(Medicare Claims Processing Manual)

 Hemodialysis : For in -center and home -hemodialysis patients prescribed for three or fewer treatments per week, the last Kt/V obtained during the month must be reported.  Facilities must report single p ool Kt/V using the preferred National Quality Forum (NQF) endorsed methods for deriving the single pool Kt/V value: Daugirdas II or Urea Kinetic Modeling (UKM). The reported Kt/V should not include residual renal function.   A value of 8.88 shall be entere d on the claim if the situation exists that a patient is prescribed and receiving greater than three hemodialysis treatments per week for a medically justified and documented clinical need.  The 8.88 value is not to be used for patients who are receiving  extra treatments for a temporary clinical need (e.g. fluid overload).  A medical justification must be submitted for patients receiving greater than 13 treatments per month.    Peritoneal Dialysis :  When measured the delivered weekly total Kt/V (dialytic and residual) should be reported.   This code is effective and required on all ESRD claims with dates of service on or after July 1, 2010.  In the event that no Kt/V reading was performed providers must report the D5 with a value of 9.99.   Occurrence Code 51  Date of last Kt/V reading.  For in -center hemodialysis patients, this is the date of the last reading taken during the billing period.  For peritoneal dialysis patients and home hemodialysis patients, this date may be before the current billing period but should be within 4 months of the claim date of service.  This code is effective for ESRD claims with dates of service on or after July 1, 2010.  This code not required when reporting value code D5 with a value of 9.99 indicating no Kt/ V reading is available for reporting or value 8.88 to indicate the patient is prescribed and receiving greater than 3 hemodialysis treatments per week for a medically justified and documented clinical need.   D.   Reporting of Infection for End Stage Renal Disease (ESRD)  Claims  Effective April 1, 2012, the infection modifiers V8 and V9 were terminated. All End Stage Renal Disease (ESRD) claims with dates of service on or after April 1, 2012, no longer require reporting of infection modifiers V8 and V9.  60 - Separately Billable ESRD Items and Services  (Rev. 10640, Issued:08- 06-21, Effective:09- 07-21, Implementation:09- 07-21)  Payment for all items and services provided for the treatment of ESRD are included in the ESRD PPS.  ESRD facilities are required to it emize the ESRD related services provided including drugs, laboratory tests and supplies that are eligible for outlier consideration.  60.1 - Lab Services  (Rev. 10640, Issued:08- 06-21, Effective:09- 07-21, Implementation:09- 07-21)  See the Medicare Benefit Policy Manual, Chapter 11, for a description of lab services included in the PPS rate.   Renal dialysis facilities must bill all lab tests provided for the treatment of ESRD.  This is true whether the tests were provided directly or  under arrangements with an independent lab.  When lab tests are billed by providers other than the ESRD facility and the lab test is provided for the treatment of ESRD, the claim will be rejected or denied.  In the event that a lab test usually provided f or the treatment of ESRD was furnished to an ESRD beneficiary for reasons other than for the treatment of ESRD, the provider may submit a claim for separate payment using modifier AY.   ESRD facilities should only bill for lab tests related to the treatment of ESRD or other lab tests performed by the dialysis facility (i.e. CLIA waived lab tests).  Lab tests that are not for the treatment of ESRD and are not performed by the ESRD facility are not to be reported on the ESRD facility claim.   60.2 - Drugs Furni shed in Dialysis Facilities (Rev. 10640, Issued:08- 06-21, Effective:09- 07-2021, Implementation:09- 07-21)  Effective January 1, 2011, section 153b of the MIPPA requires that all drugs and biologicals used in the treatment of ESRD are included in the ESRD PPS payment amount and must be billed by the ESRD facility .  60.2.1 - Billing Procedures for Drugs for Facilities  (Rev. 10640, Issued:08- 06-21, Effective:09- 07-21, Implementation:09- 07-21)  The following billing procedures apply to independent and hospital  based ESRD  facilities.   Facilities identify and bill for drugs by HCPCS code, along with revenue code 0636, Drugs Requiring Specific Information.  Example below includes the HCPCS code and indicates the dosage amount specified in the descriptor of that code.  Facilities use the units field as a multiplier to arrive at the dosage amount.   EXAMPLE:   HCPCS  Drug  Dosage (lowest denominator) Amount  J3360 Valium 5 mg $2.00  Actual dosage, 10 mg  On the bill, the facility shows J3360 and 2 in the units field (2 x 5 mg = 10 mg). For independent facilities, A/B MACs (A)  compare the price of $4.00 (2 x $2.00) to the billed charge and pay the lower, subject to coinsurance and deductible.  Effective January 1, 2006 payment is not subject to the lower of char ges or fee.  All separately payable drugs for both hospital- based and independent facilities are paid at ASP+6% except vaccines.  For information on billing and payment for vaccines see section 60.6 of this chapter.  NOTE:   When the dosage amount is greater than the amount indicated for the HCPCS code, the facility rounds up to determine units.  When the dosage amount is less than the amount indicated for the HCPCS code, use one as the unit of measure.  In the example above, if the dosage were 7 mg, the facility would show 2 in the unit field, if the dosage were 3 mg, the facility would show 1 in the unit field.  Facilities bill for supplies used to administer drugs with revenue code 0270, Medical/Surgical Supplies.  The number of administrations is shown in the units field.   EXAMPLE:   Revenue Code Units  0270 3  The number of units for supply codes billed should match the number of injections billed on the claim form.   Appropriate HCPCS codes for administration-supply of separately billable drugs would include:  A4657: Injection Administration-supply Charge: include the cost of alcohol swab, syringe, and gloves.  Reimbursement for all ESRD facilities is based on a fee of $0.50 per unit billed for A4657.  A4913: IV Administration-supply Charge: include the cost of IV solution administration set, alcohol swab, syringe, and gloves.  This code should only be used when an IV solution set is required for a drug to be given.  This rate will not be paid for drugs that only require a syringe for administration.    60.2.1.1  Separately Billable ESRD Drugs  (Rev. 10640, Issued:08- 06-21, Effective:09- 07-21, Implementation:09- 07-21)   Effective January 1, 2011, section 153b of the MIPPA requires that all drugs and biologicals that are used in the treatment of ESRD be provided and billed by the ESRD  facility.  When a drug or biological is billed by providers other than the ESRD facility and the drug or biological furnished is designated as a drug or biological that is included in the ESRD PPS ( renal dialysis service), the claim will be rejected or denied.  In the event that a drug or biological generally used in the treatment of ESRD was furnished to an ESRD beneficiary for reasons other than for the treatment of ESRD, the provider may report the drug on the claim with modifier AY and receive separate payment.  For claims with dates of service on or after July 1, 2013, when these drugs are administered through the dialysate the provider must append the modifier JE (Administered via Dialysate).    All drugs reported on the renal dialysis facility claim are considered included in the ESRD PPS, unless they are covered by an exception as discussed below. The list of drugs and biologicals for consolidated billing are designated as always  ESRD -related an d therefore no separate payment  is made to ESRD facilities.  However, CMS has determined that some of these drugs warrant separate payment when they are used to treat conditions other than ESRD.    Exceptions to Always ESRD Related Drugs:  The following drugs have been approved for separate payment consideration when billed with the AY modifier attesting to the drug not being used for the treatment of ESRD.  The ESRD facility is required to indicate (in accordance with ICD coding guidelines) the diagnosis  code for which the drug is indicated.    Vancomycin, effective January 1, 2012   Daptomycin, effective January 1, 2013   Items and services subject to the consolidated billing requirements for the ESRD PPS can be found on the CMS website at:  http://www.cms.gov/ESRDPayment/50_Consolidated_Billing.asp#TopOfPage  Other drugs and biologicals  are separately payable to the dialysis facility if the drug was not used  for the tr eatment of ESRD.  The facility must include the modifier AY to indicate it was not for the treatment of ESRD.   Drugs are assigned HCPCS codes.  If no HCPCS code is listed for a drug (e.g., a new drug) the facility bills using HCPCS code J3490, Unclassifie d Drugs, and submits documentation identifying the drug. To establish a code for the drug, the A/B MAC (A) checks HCPCS to verify that there is no acceptable HCPCS code for billing and if a code is not found checks with the local A/B MAC (B), which may ha ve a code and price that is appropriate. If no code is found the drug is processed under HCPCS code J3490. See Chapter 17 for a complete description of drug pricing.   60.2.1.2  Facilities Billing for ESRD Drugs and Biologicals Equivalent to Injectable Dru gs (Rev. 10640, Issued:08- 06-21, Effective:09- 07-2021, Implementation:09- 07-21)  The ESRD PPS includes some  injectable  drugs and biologicals that have oral equivalent    These drugs should be reported on the renal dialysis facility claim for consideration o f outlier payments.  For the drugs and biologicals  used in the treatment of ESRD  that do not have an assigned HCPCS, effective for dates of services on or after January 1, 2011, ESRD facilities should bill using revenue code 0250 and report the national drug code (NDC).  The NDC is reported on the 837i claim transaction in loop 2410 line 03.  CMS will price these oral  drugs based on a plan comparison for consideration in the outlier payment.  CMS will maintain a list of these drug categories by NDC  and wi ll post  the list on the CMS.gov website .  Payment includes a  mean dispensing fee and this amount is updated via Recurring Update Notifications.  This amount  is applied to each NDC included on the monthly claim.  CMS limits 1 dispensing fee per NDC per mont h.  Providers should report the quantity in the smallest available unit.  This is necessary because Medicare is using the mean per unit cost in calculating the outlier.  For example, if the provider reports NDC 00054312041 Calcitriol 1 mcg/ml oral solution (15/ml/bottle) and uses the full 15 ml bottle, the quantity is reported as 15, not 1.  This allows for the most accurate calculation for the outlier policy .  60.2.2 - Drug Payment Amounts for Facilities  (Rev. 10640, Issued:08- 06-21, Effective:09- 07-21, Implementation:09- 07-21) Effective for claims with dates of service on or after January 1, 2011 all drugs and biologicals used in the treatment of ESRD  are reimbursed under the ESRD PPS payment amount. For more information, please refer to Chapter 11 Benef it Policy Manual, section 20.3 Drugs and Biologicals.   60.2. 3 - Facility Billing Requirements to the A/B MAC ( A)                   (Rev. 10640, Issued:08- 06-21, Effective:09- 07-21, Implementation:09- 07-21)   See Medicare Benefit Policy Manual, Chapter 11 for coverage and effective dates applicable to intravenous iron therapy services.