Legislation and regulation
The Academy’s Ad Hoc Task Force on COVID-19 is monitoring pandemic developments daily, assessing the impact on practices, and providing guidance most relevant to dermatologists. The most current information is being posted to these pages as we have it. Check back for updates.
The AADA is monitoring legislative and regulatory developments related to COVID-19 as the government seeks to limit the spread of the virus and its impact on the nation’s economy. Below you will find information on the most recent actions taken by the federal and state governments to address the COVID-19 outbreak.
Use these links to quickly jump to topics of interest:
Most recently, the AADA:
Sent a letter to HHS, along with 21 other physician organizations, requesting that the agency create a mechanism to provide organizations regular, timely, and relevant COVID-19 information that can immediately be distributed to members.
Shared a letter of support for H.R. 6080, “Preventing Drug Shortages Act,” which would help address critical drug shortages that can lead to substitution of recommended treatments with alternative therapies, compromising or delaying critical medical procedures, and rationing drug doses. It also details the sense of urgency during the COVID-19 pandemic.
Alerted congressional leadership of the AADA’s analysis, which outlines areas of support and concern in the Coronavirus Aid, Relief and Economic Security (CARES) Act (S. 3548). This legislation is currently under review and considered phase three of the economic stimulus packages in response to COVID-19.
Raised awareness, along with the Lupus Foundation of America, American College of Rheumatology, and the Arthritis Foundation, by sending a joint letter to Vice President Mike Pence outlining concerns surrounding the increased demand for hydroxychloroquine and chloroquine. There’s an intense need for further investigation into these medications as potential treatments for COVID-19, but this limits their availability, which is troubling as they have been successfully used to treat lupus and rheumatoid arthritis for decades.
Joined an AMA sign-on letter calling on Congress to include provisions to help physicians sustain their practices and provide their patients with the best possible care during the COVID-19 emergency. This includes tax relief, no-interest loans, direct payments, payment for virtual visits including phone calls, and other measures within the final economic stimulus legislation.
Several legislative and regulatory actions have been discussed or signed into law to combat COVID-19. The Academy’s Ad Hoc Task Force on COVID-19 is reviewing policies and guidelines that will shape how dermatologists provide care and conduct business. The Academy will continue to update members as new information is available. Here’s the latest:
Federal actions taken
Tax Day moved from April 15 to July 15
Treasury Secretary Steve Mnuchin announced on March 20, 2020 that Tax Day is moved from April 15 to July 15. All taxpayers and businesses will have this additional time to file and make payments without interest or penalties.
Economic stimulus packages
Phase One: H.R. 6074 – Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 On March 6, President Donald Trump signed into law supplemental funding bills to provide $8.3 billion to address the coronavirus outbreak, which includes funding for research and development of vaccines, therapeutics, diagnostics, health care workers’ training and community health centers.
Phase Two: H.R. 6201 – Families First Coronavirus Response Act On March 18, 2020, President Donald Trump signed H.R. 6201 into all, which includes waivers and modifications of Federal nutrition program, employment-related protections and benefits, health programs and insurance coverage requirements, and related tax credits.
Phase Three: On March 27, President Trump signed a groundbreaking $2 trillion economic stimulus and COVID-19 relief package called the Coronavirus Aid, Relief and Economic Security (CARES) Act. The new law includes relief for small businesses, temporarily suspends the Medicare sequester, and further relaxes Medicare’s telehealth provisions. Additionally, the new law outlines individual and family taxpayer relief, Indian Health Services funding, preparedness and response support, and CDC and NIH grants, and addresses drug shortages and OTC drug reform as it relates to sunscreen.
The AADA continues to monitor any adjustments or next steps made by Congress.
What government health agencies are doing
Medicare sequester suspended
By direction of the CARES Act, which passed on March 27, the Medicare sequester has been temporarily suspended between May 1 and Dec. 31, 2020. The suspension of the sequester will help boost Medicare payments to physicians by approximately 2% in 2020.
Tax credits for paid sick and family leave available immediately
The U.S. Treasury Department, Internal Revenue Service, and Department of Labor have published guidance that small and midsize employers can begin taking advantage of two new refundable payroll tax credits, designed to immediately and fully reimburse them, dollar-for-dollar, for the cost of providing COVID-19-related leave to their employees. The IRS website contains guidance on how to obtain the payroll tax credits. The Department of Labor published guidance on the employer paid leave requirements, employees’ rights to paid leave, and FAQs.
CMS extends 2019 MIPS reporting deadline from March 31 to April 30, 2020, looking at 2020 reporting flexibility
CMS announced March 22 that it is providing extensions for physicians and others participating in various Medicare quality programs. The MIPS and ACO program deadlines to report 2019 data have been extended from March 31, 2020 to April 30, 2020. MIPS-eligible clinicians who have not submitted MIPS data by April 30 will automatically qualify for the extreme and uncontrollable circumstances policy and will receive a neutral payment adjustment for the 2021 MIPS payment year. If a clinician or group began submitting data but will not be able to complete it by April 30, 2020 they should submit an application for extreme and uncontrollable circumstance citing COVID-19 to have previously submitted data overridden. Applications must be submitted between April 3 – April 30, 2020. CMS is also considering options for relief for participation and data submission for 2020.
CMS announces ASC reporting program flexibility for 2019, suspends data collection for first half of 2020
For those who participate in the ambulatory surgical center quality reporting program, the deadline for 2019 Q4 data submission is now optional. Q4 data that is submitted will be used, but if it cannot be submitted, 2019 performance will be calculated on the data from the first three quarters of 2019. Additionally, CMS will not count data from the first two quarters of 2020 for the ASC program and it does not need to be submitted.
Private payer coverage of telehealth
The AADA has proactively contacted more than 65 insurers to map coverage of telehealth services through telephone and video consults. The Academy has gathered a list of policy updates from private payers (clicking this link will open a downloadable spreadsheet). Updates will be provided as more information becomes available.
The CARES act expands coverage for telehealth under Health Savings Accounts (HSAs) by allowing high deductible health plans (HDHP) to provide telehealth and remote care services without a deductible for 2020 and 2021. The bill also allows an HDHP with an HSA to cover telehealth services prior to a patient reaching the deductible.
FDA guidance on clinical trials
The FDA issued guidance on March 18 on the conduct on clinical trials during the COVID-19 outbreak. “Although the impact of COVID-19 on trials will vary depending on many factors, including the nature of disease under study, the trial design and in what region(s) the study is being conducted, the FDA outlines considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice and minimizing risks to trial integrity. Considerations recommended include, among others, sponsors evaluating alternative methods for assessments, like phone contacts or virtual visits and offering additional safety monitoring for those trial participants who may no longer have access to investigational product or the investigational site.”
National Emergency Declaration on March 13, 2020
CMS took the following actions after the administration’s March 13 declaration of a national emergency due to COVID-19:
Loosening conditions of participation or other certification requirements:
CMS is waiving the requirement for site visits, background checks, application fee, and fingerprinting for non-certified Part B suppliers, physicians and non-physician practitioners.
CMS is establishing a toll-free hotline for non-certified Part B suppliers, physicians and non-physician practitioners to enroll and receive temporary Medicare billing privileges
CMS will allow licensed providers to be paid to render services outside their state of Medicare, Medicaid, CHIP enrollment.
Suspending survey inspections: CMS will temporarily suspend non-emergency survey inspections, allowing providers to focus on the most current serious health and safety threats
Expediting Medicare appeals in Fee for Service, Medicare Advantage and Part D
Allowing states to seek waivers that
Would waive prior authorization requirements in fee -for-service programs
Permit providers located out of state/territory to provide care to another state’ s Medicaid enrollees impacted by the emergency
Temporarily suspend certain provider enrollment and revalidation requirements to increase access to care
Temporarily waive requirements that physicians and other health care professionals be licensed in the state in which they are providing services, so long as they have an equivalent licensing in another state
Department of Labor guidance for preparing workplaces
The Department of Labor released a guidance for how to prepare workplaces for COVID-19.
Fifty legislative chambers have either temporarily adjourned or moved to virtual meetings, or announced an early recess or sine die. State or public health emergency declarations have been issued in each state and territory, including the District of Columbia. Many states are updating licensing and CME requirements in response to the COVID-19 outbreak.
As of Wednesday, March 18, 50 bills have been introduced in 14 states and the District of Columbia. The legislation covers a number of issues, including appropriation requests, waiving cost-sharing requirements, paid sick leave and worker protections, and expanding the authority of state governors to address COVID-19. (View COVID-19 bills the AADA is tracking.) Here is a sampling of the legislation:
Michigan introduced legislation requiring health plans to include policies to cover COVID-19 expenses or to determine whether one has COVID-19. The expenses include physician office visits; examination, diagnosis, and prescribed treatment by telemedicine; hospitalizations; drugs as prescribed by a physician; vaccines prescribed by a physician; laboratory tests; hand sanitizer and face masks; quarantine, detention, or isolation by any governmental entity. Such expenses would not be subject to coinsurance, copayment, application to a deductible, or limit.
Similarly, Minnesota would require health plans to provide coverage under every health plan for testing, treatment, and quarantine costs related to COVID-19. Health plans would be prohibited from imposing out-of-network charges for such coverage. Further, a health plan would be prohibited from imposing cost-sharing requirements, including a deductible, coinsurance, or co-payment, on an enrollee.
An emergency bill passed by the Maryland General Assembly expands the authority of Gov. Hogan to prohibit cost–sharing by health plans for disease testing and associated costs.
The Maryland emergency bill also includes provisions regarding telemedicine. Gov. Hogan could establish or waive telehealth protocols, including authorizing health care professionals licensed out–of–state to provide telehealth to patients in Maryland. Further, he could order reimbursement for synchronous and asynchronous telehealth services provided to a patient, without regard to whether the patient is at a clinical site, if the service is (i) covered by the Maryland Medicaid program; (ii) provided by a health care provider participating in Maryland’s Medicaid program; and (iii) authorized under one’s scope of practice.
A number of states have waived licensure requirements. Mississippi is allowing out-of-state physicians to utilize telemedicine when treating patients in Mississippi without securing a Mississippi medical license provided the out-of-state physician holds an unrestricted license to practice medicine in the state in which the physician practices and currently is not the subject of an investigation or disciplinary proceeding.
The Arizona Department of Health Services and the Department of Insurance requires all state-regulated insurers to cover telemedicine visits at a lower cost-sharing point than in-office visits.
States are also addressing price gouging. Gov. Doug Ducey of Arizona has ordered the Arizona Department of Health Services and all Arizona health regulatory boards to prohibit, investigate, and take action against any licensed health professional or institution that engages in price gouging in relation to COVID-19. Price gouging is defined as “the provider or institution charging a grossly higher price than that which was charged before the onset of the emergency.”
Delaware and Maryland are defining price gouging as a 10% increase and apply to the sale of a number of goods and services.
(Updated on 3/27/20)