(Medicare Benefit Policy Manual)

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.   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)  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.   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   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    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)  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.