November 28
IN THIS ISSUE / November 28, 2018
- A biologic for adolescent AD patients: Coming soon?
- MIPS in 2019: Changes are coming
- CMS seeks to implement real-time drug pricing widgets
- FDA attempting to get out ahead of drug shortages
- Help the Academy keep dermatology’s voice strong: Join the AMA
- CMS conducting new survey on post-op visits in global surgical codes
A biologic for adolescent AD patients: Coming soon?
The FDA has granted Priority Review to the supplemental Biologics License Application (sBLA) of dupilumab (Dupixent) to treat moderate-to-severe atopic dermatitis (AD) in adolescent patients 12 to 17 years old. The sBLA is supported by phase 3 trial data indicating that dupilumab significantly improves symptoms in adolescents with moderate-to-severe AD. Read more about the phase 3 findings in DWW. It is estimated that the FDA will reach a decision in March 2019.
How have drugs like dupilumab and crisaborole changed AD treatment? What new AD drugs are on the way? Learn more in Dermatology World.
Related Links:
- Should systemic steroids be avoided in atopic dermatitis? – Dermatology World (July 2018)
- Is atopic dermatitis actually a systemic inflammatory disorder? – Dermatology World (May 2017)
- Playing the angles: New treatments target potential pathways for atopic dermatitis – Dermatology World (December 2017)
- Academy atopic dermatitis clinical guidelines
MIPS in 2019: Changes are coming
CMS has made several changes to the 2019 Merit-based Incentive Payment System (MIPS) as part of the final 2019 Medicare physician fee schedule. While CMS did not finalize any sweeping changes to the program, physicians should be aware of changes to MIPS weights and scoring, the low-volume threshold exemption, and other provisions that will impact reporting in 2019.
Want to be a MIPS high performer in 2019? Find out how in Dermatology World.
CMS seeks to implement real-time drug pricing widget
CMS has issued a proposal that would require Medicare Part D plans to provide a real-time drug price tool by January 2020. This widget would integrate with physicians’ electronic health records or e-prescribing software and would allow physicians to view the real-time price for drugs for specific patients, as well as the price of alternative drugs.
The drug pricing tool was part of a larger proposed rule that would give Medicare Part D and Medicare Advantage plans the option of excluding “protected class” drugs from their formularies when the price of the drug rises more than inflation. For Part D plans, current protected class drugs include antidepressants, antipsychotics, anticonvulsants, immunosuppressants for treatment of transplant rejection, antiretrovirals, and antineoplastics. The proposed rule would also allow more opportunities for health plans to use step-therapy and prior authorization for these protected class drugs.
Although it was not part of the official proposed rule, CMS indicated that it might implement a new policy by 2020 that would require Medicare Part D plans to factor pharmacy price concessions and dispensing fees in patient-cost sharing. This would lower patients’ out-of-pocket costs but is estimated to increase Part D premiums costing the government and taxpayers $13.6 billion to $16.6 billion over 10 years.
What’s happening with drug prices and what's being done to bring costs down? Read more in Dermatology World.
FDA attempting to get out ahead of drug shortages
The FDA stated that it will take new steps to update its inspections program of sterile injectable drug manufacturing facilities in hopes of identifying and resolving sterility problems before shortages occur. The FDA will also expand its inspections of all dosage forms of drugs in the next two years. “With better and more consistent oversight of these manufacturing facilities, we hope to be able to spot problems earlier and implement mitigation steps that can avert dangerous drug shortages,” said FDA Commissioner Scott Gottlieb, MD.
The FDA has been soliciting information and feedback from physicians, patients, and consumers alike recently about a number of issues related to drug access, including drug shortages. As a result, the AADA is conducting a survey of Academy members about the effects of drug shortages on dermatology patients. The AADA will share the results with the FDA and other policymakers. Take the survey here.
What’s happening with drug shortages and what’s being done to resolve the issue? Read more in Dermatology World.
Related Links:
- Addressing adversity – Dermatology World (July 2015)
- Safety first – Dermatology World (September 2014)
- AAD public education resource: Why see a board-certified dermatologist?
- CDC Guide to Infection Prevention for Outpatient Settings
Help the Academy keep dermatology’s voice strong: Join the AMA
Dermatology has successfully collaborated with the AMA and the greater house of medicine on many issues such as compounding, scope of practice, Medicare payment reform, and narrowed provider networks. The AADA’s representation in the AMA House of Delegates (HOD) is directly related to the number of dermatologists who are AMA members. Your AADA delegates represent the interests of dermatology by introducing and/or supporting resolutions that have a direct impact on how dermatologists practice medicine and care for their patients. The AAD needs you to join or rejoin the AMA. To join the AMA, visit www.ama-assn.org/membership.
Read more about dermatology’s fruitful alliance with the house of medicine in Dermatology World.
- AMA House of Delegates votes on critical health policy resolutions – Dermatology World Weekly (Sept. 5, 2018)
- AADA 2018 Advocacy Priorities
CMS conducting new survey on post-op visits in global surgical codes
CMS is conducting a new survey to collect data on post-operative visits in global surgical codes. Physicians in dermatology, ophthalmology, and orthopedics will be randomly selected to participate in the survey.
Dermatologists who performed a combined total of 80 or more complex repair procedures (codes 13100, 13101, 13120, 13121, 13131, 13132, 13151, or 13152) in 2017 will receive the survey — excluding those in the nine states who are already in the process of reporting their post-operative visits using CPT code 99024. The survey will collect information on the activities performed during the follow-up visits on five patients. Read more about the survey.
