June 5


IN THIS ISSUE / June 5, 2019

Self-injection of black market dermal fillers poses health concern

More than ever, people are turning to the internet to find a good deal — and this includes cosmetic chemicals, reports the New York Post. People are purchasing these unapproved chemicals, watching online tutorials, and then injecting them into their faces. In 2017, the FDA issued a formal warning about dermal fillers, urging consumers to “NEVER buy dermal fillers on the internet. They may be fake, contaminated, or harmful.”

A 2018 study published in the journal Plastic Surgery found that DIY-injectors understood the danger of self-injection and unregulated products, but this knowledge did not deter them. The Post found 1 cubic centimeter of hyaluronic acid with a syringe from a private seller on Amazon for $85. The product was soon pulled from the Amazon marketplace.

Learn more about approvals of new dermal fillers that target specific anatomic locations in Dermatology World.

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DW Insights and Inquiries: Stress2 + Hormones2 = Acne2

heymann-warren-95px.jpgI would wager that every human being has experienced at least one pimple attributed to stress. I recall a devastatingly embarrassing moment during 10th grade world history class at Martin Van Buren High School (Queens, New York), when a horrific acne cyst on my neck erupted in Vesuvian fashion, necessitating my running out of the room. The physical and emotional scars remain. Aside from the usual social challenges confronted by most adolescents, I was also stressed by algebra, geometry, and trigonometry. At an early age, I learned of the bidirectional nature of stress and acne — stress aggravates acne, while acne exacerbates stress. These unpleasant memories flooded back to me after reading about a novel approach to stress management — the Pythagorean Self-Awareness Intervention (PSAI).

In case you have forgotten, the Pythagorean Theorem is a² + b² = c², stating that the square of the hypotenuse (the side opposite the right angle) is equal to the sum of the squares of the other two sides. Pythagoras was also an advocate of practicing periods of silence, meditation, and self-introspection, hence the name PSAI. Keep reading!

CMS/NCCI announce changes to PTP edits 

Have you noticed any issues to your claims processing when reported with modifiers lately? This is because effective Jan. 1, 2019, the Centers for Medicare and Medicaid Services National Correct Coding Initiative (CMS/NCCI) implemented unexpected changes on how some code combinations were impacted with the use of modifiers

Effective July 1, 2019
Effective July 1, 2019, claims for outpatient facility services submitted to MACs will allow modifier 59 on either the column one or column two code of a PTP edit with a modifier indicator of “1”.

The problem
The NCCI edits have changed column1/column2 sequencing for Procedure to Procedure (PTP) edits. According to CMS, about 10-13 years ago, the instruction that required the placement of a modifier on the column two code was rescinded and Medicare Administrative Contractors (MACs) were instructed to accept a modifier on either column code. As far as they were concerned, the changes will have little to minimal impact on claim processing.

Unfortunately, this instruction was not implemented by the MACs. As a result, the payers and coding community have continued to follow the instruction that allows the modifier to be placed on the column two code only or the claim is deemed with ‘incorrect use of modifier’ and denied.

Following the AAD coding team concerns regarding the change in code combination and the placement of modifier 59 being required on the column two code of a PTP edit with a modifier indicator of “1”, a CMS and NCCI workgroup conducted an internal investigation. It found that MACs adjudicating practitioner claims do in fact require that modifier 59 be on the column two code of a PTP edit with a modifier indicator of “1”.  

What you should know now
Currently, physicians can submit a claim for two codes corresponding to one of the PTP code pair edits, and it will be denied if modifier 59 is applied to the wrong code. If this occurs, physicians can pursue a redetermination with a corrected claim by appending the modifier to the correct code. 

Learn more about modifier 59, including helpful tables that outline the impacted code combinations when specific procedures are performed and reported during the same encounter in the Practice Management Center. For more coding help, visit the Academy’s Coding Resource Center

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New survey highlights impact of local anesthetics shortage 

The American Academy of Dermatology Association (AADA) is aware that it has become increasingly difficult for physicians to obtain lidocaine with epinephrine, lidocaine, other local anesthetics, and sodium bicarbonate. In response to these shortages, the AADA sent a letter to the FDA requesting placement of these drugs on the proposed essential drugs list, outlining how access to these medications is critical to quality, efficient patient care.

The FDA’s Drug Shortages Task Force requested data on the causes and adverse consequences to patients and health care providers. As a result, the AADA surveyed membership in 2018 about the ongoing drug shortages. The results indicate that:

  • 9 in 10 dermatologists believe drug shortages have negatively impacted patient outcomes — even directly causing patient harm
  • 8 in 10 dermatologists have taken time away from patient care to determine alternate treatments due to shortages
  • 73% reported having had practice costs increase due to both shortages and the resulting substitutions needed
  • 4 in 10 dermatologists experience drug shortages daily; 9 in 10 experience shortages monthly

The FDA has reached out to the AADA and has indicated that it has re-initiated the temporary import of sodium bicarbonate from Australia and it is now available. However, the FDA indicated that the injectable local anesthetics including the lidocaine, lidocaine with epinephrine, bupivacaine, and others continue to be delayed.

Read more about the drug shortages at the following:

Learn more about drugs on the FDA’s drug shortage list and what the AADA is doing to advocate on the issue on the Academy’s Drug shortages web page.

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FDA approves first treatment for graft versus host disease 

The FDA has approved ruxolitinib (Jakafi) to treat graft versus host disease (GvHD) for both pediatric patients, at least 12 years of age, and adults who have failed to respond to standard steroid therapy. Ruxolitinib, which has already been approved for treating certain bone marrow and blood disorders in the United States, is the only FDA-approved treatment for GvHD. The recommended starting dose of ruxolitinib for GvHD is 5 mg given orally twice daily.

Read about how small molecule drugs have made a big splash in Dermatology World.

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What’s the direct liability for business associates under HIPAA?

The HHS has recently issued a new fact sheet that outlines all the ways in which a business associate can be held directly liable for compliance with certain requirements of HIPAA. According to the HHS website, a business associate is a “person or entity that performs certain functions or activities that involve the use or disclosure of protected health information on behalf of, or provides services to, a covered entity.” A staff member is not considered a business associate. Business associate services are legal, actuarial, accounting, consulting, data aggregation, management, administrative, accreditation, and financial.

Business associates are directly liable for HIPAA violations as follows:

  1. Failure to provide the Secretary with records and compliance reports; cooperate with complaint investigations and compliance reviews; and permit access by the Secretary to information, including protected health information (PHI), pertinent to determining compliance.
  2. Taking any retaliatory action against any individual or other person for filing a HIPAA complaint, participating in an investigation or other enforcement process, or opposing an act or practice that is unlawful under the HIPAA Rules.
  3. Failure to comply with the requirements of the Security Rule.
  4. Failure to provide breach notification to a covered entity or another business associate.
  5. Impermissible uses and disclosures of PHI.
  6. Failure to disclose a copy of electronic PHI (ePHI) to either the covered entity, the individual, or the individual’s designee (whichever is specified in the business associate agreement) to satisfy a covered entity’s obligations regarding the form and format, and the time and manner of access under 45 C.F.R. §§ 164.524(c)(2)(ii) and 3(ii), respectively.
  7. Failure to make reasonable efforts to limit PHI to the minimum necessary to accomplish the intended purpose of the use, disclosure, or request.
  8. Failure, in certain circumstances, to provide an accounting of disclosures.
  9. Failure to enter into business associate agreements with subcontractors that create or receive PHI on their behalf, and failure to comply with the implementation specifications for such agreements.
  10. Failure to take reasonable steps to address a material breach or violation of the subcontractor’s business associate agreement.

Learn more about HIPAA compliance, the Privacy and Security Rules, and more in the Academy’s HIPAA Resource Center.

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2020 committee appointment application now open

Every year, hundreds of dermatologists serve the Academy through its organizational governance structure and through other service opportunities. The Appointment Selection Committee, chaired by Bruce H. Thiers, MD, has begun accepting applications to fill 2020 open appointments. Applications must be submitted by June 30, 2019. Members who are selected to serve will be contacted in the winter. Letters of recommendation are highly suggested but not required. 

Access the 2020 online appointment application at www.aad.org/applications/cctf. Learn more about the specific committees and task forces, committee member responsibilities, and other opportunities in the Governance Handbook.