Post-pandemic checklist
The COVID public health emergency has ended. Experts discuss how dermatologists can stay compliant amid a changing policy landscape.
Feature
By Emily Margosian, Assistant Editor, June 1, 2024
COVID-19 is “over” — what’s next?
In May 2023, the Biden Administration announced the end of the COVID-19 public health emergency (PHE). Many flexibilities and exemptions put in place during the pandemic were scheduled to end at this time. However, some remain more permanent.
“While COVID-19 presented significant challenges, it also spurred innovations and adaptations within the health care system that may have lasting positive impacts,” said Faiza Wasif, MPH, Academy associate director of practice management, and Olivia Barry, MPH, Academy manager of practice management.
To help dermatologists navigate the shift, this month experts discuss what changes have endured after the end of the PHE, what is going away, and how dermatologists can prepare.
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Key takeaways from this article:
In May 2023, the Biden Administration announced the end of the COVID-19 public health emergency (PHE). Many flexibilities and exemptions put in place during the pandemic were scheduled to end at this time. However, some remain more permanent.
During the PHE, physicians could use popular applications that allow for video chat (FaceTime, Facebook Messenger, Google Hangouts video, etc.) to administer telehealth. They could also provide remote evaluation of patient video/images and virtual check-in services to both new and established patients. These provisions have ended.
However, the Consolidated Appropriations Act extended many other telehealth waivers and provisions until Dec. 31, 2024. CMS is currently reviewing these policies to determine whether they will be extended, made permanent, or removed beyond 2024.
The CMS COVID-19 vaccine mandate has ended.
During the PHE, at-home pregnancy testing was permitted to satisfy the requirements of the iPLEDGE REMS program. Physicians still have the option of using home pregnancy testing for their patients during and after isotretinoin treatment.
Due to the pandemic, the MIPS Automatic Extreme and Uncontrollable Circumstances (EUC) policy was applied to individual eligible clinicians who did not submit data for the 2021 performance year. While CMS is offering the EUC exception for 2024 MIPS, it is unlikely COVID-19 will be considered a circumstance to fit the eligible criteria.
During the PHE, CMS permitted certain referrals and the submission of related claims that would otherwise violate Stark Law. Many of these exemptions have ended with the exception of loans made during the waiver period.
Telehealth
Provisions that have ended:
During the PHE, the Office for Civil Rights (OCR) used discretion in collecting penalties for “the good faith use of telehealth” that would otherwise violate HIPAA. This meant that physicians could use popular applications that allow for video chat (FaceTime, Facebook Messenger, Google Hangouts video, etc.). These concessions have expired.
During the PHE, physicians could also provide remote evaluation of patient video/images and virtual check-in services to both new and established patients. Since the PHE has ended, virtual check-in services may only be provided to established patients.
Provisions that will expire at the end of this year:
“Although the PHE ended in May 2023, the Consolidated Appropriations Act extended many of the telehealth waivers and provisions until Dec. 31, 2024. Several flexibilities remain in place,” said Wasif and Barry.
Federal telehealth flexibilities
The Consolidated Appropriations Act of 2023 extends the following waivers through the end of 2024:
Continued coverage and payment of audio-only telehealth services.
Continued payment for telehealth services furnished by RHCs (Rural Health Clinics) and FQHCs (Federally Qualified Health Centers) using the methodology established for those telehealth services during the COVID-19 PHE.
Teaching physicians are permitted to use audio/visual real-time communication technology to be present when a resident furnishes Medicare telehealth services in all residency training locations through the end of 2024; teaching physicians and residents do not have to be co-located.
Direct supervision by a supervising practitioner through real-time audio/video communication is permitted.
Clinicians who offer telehealth services from their homes are permitted to report their practice address instead of their home address on their Medicare enrollment.
CMS will continue to allow Medicare telehealth services to be furnished to patients located anywhere within the U.S., including an individual’s home.
Dermatologists must still follow the state licensure laws of the state where the patient is located at the time of visit.
During the PHE, physicians and non-physicians could provide telehealth care to new and established Medicare patients across state lines.
However, dermatologists must still follow the state licensure laws of the state where the patient is located at the time of the visit.
Dermatologists should note that these flexibilities may not apply to private payers.
CMS is currently reviewing and finalizing the above listed telehealth policies to determine whether they will be extended, made permanent, or removed beyond 2024.
2024 new telehealth policy
Dermatologists should also be aware of a new telehealth policy enacted this year. “Telehealth services furnished to patients in their homes will be paid at the non-facility physician fee schedule rate beginning in the 2024 calendar year,” noted Wasif and Barry.
To ensure compliance with current telehealth regulations, members can access the Teledermatology Toolkit available through the Academy’s Practice Management Center. Get more information on teledermatology and COVID-19 flexibilities.
Testing and vaccines
In November 2021, OSHA and CMS both released emergency rules that expanded COVID vaccination requirements. While the OSHA rule was ultimately blocked by the U.S. Supreme Court, SCOTUS did allow the CMS rule to go forward.
The CMS rule applied to staff at any facility that accepts payment from Medicare or Medicaid, and required facilities to establish and implement a policy in which eligible staff receive one of the three approved COVID vaccines and complete their vaccination series.
While most dermatology practices were exempt from the CMS vaccine mandate, dermatologists and their staff who work for hospitals and ambulatory surgery centers would have been affected.
However, these requirements are no longer in place. “When the PHE ended in May 2023, the vaccine requirements also ended,” said Wasif and Barry. “The authorizations granted to the CDC to collect specific types of public health data have lapsed, along with the mandate for insurance providers to waive costs or offer free COVID-19 tests.”
Dealing with post-pandemic stress?
Health care is demanding and dynamic, requiring flexibility and dedication. COVID-19 put enormous stress on physicians and their staff, and now that the PHE has ended, post-COVID life also presents its own challenges to dermatology practices.
To help, the AAD has developed new resources related to physician burnout and wellness.
Access resources to help you:
Recognize common drivers of burnout
Address systems and administrative challenges
Cultivate a supportive work culture
Put wellness at the forefront of your leadership strategy
Reconnect with your purpose to build resilience
Learn where to seek help and prevent physician suicide
Read more about available resources and how the conversation surrounding physician mental health has changed.
iPLEDGE
During the PHE, at-home pregnancy testing was permitted to satisfy the requirements of the iPLEDGE REMS program. While this flexibility was set to expire at the end of the PHE, in late 2023, as a direct result of the AADA’s advocacy, the FDA agreed to implement several changes to the iPLEDGE REMS program to minimize burdens on patients and dermatologists while maintaining the safe use of isotretinoin.
“As of November 2023, all pregnancy testing before isotretinoin treatment initiation must be completed in a medical setting, for example, a prescriber’s office or clinic laboratory,” said Chad Appel, JD, AADA director of regulatory and payment policy. “However, prescribers now have the option of using home pregnancy testing for their patients during and after isotretinoin treatment.”
While this change alleviates the burden placed on the prescribing physician and patient, “prescribers who rely on the patient to perform a home pregnancy test need to take steps to minimize patients falsifying the results of these tests,” recommended Appel.
In November 2022, the AADA iPLEDGE Workgroup published recommendations on best practices to reduce the occurrence of patients falsifying pregnancy tests. See the workgroup’s recommendations.
Have more questions about recent changes to iPLEDGE?
Stay tuned for more discussion in the August issue of DermWorld, and track ongoing iPLEDGE advocacy updates.
MIPS
Due to the pandemic, the MIPS Automatic Extreme and Uncontrollable Circumstances (EUC) policy was applied to individual eligible clinicians who did not submit data for the 2021 performance year. This exemption was not applied universally for the 2022 and 2023 performance years. However, individual physicians, groups, and alternative payment models (APMs) have the option to submit a MIPS EUC application.
How does this impact dermatologists in 2024? If you are required to participate in MIPS and are seeking the EUC exemption, make sure to complete an application. Otherwise, you may be subject to a penalty. “CMS is offering the EUC exception for 2024 MIPS,” said Wasif and Barry. “However, CMS does not specify if COVID-19 will be considered a circumstance to fit the eligible criteria for EUC application approval. It’s likely it will not since the PHE ended in May of 2023.” Dermatologists can view the eligibility criteria on the CMS website.
To ensure they are compliant in meeting this year’s MIPS requirements, members can utilize the MIPS 2024 reporting 3-step guide. “This tool aids in deciding whether a physician needs to participate in MIPS, and how to avoid a penalty and earn an incentive,” said Wasif and Barry. “Members are also encouraged to review the 2024 MIPS categories in more detail."
For more guidance on what to expect for MIPS 2024 reporting, see AAD practice management staff's recent tips in DermWorld.
Stark Law
During the PHE, CMS permitted certain referrals and the submission of related claims that would otherwise violate Stark Law. “Typically, the Stark Law prohibits physicians from referring Medicare or Medicaid patients for ‘designated health services’ to a physician or facility with which they have a financial relationship, unless that relationship fits within a specific exception. However, amid the pandemic, blanket waivers allowed physicians, hospitals, and other providers to furnish and bill for their services without activating the Stark Law’s sanction provisions,” said Wasif and Barry.
“There was a fair amount that was permitted as long as it related solely to the COVID PHE,” confirmed Christina Hughes, JD, MPH, a health care attorney with Powers Pyles Sutter & Verville in Washington, D.C. Arrangements outside of traditional Stark compliance that were covered under the waiver during the PHE included activities related to the diagnosis or treatment of COVID-19, securing the services of physicians and other health care professionals in response to the COVID-19 outbreak, ensuring the ability of health care professionals to address patient and community needs during COVID-19, expanding capacity, shifting the diagnosis and care of patients to appropriate alternative settings outside of hospitals, and addressing medical practice or business interruption due to COVID-19.
“That last one is important for dermatology practices,” said Hughes. “Specifically, physicians were allowed to charge above or below market for their services to a DHS entity. They were also allowed to pay below fair market rate for leases for space and equipment. That would be either from the entity to the physician or from the physician to the entity. I don’t know exactly what a dermatologist would lease to a hospital, but if they were leasing any space or equipment from a hospital, that would be implicated. If they were receiving medical staff benefits — for example, if a dermatologist was working inside a hospital or on the staff of a hospital — they could have received additional incidental benefits and additional non-monetary compensation. For instance, if they were receiving PPE from the hospital that was in excess of the limit normally established under Stark, that would have been covered.”
During the PHE, physicians were also permitted to make loans to DHS entities, and vice versa, with interest rates that were below fair market value. “That’s fairly important, because hospitals were providing loans to practices allowing them to remain in operation due to business interruption,” said Hughes. “They also waived the writing and signature requirements of the Stark Law. For most — but not all — exceptions under Stark Law, you must have the agreement set out in writing and signed by the parties, and that must all be in place before the arrangement goes into effect. They recognized that it might be difficult to achieve during the midst of COVID and waived it during the PHE.”
However, many of these exemptions have ended. In February 2023, CMS issued guidance indicating that “when the COVID-19 PHE ends, the waivers will terminate, and physicians and entities must immediately comply with all provisions of the Stark Law.”
In most cases, dermatologists operating under these provisions should plan to go back to pre-pandemic requirements under Stark Law. However, there is one exception, according to Hughes. “Regarding any loans that were made, physicians are permitted to ride out the lifecycle of that loan, as long as no new loan proceeds are disbursed,” she explained. “For example, if it was a lump sum loan at the beginning and it’s on favorable terms, they can ride out the life of the loan on the favorable terms without having to restructure it.”
However, dermatologists should be mindful of any payments made or received after May 2023 to ensure they are in compliance with post-pandemic law. “They should be doing an audit of their records and repaying or seeking recoupment of anything they’ve received or paid in terms of compensation to or from a hospital since May 12, 2023, of last year,” said Hughes. “CMS is actively auditing on compliance with various terms of the PHE waivers and programs.”
Tips for avoiding fraud and abuse liability
Silver linings
While the pandemic presented enormous challenges to physicians, the public, and wider health care system, COVID-19 did yield some positive changes in the form of regulatory and administrative improvements.
“For example, telemedicine regulations were relaxed, allowing for greater accessibility to provide health care services remotely,” said Wasif and Barry. “This change has been particularly beneficial for patients in rural or underserved areas and those with mobility issues.”
“Additionally, streamlined processes for drug approvals and emergency authorizations were implemented during the pandemic, potentially paving the way for more efficient regulatory pathways in the future.”
Dermatologists may expect other positive lasting changes from lessons learned during the pandemic, according to Wasif and Barry. “These could include continued utilization of telemedicine for certain appointments, which can enhance patient access and convenience. Moreover, increased awareness of infection control measures and hygiene protocols may lead to improved safety practices in dermatology clinics, benefiting both patients and physicians.”
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