Last week, the U.S. Food and Drug Administration (FDA) approved a lotion to treat head lice for over-the-counter (OTC) use through a process called Rx-to-OTC switch. The FDA initially approved 0.5% ivermectin lotion as a prescription drug in February 2012 for the treatment of head lice infestation in patients six months of age and older.
Rx-to-OTC switches are generally initiated by the manufacturer of the prescription drug. The data must demonstrate that the drug is safe and effective when used as directed in the proposed labeling, and the manufacturer must show that consumers can understand how to use the drug safely and effectively without the supervision of a health care professional.
The head lice lotion will be marketed in the United States as a nonprescription drug and will no longer be available as a prescription product.
DermWorld Insights and Inquiries: Striving to alleviate the physical and emotional scars of central centrifugal cicatricial alopecia
More than half a century ago, Drs. Lopresti, Papa, and Kligman coined the term “hot comb alopecia,” asserting: ”The cause is unmistakable, namely the practice of straightening the hair with a hot comb....” Now known as central centrifugal cicatricial alopecia (CCCA), the etiology is considered far more complex.
CCCA commonly affects women of African descent, with the incidence in African-American women reportedly higher than in African women. CCCA is a progressive form of lymphocyte predominant scarring alopecia initially presenting on the crown or vertex scalp, subsequently spreading in a peripheral or centrifugal pattern. Along with the clinical observation of hair loss, there may be subclinical inflammation based on biopsy test results of a normal-appearing scalp. Recently, a new clinical variant of CCCA presenting with patches of hair loss affecting the lateral and posterior scalp has been described. Keep reading!
The future of telehealth
In this second part of the AADA's two-part series on the 2021 Medicare Physician Fee Schedule (MPFS), the future of telehealth is addressed. The COVID-19 public health emergency (PHE) pushed CMS to significantly relax regulations around telehealth so that physicians could continue to provide care to their patients.
While preserving the physician-patient relationship and the ability to see patients in-office is paramount for dermatology, the current telehealth flexibilities have been critical to patient health and safety this year. Several months later, virtual visits are still in high demand, but the future of how telehealth will be regulated and reimbursed remains uncertain.
The 2021 MPFS proposed rule provides glimpses of what that future could be. The AADA shared its comments on the agency’s potential next moves on telehealth coverage and flexibilities, among other major changes to coding and reimbursement.
The Academy supports the study of the telehealth waivers provided by CMS and followed by most private insurers during the COVID-19 PHE. These studies would include:
A quantitative analysis of the use of telehealth services, modalities, and programs used during the PHE including data on use by rural, minority, low-income, and elderly populations
An analysis of the public health impacts of the telehealth policy changes during the PHE and projecting the future impact
The AADA continues to advocate for a deliberate process for adopting any expansion of coverage or relaxation of regulations for telehealth policies. At the same time, the AADA has appreciated the agency’s efforts to:
Make store and forward a reimbursable telemedicine option for providers and supports the new proposed codes and values
Develop coding and payment for a service similar to the virtual check-in but for a longer unit of time and with an accordingly higher value
Extend the policy of direct supervision to include virtual presence of the supervising physician or practitioner using interactive, real-time audio/video technology through the end of the PHE or Dec. 31, 2021
Under waiver authority during the PHE, CMS could expand coverage for eligible sites of service and reimbursement of telehealth services. However, after the PHE ends, CMS is limited in its ability to expand coverage of telehealth beyond certain situations identified in the Social Security Act.
For example, "home" can only be an originating site for telehealth under very limited conditions for substance abuse or mental health. To make permanent changes to originating sites for broader conditions, or to permanently cover audio-only telemedicine, an act of Congress is required. In the meantime, CMS will consider the comments it receives from the 2021 MPFS proposals on telemedicine and additional studies on telehealth usage and patterns before determining permanent suggestions it has the authority to make under law.
The Office of the National Coordinator for Health Information Technology (ONC) announced that it is delaying the compliance deadline for its final rule, that addresses EHR interoperability hurdles, to April 5, 2021. The rule — which was originally to be implemented Nov. 2, 2020 — requires hospitals and other health care entities to stop data-blocking practices of digital patient information. The rule would also require hospitals and other health care service providers to allow patients access to records via software used by smartphone apps. The American Medical Association has developed educational resources for physicians on how to comply with this rule.
Read more about the road to EHR interoperability in DermWorld.
Derm Coding Consult: Payers to reinstate cost-sharing requirements for virtual appointments
During the Public Health Emergency (PHE), which has been extended until Jan. 20, 2021, many payers waived their patient cost-sharing requirements for virtual appointments. However, private payers are now slowly starting to revert to their pre-PHE financial requirements, and patients may not be aware of these changes. Read more.
Rejected VA claims can now be appealed
The Veteran’s Administration (VA) and its third-party administrators will reconsider payment to physicians who had a claim denied for simple routing errors if the original claim was filed with a VA payer on time (within 180 days of the date of service). The physician must resubmit a reconsideration request to the correct VA payer within 180 days of the initial denial.
Additionally, claims not submitted because of missing affiliation/network information on the VA referral are also eligible to be reconsidered if the claim is within 180 days of the date of the referral allocation. VA staff will send the physician an offline referral created in Health Share Referral Manager (HSRM) to the community provider with the authorization number. The HSRM offline referral will also explain who to correctly bill.
For more information, visit the VA’s website or call the Community Care Contact Center at 877-881-7618.
More than 26 million veterans, spouses, dependents, and survivors are served by the VA’s health care system. However, there are only 11,000 physicians and physician trainees employed by the VA, and an even more limited workforce of dermatologists and Mohs surgeons. As a result, in June 2019, the VA rolled out a new Community Care Network (CCN), which allows veterans to access care at non-VA facilities. Read more about CCN program and what it entails for patients and dermatologists.
FDA, UMD seek feedback on compounded drug use
In collaboration with the FDA, the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) is conducting an anonymous survey to better understand how compounded drugs containing bulk drug substances are used in clinical practice. Protecting dermatologists’ access to compounded drugs is a top advocacy priority for the AADA and quality data will help the Academy effectively advocate for the specialty and its patients.
The goal of this survey is to understand how medical practitioners prescribe and administer compounded drugs. The survey feedback will help the FDA develop a list of drugs that can be used in bulk compounding by 503B outsourcing facilities. The anonymous responses will be shared with the FDA as part their project, “Clinical Use of Drugs Including Bulk Drug Substances Nominated for Use in Compounding by Outsourcing Facilities.”
Several substances are being surveyed as it relates to the specialty, including lidocaine, epinephrine, salicylic acid, lactic acid, thymol iodide, and others. Provide your input today.
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