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Latest Oncology News

LATEST FDA APPROVALS

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FDA approved ado-trastuzumab emtansine (KADCYLA, Genentech, Inc.) for the adjuvant treatment of patients with HER2-positive early breast cancer (EBC) who have residual invasive disease after neoadjuvant taxane and trastuzumab based treatment. May 3, 2019. FDA Announcement: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ado-trastuzumab-emtansine-earlybreast-cancer. KADCYLA was granted breakthrough therapy designation for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual disease after pre-operative systemic treatment. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.  

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ONE WEEK LEFT TO REVIEW/DISPUTE PRE-PUBLICATION CMS OPEN PAYMENTS

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Open Payments is a national disclosure program that promotes a more transparent and accountable health care system by making the financial relationships between applicable manufacturers and group purchasing organizations (GPOs) and health care providers (physicians and teaching hospitals) available to the public. Pre-publication review and dispute for program year 2018 Open Payments data is available through May 15. CMS will publish program year 2018 data and updates to the previous program years’ data in June 2019. Physician and teaching hospital review of the data is voluntary, but strongly encouraged. Resources: • Open Payments website • An audio recording and transcript for the March 13 Medicare Learning Network call on Open Payments: Transparency and You. • Records eligible for review and dispute: All records submitted during the submission period of the current calendar year, including newly edited, submitted, and re-attested records from previous calendar years; See the Physician and Teaching Hospital…

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CMS RELEASES PHYSICIAN FEE SCHEDULE FINAL RULE FOR 2019

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On November 1, 2018, CMS released the CY 2019 Physician Fee Schedule (PFS) rule. In the final rule, CMS postpones most of the documentation and payment changes to evaluation and management (E/M) codes until calendar year (CY) 2021. CY 2019 & 2020 – E/M documentation rules finalized for CY 2019 & 2020 will allow providers to continue to document based on 1995 or 1997 documentation guidelines. Changes to documentation for CY 2019 & CY 2020 include the following: History and Exam – for established patients, providers are only required to focus on what has changed since the last visit or pertinent items that have not changed. Providers must still review prior data, update the information as necessary, and indicate in the medical record that they have done so. Chief Complaint and History – for both new and established patients, practitioners may review and verify the chief complaint and history entered by ancillary staff…

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CMS Releases Proposed 2019 Medicare Physician Fee Schedule Rule

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CMS RELEASES 2019 PROPOSED PHYSICIAN FEE SCHEDULE RULE On Thursday, July 12, CMS released the 2019 Proposed Physician Fee Schedule Rule. Below are a few of the proposed changes of interest to oncologists. https://s3.amazonaws.com/public-inspection.federalregister.gov/2018-14985.pdf Streamlining Evaluation and Management (E/M) Payment and Reducing Clinician Burden In the Proposed Policy, Payment, and Quality Provisions Changes to the Medicare Physician Fee Schedule for Calendar Year 2019 Fact Sheet, CMS states they are proposing to streamline E/M payment through their proposals: • To allow practitioners to choose to document office/outpatient E/M visits using medical decision-making or time instead of applying the current 1995 or 1997 E/M documentation guidelines, or alternatively practitioners could continue using the current framework; • To expand current options by allowing practitioners to use time as the governing factor in selecting visit level and documenting the E/M visit, regardless of whether counseling or care coordination dominate the visit; • To expand…

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SNF SERVICES DENIED IN ERROR TO BE REPROSSED AUTOMATICALLY BY THE MACs

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On March 1, 2018 CMS notified MACs of a Common Working File (CWF) issue causing certain allowable services with dates of service January 1, 2018 through February 27, 2018 to deny incorrectly indicating the service is part of Skilled Nursing Facility (SNF) Consolidated Billing (CB). In some cases overpayment demand letters were issued for claims that were previously paid. The CWF issue was corrected on February 27, 2018. CMS says no provider action is necessary at this time. Affected claims will be reprocessed and recoupment of any money demanded for previously paid claims due to this issue will be halted and/or returned to providers.

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MEDICALLY UNLIKELY EDIT DENIALS REPORTED

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On March 6, Bristol-Myers Squibb announced that the U.S. Food and Drug Administration (FDA) approved a supplemental biologics license application updating the nivolumab (Opdivo®) dosing schedule to include 480 mg infused every four weeks (Q4W). If you are using the new Q4W dosing schedule be aware that HCPCS J9299 nivolumab, 1 mg has a current Medically Unlikely Edit (MUE) value of 440 units. An MUE for a HCPCS/CPT code is the maximum units of service that a provider would report under most circumstances for a single beneficiary on a single date of service. MUEs are designed to prevent billing errors by denying items billed above the established number of units. In this case, J9299 would deny for units billed over the established MUE value of 440 (based on previous prescribing information). The MUE files are updated quarterly, in the meantime, MUE denials for J9299 claims of more than 440mgs should…

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