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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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 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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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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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 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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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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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_outlineIt 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.
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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.
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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.
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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.
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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.
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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!
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Revenue cycle teams should review denials to understand the root cause and submit a corrected claim (if applicable) prior to initiating an appeal.
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Pharmacy teams should be involved in the appeal process to assist with providing clinical justification for a denied drug.
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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]