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ESRD PPS Drug Designation Process

ESRD PPS Drug Designation Process

Section 217(c) of the Protecting Access to Medicare Act of 2014 (PAMA) required CMS to establish a drug designation process finalized in CY 2016 rulemaking. This process: (1) determines when a product would no longer be considered an oral-only drug; and (2) includes new injectable and intravenous products into the bundled payment under the ESRD PPS. Details regarding the drug designation process can be found in Pub. 100-02, Chapter 11, Section 20.3.1.

Definition of a New Injectable or Intravenous Product

To be considered a new injectable or intravenous product, the drug should be approved by the Food and Drug Administration (FDA), commercially available, assigned a Healthcare Common Procedure Coding System (HCPCS) code, and designated by the Centers for Medicare & Medicaid Services (CMS) as a renal dialysis service.

Determination

CMS considers the new injectable or intravenous drug to be included in the ESRD PPS bundled payment (with no separate payment available) if used to treat or manage a condition for which there is an ESRD PPS functional category. CMS applies the transitional drug add-on payment adjustment to new injectable or intravenous drugs used to treat or manage a condition for which there is not an existing ESRD PPS functional category.

ESRD PPS Functional Categories

Category

Rationale for Association

Access Management

Drugs used to ensure access by removing clots from grafts, reverse anticoagulation if too much medication is given, and provide anesthetic for access placement.

Anemia Management

Drugs used to stimulate red blood cell production and/or treat or prevent anemia. This category includes ESAs as well as iron.

Bone and Mineral Metabolism

Drugs used to prevent/treat bone disease secondary to dialysis. This category includes phosphate binders and calcimimetics.

Cellular Management

Drugs used for deficiencies of naturally occurring substances needed for cellular management.   This category includes levocarnitine.

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 category 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 electrolyte 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.

 

Transitional drug add-on payment adjustment

CMS will pay for the drug or biological using a transitional drug add-on payment adjustment if the new injectable or intravenous drug or biological is used to treat or manage a condition for which there is not an existing ESRD PPS functional category. CMS bases the transitional drug add-on payment on payment methodologies under section 1847A of the Social Security Act and this payment is applicable for a period of 2 years. While the transitional drug add-on payment adjustment applies to a new injectable or intravenous drug or biological, the drug or biological is not considered an outlier service. For more information, view the ESRD PPS Transitional Drug Add-on Payment Adjustment  page.

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.