Pharmacy Revenue Cycle Podcast

Pharmacy Revenue Cycle News aims to provide you with helpful tips, resources, and emerging updates that can improve your pharmacy revenue. We have one very simple goal. We take complex and ever changing rules and regulations to bring you awareness and practical tools that can help you understand and enhance your pharmacy revenue cycle. Our website is full of resources, tools, explanations and links that can help you navigate the pharmacy revenue cycle. Each newsletter provides you with practical tips for you to put into your practice.

The Heavy Hitters for July Quarterly Updates 07/06/2023

Beat Inflation with a Part B Rebate 03/21/2023

Don’t be “SAD”... An Alternative Way to Handle Self-Administered Drugs 02/28/2023

Botulinum toxin PA – Are you exempt? 02/07/2023

Designer HCPCS Codes are in the Mainstream Spotlight 01/17/2023

Hospital Outpatient Prospective Payment System (OPPS) Final Rule- CY2023 12/22/2022

Hospital Outpatient Prospective Payment System (OPPS) Final Rule- CY2023 The Centers for Medicare & Medicaid Services (CMS) provided the OPPS Final Rule for CY2023 in the Federal Register on Provisions in this rule will be effective for dates of service on or after January 1, 2023. Significant changes for drug reimbursement and coding occur in three areas: 340B-acquired drugs, non-opioid pain management reimbursement in Ambulatory Surgery Centers (ASC) and Hospital Outpatient Departments (HOPD), and new requirements for reporting waste in HOPD. 340B-acquired Drugs In light of the Supreme Court decision in American Hospital Association v. Becerra, 142 S. Ct. 1896 (2022), CMS is applying the default rate, generally average sales price (ASP) plus 6 percent, to 340B acquired drugs and biologicals and removing the increase to the conversion factor that was made in CY 2018 to implement the 340B policy in a budget neutral manner. These changes are reflected in posted ASP Pricing Files and Addendum B reimbursement rates. Non-opioid pain management CMS will provide separate payment for five drugs in the ASC setting (but not in the HOPD setting) as non-opioid pain management drugs that function as supplies (Exparel, Omidria, Dextenza, Xaracoll, and Posimir). Note that Zynrelef received pass-through payment status on April 1, 2022, and is therefore eligible for separate payment in both the ASC and HOPD setting in CY2023. Drug Waste Reporting in Hospital Outpatient Departments New reporting requirements for drugs where there is no discarded waste were detailed in the CY2023 Physician Fee Schedule Rule and summarized in a recent Visante and . The following links and notes provide additional information on changes in drug reimbursement in HOPD for CY2023: Pass-through expirations CY 2022- 32 drugs will have pass-through payment end on December 31, 2022. Table 57 () Pass-through Drugs and biologicals that will receive one to four quarters of separate payment in CY 2023- 43 drugs will receive separate payment in one or more quarters in CY2023. Table 58 Pass-through Drugs and biologicals with pass-through payment status to expire after CY2023 (with pass-through payment end dates)- 49 drugs will continue with pass-through status throughout CY2023. Table 59 Packaging Threshold- CMS raises the per-day cost packaging threshold for separate payments from $130 to $135. Biosimilars- Visante has provided a recent newsletter that details Hope this summary is helpful in evaluating your reimbursement for the coming year! SHOUT-OUT All pharmacy revenue cycle teams should review the OPPS CY 2023 Rule Final Rule and ensure systems are updated by January 1, 2023. /episode/index/show/87d4129a-590b-43bb-a0af-5ff85eec4eed/id/25402653

Drug Waste is Packed with a Punch and a Refund 12/08/2022

Payment Increases for Biosimilars 11/15/2022

Car T-cell Therapy: Coverage and Billing-Outpatient (Updated – October 1, 2022) 11/01/2022

Car T-cell Therapy: Coverage and Billing-Outpatient (Updated – October 1, 2022) Chimeric Antigen Receptor (CAR) T-cell therapy is an example of a rapidly emerging immunotherapy approach called adoptive cell transfer (ACT) where patients’ own immune cells are collected and used to treat their cancer. This newsletter details coverage and billing instructions when the products are used on an outpatient basis and has been updated to reflect HCPCS codes current as of October 1, 2022. The Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration (FDA) regulates cellular therapy products, human gene therapy products, and certain devices related to cell and gene therapy. The FDA provides a of approved cellular and gene therapies including six that are Car T-cell therapies: Coverage CMS finalized a National Coverage Determination () on Car T-cell therapies on 8/7/2019. The NCD detailed that for Medicare Fee-For-Service and Medicare Advantage, Medicare covers the autologous treatment for cancer with T-cells expressing at least one chimeric antigen receptor (CAR) when: Administered at healthcare facilities enrolled in the FDA risk evaluation and mitigation strategies (REMS) Used for a medically accepted indication, i.e. for either an FDA-approved indication as detailed in the FDA-approved label for the product, or for other uses when the product has been FDA-approved and the use is supported in one or more CMS-approved compendia When the above requirements are not met, the CAR T-cell therapy is non-covered. In addition, the routine costs in clinical trials that use CAR T-cell therapy as an investigational agent are covered when they meet the requirements listed in Billing and Reimbursement HCPCS/CPT codes Billing for CAR T-cell therapy on outpatients includes HCPCS codes for the therapies as well as the administration. All CAR T-cell products should be billed with revenue code 891. Kymriah (tisagenlecleucel) is reported with HCPCS code Q2042- Tisagenlecleucel, up to 600 million car-positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose. Yescarta (axicabtagene ciloleucel) is reported with HCPCS code Q2041- Axicabtagene Ciloleucel, up to 200 Million Autologous Anti-CD19 CAR T Cells, including leukapheresis and dose preparation procedures, per infusion. Tecartus- (brexucabtagene autoleucel) is reported with HCPCS code Q2053- Brexucabtagene autoleucel, up to 200 million autologous anti-cd19 car positive viable t cells, includimg leukapheresis and dose preparation procedures, per therapeutic dose. Breyanzi- (lisocabtagene maraleucel) is reported with HCPCS code Q2054- Lisocabtagene maraleucel, up to 110 million autologous anti-cd19 car-positive viable t cells, including leukapheresis and dose preparation procedures, per therapeutic dose. Abecma (idecabtagene vicleucel) is reported with HCPCS code Q2055- Idecabtagene vicleucel, up to 460 million autologous b-cell maturation antigen (bcma) directed car-positive t cells, including leukapheresis and dose preparation procedures, per therapeutic dose. Carvykti (ciltacabtagene autoleucel) received FDA approval on 2/28/2022, and CMS has assigned a new HCPCS code effective October 1, 2022: code Q2056- Ciltacabtagene autoleucel, up to 100 million autologous b-cell maturation antigen (bcma) directed car-positive t cells, including leukapheresis and dose preparation procedures, per therapeutic dose. The administration of any CAR T-cell therapy should be reported with CPT code 0540T- Chimeric antigen receptor T-cell (CAR-T) therapy; CAR-T cell administration, autologous. This CPT code should be reported with revenue code 874 – Infusion of Modified Cells w/CPT 0540T. Some payers also require that the claim include a new value code 86 with the invoice/acquisition cost when revenue code 891 is present on an outpatient claim. CMS provides instructions that providers may include all costs and charges and report them under revenue code 891, or they may separately report cell collection, storage and other preparatory activities. However, CMS does not reimburse these codes separately and they are reported for information only. Detailed examples on these two options for CAR T-cell billing for outpatients is available at - (November 13, 2020). Revenue Codes CMS has also provided instructions for specific revenue codes to report all services associated with CAR T-cell therapy for inpatients and outpatients. The following Revenue Codes are used: 0871 – Cell Collection w/Current Procedural Technology (CPT) code 0537T 0872 – Specialized Biologic Processing and Storage – Prior to Transport w/CPT 0538T 0873 – Storage and Processing after Receipt of Cells from Manufacturer w/CPT 0539T 0874 – Infusion of Modified Cells w/CPT 0540T 0891 – Special Processed Drugs – FDA Approved Cell Therapy w/HCPCS Q2041, Q2042, or C9399 SHOUT-OUTS! Pharmacy and Revenue Integrity should determine if CAR T-cell therapy will be provided and ensure that appropriate chargemaster entries for the products are established with product specific HCPCS codes and the unique revenue code, 891. Pharmacy, Managed Care and Revenue Integrity should determine if any payers require the invoice cost to be added to claim with value code 86 and establish a process to ensure that the invoice cost is correctly added to the claim. Revenue Integrity and HIM Coders should receive instructions as to which products will be utilized and the medical record location where the administration will be recorded. Pharmacy should ensure that if the product is administered under a clinical trial, or received at no cost from the manufacturer, that it is clearly indicated in the medical record to ensure proper billing and coding. Our goal is simple; we’re taking complex information and making it practical. Until our next edition, this is Maxie Friemel and Agatha Nolen providing you with tips for increasing your Pharmacy Revenue. /episode/index/show/87d4129a-590b-43bb-a0af-5ff85eec4eed/id/24872982

Vacating the 340B Payment Reduction Policy 10/19/2022

Vacating the 340B Payment Reduction Policy On September 28, 2022, the US District Court issued a that states the Department of Health and Human Services (HHS) is required to vacate the prospective portion of the 340B reimbursement rate outlined in the 2022 Outpatient Prospective Payment System (OPPS) Rule. In other words, payment rates must revert to the default of ASP + 6% rather than the reduced rate for select drugs of ASP - 22.5%. The decision was determined to not cause substantial disruption; thereby, requiring HHS to begin immediately. This was in response to American Hospital Association v. Becerra, 142 S. Ct. 1896 (2022), in which the Supreme Court ruled against the Department of Health and Human Services (HHS) stating they exceeded their statutory authority by varying its 2018 and 2019 OPPS reimbursement rates for 340B hospitals without first conducting a statutorily mandated survey of hospitals acquisition costs. has issued a statement that they will be reprocessing claims contractors paid on or after September 28, 2022, using the default rate of ASP+6%. CMS is also uploading a revised OPPS drug file that will apply the default rate generally ASP+6% to the 340B drugs for the remainder of this year. Additionally, providers can contact their MAC to make a mass adjustment for claims paid prior to September 28, 2022. Shout Outs! Revenue integrity teams should be aware that Medicare fee-for-service claims paid at the ASP - 22.5% will be reprocessed and paid at generally ASP+6%. This is effective for claims paid on or after September 28, 2022. Revenue integrity teams should contact their MAC to determine the process for making a mass adjustment to claims paid prior to September 28, 2022. Pharmacy and finance teams should review the impact to the price change and the associated impact to pharmacy budgets. Revenue cycle teams should be on the lookout for upcoming discussions and changes to the OPPS CY 2023. Our goal is simple; we’re taking complex information and making it practical. Until our next edition, this is Maxie Friemel and Agatha Nolen providing you with tips for increasing your Pharmacy Revenue. /episode/index/show/87d4129a-590b-43bb-a0af-5ff85eec4eed/id/24738000

FY23 New Technology Add-On Payment for Inpatient Reimbursement 10/04/2022

FY23 New Technology Add-On Payment for Inpatient Reimbursement The FY2023 Inpatient Prospective Payment System (IPPS) Final Rule was published in the Federal Register and is effective October 1, 2022. NTAP is considered for new services or technologies when: 1) they are new and not substantially similar to other existing services or technology; 2) the services or technology is more costly or the MS-DRG payment is inadequate for coverage of the new technology; 3) the service or technology demonstrates substantial clinical improvements over existing services or technology with the exception of certain antimicrobials which have been approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) and are authorized by the FDA as a Qualified Infectious Disease Product (QIDP). Payment Calculation ● NTAP without QIDP designation is equal to the lesser of 65% of the cost of the new technology or 65% of the amount by which the cost exceeds the standard DRG payment. ● NTAP with QIDP designation or approved under the FDA’s LPAD pathway is equal to the lesser of 75% of the costs of the new medical service technology or 75% of the amount by which the costs of the case exceed the standard DRG payment. Tool provided by Visante Pharmacy Revenue Cycle Team has been updated to reflect the FY23 changes that impact the drugs and biologicals. The crosswalk contains the newness start date, NTAP status, maximum NTAP payment and the associated ICD-10-PCS codes. Shout Outs! 1. Pharmacy team and HIM/Coding teams should collaborate to ensure that the system is updated for proper capture and application of the ICD-10-PCS codes to the claim. Without the ICD-10-PCS code, the claim will not process the NTAP payment. 2. Pharmacy teams should take into consideration NTAP payment in formulary decision making, but note these payments only last for 2 to 3 years. Our goal is simple; we’re taking complex information and making it practical. Until our next edition, this is Maxie Friemel and Agatha Nolen providing you with tips for increasing your Pharmacy Revenue Cycle. /episode/index/show/87d4129a-590b-43bb-a0af-5ff85eec4eed/id/24583359

Back to Flu Season 09/20/2022

Comment Letter on IPPS FY2023 Proposed Rule and NDC Reporting for NTAP Drugs 07/19/2022

Comment Letter on IPPS FY2023 Proposed Rule and NDC Reporting for NTAP Drugs Dear Readers:Below is the content from a letter we submitted to CMS regarding their proposal in the IPPS FY2023 Proposed Rule to discontinue ICD-10-PCS codes for identifying drugs eligible for NTAP and switch to requiring NDC numbers be reported on inpatient. We’ve made an alternate suggestion after talking with many of you, and also offered some important steps that should be taken to ensure the integrity of the data if CMS proceeds with this proposal. Please send us your feedback. We’ll do another analysis when the Final Rule is issued in August, prior to its implementation date of October 1, 2022. Our goal is simple; we’re taking complex information and making it practical. Until our next edition, this is Maxie Friemel and Agatha Nolen providing you with tips for increasing your Pharmacy Revenue. ****************************************** June 15, 2022 Via Electronic Submission to: http://www.regulations.gov (CMS-1771-P) Chiquita Brooks-Lasure, Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Attention: CMS–1771-P P.O. Box 8013 Baltimore, MD 21244–1850 Re: Comments on The Hospital Inpatient Prospective Payment Systems (IPPS) for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2023 Rate published in the May 10, 2022 Federal Register (CMS-1771-P) Dear Administrator Brooks-Lasure: We are pharmacists and consultants to health systems and practitioners in the area of pharmacy revenue cycle and are commenting on the proposal to change the claim identifier for drugs qualifying for New Technology Add-on Payment (NTAP) from the current ICD-10-PCS Code to the National Drug Code (NDC) number. This is found in section II.F.8.”Proposed Use of National Drug Codes (NDCs) To Identify Cases Involving Use of Therapeutic Agents Approved for New Technology Add-On Payment”- Federal Register / Vol. 87, No. 90 / Tuesday, May 10, 2022 / Proposed Rules/ page 28353. Background: The National Drug Code (NDC) number is a 10-digit number coordinated by the FDA which is reported on health claims as an 11-digit number. In the hospital environment, the NDC is stored in the Pharmacy IT system and is used in the clinical care of the patient for drug interaction checking, diagnosis conflicts, as well as safety aspects such as matching patient and medication through barcode medication administration and accurate restocking of floor stock supplies. Drug profiles are created in the Pharmacy IT system that have NDC numbers that link to billing information such as a procedure code, revenue code and HCPCS code as the HCPCS code has been the standard for reporting drugs for payment under the OPPS system since 2000. We understand that the ICD-10-PCS coding system was not designed to provide detailed coding for each drug manufactured. With the increased speed of FDA approval and the escalating costs of drugs, it has become cumbersome to have ICD-10-PCS codes issued for each drug, even when limiting the codes to only those drugs eligible for NTAP payment. Concerns in considering this proposal: Multiple ways to report drugs for payment based upon patient status and code sets Hospitals are faced with increasingly complex requirements to report drugs to secure reimbursement with variations based upon code sets and patient status. For Inpatient claims we have two ways of reporting drugs for additional payment: Hemophilia products are reported with HCPCS codes + billed units per date of service (DOS) NTAP-eligible drugs reported with ICD-10-PCS codes with only a single code independent of number of doses or days administered For Outpatient claims we report all drugs similar to Hemophilia products on inpatient claims (i.e. HCPCS code + billed units per DOS) with two nuances: Most oral drugs are not assigned HCPCS codes as they are typically self-administered drugs and not covered under Part B HCPCS Code C9399 (Unclassified drug or biological) is used for new drugs and biologicals that are approved by the FDA on or after January 1, 2004 for which a specific HCPCS code has not been assigned but CMS requires that the drug name, dose, amount of waste and National Drug Code (NDC) number be manually added to the remarks section of the claim. Hospital Pharmacy and Billing IT systems will need remediation with complex maintenance in order to accurately bill drugs based upon the type of drug, whether it is eligible for NTAP payment and the status of the patient. Changes in patient status will require programming to recalculate posted charges. Many hospitals currently do not bill some NTAP-eligible drugs due to the cumbersome process and low anticipated reimbursement. This can lead to inadvertent billing errors or omissions when a business decision is made that the anticipated payment will be less than the cost to remediate IT systems and maintain these complex billing rules. Inaccurate data could lead to erroneous future rate-setting by CMS when data is missing from claims. No national rules or standards on how to correctly code drugs using NDC numbers on 837I claims or that NDC numbers will be accepted by all payers on inpatient claims The 5010 HIPAA transaction standards define the NDC units of measure (F2, UN, GM, ML, ME), but do not define how they are to be applied in the hospital setting. There is no nationally recognized public or third-party database that authoritatively provides these instructions. State Medicaid programs have provided directions since requiring NDC numbers on outpatient claims beginning in 2006, but one eHR vendor has advised clients to use the “UN” unit of measure with a “unit” of “1” for all entries rather than using the most common four units of measure as directed by State Medicaid programs. In addition, vendors and providers also differ in the reporting of the actual NDC administered to the patient (usually captured with Bar-code Medication Administration (BCMA), or an NDC number that is retrieved from a database and “represents” what is administered to the patient matching only the generic identification but not the specific NDC number. Without specific guidance, current NDC reporting is often inaccurate resulting in increasing claim rejections for an invalid NDC number. Currently, some payers are requiring NDC numbers on outpatient claims, but rejecting the line if not reported with a HCPCS code. It is anticipated that this situation may occur similarly on inpatient claims with commercial payers. Future concerns with potential changes in FDA assignment of NDC numbers The FDA held public hearings in 2018 to receive input as the current structure of 10-digit NDC codes will run out of codes within 10-15 years. Although a path forward has not yet been announced, it is conceivable that a longer NDC number (e.g. 16 digits) may be required as early as 2028 requiring clinical and billing systems to be updated in all hospitals as well as updated 5010 requirements for standardized billing. CMS, MACs, and all payer systems will also require remediation to accommodate these changes. A summary of the public hearings is here: Recommendations for CMS for this section of the Proposed Rule: Consider that NTAP-eligible drugs be billed on inpatient claims with the same instructions as currently used to report hemophilia products, i.e. with HCPCS codes and billing units by DOS. Having one way to bill drugs on inpatient and outpatient claims will reduce IT programming expense and reduce errors with increased standardization. Request that the CMS HCPCS Working Group assign HCPCS codes to items eligible for NTAP payments, even if they normally would not be assigned a HCPCS code (such as drugs with inpatient-only status, or an oral drug which is not usually covered under Part B). As HCPCS codes are assigned quarterly, this would eliminate the need for special notification if new NDC numbers are marketed after the implementation of the NTAP status and before the next rule-making cycle. If CMS adopts the proposed change to use NDC numbers to identify NTAP-eligible drugs on inpatient claims, we recommend that CMS should: Work with NUBC to provide further clarification on how these 5010 standard units of measure and billing quantities should be calculated and reported prior to utilizing the NDC number to drive payment. In effect, the unit of measure and billing quantity required with 5010 standards will be meaningless on inpatient or outpatient claims. Work with NUBC to require all payers to accept NDC numbers on inpatient claims to avoid payer-specific instructions which require complex and expensive IT programming. Provide additional details in rule-making which clarify whether the NDC reported on the claim must be from the package administered to the patient or whether it can be retrieved from a database and be “representative” of the drug administered to the patient, but not necessarily the exact NDC administered to the patient. Provide additional details in rule-making if multi-day therapies with NTAP-eligible drugs must be combined into a single line and reported only once at the start of therapy, or whether the NDC number can be reported on each DOS with the appropriate NDC unit of measure and NDC billed units and CMS will provide software logic to recognize the NDC and provide appropriate payment even if the NDC number is reported on multiple dates of service. Provide a notification process when a new NDC is marketed after final rule-making for the NTAP-eligible drug. This may be a result of improved packaging or when additional vial sizes are marketed. We appreciate CMS’ proposal to provide a streamlined mechanism for reporting certain drugs on inpatient claims as an alternative to ICD-10-PCS codes and appreciate the opportunity to comment on this proposal. Regards, Maxie Friemel, Pharm.D., CRCR. Visante, Senior Director, Pharmacy Revenue Cycle Agatha Nolen, Ph.D., D.Ph., FASHP, CRCR Visante, Billing Consultant /episode/index/show/87d4129a-590b-43bb-a0af-5ff85eec4eed/id/23794103

Car T-cell Therapy: Coverage and Billing-Outpatient (Updated-July 1 2022) 06/30/2022

Car T-cell Therapy: Coverage and Billing-Outpatient (Updated-July 1 2022) Chimeric Antigen Receptor (CAR) T-cell therapy is an example of a rapidly emerging immunotherapy approach called adoptive cell transfer (ACT) where patients’ own immune cells are collected and used to treat their cancer. This newsletter details coverage and billing instructions when the products are used on an outpatient basis and has been updated to reflect HCPCS codes current as of July 1, 2022. The Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration (FDA) regulates cellular therapy products, human gene therapy products, and certain devices related to cell and gene therapy. The FDA provides a of approved cellular and gene therapies including six that are Car T-cell therapies: Coverage CMS finalized a National Coverage Determination () on Car T-cell therapies on 8/7/2019. The NCD detailed that for Medicare Fee-For-Service and Medicare Advantage, Medicare covers the autologous treatment for cancer with T-cells expressing at least one chimeric antigen receptor (CAR) when: Administered at healthcare facilities enrolled in the FDA risk evaluation and mitigation strategies (REMS) Used for a medically accepted indication, i.e. for either an FDA-approved indication as detailed in the FDA-approved label for the product, or for other uses when the product has been FDA-approved and the use is supported in one or more CMS-approved compendia When the above requirements are not met, the CAR T-cell therapy is non-covered. In addition, the routine costs in clinical trials that use CAR T-cell therapy as an investigational agent are covered when they meet the requirements listed in Billing and Reimbursement HCPCS/CPT codes Billing for CAR T-cell therapy on outpatients includes HCPCS codes for the therapies as well as the administration. All CAR T-cell products should be billed with revenue code 891. Kymriah (tisagenlecleucel) is reported with HCPCS code Q2042- Tisagenlecleucel, up to 600 million car-positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose. Yescarta (axicabtagene ciloleucel) is reported with HCPCS code Q2041- Axicabtagene Ciloleucel, up to 200 Million Autologous Anti-CD19 CAR T Cells, including leukapheresis and dose preparation procedures, per infusion. Tecartus- (brexucabtagene autoleucel) is reported with HCPCS code Q2053- Brexucabtagene autoleucel, up to 200 million autologous anti-cd19 car positive viable t cells, includimg leukapheresis and dose preparation procedures, per therapeutic dose. Breyanzi- (lisocabtagene maraleucel) is reported with HCPCS code Q2054- Lisocabtagene maraleucel, up to 110 million autologous anti-cd19 car-positive viable t cells, including leukapheresis and dose preparation procedures, per therapeutic dose. Abecma (idecabtagene vicleucel) is reported with HCPCS code Q2055- Idecabtagene vicleucel, up to 460 million autologous b-cell maturation antigen (bcma) directed car-positive t cells, including leukapheresis and dose preparation procedures, per therapeutic dose. Carvykti (ciltacabtagene autoleucel) received FDA approval on 2/28/2022, and CMS has assigned a HCPCS code effective July 1, 2022: code C9098- Ciltacabtagene autoleucel, up to 100 million autologous b-cell maturation antigen (bcma) directed car-positive t cells, including leukapheresis and dose preparation procedures, per therapeutic dose. The administration of any CAR T-cell therapy should be reported with CPT code 0540T- Chimeric antigen receptor T-cell (CAR-T) therapy; CAR-T cell administration, autologous. This CPT code should be reported with revenue code 874 – Infusion of Modified Cells w/CPT 0540T. Some payers also require that the claim include a new value code 86 with the invoice/acquisition cost when revenue code 891 is present on an outpatient claim. CMS provides instructions that providers may include all costs and charges and report them under revenue code 891, or they may separately report cell collection, storage and other preparatory activities. However, CMS does not reimburse these codes separately and they are reported for information only. Detailed examples on these two options for CAR T-cell billing for outpatients is available at - (November 13, 2020). Revenue Codes CMS has also provided instructions for specific revenue codes to report all services associated with CAR T-cell therapy for inpatients and outpatients. The following Revenue Codes are used: 0871 – Cell Collection w/Current Procedural Technology (CPT) code 0537T 0872 – Specialized Biologic Processing and Storage – Prior to Transport w/CPT 0538T 0873 – Storage and Processing after Receipt of Cells from Manufacturer w/CPT 0539T 0874 – Infusion of Modified Cells w/CPT 0540T 0891 – Special Processed Drugs – FDA Approved Cell Therapy w/HCPCS Q2041, Q2042, or C9399 SHOUT-OUTS! Pharmacy and Revenue Integrity should determine if CAR T-cell therapy will be provided and ensure that appropriate chargemaster entries for the products are established with product specific HCPCS codes and the unique revenue code, 891. Pharmacy, Managed Care and Revenue Integrity should determine if any payers require the invoice cost to be added to claim with value code 86 and establish a process to ensure that the invoice cost is correctly added to the claim. Revenue Integrity and HIM Coders should receive instructions as to which products will be utilized and the medical record location where the administration will be recorded. Pharmacy should ensure that if the product is administered under a clinical trial, or received at no cost from the manufacturer, that it is clearly indicated in the medical record to ensure proper billing and coding. /episode/index/show/87d4129a-590b-43bb-a0af-5ff85eec4eed/id/23588537

What's New? Using HCPCS Code C9399 (7/1/2022 Update) 06/15/2022

What's New? Using HCPCS Code C9399 (7/1/2022 Update) What’s NEW? Using HCPCS Code C9399 (July 1, 2022 update) HCPCS code C9399-Unclassifed drugs or biologicals, can be used to bill for new drugs, biologicals, and therapeutic radiopharmaceuticals that are approved by the FDA on or after January 1, 2004 when a product-specific HCPCS code has not yet been assigned when furnished in hospital outpatient departments. (). This C9399 tool includes the generic and brand names, approval dates, manufacturer, and a link to the prescribing information (PI). (<link to spreadsheet on Tools>) for injectable drugs that have been approved by the FDA but have not been assigned a HCPCS code by CMS. This list is updated each quarter to reflect newly released HCPCS codes. These “Not-otherwise-classified codes” (e.g. C9399) should only be used when a more specific HCPCS code has not been assigned. What do I need to know about billing with C9399? HCPCS code C9399 is billed with a quantity of “1” (one) on the claim which is essentially a placeholder and directs the payer to review additional information in the NOTES section of the 837I claim. For Medicare and some other payers, discarded waste from separately payable single-dose vials must be recorded in the patient’s medical record. When reporting C9399, a separate charge line on the claim with the JW modifier should NOT be reported. Instead the amount administered and amount wasted (if documented) is reported in the NOTES section of the claim. For Medicare outpatients, when reporting C9399, hospitals must also report the National Drug Code (NDC) and quantity administered (expressed in the NDC unit of measure) as well as the date the drug was furnished in the NOTES section. For Medicare outpatients, the MAC will manually calculate the payment for the drug or biological at 95 percent of the average wholesale price (AWP). The MAC will pay 80 percent of the calculated payment to the hospital and the beneficiary will be responsible for the 20 percent co-pay after the deductible is met. Drugs/biologicals manually priced at 95 percent of AWP are not eligible for outlier payment. Other payers may pay similarly to Medicare or have an established fee schedules for new drugs. Some payers may provide alternate billing instructions (e.g. J3490, J3590) and they should be followed when available. Please note that physician offices are not eligible to bill using HCPCS codes beginning with “C”, and must select a different unclassified code, e.g. “J” code. Why have some drugs been approved for years, and still don’t have a HCPCS code assigned? The HCPCS Workgroup assigns HCPCS code quarterly and holds an annual Public Meeting to gain feedback on their preliminary decisions. Typically a manufacturer or insurer submits an requesting a HCPCS code assignment. Approved codes are posted on the CMS page. What else should I know about these drugs that don’t have an assigned HCPCS code? Medicare may consider some of these drugs that are administered subcutaneously as “self-administered” and therefore not covered in a hospital outpatient department. For other payers, the drugs may be covered in a hospital outpatient department, or covered as a pharmacy benefit rather than the medical benefit. Medicare has also provided different instructions for billing diagnostic radiopharmaceuticals and contrast agents when a specific code has not been assigned. These instructions are available in the . Shout-outs! Pharmacy should review these 50+ C9399 drugs to determine if they are in use and if so, ensure that the HCPCS code C9399 is used for billing with revenue code 636. Finance should review payments for C9399 to determine if payers are reimbursing at 95% AWP (Medicare and payers like Medicare), or at a contracted fee schedule rate. Revenue Integrity should review any drugs in use to ensure they are not on the facility’s from the MAC, and therefore not covered when furnished in a hospital outpatient department. /episode/index/show/87d4129a-590b-43bb-a0af-5ff85eec4eed/id/23442326

Car T-cell Therapy-Billing and Coverage for Outpatients (Updated) 03/15/2022

Car T-cell Therapy-Billing and Coverage for Outpatients (Updated) Chimeric Antigen Receptor (CAR) T-cell therapy is an example of a rapidly emerging immunotherapy approach called adoptive cell transfer (ACT) where patients’ own immune cells are collected and used to treat their cancer. This newsletter details coverage and billing instructions when the products are used on an outpatient basis and has been updated to reflect HCPCS codes current as of April 1, 2022. The Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration (FDA) regulates cellular therapy products, human gene therapy products, and certain devices related to cell and gene therapy. The FDA provides a of approved cellular and gene therapies including six that are Car T-cell therapies: Coverage CMS finalized a National Coverage Determination () on Car T-cell therapies on 8/7/2019. The NCD detailed that for Medicare Fee-For-Service and Medicare Advantage, Medicare covers the autologous treatment for cancer with T-cells expressing at least one chimeric antigen receptor (CAR) when: Administered at healthcare facilities enrolled in the FDA risk evaluation and mitigation strategies (REMS) Used for a medically accepted indication, i.e. for either an FDA-approved indication as detailed in the FDA-approved label for the product, or for other uses when the product has been FDA-approved and the use is supported in one or more CMS-approved compendia When the above requirements are not met, the CAR T-cell therapy is non-covered. In addition, the routine costs in clinical trials that use CAR T-cell therapy as an investigational agent are covered when they meet the requirements listed in Billing and Reimbursement HCPCS/CPT codes Billing for CAR T-cell therapy on outpatients includes HCPCS codes for the therapies as well as the administration. All CAR T-cell products should be billed with revenue code 891. Kymriah (tisagenlecleucel) is reported with HCPCS code Q2042- Tisagenlecleucel, up to 600 million car-positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose. Yescarta (axicabtagene ciloleucel) is reported with HCPCS code Q2041- Axicabtagene Ciloleucel, up to 200 Million Autologous Anti-CD19 CAR T Cells, including leukapheresis and dose preparation procedures, per infusion. Tecartus- (brexucabtagene autoleucel) is reported with HCPCS code Q2053- Brexucabtagene autoleucel, up to 200 million autologous anti-cd19 car positive viable t cells, includimg leukapheresis and dose preparation procedures, per therapeutic dose. Breyanzi- (lisocabtagene maraleucel) is reported with HCPCS code Q2054- Lisocabtagene maraleucel, up to 110 million autologous anti-cd19 car-positive viable t cells, including leukapheresis and dose preparation procedures, per therapeutic dose. Abecma (idecabtagene vicleucel) is reported with HCPCS code Q2055- Idecabtagene vicleucel, up to 460 million autologous b-cell maturation antigen (bcma) directed car-positive t cells, including leukapheresis and dose preparation procedures, per therapeutic dose. Carvykti (ciltacabtagene autoleucel) (received FDA approval on 2/28/2022, but CMS has not yet assigned a HCPCS code and we recommend that this product be reported with C9399- Unclassified drugs or biologicals. This HCPCS code is used to report newly approved products prior to HCPCS specific code assignment. The administration of any CAR T-cell therapy should be reported with CPT code 0540T- Chimeric antigen receptor T-cell (CAR-T) therapy; CAR-T cell administration, autologous. This CPT code should be reported with revenue code 874 – Infusion of Modified Cells w/CPT 0540T. Some payers also require that the claim include a new value code 86 with the invoice/acquisition cost when revenue code 891 is present on an outpatient claim. CMS provides instructions that providers may include all costs and charges and report them under revenue code 891, or they may separately report cell collection, storage and other preparatory activities. However, CMS does not reimburse these codes separately and they are reported for information only. Detailed examples on these two options for CAR T-cell billing for outpatients is available at - (November 13, 2020). Revenue Codes CMS has also provided instructions for specific revenue codes to report all services associated with CAR T-cell therapy for inpatients and outpatients. The following Revenue Codes are used: 0871 – Cell Collection w/Current Procedural Technology (CPT) code 0537T 0872 – Specialized Biologic Processing and Storage – Prior to Transport w/CPT 0538T 0873 – Storage and Processing after Receipt of Cells from Manufacturer w/CPT 0539T 0874 – Infusion of Modified Cells w/CPT 0540T 0891 – Special Processed Drugs – FDA Approved Cell Therapy SHOUT-OUTS! 1. Pharmacy and Revenue Integrity should determine if CAR T-cell therapy will be provided and ensure that appropriate chargemaster entries for the products are established with product specific HCPCS codes and the unique revenue code, 891. 2. Pharmacy, Managed Care and Revenue Integrity should determine if any payers require the invoice cost to be added to claim with value code 86 and establish a process to ensure that the invoice cost is correctly added to the claim. 3. Revenue Integrity and HIM Coders should receive instructions as to which products will be utilized and the medical record location where the administration will be recorded. 4. Pharmacy should ensure that if the product is administered under a clinical trial, or received at no cost from the manufacturer, that it is clearly indicated in the medical record to ensure proper billing and coding. Our goal is simple; we’re taking complex information and making it practical. Until our next edition, this is Maxie Friemel and Agatha Nolen providing you with tips for increasing your Pharmacy Revenue. Contact Maxie: /episode/index/show/87d4129a-590b-43bb-a0af-5ff85eec4eed/id/22479935

If All Else Fails, Submit and Appeal 03/01/2022

If All Else Fails, Submit and Appeal It may seem like a scary or intimidating endeavor, but many pharmacy related denials can be overturned when following the appeal process. Medicare has five levels of appeals beginning with a redetermination by the MAC to Judicial Review in the Federal District Court. Before beginning the appeals process, it is prudent to ensure that the claim was coded and billed accurately. Claims that have an error in billing may be corrected by re-submitting utilizing the corrected claim process. Additionally, it is important to understand the reason for the initial denial and ensure there is clinical justification or other supporting evidence for billing the denied service. Once your homework is complete and an appeal may be justified, follow the process outlined by the payer and work to overturn the denial. Each level of a Medicare appeal must be completed in writing and follow a specific set of instructions. This includes a specific form and each level outlines the number of days in which the appeal should be submitted from the time of the determination. Each appeal should clearly explain why the appellant disagrees with the decision made and provide any relevant documentation or other justification. First level of appeal is a redetermination by a Medicare Administrative Contractor (MAC), and must be submitted within 120 days from the date of the initial claim determination. Second level of appeal is a reconsideration by a Qualified Independent Contractor (QIC) in the event that any party is dissatisfied with the decision from the MAC. The appellant has 180 days from the receipt of the redetermination to file a reconsideration. Third level of appeal is to request a hearing before an Administrative Law Judge (ALJ). The hearing must be filed with the Office of Medicare Hearings and Appeals (OMHA) within 60 days of the reconsideration decision from the QIC. Fourth level of appeal is to request a review by the Medicare Appeals Council and must be filed within 60 days of the ALJ decision. Fifth level of appeal is to request a judicial review in Federal District Court within 60 days of the decision by the Council. Appealing a claim can be a lengthy process, but a worthy endeavor especially when high cost drug denials are on the line! Shout Outs! Revenue cycle teams should review denials to understand the root cause and submit a corrected claim (if applicable) prior to initiating an appeal. Pharmacy teams should be involved in the appeal process to assist with providing clinical justification for a denied drug. Revenue cycle teams should track each appeal to ensure reconsiderations are submitted in a timely fashion. Our goal is simple; we’re taking complex information and making it practical. Until our next edition, this is Maxie Friemel and Agatha Nolen providing you with tips for increasing your Pharmacy Revenue. Reach out to Maxie! /episode/index/show/87d4129a-590b-43bb-a0af-5ff85eec4eed/id/22309868

Convalescent Plasma: New HCPCS Code for Outpatients 02/15/2022

Notice: Read All About an ABN 02/01/2022

Notice: Read All About an ABN Pharmacy teams are increasingly embedding themselves within revenue cycle teams and prior authorization processes within infusion and cancer centers as well as other outpatient departments. As this occurs the term ABN may increasingly become an important factor that pharmacy teams otherwise would not originally have dealt with. Or, maybe you as a Medicare beneficiary have wondered what they are and their importance. is a written notice given to Medicare fee-for-service or original Medicare beneficiaries to convey that the item or service may not be covered by Medicare Part B since they are medically unnecessary or custodial in nature. Examples of situations in which an ABN is required include: When a Medicare item or service isn’t reasonable and necessary When providing custodial care Experimental and investigational or considered research only Before providing preventative care that is usually covered but won’t be covered in specific situations in which it exceeds the frequency limits A more complete list may be found ABNs are not required for items or services that are considered statutorily excluded by Medicare. They may be given on a voluntary basis or as a courtesy to the beneficiary notifying them of the potential financial liability. The primary example as it pertains to pharmacy is self-administered drugs that are statutorily excluded under payment from Medicare Part B. An ABN is prohibited when the service is denied due to a Medically Unlikely Edit or MUE or when Medicare covers the service under a bundled payment. Additionally, an ABN is not used for Medicare Part D. The ABN is a protective mechanism for both the Medicare beneficiary and provider related to financial liability. An ABN should be issued far enough in advance for the beneficiary to allow time for the patient to consider all available options. Ideally, an ABN is issued in person and explained in its entirety. The standard, approved must be used and the patient must elect (option 1) to receive the treatment followed by a signature. When an ABN is issued appropriately to a beneficiary and the beneficiary agrees and signs, financial liability may shift from a provider to the beneficiary in the event of a Medicare denial. Shout Outs! Pharmacy and prior authorization teams should understand the ABN process upon evaluating National and Local Coverage Determinations (NCD and LCD) to understand when drugs may not be covered. Clinical teams should ensure documentation supports the medical necessity of the drug, and when a denial is received should determine if an appeal may be more appropriate based on clinical support prior to shifting liability to the patient. It is important to understand when it is required, voluntary and prohibited to issue an ABN to a Medicare beneficiary. Teams should evaluate that a signed form is on file prior to administering drugs that are considered not covered. Our goal is simple; we’re taking complex information and making it practical. Until our next edition, this is Maxie Friemel and Agatha Nolen providing you with tips for increasing your Pharmacy Revenue. /episode/index/show/87d4129a-590b-43bb-a0af-5ff85eec4eed/id/21998216

Aduhelm and Medicare Coverage 01/25/2022

Aduhelm and Medicare Coverage On January 11, 2022, CMS released a proposed National Coverage Determination (NCD) decision memorandum which would cover monoclonal antibodies that target amyloid for the treatment of Alzheimer’s disease through coverage with evidence development (CED). This means that FDA-approved drugs in this class would be covered for people with Medicare only if they are enrolled in a qualifying clinical trial and it must be administered in a hospital outpatient setting. The proposed NCD is open to public comment and comments can be submitted until February 10, 2022 at the NCD database for CAG-00460N: . CMS anticipates a final decision by April 11, 2022. Currently Aduhelm is the only monoclonal antibody directed against amyloid beta approved by the FDA for the treatment of Alzheimer’s disease receiving approval on June 7, 2021. Initially the pharmaceutical company, Biogen, announced that the selling price would be $56,000 per patient per year. However, in , the company announced that it was cutting the price in half to $28,000 per patient per year. The cost and coverage has not been without controversy. As the target population is Medicare-age, CMS recalculated the premium costs for Part B coverage at the initial selling price, with Part B premiums increasing 14.5% in 2022 in part due to the uncertainty of the . On January 10, 2022, Health and Human Services Secretary Xavier Becerra announced that he is to reassess this year’s standard premium in view of the proposed NCD and the manufacturer’s drop in price. To read the proposed National Coverage Determination decision memorandum, visit: SHOUT-OUTS! 1. Pharmacy should be aware of developing CMS-criteria for monoclonal antibodies for the treatment of Alzheimer’s disease including the proposed requirement for the patient to be enrolled in a CMS-qualifying clinical trial with a final decision by April 11, 2022. 2. The monoclonal antibody must be administered in a hospital outpatient setting to be covered under the proposed NCD. 3. Facilities which anticipate providing monoclonal antibodies for Alzheimer’s patients should consider submitting comments to CMS by February 10, 2022 on the proposed NCD. Our goal is simple; we’re taking complex information and making it practical. Until our next edition, this is Maxie Friemel and Agatha Nolen providing you with tips for increasing your Pharmacy Revenue. /episode/index/show/87d4129a-590b-43bb-a0af-5ff85eec4eed/id/21998189

Covid Tidal Wave and Remdesivir Changes 01/18/2022

Covid Tidal Wave and Remdesivir Changes Many of you may be experiencing another tidal wave of surges with the Omicron Covid-19 variant. Though we have been fighting the pandemic for almost two years, each surge seems to bring new battles. The NIH recently published new outpatient therapy to help combat the Omicron variant; as well as, we have received a few questions from our readers on how to handle the billing changes. Remdesivir is now among one of the treatment options for non-hospitalized patients when Omicron is the predominant circulating variant. CMS has designated HCPCS code J0248, injection remdesivir, 1 mg. The code is effective for dates of service beginning December 23, 2021 and may be used to rebill any previously administered outpatient remdesivir account. Remdesivir is FDA approved for hospitalized patients and utilizing remdesivir for outpatients is considered off-labeled. It is prudent to ensure patients meet the criteria outlined by the NIH to avoid any denials by the MACs. If denied for payment, following the appeal process to overturn any remdesiver when used according to recommendations. Note, Medicare beneficiaries will be responsible for the 20% deductible for the drug and administration of remdesivir. Currently, J0248 code for remdesivir has not been updated in the Outpatient Code Editor (OCE). Payers may not be able to process claims until this update has occurred. In which case, it may be advantageous to hold claims temporarily until the payers are ready to accept the newly created code. Other updates for Covid-19 Vaccine and Monoclonal Antibodies Effective January 1, 2022, Original Medicare (or Medicare Fee for Service) will no longer cover the vaccine or monoclonal antibodies on behalf of the Medicare Advantage (MA) plans. MA claims should have split any vaccine or covid related monoclonal antibodies to be billed to the Original Medicare plan. This claim split should be “undone” for any claims billed out after January 1, 2022. MA and Medicare plans will continue to cover the vaccine and monoclonal antibodies respectively once billed. Shout Outs! Pharmacy Revenue Cycle and Informatics Teams should update the CDM for remdesivir to reflect the new code J0248, injection 1 mg. Revenue Integrity teams should conduct an audit of any outpatient account who utilized remdesivir from dates of service December 23, 2021 to rebill accounts when used in accordance to the NIH guidelines. Revenue Integrity and Billing teams should monitor claims to ensure claim processing software at the MAC is accepting the new remdesivir code and may consider holding claims until they process cleanly. Billing teams should ensure that for dates of service Covid-19 vaccines and monoclonal antibody infusions prior to 2022 were billed to the Original Medicare for payment. Claims logic should be undone to allow for the traditional billing to both MA and Original Medicare. Our goal is simple; we’re taking complex information and making it practical. Until our next edition, this is Maxie Friemel and Agatha Nolen providing you with tips for increasing your Pharmacy Revenue. /episode/index/show/87d4129a-590b-43bb-a0af-5ff85eec4eed/id/21998141

Pegfilgrastim: Dose Change with New HCPCS Code 01/11/2022

Sequestration Suspension Extended: Impact on Drug Reimbursement 01/04/2022

Sequestration Suspension Extended: Impact on Drug Reimbursement Pharmacy departments may periodically be asked to compare drug payment with cost, particularly when expensive drugs are utilized on outpatients. It is also important to calculate anticipated revenue when preparing annual budgets. The ASP (Average Sales Price) file is published by CMS each quarter and can be used to verify payment for Medicare outpatients or commercial contracts which pay based upon Medicare payment. It sounds straightforward, but there is a catch: “sequestration”. Sequestration is the automatic reduction of federal spending originally established by Congress in the Balanced Budget and Emergency Deficit Control Act of 1985 (BBEDCA, also known as the Gramm-Rudman-Hollings Act). This applies to most areas of the federal budget but was first “triggered” for Medicare in FY2013 resulting in a 2% reduction in Medicare payments to providers over stated payment rates. This 2% reduction has continued each fiscal year until the pandemic when the sequestration was “suspended” meaning there is no current payment reduction and provided receive the full payment. The was signed into law on December 10, 2021 and extends the suspension through March 31, 2022. However, the sequestration will be gradually applied once the extension expires. From April 1, 2022 through June 30, 2022, the payment adjustment will be 1% and effective July 1, 2022, the payment adjustment shall return to the 2% for all Medicare Fee-for-service claims. Any changes to this reinstatement would require further Congressional action. Because Medicare beneficiary co-payments are not subject to the payment reduction, they continue to pay the same co-payment amounts regardless of sequestration. Here’s a formula to use when the “sequestration” suspension begins to expire on April 1, 2022: ((Payment rate-copayment)*0.99)+ copayment Let’s take a drug example from January 2022. Using Addendum B, we see the following: Since Addendum B doesn’t have the dose description for this HCPCS code, we can find that information on the ASP file for the quarter: Denosumab, J0897 has a payment limit of $21.205 per 1 mg effective January 1, 2022 from the ASP file. Calculating the new payment rate when subject to a 1% sequestration results in the following: (($21.205-$4.25)*0.99) + $4.25 = $21.035 For a 60 mg dose, the payment difference is $10.173 (($21.205-$21.035)*60)) Note: The rates reflected in Addendum B are “unadjusted copayments” and these co-pay amounts may be different for different providers based upon geographic adjustments. SHOUT- OUTS Pharmacy and Finance should take into consideration if there is a payment “sequestration” triggered when projecting budgets and business plans especially for expensive drugs used on outpatients. Pharmacy and Finance should be aware of congressional actions which may impact drug payments. Our goal is simple; we’re taking complex information and making it practical. Until our next edition, this is Maxie Friemel and Agatha Nolen providing you with tips for increasing your Pharmacy Revenue. /episode/index/show/87d4129a-590b-43bb-a0af-5ff85eec4eed/id/21998087

Connecting the Dots: Pharmacy Involvement in Revenue Cycle 12/28/2021

Connecting the Dots: Pharmacy Involvement in Revenue Cycle It may seem like unnecessary work to review the items on our each quarter to identify changes and updates. Some tasks may be delegated to other groups such as Chargemaster Managers or Billers, but for one task, pharmacy is the best department to “connect the dots”: Restated Payment Rates. Our “action to take” recommendation is: “Map restated payments to the effective quarter, determine impact, and rebill as necessary.” We believe that the pharmacy department is in the best position to take this action and in some cases, increase pharmacy revenue. Let’s walk through an example in more depth. As noted on our Quarterly Checklist, CMS posts “” each quarter. For January 2022, the file has this information: Here are the steps to process this file to determine impact: 1. Review Addendum B for the appropriate quarter to determine what the posted payment rate was. Since the “payment” column includes the “copay”, it is only necessary to add the payment column from the previous quarter. 2. Calculate the payment difference. 3. Add the “short descriptor” from Addendum B to determine the HCPCS code dose amount. 4. If the “short descriptor” from Addendum B does not include the HCPCS code dose amount, go to the on the HCPCS Quarterly Update page to retrieve the “long description”. Use the HCPCYYYY_MMM_ANWEB_vN.xlsx file. 5. Add prescribing information and calculate the average adult dose using 100 kg or 3M2 for BSA. For every 3 week regimens use 5 potential doses; for every 4 week regimens use 4 potential doses (assumes patient received first dose on first day of quarter). 6. Calculate the average payment difference for one quarter for one patient to determine financial impact of restated rates. In consultation with the Finance Department, Pharmacies should establish policies as to which payment difference amounts are “significant” to determine rebill potential. (In our example for January 2022, some providers would consider the $1320.00 to be significant and review accounts with HCPCS code J9353) 7. When rebill thresholds are met, Pharmacy should estimate the total change in revenue based upon actual patient usage and review potential rebills for the quarter with Finance to obtain authorization for rebilling. (Timely filing for Medicare is one year from date of service but rebills should be generated as soon as authorized). 8. Managed Care Contracting group should be notified to determine if any managed care contract payments are based upon Medicare rates and if rebilling of any commercial/Medicare advantage accounts is warranted. 9. Your completed analysis for finance review will look like this: SHOUT-OUTS 1. The Department of Pharmacy is in the best position to evaluate restated payment rates for drugs each quarter and provide information to Finance for potential rebilling opportunities. 2. The Finance Department should determine in advance a “payment threshold difference” which is considered “significant” to warrant further investigation into rebilling opportunities. 3. The Managed Care Contracting group should be notified if any HCPCS codes are selected to be rebilled to determine if any Commercial/Medicare Advantage payments are similarly impacted and to determine if those accounts should similarly be rebilled. Our goal is simple; we’re taking complex information and making it practical. Until our next edition, this is Maxie Friemel and Agatha Nolen providing you with tips for increasing your Pharmacy Revenue. /episode/index/show/87d4129a-590b-43bb-a0af-5ff85eec4eed/id/21998069

End of Year Checklist for New Codes 12/21/2021

Everything's made up and the points don't matter. The points are like setting hospital drug charges. 12/14/2021

Everything's made up and the points don't matter. The points are like setting hospital drug charges. Have you ever thought the pharmacy charge structure could have been an intro to the Drew Carey Whose Line Is It Anyway? Well, that may be what most people think, but with the new price transparency regulations that are being pushed forward, understanding how the drug charges are set and optimizing the charge structure is more important now than ever. CMS cannot dictate how much a provider charges, which leaves little guidance for hospitals. This edition will walk through at high level some strategies to consider when establishing the pharmacy markup structures. First and foremost! Charge enough so that the payer negotiated rate covers your actual acquisition cost. This may be a no-brainer, but is a common pitfall. Payer negotiated contracts should be taken into consideration when evaluating if the charge will recoup the cost. Take a deeper look at this simple example: Payer negotiated rate: 20% of charge Drug Cost: $1,000 Drug Markup: 1.5 x cost Gross Charge: $1,500 Reimbursement: $300 This is also true when charged at a flat fee schedule rate to ensure the charge is greater than the fee schedule. If charge is submitted less then the fee schedule, likely you will receive the lesser of the charge or fee schedule rate. This would be dependent on contract language, but emphasizes the importance of understanding payer contracts when evaluating pharmacy charge structure. Second, keep your strategy simple and justifiable. Markup structures range in complexity from very simple flat markups on cost to multi-cost tiers based on selected drug categories or methods. There are typically some basic elements to most charge structures. If not a straight markup, generally there are some form of categories or methods that drive drugs to selected markup formulas. Then, a base cost is selected (e.g. actual cost, WAC, AWP) and applied markup +/- additional fee. The multiple NDC, prices and dosages can all impact the charge for a similar drug. Drug categories or methods should be defined in a manner that can be consistently applied by all pharmacists, technicians or analysts who may build and maintain pharmacy charge records. Utilize a cost basis that is easily updated and preferably can be an automated process. Various wholesalers and EHR define units of measures differently and can lead to an over or underinflated charge. For example, you may purchase a bottle of 100 tablets as 1 each and dispense each tablet. Ensure you validate the “each” price in the EHR calculates that correct charge based on what is dispensed. Third, implement a routine maintenance process to ensure base cost is current. Updates or changes to the pharmacy markup structure should be a coordinated effort with the entities chargemaster and finance team. Small changes in drug markups may have large impacts on the hospital's overall gross charge increase. Shout Outs! Review and understand drug markup structure and processes to ensure it is contemporary and definsable. Keep methodology and markup formulas simple. Updating pharmacy markup structures is a large undertaking and should be coordinated with the entity's entire chargemaster charge updates. Our goal is simple; we’re taking complex information and making it practical. Until our next edition, this is Maxie Friemel and Agatha Nolen providing you with tips for increasing your Pharmacy Revenue. /episode/index/show/87d4129a-590b-43bb-a0af-5ff85eec4eed/id/21998027

Dietary Supplements: Billing Pitfalls to Avoid 12/06/2021

Dietary Supplements: Billing Pitfalls to Avoid Hospital pharmacies often carry and dispense dietary supplements and herbal products in order to maintain a patient on their home regimens. Pharmacies may determine which dietary supplements and herbal products they carry based upon patient needs and internal policies, but they can’t be billed as a drug. What does that mean? Just like , dietary supplements and herbal products may be supplied by the pharmacy, but it is important that they NOT be billed as a drug as only drugs and biologicals are billed with revenue codes 25x (250-259) and 63x (631-637). It is important that these products NOT be set up in chargemasters under a 259 or 637 revenue code as these revenue codes are reserved for “self-administered drugs”. Since dietary supplements are not drugs, they can’t be billed as a self-administered drug and billed to a Medicare outpatient. Typically, facilities choose one of two options for billing and coding of dietary supplements and herbal products: Consider them as “supplies” and bill them with revenue code 27x, or Consider them as “nutritional supplements” including the cost in other services such as room and board on inpatients or within procedure charges for outpatients. A separate charge is not generated for this option. As we mentioned in our previous on medical devices, revenue codes are established by the National Uniform Billing Committee (NUBC) and they provide instructions on how they are to be used. All providers must follow the applicable rules from NUBC in billing for healthcare services. How can I tell if a product is a dietary supplement? There isn’t a comprehensive database like there is with drugs and the FDA NDC Directory. The easiest way is to look at the package (or Google an image) as these products must be clearly labelled as “dietary supplements”. Dietary supplements are prohibited from having an NDC number, so any 10- or 11-digit number on the package is for tracking only, and is not an NDC number. SHOUT-OUTS! 1. Pharmacy and Chargemaster Managers should review chargemaster entries to ensure that dietary supplements and herbal products are not billed with “pharmacy” revenue codes (i.e. 259 or 637) 2. Pharmacy should confirm that the set-up process for a new product includes checking to see if the product is a prescription or O-T-C drug, a medical device, a dietary supplement, or an herbal product. Only drugs and biologicals can be billed with pharmacy revenue codes such as 25x and 63x. 3. Pharmacy and Finance should determine if the facility will bill separately for non-drug products under a supply revenue code, 27x, or if they will not be billed separately and the cost will be included in charges for room and board or other procedures. Dietary supplements and herbal products are not drugs, and therefore cannot be billed to the patient as a self-administered drug with revenue code 259 or 637. Our goal is simple; we’re taking complex information and making it practical. Until our next edition, this is Maxie Friemel and Agatha Nolen providing you with tips for increasing your Pharmacy Revenue. /episode/index/show/87d4129a-590b-43bb-a0af-5ff85eec4eed/id/21998000

The Basics of Critical Access Hospitals (CAHs) 11/29/2021

The Basics of Critical Access Hospitals (CAHs) A reader inquired about Critical Access Hospitals (CAH), so we have put together a few items that pertain to the intricacies of CAHs and how they differ from the Hospital Outpatient/Inpatient Departments. are located in rural areas of a State that has established a Medicare rural hospital flexibility program, or located in a Metropolitan Statistical Area (MSA) that is treated as being located in a rural area based on law or regulation of the State. It is required to be more than a 35-mile drive from any other hospital or “necessary provider”. If located in mountainous terrain or areas with only secondary roads, the CAH is only required to be 15 miles from another necessary provider. Additional eligibility criteria include: Must provide 24-hour emergency care No more than 25 beds for acute inpatient care or skilled nursing facility swing beds Maintain an annual average length of stay of no longer than 96 hours Must be certified by CMS and required to meet the conditions of participations for CAH The first call out pertaining to CAH, is they are not reimbursed utilizing the inpatient prospective payment system (IPPS) or the outpatient prospective payment system (OPPS). The following reimbursement rules do not apply: The lesser of cost or charges rule Ceilings on hospital operating costs The reasonable compensation equivalent limits for physician services to hospitals 1- and 3- day payment window provisions. In other words, outpatient services provided within the 1- and 3- day payment window will continue to be paid as an outpatient service rather than bundled on the inpatient claim. Inpatient is based upon 101% of reasonable cost or some MACs may pay on a per diem rate. Outpatient payment can be made using one of two methods. Method I (standard option) in which professional services are billed to Part B and reimbursement is 101% of reasonable cost less the deductible and coinsurance amounts. CAHs have the option to elect an alternative payment method or Method II (optional) when professional services are billed to Part A. Payment is the sum of the 101% of the reasonable cost of the facility services and 115% of the Medicare Physician Fee Schedule (MPFS) for professional services, less any deductible or coinsurance. Refer to the respective MAC regarding billing guidance. CAH, while generally 340B eligible, are not required to report the TB or JG modifiers as we have discussed in a previous . CAH are not subject to regulations of the HOPPS; thus, regardless of payment methods chosen, they are not subject to the ASP reduction. Shout Outs! Health systems big or small should understand the differences and regulations when billing CAH from other hospital or physician departments. Our goal is simple; we’re taking complex information and making it practical. Until our next edition, this is Maxie Friemel and Agatha Nolen providing you with tips for increasing your Pharmacy Revenue. /episode/index/show/87d4129a-590b-43bb-a0af-5ff85eec4eed/id/21997964

Top 5 Newsletters and NEWS 11/22/2021

Medical Devices: Billing Pitfalls to Avoid 11/15/2021

Medical Devices: Billing Pitfalls to Avoid Hospital pharmacies often carry and dispense medical devices in order to administer medications, or as part of a package for operating room cases. Pharmacies may determine which medical devices they carry based upon patient needs, but they can’t be billed as a drug. What does that mean? The (NUBC) was formed in 1975 to develop and maintain a single billing form and standard data set to be used nationwide by institutional, private and public providers and payers for handling health care claims. Therefore, the Committee is responsible for establishing revenue codes that are used on hospital claims. Drugs and biologicals are billed with revenue codes 25x (250-259) and 63x (631-637). Special revenue codes have been developed for diagnostic and therapeutic radiopharmaceuticals (343/344) and Car T-cell therapy/gene therapy (891/892). Products which are NOT approved under the FDA’s drug and biological pathways are typically billed as a supply with revenue code 27x. Drugs and Biologics The pharmacy revenue codes are used to bill for drugs and biologics and include both prescription drugs and O-T-C drugs that have approval from the FDA and are listed in the (which is updated daily). They also can be distinguished as entries often include an NDA/ANDA/BLA tag which indicates under which drug or biological pathway the products were approved. Often package inserts are available on the ebsite that contains the necessary information. Medical Devices Medical Devices may include drugs within the device, but if the primary action of the product is due to the device and not the drug, it is labelled as a device rather than a drug. One common example is pre-filled heparin flush syringes of 1ml, 2 ml and 5 ml which are labelled as devices. However, products from Fresenius Kabi, Hospira, Baxter, and B. Braun which contain 200 units of heparin per 100 ml are all labeled as drugs (and approved under NDA/ANDAs). Other medical devices that may be dispensed by the hospital pharmacy include viscoelastics ( and and nd . Other items that are used in the OR may appear similar but are approved as drugs or biologicals: , and By now you are probably asking: “So, I can go to the FDA NDC Directory, or DAILYMED to verify a product was approved under an NDA/ANDA or BLA, but where is a comprehensive list of all products labelled as a “device”? Unfortunately, the answer is, “There isn’t a list.” Medical Devices have a limited approval pathway and range from simple tongue depressors and hospital gowns to complex programmable pacemakers and robotic surgical systems. The FDA maintains the ver 6,000 types of medical devices regulated by FDA's Center for Medical Devices and Radiological Health (CDRH) and the classification assigned to each type. You can search the FDA often doesn’t return information unless the exact product name is searched. One of the best sources of information is the product itself where the package or package insert will often identify that it is a “device”. Why is this important? A product that is not a drug or biological cannot have a National Drug Code (NDC) number assigned. Payers who require an NDC number will often examine claim lines in revenue code 250 or 636 and require an NDC number. If non-drugs are reported in these revenue codes, 11-digit numbers reported are flagged as “invalid” and the entire claim may be rejected. Conversely, products labeled as drugs or biological should be reported in revenue codes 25x or 63x as managed care contracts often contain language for additional reimbursement for products appropriately reported in revenue code 636. Reporting these drugs/biologicals in a supply revenue code such as 270 may result in loss of revenue. SHOUT-OUTS! 1. Pharmacy Chargemasters should be reviewed to ensure that only products labelled as drugs or biologicals are reported in pharmacy revenue codes, i.e. 25x and 63x. Products which are dispensed from the pharmacy, but labelled as devices should be reported in a supply revenue code such as 27x. 2. Claim rejections or line item rejections with a reason of “invalid NDC” should be reviewed to determine if the charges being rejected are for products labelled as medical devices. If so, the revenue code should be corrected to reflect that they are not drugs. 3. As products are reviewed or new products received, the FDA NDC Directory can be used to verify the product by the “11-digit” number. Package inserts in DAILYMED can also be used to determine the approval status. If not found in the FDA NDC Directory or DAILYMED, the FDA 501(k) Database should be consulted. Once received, the product or product insert will also contain the information distinguishing between drugs, biologicals, and medical devices. Our goal is simple; we’re taking complex information and making it practical. Until our next edition, this is Maxie Friemel and Agatha Nolen providing you with tips for increasing your Pharmacy Revenue. /episode/index/show/87d4129a-590b-43bb-a0af-5ff85eec4eed/id/21997922

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