker  1st month -  every 2 weeks.  2nd through 30th month -  every 12 weeks.  31st through 48th month - every 8 weeks.  Thereafter - every 4 weeks.  D.  Pacemaker Clinic Services   1.  General   Pacemaker monitoring is also covered when done by pacemaker clinics.  Clinic visits may be done in conjunction wi th transtelephonic monitoring or as a separate service; however, the services rendered by a pacemaker clinic are more extensive than those currently possible by telephone.  They include, for example, physical examination of patients and reprogramming of pa cemakers.  Thus, the use of one of these types of monitoring does not preclude concurrent use of the other.   2.  Frequency Guidelines   As with transtelephonic pacemaker monitoring, the frequency of clinic visits is the decision of the patients physician, taking into account, among other things, the medical condition of the patient.  However, A/B MACs can develop monitoring guidelines that will prove useful in screening claims.  The following are recommendations for monitoring guidelines on lithium -battery pacemakers:    For single -chamber pacemakers -  twice in the first 6 months following implant, then once every 12 months.   For dual -chamber pacemakers -  twice in the first 6 months, then once every 6 months.  20.8.2 - Self-Contained Pacemaker Monitors (Rev. 1, 10- 03-03)  CIM 60 -7  Self-contained pacemaker monitors are accepted devices for monitoring cardiac pace -makers.  Accordingly, program payment may be made for the rental or purchase of either of the following pacemaker monitors when a physician for a patient prescribes it with a cardiac pacemaker:   A.  Digital Electronic Pacemaker Monitor
(Medicare National Coverage Determinations Manual)
A.  Digital Electronic Pacemaker Monitor   This device provide s the patient with an instantaneous digital readout of his pacemaker pulse rate.  Use of this device does not involve professional services until there has been a change of five pulses (or more) per minute above or below the initial rate of the pacemaker; when such change occurs, the patient contacts his physician.   B.  Audible/Visible Signal Pacemaker Monitor   This device produces an audible and visible signal which indicates the pacemaker rate.  Use of this device does not involve professional services until a change occurs in these signals; at such time, the patient contacts his physician.   NOTE:  The design of the self -contained pacemaker monitor makes it possible for the patient to monitor his pacemaker periodically and minimizes the need for regular vis its to the outpatient department of the provider.   Therefore, documentation of the medical necessity for pacemaker evaluation in the outpatient department of the provider should be obtained where such evaluation is employed in addition to the self -containe d pacemaker monitor used by the patient in his home.  Cross -reference:  20.8.1   20.8.3  Single Chamber and Dual Chamber Permanent Cardiac Pacemakers  (Rev.  187, Issued: 12- 10-15, Effective:  08-13-13, Issued: 01- 13-16)  A. General   Permanent cardiac pacemakers refer to a group of self -contained, battery operated, implanted devices that send electrical stimulation to the heart through one or more implanted leads.  They are often classified by the number of chambers of the heart that the devices stimulate (pulse or depolarize).  Single chamber pacemakers typically target either the right atrium or right ventricle.  Dual chamber pacemakers stimulate both the right atrium and the rig ht ventricle.
(Medicare National Coverage Determinations Manual)
The implantation procedure is typically performed under local anesthesia and requires only a brief hospitalization.  A catheter is inserted into the chest and the pacemakers leads are threaded through the catheter to the appropriate chamber (s) of the heart.  The surgeon then makes a small pocket in the pad of the flesh under the skin on the upper portion of the chest wall to hold the power source.  The pocket is then closed with stitches.   The Centers for Medicare & Medicaid Services (CMS)  has determined that the evidence is sufficient to conclude that implanted permanent cardiac pacemakers, single chamber or dual chamber, are reasonable and necessary for the treatment of non -reversible symptomatic bradycardia due to sinus node dysfunction and second and/or third degree atrioventricular block.  Symptoms of bradycardia are symptoms that can be directly attributable to a heart rate less than 60 beats per minute (for example:  syncope, seizures, congestive heart failure, dizziness, or confusion).   B. Nationally Covered Indications   The following indications are covered for implanted permanent single chamber or dual chamber cardiac pacemakers:   1. Documented non- reversible symptomatic bradycardia due to sinus node dysfunction, and  2. Documented non- reversible symptomatic bradycardia due to second degree and/or third degree atrioventricular block.   C. Nationally Non -Covered Indications   The following indications are non- covered for implanted permanent single chamber or dual chamber cardiac pacemakers:
(Medicare National Coverage Determinations Manual)
C. Nationally Non -Covered Indications   The following indications are non- covered for implanted permanent single chamber or dual chamber cardiac pacemakers:   1. Reversible causes of bradycardia such as electrolyte abnormalities, medications or drugs, and hypothermia,  2. Asymptomatic first degree atrioventricular block,  3. Asymptomatic sinus bradycardia,  4. Asymptomatic sino -atrial block or asymptomatic sinus arrest,  5. Ineffective atrial contractions (e.g., chronic atrial fibrillation or flutter, or giant left atrium) without symptomatic bradycardia,  6. Asymptomatic second degree atrioventricular block of Mobitz Type I unless the QRS complexes are prolonged or electrophysi ological studies have demonstrated that the block is at or beyond the level of the His Bundle (a component of the electrical conduction system of the heart),  7. Syncope of undetermined cause,  8. Bradycardia during sleep, 9. Right bundle branch block with left axi s deviation (and other forms of fascicular or bundle branch block) without syncope or other symptoms of intermittent atrioventricular block,  10. Asymptomatic bradycardia in post -myocardial infarction patients about to initiate long- term beta -blocker drug thera py, 11. Frequent or persistent supraventricular tachycardias, except where the pacemaker is specifically for the control of tachycardia, and  12. A clinical condition in which pacing takes place only intermittently and briefly, and which is not associated with a re asonable likelihood that pacing needs will become prolonged.   D. Other  A/B MACs will determine coverage under section 1862(a)(1)(A) of the Social Security Act for any other indications for the implantation and use of single chamber or dual chamber cardiac pa cemakers that are not specifically addressed in this national coverage determination.   (This NCD last reviewed August 2013.)   20.8.4  Leadless Pacemakers  (Rev.  201, Issued: 07- 28-17, Effective: 01 -18-18, Implementation: 08- 29-17- for MAC local edits; Jan uary 2, 2018 -  for MCS shared edits)   A. General
(Medicare National Coverage Determinations Manual)
A. General   The leadless pacemaker eliminates the need for a device pocket and insertion of a pacing lead which are integral elements of traditional pacing systems. The removal of these elements eliminate an important source of complications associated with traditiona l pacing systems while providing similar benefits. Leadless pacemakers are delivered via catheter to the heart, and function similarly to other transvenous single -chamber ventricular pacemakers.   B. Nationally Covered Indications   Effective January 18, 2017, the Centers for Medicare & Medicaid Services (CMS) covers leadless pacemakers through Coverage with Evidence Development (CED).  CMS covers leadless pacemakers when procedures are performed in Food and Drug Administration (FDA) approved studies.  CMS al so covers, in prospective longitudinal studies, leadless pacemakers that are used in accordance with the FDA approved label for devices that have either:   an associated ongoing FDA approved post -approval study; or   completed an FDA post -approval study.   Each  study must be approved by CMS and as a fully- described, written part of its protocol, must address the following research questions:   What are the peri -procedural and post -procedural complications of leadless pacemakers?   What are the long term outcomes of leadless pacemakers?   What are the effects of patient characteristics (age, gender, comorbidities) on the use and health effects of leadless pacemakers?   CMS will review studies to determine if they meet the 13 criteria listed below.  If CMS determines that  they meet these criteria, the study will be posted on CMS CED website (https://www.cms.gov/Medicare/Coverage/Coverage -with-Evidence -Development/index.html ).
(Medicare National Coverage Determinations Manual)
a. The principal purpose of the study is to test whether the item or service meaningfully improves health outcomes of affected beneficiaries who are represented by the enrolled subjects.    b. The rationale for the study is well supported by available scientific and medical evidence.  c. The study r esults are not anticipated to unjustifiably duplicate existing knowledge.  d. The study design is methodologically appropriate and the anticipated number of enrolled subjects is sufficient to answer the research question(s) being asked in the National Coverag e Determination.  e. The study is sponsored by an organization or individual capable of completing it successfully.  f. The research study is in compliance with all applicable Federal regulations concerning the protection of human subjects found in the Code of F ederal Regulations (CFR) at 45 CFR Part 46. If a study is regulated by the Food and Drug Administration (FDA), it is also in compliance with 21 CFR Parts 50 and 56.  In addition, to further enhance the protection of human subjects in studies conducted unde r CED, the study must provide and obtain meaningful informed consent from patients regarding the risks associated with the study items and/or services, and the use and eventual disposition of the collected data.  g. All aspects of the study are conducted according to appropriate standards of scientific integrity.  h. The study has a written protocol that clearly demonstrates adherence to the standards listed here as Medicare requirements.  i. The study is not designed to exclusively test toxicity or disease pathophysiology in healthy individuals. Such studies may meet this requirement only if the disease or condition being studied is life threatening as defined in 21 CFR 312.81(a) and the patient has no other viable treatment options.  j. The clinical research studies and registries are registered on the www.ClinicalTrials.gov website by the principal sponsor/investigator prior to the enrollment of the first study subject.   Registries are also registered in the Agency for Healthcare Research and Quality (AHRQ) R egistry of Patient Registries (RoPR).  k. The research study protocol specifies the method and timing of public release of all prespecified outcomes to be measured including release of outcomes if outcomes are negative or study is terminated early.   The resul ts must be made public within 12 months of the studys primary completion date, which is the date the final subject had final data collection for the primary endpoint, even if the trial does not
(Medicare National Coverage Determinations Manual)
negative or study is terminated early.   The resul ts must be made public within 12 months of the studys primary completion date, which is the date the final subject had final data collection for the primary endpoint, even if the trial does not achieve its primary aim.  The results must include number started/completed, summary results for primary and secondary outcome measures, statistical analyses, and adverse events. Final results must be reported in a publicly accessibly manner; either in a peer -reviewed scientific journal (in print or on-line), in an on- line publicly accessible registry dedicated to the dissemination of clinical trial information such as ClinicalTrials.gov, or in journals willing to publish in abbreviated format (e.g., for studies with negative or incomplete results).  l. The study protoc ol must explicitly discuss beneficiary subpopulations affected by the item or service under investigation, particularly traditionally underrepresented groups in clinical studies, how the inclusion and exclusion criteria effect enrollment of these populations, and a plan for the retention and reporting of said populations in the trial.  If the inclusion and exclusion criteria are expected to have a negative effect on the recruitment or retention of underrepresented populations, the protocol must discuss why these criteria are necessary.  m. The study protocol explicitly discusses how the results are or are not expected to be generalizable to affected beneficiary subpopulations. Separate discussions in the protocol may be necessary for populations eligible for Me dicare due to age, disability or Medicaid eligibility.
(Medicare National Coverage Determinations Manual)
Consistent with section 1142 of the Act, the Agency for Healthcare Research and Quality (AHRQ) supports clinical research studies that CMS determines meet the above- listed standards and address the a bove -listed research questions.   All clinical research study protocols must be reviewed and approved by CMS.  The principal investigator must submit the complete study protocol, identify the relevant CMS research question(s) that will be addressed and cit e the location of the detailed analysis plan for those questions in the protocol, plus provide a statement addressing how the study satisfies each of the standards of scientific integrity (a. through m. listed above), as well as the investigators contact information, to the address below. The information will be reviewed, and approved studies will be identified on the CMS website.   Director, Coverage and Analysis Group  Re: Leadless Pacemakers CED  Centers for Medicare & Medicaid Services (CMS)  7500 Securit y Blvd., Mail Stop S3- 02-01 Baltimore, MD 21244- 1850  Email address for protocol submissions: clinicalstudynotification@cms.hhs.gov Email subject line: CED [NCD topic (i.e. Leadless Pacemakers)] [name of sponsor/primary investigator]   C. Nationally Non -Covered Indications   Leadless pacemakers are non -covered when furnished outside of a CMS approved CED study.  D. Other   NA  (This NCD last reviewed January 2017.)   20.9 - Artificial Hearts and Related Devices (RETIRED)  (Rev. 11892; Issued: 03- 09-23; Effective: 04 -10-23; Implementation:04- 10-23)    This section has been removed from the NCD Manual and incorporated into NCD 20.9.1 effective December 1, 2020.  20.9.1 - Ventricular Assist Devices (VADs)  (Rev.10837; Issued: 06- 11-21; Effective: 12 -01-20; Implementation: 07 -27-21)  A. General   A ventricular assist device (VAD) is surgically attached to one or both intact ventricles and is used to assist or augment the ability of a damaged or weakened native heart to pump blood. Improvement in the performance of the native heart may allow the device to be removed.   Indications and Limitations of Coverage