evekhm/cms_iom_500 huggingface dataset:
(Medicare Benefit Policy Manual)
NOTE:   ESRD patients should not be sent to other settings for the purpose of receiving separate payment for renal dialysis injectable drugs and biologicals or for the purpose of not assuming financial responsibility for renal dialysis items and services.   ESRD facilities must report the a ppropriate Healthcare Common Procedure Coding System (HCPCS) codes used for the administration and furnishing of renal dialysis drugs and biologicals.  This includes drugs and biologicals that are furnished in the beneficiarys home.  These supplies include:    A4657: Injection administration- supply charge (includes the cost of alcohol swab, syringe, and gloves) and    A4913: IV administration- supply charge (includes the cost of IV solution administration set, alcohol swab, syringe, and gloves).  A4913 should only be used when an IV solution set is required for a drug to be given.   See Pub. 100- 04, Medicare Claims Processing Manual, chapter 8, 60.2.1 for billing procedures.  These supplies are eligible for payment as outlier services in accordance with 60.D of this chapter.   C.  Oral or Other Forms of Injectable Drugs and Biologicals   The ESRD PPS includes certain drugs and biologicals that were previously paid under Part D.  Oral or other forms of injectable renal dialysis drugs and biologicals, for example, Vitamin D analogs, Levocarnitine, antibiotics or any other oral or other form of injectable drug or biological furnished as renal dialysis services are also included in the ESRD PPS and may not be separately paid.   The ESRD facility should report any drug or biological furnished on the ESRD claim with the line item date of service and the quantity of the drug or biological furnished at the time of the visit.  For claims processing instructions see Pub. 100- 04, Medicare Claims Processing Manual, chapter 8,  60.2.1.2.  For oral or other forms of renal dialysis drugs that are filled at the pharmacy for home use, ESRD facilities should report one line item per prescription, but only for the quantity of the drug expected to be taken during the claim billing perio d.
(Medicare Benefit Policy Manual)
Example:  A prescription for oral vitamin D was ordered for one pill to be taken 3 times daily for a period of 45 days.  The patient began taking the medication on April 15, 2011.  On the April claim, the ESRD facility would report the appropriate Nati onal Drug Code (NDC) code for the drug with the quantity 45 (15 days x 3 pills per day).  The remaining pills which would be taken in May would appear on the May claim for a quantity of 90 (30 days x 3 pills per day).  Prescriptions for a 3 month supply of  the drug would never be reported on a single claim.  Only the amount expected to be taken during the month would be reported on that months claim.   Oral and other forms of injectable renal dialysis drugs are eligible for consideration as outlier services .  See the CMS website at http://www.cms.gov/Medicare/Medicare -Fee-for-Service -Payment/ESRDpayment/Outlier_Services.html for a list of these drugs .  CMS prices these drugs using national average drug prices based on the Medicare Prescription Drug Plan Finder.  Payment also includes a mean dispensing fee that is applied to each NDC included on the monthly claim, in accordance with Pub. 100-04, Medica re Claims Processing Manual, chapter 8, 60.2.1.2.   Payments for oral or other forms of renal dialysis injectable drugs or biologicals are included in the ESRD PPS and are only made to the ESRD facility.  ESRD facilities should report all oral or other for ms of renal dialysis injectable drugs and biologicals furnished to their patients on the claim.    D.  Oral -Only Renal Dialysis Service Drugs and Biologicals   Oral-only forms of renal dialysis drugs and biologicals that have no other form of administration will be included in the ESRD PPS as a Part B renal dialysis service.   NOTE:   Implementation of renal dialysis oral -only drugs has been delayed until January 1, 2025.   E.  Drugs and Biologicals Furnished for Reasons Other than for the Treatment of ESRD
(Medicare Benefit Policy Manual)
NOTE:   Implementation of renal dialysis oral -only drugs has been delayed until January 1, 2025.   E.  Drugs and Biologicals Furnished for Reasons Other than for the Treatment of ESRD   Drugs and biologicals furnished by an ESRD facility that are not used for the treatment of ESRD may be billed separately when coded with the AY modifier.  The AY modifier serves as an attestation that the item or service is deemed medically necessary for t he dialysis patient but is not being used for the treatment of ESRD.  See Pub. 100- 04, Medicare Claims Processing Manual, chapter 8, 60.2.1.1 for more information.  F.  Drugs and Biologicals Under the Composite Rate   Prior to the implementation of the ESR D PPS, certain drugs used in furnishing outpatient maintenance dialysis treatments were considered composite rate drugs and not billed separately.  Payments for these drugs are included in the ESRD PPS and are not paid separately under the composite rate portion of the blended payment.  All payment policies in effect for drugs and biologicals prior to the implementation of the ESRD PPS remained after implementation unless otherwise noted.   Drugs that were used as a substitute for any of these drugs or are used to accomplish the same effect are also covered under the composite rate.   The following list is comprised of drugs and biologicals under the composite rate.  Staff time and supplies used to furnish these drugs are covered under the composite rate and a re not billed separately.    Heparin   Mannitol   Glucose   Antiarrhythmics   Saline   Antihypertensives   Protamine   Pressor Drugs   Antihistamines   Local Anesthetics   Heparin Antidotes   Dextrose  Apresoline (hydralazine)   Benadryl   Inderal   Dopamine   Hydralazine   Levophed   Insulin   Lanoxin  Verapamil   Lidocaine   Solu- cortef   Antibiotics*
(Medicare Benefit Policy Manual)
*Antibiotics -  Effective January 1, 2012, antibiotics when used at home by a patient to treat an infection of the catheter site or peritonitis associated with peritoneal dialysis are no longer consider ed composite rate drugs and may be billed separately by ESRD facilities, under the composite rate portion of the blended payment during the transition.  Under the ESRD PPS, all antibiotics used to treat vascular access -related and peritonitis infections in cluding those furnished in the home are included in the ESRD PPS and are not eligible for separate payment, although they may be eligible for outlier payments.  For more information regarding the outlier policy see 60.D of this chapter.  Thrombolytic drug s (such as heparin) furnished by ESRD facilities to Medicare ESRD beneficiaries for access management purposes are recognized as composite rate drugs under the ESRD PPS.  Effective January 1, 2012, thrombolytics are not eligible for outlier payments.  Effe ctive January 1, 2013, payment for thrombolytic drugs is included in the ESRD PPS and may not be separately paid when furnished to an ESRD Medicare beneficiary.  Refer to 42 CFR 413.237 (a)(1)(i) for more information.  G.  Separately Billable Drugs and Bi ologicals   The staff time used to furnish the separately billable drugs is included in the ESRD PPS and should not be billed separately.    Albumin may be reasonable and medically necessary for the treatment of certain medical complications in renal dialysis  patients.  In such cases, facilities must document medical need to the satisfaction of the A/B MACs (A) medical staff.  If the A/B MAC (A) determined that the drug was medically necessary, then separate payment in addition to the ESRD facilitys composit e rate could have been made.   However, if albumin was used as a substitute for any drug covered under the composite rate or used to accomplish the same effect, for example, as a volume expander, then payment for it must have been included in the ESRD facilitys composite rate payment for maintenance dialysis.
(Medicare Benefit Policy Manual)
 Payment for furnishing blood, blood products, or blood supplies is excluded from the ESRD PPS and will remain separately billable when they are administered in an ESRD facility.  For further deta il, see Pub. 100- 04, chapter 8, 60.3.   Immunizations may be separately billed when furnished by an ESRD facility to a Medicare ESRD Beneficiary. For further detail, see Pub. 100- 04, Medicare Claims Processing Manual, chapter 8, 60.6.  H.  Drug Overfill P olicy   Medicare does not pay for additional medications in drug containers provided at no cost to the ESRD facility.  ESRD facilities may not receive additional payment under the ESRD PPS when they furnish drug overfill medications to Medicare beneficiaries.  Drug overfill amounts are not eligible for outlier payments.  In addition, ESRD facilities may not receive separate payment under the composite rate portion of the blended payment under the transition.  20.3.1  Drug Designation Process  (Rev. 224, Issued: 06 -03-16, Effective: 01- 01-16, Implementation: 09- 06-16)  A.  Definition of a New Injectable or Intravenous Product   A new injectable or intravenous product is an injectable or intravenous product that is approved by the Food and Drug Administratio n (FDA) under section 505 of the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act, commercially available, assigned a Healthcare Common Procedure Coding System (HCPCS) code, and designated by CMS as a renal dialysis serv ice.  B.  Determination   To make the determination as to whether a product is a new injectable or intravenous drug or biological, whether the new injectable or intravenous drug or biological is a renal dialysis service, and whether the new injectable or in travenous drug or biological fits into an existing functional category CMS will:   1. Review the new products FDA labeling data and information;   2. Review the new products information presented for obtaining a HCPCS code; and   3. Conduct an internal medical review following the announcement of the new products  FDA and HCPCS decision.
(Medicare Benefit Policy Manual)
2. Review the new products information presented for obtaining a HCPCS code; and   3. Conduct an internal medical review following the announcement of the new products  FDA and HCPCS decision.   If a new injectable or intravenous drug is used to treat or manage a condition for which there is an ESRD PPS functional category, the new drug would be considered included in the ESRD PPS bundled payment and no separate payment is available.  If the new injectable or intravenous drug is used to treat or manage a condition for which there is not an ESRD PPS functional category, the following steps occur:   1. The new injectable or i ntravenous drug or biological would be paid for using a transitional drug add -on payment adjustment;   2. At the next rulemaking opportunity, CMS would add a new functional category applicable to the new injectable or intravenous drug or biological being used in the treatment of ESRD;   3. The new injectable or intravenous product would be added to the ESRD PPS bundled payment following payment of the transitional drug add- on payment adjustment.  C.  Transitional Drug Add -On Payment Adjustment   If the new injectabl e or intravenous drug or biological is used to treat or manage a condition for which there is not an ESRD PPS functional category, CMS will pay for the drug or biological using a transitional drug add-on payment adjustment.  The transitional drug add -on pa yment is based on payment methodologies under section 1847A and would continue for a period of 2 years.   During the time that injectable or intravenous drugs and biologicals are paid the transitional drug add -on payment adjustment, the drug or biological i s not considered an outlier service.   D.  Determination of When an Oral -Only Renal Dialysis Service Drug or Biological is No Longer Oral -Only   An oral -only renal dialysis service drug or biological is a drug or biological with no injectable equivalent or other form of administration other than an oral form.  An oral -only renal dialysis service drug or biological is no longer considered oral -only when a non- oral version of the oral -only drug or biological is approved by the FDA.   20.4 - Equipment and Supplies  (Rev. 200, Issued: 12- 02-14, Effective: 01- 01-15, Implementation: 01- 05-15)
(Medicare Benefit Policy Manual)
20.4 - Equipment and Supplies  (Rev. 200, Issued: 12- 02-14, Effective: 01- 01-15, Implementation: 01- 05-15)  All medically necessary equipment and supplies used to furnish dialysis (in -facility or in a patients home) are included in the ESRD PPS and are not separately paid as of January 1, 2011.  The equipment and supplies include but are not limited to    Equipment and supplies included under the composite rate (see 20.1 of this chapter) as of December 31, 2010,   Equipment and supplies that were billed by ESR D facilities and paid separately by Medicare, and    Equipment and supplies furnished to home patients that were under Method II prior to January 1, 2011, and billed by Durable Medical Equipment (DME) suppliers and paid separately by Medicare.   ESRD facilities and monthly capitation payment practitioners may determine that it is medically necessary for a dialysis patient to use dressings or protective access coverings, including catheter coverings, on their access site.  All medically necessary dressings or p rotective access coverings used during or after dialysis to protect a dialysis patients access site including for example, coverings used for day -to-day activities such as bathing, are considered to be renal dialysis items.  To the extent that dressings a nd protective access coverings, including catheter coverings, are determined to be medically necessary, an ESRD facility should provide them.  Medicare payment for vascular access equipment and supplies is included in the ESRD PPS for all dialysis patients  regardless of the method of dialysis or where they receive dialysis treatments.   Separate payment for renal dialysis equipment and supplies is not made under the ESRD PPS or under the blended payment during the ESRD PPS transition.   ESRD facilities may no t receive payment for renal dialysis equipment and supplies from ESRD beneficiaries.   A.  Home Dialysis Equipment and Supplies   All home dialysis equipment, supplies, and other medically necessary items for home dialysis ordered by a physician were included in the composite rate and are therefore included under the ESRD PPS.  The ESRD facility with which the patient is associated assumes responsibility for providing all home dialysis equipment, supplies, and support services either directly or under arrange ments to all of its home dialysis patients.
(Medicare Benefit Policy Manual)
1.  Home Dialysis Equipment Provided to Home Hemodialysis and Peritoneal Dialysis Patients   Coverage of any item of home dialysis equipment used for home dialysis depends on its medical necessity.  Medical necessity is established by the physicians order, and by the equipment meeting Medicare guidelines that define home dialysis equipment.   Nonmedical items are also included in the ESRD PPS and may not be billed separately.  For example, if a home patient i s wheelchair bound and it is medically necessary for the patient to weigh themselves before and after a dialysis treatment, the ESRD facility is responsible for furnishing the patient with a wheelchair scale.   a. Installation and Delivery of Home Dialysis Equipment   ESRD facilities are responsible for all reasonable and necessary expenses incurred in the original installation of home dialysis equipment.  This coverage is not extended to expenses attributable to home improvement (e.g., plumbing or electrical  work beyond that necessary to tie in with existing plumbing and power lines).  Testing and assurance of equipment performance, which may be billed for as part of the basic delivery charge, are also covered.  Medicare does not cover maintenance contracts o n equipment, since Medicare pays only for costs that are actually incurred.  The delivery and installation charge should be itemized, either on the face of the bill or an attached invoice.   b. Other Requirements for Coverage of Home Dialysis Equipment   Effective for renal dialysis services provided on or after January 1, 2011, the ESRD facility is responsible for fulfilling the requirements necessary for furnishing home dialysis.   This includes but is not limited to:    Supportive equipment that is used in conjunction with the basic dialysate delivery system.  This includes blood, heparin pumps, air bubble detectors, blood leak detectors, and unipuncture devices.    Adjustable chairs, such as recliners, as these chairs serve to preserve patients health by allow ing rapid manipulation in body position when medical circumstances warrant such changes during dialysis (e.g., when acute hypotension occurs and the patient is in danger of going into shock).   Home dialysis equipment must also meet the requirements outlined in Pub. 100- 02, Medicare Benefit Policy Manual, chapter 15, 110.  2.  Home Dialysis Supplies Provided to Home Hemodialysis and Peritoneal Dialysis Patients
(Medicare Benefit Policy Manual)
Home dialysis equipment must also meet the requirements outlined in Pub. 100- 02, Medicare Benefit Policy Manual, chapter 15, 110.  2.  Home Dialysis Supplies Provided to Home Hemodialysis and Peritoneal Dialysis Patients   ESRD facilities are responsible for supplies necessary for the effective performance of all modalities of home dialysis, for example, alcohol wipes, sterile drapes, gloves, telfa pads, bandages, etc.  Necessary supplies could also include but are not limited to start -up durable supplies (whether or not they are part of a start-up kit) such as weight scales, sphygmomanometer, I.V. stand, and dialysate heaters; and consumable and disposable supplies such as dialysate, tubing, and gauze pads.   Instruments and nonmedical supplies, such as scales, stopwatches, and blood pressure apparatus (this does  not include automatic blood pressure monitoring devices such as those mentioned in Pub. 100- 03, Medicare National Coverage Determinations Manual, Chapter 3), are included in the ESRD PPS, regardless of whether provided separately or as part of a start -up kit.   B.  Coverage for Surgical Dressings   When dialysis access has been surgically placed in a patient to enable an ESRD facility to provide dialysis treatment, and the patient has started dialysis, the dressing changes are part of the home support provided by the ESRD facility.  When surgical wounds are not related to ESRD, the patient may be eligible for care under the home health benefit found in 20.4.C of this chapter.   C.  Equipment and Supplies Used for Reasons Other Than for the Treatment of ESRD   1.  ESRD Facilities   Occasionally ESRD facilities furnish items and services that are not used for the treatment of ESRD.  When this occurs, ESRD facilities can bill separately by using the AY modifier for the appropriate HCPCS codes used for the administr ation -supply of the drug and/or biological that is being used for reasons other than for the treatment of ESRD.  Any equipment or supply billed using the AY modifier will not be considered an eligible outlier service.  These supplies include:    A4657: Injec tion administration -supply charge (includes the cost of alcohol swab, syringe, and gloves) and
(Medicare Benefit Policy Manual)
 A4657: Injec tion administration -supply charge (includes the cost of alcohol swab, syringe, and gloves) and    A4913: IV administration- supply charge (includes the cost of IV solution administration set, alcohol swab, syringe, and gloves).  A4913 should only be used when an IV solution set is necessary for drugs or biologicals given for reasons other than for the treatment of ESRD.  For additional information regarding billing procedures for ESRD facilities that are transitioning into the ESRD PPS and that are furnishing drugs and biologicals for reasons other than for the treatment of ESRD, see Pub. 100- 04, chapter 8, 60.2.1.  2.  Other Providers   There are renal dialysis equipment and supplies that may also be used in other provider settings for reasons other than for the treatment of ESRD.  These equipment and supplies can be found in the document titled Items and Services Subject to Consolidated Billing for the ESRD PPS located at the ESRD Payment website:  http://www.cms.gov/Medicare/Medicare -Fee-for-Service-Payment/ESRDpayment/Con solidated_Billing.html .  To allow DME suppliers to receive payment for furnishing these services to other provider types, the DME suppliers can bill the DME MAC for the supplies included on this list with the AY modifier to indicate that the equipment is u sed for reasons other than for the treatment of ESRD .  There are renal dialysis equipment and supplies that are not used in other provider settings.  These equipment and supplies are also listed in the document titled Items and Services Subject to Consoli dated Billing for the ESRD PPS.  These supplies and equipment are not otherwise covered by Medicare ; therefore DME suppliers are not able to bill any of the supplies on this list using the AY modifier .  30 - Home Dialysis (Rev. 171, Issued: 06 -07-13, Effe ctive: 01 -01-11, Implementation: 09- 09-13)
(Medicare Benefit Policy Manual)
30 - Home Dialysis (Rev. 171, Issued: 06 -07-13, Effe ctive: 01 -01-11, Implementation: 09- 09-13)  For home dialysis services furnished prior to January 1, 2011, a beneficiary selected one of two methods to secure home dialysis items and services.  Method I was when the ESRD facility with which the patient is associated assumes total responsibility for furnishing all home dialysis items or services.  The second was Method II, which was when the beneficiary dealt directly with a single dialysis supplier to secure home dialysis items and services.  Beginning January 1, 2011, Method II is no longer an option for home dialysis under Medicare.  Therefore, all home dialysis patients are under Method I.  For more information on Method II, see 10.E of this chapter.  30.1 - Home Dialysis Items and Services  (Rev. 200, Is sued: 12 -02-14, Effective: 01- 01-15, Implementation: 01- 05-15)  Effective January 1, 2011, payment for renal dialysis services furnished for home dialysis are covered under the ESRD PPS and are not separately paid.  ESRD facilities shall not bill Medicare beneficiaries directly when they furnish renal dialysis items an d services included under the ESRD PPS.  T he ESRD facility receives the same Medicare dialysis payment rate for home patients as it would receive for an in -facility patient under the ESRD PPS.   The ESRD facility is responsible for the overall management of  the home dialysis patient, including assuring that the patient is provided with equipment and supplies that are functional.  This means the ESRD facility is responsible for delivering, installing, monitoring and maintaining supplies and equipment necessar y to furnish all modalities of home dialysis.   All renal dialysis items and services described in this section were included under the composite rate and are included under the ESRD PPS.  Therefore these items and services must be furnished by the ESRD fac ility, either directly or under arrangement.  The ESRD facility is responsible for all renal dialysis items and services which include but is not limited to:    Medically necessary home dialysis equipment (see 20.4.A of this chapter);