July 4
IN THIS ISSUE / JULY 4, 2018
- iPLEDGE hits a snag with patients
- Hawaii governor signs legislation banning sunscreen with oxybenzone and octinoxate
- Medicare announces new MUE limit for aminolevulinic acid HCI, 10% (Ameluz)
- How did you fare with MIPS in 2017? Take a look.
- FDA withdraws draft guidance on biosimilars
- Is there a connection between HS and Crohn’s?
iPLEDGE hits a snag with patients
According to a recent paper accepted for publication in JAAD, patients may be having trouble reading and comprehending the iPLEDGE program’s patient education materials. Researchers conducted an analysis of the text on the iPLEDGE consent agreement and the iPLEDGE brochure using a readability software system, and found that that average reading grade level for the consent form was 12.33 and the brochure was 10.19. According to the authors, “These results support the need to reevaluate iPLEDGE and consider revision of the materials, especially the consent agreement.”
Comprehension of treatment regimens can be a challenge for many patients which can adversely impact treatment adherence. Read more about how to improve treatment adherence in elderly patients in this month’s issue of Dermatology World.
Related Links:
- A spoonful of sugar – Dermatology World (January 2017)
- Would you start a heterosexual young woman on isotretinoin who says she will practice abstinence? – Dermatology World (April 2017)
- The risk of isotretinoin and inflammatory bowel disease – Dermatology World (March 2016)
- Acne update – Dermatology World (October 2016)
- Overusing acne antibiotics? – Dermatology World (August 2015)
- Academy product: Simulated Patient Encounter – Medication Management
Hawaii governor signs legislation banning sunscreen with oxybenzone and octinoxate
Hawaii Gov. David Ige (D) has signed a bill into law that bans the sale of sunscreens that contain the ingredients oxybenzone and octinoxate. According to the legislation language, these ingredients “have significant harmful impacts on Hawaii’s marine environment and residing ecosystems.” The bill will go into effect in 2021. The AADA and the Hawaii Dermatological Society opposed this legislation.
There are several sunscreen ingredients that are not approved for use in the United States. Read more about these ingredients and where things stand in the approval pipeline in Dermatology World.
Related Links:
- Do European sunscreens outperform those in the U.S.? – Dermatology World (October 2017)
- Are teens tanning less? Signs point to progress, but work remains – Dermatology World (May 2018)
- What do you ask your skin cancer patients at follow up visits? – Dermatology World (July 2017)
Medicare announces new MUE limit for aminolevulinic acid HCI, 10% (Ameluz)
As a result of the AAD/A’s and drug manufacturer Biofrontera’s advocacy efforts, Medicare has decided to vacate its initial decision to limit Ameluz medically unlikely edits (MUE) to 3 units, and increase it to 200 units effective July 1, 2018.
In his correspondence to the AAD, Niles Rosen, MD, of Correct Coding Solutions LLC and on behalf of CMS ― which owns MUE and determines its contents ― stated “The MUE value for practitioner and outpatient claims for this code will be three (3) effective July 1, 2018. CMS will increase the MUE value to 200 in the Oct. 1, 2018, version of MUE updates. This change will be retroactive to July 1, 2018. This MUE is a date of service edit.”
Dermatologists should be advised that when the billed units of service (UOS) for HCPCS code J7345 are denied based on MUE values, the practice can appeal the denial. Medicare Administrative Contractors (MACs) will pay UOS in excess of the MUE limit if documentation supports medically reasonable and necessary UOS in excess of the MUE value.
Because the MUE increase will be reflected on Oct. 1, 2018, providers may choose one of the following options for services rendered prior to Oct. 1:
- Delay submission of claims for this code until after that date;
- Appeal claim denials due to MUE providing documentation with the appeal; or
- Resubmit claims denied due to the MUE after Oct. 1, 2018, if allowed by the A/B MAC or state Medicaid program.
Important note: Dermatology practices cannot use an Advanced Beneficiary Notice (ABN) to seek payment from a Medicare beneficiary for services denied based on an MUE. If a claim denial is based on an MUE denial, the unpaid claim is considered a provider liability.
For more information, contact the Academy’s Manager of Coding and Reimbursement Faith McNicholas at fmcnicholas@aad.org.
How did you fare with MIPS in 2017? Take a look.
CMS has posted physician scores and payment adjustment information for the 2017 Merit-based Incentive Payment System (MIPS) on the Quality Payment Program (QPP) website. Physicians can view their final performance feedback, which includes the final score and payment adjustment information by logging onto the QPP website.
Read more about MIPS reporting in 2018 in Dermatology World and check out the Academy’s 2018 MIPS Reporting Module ― now available for purchase.
Related Links:
- What are your plans for MIPS reporting in 2018? – Dermatology World (January 2018)
- MACRA and MIPS tips – Dermatology World (July 2017)
- AAD DataDerm™
- Academy MACRA Resource Center
FDA withdraws draft guidance on biosimilars
After review of public comments, the FDA has withdrawn draft guidance ― that was issued in September ― that would have provided advice for sponsors developing biosimilars regarding the “evaluation of analytical similarity between a proposed biosimilar product and the reference product.” The public comments addressed a number of issues that could affect the cost and efficacy of biosimilar development, so the FDA has indicated that it wants to take a step back for “further consideration to the scientific and regulatory issues involved.” Additionally, the FDA has launched a new program that will allow biologic product developers to regularly meet with the FDA to discuss the “development process and obtain advice on a wide range of development-related topics.”
The jury is still out on whether biosimilars will ultimately be a cheaper option for patients. Read more about whether biosimilars are the silver bullet for the growing cost of drugs in Dermatology World.
Related Links:
- Ripe for the picking – Dermatology World (September 2015)
- Battling for biologics: The impact of biosimilars (sidebar) – Dermatology World (September 2015)
- The promise and pitfalls of biosimilars – Dermatology World (June 2013)
- AADA position statement on Patient Access to Affordable Treatments
Is there a connection between HS and Crohn’s?
According to a recent study published in JAMA Dermatology, patients with hidradenitis suppurativa (HS) are three times more likely to have Crohn’s Disease compared to individuals without HS. Researchers conducted a cross-sectional analysis of electronic health records of more than 18 million adults. Among the 51,340 patients with HS, 2% had Crohn’s while only 0.6% of the patients without HS had Crohn’s.
In addition to Crohn’s, are HS patients at increased risk for CV events? Read more in Dermatology World.
Related Links:
