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July 2023 is here and time to validate another round of quarterly updates from CMS. The JZ modifier, in addition to the JW modifier, is now required to effectively bill for drug waste (JW) and to attest when no drug was discarded (JZ) for all separately payable that are single-dose or single-use containers. Additionally, we have updated the Visante Quarterly Update Tool and the C9399 Tool to help organizations validate that their system is up to date with the recent changes.
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As a part of the Inflation Reduction Act of 2022, CMS is requiring manufacture rebates for certain Medicare Part B drugs in which the cost has exceeded inflation. Beneficiaries out of pocket costs will be reduced to 20% of the inflation-adjusted payment described in the Act.
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Self-administered drugs (SAD) have been a long-standing controversy when administered in a hospital outpatient setting from the perspectives of a patient, frontline healthcare workers, and billing. “Why does my Tylenol cost $10 per tablet, but the 1,000-count bottle I have at home was purchased for $3?” This question is often difficult to answer and may lead to unintended operational consequences.
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The new year brings a new focus on resolutions including prior authorization processes. In July 2020, Medicare implemented a prior authorization process for select services including botulinum toxin. Its time to revisit workflow processes and, if not exempt, confirm with respective teams that a prior authorization is obtained prior to providing the service.
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The Pharmacy Revenue Cycle is starting out with a new fashion design for 2023 as there are 36 new brand-specific HCPCS codes. CMS has been reviewing its approach for assigning HCPCS Level II codes for drugs that have been approved under the Food, Drug and Cosmetic Act 505(b)(2) New Drug Application (NDA) or the Biologics License Application (BLA) after October 2003. These drugs are not rated therapeutically equivalent to the reference drug listed in the FDA’s Orange Book and therefore are considered single-source products according to section 1847A(c)(6) of the Social Security Act. Each single source product should be assigned a unique billing and payment code which now includes the brand name in the description to differentiate the HCPCS. Additionally, CMS removes brand names from the HCPCS description when the code is used for multiple source drugs.
In efforts to decrease the use of “not otherwise specified codes” and align with the definitions embedded within the Social Security Act for single and multisource products, CMS plans to continue their review of products that were approved under separate NDA or BLA pathways after October 2003 and are not considered therapeutically equivalent to a listed reference product in an existing code.
Shout Outs!
Pharmacy and revenue integrity teams should ensure their HCPCS codes have been updated to reflect the changes effective 1/1/2023 and be on the lookout for additional brand-specific HCPCS codes in quarterly updates. Pharmacy and IT teams should evaluate their processes to ensure each NDC is matched to the correct HCPCS and that the NDC being administered to the patient is the NDC that is represented on the claim. Don’t forget to check out our updated tools to help you manage your pharmacy revenue cycle! -
The Centers for Medicare & Medicaid Services (CMS) provided the OPPS Final Rule for CY2023 in the Federal Register on November 23, 2022. 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 newsletter and podcast.
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 (page 198 pdf) 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 (pg 202 pdf) 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 (pg 208 pdf) 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 payment increases for biosimilars.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. -
Dive into the CY23 CMS Physician Fee Schedule rule as it relates to the new requirements for discarded drugs or drug waste. A JW and JZ modifier are required for all Part B separately payable single-dose or single-use packages. Additionally, manufacturers are required to pay a refund for discarded drugs that exceed 10% of the total charges.
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Payment Increases for Biosimilars
Pharmacy and Finance Teams - should review your biosimilar strategy and financial models. CMS 2022 Q4 pricing files were uploaded to reflect the 8% temporary price increase. Our goal is simple; we’re taking complex information and making it practical.
On April 16th, 2022, the Inflation Reduction Act of 2022 was signed into law. Section 11403 requires a temporary increase in add-on payment for qualifying biosimilars from 6% to 8% for 5 years. This change was implemented on October 1, 2022, and CMS uploaded pricing files that already include the temporary price increase.
Applicable 5-year period
This increase began on October 1, 2022, for products for which payment was made by September 30, 2022. For other biosimilar products in which payment was made between October 1, 2022 - December 31, 2027, the 5-year period will begin on the first day of such a calendar quarter in which the payment was first made. For example, payments made between October 1, 2022 - December 31, 2022, the 5-year period will begin October 1, 2022, through September 30, 2027.
Qualifying biosimilar
A qualifying biosimilar product is defined as a biosimilar biological product with an ASP that is not more than the ASP of the reference product. Also, a biosimilar biological product ASP during a calendar quarter throughout the 5-year period is not more than the ASP of the reference product for such quarter.
Add on payment
The temporary price increase applies an 8% of the reference product ASP to the ASP of the biosimilar. This applies to separately payable pass-through and non-pass-through status biosimilars in accordance with the OPPS.
Shout Outs
Until our next edition, this is Maxie Friemel and Agatha Nolen providing you with tips for increasing your Pharmacy Revenue Cycle. -
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 list of approved cellular and gene therapies including six that are Car T-cell therapies:
ABECMA (idecabtagene vicleucel)
BREYANZI (lisocabtagene maraleucel)
CARVYKTI (ciltacabtagene autoleucel)
KYMRIAH (tisagenlecleucel)
TECARTUS (brexucabtagene autoleucel)
YESCARTA (axicabtagene ciloleucel)
Coverage
CMS finalized a National Coverage Determination (NCD 110.24) 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 compendiaWhen 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 NCD 310.1.
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 CMS Transmittal #10454- (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.
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On September 28, 2022, the US District Court issued a ruling 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.
CMS 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.
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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.
The New Technology Add-on Payment (NTAP) for Inpatient Claims (FY2023) 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.
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It’s that time of year again when school supplies are purchased and vaccines are updated. Influenza vaccines continue to challenge organizations to ensure each NDC, CVX code and HCPCS code are appropriately mapped in EMRs. We simplify this process with an Influenza Vaccine Billing Tool that can be found on our webpage Pharmacy Revenue Cycle | Visante.
Shout Outs!
Pharmacy and revenue integrity teams ensure the new NDCs are updated for accurate billing. Pharmacy and revenue integrity teams revalidate Sanofi Pasteur's high dose formulation at 0.7 mL versus the traditional 0.5 mL. CPT code 90662 will be used to code the high-dose formulation. Ensure the CDM or billing crosswalks reflect the updated 0.7 mL per billed unit or are based on a per dose and only one billed unit is calculated per dose. Pharmacy and revenue integrity teams CPT 90686 and 90685 differ only by the dosage administered but often represent the same NDC. Validate that your system produces the correct CPT based on the dose administered and only one billed unit per dose. Applying a “dosing” rule that allows the CPT to alternate when a 0.25 mL vs. 0.5 mL dose is documented may be helpful.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. -
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.
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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 administeredFor 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: https://www.fda.gov/drugs/news-events-human-drugs/public-hearing-future-format-national-drug-code https://www.wolterskluwer.com/en/expert-insights/are-you-prepared-for-a-major-industry-change-to-the-national-drug-code-ndc-number
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
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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 list of approved cellular and gene therapies including six that are Car T-cell therapies:
ABECMA (idecabtagene vicleucel)
BREYANZI (lisocabtagene maraleucel)
CARVYKTI (ciltacabtagene autoleucel)
KYMRIAH (tisagenlecleucel)
TECARTUS (brexucabtagene autoleucel)
YESCARTA (axicabtagene ciloleucel)
Coverage
CMS finalized a National Coverage Determination (NCD 110.24) 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 compendiaWhen 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 NCD 310.1.
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 CMS Transmittal #10454- (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.
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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. (Medicare Claims Processing Manual, pg 63).
This C9399 tool includes the generic and brand names, approval dates, manufacturer, and a link to the prescribing information (PI). () 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 on-line application requesting a HCPCS code assignment. Approved codes are posted on the CMS HCPCS Quarterly update 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 January 2017 OPPS update.
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 “Self-Administered Drug” listing from the MAC, and therefore not covered when furnished in a hospital outpatient department. -
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 list of approved cellular and gene therapies including six that are Car T-cell therapies:
ABECMA (idecabtagene vicleucel) BREYANZI (lisocabtagene maraleucel) CARVYKTI (ciltacabtagene autoleucel) KYMRIAH (tisagenlecleucel) TECARTUS (brexucabtagene autoleucel) YESCARTA (axicabtagene ciloleucel)Coverage
CMS finalized a National Coverage Determination (NCD 110.24) 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 NCD 310.1.
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 CMS Transmittal #10454- (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.
Sign up for our Newsletter! Contact Maxie: [email protected] -
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! [email protected]
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On December 28, 2021, the FDA revised the emergency use authorization (EUA) for COVID-19 convalescent plasma with high titers of anti-SARS-CoV-2 antibodies. It is now authorized in both the inpatient and outpatient setting for patient with immunosuppressive disease or getting immunosuppressive treatment.
On February 10, 2022, CMS issued a new HCPCS code, C9507-Fresh frozen plasma, high titer COVID-19 convalescent, frozen within 8 hours of collection, each unit, billable for dates of service on or after December 28, 2021. The CMS payment rate for C9507 is $750.50.
Pharmacies may not purchase or dispense the product but may be involved in reviewing the patient’s record and profiling the convalescent plasma to provide a comprehensive COVD-19 treatment record in the EHR. Although convalescent plasma is not yet approved by the FDA, it can be provided either under the current EUA or an investigational new drug (IND) application. The product is regulated as a biologic under the Center for Biologics Evaluation and Research (CBER) division of the Food and Drug Administration (FDA).
SHOUT-OUTS!1. Pharmacy Departments and Blood Banks should review ordering and dispensing of convalescent plasma to ensure that patients meet all criteria authorized in the EUA and that the product is handled and billed as a biologic with HCPCS code C9507 when administered to outpatients.
2. Revenue Integrity should review all patient records for outpatients who received convalescent plasma on or after December 28, 2021 and consider re-billing claims with the new HCPCS code.
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.
Sign up for our Newsletter!
Have a question? Contact Maxie! [email protected]
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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.
Advance Beneficiary Notice of Noncoverage or ABN 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 here
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 form 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.
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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: https://www.cms.gov/medicare-coverage-database/view/nca.aspx?ncaid=305&bc=0. 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 December 2021, 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 cost and coverage of Aduhelm. On January 10, 2022, Health and Human Services Secretary Xavier Becerra announced that he is instructing the Centers for Medicare & Medicaid Services 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: https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=Y&NCAId=305
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.
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