The Heavy Hitters for July Quarterly Updates
Pharmacy Revenue Cycle Podcast
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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Beat Inflation with a Part B Rebate
Pharmacy Revenue Cycle Podcast
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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Don’t be “SAD”... An Alternative Way to Handle Self-Administered Drugs
Pharmacy Revenue Cycle Podcast
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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Botulinum toxin PA – Are you exempt?
Pharmacy Revenue Cycle Podcast
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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Designer HCPCS Codes are in the Mainstream Spotlight
Pharmacy Revenue Cycle Podcast
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 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...
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Hospital Outpatient Prospective Payment System (OPPS) Final Rule- CY2023
Pharmacy Revenue Cycle Podcast
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....
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Drug Waste is Packed with a Punch and a Refund
Pharmacy Revenue Cycle Podcast
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 Revenue Cycle Podcast
Payment Increases for Biosimilars 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...
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Car T-cell Therapy: Coverage and Billing-Outpatient (Updated – October 1, 2022)
Pharmacy Revenue Cycle Podcast
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...
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Vacating the 340B Payment Reduction Policy
Pharmacy Revenue Cycle Podcast
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...
info_outlineOn 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.
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Until our next edition, this is Maxie Friemel and Agatha Nolen providing you with tips for increasing your Pharmacy Revenue.