Moving forward

By Ruth Carol, Contributing Writer, January 1, 2022

Every year, the American Academy of Dermatology Association (AADA) tackles a long list of federal and state legislative and regulatory issues that affect dermatologists and their patients. While the COVID-19 Public Health Emergency (PHE) continued into 2021, consuming many legislative and regulatory bodies, the Academy moved the needle forward on key advocacy priorities. The following is a behind-the-scenes look at these advocacy wins. 

Payment cuts avoided

For the last decade, physicians have endured a 2% Medicare payment reduction as part of sequestration — a component of the 2011 Budget Control Act. But in its attempt to provide some relief for physicians who were hard hit by the COVID-19 PHE, Congress suspended the scheduled 2% across-the-board Medicare payment reduction through 2020. Despite the PHE lasting beyond 2020, Congress was planning to reinstate the Medicare sequestration for 2021, noted Blake McDonald, the AADA’s assistant director of congressional policy. 

The Academy joined other Medicare provider groups to call on Congress to extend the sequester moratorium through 2021. At the AADA’s Legislative Conference, held virtually in September 2020, more than 330 attendees from 44 states and the District of Columbia reiterated the request, which would allow more time for dermatologists to recover financially from the PHE. As a result, in December 2020, Congress signed into law the Consolidated Appropriations Act of 2021, extending the moratorium — however, only through March 31, 2021.

In February 2021, the AADA sent a letter to congressional leadership to further delay sequester cuts through the end of the year. In a huge win for dermatology, in March, both the House of Representatives and Senate passed legislation to extend the sequestration moratorium through the end of 2021, which President Biden signed into law last April. In December 2021, Congress reached a deal to fully relieve physicians from the 2% sequester cut until April 2022. 

However, the Academy’s work isn’t over and the AADA has been advocating Congress to prevent future cuts. Avoiding a 2% cut is a win, but the sequestration was extended, McDonald explained. That means the sequestration will continue to be a point of contention for the next decade, he said. 

In addition, approval of the American Rescue Plan Act, signed into law in March 2021, triggered a federal spending threshold, known as Pay-As-You-Go or PAYGO, which is designed to keep newly enacted legislation from racking up deficit increases. This could result in future cuts to Medicare payments, McDonald said. 

In 2022, the Academy will continue to work with larger coalitions within the house of medicine to push for a moratorium on the sequestration and determine a long-term solution to eliminate such cuts, McDonald said. “The trend toward cutting Medicare reimbursement for physicians to pay for other programs in the federal government is sending the wrong message to health care providers. It suggests that their expertise is not valuable, or they should make do with less at a time when physicians are being asked to do a lot more,” he concluded.  

Scope of practice creep averted

The Academy has been working on scope of practice issues for two decades, noted Lisa Albany, JD, the AADA’s director of state policy. During the COVID-19 PHE, however, non-physician clinicians seized the opportunity to loosen the scope of practice laws across the country. Additionally, non-physician clinicians have tried to leverage the waivers issued during the pandemic as another means to justify their ability to practice independently, stated Bruce Brod, MD, MHCI, FAAD, chair of the AADA’s Government Affairs and Health Policy (GAHP) Council. 

Last year also saw physician assistants (PAs) come out in full force to seek independent practice, attempt to chip away at existing laws, try to expand the physician-to-PA supervision ratio, and change the requirements for a physician signature on charts of patients seen by the PA, Albany said. “The PAs argue that if NPs are allowed to practice independently, they should be too,” she added. “They claim it’s affecting their ability to practice.”

Pharmacists, naturopaths, optometrists, and aestheticians also sought to expand their scope of practice in 2021. Last year, the AADA was tracking scope of practice legislation in 30 states. Each state has its own scope of practice laws governing what a non-physician clinician can do and whether supervision is required. 

The Academy supports physician-led, team-based care, recognizing that non-physician clinicians play a valuable role in the delivery of health care. But legislators don’t necessarily understand how significant the differences in education and training are between dermatologists and non-physician clinicians, and how those differences lead to quality care issues and higher health care costs, Albany stated. Studies have shown that care provided by non-physician clinicians increases costs due to inappropriate prescribing, unnecessary referrals to specialists, and unneeded diagnostic imaging studies, all of these occurring across specialties. Within dermatology, studies have shown that non-physician clinicians order significantly more biopsies than dermatologists. 

The AADA serves on the American Medical Association Scope of Practice Partnership (AMA SOPP), and works with state and local dermatology and medical societies, to combat dangerous scope of practice expansions for non-physician clinicians. “The house of medicine is most effective when it works together because we are able to pool our resources and present a broader picture of the implications of the scope of practice for patients,” she said. “It also increases our grassroots efforts and our presence at state houses.” Relaying patients’ stories often helps carry the Academy’s messages, but when the stories span the specialties, there is a better chance of one resonating with a legislator, Albany added. 

Advocacy efforts include writing comment letters, providing software to dermatologists that allow them to contact their legislator by email and/or telephone, and helping fund a branded communications campaign informing the legislators and the public about the importance of physician-led, team-based care. Sometimes, the Academy provides funding to state dermatologic societies through an advocacy grant. All these efforts, and more, were used to minimize the spread of scope of practice for non-physician clinicians in 2021.

In Louisiana, the state legislature rejected several pieces of legislation that would have authorized PAs and NPs to practice independently. The AADA worked with the Louisiana Dermatological Society, Louisiana State Medical Society, and the AMA SOPP to successfully explain to state lawmakers the importance of physician-led, team-based care.

In Mississippi, the Academy partnered with the Mississippi Dermatology Association and the AMA SOPP to defeat a bill that would have authorized advanced practice registered nurses to practice independently after completing only 3,600 transition-to-practice hours.

In South Dakota, the AADA, South Dakota State Medical Association, and AMA teamed up to successfully defeat legislation that would have expanded the scope of practice of PAs, allowing them to practice without physician involvement after only 520 practice hours. 

In Virginia, a bill was defeated that would have allowed naturopaths to perform minor surgical procedures and order lab tests, including biopsies. The AADA and the Virginia Dermatology Society defeated legislation that would have licensed naturopaths and allowed them to use numerous misleading terms to identify themselves, including naturopathic medical doctor, doctor of natural medicine, doctor of naturopathy, and doctor of naturopathic medicine.

“You can’t work on scope of practice without working on truth in advertising,” Albany stated. The Virginia bill shows the importance of increasing health care transparency laws around the country to maintain clarity about the qualifications of those providing patient care. Studies show that patients are truly confused about the level of education and training of their health care providers, she said. This is especially true when many non-physician clinicians have earned advanced degrees that confer the title doctor. The AMA Truth in Advertising Campaign calls for legislation requiring health care providers to state their level of training, education, and licensing clearly and honestly. 

The Academy is already preparing for 2022 scope of practice battles, beginning with South Dakota. “We know they are planning to introduce a similar bill next year,” Albany stated. Additionally, the AMA SOPP granted financial assistance to the South Dakota State Medical Association to oppose legislation to be introduced this year. “I would not be surprised if all of the defeated bills come back,” she said. Although it can get frustrating fighting these battles year after year, the key is to not give up, Albany said. “We will continue to build our grassroots networks and educate legislators.” After elections, there are always opportunities to build relationships with new legislators. “The non-physicians show up year after year and so must we,” she said.

Compounding burdens relieved

In 2013, Congress passed the Drug Quality and Security Act (DQSA), which tightened the FDA’s oversight of compounding facilities. The agency subsequently decided to restrict physician in-office compounding and office-use compounding. Based on the FDA’s interpretation of the DQSA, the agency issued a draft guidance that threatened dermatologists’ ability to prepare medications, such as buffered lidocaine and reconstituted botulinum toxin, in the clinical setting.

The AADA formed the Compounding Workgroup composed of leaders from the Academy, American Society of Dermatologic Surgery Association, American College of Mohs Surgery, and American Society of Mohs Surgery. The workgroup also had the support of the AMA and other medical specialties. The AADA’s position is that dermatologists only prepare low-risk drugs and in low volumes. Given that, the workgroup held meetings with the FDA to secure an exemption for physicians conducting in-office preparations from meeting the same onerous equipment and process requirements as large compounding facilities.

“The Academy and its sister societies have done a really good job at the federal level, and we are gearing up at the state level to preserve dermatologists’ ability to compound in the office under the normal practice of medicine.”

In November 2020, the FDA loosened its restrictions stating that the agency would not take actions against physicians who are compounding medications in-office, noted AJ Custard, JD, the AADA’s manager of regulatory policy. But not penalizing physicians is not the same as granting them a permanent exemption. 

In 2021, the Academy began working with the United States Pharmacopeia (USP) to carve out a permanent exemption in the form of a monograph, Custard said. To obtain that exemption, the AADA has hired an independent laboratory to demonstrate that lidocaine can be buffered in a physician’s office safely and effectively. Once the monograph is released, state pharmacy boards will have to adopt it to put the issue to rest, he added. 

“The Academy and its sister societies have done a really good job at the federal level, and we are gearing up at the state level to preserve dermatologists’ ability to compound in the office under the normal practice of medicine,” Dr. Brod noted. That requires working with the USP to generate the data for the monograph and engaging with state pharmacy boards to ensure there is no over-encroachment in the office. “The work we’re doing with the USP will go a long way to help the latter,” he said.

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