(Medicare Claims Processing Manual)

There are rare situations where a hospital provides a radiolabeled product to an inpatient, and then the patient is discharged and later returns to the outpatient department for a  nuclear medicine imaging procedure but does not require additional radiolabeled product.  In these situations, hospitals are to include HCPCS code C9898 (Radiolabeled product provided during a hospital inpatient stay) with a token charge (of less than $1.01) on the same claim as the nuclear medicine procedure in order to receive payment for the nuclear medicine procedure.  HCPCS code C9898 should only be reported under the circumstances described above, and the date of service for C9898 should be the same a s the date of service for the diagnostic nuclear medicine procedure.   2. Diagnostic Radiopharmaceuticals   Beginning in CY 2008, payment for nonpass -through diagnostic radiopharmaceuticals is packaged into the payment for the associated nuclear medicine procedure.   3. Therapeutic Radiopharmaceuticals   The OPPS will continue to pay for therapeutic radiopharmaceuticals at charges adjusted to cost from January 1, 2008 through December 31, 2009  E. Biosimilars  The payment rate for biosimilars is calculated as the Average Sales Price (ASP) of the biosimilar described by the HCPCS code + 6 percent of the ASP of the biosimilar reference product. Biosimilars will also continue to be eligible for transitional pass -through payment for which payment will be made at ASP of the biosimilar described by the HCPCS code + 6 percent of the ASP of the biosimilar reference product.  F. 340B -Acquired Drugs   Beginning January 1, 2018, separately payable Part B drugs and biologicals (assigned status indicator K), other than vaccines (assigned status indicator L or M) and drugs and biologicals on pass -through payment status (assigned status indicator G), that are acquired through the 340B Program or through the 340B prime vendor program will be paid at the ASP minus 22.5 percent of the ASP of the drug or biological when billed by a hospital paid under the OPPS that is not excepted from the payment adjustm ent. Biosimilars that are acquired through the 340B Program or through the 340B prime vendor program will be paid at the ASP minus 22.5 percent of the ASP of the drug or biological when billed by a hospital paid under the OPPS that is not excepted from the  payment adjustment.  Hospital types that are excepted from the 340B payment policy in CY 2018 include rural sole community hospitals (SCHs), childrens hospitals, and PPS -exempt cancer hospitals. Critical Access Hospitals and Maryland waiver hospitals are not paid under the OPPS and therefore are not impacted by this policy. Medicare will continue to pay separately payable drugs and biologicals that were not purchased with a 340B discount at ASP+6 percent.  In addition, effective January 1, 2018, hospitals paid under the OPPS that are not excepted from the 340B drug payment policy for CY 2018, are required to report modifier JG( (Drug or biological acquired with 340B Drug Pricing Program Discount) on the sa me claim line as the drug HCPCS code to identify a 340B -acquired drug. Since rural SCHs, childrens hospitals and PPS -exempt cancer hospitals are excepted from the  340B payment adjustment in CY 2018, these hospitals will be required to report informational modifier TB (Drug or Biological Acquired With 340B Drug Pricing Program Discount, Reported for Informational Purposes) for 340B -acquired drugs, and will continue  to be paid ASP+6 percent.   90.2.1 - HCPCS Codes Replacements (Rev. 2903, Issued: 03- 11-14, Effective: 04 -01-14, Implementation: 04- 07-14)  The HCPCS code list of retired codes and new HCPCS codes reported under the hospital OPPS is published quarterly via Recurring Update Notification.  The latest payment rates associated with each APC number may be found in the OPPS PRICER file available on the CMS Web site, as well as in Addendum A and B of OPPS, which is available at http://www.cms.gov/Medicare/Medicare -Fee-for-Service-Payment/HospitalOutpatientPPS/Addendum -A-and-Addendum -B-Updates.html   90.3 - Hospital Outpatient Payment Under OPPS for New, Unclassified Drugs and Biologicals After FDA Approval But Before Assignment of a Product -Specific Drug or Biological HCPCS Code  (Rev. 3085, Issued: 10- 03-14, Effective: ICD -10: Upon Implementation of ICD -10; ASC X12: January 1, 2012, Implementation: ICD -10: Upon Implementation of ICD -10; ASC X12: November 4, 2014)   Section 621(a) of the MMA amends Section 1833(t) of the Social Security Act by adding paragraph (15), Payment for New Drugs and Biologicals Until HCPCS Code Assigned.  Under this provision, payment for an outpatient drug or biological that is furnished as part of covered outpatient department services for which a product -specific HCPCS code has not been assigned shall be paid an amount equal to 95 percent of average wholesale price (AWP).  This provision applies only to payments under the hospital outpatient prospective payment system (OPPS).  Beginning January 1, 2004, hospital outpatient departments may bill for new drugs and biologicals that are approved by the FDA on or after January 1, 2004, for which a product -specific HCPCS code has not been assigned.  Beginning on or after the date of FDA approval, hospitals may bill for the drug or biological using HCPCS code C9399, Unclassified drug or biological.  Hospitals report in the ASC X12 837 institutional claim format in specific locations, or in the Remarks section of Form CMS -1450):    the National Drug Code (NDC),   the quantity of the drug that was administered, expressed in the unit of measure applicable to the drug or biological, and   the date the drug was furnished to the beneficiary.    Contractors shall manually price the drug or biological at 95 percent of AWP.  They shall pay hospitals 80 percent of the calculated price and shall bill beneficiaries 20 percent of the calculated price, after the deductible is met.  Drugs and biologicals that are manually priced at 95 percent of AWP are not eligible for outlier payment.  HCPCS code C9399 is only to be reported for new drugs and biologicals that are approved by FDA on or after January 1, 2004, for which there is no HCPCS code that describes the drug.   90.4 - Hospital Billing For Take -Home Drugs  (Rev. 3085, Issued: 10- 03-14, Effective: ICD -10: Upon Implementation of ICD -10; ASC X12: January 1, 2012, Implementation: ICD -10: Upon Implementation of ICD -10; ASC X12: November 4, 2014)   All hospitals, including critical access hospitals (CAHs), bill the appropriate DME MAC for take -home supplies of oral anti -cancer drugs, oral anti -emetic drugs and multi- day supplies of immunosuppressive drugs, as well as the associated supplying fees.  A ll inhalation drugs and the associated dispensing fees are also billed to the DME MAC.  Claims for these take -home drugs are billed on the NCPDP, a HIPAA -compliant telecommunication format specifically designed for drug billing.  All entities billing on the NCPDP use the NDC for the particular drug being billed, and list units as multiples of  the quantity represented by the NDC.  Follow this link to reach the DME MAC version of the NCPDC implementation guide: http://www.cms.hhs.gov/transmittals/downloads/R689CP.pdf .  When beneficiaries come to a hospital outpatient department and have an encounter with a physician or mid- level professional (e.g., a physician assistant or nurse practitioner) during which one or more specimens are collected for laboratory work, treatment  is monitored (including anti -cancer drugs, either oral or infused), and a drug is administered, this is considered an outpatient visit.  Only when more than a single days supply of a drug is dispensed to the beneficiary for take home use are the drugs so dispensed to be billed to the appropriate DME MAC.  When only todays drug(s) is (are) dispensed and other services are rendered in conjunction with the treatment, the entire visit is billed by the hospital to the local A/B MAC (A)   When a beneficiary in a hospital or skilled nursing facility (SNF) non -covered stay, or a hospital/SNF inpatient that has exhausted benefits (TOBs 12x or 22x, respectively) is given a covered oral anti -cancer or anti -emetic drug, or a covered immunosuppres sive drug, the hospital or SNF bills its regular A/B MAC (A).  Payment to hospitals is dependent on the applicable payment mechanism for the type of hospital (reasonable cost for TEFRA hospitals and CAHs, ambulatory payment classifications (APCs) for hospi tals subject to the hospital outpatient PPS (OPPS).   Immunosuppressive drugs and supplying fees provided by a dialysis facility in the State of Washington are billed to and paid by the A/B MAC (A).    Supplying fees and dispensing fees must be billed on the same claim as the drug.  100 - The Competitive Acquisition Program (CAP) for Drugs and Biologicals Not Paid on a Cost or Prospective Payment Basis  (Rev. 4233, Issued: 02- 08-19, Effective: 03 -12-19, Implementation: 03- 12-19)  The term Medicare beneficiary identifier (Mbi) is a general term describing a beneficiary's Medicare identification number. For purposes of this manual, Medicare beneficiary identifier references both the Health Insurance Claim Number (HICN) and the Medicare Beneficiary Identifier (MBI) during the new Med icare card transition period and after for certain business areas that will continue to use the HICN as part of their processes.   Section 303 (d) of the Medicare Prescription Improvement and Modernization Act (MMA) of 2003 requires the implementation of a competitive acquisition program (CAP) for Medicare Part B drugs and biologicals not paid on a cost or prospective payment system b asis.  Beginning with drugs administered on or after July 1, 2006, physicians will be given a choice between buying and billing these drugs under the average sales price (ASP) system, or obtaining these drugs from vendors selected in a competitive bidding process.  For purposes of the CAP, the term a physician includes individuals defined under 1861(s) of the Social Security Act who are authorized to provide physician services under 1861(s) of the Act and who can, within their States scope of practice, prescribe and order drugs covered under Medicare Part B.   For 2006, the first CAP year will run from July 1, 2006 through December 31, 2006. In subsequent years, it will run annually on a calendar year basis.   The Secretary may exclude drugs from the CAP if competitive pricing will not result in significant savings, or is likely to have an adverse impact on access to such drugs.  The statute gives CMS the authority to select drugs, or categories of drugs, that w ill be included in the program, to establish geographic competitive acquisition areas, and to phase in these elements as appropriate.