evekhm/cms_iom_500 huggingface dataset:
(Medicare Claims Processing Manual)
Durable Medical Equipment  90 - Claims Processing Rules for Hospital Outpatient Billing and Payment  90.1 -  Blood/Blood Products and Drugs Classified in Separate APCs for Hospital Outpatients  90.2 -  Drugs, Biologicals, and Radiopharmaceuticals  90.3 -  Hospital Outpatient Payment Under OPPS for New, Unclassified Drugs and Biologicals After FDA Approval But Before Assignment of a Product -Specific Drug/Biological HCPCS Code  90.4 -  Hospital Billing for Take Home Drugs  100 -  The Competitive Acquisition Program (CAP) for Drugs and Biologicals Not Paid on a Cost or Prospective Payment Basis  100.1 -  Physician Election and Information Transfer Between A/B MACs (B) and the Designated A/B MAC (B)  for CAP Claims  100.1.1 -  Physician Information for the Designated A/B MAC (B)  100.1.1.1 -  Quarterly Updates  100.1.2 -  Format for Data  100.1.3 -  Physician Information for the Vendors  100.2 -  Claims Processing Instructions for CAP Claims for the A/B MACs (B)  100.2.1 -  CAP Required Modifier s 100.2.2 -  Submitting the Charges for the Administration of a CAP Drug and the No Pay Service Lines  100.2.3 -  Submitting the Prescription Order Numbers and No Pay Modifiers  100.2.3.1 -  Further Editing on the Prescription Order Number  100.2.4 -  CAP Claims Submitted With Only the No Pay Line  100.2.5 -  Use of the Restocking Modifier  100.2.6 -  Use of the Furnish as Written Modifier  100.2.7 -  Monitoring of Claims Submitted With the J2 and/or J3 Modifiers  100.2.8 -  Claims Submitted for Only Drugs Listed on the Approved CAP Vendors Drug List 100.2.9 -  Submission of Claims With  the Modifier JW, Drug Amount Discarded/Not Administered to Any Patient  100.2.10 -  MSP Situations Under CAP  100.3 -  Application of Local Medical Review Policies  100.4 -  Claims Processing Instructions for the Designated A/B MAC (B)  100.4.1 -  Creation of Internal Vendor Provider Files  100.4.2 -  Submission of Paper Claims by Vendors  100.4.3 -  Submission of Claims from Vendors With the J1 No Pay Modifier  100.4.4 -  Submission of Claims from Vendors Without a
(Medicare Claims Processing Manual)
Creation of Internal Vendor Provider Files  100.4.2 -  Submission of Paper Claims by Vendors  100.4.3 -  Submission of Claims from Vendors With the J1 No Pay Modifier  100.4.4 -  Submission of Claims from Vendors Without a Provider Primary Identifier for the Ordering Physician  100.4.5 -  New MSN Message to Be Included on All Vendor Claims  100.4.6 -  Additional Medical Information  100.4.7 -  CAP Fee Schedule 100.5 -  Matching the Physician Claim to the Vendor Claim  100.5.1 -  Denials Due to Medical Necessity  100.5.2 -  Denials For Reasons Other Than Medical Necessity  100.5.3 -  Changes to Pay/Process Indicators  100.5.4 -  Post -Payment Overpayment Recovery Actions  100.5.5 -  Pending and Recycling the Claim When All Lines Do Not Have a Match 100.5.6 -  Creation of a Weekly Report for Claims That Have Pended More Than 90 Days and Subsequent Action 100.6 -  Coordination of Benefits  100.7 -  National Claims History  100.8 -  Adding New Drugs to CAP  100.8.1-  Updating Fee Schedule for New Drugs in CAP  100.8.2- Changes to the List of Drugs Supplied by Approved CAP Vendors  100.8.3 -  CAP Not Otherwise Classified (NOC) Drugs  100.8.3.1 -  Editing for CAP NOC Drugs  100.9 -  Non -participating Physicians Who Elect the CAP  101 -  The Competitive Acquisition Program (CAP) for Drugs and Instructions on Special CAP Appeals Requirements and Delivery of Dispute Resolution Services  101.1- Dispute Resolution Services for Vendors  101.2- Dispute Resolution Services for Physicians  101.3- Dispute Resolution Services for Beneficiaries
(Medicare Claims Processing Manual)
10 - Payment Rules for Drugs and Biologicals  (Rev.11764, Issued: 12-22-2022; Effective:01-01- 23; Implementation:01-03 -23 )  Drugs for inpatient hospital and inpatient skilled nursing facility (SNF) beneficiaries are included in the respective prospective payment system (PPS) rates, except for hemophilia clotting factors for hospital inpatients under Part A.   All hospital outpatient drugs are excluded from SDP because the payment allowance for such drugs is determined by a different methodology.  Non pass -through drugs with estimated per day costs less than or equal to the applicable drug packaging threshold that are furnished to hospital outpatients are packaged under the outpatient prospective payment system (OPPS).  Their costs are recognized and included but paid as part of the ambulatory payment classification (APC) group payment for the service with which they are billed.  Non pass -through drugs with estimated per day costs greater than the applicable drug packaging threshold are paid separately.   Drugs that are granted pass through payment status are required by law to be paid at either the amount paid under the physician fee schedule, or, if the drug is included in the Part B drug competitive acquisition program (CAP), at the Part B drug CAP rat e.  Drugs that have pass -through status may have coinsurance amounts that are less than 20 percent of the OPPS payment amount.  This is because pass -through payment amounts, by law, are not subject to coinsurance.  CMS considers the amount of the pass-through drug payment rate that exceeds the otherwise applicable OPPS payment rate to be the pass-through payment amount.  Thus, in situations where the pass -through payment rate exceeds the otherwise applicable OPPS payment rate, the coinsurance is based on a portion of the total drug payment rate, not the full payment rate.
(Medicare Claims Processing Manual)
Hospitals must report all appropriate HCPCS codes and charges for separately payable drugs, in addition to reporting the applicable drug administration codes.  Hospitals should also report the HCPCS codes and charges for drugs that are packaged into payments for the corresponding drug administration or other separately payable services.  Historical hospital cost data may assist with future payment packaging decisions for such drugs.  Drugs are billed in multiples of the dosage specified in the HCPCS code lo ng descriptor.  If the drug dose used in the care of a patient is not a multiple of the HCPCS code dosage descriptor, the provider rounds to the next highest unit based on the HCPCS long descriptor for the code in order to report the dose provided.   If the full dosage provided is less than the dosage for the HCPCS code descriptor specifying the minimum dosage for the drug, the provider reports one unit of the HCPCS code for the minimum dosage amount.   OPPS Pricer includes a table of drugs and prices and provides the contractor with the appropriate prices.   Section 90 relates specifically to billing for hospital outpatients.  The remainder of this chapter relates to procedures for pricing and paying DME recipients, and to beneficiaries who receive drugs under special benefits such as pneumococcal, flu and hepatitis vaccines; clotting factors, immunosuppressive therapy, self administered cancer and anti emetic drugs, and drugs incident to physicians  services.   The Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003 defines a Specified Covered Outpatient Drug (SCOD) as a covered outpatient drug for which a separate APC has been established and that is either a radiopharmaceutical agent, o r a drug or biological for which payment was made on a pass -through basis on or before December 31, 2002.  Payment for SCODs is set, by law, at the average acquisition cost.  Under the OPPS, a single payment is made for SCODs that represents payment for both the acquisition cost of the drug and any associated pharmacy overhead or nuclear medicine handling costs.  Drugs or biologicals must meet the coverage requirements in Chapter 15 of the Medicare Benefit Policy Manual.  Additionally, for end stage renal disease (ESRD) patients, see the Medicare Benefit Policy Manual, Chapter 11.  For ESRD patient billing for drugs and claims processing, see Chapter 8 of this manual.
(Medicare Claims Processing Manual)
The following chart describes the general payment provisions for drugs.  Table - Drug Payment Methodology Key to the following Table:  NOTES:  DME MACs do not process claims for blood clotting factors.  Unless noted otherwise, claims for these drugs are submitted to the A/B MAC (B)   - Drugs & biologicals outside the composite rate and/or ESRD PPS are paid as described in 2 below. Those inside the composite rate and/or ESRD PPS are paid as described in 1. (ESRD PPS effective January 1, 2011)  1 - Included in PPS rate, or other provider -type all inclusive encounter rate  2  Price taken from CMS drug/biological pricing file effective on the specific date of service.  3 - Based on reasonable cost (101% reasonable cost in CAH)  4 - Lower of cost or 95% AWP paid for drug in addition to PPS rate, or in addition to reasonable cost if excluded from PPS  5 - OPPS- APC, whether pass -thru drug or not  6 - Cannot furnish as that provider type  7 - May not bill DME -MAC or MAC for drugs furnished incident -to a physicians service  8 - Payment made at the time of cost settlement  A - Bills are submitted to the DME MAC  ++  Except  in the State of Washington, where CMS permits the ESRD Facility to bill for immunosuppressive drugs due to the unique State assistance to the beneficiary provided only via the ESRD Facility.
(Medicare Claims Processing Manual)
Provider/Drug  Hepatitis  Vaccine Pneumococcal &  Flu Vaccines  Hemophilia Clotting  Factors  Immuno -Suppressive Erythrop  oiesis  Stimulati  ng Agents  ESAs)  Self Admin  Anti -Cancer Anti -Emetic for cancer  treatment  Other Drugs  Hospital Inpatient (IP) A -Prospective Payment System (IPPS)  3 3 2 1 1 1 1 Hospital IP A -  not IPPS  3 3 3 3 3 3 3 Hospital IP B -  Outpatient Prospective 3 3 5 5 5 5 5 Payment System (OPPS)  Hospital IP B -  not OPPS hospital  3 3 3 3 3 3 3 Hospital Outpatient (OP) - OPPS hospital  3 3 5 5 (8 - for 30-day supply)  5 5 5 Hospital OP -  not OPPS hospital  3 3 3 3 (8 - for 30-day supply)  3 3 5 Skilled Nursing Facility (SNF) IP  3 3 1 1 1 1 1 SNF OP or IP B  3 3 3 3 6 6 6 End Stage Renal Disease (ESRD) Facility  2 2 6 6++ 1 or 2  6 1 or 2  Comprehensive Outpatient Rehabilitation Facility (CORF)/ Outpatient Rehabilitation Facility (ORF)  2 2 6 6 6 6 6 Community Mental Health Clinic (CMHC)  6 6 6 6 6 6 6 Rural Health Clinical (RHC)/Federally Qualified Health Clinic (FQHC) -hospital based 1 8 5 5 5 5 5 RHC/FQHC -independent  1 8 6 6 6 6 6 Home Health Agencies  3 3 6 6 6 6 6  Hospice  6 6 6 6 1 1 1 Physicians  2 2 2 2 2 2 2 Pharmacy  2 2 2, 7 2, A 2 2, A 2, 7 Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Supplier  2 2 2 2 2 2  2 Critical Access Hospital (CAH) IP A or B  3 3 3 3 3 3 3 CAH OP -Method I or II  3 3 3 3 (8 - for 30-day supply)  3 3 3   NOTES:
(Medicare Claims Processing Manual)
NOTES:   Independent and provider -based  RHCs and FQHCs generally do not bill for pneumococcal/influenza vaccines, except when the only service involved is the administration of the vaccine.  Instead, RHCs/FQHCs are generally paid for pneumococcal/influenza vaccines at cost settlement via the Medicare cost report.  Hepatitis B vaccine payment is bundled into the encounter rate for both Independent and provider -based  RHCs and FQHCs.   Influenza, pneumococcal, and Hepatitis B vaccines are paid on a reasonable cost basis in a hospital outpatient department.  Neither deductible nor coinsurance apply.   HHAs cannot bill for vaccines, except on TOB 34X, since vaccines are not part of the HH benefit and cannot be paid under HH PPS.   Influenza, PPV, and Hepatitis B vaccines are paid once for the vaccine and once for the administration of the vaccine.  The provider or supplier (including physician) must enter each of the HCPCS on separate lines of the claim.   A Part B blood clotting factor claim from a Part B supplier is processed by the A/B MAC (B) .  A Part A blood clotting factor claim from a Part A provider, including a hospital -based hemophilia center, is processed by the hospitals Medicare contractor.   20 - Payment Allowance Limit for Drugs and Biologicals Not Paid on a Cost or Prospective Payment Basis (Rev. 131, 03- 26-04)  Prior to January 1, 2004, drugs and biologicals not paid on cost or prospective payment are paid based on the lower of the billed charge or 95 percent of the average wholesale price (AWP) as reflected in published sources (e.g., Red Book, Price Alert, etc.).  Examples of drugs that are paid on this basis include, but are not limited to, drugs furnished incident to a physicians service, immunosuppressive drugs furnished by pharmacies, drugs furnished by pharmacies under the durable medical equipment benefit , covered oral anticancer drugs, and blood clotting factors.   The Medicare Prescription Drug, Improvement, and Modernization Act of 2003, changed the basis for payment of drugs and biologicals not paid on a cost or prospective payment basis. For January 1, 2004, through December 31, 2004, such drugs or biologicals ar e paid as described below:
(Medicare Claims Processing Manual)
 The payment limits for blood clotting factors will be 95 percent of the AWP.   The payment limits for new drugs or biologicals will be 95 percent of the AWP.  A new drug is defined as an unlisted drug (not currently covered by a HCPCS code) that was FDA approved subsequent to April 1, 2003.  A drug would not be considered new if:   o the brand or manufacturer of the drug changed;  o a new formulation of the vial size is developed; or  o the drug received a new indication.   The payment limits for pneumococcal and hepatitis B drugs and biologicals will be 95 percent of the AWP.    The payment limits for certain drugs studied by the OIG and GAO are based on the percentages of the April 1, 2003 AWPs specified on Table 1 below.    The payment limits for infusion drugs furnished through an item of implanted durable medical equipment on or after January 1, 2004, will be 95 percent of the October 1, 2003 AWP.   Drugs and biologicals not described above are paid at 85 percent of the April 1, 2003 AWP .  Payment limits determined under this instruction shall not be updated during 2004. Table 1: Percentages of April 1, 2003 AWP for Selected Drugs   HCPCS  Applicable Percentage  J0640  80 J1100  86 J1260  80 J1440  81 J1441  81 J1561/J1563  80 J1626  80 J1642  80 J2405  87 J2430  85 J2820  80 J7320  82 J7517  86 J7608  80 J7619  80 J7631  80 J7644  80 J8520/J8521*  90 J9000  80 J9045  81 J9170  80 J9201  80 J9202  80 J9206  80 J9217  81 J9265  81 J9310  81 J9350  84 J9390  81 Q0136  87  * Use the following NDC numbers when processing claims:    00004- 1100- 20  150 mg  00004- 1100- 51  150 mg  00004- 1101- 16  500mg  00004- 1101- 50  500mg
(Medicare Claims Processing Manual)
 00004- 1100- 20  150 mg  00004- 1100- 51  150 mg  00004- 1101- 16  500mg  00004- 1101- 50  500mg  20.1 - MMA Drug Pricing - Average Sales Price  (Rev. 1513; Issued:  05- 23-08; Effective/Implementation Date:  06 -23-08)  In general, CMS establishes a single, national payment limit for A/B MAC (A), A/B MAC (B), A/B MAC (HHH) and DME MAC payment for each Medicare- covered drug whose payment is determined based on the methodology described above.  Drugs billed to DME MACs are still priced locally, albeit under the new statutory formula, as applicable.  The four DME MACs jointly establish drug payment limits for drugs that are billed to DME MACs.   The CMS provides an ASP file to each MAC for pricing drugs.  Each MAC must accept the ASP files made available by CMS for pricing bills/claims for any drug identified on the price files.  The ASP drug pricing file shall contain 3 places after the decimal point in the currency field for the ASP file and contractors shall load the ASP file including 3 places after the decimal point.  Contractors shall carry 3 places after the decimal point fo r the calculation of the amount due for a line item for each covered drug, then follow standard rounding procedures in determining the final allowance for that line item.  The final  allowed amounts will continue to carry 2 places after the decimal point.   The payment limits included in the revised ASP and Not Otherwise Classified (NOC) payment files supersede the payment limits for these codes in any publication published prior to this document.  20.1.1 - Online Pricing Files for Average Sales Price  (Rev. 509, Issued: 03- 18-05; Effective:  07 -01-05; Implementation: 07 -05-05)  Beginning July1, 2005, the standard for the number of online pricing files maintained by DME MACs for determining the applicable allowed amount for paying drug claims is eight fee screens/pricing files for Part B drugs billed to DME MACs for payment on a f ee-for-service basis.
(Medicare Claims Processing Manual)
20.1.2 - Average Sales Price (ASP) Payment Methodology (Rev. 3292, Issued: 07- 10-15, Effective: 07 -01-15, Implementation: 07- 06-15)  Section 303(c) of the Medicare Modernization Act of 2003 (MMA) revised the payment methodology for Part B covered drugs and biologicals that are not priced on a cost or prospective payment basis.  Per the MMA, beginning January 1, 2005, the vast majority of drugs and biologicals not priced on a cost or prospective payment basis will be priced based on the average sales price (ASP) methodology.  Pricing for compounded drugs is performed by the local contractor.  Beginning in July 2015, claims for compounded drugs shall be submitted using a compounded drug, not otherwise classified (NOC) HCPCS code.  Beginning in 2006, all ESRD drugs furnished by both independent and hospital -based ESRD facilities, as well as specified covered outpatient drugs, and drugs and biologicals with pass -through status under the Outpatient Prospective Payment System (OPPS), will be priced based on the ASP methodology.  The ASP methodology is  based on quarterly data submitted to CMS by manufacturers. CMS will supply contractors with the  ASP drug pricing files for Medicare Part B drugs on a quarterly basis.  Contractors will be notified of the availability of this file via a Recurring Update Notification.  Visit http://www.cms.gov/Medicare/Medicare -Fee-for-Service -Part-B-Drugs/McrPartBDrugAvgSalesPrice/index.html?redirect=/McrPartBDrugAvgSalesPrice for more information about the ASP payment methodology.  The absence or presence of a HCPCS code and its associated payment limit does not indicate Medicare coverage of the drug or biological.  Similarly, the inclusion of a payment limit within a specific column does not indicate Medicare coverage of the drug in that specific category.  The local Medicare contractor processing the claim shall make these determinations.
(Medicare Claims Processing Manual)
Beginning January 1, 2005, in general, the payment allowance limits for Medicare Part B drugs and biologicals that are not paid on a cost or prospective payment basis are 106 percent of the ASP.  Beginning January 1, 2006, in general, the payment allowance  limits for ESRD drugs when separately billed by freestanding and hospital -based ESRD facilities, as well as specified covered outpatient drugs, and drugs and biologicals with pass -through status under the OPPS, will be paid based on 106 percent of the ASP .  CMS will update the payment allowance limits quarterly.   As announced in late 2006, CMS has been working further to ensure that accurate and separate payment is made for single source drugs and biologicals as required by Section 1847A of the Social Security Act.  As part of this effort, we have also reviewed how  we have operationalized the terms single source drug, multiple source drug, and biological product in the context of payment under Section 1847A.  For the purposes of identifying single source drugs and biological products subject to payment under Section 1847A, generally CMS (and its contractors) will utilize a multi- step process.  We will consider:    The FDA approval;    Therapeutic equivalents as determined by the FDA; and    The date of first sale in the United States.   For a biological product (as evidenced by a new FDA Biologic License Application or other relevant FDA approval) or a single source drug (that is, not a drug for which there are two or more drug products that are rated as therapeutically equivalent in the most recent FDA Orange Book) first sold in the United States after October 1, 2003, the payment limit for a biological product or single source drug will be based on the pricing information for products marketed or sold under the applicable FDA approval.  As appropriate, a unique HCPCS code will be assigned to facilitate separate payment.  Separate payment may be operationalized through use of not otherwise classified HCPCS codes.  20.1.3 - Exceptions to Average Sales Price (ASP) Payment Methodology  (Rev. 2437, Issued: 04- 04-12; Effective: 01 -01-13; Implementation: 01 -01-13)
(Medicare Claims Processing Manual)
The payment allowance limits for blood and blood products (other than blood clotting factors) that are not paid on a reasonable charge or prospective payment basis, are determined in the same manner the payment allowance limits were determined on October 1 , 2003.  Specifically, the payment allowance limits for blood and blood products are 95 percent of the average wholesale price (AWP) as reflected in the published compendia.  The payment allowance limits will be updated on a quarterly basis.  Blood and blood products furnished in the hospital outpatient department are paid under OPPS at the amount specified for the Ambulatory Payment Classification (APC) to which the product is assigned.   The payment allowance limits for infusion drugs furnished through a covered item of durable medical equipment on or after January 1, 2005, will continue to be 95 percent of the AWP reflected in the published compendia as of October 1, 2003, unless the drug is compounded or the drug is furnished incident to a professional service.  The payment allowance limits for infusion drugs furnished through a covered item of durable medical equipment that were not listed in the published compendia as of October 1, 2003, (i.e., new drugs) are 95 percent of the first published AWP unless the drug is compounded or the drug is furnished incident to a professional service.   The payment allowance limits for influenza, Pneumococcal and Hepatitis B vaccines are 95 percent of the AWP as reflected in the published compendia except where the vaccine is furnished in a hospital outpatient department.  Where the vaccine is administered in the hospital outpatient department, the vaccine is paid at reasonable cost.  CMS will supply contractors with the payment allowance limits annually to be effective on August 1 of each year.  Contractors will be notified of the availability of payment allowance limits via a Recurring Update Notification.
(Medicare Claims Processing Manual)
The payment allowance limits for drugs and biologicals that are not included in the ASP Medicare Part B Drug Pricing File or Not Otherwise Classified (NOC) Pricing File, other than new drugs that are produced or distributed under a new drug application (or other application) approved by the Food and Drug Administration, are based on the published Wholesale Acquisition Cost (WAC) or invoice pricing, except under OPPS where the payment allowance limit is  95 percent of the published AWP.  In determining the payment limit based on WAC, the contractors follow the methodology specified in Publication. 100- 04, Chapter 17, Drugs and Biologicals, for calculating the AWP, but substitute WAC for AWP.  The payment limit is 106 percent of the lesser of the lowest- priced brand or median generic WAC.   MACs shall develop payment allowance limits for covered drugs when CMS does not supply the payment allowance limit on the ASP drug pricing file.  At the contractors  discretion, contractors may contact CMS to obtain payment limits for drugs not included in the quarterly ASP or NOC files or otherwise made available by CMS on the CMS Web site.  If the payment limit is available from CMS, contractors will substitute CMS -provided payment limits for pricing based on WAC or invoice pricing. CMS will provide the payment limits either directly to the requesting contractor or via posting an MS Excel file on the CMS Web site.