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_outlinePharmacy 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:
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When a Medicare item or service isn’t reasonable and necessary
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When providing custodial care
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Experimental and investigational or considered research only
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Before providing preventative care that is usually covered but won’t be covered in specific situations in which it exceeds the frequency limits
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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!
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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.
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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.
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It is important to understand when it is required, voluntary and prohibited to issue an ABN to a Medicare beneficiary.
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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.