Dermatologists will likely have to wait before the Biden administration turns its attention to health care issues impacting the specialty.
Feature
By Ruth Carol, contributing writer, March 1, 2021
The novel coronavirus will dominate the Biden administration’s health care agenda in 2021. Depending on how quickly the COVID-19 vaccine is rolled out, the 46th President can pivot to tackle other pressing health care issues such as the Affordable Care Act (ACA), alternative payment models (APMs), drug pricing, telemedicine, and indoor tanning, among others.
Broader health care issues will be placed on the back burner as the Biden administration focuses on getting the COVID-19 pandemic under control, noted Kelley Pagliai Redbord, MD, chair of the AADA’s Congressional Policy Committee. That includes getting the economy back on track and addressing the social injustice that continues to divide the country, both of which are tied to the novel coronavirus. Given the widespread impact of the pandemic, COVID-19-related issues will take center stage not only for federal health care agencies, but for every branch of government, Dr. Redbord said.
Starting with the task force
In late November 2020, then President-elect Joe Biden announced his transition team’s COVID-19 task force. The 16-member task force, composed largely of former government health officials and academicians, is charged with developing a robust and aggressive response to contain the virus.
“I’m optimistic that the task force will provide more of a national strategy on many fronts, such as messaging to the public about the vaccine and its distribution,” said Bruce Brod, MD, MHCI, chair of the Academy’s Council on Government Affairs and Health Policy. “The last administration seems to have had more of a patchwork strategy leaving many of these efforts to the states.”
“We must develop relationships with key members of Congress to have a trusted voice there, so we can be part of the conversation and work with all sides.”
President Biden has said he will invest an additional $160 billion for a national vaccine program, including $20 billion for distribution, and an additional $50 billion for expanded testing, noted Gideon Smith, MD, PhD, MPH, chair of the AADA’s Regulatory Policy Committee. More recently, he has pledged to deliver 100 million vaccine shots in his first 100 days in office, which would cover 50 million people.
Distributing, on average, one million vaccinations a day will require a robust supply chain of vaccine materials, face masks and shields, and other personal protective equipment (PPE). The President has said he will invoke the Defense Production Act to ramp up their production. He wants an American-sourced supply chain to prevent being dependent on other countries for supplies, Dr. Smith added.
President Biden has stated he will collaborate with state governors to accelerate the equitable distribution of vaccines. Mobile units will be used in hard-to-reach communities along with regular vaccination sites. A public education campaign will encourage people to get vaccinated.
Regarding masks, the president will require all federal workers to wear them. Additionally, he will ask every person in the country to wear a mask during his first 100 days in office. To that end, President Biden will work with local and state government officials to launch mask mandates in their municipalities and states.
Establishing a Pandemic Testing Board is expected to bolster testing. President Biden has said he would like to double the number of drive-through testing sites and invest in at-home tests and rapid tests, Dr. Smith said. A Public Health Jobs Corps is expected to strengthen fragmented state programs by mobilizing 100,000 contact tracers to assist local health departments. Contact tracing is key to curbing the spread of the virus, Dr. Smith said, noting that a similar idea was introduced in the House and Senate in May 2020, with both proposals being referred to various committees.
President Biden’s plan also calls for opening the majority of schools during the first 100 days of his administration. Re-opening kindergarten through eighth grade would require increased testing and transportation options, enhanced cleaning protocols, and improved ventilation systems.
Whether all these measures can be accomplished will depend on how much support the President will have to make legislative policy changes and how much support he can get from Congress, said Shawn Friesen, director of legislative, political, and grassroots advocacy at the Academy. Implementing all of them is expected to cost tens of billions of dollars. It also depends on how well the President works with governors to promote key responses, Friesen added.
Given the 50/50 split in the Senate with Vice President Kamala Harris serving as the tie-breaker for votes in the chamber, President Biden can expect more support than if the Republicans had maintained the Senate in the January Georgia runoff election. However, it is still a narrow margin that the Democrats have, he said. “Given the political scenario, people will have to work across the aisle. The most important policy wins and changes happen in that space,” Friesen said, adding, “The AADA has a lot of good relationships in those places.”
Helping small businesses
Helping small businesses, such as dermatology practices, may come in the form of another COVID-19 relief bill. The $908 billion stimulus package approved by Congress in December under the Trump administration included $600 checks for eligible adults, extended federal unemployment insurance and the Paycheck Protection Program, reopened the Paycheck Protection Program, and extended the deadline for the payroll tax repayment.
President Biden, who has repeatedly referred to the second relief package as a “down payment” for what is to come, is pushing for a third round of stimulus checks. He has also proposed a “restart package” that would include funds for small businesses to help retain and rehire employees and grants to help them cover the cost of operating safely, including the purchase of acrylic shields and PPE, Dr. Smith said.
Paycheck Protection Program
Learn more about the PPP at the Academy COVID-19 Resource Center.
Leslie Stein Lloyd, JD, CAE, IOM, the AADA’s director of public policy and health care economics, expects the Biden administration to provide more clear messaging about COVID-19 than the Trump administration, making it easier for dermatologists in small practices to follow. For example, there was confusion about whether payments received under the Paycheck Protection Program passed with the first relief package were taxable; ultimately, congressional action at the end of 2020 ensured that this relief will not be taxable.
Additionally, guidance on the Centers for Disease Control and Prevention’s website has been confusing and contradictory, leading to extra burdens for physician practices, she said.
Shoring up the ACA
On the campaign trail, Biden supported a government-funded public option. However, it is unlikely that Congress would pass a public option, even with the 50/50 split in the Senate, stated Katie Keith, JD, MPH, a health law professor at Georgetown University. “Much of that conversation has fallen away in favor of enhancing the ACA,” she added.
Many moderate Democrats will likely push back on anything that sounds like socialized medicine, Friesen said. There are also some conservative Democrats who would likely oppose a public option. Additionally, the President is leaving three seats in the House vacant as he picks people to serve as members in his Cabinet and in other senior administration positions. There are also two other recent vacancies. These seats will have to be filled by special election and could potentially be competitive, Friesen added.
“Given the political scenario, people will have to work across the aisle. The most important policy wins and changes happen in that space.”
That leaves bolstering the ACA as the goal. “We saw a lot of rolling back of the ACA under the Trump administration,” Dr. Brod said. President Biden could reverse those measures by eliminating work requirements for Medicaid, re-instating the limit on short-term health plans to three months and making them non-renewable, and excluding the religious and moral clause.
Particularly in 2020, the Trump administration passed numerous measures to tie the hands of the incoming administration that will have to be addressed by regulation, Keith said. “For better or worse, a lot of the immediate agenda is reacting to these measures,” she added. It is unclear whether President Biden will defend all the rules that the Trump administration tried reversing. If he does, then the court schedule may dictate the administration’s priorities.
The president could tie a lot of ACA improvements to the public health and economic crises caused by the COVID-19 pandemic, Keith said. With so many people losing their employer-based health insurance, he could expand subsidies for individuals in the middle-income bracket and fix the “family glitch,” which bases eligibility for subsidies on whether employer-based insurance is affordable for the employee even if it is not affordable for the entire family. “Right now, the ACA works fairly well, but much better for lower income folks than for middle income folks,” she said.
Other possibilities include bolstering subsidies for insurance exchanges, increasing incentives to expand Medicaid, and enhancing states’ abilities to strengthen Medicaid driven from the executive branch, Dr. Brod said. “Economics sometimes drives change more than policies do,” he added.
Keith anticipates that the Biden administration will create more open enrollment opportunities, perhaps holding special enrollment periods or keeping them open for longer timeframes. It will likely increase funding for advertising and outreach about the ACA, much of which was cut by the Trump administration.
She also expects a June decision, or possibly sooner, from the Supreme Court about the ACA’s constitutionality. Given the oral arguments on the case, it is unlikely that the ACA will be struck down, Keith said. Justice Alito compared the individual health insurance mandate to equipment for operating an airplane, she explained. This equipment was considered vital to keeping the plane in the air, but the equipment has been gone for a while and the plane is still flying. Dr. Brod suggested that President Biden could reinstate the mandate for a ridiculously low cost just to maintain the constitutionality of the ACA.
The Affordable Care Act
It survived for a decade, but will it survive another 10 years after COVID-19? Learn more about the ACA in DermWorld.
Reviewing payment options
“Expect the Biden administration to be very interested in reactivating the Centers for Medicare and Medicaid Innovation and moving forward with more APMs and accountable care organizations with an emphasis on primary care,” Stein Lloyd stated. The Trump administration was more focused on rebalancing fee-for-service payments between primary care and specialties, she added.
While APMs work well for primary care physicians who participate in long episodes of care and deliver a variety of services to treat the whole body, APMs are far more nuanced for dermatologists, whose care is more focused and who are not hospital-based physicians, she explained. Payers historically have not been interested in developing APMs for dermatology; they are looking to address chronic diseases and expensive multi-system co-morbidities, such as cardiac care and diabetes, among others. “It just makes more sense to pay some specialties fee-for-service,” Stein Lloyd said, adding, “a big priority at the Academy is to make sure the Biden administration really understands how payment change could drastically impact patient access and quality of care.”
Expecting more regulations
Traditionally, a Democratic administration issues more regulations than a Republican one, Dr. Redbord said. Additional regulations could be burdensome for dermatology practices, she added. The Biden administration would not likely look to eliminate regulations, which may be tough for physicians because they are so highly regulated already, Stein Lloyd noted. The Trump administration’s mandate was for every regulation put forth, two had to be deleted. Because some health care agencies could not eliminate regulations, they shifted to issuing guidance, due in part to the COVID-19 pandemic and the need to respond rapidly.
When the Trump administration published regulations, it did not always adhere to the proper notice and comment periods, Stein Lloyd said. Executive orders were not terribly effective, as many were challenged in the courts. Additionally, there was a great deal of dissidence between the White House and the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS), Stein Lloyd said. Much of the information that came out was contradictory or incomplete. “We can expect a more thoughtful, cohesive approach to regulatory policy under the Biden administration,” she added. Adhering to the proper rules for notice and comment will make it more difficult for the regulations to be challenged.
“Following rulemaking will be both a blessing and a curse,” Friesen said. The Trump administration’s focus on regulatory relief was welcomed as were its efforts, especially in HHS, to engage with the physician community regarding CMS policy and fee schedules. Friesen agrees there was at times a seeming disconnect between the White House and HHS and CMS. “But for all the noise in the press, there was a good staff environment within HHS,” he said. Additionally, there was an openness and receptiveness to the specialty community that Friesen has not seen in previous administrations. Whether that receptiveness will be replicated in a Biden administration remains to be seen.
Tracking other dermatology-related issues
Drug pricing. President Biden has been clear about addressing drug pricing, Dr. Smith said. Options he has spoken about are allowing Medicare/CMS to negotiate pricing, allowing medications to be imported from abroad, and linking medication pricing to inflation.
Given the bipartisan agreement on this issue, the Biden administration will possibly freeze any regulatory actions taken by the Trump administration and then build on such ideas as reducing drug pricing to the most favored nation level and eliminating pharmacy benefit manager rebates, Dr. Brod said. The Trump administration’s executive order calling for CMS to use the most favored nations rule to purchase cheaper drugs issued in October 2020 was struck down in the courts in December for failing to follow the required notice and comment procedures.
There may be more conversations about value-based purchasing or outcomes-based pricing of drugs, he added. Determining positive outcomes may be more challenging for psoriatic drugs, for example, than for cancer drugs, said Dr. Brod, who emphasized the need for dermatologists to lead discussions related to drugs prescribed to treat dermatologic conditions.
There is bipartisan agreement for addressing pharmacy benefit managers and insurance practices such as requiring step therapy and prior authorization, Friesen said. Movement could be made on those issues at the end of President Biden’s first year.
Telemedicine. The president has pledged increased federal support for virtual care and his rural health care plan specifically supports telemedicine as a mechanism to increase access, Dr. Smith said.
The Trump administration had taken telemedicine coverage as far as it could under the current laws, Stein Lloyd said. CMS added more than 60 telemedicine services that will remain reimbursable during the COVID-19 pandemic. However, Congress would have to act to make those changes permanent, she said.
Dermatologists will need to figure out how to best incorporate telemedicine into normal care, Dr. Redbord said. Telemedicine is extremely helpful for providing follow-up care for acne patients, but not for seeing new patients or conducting full-body exams, she noted. “It’s important to preserve the in-person visit, but there is a role for telemedicine, and we’d be remiss if we didn’t find it,” Dr. Redbord noted.
Teledermatology and COVID-19
Learn about new opportunities to practice teledermatology and be reimbursed under relaxed regulations during the pandemic.
Indoor tanning. President Biden’s mission for cancer prevention and treatment aligns with the treatment of melanoma and skin cancer, Dr. Redbord said. “We see the effects of tanning beds and sun exposure on the development of skin cancer on a daily basis,” she added. While many states have passed indoor tanning bans for minors, in large part due to the AADA’s advocacy efforts, it might be time to start a conversation about indoor tanning restrictions on a federal level, Dr. Brod suggested. The Academy decided not to raise that issue or the reclassification of tanning beds with the Trump administration because of its emphasis on reducing regulations.
Forging new relationships
It is very important for the AADA to build relationships with the new administration early on and maintain them, Stein Lloyd said. “We are excited to share our agenda and demonstrate how our priorities can align with increased access to appropriate care.”
It is also important to remember that the Academy is non-partisan and supports policymakers in a bipartisan manner, Dr. Brod said. Furthermore, the political winds shift every two years, highlighting the need to advocate for patients and members on an ongoing basis. “We must develop relationships with key members of Congress to have a trusted voice there, so we can be part of the conversation and work with all sides,” he added.