evekhm/cms_iom_500 huggingface dataset:
(Medicare National Coverage Determinations Manual)
o A suitability for short -term warfarin but deemed unable to take long- term oral anticoagulation following the conclusion of shared decision making, as LAAC is only covered as a second line therapy to oral anticoagulants.  The patient (preoperatively and postoperatively) is under the care of a cohesive, multidisciplinary team (MDT) of medical professionals.  The procedure must be furnished in a hospital with an established structural heart disease (SHD) and/or electrophysiology (EP) program.   The procedur e must be performed by an interventional cardiologist(s), electrophysiologist(s), or cardiovascular surgeon (s) that meet the following criteria:    Has received training prescribed by the manufacturer on the safe and effective use of the device prior to per forming LAAC; and,    Has performed  25 interventional cardiac procedures that involve transeptal puncture through an intact septum; and,   Continues to perform  25 interventional cardiac procedures that involve transeptal puncture through an intact septum, of which at least 12 are LAAC, over a 2-year period.   The patient is enrolled in, and the MDT and hospital must participate in, a prospective, national, audited registry that: 1) consecutively enrolls LAAC patients, and, 2) tracks the following annual outcomes for each patient for a period of at least 4 years  from the time of the LAAC:    Operator -specific complications   Device- specific complications including device thrombosis   Stroke, adjudicated, by type   Transient Ischemic Attack (TIA)   Systemic embolism   Death   Major bleeding, by site and severity   The registry m ust be designed to permit identification and analysis of patient, practitioner, and facility level factors that predict patient risk for these outcomes.  The registry must collect all data necessary to conduct analyses adjusted for relevant confounders, and have a written executable analysis plan in place to address the following questions:    How do the outcomes listed above compare to outcomes in the pivotal clinical trials in the short term (12 months) and in the long term ( 4 years)?    What is the long t erm ( 4 year) durability of the device?
(Medicare National Coverage Determinations Manual)
 What is the long t erm ( 4 year) durability of the device?    What are the short term (12 months) and the long term (4 years) device -specific complications including device thromboses?   To appropriately address some of these questions, Medicare claims or other outside data may be necessary.   Registries must be reviewed and approved by CMS.  Potential registry sponsors must submit all registry documentation to CMS for approval, including the written executable analysis plan and auditing plan.  CMS will review the  qualifications of candidate registries to ensure that the approved registry follows standard data collection practices, and collects data necessary to evaluate the patient outcomes specified above.  The registrys national clinical trial number must be re corded on the claim.  Consistent with section 1142 of the Social Security Act (the Act), the Agency for Healthcare Research and Quality (AHRQ) supports clinical research studies that CMS determines address the above -listed research questions and the a -m criteria listed in Section c. of this decision.  All approved registries will be posted on the CED website located at: https://www.cms.gov/Medicare/Coverage/Coverage- with-Evidence -Development/index.html .  b. LAAC is covered for NVAF patients not included in Section a. of this decision when performed within an FDA -approved randomized controlled trial (RCT) if such trials meet the cr iteria established below:   As a fully -described written part of its protocol, the RCT must critically answer, in comparison to optimal medical therapy, the following questions:    As a primary endpoint, what is the true incidence of ischemic stroke and syste mic embolism?    As a secondary endpoint, what is cardiovascular mortality and all -cause mortality?   FDA -approved RCTs must be reviewed and approved by CMS. Consistent with section 1142 of the Act, AHRQ supports clinical research studies that CMS determines address the above -listed research questions and the a -m criteria listed in Section c. of this decision.
(Medicare National Coverage Determinations Manual)
The principal investigator must submit the complete study protocol, identify the relevant CMS research question(s) that will be addressed, a nd cite 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 in section c. of this decision, as well a s the investigators contact information, to the address below.  Director, Coverage and Analysis Group  Re: LAAC CED  Centers for Medicare & Medicaid Services  7500 Security Blvd., Mail Stop S3- 02-01 Baltimore, MD 21244- 1850  c. All clinical studies, RCTs and r egistries submitted for review must adhere to the following standards of scientific integrity and relevance to the Medicare population:   a. The principal purpose of the study is to test whether the item or service meaningfully improves health outcomes of affe cted 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 results 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 Coverage Determination.  e. The study is sponsored by an organization or individual capable of c ompleting 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 Federal Regulations (CFR) at 45 CFR Part 46. If a study is regulated by the FDA, it is also in compliance with 21 CFR Parts 50 and 56. In addition, to furt her enhance the protection of human subjects in studies conducted under 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 dispositi on 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.
(Medicare National Coverage Determinations Manual)
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 register ed in the AHRQ Registry 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 e arly. The results 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 protocol 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 t hese 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.
(Medicare National Coverage Determinations Manual)
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 el igible for Medicare due to age, disability, or Medicaid eligibility.   C.  Nationally Non -Covered Indications   LAAC is non -covered for the treatment of NVAF when not furnished under CED according to the above -noted criteria.   (This NCD last reviewed February 2016.)   20.35 - Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD)  (Rev. 207, Issued: 05- 11-18, Effective: 05 -25-17, Implementation: 07- 02-18)  A.  General   Research has shown supervised exercise therapy (SET) to be an effective, minimally invasive method to alleviate the most common symptom associated with peripheral artery disease (PAD)  intermittent claudication (IC).   SET has been shown to be significantl y more effective than unsupervised exercise, and could prevent the progression of PAD and lower the risk of cardiovascular events that are prevalent in these patients.   SET has also been shown to perform at least as well as more invasive revascularization treatments that are covered by Medicare.     B.  Nationally Covered Indications   Effective for services performed on or after May 25, 2017, the Centers for Medicare & Medicaid Services has determined that the evidence is sufficient to cover SET for beneficiaries with IC for the treatment of symptomatic PAD.   Up to 36 sessions over a 12-week period are covered if all of the following components of a SET program are met. The SET program must:    consist of sessions lasting 30- 60 minutes comprising a therapeutic  exercise -training program for PAD in patients with claudication;   be conducted in a physicians office;   be delivered by qualified auxiliary personnel necessary to ensure benefits exceed harms, and who are trained in exercise therapy for PAD; and   be unde r the direct supervision of a physician (as defined in 1861(r)(1)), physician assistant, or nurse practitioner/clinical nurse specialist (as identified in 1861(aa)(5)) who must be trained in both basic and advanced life support techniques.
(Medicare National Coverage Determinations Manual)
Beneficiaries must have a face- to-face visit with the physician responsible for PAD treatment to obtain the referral for SET.   At this visit, the beneficiary must receive information regarding cardiovascular disease and PAD risk factor reduction, which could include education, counseling, behavioral interventions, and outcome assessments.    C.  Nationally Non -Covered Indications   SET is non -covered for beneficiaries with absolute contraindications to exercise as determined by their primary physician.   D.  Other  Medicare Administrative Contractors (MACs) have the discretion to cover SET beyond the nationally covered 36 sessions over a 12- week period. MACs may cover an additional 36 sessions over an extended period of time.  A second referral is required fo r these additional sessions   (This NCD last reviewed May 2017.)   30 - Complementary and Alternative Medicine  (Rev. 1, 10- 03-03)  30.1 - Biofeedback Therapy  (Rev. 1, 10- 03-03) CIM 35 -27  Biofeedback therapy provides visual, auditory or other evidence of the status of certain body functions so that a person can exert voluntary control over the functions, and thereby alleviate an abnormal bodily condition.  Biofeedback therapy often uses ele ctrical devices to transform bodily signals indicative of such functions as heart rate, blood pressure, skin temperature, salivation, peripheral vasomotor activity, and gross muscle tone into a tone or light, the loudness or brightness of which shows the e xtent of activity in the function being measured.   Biofeedback therapy differs from electromyography which is a diagnostic procedure used to record and study the electrical properties of skeletal muscle.  An electromyography device may be used to provide f eedback with certain types of biofeedback.  Biofeedback therapy is covered under Medicare only when it is reasonable and necessary for the individual patient for muscle re -education of specific muscle groups or for treating pathological muscle abnormalitie s of spasticity, incapacitating muscle spasm, or weakness, and more conventional treatments (heat, cold, massage, exercise, support) have not been successful.  This therapy is not covered for treatment of ordinary muscle tension states or for psychosomatic  conditions.  (See the Medicare Benefit Policy Manual, Chapter 15, for general coverage requirements about physical therapy requirements.)
(Medicare National Coverage Determinations Manual)
30.1.1 - Biofeedback Therapy for the Treatment of Urinary Incontinence  (Rev. 1, 10- 03-03) CIM 35 -27.1  Biofeedback Therapy for the Treatment of Urinary Incontinence   This policy applies to biofeedback therapy rendered by a practitioner in an office or other facility setting.   Biofeedback is covered for the treatment of stress and/or urge incontinence in cognitively intact patients who have failed a documented trial of pelvic muscle exercise (PME) training.  Biofeedback is not a treatment, per se, but a tool to help patients learn how to perform PME.  Biofeedback -assisted PME incorporates the use of an electr onic or mechanical device to relay visual and/or auditory evidence of pelvic floor muscle tone, in order to improve awareness of pelvic floor musculature and to assist patients in the performance of PME.   A failed trial of PME training is defined as no cli nically significant improvement in urinary incontinence after completing four weeks of an ordered plan of pelvic muscle exercises to increase periurethral muscle strength.   Contractors may decide whether or not to cover biofeedback as an initial treatment modality.   Home use of biofeedback therapy is not covered.   30.2 - Thermogenic Therapy  (Rev. 1, 10- 03-03) CIM 35 -6  Not Covered
(Medicare National Coverage Determinations Manual)
Home use of biofeedback therapy is not covered.   30.2 - Thermogenic Therapy  (Rev. 1, 10- 03-03) CIM 35 -6  Not Covered   Thermogenic therapy which is the production of artificial fever, has been in use since 1919 in the treatment of certain types of resistant infectious diseases, rheumatoid arthritis and Sydenhams chorea.  Regardless of the medium by which the fever is induced, this modality is not scientifically accepted for the treatment of any specific disease.  Since the advent of potent antibi otics, the procedure has for all practical purposes been replaced as a mode of treatment.  Therefore, thermogenic therapy is not considered reasonable and necessary for the treatment of an illness or injury as required by 1862(a)(1)  of the Act.  (Of course, where other covered services are needed and it would be reasonable and necessary that they be furnished on an inpatient hospital basis, payment would not be excluded for the inpatient stay, notwithstanding the fact that reimbursem ent may not be made for thermogenic therapy furnished during the hospital stay.)   30.3 - Acupuncture  (Rev.  10337, Issued: 08- 27-20, Effective: 01 -21-20, Implementation:  06-24 - 20 - A/B MACs; 10 -05-20-SSM Edits; 01 - 04-21 - BR 13 CWF only)   A. General  Acupuncture is the selection and manipulation of specific acupuncture points by a variety of needling and non- needling techniques.  B. Nationally Covered  Indications  Effective for claims with dates of service on and after January 21, 2020, acupuncture is only covered for chronic low back pain under section 1862(a)(1)(A) of the Social Security Act (the Act). See National Coverage Determination section 30.3.3 for specific coverage criteria.  C. Nationally Non -Covered  Indications   Medicare reimbursement for acupuncture, as an anesthetic, or as an analgesic or for other therapeutic purposes, may not be made unless the specific indication is excepted.  All indications for acupuncture outside of NCD section 30.3.3 remain non- covered.  D. Other N/A (This NCD last rev iewed January 2020.)
(Medicare National Coverage Determinations Manual)
30.3.1  Acupuncture for Fibromyalgia (Effective April 16, 2004)  (Rev.  10337, Issued: 08- 27-20, Effective: 01 -21-20, Implementation:  06-24 - 20 - A/B MACs; 10 -05-20-SSM Edits; 01 - 04-21 - BR 13 CWF only)   A. General  Acupuncture is the selection and manipulation of specific acupuncture points by a variety of needling and non- needling techniques.  B. Nationally Covered  Indications  N/A for acupuncture for fibromyalgia.  C. Nationally Non -Covered  Indications   Effective for claims  with dates of service on and after April 16, 2004, after careful reconsideration of its initial non -coverage determination for acupuncture, the Centers for Medicare & Medicaid Services (CMS) concludes that there is no convincing evidence for the use of acupuncture for pain relief in patients with fibromyalgia. Study design flaws presently prohibit assessing acupunctures utility for improving health outcomes. Accordingly, CMS determines that acupuncture is not considered reasonable and necessary for the tr eatment of fibromyalgia within the meaning of 1862(a)(1) of the Social Security Act, and the national non- coverage determination for acupuncture for fibromyalgia continues. D. Other N/A (This NCD last reviewed April 2004.)   30.3.2  Acupuncture for Osteoarthritis (Effective April 16, 2004)  (Rev.  10337, Issued: 08- 27-20, Effective: 01 -21-20, Implementation:  06-24 - 20 - A/B MACs; 10 -05-20-SSM Edits; 01 - 04-21 - BR 13 CWF only)   A. General  Acupuncture is the selection and manipulation of specific acupuncture points by a variety of needling and non- needling techniques.  B. Nationally Covered  Indications  N/A for acupuncture for osteoarthritis. C. Nationally Non -Covered  Indications
(Medicare National Coverage Determinations Manual)
Effective for claims with dates of service on and after April 16, 2004, after careful reconsideration of its initial non -coverage determination for acupuncture, the Centers for Medicare & Medicaid Services (CMS) concludes that there is no convincing evidence for the use of acupuncture for pain relief in pa tients with osteoarthritis. Study design flaws presently prohibit assessing acupunctures utility for improving health outcomes. Accordingly, CMS determines that acupuncture is not considered reasonable and necessary for the treatment of osteoarthritis within the meaning of 1862(a)(1) of the Social Security Act, and the national non- coverage determination for acupuncture for osteoarthritis continues. D. Other N/A (This NCD last reviewed April 2004.)   30.3.3  Acupuncture for Chronic Lower Back Pain (cLBP)  (Rev.  10337, Issued: 08- 27-20, Effective: 01 -21-20, Implementation:  06-24 - 20 - A/B MACs; 10 -05-20-SSM Edits; 01 - 04-21 - BR 13 CWF only)  A.  General  Acupuncture is the selection and manipulation of specific acupuncture points by a variety of needling and no n-needling techniques. B. Nationally Covered  Indications Effective for services performed on or after January, 21, 2020, CMS will cover acupuncture for Medicare patients with chronic Lower Back Pain (cLBP.) Up to 12 visits in 90 days are covered for Medicare beneficiaries under the following circumstance:    For the purpose of this decision, cLBP is defined as:  o Lasting 12 weeks or longer;  o nonspecific, in that it has no identifiable systemic cause (i.e., not associated with metastatic, inflammatory, infectious, etc.  disease);  o not associated with surgery;  and, o not associated with  pregnancy.    An additional 8 sessions will be covered for those patients demonstrating an improvement.    No more than 20 acupuncture treatments may be administered annually.
(Medicare National Coverage Determinations Manual)
 An additional 8 sessions will be covered for those patients demonstrating an improvement.    No more than 20 acupuncture treatments may be administered annually.    Treatment must be discontinued if the patient is not improving or is regressing.  Physicians (as defined in 1861(r)(1) of the Social Security Act (the Act) may furnish acupuncture in accordance with applicable state requirements.  Physician assistants (PAs), nurse practitioners (NPs)/clinical nurse specialists (CNSs) (as identified in 1861(aa)(5) of the Act), and auxiliary personnel may furnish acupuncture if they meet all applicable state requirements and have:   a masters or doctoral level de gree in acupuncture or Oriental Medicine from a school accredited by the Accreditation Commission on Acupuncture and Oriental Medicine  (ACAOM); and,    a current, full, active, and unrestricted license to practice  acupuncture in a State, Territory, or Commonwealth (i.e. Puerto Rico) of the United States, or District of Columbia.  Auxiliary personnel furnishing acupuncture must be under the appropriate level of supervision of a physician, PA, or NP/CNS required by our regulations at 42 CFR  410.26 and 410.27.   C. Nationally Non -Covered  Indications All types of acupuncture including dry needling for any condition other than cLBP are non-covered by Medicare.   D. Other  N/A (This NCD last reviewed January 2020.)   30.4 - Electrosleep Therapy  (RETIRED)  (Rev. 11892; Issued: 03- 09-23; Effective: 04 -10-23; Implementation:04- 10-23)    Effective January 1, 2021, the Centers for Medicare & Medicaid Services determined that no national coverage determination (NCD) is appropriate at this time for Electrosleep Th erapy. In the absence of an NCD, coverage determinations will be made by the Medicare Administrative Contractors under 1862(a)(1)(A) of the Social Security Act.   30.5 - Transcendental Meditation  (Rev. 1, 10- 03-03) CIM 35 -92  Not Covered