evekhm/cms_iom_500 huggingface dataset:
Article - Billing and Coding: CPT Code 87641 (Infectious agent detection by nucleic acid (DNA or RNA); Staphylococcus aureus, methicillin resistant, amplified probe technique) (A52379)
The worldwide emergence of MRSA is mainly the result of the extensive spread of a limited number of strains in hospitals, which are high risk settings for MRSA infection.Staphyloccocus aureusis an opportunistic pathogen that mainly infects patients who have had surgery or who have invasive devices (such as intravascular catheters). The epidemiology of MRSA has changed recently infections are no longer confined to the hospital setting, but also appear in healthy people in the community with no established risk factors for acquiring MRSA. These community associated MRSA strains differ from hospital associated strains. Most carriers ofS aureus, both hospital inpatients and others, are healthy asymptomatic people without evident infection. In hospitals where MRSA is endemic, patients risk being colonized by spread from other patients or healthcare workers. Colonization withS aureusin hospital is a risk factor for subsequent infection. (Kluytmans J, 2009).CPT code 87641 was established to report methicillin resistant Staphylococcus aureus (MRSA) by amplified probe technique and it is used to bill for assays that detect methicillin resistance and identify Staphylococcus aureus using a single nucleic acid sequence." (CPT Changes 2007  An Insiders View)The availability of nucleic acid probes has permitted the rapid direct identification of microorganisms DNA or RNA. Amplification techniques, including, but not limited to the polymerase chain reaction (PCR), results in the doubling of copies of specified target DNA with each round of amplification, eventually resulting in millionfold levels of amplification. The product of the amplification (i.e., DNA) is then detected using a variety of techniques. (Blue Cross & Blue Shield of Mississippi. Identification of Microorganisms Using Nucleic Acid Probes)Although some hospitals are screening patients prior to inpatient or outpatient hospitalization to identify carriers of methicillin resistant Staphylococcus aureus as an infection control measure, additional research will be required to demonstrate whether the use of universal rapid MRSA admission screening will reduce nosocomial MRSA infection in hospitals compared to the use of alternative control measures against MRSA.
Article - Billing and Coding: CPT Code 87641 (Infectious agent detection by nucleic acid (DNA or RNA); Staphylococcus aureus, methicillin resistant, amplified probe technique) (A52379)
Screening tests are statutorily non-covered based on Title VIII of the Social Security Act, Section 1862(a)(1)(A) which excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. This purpose of this article is to alert providers that National Government Services considers CPT code 87641 to be a test used for screening purposes for which payment will not be allowed.Specific Coding Guideline:Claims for CPT Code 87641 (Infectious agent detection by nucleic acid (DNA or RNA); Staphylococcus aureus, methicillin resistant, amplified probe technique) services are not payable under Medicare Part B for screening purposes and will be denied.When billing CPT code 87641 for screening purposes (statutorily non-covered), ICD-10-CM codes, including but not limited to those listed below, may be reported. The GY modifier should be reported, as applicable.Coding Information:Procedure codes may be subject to National Correct Coding Initiative (NCCI) edits or OPPS packaging edits. Refer to NCCI and OPPS requirements prior to billing Medicare.For services requiring a referring/ordering physician, the name and NPI of the referring/ordering physician must be reported on the claim.A claim submitted without a valid ICD-10-CM diagnosis code will be returned to the provider as an incomplete claim under Section 1833(e) of the Social Security Act.The diagnosis code(s) must best describe the patient's condition for which the service was performed. For diagnostic tests, report the result of the test if known; otherwise the symptoms prompting the performance of the test should be reported.
Article - Billing and Coding: Denosumab (Prolia &trade;, Xgeva &trade;) (A52399)
CMS National Coverage PolicyN/AArticle TextThis article contains billing and coding guidelines that complement the Local Coverage Determination (LCD) Drugs and Biologicals, Coverage of, for Label and Off-Label Uses.Abstract:Denosumab is a receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitor. Binding to the transmembrane or soluble protein RANKL inhibits the formation, function, and survival of osteoclasts resulting in decreased bone resorption and increased bone mass and strength.Supplemental calcium and vitamin D are required.Hypocalcemia must be corrected prior to initiation of denosumab therapy.The FDA has approved the use of denosumab (Prolia). Medicare has determined under Section 1861(t) that this drug may be paid when it is administered incident to a physicians service and is determined to be reasonable and necessary. Such determination of reasonable and necessary is currently left to the discretion of the Medicare contractors.Documentation Requirements:The patient's medical record should contain documentation that fully supports the medical necessity for the administration of either formulation. Requirements specific to each formulation are as follows:Denosumab(Prolia)Patient adequately supplemented with calcium and vitamin D (calcium 1000 mg daily and at least 400 IU vitamin D daily).For postmenopausal osteoporosis at high risk for fracture, documentation should include but is not limited to:Menopausal status (for female beneficiaries only)Patients age and sex.Documentation supporting the diagnosis of osteoporosis.Previous treatment of osteoporosis, agents used, outcomes and adverse reactions if any.History of previous fractures, including type of fracture, cause and time since occurrence.Risk factors for future fracture including preventive measures.For the treatment of cancer treatment-induced bone loss (CTIBL) due to hormone ablation such documentation should include, but is not limited to:Documentation supporting the diagnosis of breast cancer or nonmetastatic prostate cancer.Use of adjuvant aromatase inhibitor (AI) therapy or androgen deprivation therapy (ADT).Additional diagnosed risk factors, if any.Denosumab (Xgeva)Documentation should include, but is not limited to:For treatment of bone metastasis from a solid tumor:Patient adequately supplemented with calcium and vitamin D
Article - Billing and Coding: Denosumab (Prolia &trade;, Xgeva &trade;) (A52399)
Denosumab (Xgeva)Documentation should include, but is not limited to:For treatment of bone metastasis from a solid tumor:Patient adequately supplemented with calcium and vitamin DFor management of hypercalcemia of malignancy (ICD-10-CM code E83.52)The related malignancyThe rationale for the use of the drugUtilization:Dose and frequency should be in accordance with the FDA label or recognized compendia (for off-label uses). When services are performed in excess of established parameters, they may be subject to review for medical necessity.Coding Information:HCPCS code J0897 should be used to report denosumab (Prolia, Xgeva) for claims submitted to the Part A and Part B MAC.Correct coding requires that a bone metastasis diagnosis (ICD-10-CM code C79.51) be present on the claim as the primary diagnosis and the original cancer or history of cancer be included as the secondary diagnosis. This article does not limit the primary cancer (as long as it is a solid tumor and not a myeloma or other cancer of the blood). Effective for dates of service on or after 01/04/2018, the FDA has approved denosumab (Xgeva) for the treatment of skeletal-related events in patients with multiple myeloma.Anysignificant and separately identifiableE&M service billed should accurately reflect the level of the components documented. Observation of the patient by the physician post-injection may be included in the E&M service. Only face-to-face time with the physician may be considered. Observation and treatment time by the office or hospital staff may not be billed separately or counted towards a physician E&M service.FDA and Compendia Review
Article - Billing and Coding: Denosumab (Prolia &trade;, Xgeva &trade;) (A52399)
FDA and Compendia ReviewClinical Pharmacology Web site. http://www.clinicalpharmacology.com/. Accessed 08/21/2023.FDA label for Prolia https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125320s202lbl.pdfFDA label for XGEVA https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125320s196s199lbl.pdfLexi-Drugs Web site. http://online.lexi.com. Accessed 08/21/2023.Micromedex DrugDex. http://www.thomsonhc.com/home/dispatch. Accessed 08/21/2023.National Comprehensive Cancer Network Web site. http://www.nccn.org/index.asp. Accessed 08/21/2023.Prolia Web site. http://www.proliahcp.com/. Accessed 10/01/2010.
Article - Billing and Coding: Hyaluronans Intra-articular Injections of (A52420)
CMS National Coverage PolicyN/AArticle TextThis article contains billing and coding guidelines that complement the Local Coverage Determination (LCD) Drugs and Biologicals, Coverage of, for Label and Off-Label Uses.Abstract:Purified natural hyaluronans have been approved by the FDA for the treatment of pain associated with osteoarthritis of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics. The synovial fluid's capacity to lubricate and absorb shock is typically reduced in joints affected by osteoarthritis. These changes are partly due to a reduction in the concentration and size of hyaluronic acid molecules that are naturally present in synovial fluid. In addition to the FDA approved use, hyalurons have been recognized as a therapeutic option in osteoarthritis of the shoulder. This article defines coverage criteria for the injection of the knee or shoulder with either sodium hyaluronate (Hyalgan, Supartz or Visco-3, Euflexxa, Monovisc, GelSyn-3, GenVisc 850, Durolane, TriVisc, Synojoynt, Triluron), hylan G-F 20 (Synvisc, Synvisc-One ), hyaluronic acid (Gel-One), high molecular weight hyaluronan (Orthovisc) or high molecular weight viscoelastic hyaluronan (Hymovis).Documentation Requirements:
Article - Billing and Coding: Hyaluronans Intra-articular Injections of (A52420)
The patient's medical record should contain documentation that fully supports the medical necessity for intra-articular injections of sodium hyaluronate (Hyalgan, Supartz or Visco-3, Euflexxa, Monovisc, GelSyn-3, GenVisc 850, Durolane, TriVisc, Synojoynt, Triluron), hylan G-F 20 (Synvisc, Synvisc-One ), hyaluronic acid (Gel-One), high molecular weight hyaluronan (Orthovisc) and high molecular weight viscoelastic hyaluronan (Hymovis). This documentation includes, but is not limited to, relevant medical history, physical examination and results of pertinent diagnostic tests or procedures, and history of pharmacologic therapy. Documentation of subsequent courses of treatment must clearly establish reduction of patient symptomatology and medication usage. This documentation must be submitted upon request. Claims submitted without requested supporting evidence in the medical record will be denied as being not medically necessary.Utilization:The dose and frequency of administration should be consistent with the FDA approved labeling.It is expected that an injection (Synvisc-One , Gel-One, Durolane) or course of the injections (Synvisc, Hyalgan, Supartz or Visco-3, Euflexxa, Orthovisc, GelSyn-3, GenVisc 850, Hymovis,TriVisc,Synojoynt, Triluron) will not be repeated within six months time.A repeat series of injections may be allowed when:The indicationscontinue to be met; andSignificant improvement in pain and functional capacity from the prior series of injections is documented in the medical record; andThe last injection (in a prior course) was given at least six (6) months ago.Repeat injections for shoulder arthritis are limited to a single repeat course.Coding information:
Article - Billing and Coding: Hyaluronans Intra-articular Injections of (A52420)
Repeat injections for shoulder arthritis are limited to a single repeat course.Coding information:If an aspiration and an injection procedure are performed at the same session, bill only one unit for CPT code 20610 or 20611.The appropriate site modifier (RT or LT) must be appended to CPT code 20610 or 20611 to indicate if the service was performed unilaterally and modifier (50) must be appended to indicate if the service was performed bilaterally.Use "EJ" modifier on drug codes to indicate subsequent injections of a series. Do not use this modifier for the first injection of each series. A series is defined as the set of injections for each joint and each treatment. Injection of the left knee or shoulder is a separate series from injection of the right knee or shoulder.If the drug is denied as not reasonable and necessary, the associated injection code will also be denied.FDA and Compendia Review:American Society of Health-System Pharmacists, Inc.AHFS Drug Information.Bethesda, MD: 2007.Clinical Pharmacology Web site. http://www.clinicalpharmacology.com/. Accessed 07/06/2021.FDA approval letter and manufacturer's insert.Full Prescibing Information for ORTHOVISC Date: 01/04.Lexi-Drugs Web site. http://online.lexi.com. Accessed 07/06/2021.Micromedix DrugDex Thomson Web site. http://www.thomsonhc.com/home/dispatch. Accessed 07/06/2021.National Comprehensive Cancer Network Web site. http://www.nccn.org/index.asp. Accessed 07/06/2021.Product Information for EUFLEXXA Issue Date: 10/05.Product information for Synvisc-One, FDA Web site: http://www.fda.gov/MedicalDevices/default.htm. Accessed 06/02/2009.United States Pharmacopoeia (USP), Volume I; Drug Information for the Health Care Professional, 2007.U.S. Food and Drug Administration Premarket Notification Database:
Article - Billing and Coding: Hyaluronans Intra-articular Injections of (A52420)
Euflexxa. P010029. Rockville, MD: FDA. October 11, 2011. Available at:http://www.accessdata.fda.gov/cdrh_docs/pdf/p010029s008a.pdf.Gel-One. P080020. Rockville, MD: FDA. March 22, 2011. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf8/p080020a.pdf.GelSyn-3. P110005. Rockville, MD: FDA. May 9, 2014. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf11/P110005b.pdf.GenVisc 850. No P140005. Silver Spring, MD: FDA September 2, 2015. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=p140005.Hyalgan. P950027. Rockville, MD: FDA. May 28, 1997. Available at http://www.accessdata.fda.gov/cdrh_docs/pdf/P950027A.pdfHymovis P150010. Silver Spring, MD.FDA. August 28, 2015. Available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=p150010Monovisc. P090031. Bedford, MA: FDA. February 25, 2014. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf9/P090031a.pdfOrthovisc. P030019. Rockville, MD: FDA. February 4, 2004. Available at:http://www.accessdata.fda.gov/cdrh_docs/pdf3/p030019a.pdf.
Article - Billing and Coding: Hyaluronans Intra-articular Injections of (A52420)
http://www.accessdata.fda.gov/cdrh_docs/pdf3/p030019a.pdf.Supartz or Visco-3. P980044. Rockville, MD: FDA. January 24, 2001. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/P980044a.pdf.Synvisc. P940015. Rockville, MD: FDA August 8, 1997. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/P940015A.pdfSynvisc-One. No. P940015. Rockville, MD: FDA. February 26, 2009. Available at:http://www.accessdata.fda.gov/cdrhdocs/pdf/P940015S012a.pdf.Durolane - https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?ID=402834Trivisc - https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160057a.pdf.Synojoynt - htttps://www.fda.gov/medical-devices/recently-approved-devices/synojoynttm-p170016.Triluron - https://www.fda.gov/medical-devices/recently-approved-devices/trilurontm-p180040.
Article - Billing and Coding: Ibandronate Sodium (A52421)
CMS National Coverage PolicyN/AArticle TextThis article contains billing and coding guidelines that complement the Local Coverage Determination (LCD) Drugs and Biologicals, Coverage of, for Label and Off-Label Uses.The intravenous form of ibandronate was approved by the Food and Drug Administration (FDA) for use every three (3) months.Specific coding guidelines for this drug:Ibandronate sodium is available in oral and intravenous forms. National Government Services will consider the intravenous form to be reasonable and necessary only for patients for whom biphosphonate therapy including oral ibandronate sodium is medically necessary and who cannot tolerate oral therapy. Documentation must show that the patient cannot tolerate oral biphosphonates or that they are otherwise medically contraindicated.Coding Information:When submitting claims for senile osteoporosis or other osteoporosis, ICD-10-CM code K20.80, K20.81, K20.90, K20.91 or Z87.19 shouldonlybe added to claims to indicate that the patient has severe esophagitis and cannot take the oral drugs.When submitting claims for senile osteoporosis or other osteoporosis, ICD-10-CM code T50.995A-T50.995S, Y63.8, Z91.89 or Z92.89 shouldonlybe added to claims to indicate that the patient cannot tolerate oral ibandronate sodium.For management of hypercalcemia of malignancy (E83.52), the rationale for the use of the drug and the related malignancy must be documented in the patients medical record.When submitting claims for patients with osteoporosis as a complication of transplant, the related complication of transplant code as well as T50.995A-T50.995S or Z87.19 is required.When ibandronate is used to prevent osteoporosis in a postmenopausal woman who is not being treated for osteopenia, the claim should include the -GY modifier which will result in denial of Medicare payment.Utilization:
Article - Billing and Coding: Ibandronate Sodium (A52421)
Utilization:Dose and frequency should be in accordance with the FDA label or recognized compendia (for off-label uses). When services are performed in excess of established parameters, they may be subject to review for medical necessity.FDA and Compendia Review:American Society of Health-System Pharmacists, Inc.AHFS Drug Information.Bethesda, MD: 2007.Clinical Pharmacology Web site. http://www.clinicalpharmacology.com/. Accessed 08/21/2023.Lexi-Drugs Web site. http://online.lexi.com. Accessed 08/21/2023.Micromedex DrugDex. http://www.micromedexsolutions.com/home/dispatch. Accessed 08/21/2023.National Comprehensive Cancer Network Web site. http://www.nccn.org/index.asp. Accessed 08/21/2023.U.S. Food and Drug Administration label approved 01/06/2006 accessed on line athttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/on 11/19/2007.United States Pharmacopoeia (USP), Volume I; Drug Information for the Health Care Professional, 2007.
Article - Billing and Coding: Infliximab and biosimilars (A52423)
CMS National Coverage PolicyN/AArticle TextThis article contains billing and coding guidelines that complement the Local Coverage Determination (LCD) Drugs and Biologicals, Coverage of, for Label and Off-Label Uses.Abstract:Infliximab is a chimeric monoclonal antibody that binds to tumor necrosis factor alpha (TNFa), which is believed to be critical to the human bodys reaction to inflammation. TNFa is a cytokine that is a key biologic response mediator found to be increased in such chronic and inflammatory disorders as Crohns disease and rheumatoid arthritis, among others.Infliximab-dyyb is the second biosimilar of reference biologic Remicade (infliximab)Infliximab-abda and infliximab axxq are other biosimilars of reference biologic Remicade (infliximab)Documentation Requirements:Medical records should include:1) The basis for each diagnosis and that the diagnosis was made in accordance with recognized standards such as guidelines published by the American College of Rheumatology (ACR).2) Weight when needed to determine appropriate dosing.3) Evaluation for latent tuberculosis infection through medical evaluation and TB test. Treatment of latent tuberculosis infection should be initiated prior to therapy with infliximab.4) Documentation of the disease specific relevant symptoms and signs which are both being treated and being followed to assess for response to treatment.5) Documentation of Inadequate Response (includes lack of efficacy, adverse effects prohibiting further use of the drug or medical contraindications) to a 3 month trial of appropriately dosed and disease specific conventional (non-biologic) therapy).Crohns disease: Relevant information includes the presence and severity of abdominal pain, diarrhea, extra-intestinal manifestations, enterocutaneous and/or rectovaginal fistulae. Retreatment of patients with Crohns disease will be covered when the medical record substantiates that the patient had a reduction in the clinical signs and symptoms of the disease after the initial treatment.
Article - Billing and Coding: Infliximab and biosimilars (A52423)
Plaque Psoriasis: For the treatment of plaque psoriasis, documentation to support that the conditions is chronic, severe, extensive or disabling could include percent body surface area (BSA) affected; Psoriasis Area Severity Index (PASI) score; Psoriasis Disability Index (PDI) score; and/or results from other psoriasis assessment tool(s). Infliximab given to treat plaque psoriasis should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician. Psoriasis patients should be monitored for nonmelanoma skin cancers, particularly those patients who have had prior prolonged phototherapy treatment.Rheumatoid Arthritis: To support the continued use of infliximab beyond 30 weeks for the treatment of rheumatoid arthritis, the medical record must include evidence of at least 20% improvement in tender joint count and at least 20% improvement in swollen joint count. The patients medical record mustdocument that the patient is also receiving methotrexate orclearly indicates the reason that the patient cannot take methotrexate.Utilization:Dose and frequency for infliximaband biosimilars,should be in accordance with the FDA label or recognized compendia (for off-label uses). When services are performed in excess of established parameters, they may be subject to review for medical necessity.Services performed for excessive frequency are subject to denial as not medically necessary. Frequency is considered excessive when services are performed more frequently than recommended in the FDA-approved package insert.Coding Information:Claims submitted for treatment of pyoderma gangrenosum with coexisting inflammatory bowel disease must be submitted with a primary and a secondary ICD-10-CM code. If both the primary and secondary ICD-10-CM codes are not indicated on the claim, the service will be denied.For claims submitted to the Part B MAC:Infliximaband biosimilars are available in 100-mg vials. The dosage associated with the HCPCS code is 10 mg. The number of units (rounded up to a whole unit) used, should be entered in Item 24G of the CMS 1500 claim form or the electronic equivalent.
Article - Billing and Coding: Infliximab and biosimilars (A52423)
The following is an example of the correct reporting methodology for infliximaband biosimilars:If the dosage administered is 375 mg, 4 vials (or a total of 400 mg) will be used. Report this with a "40" in the units field. Since this will result in product wastage, the JW modifier should be applied to the amount of the drug or biological that is discarded and should be billed as a separate line item. Effective July 1, 2023, the JZ modifier should be reported on all claims that bill for infliximab and biosimilars when there are no discarded amounts from single-dose containers or single-use packages.FDA and Compendia Review: