ParaRev Weekly eJournal, March 22, 2023

On March 9, 2023, the U S Food and Drug Administration issued revised regulations for mammography. Effective September 10, 2024, mammography centers must inform patients about their breast density. The FDA has also enhanced its supervision and enforcement of these facilities and is assisting radiologists in accurately evaluating and categorizing mammograms. https://public-inspection.federalregister.gov/2023-04550.pdf

These regulations were issued under the Mammography Quality Standards Act (MQSA) of 1992 The MQSA oversees accreditation, certification, annual inspections, and enforcement of standards for mammography facilities

Dense breast tissue lowers the sensitivity of mammography studies Notifying patients of their breast density will offer additional information regarding the potential limitations of their mammogram results It will also allow patients and their healthcare providers to make informed decisions about ordering additional tests and discuss their individual risk for breast cancer.

The MQSA Final Rule outlines the specific requirements for reporting breast density and the standardized language which should be used The above amendments to MQSA must be implemented within 18 months (by September 10, 2024). According to the FDA, these new regulations will improve the examination of mammography practices and the exchange of information with patients and providers

At least 1 2 million adults in the U S live with severe or profound hearing loss ? a level of impairment that isn? t sufficiently corrected with hearing aids. There are a number of other devices that can aid in the improvement of hearing in the appropriate patient Among these devices are cochlear implants Cochlear implants bypass nonfunctional or missing cochlear hair cells and directly stimulate the surviving cells of the distal cochlear nerve. There are various cochlear implants available commercially.

Effective September 16, 2022, the expanded coverage applies to treatment of bilateral pre- or post-linguistic, sensorineural, moderate-to-profound hearing loss in people who demonstrate limited benefit from amplification as defined by test scores of less than or equal to 60%correct in the best-aided listening condition on recorded tests of open-set sentence recognition.

CMSmay provide coverage of cochlear implants for patients not meeting this coverage criteria when performed in the context of FDA-approved category B investigational device exemption clinical trials as defined at 42 CFR405 201 or as a routine cost in clinical trials under Section 310.1 of the NCD Manual titled, ?Routine Costs in Clinical Trials ?

Billing and Coding Requirements

The billing requirements for expanded coverage of cochlear implantation effective for dates of service on or after September 26, 2022, are in the revised Chapter 32, Section 100 of the Medicare Claims Processing Manual, attached to CR 13073

Details can be found in the MedLearn here

NATIONAL COVERAGEDETERMINATION: COCHLEARIMPLANT

According to an MLN Fact Sheet published in December, 2022, Medicare will require all 340(B) entities, including Critical Access Hospitals, which submit claims for separately payable Part B drugs and biologicals to report modifier ?JG?or ?TB?on claim lines for drugs acquired through the 340(B) discount program.

The MLN is available at the following website:

www cms gov/files/document/mln4800856-medicare-part-b-inflation-rebate-guidance-use340b-modifier pdf

ALL FACILITIESREQUIRED TO REPORT340B MODIFIERSIN 2024

This is a substantial change from the original 340B billing requirement Previously, Critical Access Hospitals and Maryland All-Payer or Total Cost of Care Model hospitals were not required to report a modifier on 340(B) drugs. CMSissued a companion ?FAQ?document which reiterates this point:

https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/ Downloads/Billing-340B-Modifiers-under-Hospital-OPPS.pdf

ALL FACILITIESREQUIRED TO REPORT340B MODIFIERSIN 2024

The FAQ document provides a table summarizing the requirement for affected provider types:

The modifier requirement does not apply to all drugs purchased under 340(B), although hospitals may opt to report the modifier for all 340B drugs. The obligation to append a modifier applies to only Part B drugs and biologicals assigned OPPSStatus Indicator G or K(?separately payable?under OPPS.)

PARA Dat a Edit or users may identify the line items within the hospital charge master which are separately payable drugs by navigating to the ?Filters?tab, clicking the checkbox next to ?Status Indicator?, and clicking on both status G and status K, as illustrated below:

PARA invit es you t o check out t he m lnconnect s page available from t he Cent ers For Medicare and Medicaid (CMS). It 's chock full of new s and inform at ion, t raining opport unit ies, event s and m ore! Each w eek PARA w ill bring you t he lat est new s and links t o available resources. Click each link for t he PDF!

Thursday, March 16, 2023

New s

- HHSReleases Initial Guidance for Historic Medicare Drug Price Negotiation Program for Price Applicability Year 2026

- Quality Payment Program: 2021 Care Compare Performance Information

- Short-Term Acute Care Hospitals: Program for Evaluating Payment Patterns

Electronic Reports

- Skilled Nursing Facility Value-Based Purchasing Program: March Feedback Report

- Audiologists Can Furnish Certain Diagnostic Tests Without a Physician Order

- Colorectal Cancer: Screening Saves Lives

Claim s, Pricers, & Codes

- COVID-19: Don? t Report CRModifier & DRCondition Code After Public Health Emergency

- Split (or Shared) Critical Care Visits: Billing Correction

- ICD-10 Coordination & Maintenance Committee: Meeting Materials &

Deadlines

t r ans mit t al s

Therew ereEIGHT new or revised Transmittalsreleased thisw eek.

To go to thefull Transmittal document simply click on thescreen shot or thelink.

TRANSMITTAL R11912OTN

TRANSMITTAL R11905BP

TRANSMITTAL R11903CP

TRANSMITTAL R11902CP

TRANSMITTAL R11901BP

TRANSMITTAL R11910CP

TRANSMITTAL R11909CP

TRANSMITTAL R11904OTN

1 m edl ear ns

Therew asONEnew or revised MedLearnsreleased thisw eek.

To go to thefull Transmittal document simply click on thescreen shot or thelink.

Theprecedingmaterialsare for instructional purposesonly. Theinformation ispresented "as-is"and to the best of ParaRev?s knowledgeisaccurate at thetime of distribution. However, dueto theever changing legal/regulatorylandscapethisinformation issubject to modification, asstatutes/laws/regulationsor other updatesbecomeavailable.

Nothingherein constitutes, isintended to constitute, or should berelied on as, legal advice ParaRev expressly disclaimsanyresponsibilityfor anydirect or consequential damagesrelated in anywayto anythingcontained in thematerials, which areprovided on an ?as-is?basisand should beindependentlyverified beforebeing applied.

You expresslyaccept and agree to thisabsoluteand unqualified disclaimer of liability.Theinformation in this document isconfidential and proprietaryto ParaRev and isintended onlyfor thenamed recipient. No part of thisdocument maybereproduced or distributed without expresspermission. Permission to reproduce or transmit in anyform or byanymeanselectronicor mechanical, includingpresenting, photocopying, recording and broadcasting, or byanyinformation storageand retrieval system must be obtained in writingfrom ParaRev. Request for permission should be directed to sales@pararevenue.com.

ParaRev is excited to announce we have joined industry leader CorroHealt h to enhance the reach of our offerings! ParaRev services lines are additive in nature strengthening CorroHealt h?s impact to clients?revenue cycle. In addition, you now have access to a robust set of mid-cycle tools and solutions from CorroHealt h that complement ParaRev offerings

In terms of the impact you?ll see, there will be no change to the management or services we provide The shared passion, philosophy and cultures of our organizations makes this exciting news for our team and you, our clients

While you can review the CorroHealt h site HERE, we can coordinate a deeper dive into any of these solutions Simply let us know and we?ll set up a meeting to connect.

As always, we are available to answer any questions you may have regarding this news We thank you for your continued partnership