evekhm/cms_iom_500 huggingface dataset:
Article - Investigational Device Exemptions (IDE) - IDE Documentation Requirements for Studies with an FDA Approval dated January 01, 2015, or later (A54917)
CMS National Coverage PolicyN/AArticle TextEffective January 01, 2015, CMS Coverage Analysis Group began reviewing all IDE trials for approval. Once CMS approves the trial, they list the trial on their web site as approved. This process is streamlining the approval process for all parties involved.Noridian has reviewed our requirements for such studies. For IDE trials with an FDA approval letter on or after January 01, 2015, that have been approved by CMS Noridian will only require:1. Notice of participation in the trial,2. IDE designator assigned by the FDA3. Clinical trial number as listed onclinical trials.govA letter including the three above stated requirements along with the PTAN of the facility, the names of the principal investigator, study doctors and their NPIs is to be submitted at time of request to Noridian.Such notice is necessary to input into the Noridian claims payment systems to assure proper processing of our providers claims related to such trial. For further information on this process please visit the CMS website:CMS websiteIDE Documentation Requirements for Studies with an FDA Approval dated prior to January 01, 2015For any IDE trial with an FDA approval letter date before January 01, 2015, Noridian will continue to require the following documentation:1. Name of the trial, the assigned FDA IDE number and the Clinical Trial number;2. The study protocol;3. The most recent institutional IRB approval letter;4. The most recent IRB approved informed consent which includes a financial disclosure for the facility and investigators;5. For the purposes of an IDE approval the following financial disclosuresshallbe included in the informed consent and be clearly marked as such therein:Funding source(s) for the project;Funding for the facility;Funding for the investigators and if that funding is direct to the provider or if the facility is provided funds to offset his/her salary;Any relationship that the provider has with the sponsor. These include but are not limited to being a speaker for the sponsor, receiving other gratuities fromthe sponsor and/or being a paid consultant for the sponsor;Other financial interests in the sponsor(s) such as stocks or other investments;Any other potential conflict of interest as it regards the respective study;Any such interest as disclosed to the Institutional Review Board.
Article - Investigational Device Exemptions (IDE) - IDE Documentation Requirements for Studies with an FDA Approval dated January 01, 2015, or later (A54917)
Other financial interests in the sponsor(s) such as stocks or other investments;Any other potential conflict of interest as it regards the respective study;Any such interest as disclosed to the Institutional Review Board.The informed consent does not necessarily need to include the extent of such potential conflict (e.g. how many stocks the institution/ primary investigator (PI)/ secondary or other investigators (SI) has from the sponsor or the actual monies paid directly to the institution/PI/SI) only that one exits. Noridian does reserve the right to request a budgetary review of IDE trials/studies, but the latter does not need to be submitted with the application.Failure to provide such information either in the affirmative with a listing of such items or in the negative (no known conflicts) will result in a denial of the request. The provision of fraudulent information will be referred to Medicare enforcement agencies.IDE SubmissionsAll IDE submissions regardless of FDA letter date should be sent to one of the following:Email:iderequests@noridian.comHard copy:ATTN: IDE CoordinatorPO Box 6782Fargo, ND 58103-6722For those IDE studies with an FDA approval letter datedbeforeJanuary 01, 2015, provider notification will be sent out upon approval/disapproval. If an application is approved, the system will be set to accept a providers claims.For those studies with an FDA approval letter dated on or after January 01, 2015, a notice of receipt of the information and confirmation that the study has been vetted by CMS will be sent to the provider.ResourcesProviders should adhere to the CMS billing requirements to ensure the proper processing of IDE claims.CMS Internet Only Manual (IOM), Publication 100-4, Medicare Claims Processing Manual, Chapter 32, Section 68IOM, Publication 100-02, Medicare Benefit Policy Manual, Chapter 14, Section 20Federal Register Vol. 78, No. 237CMS Change Request (CR) 8401
Article - Investigational Device Exemptions (IDE) - IDE Documentation Requirements for Studies with an FDA Approval dated January 01, 2015, or later (A54919)
CMS National Coverage PolicyN/AArticle TextEffective January 01, 2015, CMS Coverage Analysis Group began reviewing all IDE trials for approval. Once CMS approves the trial, they list the trial on their web site as approved. This process is streamlining the approval process for all parties involved.Noridian has reviewed our requirements for such studies. For IDE trials with an FDA approval letter on or after January 01, 2015, that have been approved by CMS Noridian will only require:1. Notice of participation in the trial,2. IDE designator assigned by the FDA3. Clinical trial number as listed onclinical trials.govA letter including the three above stated requirements along with the PTAN of the facility, the names of the principal investigator, study doctors and their NPIs is to be submitted at time of request to Noridian.Such notice is necessary to input into the Noridian claims payment systems to assure proper processing of our providers claims related to such trial. For further information on this process please visit the CMS website:CMS websiteIDE Documentation Requirements for Studies with an FDA Approval dated prior to January 01, 2015For any IDE trial with an FDA approval letter date before January 01, 2015, Noridian will continue to require the following documentation:1. Name of the trial, the assigned FDA IDE number and the Clinical Trial number;2. The study protocol;3. The most recent institutional IRB approval letter;4. The most recent IRB approved informed consent which includes a financial disclosure for the facility and investigators;5. For the purposes of an IDE approval the following financial disclosuresshallbe included in the informed consent and be clearly marked as such therein:Funding source(s) for the project;Funding for the facility;Funding for the investigators and if that funding is direct to the provider or if the facility is provided funds to offset his/her salary;Any relationship that the provider has with the sponsor. These include but are not limited to being a speaker for the sponsor, receiving other gratuities fromthe sponsor and/or being a paid consultant for the sponsor;Other financial interests in the sponsor(s) such as stocks or other investments;Any other potential conflict of interest as it regards the respective study;Any such interest as disclosed to the Institutional Review Board.
Article - Investigational Device Exemptions (IDE) - IDE Documentation Requirements for Studies with an FDA Approval dated January 01, 2015, or later (A54919)
Other financial interests in the sponsor(s) such as stocks or other investments;Any other potential conflict of interest as it regards the respective study;Any such interest as disclosed to the Institutional Review Board.The informed consent does not necessarily need to include the extent of such potential conflict (e.g. how many stocks the institution/ primary investigator (PI)/ secondary or other investigators (SI) has from the sponsor or the actual monies paid directly to the institution/PI/SI) only that one exits. Noridian does reserve the right to request a budgetary review of IDE trials/studies, but the latter does not need to be submitted with the application.Failure to provide such information either in the affirmative with a listing of such items or in the negative (no known conflicts) will result in a denial of the request. The provision of fraudulent information will be referred to Medicare enforcement agencies.IDE SubmissionsAll IDE submissions regardless of FDA letter date should be sent to one of the following:Email: iderequests@noridian.comHard Copy:ATTN: IDE CoordinatorPO Box 6782Fargo, ND 58103-6722For those IDE studies with an FDA approval letter datedbeforeJanuary 01, 2015, provider notification will be sent out upon approval/disapproval. If an application is approved, the system will be set to accept a providers claims.For those studies with an FDA approval letter dated on or after January 01, 2015, a notice of receipt of the information and confirmation that the study has been vetted by CMS will be sent to the provider.ResourcesProviders should adhere to the CMS billing requirements to ensure the proper processing of IDE claims.CMS Internet Only Manual (IOM), Publication 100-4, Medicare Claims Processing Manual, Chapter 32, Section 68IOM, Publication 100-02, Medicare Benefit Policy Manual, Chapter 14, Section 20Federal Register Vol. 78, No. 237CMS Change Request (CR) 8401
Article - Billing and Coding: Bariatric Surgery for Treatment of Co-Morbidities Conditions Related to Morbid Obesity (A54923)
CMS National Coverage PolicyN/AArticle TextItalicized fontrepresents CMS national language/wording copied directly from CMS Manuals or CMS Transmittals. Contractors are prohibited from changing national NCD language/wording.Bariatric Surgery for Treatment of Morbid Obesity is a payable Medicare service when billed in accordance with instructions outlined in:CMS Pub 100-03Medicare National Coverage Determinations (NCD) Manual,Chapter 1  Coverage Determinations, Part 2 (Sections 90-160.2), Section 100.1 - Bariatric Surgery for Treatment of Co-morbid Conditions Related to Morbid Obesity (Effective September 24, 2013).CMS Pub 100-04Medicare Claims Processing Manual,Chapter 32  Billing Requirements for Special Services, Section 150- Billing Requirements for Bariatric Surgery for Morbid Obesity.This local coverage Article lists the additional diagnoses that are covered for bariatric surgery for treatment of co-morbid conditions related to morbid obesityfor the procedure codes for Part A providers found in CMS Pub 100-04Medicare Claims Processing Manual, Chapter 32  Billing requirements for Special Services, Section 150- Billing Requirements for Bariatric Surgery for Morbid Obesity; and the listed CPT codes in the article. The diagnoses codes listed in section150.5.1 -ICD Codes for Type II Diabetes Mellitus Complication are not included in this article but are covered based on the IOM.
Article - Billing and Coding: Single Chamber and Dual Chamber Permanent Cardiac Pacemakers (A54926)
CMS National Coverage PolicyN/AArticle TextAbstract:The National Coverage Determination (NCD) 20.8.3, Single Chamber and Dual Chamber Permanent Cardiac Pacemakers, was revised with an effective date of August 13, 2013. The CMS A/B Medicare Administrative Contractors (MACs) have been instructed to implement the NCD at the local level. The following provides coding and billing instructions for the implementation of NCD 20.8.3. (CMS policy language is initalics.) The NCD Item/Service Description and Indications and Limitations are repeated here.Item/Service DescriptionA. GeneralPermanent 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 right ventricle.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).Indications and Limitations of CoverageB. Nationally Covered IndicationsThe following indications are covered for implanted permanent single chamber or dual chamber cardiac pacemakers:
Article - Billing and Coding: Single Chamber and Dual Chamber Permanent Cardiac Pacemakers (A54926)
Indications and Limitations of CoverageB. Nationally Covered IndicationsThe following indications are covered for implanted permanent single chamber or dual chamber cardiac pacemakers:Documented non-reversible symptomatic bradycardia due to sinus node dysfunction, andDocumented non-reversible symptomatic bradycardia due to second degree and/or third degree atrioventricular block.C. Nationally Non-Covered IndicationsThe following indications are non-covered for implanted permanent single chamber or dual chamber cardiac pacemakers:Reversible causes of bradycardia such as electrolyte abnormalities, medications or drugs, and hypothermia,Asymptomatic first degree atrioventricular block,Asymptomatic sinus bradycardia,Asymptomatic sino-atrial block or asymptomatic sinus arrest,Ineffective atrial contractions (e.g., chronic atrial fibrillation or flutter, or giant left atrium) without symptomatic bradycardia,Asymptomatic second degree atrioventricular block of Mobitz Type I unless the QRS complexes are prolonged or electrophysiological 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),Syncope of undetermined cause,Bradycardia during sleep,Right bundle branch block with left axis deviation (and other forms of fascicular or bundle branch block) without syncope or other symptoms of intermittent atrioventricular block,Asymptomatic bradycardia in post-myocardial infarction patients about to initiate long-term beta-blocker drug therapy,Frequent or persistent supraventricular tachycardias, except where the pacemaker is specifically for the control of tachycardia, andA clinical condition in which pacing takes place only intermittently and briefly, and which is not associated with a reasonable likelihood that pacing needs will become prolonged.D. OtherMedicare Administrative Contractors 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 pacemakers that are not specifically addressed in this national coverage determination.(This NCD last reviewed August 2013.)
Article - Billing and Coding: Single Chamber and Dual Chamber Permanent Cardiac Pacemakers (A54926)
Please note:The Decision Memo for Cardiac Pacemakers: Single-Chamber and Dual-Chamber Permanent Cardiac Pacemaker (CAG-00063R3) states:CMS initiated this current national coverage analysis to reconsider coverage indications for single chamber and dual chamber cardiac pacemakers. The scope of this reconsideration and this decision memorandum does not address biventricular pacemakers, pacemakers that stimulate more than two heart chambers, those devices used to treat tachyarrhythmias and cardiac dyssynchrony, cardiac resynchronization therapy, cardiac pacemaker evaluation services, or self-contained pacemaker monitors.Medicare Administrative Contractors 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 pacemakers that are not specifically addressed in this national coverage determination.The coding and billing guidelines only apply to those CPT codes for the initial insertion of cardiac pacemakers:33206 Insertion of new or replacement of permanent pacemaker with transvenous electrode(s); atrial33207 ventricular33208 atrial and ventricularThe NCD does not address replacement of pacemaker generators. CPT codes 33227, 33228 and 33229 or 33233 are therefore not addressed in this coding article.CMS NCD Covered Conditions and Diagnosis Codes  Group IClinical Conditions:Documented non-reversible symptomatic bradycardia due to sinus node dysfunctionDocumented non-reversible symptomatic bradycardia due to second degree and/or third degree atrioventricular blockDiagnosis Codes (ICD-10-CM) (Attest with Modifier - KX):Atrioventricular (AV) block (I44.2)Mobitz (type II) AV block (I44.1)Other second degree AV block (I44.1)Sinoatrial node dysfunction/Sick sinus syndrome (I49.5)Congenital heart block (Q24.6)Contractor (Additional) Diagnosis Codes (ICD-10-CM) Allowed by the NCD  Group II (Attest with Modifier - KX)
Article - Billing and Coding: Single Chamber and Dual Chamber Permanent Cardiac Pacemakers (A54926)
Contractor (Additional) Diagnosis Codes (ICD-10-CM) Allowed by the NCD  Group II (Attest with Modifier - KX)Atrioventricular block, unspecified (Symptomatic) (I44.30)First-degree atrioventricular block (Symptomatic with PR interval more than 300 milliseconds) (I44.0)Left bundle branch block, other or unspecified (I44.7)Right bundle branch block, unspecified or other (I45.10 / I45.19)Bundle branch block, unspecified (I45.10 or I45.19)Right bundle branch block and left posterior fascicular block (I45.2)Right bundle branch block and left anterior fascicular block (I45.2)o Other bilateral bundle branch block (I45.2)o Bifascicular block (I45.2)o Trifascicular block (I45.3)Supraventricular tachycardias in which a pacemaker is specifically for control of the tachycardia (I47.1 or I47.9)Paroxysmal supraventricular tachycardia/supraventricular tachycardia (SVT that is reproducibly terminated by pacing when catheter ablation and/or drugs fail to control the arrhythmia or produce intolerable side effects) (I47.1/I47.9)Atrial fibrillation/atrial fibrillation, persistent; unspecified atrial fibrillation (I48.11/I48.19/I48.91) with symptomatic bradycardia due to necessary medical therapyAtrial flutter/atrial flutter, typical/atypical/unspecified (I48.3/I48.4 /or I48.92 with symptomatic bradycardia due to necessary medical therapyHypersensitive carotid sinus syndrome and neurocardiogenic syncope (Syncope without clear, provocative events and with a hypersensitive cardioinhibitory response of 3 seconds or longer or for significantly symptomatic neurocardiogenic syncope associated with bradycardia documented spontaneously or at the time of tilt-table testing (G90.01)
Article - Billing and Coding: Single Chamber and Dual Chamber Permanent Cardiac Pacemakers (A54926)
Other Conditions Not Addressed by the NCD or by the Contractor - Group III include but are not limited to the following (Attest with Modifier - SC):Cardiac resynchronization therapyObstructive hypertrophic cardiomyopathyPacing in children, adolescents, and patients with congenital heart diseasePacemaker or generator replacementsSustained pause-dependent ventricular tachycardia, with or without QT prolongationModifier Usage:Modifier - KX (Requirements specified in the medical policy have been met) must be used as an attestation by the practitioner and/or provider of the service that documentation is on file verifying the patient has a symptomatic arrhythmia or a high potential for progression of the rhythm disturbance requiring a permanent pacemaker forGroups I and II. Bradycardia that is the consequence of essential long-term drug therapy of a type and dose for which there is no acceptable alternativedoes not excludethe use of modifier - KX.In addition, use of modifier - KX may be used in patients without symptoms in Groups I and II in the following situations:
Article - Billing and Coding: Single Chamber and Dual Chamber Permanent Cardiac Pacemakers (A54926)
In addition, use of modifier - KX may be used in patients without symptoms in Groups I and II in the following situations:Awake, symptomfree patients in sinus rhythm, with documented periods of asystole greater than or equal to 3.0 seconds or any escape rate less than 40 beats per minute (bpm), or with an escape rhythm that is below the AV nodeAwake, symptom-free patients with atrial fibrillation and bradycardia with one or more pauses of at least 5 seconds or longerCatheter ablation of the AV junctionPostoperative AV block that is not expected to resolve after cardiac surgeryPatients with neuromuscular diseases, e.g., myotonic muscular dystrophy, Kearns-Sayre syndrome, Erb dystrophy, and peroneal muscular atrophy, with third-degree and advanced second-degree AV block at any anatomic levelAsymptomatic persistent third-degree AV block at any anatomic site with average awake ventricular rates of 40 bpm or faster if cardiomegaly or LV dysfunction is present or if the site of block is below the AV nodeSecond or third-degree AV block during exercise in the absence of myocardial ischemiaPersistent third-degree AV block with an escape rate greater than 40 bpm in asymptomatic adult patients without cardiomegalyAsymptomatic second-degree AV block at intra-or infra-His levels found at electrophysiological studyFirst- or second-degree AV block with symptoms similar to those of pacemaker syndrome or hemodynamic compromiseAsymptomatic type II second-degree AV block with a narrow QRS. Second-degree AV block with a wide QRS including isolated right bundle-branch blockFor medically necessary pacemaker insertion in conditions not addressed by the NCD or this article,Group III, usemodifier - SC(Medically necessary service or supply).
Article - Billing and Coding: Single Chamber and Dual Chamber Permanent Cardiac Pacemakers (A54926)
For medically necessary pacemaker insertion in conditions not addressed by the NCD or this article,Group III, usemodifier - SC(Medically necessary service or supply).Modifiers GA and GZ:Modifier GA (Waiver of liability statement issued as required by payer policy, individual case) should be used when the provider wants to indicate that he/she anticipates that Medicare will deny a specific service as not reasonable and necessary and an Advanced Beneficiary Notice (ABN) Form CMS-R-131 has been signed by the beneficiary and is on file. Modifier GA may also be used on assigned claims when a patient refuses to sign the ABN and the latter is properly witnessed. For claims submitted to the Part A MAC, occurrence code 32 and the date of the ABN are required.Modifier GZ should be used when the provider wants to indicate that it is expected that Medicare will deny the specific services as not reasonable and necessary and the beneficiary was not asked to sign an ABN.Claims for pacemaker claims that do not meet the criteria for modifier KX or SC should have modifier GA or GZ appended depending on the ABN status and will be denied.Documentation RequirementsAll documentation must be maintained in the patient's medical record and made available to the contractor upon request.Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.The submitted medical record must support the use of the selected ICD-10-CM code(s). The submitted CPT/HCPCS code must describe the service performed.