evekhm/cms_iom_500 huggingface dataset:
Article - Response to Comments for MolDX: Genetic Testing for BCR-ABL Negative Myeloproliferative Disease (A54612)
CMS National Coverage PolicyN/AArticle TextStep-wise TestingComment:A commenter indicated he had serious concern about stepwise molecular testing for BCR-ABL negative myeloproliferative disease (MPD).  He noted the following reasons for MPD:Heterogeneity at presentation;Patients may present with smoldering rising blood countsSome patients with life-threateningly high cell counts; need to diagnose quicly to prevent permanent debilitation due to infarct, sepsis, or bleeding, or death;Testing only on fresh diagnostic material, not FFPE or cryopreserved tissuesSequential testing add turn-around timeDifferential dx includes, besides myeloproliferative disease, myelodysplasia, CMML, CML, AML, ALL, idiopathic aplastic anemia, hairy cell leukemia, lymphoma, etc.When counts are life-threatening or diagnosis is not completely obvious, initial testing is almost always urgent or emergent bone marrow aspiration and biopsy.Comment:A commenter writes BCR/ABL and JAK2 should be ordered at the same time rather than JAK2 as a reflex test in patients with suspected PV, ET and PMF. These diseases are by definition BCR/ABL negative (thus requiring that test) and very often JAK2 positive. If they are suspected it does not make sense to delay testing with JAK2 which is critical testing for diagnosis. In other words you know/expect BCR/ABL to be negative so why wait before the next step.  We believe that the sequence should read if PV is suspected and JAK2 is negative then reflex  to exon 12 testing (and consider reflex to MPR/CALR if exon 12 is negative). If ET or PMF are suspected and JAK2 is negative should reflex first to MPL/CALR and only reflex to exon 12 if those are negative.
Article - Response to Comments for MolDX: Genetic Testing for BCR-ABL Negative Myeloproliferative Disease (A54612)
Comment:Numerous commenters indicate that a tiered reflexive approach is often neither the most clinically appropriate nor the most economical method of testing.  They note the following:Many labs with next generations (NGS) or non-NGS multi-gene testing methods can test for all five of the genetic variants for this disease in a single assay that is more rapid and less expensive than performing five sequential single-gene assays;Other genes are often included in multi-gene myeloproliferative panels that are not included in this policy such as CSF3R, which is virtually pathognomonic for atypical chronic myeloid leukemia or chronic neutrophilic leukemia.A stepped approach is not optimal because many of these diseases have effective FDA-approved therapies that need to be initiated immediately, citing 2-3 week turn around for sequential testing vs 3-10 days for simultaneous multi-gene or NGS testingMutations in CBL, TET2, SRSF2 or ASXL1 would favor a diagnosis of CMMLConsiderable clinical and morphologic overlap exists between various MPNs and some of the MDS/MPNs so a tiered approach is often not applicable.JAK2 is commonly mutated in other myeloid neoplasm (non-MPNs), as well as, age-related clonal hematopoiesis or indeterminate potential.Response:This Medicare contractor appreciates the above important comments, and has changed the policy to include coverage for multi-gene panel or NGS testing.  In addition, this contractor agrees that concurrent BCR-ABL and JAK2 testing is medically reasonable and necessary if the clinician is suspicious of a myeloproliferative disease when sequential testing is performed.ICD-9 vs ICD-10 CodingComment:ICD-9 had most myeloproliferative disorders lumped under myelodysplasia.  ICD-10 splits them into 2 categories, but sadly clinical overlap exists and labeling one way or the other may be clinically very arbitrary.  Many clinicians code patients on the disease they have the highest suspicion of rather than just coding for the abnormal cell counts.  ICD-10, with its specificity for cause of abnormal blood counts and EHR records that force certain codes to be used, may be more problematic.Response:Agree.Repeat Testing of Negative Diagnostic Markers
Article - Response to Comments for MolDX: Genetic Testing for BCR-ABL Negative Myeloproliferative Disease (A54612)
Response:Agree.Repeat Testing of Negative Diagnostic MarkersComment:An LCD must be written with much forethought and concern for not missing caveats of specific clinical circumstances, and should not create an access to care issue for patients with rare diseases or rare genetic abnormalities.  Ideally, a lab with initial diagnostic testing should not allow repeat testing if negative initially.  However, some patients with emergency complications may not be facile giving good information about prior testing under emergency circumstances.  This is also complicated when a patient presents to a new health care system, and as a result of the very primitive interoperability of electronic health records.Response:Policies are designed for the usual circumstances or norm.  The appeals process is designed to accommodate the unusual or rare situations that fall outside of the norm, with supporting documentation in the patients medical record.Addition of CPT CodesComment:The commenter writes:  If BCR-ABL testing and all of the other single genes are to be covered when performed as part of these multi-gene panels, we recommend that 81401, 81405, 81406, 81445, 81450 and 81455 be covered to allow appropriate (lower cost) payment.Response:A panel by definition has a single unit of service (UOS).  Regardless of whether a panel has 2 or 10 or 100 component parts, the UOS is 1, not the number of component parts.  Consequently, a molecular panel must be assigned 81479, 81445, 81450 or 81455, as appropriate to the descriptor.  Reimbursement of multi-gene panels and NGS does not consist of the cumulative reimbursement of individual Tier1 or 2 CPT codes.Individual CPT Tier 1 and Tier 2 codes can only be submitted on claims when the testing is performed sequentially, and NOT a component in a panel.Addition of ICD-10 CodesComment:Twenty-two additional ICD-10 codes were requested to be added to the policy.Response:Agree with the ICD-10 codes which have been added to the policy.CALR vs MPL/CALR Testing
Article - Response to Comments for MolDX: Genetic Testing for BCR-ABL Negative Myeloproliferative Disease (A54612)
Comment:Twenty-two additional ICD-10 codes were requested to be added to the policy.Response:Agree with the ICD-10 codes which have been added to the policy.CALR vs MPL/CALR TestingComment:A commenter writes that CALR is far more useful than MPL/CALR, we recommend that this message be made apparent in the policy. The commenter notes appreciation for CALR coverage,  but posits that it should not require a negative JAK2 exon 12 result first.Response:The policy reflects the usefulness of CALR over MPL.  However, the policy does not require a negative JAK2 exon 12 result prior to CALR coverage, rather it requires a negative JAK2V617F mutation.
Article - Response to Comments for MolDX: Genomic Health™ Oncotype DX® Prostate Cancer Assay (A54613)
CMS National Coverage PolicyN/AArticle TextInclude Coverage for NCCN/AUA Intermediate Risk PatientsComment:A commenter submitted anecdotal information regarding his personal use of this assay.  He said that maturing date shows that Gleason 3+4=7 carcinoma do well on active surveillance and carry a similar cancer specific survival to those of Gleason 3+3=6.  While AS (active surveillance) may not be appropriate for all intermediates, the assay (aka Genomic Prostate Score  GPS) provides my patients with the additional information needed to better understand if AS is an appropriate consideration.  I strongly urge the reconsideration of approval for NCCN intermediate risk patients.  A number of other commenters also expressed coverage for intermediate risk patients.Another commenter writes patients with Gleason sum 3+4 intermediate risk prostate cancer can have clinical outcomes indistinguishable from low risk disease (Raldow JAMA Oncol 2015) and recent studies indicates that between 8-16% of intermediate risk patients use AS as their primary management strategy (Shelton AUA 2015, Loeb AUA 2015).  This commenter notes that accurate risk stratification remains a challenge and believes this GPS provides an independent measure of aggressiveness.Response:Accurate prostate cancer risk stratification remains a challenge.  The GPS assay validation studies showed that incorporation of GPS results with clinical assessment more accurately identified very low- and low risk biological potential, and thus, appropriate candidates for AS.   Despite limited data from the validation studies that suggested some intermediate patients with a low GPS benefit from AS, the NCCN and other medical groups do not recommend this approach.Prospective clinical studies are ongoing by the test manufacturer aimed at addressing the clinical utility of GPS for intermediate risk patient.  The results of these studies may allow Medicare coverage of intermediate risk patients in the future.Life Expectancy of 10-20 YearsComment:A commenter disagrees with the coverage requirement of 10-20 years.  He indicates that life expectancy should not limit the opportunity to utilize this important piece of data that will impact shared decision making at the time of diagnosis.  He also indicates by accepting patients of all life expectancy, we can avoid any bias in our utilization and offer the same resources to all patients.
Article - Response to Comments for MolDX: Genomic Health™ Oncotype DX® Prostate Cancer Assay (A54613)
Another commenter writes that a life expectancy of = 10 years makes much more sense as it falls in line with NCCN guidelines and with the usual clinical approach to life expectancy assessments.  He indicated that capping life expectancy at 20 years does not make intuitive or clinical sense stating Why would a patient whose life expectancy is = 20 years not qualify for risk stratification with this assay?Response:Since coverage is predicated on prospective longitudinal data which for prostate cancer may require 10-20 years, little to no data would be forthcoming if the assay was used for patients with significantly shorter life expectancies.  The purpose of this policy is to provide Medicare coverage for an assay with very limited clinical utility (assay results in improved patient outcomes) that would not otherwise be covered due to very limited prospective utility.The life expectancy criteria has been changed to = 10 years.CTR (Certification and Training Registry) ProgramComment:CTR appears to be a valid concept to ensure the proper utilization and tracking of outcomes.  The commenter states that the reality though is that this type of program will impact and prove excessive burden on myself and office staff to complete this additional data capture.   The commenter suggests that the detail of the CTR be reconsidered.Response:The data capture consists of requisite patient information on the test requisition and biennial (2x/yr) submission of prostate cancer-related morbidity or mortality, (if any).  This does not constitute an excessively burdensome requirement for coverage.Prevent Unnecessary Harms of Definitive TreatmentComment:One commenter said that patients are often scared when they are first diagnosed with prostate cancer and are wary of the concept of AS.  He indicates that use of this assay has provided reassurance to these newly-diagnosed patients because they can easily comprehend why it is safe to intentionally delay treatment and are even provided a numerical, quantitated risk result.  He also indicates that an elevated assay result can reinforce when patients who met criteria for low risk NCCN prostate cancer need to be treated.
Article - Response to Comments for MolDX: Genomic Health™ Oncotype DX® Prostate Cancer Assay (A54613)
Response:The purpose of this Coverage with Data Development policy is to provide limited coverage for an assay with limited clinical utility (assay results in improved patient outcomes) as currently documented in existing publications. This policy support the opportunity to develop that data within the limited scope of the policys parameters  that would not otherwise be eligible for coverage as reasonable and necessary.Patient Registry RequirementsComment:A commenter indicates that many of the patient registry requirements are being met in an ongoing, prospective observational trial of 1200 newly diagnosed prostate cancer patients that is being conducted by Genomic Health.  The commenter hopes that the data collection will supplement the data collection under this policy to allow full coverage without data collection and CTR requirements.Response:Unconditional coverage predicated on solid scientific data for low and intermediate risk prostate cancer patients is desired by both Genomic Health and Palmetto GBA.Correction of CGS and MolDx contractor ErrorCommenter:The current policy incorrectly states To ensure that physicians understand the limitation of the test based on its validation through retrospective non-US based standards of care studies.Response:CGS and the MolDx contractor apologizes for the incorrect statement and recognizes that Genomic Health validations studies were all US based and used contemporary standards of care.  The incorrect statement in the policy has been corrected to read:  To ensure that physicians understand the limitation of the test based on its validation.
Article - Billing and Coding: Hydration Services (A54635)
CMS National Coverage PolicyInternet Only Manual Pub 100-8; Medicare Program Integrity Manual Chapter 3, Section 3.6.2.2 - Reasonable and Necessary CriteriaArticle TextNoridian Medical Review (MR) has observed errors in billing for intravenous (IV) hydration services. This article is to assist in better understanding the proper usage of the below codes for billing and coding purposes.CPT Definition:96360: Intravenous Infusion, hydration; initial, 31 minutes to 1 hour96361: Intravenous Infusion, hydration; each additional hour (list separately in addition to code for primary procedure)These codes are intended to report a hydration IV infusion consisting of pre-packaged fluid with or without electrolytes (e.g. normal saline, D5-1/2 normal saline+30mEq KCl/liter) and are not used to report infusion of drugs or other substances.Hydration Defined:The hydration codes 96360 and 96361 were developed to report specific therapeutic interventions undertaken when a patient presents with dehydration and volume loss requiring clinically necessary intravenous fluid.The necessity for hydration should be supported in the medical record.Documentation would include but is not limited to:A. Clinical assessment, typically on the same date of service, of the patients anticipated fluid needs. This can be demonstrated from the patients history, clinical examination, and pertinent laboratory testing to support the need for IV hydration therapy as reasonable and necessary for the patients treatment or diagnosis.Documentation of the assessment should describe symptoms warranting hydration, such as those associated with dehydration, the inability to ingest fluids or clear clinical contraindication to oral intake, abnormal fluid losses, abnormal vital signs, and/or abnormal laboratory studies, such as an elevated BUN, creatinine, glucose or lactic acid.Nausea itself does not necessarily indicate fluid volume depletion nor support necessity of fluid repletion.
Article - Billing and Coding: Hydration Services (A54635)
B. These codes are not intended to be reported/billed by the physician or other qualified healthcare professional in thefacilitysetting, as these codes most likely represent facility charges with applicable reimbursement through the respective fee schedule. However,in the physicianofficesetting (example, Place of Service 11), the physician may report these codes when the physicians clinical staff or the physician administers the fluids.C. Forfacilityreporting, an initial infusion is predicated on using a hierarchy.D. When administering multiple infusions (e.g. IV fluids and subsequent IV chemotherapy infusion on same date of service), only one primary infusion code should be reported for a given date, unless protocol requires that two separate IV sites must be used.E. Hydration cannot be reportedconcurrentlywith any other infusion or drug administration service.F. The definition of infusion time is inherent and presented in the guidelines for these codes. In other words, a minimum time duration of 31 minutes of hydration infusion is required to report the service.G. Consequently, infusion time is calculated from the time the administration commences (i.e. the infusion starts dripping) to when it ends (i.e. the infusion stops dripping).H. In accordance withMedicare Reasonable and Necessary Criteria,(Medicare Program Integrity Manual, Chapter 3, Section 3.6.2.2), the benefit must meet butdoes not exceedthe beneficiarys medical need, and as such, IV fluids should be avoided if not deemed clinically necessary.For example, although some conditions may warrant intravenous rehydration, if documentation supports the same benefit could be achieved by oral hydration, IV hydration would not be considered reasonable and necessary.However, it is understood that there are clinical scenarios in which the patient's need for hydration cannot wait for oral trials, even if an option. The intent should be understood within the body of documentation.I.Examplesof Additional Payable Scenarios:If therapeutic fluid administration is medically necessary:for the correction of dehydration or prevention of nephrotoxicity immediately before or after transfusion, chemotherapy, or administration of potentially nephrotoxic medications.immediately before or after IV contrast infusion for a diagnostic procedure in a patient with renal insufficiency.
Article - Billing and Coding: Hydration Services (A54635)
J.Non-payable scenarios :The following infusion circumstancesdo not represent hydrationand should not be reported using any of these CPT codes:If the sole purpose of the intravenous fluid is to maintain patency (i.e. keep open) of an IV line prior to, during, or subsequent to a chemotherapeutic or therapeutic infusion, or transfusion.If used as maintenance IV therapy replacing normal sensible and insensible fluid losses, not losses associated with a pathological condition.When the purpose of the infusion is to accommodate a therapeutic IV piggyback through the same IV access to safely infuse the agent (e.g. IV fluids infused simultaneously with drug administration).If the fluid is used as the diluent to mix the drug (i.e. the fluid is the vehicle in which the drug is administered).Hydration that is integral to the performance of a surgical procedure to establish an initial and underlying IV flow for a diagnostic or therapeutic infusion is not separately billable (e.g. IV fluids administered preoperatively, intraoperatively, and/or postoperatively).Routine administration of IV fluids, pre/post operatively while the patient is NPO for example, without documentation supporting signs and/or symptoms including those of dehydration or fluid loss is not supported as medically necessary.Infusion of IV fluids with electrolytes for the purpose of treating an electrolyte deficiency (e.g. hypokalemic patient being treated specifically for low potassium level for which 20 mEq of KCL is added to an IV fluid).
Article - Billing and Coding: Hydration Services (A54635)
In conclusion, themain question that should be asked when considering billing for 96360 and 96361 is whether IV hydration is an appropriate, accepted standard of medical practice as a diagnostic or specific treatment for a beneficiarys condition,is one that meets, BUT does NOT exceed the beneficiarys medical need, and cannot be met with oral hydration.Note:It is understood that depending on the clinical scenario, upon presentation, an IV line may be established, fluids initiated, labs drawn and sent for evaluation and imaging completed with examinations. Although it may be reasonable to start fluids upon presentation, in order to bill the IV hydration codes, the medical necessity for the hydration services must also be supported. If the final clinical assessment does not support intravenous hydration was necessary for beneficiarys medical needs, hydration codes should not be billedReferences:CPT Assistant Coding Update:Infusion/Injection services; February 2009; Volume 19, Issue 2, pages 17-21).CPT Assistant Coding Clarification;Facility reporting-Multiple Infusions (Codes 96360, 96361, 96365-96367); December, 2011; Volume 21, Issue 12, pages 3-5).National Institute for Health and Care Excellence (NICE) Guidelines; Intravenous Fluid Therapy in Adults in Hospital;December, 2013.2020 CMS NCCI Policy Manual for MC Services; Ch. 11, Medicine E/M Services CPT codes 90000-99999 and corresponding CMS NCCI edits.5. Medicare Program Integrity Manual Chapter 3, Section 3.6.2.2 - Reasonable and Necessary Criteria.
Article - Billing and Coding: Intravenous Immune Globulin (IVIg)-NCD 250.3 (A54641)
CMS National Coverage PolicyCMS National Coverage Determination Manual, 250.3Article TextThis article describes CMS national coverage effective on/after October 1, 2001. Please see the Noridian Local Coverage Determination for additional indications.Patient must meet at least one of the following criteria: Failed conventional therapy. Contractors have the discretion to define what constitutes failure of conventional therapy; Conventional therapy is contraindicated. Contractors have the discretion to define what constitutes contraindications to conventional therapy; or Have rapidly progressive disease in which a clinical response could not be affected quickly enough using conventional agents. In these situations, IVIg therapy would be give along with conventional treatment(s) and the IVIg would be used only until conventional therapy could take effect.Note: In addition, IVIg for the treatment of autoimmune mucocutaneous blistering disease must be used only for short term therapy and not as a maintenance therapy. Again, contractors have the discretion to decide what constitutes short-term therapy.
Article - Billing and Coding: Intravenous Immune Globulin (IVIg)-NCD 250.3 (A54643)
CMS National Coverage PolicyCMS National Coverage Determination Manual, 250.3Article TextThis article describes CMS national coverage effective on/after October 1, 2001. Please see the Noridian Local Coverage Determination for additional indications.Patient must meet at least one of the following criteria: Failed conventional therapy. Contractors have the discretion to define what constitutes failure of conventional therapy; Conventional therapy is contraindicated. Contractors have the discretion to define what constitutes contraindications to conventional therapy; or Have rapidly progressive disease in which a clinical response could not be affected quickly enough using conventional agents. In these situations, IVIg therapy would be give along with conventional treatment(s) and the IVIg would be used only until conventional therapy could take effect.Note: In addition, IVIg for the treatment of autoimmune mucocutaneous blistering disease must be used only for short term therapy and not as a maintenance therapy. Again, contractors have the discretion to decide what constitutes short-term therapy.