Risk Management and Compliance

As of Friday October 18th, 2019, Allergan reached out to surgeons to inform them that unused XEN 45 devices are on hold in the U.S. and globally. Consequently, the Company recommended surgeons postpone any upcoming surgeries using XEN and not implant any unused XEN devices currently in their practice/office/surgical suite/OR. Since then, Allergan has voluntarily recalled all lots of XEN® Glaucoma Treatment System (XEN® 45 Gel Stent preloaded into a XEN® Injector).

Is your practice coding for maximum reimbursement and staying compliant on legal and regulatory issues? ASOA can help!

Developed in partnership with BSM Consulting and Arnold & Porter, these resources provide education on what you need to know:

If you are unable to view the video above, you can access it via Youtube here: https://youtu.be/_Rl2GXBwazw

FDA Recall: RXQ Compounding Issues Voluntary Nationwide Recall of All Sterile Products within Expiry

RXQ Compounding is voluntarily recalling all sterile human drug products within expiry to the user level due to lack of sterility process assurance associated with the production of the company’s sterile products. In addition, RXQ is voluntarily ceasing all sterile production at its current location as RXQ transitions into the company's new outsourcing facility.

The data submission period for the 2018 Merit-Based Incentive Payment System (MIPS) closed on April 2. If you submitted data through the Quality Payment Program (QPP) website, you can review your preliminary performance feedback data.

Please note, this does not include information on the Cost category. Additionally, between now and June 30, your score could change based on:

The U.S. Food and Drug Administration is alerting healthcare professionals and patients not to use drug products intended to be sterile that are produced and distributed by Pharm D Solutions LLC, Houston, Texas, due to lack of sterility assurance.

ASCRS•ASOA has updated the Medicare Participation Kit for 2019 to help members make decisions about their participation in Medicare. The kit provides details about Medicare in 2019, such as the 0.25% update factor, which was reduced from the MACRA-instituted 0.5% level as an offset for the Bipartisan Budget Act. In addition, the kit outlines the three options for Medicare participation: participating provider, non-participating provider, and private contracting.

ASCRS•ASOA members have exclusive access to a new overview guide of the 2019 QPP, which includes MIPS and Advanced Alternative Payment Models (APM) and impacts 2021 payments.

CMS has announced it is eliminating an existing prohibition for MA plans to use a cost containment strategy known as “step therapy” for drugs administered in the physician’s office or facility. Step therapy requires physicians to prescribe an insurer’s preferred treatment first, and only covers more expensive treatments if the patient does not respond to the initial treatment.

CMS has released 2017 MIPS feedback reports, which include information on 2019 payment adjustments. You must log into the Quality Payment Program (QPP) site to access the report. CMS will not distribute the reports through email or U.S. mail. Log into your portal on the QPP site using your Enterprise Identity Management (EIDM) credentials.

As of this week, all Medicare Administrative Contractors (MAC) secure portals Medicare Beneficiary Identifier (MBI) look-up tools are available for use. This tool is used to look up MBIs for Medicare patients when they have lost or do not have their Medicare card. To access the tool, you will need to sign up for your MAC’s portal.

The American Society of Cataract and Refractive Surgery (ASCRS), the American Academy of Ophthalmology (AAO), and the Outpatient Ophthalmic Surgery Society (OOSS) have released new specialty-specific guidelines for the sterile processing of ophthalmic surgical instruments. This document makes evidence-based recommendations regarding issues that may be unique to the cleaning and sterilization of intraocular instrumentation.

Recent advocacy by ASCRS•ASOA and the medical community has prompted Congress to enact technical corrections to the MACRA statute last week. These changes mean that physicians and practices will have additional time to implement the MIPS program and will be able to succeed in the coming years.

New MIPS Resources: 2018 MIPS Small Practice Guide; EyeTalks Podcast on Key Changes to MIPS for 2018 and New Details on the Four MIPS Categories