evekhm/cms_iom_500 huggingface dataset:
(Medicare National Coverage Determinations Manual)
Prospectively, in Medicare-aged subjects whose warfarin therapy management includes pharmacogenomic testing of CYP2C9 or VKORC1 alleles to predict warfarin response, what is the frequency and severity of the following outcomes, compared to subjects whose warfarin therapy management does not include pharmacogenomic testing?   Major hemorrhage  Minor hemorrhage  Thromboembolism related to the primary indication for anticoagulation  Other thromboembolic event  Mortality   The study must adhere to the following standards of scientific integrity and relevance to the Medicare population:  a. The principal purpose of the research study is to test whether a particular intervention potentially improves the participants health outcomes.  b. The research study is well -supported by available scientific and medical information or it is intended to clarify or establish the health outcomes of interventions already in common clinical use.  c. The research study does not unjustifiably duplicate existing studies.  d. The research study design is appropriate to answer the research question being asked in the study.  e. The research study is sponsored by an organization or individual capable of executing the proposed study 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 also must be in compliance with  21 CFR Parts 50 and 56.  g. All aspects of the research study are conducted according to the appropriate standards of scientific integrity.   h. The research study has a written protocol that clearly addresses, or incorporates by reference, the Medicare standards.   i. The clinical research study is not designed to exclusively test toxicity or disease pathophysiology in healthy individuals. Trials of all medical technologies measuring therapeutic outcomes as one of the objectives meet this standard 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 study is registered on the www.ClinicalTrials.gov  website by the principal sponsor/investigator prior to the enrollment of the first study subject.
(Medicare National Coverage Determinations Manual)
k. The research study protocol specifies the method and timing of public release of all pre- specified outcomes to be measured including release of outcomes if outcomes are negative or study is terminated early. The results must be made public within 24 months of the end of data collection. If a report is planned to be published in a peer- reviewed journal, then that initial release may be an abstract that meets the requirements of the International Committee of Medical Journal Editors. However, a full report of the outcomes must be made public no later than 3 years after the end of data collection.  l. The research study protocol must explicitly discuss subpopulations affected by the treatment under investigation, particularly traditionally underrepresented groups in clinical studies, how the inclusion and exclusion criteria affect enrollment of these po pulations, and a plan for the retention and reporting of said populations on 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 research study protocol explicitly discusses how the results are or are not expected to be generalizable to the Medicare population to infer whether Medicare patients may benefit from the intervention. Separate discussions in the protocol may be necessary for populations eligible for Medicare due to age, disability or Medicaid eligibility.   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 above- listed research questions.  B. Nationally Non-Covered Indications  The CMS believes that the available evidence does not demonstrate that pharmacogenomic testing of CYP2C9  or VKORC1  alleles to predict warfarin responsiveness improves health outcomes in Medicare beneficiaries outside the context of CED, and is therefore not reasonable and necessary under 1862(a)(1)(A) of the Act.   C. Other
(Medicare National Coverage Determinations Manual)
C. Other  This NCD does not determine coverage to identify CYP2C9 or VKORC1 alleles for other purposes, nor does it determine national coverage to identify other alleles to predict warfarin responsiveness.  (This NCD last reviewed August 2009.)  90.2 Next Generation Sequencing (NGS)  for Patients with Somatic (Acquired)  and Germline (Inherited) Cancer  (Rev. 10346, Issued: 09-11-20, Effective: 01-27-20, Implementation: 11-13-20)  A.  General  Clinical laboratory diagnostic tests can include tests that, for example, predict the risk associated with one or more genetic variations.  In addition, in vitro companion diagnostic laboratory tests provide a report of test results of genetic variations a nd are essential for the safe and effective use of a corresponding therapeutic product.  Next Generation Sequencing (NGS) is one technique that can measure one or more genetic variations as a laboratory diagnostic test, such as when used as a companion in vitro diagnostic test.   This National Coverage Determination (NCD) is only applicable to diagnostic lab tests using NGS for somatic (acquired) and germline (inherited) cancer.   Medicare Administrative Contractors (MACs) may determine coverage of diagnostic lab tests using NGS for RNA sequencing and protein analysis.    B. Nationally Covered Indications  1. Somatic (Acquired) Cancer   Effective for services performed on or after March 16, 2018, the Centers for Medicare & Medicaid Services (CMS) has determined that Next Generation Sequencing (NGS) as a diagnostic laboratory test is reasonable and necessary and covered nationally, when performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory, when ordered by a treating physician, and when all of the following requirements are met:   a. Patient has:  i. either recurrent, relapsed, refractory, metastatic, or advanced stage III or IV cancer; and  ii. not been previously tested with the same test using NGS for the same cancer genetic content, and iii. decided to seek further cancer treatment (e.g., therapeutic chemotherapy).
(Medicare National Coverage Determinations Manual)
b. The diagnostic laboratory test using NGS must have: i. Food & Drug Administration (FDA) approval or clearance as a companion in vitro diagnostic; and, ii. an FDA -approved or - cleared indication for use in that patients cancer; and,  iii. results provided to the treating physician for management of the patient using a report template to specify treatment options.   2. Germline (Inherited) Cancer   Effective for services performed on or after January 27, 2020, CMS has determined that NGS as a diagnostic laboratory test is reasonable and necessary and covered nationally for patients with germline (inherited) cancer, when performed in a CLIA- certified laboratory, when ordered by a treating physician and when all of the following requirements are met:  a. Patient has:  i. ovarian or breast cancer; and, ii. a clinical indication for germline (inherited) testing for hereditary breast or ovarian cancer; and, iii. a risk factor for germline (inherited) breast or ovarian cancer; and  iv. not been previously tested with the same germline test using NGS for the same germline genetic content.   b. The diagnostic laboratory test using NGS must have all of the following: i. FDA -approval or clearance; and,  ii. results provided to the treating physician for management of the patient using a report template to specify treatment options.   C. Nationally Non -Covered  Indications   1. Somatic (Acquired) Cancer   Effective for services performed on or after March 16, 2018, NGS as a diagnostic laboratory test for patients with acquired  (somatic)  cancer are non -covered if the cancer patient does not meet the criteria noted in section B.1., above.   D. Other   1. Somatic (Acquired) Cancer   Effective for services performed on or after March 16, 2018, Medicare Administrative Contractors (MACs) may determine coverage of NGS as a diagnostic laboratory test for patients with  advanced  cancer only when the test is performed in a CLIA -certified laboratory, when  ordered by a treating physician, and when the patient has:   a. either recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer; and,  b. not been previously tested with the same test using NGS for the same cancer genetic content, and c. decided to seek further cancer treatment (e.g., therapeu tic chemotherapy).
(Medicare National Coverage Determinations Manual)
2. Germline (Inherited) Cancer   Effective for services performed on or after January 27, 2020, MACs may determine coverage of NGS as a diagnostic laboratory test for patients with germline (inherited) cancer only when the test is performed in a CLIA -certified laboratory, when ordered by a treating physician, when results are provided to the treating physician for management of the patient and when the patient has:  a. any cancer diagnosis; and,  b. a clinical indication for germline (inherited) testing of hereditary cancers; and,  c. a risk factor for germline (inherited) cancer; and,  d. not been previously tested with the same germline test using NGS for the same germline genetic content.  (This NCD last reviewed January 2020)   100 - Gastrointestinal System  (Rev. 1, 10-03-03)  100.1 - Bariatric Surgery for Treatment of Co -Morbid Conditions Related to Morbid Obesity (Rev. 158, Issued: 12-23-13, Effective: 09-24-13, Implementation: 12-17-13)  Please note, sections 40.5, 100.8, 100.11, and 100.14 have been removed from the National Coverage Determination (NCD) Manual and incorporated into NCD 100.1  A. General
(Medicare National Coverage Determinations Manual)
Obesity may be caused by medical conditions such as hypothyroidism, Cushing's disease, and hypothalamic lesions, or can aggravate a number of cardiac and respiratory diseases as well as diabetes and hypertension.  Non-surgical services in connection with t he treatment of obesity are covered when such services are an integral and necessary part of a course of treatment for one of these medical conditions.  In addition, supplemented fasting is a type of very low calorie weight reduction regimen used to achieve rapid weight loss.  The reduced calorie intake is supplemented by a mixture of protein, carbohydrates, vitamins, and minerals. Serious questions exist about the safety of prolonged adherence for 2 months or more to a very low calorie weight reduction regimen as a general treatment for obesity, because of instances of cardiopathology and sudden death, as well as possible loss of body protein.  Bariatric surgery procedures are performed to treat comorbid conditions associated with morbid obesity. Two types of surgical procedures are employed. Malabsorptive procedures divert food from the stomach to a lower part of the digestive tract where the no rmal mixing of digestive fluids and absorption of nutrients cannot occur. Restrictive procedures restrict the size of the stomach and decrease intake. Surgery can combine both types of procedures.   The following are descriptions of bariatric surgery procedures:   1. Roux- en-Y Gastric Bypass (RYGBP)
(Medicare National Coverage Determinations Manual)
The RYGBP achieves weight loss by gastric restriction and malabsorption. Reduction of the stomach to a small gastric pouch (30 cc) results in feelings of satiety following even small meals. This small pouch is connected to a segment of the jejunum, bypassing the duodenum and very proximal small intestine, thereby reducing absorption. RYGBP procedures can be open or laparoscopic.   2. Biliopancreatic Diversion with Duodenal Switch (BPD/DS) or Gastric Reduction Duodenal Switch (BPD/GRDS)   The BPD achieves weight loss by gastric restriction and malabsorption. The stomach is partially resected, but the remaining capacity is generous compared to that achieved with RYGBP. As such, patients eat relatively normal-sized meals and do not need to re strict intake radically, since the most proximal areas of the small intestine (i.e., the duodenum and jejunum) are bypassed, and substantial malabsorption occurs. The partial BPD/DS or BPD/GRDS is a variant of the BPD procedure. It involves resection of the greater curvature of the stomach, preservation of the pyloric sphincter, and transection of the duodenum above the ampulla of Vater with a duodeno- ileal anastomosis and a lower ileo -ileal anastomosis. BPD/DS or BPD/GRDS procedures can be open or laparosc opic.   3. Adjustable Gastric Banding (AGB)   The AGB achieves weight loss by gastric restriction only. A band creating a gastric pouch with a capacity of approximately 15 to 30 ccs encircles the uppermost portion of the stomach. The band is an inflatable doughnut-shaped balloon, the diameter of which can be adjusted in the clinic by adding or removing saline via a port that is positioned beneath the skin. The bands are adjustable, allowing the size of the gastric outlet to be modified as needed, depending on the rate of a patients weight loss. AGB procedures are laparoscopic only.   4. Sleeve Gastrectomy
(Medicare National Coverage Determinations Manual)
Sleeve gastrectomy is a 70% -80% greater curvature gastrectomy (sleeve resection of the stomach) with continuity of the gastric lesser curve being maintained while simultaneously reducing stomach volume. In the past, sleeve gastrectomy was the first step in  a two -stage procedure when performing RYGBP, but more recently has been offered as a stand -alone surgery. Sleeve gastrectomy procedures can be open or laparoscopic.   5. Vertical Gastric Banding (VGB)   The VGB achieves weight loss by gastric restriction only. The upper part of the stomach is stapled, creating a narrow gastric inlet or pouch that remains connected with the remainder of the stomach. In addition, a non-adjustable band is placed around this new inlet in an attempt to prevent future enlargement of the stoma (opening). As a result, patients experience a sense of fullness after eating small meals. Weight loss from this procedure results entirely from eating less. VGB procedures are essentially n o longer performed.   B. Nationally Covered Indications
(Medicare National Coverage Determinations Manual)
B. Nationally Covered Indications  Effective for services performed on and after February 21, 2006, Open and laparoscopic Roux- en-Y gastric bypass (RYGBP), open and laparoscopic Biliopancreatic Diversion with Duodenal Switch (BPD/DS) or Gastric Reduction Duodenal Switch (BPD/GRDS), and laparoscopic adjustable gastric banding (LAGB) are covered for Medicare beneficiaries who have a body -mass index  35, have at least one co- morbidity related to obesity, and have been previously unsuccessful with medical treatment for obesity.   Effective for dates of service on and after February 21, 2006, these procedures are only covered when performed at facilities that are: (1) certified by the American College of Surgeons as a Level 1 Bariatric Surgery Center (program standards and requirements in effect on February 15, 2006); or (2) certified by the American Society for Bariatric Surgery as a Bariatric Surgery Center of Excellence (program standards and requirements in effect on February 15, 2006).  Effective for dates of service on and after September 24, 2013, facilities are no longer required to be certified.  Effective for services performed on and after February 12, 2009, the Centers for Medicare & Medicaid Services (CMS) determines that Type 2 diabetes mellitus is a co -morbidity for purposes of this NCD.   A list of approved facilities and their approval dates are listed and maintained on the CMS Coverage Web site at http://www.cms.gov/Medicare/Medicare- General -Information/MedicareApprovedFacilitie/Bariatric -Surgery.html  , and published in the Federal  Register  for services provided up to and including date of service September 23, 2013.  C. Nationally Non-Covered Indications  Treatments for obesity alone remain non- covered.   Supplemented fasting is not covered under the Medicare program as a general treatment for obesity (see section D. below for discretionary local coverage).  The following bariatric surgery procedures are non- covered for all Medicare beneficiaries:   Open adjustable gastric banding;   Open sleeve gastrectomy;    Laparoscopic sleeve gastrectomy (prior to June 27, 2012);   Open and laparoscopic vertical banded gastroplasty;   Intestinal bypass surgery; and,   Gastric balloon for treatment of obesity.  D. Other
(Medicare National Coverage Determinations Manual)
Effective for services performed on and after June 27, 2012, A/B Medicare Administrative Contractors (A/B MACs) acting within their respective jurisdictions may determine coverage of stand -alone laparoscopic sleeve gastrectomy (LSG) for the treatment of co -morbid conditions related to obesity in Medicare beneficiaries only when all of the following conditions a.- c. are satisfied.   a. The beneficiary has a body-mass index (BMI)  35 kg/m2,   b. The beneficiary has at least one co -morbidity related to obesity, and,   c. The beneficiary has been previously unsuccessful with medical treatment for obesity.   The determination of coverage for any bariatric surgery procedures that are not specifically identified in an NCD as covered or non-covered, for Medicare beneficiaries who have a body -mass index  35, have at least one co -morbidity related to obesity, and have been previously unsuccessful with medical treatment for obesity, is left to the local MACs.   Where weight loss is necessary before surgery in order to ameliorate the complications posed by obesity when it coexists with pathological conditions such as cardiac and respiratory diseases, diabetes, or hypertension (and other more conservative technique s to achieve this end are not regarded as appropriate), supplemented fasting with adequate monitoring of the patient is eligible for coverage on a case-by- case basis or pursuant to a local coverage determination. The risks associated with the achievement of rapid weight loss must be carefully balanced against the risk posed by the condition requiring surgical treatment.  100.2 - Endoscopy  (Rev. 1, 10-03-03) CIM 35 -59  Endoscopy is a technique in which a long flexible tube-like instrument is inserted into the body orally or rectally, permitting visual inspection of the gastrointestinal tract.  Although primarily a diagnostic tool, endoscopy includes certain therapeutic procedures such as removal of polyps, and endoscopic papillotomy, by which stones are removed from the bile duct.   Endoscopic procedures are covered when reasonable and necessary for the individual patient.  100.3 - 24-Hour Ambulatory Esophegeal pH Monitoring  (Rev. 1, 10- 03-03) CIM 35 -83
(Medicare National Coverage Determinations Manual)
Endoscopic procedures are covered when reasonable and necessary for the individual patient.  100.3 - 24-Hour Ambulatory Esophegeal pH Monitoring  (Rev. 1, 10- 03-03) CIM 35 -83  Twenty -four hour ambulatory esophageal pH monitoring is a diagnostic procedure involving the placement of an indwelling electrode into the lower esophagus of a patient for the purpose of determining the presence of gastric reflux and measuring abnormal esophageal acid exposure.   Twenty -four hour ambulatory pH monitoring is covered by Medicare for patients who are suspected of having gastric reflux, but only if the patient presents diagnostic problems associated with atypical symptoms or the patients symptoms are suggestive of ref lux, but conventional tests have not confirmed the presence of reflux.   100.4 - Esophageal Manometry  (Rev. 1, 10- 03-03) CIM 50 -25  Esophageal manometry is covered under Medicare where it is determined to be reasonable and necessary for the individual patient.  The major use of esophageal manometry is to measure pressure within the esophagus to assist in the diagnosis of esophageal pat hology including aperistalsis, spasm, achalasia, esophagitis, esophageal ulcer, esophageal congenital webs, diverticuli, scleroderma, hiatus hernia, congenital cysts, benign and malignant tumors, hypermobility, hypomobility, and extrinsic lesions.  Esophageal manometry is mostly used in difficult diagnostic cases and as an adjunct to x- rays and direct visualization of the esophagus (endoscopy) through the fiberscope.   100.5 - Diagnostic Breath Analyses  (Rev. 1, 10- 03-03) CIM 50 -51  Diagnostic breath analyses are tests performed to measure either the hydrogen or carbon dioxide content of the breath after the ingestion of certain compounds. The analyses are performed to diagnose certain gastrointestinal disease states.   The Following Breath Test Is Covered:   Lactose breath hydrogen to detect lactose malabsorption.  The Following Breath Tests Are Excluded From Coverage:   Lactulose breath hydrogen for diagnosing small bowel bacterial overgrowth and measuring small bowel transit time.
(Medicare National Coverage Determinations Manual)
Lactose breath hydrogen to detect lactose malabsorption.  The Following Breath Tests Are Excluded From Coverage:   Lactulose breath hydrogen for diagnosing small bowel bacterial overgrowth and measuring small bowel transit time.   CO2  for diagnosing bile acid malabsorption.   CO2  for diagnosing fat malabsorption.  100.6 - Gastric Freezing  (Rev. 1, 10- 03-03) CIM 35 -65  Gastric freezing for chronic peptic ulcer disease is a non -surgical treatment which was popular about 20 years ago but now is seldom done.  It has been abandoned due to a high complication rate, only temporary improvement experienced by patients, and lack of effectiveness when tested by double-blind, controlled clinical trials.  Since the procedure is now considered obsolete, it is not covered.  100.7 - Colonic Irrigation  CIM 35 -1  Not Covered  Colonic irrigation is a procedure to wash out or lavage material on the walls of the bowel to an unlimited distance without inducing defecation.  This procedure is distinguished from all types of enemas which are primarily used to induce defecation.  There are no conditions for which colonic irrigation is medically indicated and no evidence of therapeutic value.  Accordingly, colonic irrigation cannot be considered reasonable and necessary within the meaning of 1862(a)(1) of the Act.   100.8  Intestinal Bypass Surgery  (RETIRED)  (Rev. 11892; Issued: 03-09- 23; Effective: 04 -10-23; Implementation:04-10-23)    Please note section  100.8 has  been  removed  from  the NCD Manual  and incorporated into  NCD 100.1 effective September 24, 2013.    100.9 - Implantation of Anti-Gastroesophageal Reflux Device  (RETIRED)  (Rev. 11892; Issued: 03-09- 23; Effective: 04 -10-23; Implementation:04 -10-23)