evekhm/cms_iom_500 huggingface dataset:
(Medicare Claims Processing Manual)
Payment for drugs, biologicals and radiopharmaceuticals under the OPPS is inclusive of both the acquisition cost and the associated pharmacy overhead or nuclear medicine handling cost.  Hospitals should include these costs in their line -item charges for dr ugs, biologicals, and radiopharmaceuticals.  Under the OPPS, if commercially available products are being mixed together to facilitate their concurrent administration, the hospital should report the quantity of each product (reported by HCPCS code) used in the care of the patient.  Alternatively, if the hospital is compounding drugs that are not a mixture of commercially available products, but are a different product that has no applicable HCPCS code, then the hospital should report an appropriate unlisted drug code (J9999 or J3490).  In these situat ions, it is not appropriate to bill HCPCS code C9399.  HCPCS code C9399, Unclassified drug or biological, is for new drugs and biologicals that are approved by FDA on or after January 1, 2004, for which a specific HCPCS code has not been assigned.   The HCPCS code list of retired codes and new HCPCS codes reported under the hospital OPPS is published quarterly via Recurring Update Notifications.  The latest payment rates associated with each APC and HCPCS code may be found in the most current Addendum  A and Addendum B, respectively that can be found under the CMS quarterly provider updates on the CMS Web site at:   http://www.cms.gov/Medicare/Medicare -Fee-for-Service-Payment/HospitalOutpatientPPS/index.html   Future updates will be issued in a Recurring Update Notification.   B. Pass -Through Drugs, Biologicals, and Radiopharmaceuticals
(Medicare Claims Processing Manual)
Future updates will be issued in a Recurring Update Notification.   B. Pass -Through Drugs, Biologicals, and Radiopharmaceuticals   Payment for drugs, biologicals, and radiopharmaceuticals may be made under the pass -through provision which provides additional payments for drugs, biologicals, and radiopharmaceuticals that meet certain requirements relating to newness and relative  costs.  According to section 1833(t) of the Social Security Act, transitional pass -through payments can be made for at least 2 years, but no more than 3 years.  For the process and information required to apply for transitional pass -through payment status for drugs, biologicals, and radiopharmaceuticals, go to the main OPPS Web page, currently at:   http://www.cms.gov/Medicare/Medicare -Fee-for-Service-Payment/HospitalOutpatientPPS/index.html to see the latest instructions.  ( NOTE:  Due to the continuing development of the new cms.hhs.gov Web site, this link may change.)  Payment rates for pass -through drugs, biologicals, and radiopharmaceuticals are updated quarterly.  The all -inclusive list of billable drugs, biologicals, and radiopharmaceuticals for pass -through payment is included in the current quarterly Addendum B.  The most current Addendum B can be found under the CMS quarterly provider updates on the CMS website.   C. Non Pass -Through Drugs and Biologicals   Under the OPPS, drugs and biologicals that are not granted pass -through status receive either packaged payment or separate payment.  Payment for drugs and biologicals with estimated per day costs equal to or below the applicable drug packaging threshold is  packaged into the payment for the associated procedure, commonly a drug administration procedure.  Drugs and biologicals with per day costs above the applicable drug packaging threshold are paid separately through their own APCs.   D. Radiopharmaceuticals   1. General   Beginning in CY 2008, the OPPS divides radiopharmaceuticals into two groups for payment purposes: diagnostic and therapeutic.  Diagnostic radiopharmaceuticals function effectively as products that enable the provision of an independent service, specificall y, a diagnostic nuclear medicine scan.  Therapeutic radiopharmaceuticals are themselves the primary therapeutic modality.
(Medicare Claims Processing Manual)
Beginning January 1, 2008, the I/OCE requires claims with separately payable nuclear medicine procedures to include a radiolabeled product (i.e., diagnostic radiopharmaceutical, therapeutic radiopharmaceutical, or brachytherapy source).  Hospitals are requ ired to submit the HCPCS code for the radiolabeled product on the same claim as the HCPCS code for the nuclear medicine procedure.  Hospitals are also instructed to submit the claim so that the services on the claim each reflect the date the particular ser vice was provided.  Therefore, if the nuclear medicine procedure is provided on a different date of service from the radiolabeled product, the claim will contain more than one date of service.  More information regarding these edits is available on the OPPS Web site at http://www.cms.gov/Medicare/Medicare -Fee-for-Service -Payment/HospitalOutpatientPPS/index.html   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
(Medicare Claims Processing Manual)
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,
(Medicare Claims Processing Manual)
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.
(Medicare Claims Processing Manual)
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):
(Medicare Claims Processing Manual)
 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 .
(Medicare Claims Processing Manual)
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)
(Medicare Claims Processing Manual)
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.
(Medicare Claims Processing Manual)
A competition will be held every 3 years to award contracts to approved CAP vendors that will supply drugs and biologicals for the program.  A 3- year contract will be awarded to qualified approved CAP vendors in each geographic area who have and maintain: 1) Sufficient means to acquire and deliver competitively biddable drugs within the specified contract area; 2) Arrangements in effect for shipping at least 5 days each week for the competitively biddable drugs under the contract and means to ship drugs in emergency situations; 3) Quality, service, financial performance, and solvency standards; and 4) A grievance and appeals process for dispute resolution.  A vendors contract may be terminated during the contract period if they do not abide by the terms of their contract with CMS.  CMS will establish a single payment amount for each of the competitively bid drugs and areas, for this 3year cycle there will be one drug category and one  geographic area.  After CAP drug prices are determined and vendor contracts are awarded the information will be posted to a directory on the Medicare Web site.  Medicare physicians will be given an opportunity to elect to participate in the CAP on an annual basis.  Physicians who elect to participate in CAP will continue to bill their local A/B MAC (B) for drug administration.  Except where applicable State pharmacy law prohibits it, the CAP Participating Physicians will supply the following information to the approved CAP vendor at the time that a CAP drug order is placed:  date of order, beneficiary name, addre ss, and phone number, physician identifying information:  name, practice location/shipping address, group practice information, NPI; drug name, strength, quantity ordered, dose, frequency/ instructions, anticipated date of administration, Medicare benefici ary identifier, supplementary insurance information (if applicable), Medicaid information (if applicable), additional patient information: date of birth, allergies, height/weight, and diagnosis if necessary.  Claims for erythropoiesis stimulating agents (E SAs) must contain the most recent hematocrit or hemoglobin value.  CAP drug claims for any drugs furnished to an individual for the treatment of anemia shall be returned if the most recent laboratory values for hemoglobin or hematocrit are not reported on the claim per Medicare requirements.
(Medicare Claims Processing Manual)
The participating CAP physicians will receive all of their drugs from the approved CAP vendor for the drug categories they have selected, with only one exception.  The exception will be for furnish as written situations where the participating CAP physic ian requires that, due to medical necessity, the beneficiary must have a specific drug, defined by its National Drug Code (NDC), for one of the HCPCS codes within the approved CAP vendors drug list if that specific drug NDC is not available on the CAP drug list.  The participating CAP physician may buy the drug, administer it to the beneficiary and bill Medicare using the ASP system.  The local A/B MAC (B) will monitor drugs obtained using the furnish as written provision to ensure that the participating  CAP physician is complying with Medicare payment rules.   The CAP will also allow a participating CAP physician to provide a drug to a Medicare beneficiary from his or her own stock and obtain the replacement drug from the approved CAP vendor when certain conditions are met.  The A/B MAC (B) will monitor drugs ordered under the replacement provision to ensure that the participating CAP physician is complying with Medicare payment rules.
(Medicare Claims Processing Manual)
Approved CAP vendors must qualify for enrollment in Medicare as a supplier, and will be enrolled as a new provider specialty type.  The approved CAP vendors claims for the drugs will be submitted to one designated Medicare A/B MAC (B).  The approved CAP vendor will bill the Medicare designated A/B MAC (B) for the drug and the beneficiary for any applicable coinsurance and deductible under the MMA, for CAP claims submitted after July 1, 2006 but before April 1, 2007, payment to the approved CAP vendor for t he drug was conditioned on verification that the drug was administered to the Medicare beneficiary.  Proof that the drug was administered was established by matching the participating CAP physicians claim for drug administration with the approved CAP vendors claim for the drug in the Medicare claims processing system by means of a  prescription number on both claims.  When the claims matched in the claims processing system, the approved CAP vendor was paid in full.  Title II, section 108(a) of the Tax Relief and Health Care Act of 2006 (TRHCA), struck language used to develop the existing CAP claims matching process and furthermore required the implementation of a post payment review process effective April 1, 2007.  The post payment review process is required to assure that drugs supplied under the CAP have been administered to a beneficiary and the process must establish a mechanism to recoup, offset or collect any overpayments to the approved CAP vendor.  The CMS is  implementing CAP claims processing changes in order to comply with THRCA by April 1, 2007.  Pending CAP claims submitted prior to April 1, 2007, and all new CAP claims submitted on or after April 1 will be subject to the post payment review process.  Unti l drug administration is verified, the approved CAP vendor may not bill the beneficiary and/or his third party insurance for any applicable coinsurance and deductible.  For more information on the CAP claims processing see FR70251.  100.1 - Physician Election and Information Transfer Between A/B MACs (B) and the Designated A/B MAC (B) for CAP Claims (Rev. 866, Issued: 02- 17-06, Effective: 07 -01-06, Implementation: 07- 03-06)
(Medicare Claims Processing Manual)
Prior to each annual election period, CMS will post on its Web site a list of the vendors that have been selected to participate in the CAP, the categories of drugs they will be providing, and the geographic areas within which each vendor will operate.  Physicians will then elect the approved CAP vendors they choose to receive drugs from under the CAP.  The election period will end each year approximately 45 days after the list of vendors is posted on the CMS Web site.  100.1.1 - Physician Information for the Designated A/B MAC (B)  (Rev. 866, Issued: 02- 17-06, Effective: 07 -01-06, Implementation: 07- 03-06)  10 Calendar days after the end of the annual election period, the 2006 election period, by May 25, 2006 A/B MACs (B) shall create a table and forward it to the designated A/B MAC (B).  The table will indicate which physicians have elected to participate in  CAP, for which drugs, and with which vendors.  When A/B MACs (B) receive applications, they shall verify that the chosen vendor is valid per the CMS Web site.  If an invalid vendor has been chosen, an educational contact shall be made to resolve the issue .  A/B MACs (B) shall forward this table each year to the designated A/B MAC (B) by 7calender days after the end of the election period.  Should that date fall on a weekend, it shall be extended to the following Monday.  The table shall include the physicians name, the street address, city, state, zip code, and phone number of each practice address/shipping address (the physical location where the drugs will be administered and the CAP drugs shipped to), PIN, UPIN (or NPI  when effective), e -mail address (if available).  If the mailing/correspondence address (where the participating CAP physician can be contacted directly) is different from the  practice/shipping address, the mailing/correspondence shall be included.  If the group or individual practice has more than one practice location where drugs are administered, each practice address/shipping location where drugs will be administered shall a lso be included.  For group practices that elect to participate in CAP, the group PIN as well as the individual PINs and UPINs (NPI when effective) shall be included.