(Medicare Benefit Policy Manual)

Any other drugs (other than those categories described above and below) when used for the treatment of ESRD are also included in the ESRD PPS.  For example,   Patient A experiences nausea or pain during a hemodialysis dialysis treatment and requires medications.  Any medication furnished during the dialysis treatment or after the treatment is considered a renal dialysis service and may not be billed separately.    Patient B experiences anxiety with dialysis treatments and is prescribed anti -anxiety medication during and between the dialysis treatments.  Any medications furnished in preparation for the dialysis treatment, during the dialysis treatment or after the dialysis treatment, is considered a renal dialysis service and may not be billed separately.    Any drug or biological added to patient dialysate solutions.   Functional Categories Includ ed in the ESRD Base Rate but May be Used for Dialysis and Non -Dialysis Purposes   Category  Rationale for Association  Antiemetic  Used to prevent or treat nausea and vomiting related to dialysis.  Excludes antiemetics used for purposes unrelated to dialysis, such as those used in conjunction with chemotherapy as these are covered under a separate benefit category.  Anti-infectives  Used to treat vascular access -related and peritonitis infections.  May include antibacterial and antifungal drugs.  Antipruritic  Drugs in this classification have multiple clinical indications.  Use within an ESRD functional category includes treatment for itching related to dialysis.  Anxiolytic  Drugs in this classification have multiple actions.  Use within an ESRD functional categ ory includes treatment of restless leg syndrome related to dialysis.  Excess Fluid Management  Drug/fluids used to treat fluid excess/overload.  Fluid and Electrolyte Management Including Volume Expanders  Intravenous drugs/fluids used to treat fluid and ele ctrolyte needs.  Pain Management  Drugs used to treat vascular access site pain and to treat pain medication overdose, when the overdose is related to medication provided to treat vascular access site pain.   B.  Injectable Drugs and Biologicals   All injectable drugs or biologicals used for the treatment of ESRD are included in the ESRD PPS and are not separately paid.  This includes renal dialysis drugs and biologicals that prior to the implementation of the ESRD PPS were separately billable under Par t B.  During the transition period, ESRD facilities receiving a blended payment were permitted to receive a separate payment for these drugs and biologicals under the composite rate portion of the blend during the transition.  Since January 1, 2014, all fa cilities are paid 100 percent under the ESRD PPS and no separate payment is permitted for drugs and biologicals used for the treatment of ESRD.  For more information on the transition, see 70 of this chapter.   Injectable drugs and biologicals furnished to Medicare ESRD patients that are not used for the treatment of ESRD may continue to be paid separately, when reported on the claim with an AY modifier.  See 20.4.C of this chapter for more information on the AY modifier.  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.  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   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*   *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.    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.