evekhm/cms_iom_500 huggingface dataset:
Article - Billing and Coding: MolDX: FDA-Approved KRAS Tests (A54498)
CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.Article TextThe following coding and billing guidance is to be used with its associated Local coverage determination.Two tests have met the Food and Drug Administration (FDA) criteria for KRAS genetic testing:1. Effective 7/06/2012therascreen KRAS to detect 7 somatic mutations in the human KRAS oncogene was developed to aid in the identification of colorectal cancer (CRC) patients for treatment with Erbitux (cetuximab).2. Effective 5/7/2015cobas KRAS to detect mutations in codons 12 and 13 of the KRAS gene was developed to aid in identification of CRC patients for treatment with Erbitux (cetuximab) or Vectibix (panitumumab).To report an FDA approved or laboratory developed test (LDT) KRAS, service, please submit the following claim information.Select the appropriate CPT codeEnter 1 unit of Service (UOS)Enter the appropriate DEXZ-Code Identifier in the comment/narrative field for the following Part B claim field/types:Loop 2400 or SV101-7 for the 5010A1 837PItem 19 for paper claimEnter the appropriate DEXZ-Code Identifier in the comment/narrative field for the following PartA claim field/types:Line SV202-7 for the 837I electronic claimBlock 80 for the UB04 claim formSelect the appropriate ICD-10-CM diagnosis.NOTE:MolDX will apply National Provider Identifier (NPI) to ID editing on FDA approved KRAS kits. All labs that submit claims for a KRAS, codon 12 and 13 test kitMUSTregister the test and confirm theUNMODIFIEDuse of the kit. Tests may be registered on theDEX Diagnostics Exchange:https://app.dexzcodes.com/login.This article reflects the FDA-approved indications on article creation date. MolDX will allow future FDA approved and amended indications for these tests.
Article - Billing and Coding: MolDX: FDA-Approved KRAS Tests (A54500)
CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.Article TextThe following coding and billing guidance is to be used with its associated Local coverage determination.Two tests have met the Food and Drug Administration (FDA) criteria for KRAS genetic testing:Effective 7/6/2012therascreen KRAS to detect 7 somatic mutations in the human KRAS oncogene was developed to aid in the identification of colorectal cancer (CRC) patients for treatment with Erbitux (cetuximab).2. Effective 5/7/2015cobas KRAS to detect mutations in codons 12 and 13 of the KRAS gene was developed to aid in identification of CRC patients for treatment with Erbitux (cetuximab) or Vectibix (panitumumab).To report an FDA approved or laboratory developed test (LDT) KRAS, service, please submit the following claim information.Select the appropriate CPT codeEnter 1 unit of service (UOS)Enter the appropriate DEXZ-Code Identifier in the comment/narrative field for the following Part B claim field/types:Loop 2400 or SV101-7 for the 5010A1 837PItem 19 for paper claimEnter the appropriate DEXZ-Code Identifier in the comment/narrative field for the following PartA claim field/types:Line SV202-7 for the 837I electronic claimBlock 80 for the UB04 claim formSelect the appropriate ICD-10-CM diagnosis.NOTE:MolDX will apply National Provider Identifier (NPI) to ID editing on FDA approved KRAS kits. All labs that submit claims for a KRAS, codon 12 and 13 test kitMUSTregister the test and confirm theUNMODIFIEDuse of the kit. Tests may be registered on theDEX Diagnostics Exchange:https://app.dexzcodes.com/login.This article reflects the FDA-approved indications on article creation date. MolDX will allow future FDA approved and amended indications for these tests.
Article - Bowel Management Devices - Policy Article (A54516)
CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).In order for any item to be eligible for coverage under Medicare, the item must be eligible for inclusion into one of the existing coverage Benefit Categories. Rectal inserts and electrical incontinence aids are covered under the Prosthetic Devices benefit (Social Security Act 1861(s)(9)). Bed pans are covered under the Durable Medical Equipment benefit (Social Security Act 1861(s)(6)). In order for a beneficiarys equipment to be eligible for reimbursement, the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.Many bowel management devices (see bulleted list below, not all inclusive) fail one or more of the relevant requirements in 1861(n) of the Act and are thus statutorily excluded from coverage (see the CMS Nation Coverage Determinations Manual (Internet-only Manual 100-03) Chapter 1, Part 4, 280.1):Disposable Sheets and Bags (A4335)  Deny  Non-reusable disposable suppliesIncontinence Pads (A4553 and A4554)  Deny  Non-reusable supply; Hygienic itemDiapers (A4520) - Deny  Non-reusable supply; Hygienic item
Article - Bowel Management Devices - Policy Article (A54516)
Diapers (A4520) - Deny  Non-reusable supply; Hygienic itemManual pump enema systems (e.g., Peristeen- Coloplast, Minneapolis, MN) or gravity-administered enema systems do not meet the Durable Medical Equipment (DME) benefit because these devices do not meet the requirement of durability. In addition, these devices do not meet the Prosthetic Benefit because they do not replace a non-functioning internal body organ.Rectal catheters/tubes and related collection systems do not meet the Durable Medical Equipment (DME) benefit because these devices do not meet the requirement of durability. In addition, these devices do not meet the Prosthetic Benefit because they do not replace a non-functioning internal body organ.Pulsed irrigation and evacuation devices (PIE  P.I.E. Medical Inc., Buford, GA) do not meet the DME benefit because they are considered institutional equipment.Vaginal inserts and related accessories (Eclipse Vaginal Insert system - Pelvalon, Inc) for the treatment of fecal incontinence are not DME MAC jurisdiction. Claims for vaginal inserts and related accessories(A4563 -RECTAL CONTROL SYSTEM FOR VAGINAL INSERTION, FOR LONG TERM USE, INCLUDES PUMP AND ALL SUPPLIES AND ACCESSORIES, ANY TYPE EACH)submitted to the DME MACs will be rejected as wrong jurisdiction.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.
Article - Bowel Management Devices - Policy Article (A54516)
Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD prior to delivery, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.CODING GUIDELINESRectal inserts are prosthetic devices constructed of rubber, latex, silicone or other similar material and act as a barrier to the passage of fecal matter through the rectum. Use code A4337 (INCONTINENCE SUPPLY, RECTAL INSERT, ANY TYPE, EACH) for this item. Code A4337 includes the insert and any associated supplies or accessories for insertion and maintenance of the device.Rectal catheters/tubes and related collection systems are products designed to be inserted into the rectum to collect fecal material. They also serve to assist in protection of perianal skin integrity in the patient with fluid and semi-fluid waste.An electrical continence aid is a prosthetic device consisting of a plastic plug, molded into the shape of the patient's anal canal, which contains two implanted electrodes that are connected by a wire to a small portable generator. An electrical current is produced which stimulates the anal musculature to cause a contraction sufficient to hold the plug in while allowing the patient to ambulate without incontinence.
Article - Bowel Management Devices - Policy Article (A54516)
HCPCS codes A4458 (ENEMA BAG WITH TUBING, REUSABLE) and code A4459 (MANUAL PUMP ENEMA SYSTEM, INCLUDES BALLOON, CATHETER AND ALL ACCESSORIES, REUSABLE, ANY TYPE) describe devices used to empty the lower bowel and to prevent chronic constipation and fecal incontinence or simply as a method of bowel management. An enema system consists of an irrigation fluid holding chamber and a rectal catheter (with or without an inflatable balloon). Fluid is instilled either via gravity or a manual pump.The Peristeen transanal irrigation system is a device used to empty the lower bowel and to prevent chronic constipation and fecal incontinence or simply as a method of bowel management. The system consists of an enema bag, a rectal catheter with an inflatable balloon and a pump. Effective for claims with dates of service on or after January 1, 2015, the correct code to bill is A4459 (MANUAL PUMP ENEMA SYSTEM, INCLUDES BALLOON, CATHETER AND ALL ACCESSORIES, REUSABLE, ANY TYPE).HCPCS code A4459 is an all-inclusive code at initial issue. Separate billing of any of the individual components is not allowed at initial issue. For billing refills of the disposable rectal catheter, HCPCS code A4453 (RECTAL CATHETER FOR USE WITH THE MANUAL PUMP-OPERATED ENEMA SYSTEM, REPLACEMENT ONLY) must be used.HCPCS code E0350 describes a colorectal irrigation system that consists of an irrigation fluid holding chamber, a rectal catheter with an inflatable balloon and an electric pump. Irrigation fluid is administered in a pulsatile manner to hydrate stool to a semi-liquid form and allow the liquefied stool to evacuate. Code E0352 describes all disposable supplies and accessories used with code E0350 including, but not limited to, a water reservoir, speculum, valve mechanism and collection bag or box.
Article - Bowel Management Devices - Policy Article (A54516)
HCPCS codes E0275 (BED PAN, STANDARD, METAL OR PLASTIC) and E0276 (BED PAN, FRACTURE, METAL OR PLASTIC) describe a shallow vessel placed under a bedridden patient to collect feces and urine. To meet Medicare coverage and DME benefit requirements, they must be durable. Disposable bed pans must be billed using code A9270 (NONCOVERED ITEM OR SERVICE).Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of these items.
Article - Therapeutic Apheresis for Familial Hypercholesterolemia (A54543)
CMS National Coverage PolicyN/AArticle TextNational Coverage Determination (NCD) for Apheresis Therapeutic Pheresis (110.14) allows Medicare Administrative Contractor coverage discretion in the use of therapeutic apheresis in the treatment of refractory familial hypercholesterolemia.Note: CMS Medicare Learning Network (MLN) (MM) 4250 does not apply to or restrict this use.Noridian covers plasma apheresis for the treatment of familial hypercholesterolemia that is resistant to appropriate lifestyle changes combined with maximal use of statin agents with or without the use of ezetimibe in:1.Functional homozygotes with an LDL cholesterol greater than 500mg/dl;2.Functional heterozygotes with no known cardiovascular disease but a LDL cholesterol greater than 300mg/dl;3.Functional heterozygotes with known cardiovascular disease and a LDL cholesterol greater than 200mg/dl;4.Familial hypercholesterolemia in pregnancy when the physician feels usual therapy is inadequate to assure uteroplacental perfusion.All such claims are subject to either pre- or post-pay review by Noridian or any of the authorized Medicare auditors. The need for this procedure must be clearly documented in the medical records for each visit including which pharmacologic agents are/have been used and what lifestyle changes have been made and, if a beneficiary was intolerant of statins, the actual findings and symptoms reported. Be sure that the clinical notes are properly signed by the treating provider and dated for the date of service.
Article - Therapeutic Apheresis for Familial Hypercholesterolemia (A54545)
CMS National Coverage PolicyN/AArticle TextNational Coverage Determination (NCD) for Apheresis Therapeutic Pheresis (110.14) allows Medicare Administrative Contractor coverage discretion in the use of therapeutic apheresis in the treatment of refractory familial hypercholesterolemia.Note: CMS Medicare Learning Network (MLN) (MM) 4250 does not apply to or restrict this use.Noridian covers plasma apheresis for the treatment of familial hypercholesterolemia that is resistant to appropriate lifestyle changes combined with maximal use of statin agents with or without the use of ezetimibe in:1. Functional homozygotes with an LDL cholesterol greater than 500mg/dl;2. Functional heterozygotes with no known cardiovascular disease but a LDL cholesterol greater than 300mg/dl;3. Functional heterozygotes with known cardiovascular disease and a LDL cholesterol greater than 200mg/dl;4. Familial hypercholesterolemia in pregnancy when the physician feels usual therapy is inadequate to assure uteroplacental perfusion.All such claims are subject to either pre- or post-pay review by Noridian or any of the authorized Medicare auditors. The need for this procedure must be clearly documented in the medical records for each visit including which pharmacologic agents are/have been used and what lifestyle changes have been made and, if a beneficiary was intolerant of statins, the actual findings and symptoms reported. Be sure that the clinical notes are properly signed by the treating provider and dated for the date of service.
Article - Billing and Coding: Eculizumab (A54548)
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.Utilization Guidelines: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.Documentation Requirements:Clinical records should document either immunization with a meningococcal vaccine at least 2 weeks prior to administration of the first dose of eculizumab or that the risks of delaying eculizumab outweighed the risk of meningococcal infection.When used for the treatment of an individual with PNH, the following should be documented at initiation of therapy:Flow cytometry confirming the diagnosis of PNH and either of the following (a or b)Evidence of clinically significant hemolysis; orDocumented history of a major adverse vascular event (MAVE) from thromboembolism.Note: for individuals with confirmed PNH who do not meet the documentation requirements above and who were started on a course of eculizumab prior to the effective date of this document, continuation of therapy may be allowed based on the potential risk of adverse events which may occur upon discontinuation or interruption of therapy.When given as an initial trial (generally 6-12 weeks) for the treatment of aHUS, the individual was assessed and both:Had no signs of Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS); andThrombotic thrombocytopenic purpura (TTP) was ruled out (for example, normal ADAMTS 13 activity and no evidence of an ADAMTS 13 inhibitor), or if TTP could not be ruled out by laboratory and clinical evaluation, a trial of plasma exchange did not result in clinical improvementWhen eculizumab is continued following an initial trial for aHUS, the records should reflect that there had been clinical improvement (for example, increased platelet count or laboratory evidence of reduced hemolysis).When eculizumab is given for biopsy proven dense deposit disease, elevated serum levels of sC5b-9 (serum Membrane Attack Complex (sMAC) must be documented.
Article - Billing and Coding: Eculizumab (A54548)
FDA and Compendia Review:Clinical Pharmacology website http://www.clinicalpharmacology.com/. Accessed 09/08/2022.FDA label for Soliris (eculizumab). FDA website http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetailsLexi-Drugs Web site. http://online.lexi.com. Accessed 09/08/2022.Micromedex DrugDex. http://www.thomsonhc.com/home/dispatch. Accessed 09/08/2022.National Comprehensive Cancer Network website http://www.nccn.org/index.asp. Accessed 09/08/2022.
Article - Billing and Coding: Low frequency, non-contact, non-thermal ultrasound (A54555)
CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.Title XVIII of the Social Security Act, 1862(a)1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.Article TextLow frequency, non-contact, non-thermal ultrasound (CPTcode 97610) describes a system employed in wound care that uses continuous low frequency ultrasonic energy to atomize a liquid and deliver continuous low frequency ultrasound to the wound bed. MIST therapy or other similar products are included in the payment for the treatment of the same wound with other active wound care management or wound debridement CPTcodes (97597, 97598, 97602, 97605, 97606).
Article - Billing and Coding: Xofigo Billing Instructions (A54559)
CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1833(e) prohibits Medicare payment for any claim lacking the necessary documentation to process the claimArticle TextOn May15, 2013, the U. S. Food and Drug Administration (FDA)approved radium Ra 223 dichloride (XofigoInjection, Bayer HealthCare Pharmaceuticals Inc.) for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. Xofigois an alpha-particle emitting radiotherapeutic drug which mimics calcium and forms complexes with hydroxyapatite at areas of increased bone turnover, such as bone metastases.Therecommendeddoseand scheduleforXofigois 55 kBq/kg (1.49 microcuries/kg)administered by slow intravenous injection over 1 minute every 4 weeks for 6 doses.Submit:HCPCS code A9606Diagnoses: ICD-10 code C61 - Malignant neoplasm of prostate and C79.51 - Secondary malignant neoplasm of boneORC79.52 - Secondary malignant neoplasm of bone marrowNarrative field or electronic equivalent state "visceral metastases are absent".
Article - Surgical Dressings - Policy Article (A54563)
CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).Surgical Dressings are covered under the Surgical Dressings Benefit (Social Security Act 1861(s)(5)). The CMS Benefit Policy Manual (IOM 100-02), CH 15, 100 provides interpretive guidance to contractors for the implementation of this provision. The relevant part of the manual section establishes two separate benefit criteria:The necessity for and definition of a qualifying wound; and,The requirements necessary for any product to be classified as a surgical dressing for purposes of coverage under this benefit.In order for a beneficiarys item(s) to be eligible for reimbursement, all benefit requirements discussed below and the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met.QUALIFYING WOUNDSurgical dressings are covered when a qualifying wound is present. A qualifying wound is defined as either of the following:A wound caused by, or treated by, a surgical procedure; or,After debridement of the wound, regardless of the debridement technique.The surgical procedure or debridement must be performed by a treating practitioner or other healthcare professional to the extent permissible under State law. Debridement of a wound may be any type of debridement (examples given are not all-inclusive):Surgical (e.g., sharp instrument or laser)Mechanical (e.g., irrigation or wet-to-dry dressings)Chemical (e.g., topical application of enzymes) orAutolytic (e.g., application of occlusive dressings to an open wound).
Article - Surgical Dressings - Policy Article (A54563)
Dressings used for mechanical debridement, to cover chemical debriding agents, or to cover wounds to allow for autolytic debridement are covered although the debridement agents themselves are noncovered.Examples (not all-inclusive) of clinical situations in which dressings are noncovered under the Surgical Dressings benefit are:Drainage from a cutaneous fistula which has not been caused by or treated by a surgical procedure; or,A Stage 1 pressure ulcer; or,A first degree burn; or,Wounds caused by trauma which do not require surgical closure or debridement - e.g., skin tear or abrasion; or,A venipuncture or arterial puncture site (e.g., blood sample) other than the site of an indwelling catheter or needle.Claims for surgical dressings used for clinical conditions other than the qualifying wounds as described above will be denied as statutorily non-covered, no benefit.QUALIFYING DRESSING REQUIREMENTSProducts that are eligible to be classified as a surgical dressing are defined as:Primary dressings - Therapeutic or protective coverings applied directly to wounds or lesions either on the skin or caused by an opening to the skin.Secondary dressings - Materials that serve a therapeutic or protective function and that are needed to secure a primary dressing. Items such as adhesive tape, roll gauze, bandages, and disposable compression material are examples of secondary dressings.Some items, such as transparent film, may be used as a primary or secondary dressing.The following are examples of wound care items which are non-covered under the surgical dressing benefit because they do not meet the statutory definition of a dressing (not all-inclusive):