Lidocaine shortage, FDA biosimilar approval, cyber-attacks, Physician Compare updates, dermal filler approval, MIPS virtual group deadline, and antiseptic ban. View this email in your browser
Dermatology World Weekly
December 20, 2017
Dermatology World Weekly will not be published next week. It will return on Wednesday, Jan. 3. Happy New Year!
Lidocaine added to FDA drug shortage list

Lidocaine hydrochloride (Xylocaine) injection has been added to the FDA drug shortage list. Currently, sodium bicarbonate and lidocaine hydrochloride injection with epinephrine are also in shortage. The American Academy of Dermatology Association (AADA) recently sent a letter to the Federal Trade Commission (FTC) on increasing drug access and promoting innovation. Specifically, the AADA requested that the FTC institute a main point of contact for national drug shortages. Additionally, the AADA called on the FTC to monitor generic drug prices before and after a shortage, and to analyze whether there are any market trends leading to an increase in drug shortages. The AADA will continue to monitor the situation and report on updates as they become available. If affected by this shortage, members may wish to consult the Academy’s guidelines for other options. Physicians are also encouraged to check the FDA drug shortage website for updates on availability of lidocaine hydrochloride injection.

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FDA approves three dermatology drugs

It was a busy week for the U.S. Food and Drug Administration (FDA). The agency approved ozenoxacin cream 1% (Xepi Cream) for impetigo in patients two months and older. The topical antimicrobial drug is approved for applications to the skin twice daily for five days. Additionally, the FDA approved Eskata™ (hydrogen peroxide) topical solution, 40% (w/w) for the treatment of raised seborrheic keratosis (SKs). According to the manufacturer’s website, the solution is the only FDA-approved topical and non-invasive treatment for raised SKs. The FDA also approved infliximab-qbtx (Ixifi) — the third approved biosimilar for Remicade — for several conditions including plaque psoriasis. It is the sixth biosimilar approved for psoriasis, following infliximab-dyyb (Inflectra) and infliximab-abda (Renflexis) for Remicade, adalimumab-atto (Amjevita) and adalimumab-adbm (Cyltezo) for Humira, and etanercept-szzs (Erelzi) for Enbrel.

As more revolutionary biologic treatments come on the scene, the medical world has been hailing biosimilars as a potentially cheaper treatment option for many conditions. However, will patent challenges delay the promise of price reductions? Read more in Dermatology World.

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Victim of a cyber-attack? You’re not alone.

About 83% of physicians in the United States report having been the victim of some type of cybersecurity attack. A survey conducted by Accenture and the American Medical Association found that 64% of these physicians experienced up to four hours of downtime due to the attack, and 29% of physicians in a medium-sized practice setting indicated that they experienced almost a full day of down time.

How safe is your information? Read more about how to protect yourself and your practice from a cybersecurity breach in this month’s issue of Dermatology World. Also, check out the Academy’s Guide to HIPAA and HITECH for Dermatology Manual and learn more about the steps you need to take to protect your patient data and avoid a breach. In addition, stay tuned for the February issue of Dermatology World that will discuss how to protect your patients’ data from hacking attempts.

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CMS adds new quality data to Physician Compare

The Centers for Medicare and Medicaid Services (CMS) has added new quality information to the Physician Compare website ― an online tool that allows patients to search for and compare Medicare physicians. According to CMS, the measures that are now available on provider profile pages include “a subset of 2016 Physician Quality Reporting System (PQRS) measures reported as star ratings; Consumer Assessment of Healthcare Providers and Systems (CAHPS) for PQRS summary survey measures; and/or non-PQRS Qualified Clinical Data Registry (QCDR) measures.” The information that is now available in the agency’s downloadable database include, 2016 PQRS measures, CAHPS for PQRS summary survey measures, and non-PQRS QCDR measures for groups, and 2016 PQRS and non-PQRS QCDR measures, and 2015 utilization data for individual providers. The 2016 PQRS performance categories include Preventive care – general health; Preventive care – cancer screening; Patient safety; Care planning; Diabetes; Heart disease; Respiratory diseases; and Behavioral health.

Patients, payers, and purchasers all want data about the value of provider care, but the definition of value may differ between stakeholders. Many dermatologists have called for renewed efforts to develop broad-based value measurement. Read more about how broad-based measures help dermatologists demonstrate their value in Dermatology World.

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New dermal filler gets the green light

The U.S. Food and Drug Administration (FDA) has approved Revanesse Ultra to be marketed in the United States for the treatment of nasolabial folds in patients older than 22. The filler is an injectable gel that “consists of crosslinked hyaluronic acid (HA) made by Streptococcus bacteria.” Take a look at what's shaping up in cosmetic dermatology in DW’s special focus issue on fat.

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Deadline for MIPS ‘virtual group’ election period is Dec. 31

The election period to form a Merit-based Incentive Payment System (MIPS) virtual group will close on Dec. 31. Through these virtual groups, solo and small practices have the option to join together and report on MIPS requirements as a collective entity for the 2018 performance period. To learn more, download CMS’s 2018 Virtual Groups Toolkit.

Are you ready for MIPS? Read more about what steps you can take to avoid a penalty in this month’s issue of Dermatology World. Also, check out the Academy’s MACRA Resource Center for more information.

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OTC antiseptic products to be banned

The FDA has issued a final rule that bans the marketing of over-the-counter antiseptic products that contain triclosan and several other ingredients, as the agency has deemed these ingredients not generally recognized as safe and effective (GRASE). Products that contain these ingredients, such as hand washes and rubs, surgical hand scrubs and rubs, and antiseptic skin products, will now need to undergo premarket review and file a New Drug Application. Manufacturers have one year to remove or reformulate the products.

While many adverse events are beyond physician control, preparing for the worst-case scenario can help. Read more in Dermatology World.

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Links to this month's issue

Employee vs. Employer
Last-minute MIPS!
Predatory practices
Residency shortage





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