by: Karen Owens, Coppersmith Brockelman PLC[1]
Section 1557 of the Affordable Care Act,[2] the first health care-specific anti-discrimination provision in federal law, has been in the news again recently. The law and its regulations have had a complicated history, and the situation is still dynamic.
The Affordable Care Act passed in 2010, and an initial regulation set was promulgated in 2016.[3] That set established 1557’s broad coverage, including requirements that health care entities provide signage and documents in various languages and a declaration that the term “sex discrimination” in the law extended to protect transgender individuals and pregnancy-related health care. For the Trump Administration, rewriting the Section 1557 regulations was a priority, and 2020 saw the publication of an entirely new regulation set. The 2020 regulations made big changes, including narrowing the entities subject to Section 1557’s anti-discrimination provisions, limiting the language and signage requirements, and removing transgender and pregnancy-related protections.
Since then, the courts, including the U.S. Supreme Court, have weighed in on aspects of 1557 and related laws. Now the Biden Administration is actively addressing the scope of the regulations through enforcement positions and proposed revision to the regulations themselves.
Here is a summary of the status of the key regulatory provisions under Section 1557 and prospects for future changes.
Scope of Regulatory Coverage
The 2016 regulations had covered essentially all health insurers, prohibiting discriminatory denials, cancellations, limitations, refusals to issue or renew policies, denials and limitation of claims, imposition of discriminatory limitations/restrictions on coverage, and discriminatory marketing practices or benefit design.
The 2020 regulations, which are still in place, removed the blanket application of 1557 to virtually all health insurers. Currently, only the portions of an insurer’s business that receive federal funding are subject to regulation, and the only applicable federal funding is funding under title 1 of the Affordable Care Act. The practical effect is that insurers for the most part are no longer subject to Section 1557 regulations.
To date, we do not know whether the Biden Administration will address the scope of coverage through new regulations.
Scope of Sex Discrimination
1. Transgender Discrimination
The 2016 regulations defined sex discrimination to include discrimination based on gender identity and sex stereotyping (but not sexual orientation). The gender identity definition explicitly included gender expression/transgender status. This led to an explicit prohibition on denial of gender transition health care coverage and services, as well as a prohibition on the denial or limitation of services ordinarily available to only one sex/gender when a person of another sex/gender needed those services.
A federal district court in Texas issued a nationwide injunction on this part of the 2016 regulations before it went into effect.[4]
The 2020 regulations removed the definition of sex discrimination altogether and instructed health care entities to look to the “plain meaning in the statute,” which the Department of Health and Human Services (HHS) said was a biological binary of male/female based on birth. The 2020 regulations also removed the definition of “gender identity”; removed the requirement that individuals be treated consistent with their gender identity; removed the prohibition on refusing care ordinarily limited to one gender; and removed coverage requirements regarding gender transition services.
Then, in a game-changing opinion, in Bostock v. Clayton County, the U.S. Supreme Court held that Title VII protects employees from discrimination based on gender identity and sexual orientation.[5] In a 6-3 decision, Justice Gorsuch stated: “it is impossible to discriminate against a person for being homosexual or transgender without discriminating against that individual based on sex.” Id. At 1741. After Bostock, two federal district courts issue nationwide injunctions against enforcement of 2020 regs re gender identity and sexual orientation.[6]
The Biden Administration wasted no time in following up on Bostock. One of the President’s first-day Executive Orders stated: “All persons should receive equal treatment under the law, no matter their gender identity or sexual orientation” and ordered agency review of all regulations, policies, guidance, etc., inconsistent with this policy. On May 10, 2021, HHS said that the Office for Civil Rights would include gender identification and sexual orientation in its interpretation and enforcement of the Section 1557 sex discrimination prohibition. Notably, gender orientation was not in the 2016 regulations, but was approved in Bostock.
While we do not have a new set of regulations from the Biden Administration, there can be no doubt that any new regulations will renew protections for transgender individuals. Those protections may be broader than the 2016 provisions afforded, as they will incorporate protections based on sexual orientation in accordance with Bostock.
2. Pregnancy-Related Discrimination
The 2016 regulations also included pregnancy-related discrimination, including discrimination related to abortion, as part of 1557’s protections against “sex discrimination.” While the regulation allowed for a religious exemption, it was considered narrow. This part of the 1557 regulations also was the subject of a nationwide injunction before it went into effect.[7]
Unsurprisingly, the 2020 regulations eliminated the prohibition on discrimination based on pregnancy and pregnancy termination and created a blanket abortion and religious objection exemption.
The 2020 version remains in place. The injunction against enforcement of the regulations with respect to pregnancy is still the law, and the Biden Administration stated that it will abide by the injunction.
Limited English Proficiency (LEP) Discrimination
The 2016 regulationsstated that a covered entity must take reasonable steps to provide meaningful access to each LEPindividual eligible to be served or likely to be encountered in a health care entity. The entity had to evaluate and give substantial weight to the nature and importance of the health program/activity and the particular communication at issue. The regulations also required covered entities to offer a qualified interpreter when oral interpretation as a reasonable step to provide meaningful access, use a qualified translator when translating written content, and if no live interpreter was available, offer real-time video for foreign language interpreters, using a “sharply delineated image that is large enough to display the interpreter’s face. . . .”
Importantly, the 2016 regulations required health care entities to insert taglines on all “significant” documents and notices in top 15 languages in the state where the document would be received. Further, employers with at least 15 employees had to provide notices about nondiscrimination policies, designate at least one employee to carry out 1557 responsibilities, adopt grievance procedures with appropriate due process standards to resolve actions prohibited under Section 1557.
The 2020 regulations made huge changes. First, they changed the regulatory focus from individual patients to the overall handling of the LEP population. They stated that when language services are required, they must be free, accurate and timely, and preserve the privacy and independence of the LEP individuals. To determine whether language services would be required, the 2020 regulations adapted guidance from 2003 to call for a 4 factor test that deemphasized nature of the communication and focused on the number/proportion of LEP eligible/likely to be served; frequency of contact; nature/importance of program/activity; and resources & costs.
The 2020 regulations replaced the requirement that language interpreters be “qualified” with directives that interpreters must translates effectively, accurately, and impartially, both receptively and expressively, using any necessary specialized vocabulary, and must demonstrate proficiency in speaking or understanding, both spoken English and at least one other language.
The 2020 regulations replaced the real-time video requirement with real-time audio over a dedicated high-speed, wide bandwidth video connection or wireless connection that delivers high-quality audio without lags or irregular pauses in communication.
The 2020 regulations deleted the tagline and notice requirements entirely.
In the LEP area, all of the 2020 revisions to the Obama-era 1557 requirements remain in place. It remains to be seen whether the Biden Administration will re-impose any of the 2016 provisions; we can speculate that some of the 2020 streamlining may remain. For example, the tagline and multiple language provisions were widely seen as overly burdensome and may not be reimposed.
Disability Discrimination
In contrast to the LEP discrimination changes, there have been relatively few revisions regarding disability discrimination.
The 2016 regulations required covered entities to provide appropriate auxiliary aids and services to people with impaired sensory, manual, or speaking skills, where necessary to afford an equal opportunity to benefit from the health program or activity. They adopted the 2010 ADA Standards for Accessible Design for new construction or alternation of facilities of covered entities that receive federal funding and state-based Marketplaces. And they required covered entities to make reasonable modifications in policies, practices, and procedures to avoid disability-based discrimination, unless doing so would fundamentally alter the nature of the health program or activity.
The 2020 regulation set omitted “acquisition or modification of equipment and devices; and other similar services and actions” from the list of examples of appropriate auxiliary aids and services. The 2020 regulations left in place the 2010 ADA Standards for Accessible Design, and did not adopt additional exemptions for multi-story building elevators and TTY standards. And the 2020 regulation set maintained the 2016 “reasonable modification” standards.
There has not been a great deal of attention to the more modest 2020 revisions in this area. Again, it remains to be seen whether any regulations promulgated in the current HHS will address this area at all.
Grievances/Enforcement
The 2020 regulations made important changes to grievances and enforcement. First, they deleted the 2016 requirement of a grievance policy and a 1557 coordinator. Second, they removed the right to sue based on 1557 regulations. But HHS did acknowledge that a right to sue under the statute itself remains in place.
Again, we do not know whether HHS will pay attention to this area if and when new regulations are issued.
What’s Next?
- It seems likely that there will be further litigation around sex discrimination, probably addressing not only 1557 but Title VI, Title VII and Title IX.
- The Biden HHS has promised new regulations, but if they follow the timing pattern set by both the Obama and Trump Administrations, we should not expect them until 2024.
- We just don’t know whether/to what extent new regulations will restore or expand Section 1557 provisions unrelated to the definition of sex discrimination (e.g., discrimination in health insurance benefit design, language access, notices, grievance procedures, enforcement, covered entities, pregnancy termination).
- At present, virtually all of the 2020 regulations remain in place. The extent of enforcement (outside of transgender protections) is unknown. It may well be that the next iteration of 1557 standards will continue to be narrower than the initial version.
[1] With thanks to Trent Stechschulte, General Counsel and Compliance Officer, Equitas Health, Columbus, Ohio, whose slides on LEP and disability discrimination are the source of those parts of this blog.
[2] 42 U.S.C. § 18116.
[3] 42 C.F.R. §§ 92.1 et seq.
[4] Franciscan Alliance v. Burwell, 227 F.Supp.3d 660 (N.D. Tx 2016). On August 9, 2021, the court made the injunction permanent. Franciscan Alliance v. Becerra, 2021 WL 3492338, N.D.Tex., Aug. 09, 2021. See https://www.healthaffairs.org/do/10.1377/hblog20210811.110777/full/ for a discussion of the complicated history of this case.
[5] Bostock v. Clayton County, 140 S. Ct. 1731 (2020).
[6] Whitman-Walker Clinic v. Azar, 485 F. Supp. 3d 1 (D.D.C. 2020); Asapansa-Johnson-Walker v. Azar, 2020 WL 6363970 (E.D.N.Y.)
[7]See note 1.
Update on the Status of the Section 1557 Health Care Non-discrimination Regulations
by: Karen Owens, Coppersmith Brockelman PLC[1]
Section 1557 of the Affordable Care Act,[2] the first health care-specific anti-discrimination provision in federal law, has been in the news again recently. The law and its regulations have had a complicated history, and the situation is still dynamic.
The Affordable Care Act passed in 2010, and an initial regulation set was promulgated in 2016.[3] That set established 1557’s broad coverage, including requirements that health care entities provide signage and documents in various languages and a declaration that the term “sex discrimination” in the law extended to protect transgender individuals and pregnancy-related health care. For the Trump Administration, rewriting the Section 1557 regulations was a priority, and 2020 saw the publication of an entirely new regulation set. The 2020 regulations made big changes, including narrowing the entities subject to Section 1557’s anti-discrimination provisions, limiting the language and signage requirements, and removing transgender and pregnancy-related protections.
Since then, the courts, including the U.S. Supreme Court, have weighed in on aspects of 1557 and related laws. Now the Biden Administration is actively addressing the scope of the regulations through enforcement positions and proposed revision to the regulations themselves.
Here is a summary of the status of the key regulatory provisions under Section 1557 and prospects for future changes.
Scope of Regulatory Coverage
The 2016 regulations had covered essentially all health insurers, prohibiting discriminatory denials, cancellations, limitations, refusals to issue or renew policies, denials and limitation of claims, imposition of discriminatory limitations/restrictions on coverage, and discriminatory marketing practices or benefit design.
The 2020 regulations, which are still in place, removed the blanket application of 1557 to virtually all health insurers. Currently, only the portions of an insurer’s business that receive federal funding are subject to regulation, and the only applicable federal funding is funding under title 1 of the Affordable Care Act. The practical effect is that insurers for the most part are no longer subject to Section 1557 regulations.
To date, we do not know whether the Biden Administration will address the scope of coverage through new regulations.
Scope of Sex Discrimination
1. Transgender Discrimination
The 2016 regulations defined sex discrimination to include discrimination based on gender identity and sex stereotyping (but not sexual orientation). The gender identity definition explicitly included gender expression/transgender status. This led to an explicit prohibition on denial of gender transition health care coverage and services, as well as a prohibition on the denial or limitation of services ordinarily available to only one sex/gender when a person of another sex/gender needed those services.
A federal district court in Texas issued a nationwide injunction on this part of the 2016 regulations before it went into effect.[4]
The 2020 regulations removed the definition of sex discrimination altogether and instructed health care entities to look to the “plain meaning in the statute,” which the Department of Health and Human Services (HHS) said was a biological binary of male/female based on birth. The 2020 regulations also removed the definition of “gender identity”; removed the requirement that individuals be treated consistent with their gender identity; removed the prohibition on refusing care ordinarily limited to one gender; and removed coverage requirements regarding gender transition services.
Then, in a game-changing opinion, in Bostock v. Clayton County, the U.S. Supreme Court held that Title VII protects employees from discrimination based on gender identity and sexual orientation.[5] In a 6-3 decision, Justice Gorsuch stated: “it is impossible to discriminate against a person for being homosexual or transgender without discriminating against that individual based on sex.” Id. At 1741. After Bostock, two federal district courts issue nationwide injunctions against enforcement of 2020 regs re gender identity and sexual orientation.[6]
The Biden Administration wasted no time in following up on Bostock. One of the President’s first-day Executive Orders stated: “All persons should receive equal treatment under the law, no matter their gender identity or sexual orientation” and ordered agency review of all regulations, policies, guidance, etc., inconsistent with this policy. On May 10, 2021, HHS said that the Office for Civil Rights would include gender identification and sexual orientation in its interpretation and enforcement of the Section 1557 sex discrimination prohibition. Notably, gender orientation was not in the 2016 regulations, but was approved in Bostock.
While we do not have a new set of regulations from the Biden Administration, there can be no doubt that any new regulations will renew protections for transgender individuals. Those protections may be broader than the 2016 provisions afforded, as they will incorporate protections based on sexual orientation in accordance with Bostock.
2. Pregnancy-Related Discrimination
The 2016 regulations also included pregnancy-related discrimination, including discrimination related to abortion, as part of 1557’s protections against “sex discrimination.” While the regulation allowed for a religious exemption, it was considered narrow. This part of the 1557 regulations also was the subject of a nationwide injunction before it went into effect.[7]
Unsurprisingly, the 2020 regulations eliminated the prohibition on discrimination based on pregnancy and pregnancy termination and created a blanket abortion and religious objection exemption.
The 2020 version remains in place. The injunction against enforcement of the regulations with respect to pregnancy is still the law, and the Biden Administration stated that it will abide by the injunction.
Limited English Proficiency (LEP) Discrimination
The 2016 regulationsstated that a covered entity must take reasonable steps to provide meaningful access to each LEPindividual eligible to be served or likely to be encountered in a health care entity. The entity had to evaluate and give substantial weight to the nature and importance of the health program/activity and the particular communication at issue. The regulations also required covered entities to offer a qualified interpreter when oral interpretation as a reasonable step to provide meaningful access, use a qualified translator when translating written content, and if no live interpreter was available, offer real-time video for foreign language interpreters, using a “sharply delineated image that is large enough to display the interpreter’s face. . . .”
Importantly, the 2016 regulations required health care entities to insert taglines on all “significant” documents and notices in top 15 languages in the state where the document would be received. Further, employers with at least 15 employees had to provide notices about nondiscrimination policies, designate at least one employee to carry out 1557 responsibilities, adopt grievance procedures with appropriate due process standards to resolve actions prohibited under Section 1557.
The 2020 regulations made huge changes. First, they changed the regulatory focus from individual patients to the overall handling of the LEP population. They stated that when language services are required, they must be free, accurate and timely, and preserve the privacy and independence of the LEP individuals. To determine whether language services would be required, the 2020 regulations adapted guidance from 2003 to call for a 4 factor test that deemphasized nature of the communication and focused on the number/proportion of LEP eligible/likely to be served; frequency of contact; nature/importance of program/activity; and resources & costs.
The 2020 regulations replaced the requirement that language interpreters be “qualified” with directives that interpreters must translates effectively, accurately, and impartially, both receptively and expressively, using any necessary specialized vocabulary, and must demonstrate proficiency in speaking or understanding, both spoken English and at least one other language.
The 2020 regulations replaced the real-time video requirement with real-time audio over a dedicated high-speed, wide bandwidth video connection or wireless connection that delivers high-quality audio without lags or irregular pauses in communication.
The 2020 regulations deleted the tagline and notice requirements entirely.
In the LEP area, all of the 2020 revisions to the Obama-era 1557 requirements remain in place. It remains to be seen whether the Biden Administration will re-impose any of the 2016 provisions; we can speculate that some of the 2020 streamlining may remain. For example, the tagline and multiple language provisions were widely seen as overly burdensome and may not be reimposed.
Disability Discrimination
In contrast to the LEP discrimination changes, there have been relatively few revisions regarding disability discrimination.
The 2016 regulations required covered entities to provide appropriate auxiliary aids and services to people with impaired sensory, manual, or speaking skills, where necessary to afford an equal opportunity to benefit from the health program or activity. They adopted the 2010 ADA Standards for Accessible Design for new construction or alternation of facilities of covered entities that receive federal funding and state-based Marketplaces. And they required covered entities to make reasonable modifications in policies, practices, and procedures to avoid disability-based discrimination, unless doing so would fundamentally alter the nature of the health program or activity.
The 2020 regulation set omitted “acquisition or modification of equipment and devices; and other similar services and actions” from the list of examples of appropriate auxiliary aids and services. The 2020 regulations left in place the 2010 ADA Standards for Accessible Design, and did not adopt additional exemptions for multi-story building elevators and TTY standards. And the 2020 regulation set maintained the 2016 “reasonable modification” standards.
There has not been a great deal of attention to the more modest 2020 revisions in this area. Again, it remains to be seen whether any regulations promulgated in the current HHS will address this area at all.
Grievances/Enforcement
The 2020 regulations made important changes to grievances and enforcement. First, they deleted the 2016 requirement of a grievance policy and a 1557 coordinator. Second, they removed the right to sue based on 1557 regulations. But HHS did acknowledge that a right to sue under the statute itself remains in place.
Again, we do not know whether HHS will pay attention to this area if and when new regulations are issued.
What’s Next?
[1] With thanks to Trent Stechschulte, General Counsel and Compliance Officer, Equitas Health, Columbus, Ohio, whose slides on LEP and disability discrimination are the source of those parts of this blog.
[2] 42 U.S.C. § 18116.
[3] 42 C.F.R. §§ 92.1 et seq.
[4] Franciscan Alliance v. Burwell, 227 F.Supp.3d 660 (N.D. Tx 2016). On August 9, 2021, the court made the injunction permanent. Franciscan Alliance v. Becerra, 2021 WL 3492338, N.D.Tex., Aug. 09, 2021. See https://www.healthaffairs.org/do/10.1377/hblog20210811.110777/full/ for a discussion of the complicated history of this case.
[5] Bostock v. Clayton County, 140 S. Ct. 1731 (2020).
[6] Whitman-Walker Clinic v. Azar, 485 F. Supp. 3d 1 (D.D.C. 2020); Asapansa-Johnson-Walker v. Azar, 2020 WL 6363970 (E.D.N.Y.)
[7]See note 1.
Deputy General Counsel – Office of Administrative Legal Services
The Office of Administrative Legal Services (OALS) is looking for a highly motivated individual to join our team as a Deputy General Counsel. This position will focus on providing legal services to…
Staff Attorney – HonorHealth
Requisition IDJob LocationShiftDepartmentFacilityPosition TypePhysical Work LocationWork Hours2021-39997US-AZ Scottsdale01-DaysLegalSupport ServicesRegular Full-Time8125 N Hayden RdMonday- Friday 8am-5pm Overview HonorHealth is a non-profit, local community healthcare system serving an area of 1.6 million…
OCTOBER 22, 2021 PROGRAM ANNOUNCEMENT
Eliminating Racial Disparities in Maternal Mortality and Morbidity
Time: 12:00 noon to 1:30 pm
Place: Cisco WebEx
Maternal mortality in the United States has steadily increased over the last quarter century, meaning that the United States is currently a deadlier place to be pregnant and give birth than it was in the recent past. Researchers estimate that more than half of these deaths are preventable. The path to motherhood is significantly deadlier for women of color than it is for their white counterparts. Nationally, black women are three to four times as likely to die from pregnancy-related causes than white women, a disparity that has only widened in recent years. There is also significant variation in racial disparities in maternal mortality across cities and states, with some states experiencing far poorer maternal outcomes than others.[1] In Arizona, maternal mortality rates are far higher for Native American women than any other group.
This presentation will explore the injustice of racial disparities in maternal mortality, both nationally and in Arizona. This distinguished panel of speakers will discuss the data demonstrating that birthing individuals of color in Arizona experience maternal mortality and morbidity at strikingly higher rates than white birthing persons, explain some of the contributing factors, describe evidence-based solutions that have been identified and successfully implemented, and discuss what healthcare attorneys can do to effect change on this critical issue.
Speaker Biographies:
Andrew F. Rubenstein, MD, is the Academic Chair of Women’s Health, Obstetrics and Gynecology at the Dignity Health Medical Group at Dignity Health/St. Joseph’s Hospital and Medical Center in Phoenix, Arizona, Vice-Chair in the Department of Obstetrics & Gynecology at the Creighton University School of Medicine – Phoenix Campus and an Associate Professor at the Creighton University School of Medicine – Phoenix Campus. He presently serves as the Co-Chair of the Arizona Department of Health Services (AZDHS) Maternal Mortality Review Committee (MMRC) and on the Executive Committee for the Arizona Alliance for Innovation for Maternal Health (AZ AIM).
As a women’s health care leader, Dr. Rubenstein’s vision is that the maternal and child health care teams must come together to ensure that every care setting has a systematic and comprehensive framework for obstetrical and perinatal care delivery and delivers this within the health equity lens. By focusing on improving and monitoring quality metrics, related to obstetrical and postpartum care, and collaborating with colleagues on advancement of maternal child health, health equity and standardization of health care processes, Dr. Rubenstein has emerged as an early champion in helping to improve obstetrical safety and maternal health care outcomes.
Leila Barraza, J.D., M.P.H., is an Associate Professor in Community, Environment & Policy at the Mel and Enid Zuckerman College of Public Health, University of Arizona, and a Senior Consultant for the Western Region of the Network for Public Health Law. She is also the Director of the Arizona Area Health Education Centers Program. Her research interests include studying the impact of laws and policies on population health, both nationally and globally. Professor Barraza instructs a public health law course for public health and law students, and she has also provided numerous presentations at national and local conferences on a variety of critical public health law issues.
Patricia Tarango currently serves as the Chief for the Bureau of Women’s and Children’s Health, Division of Public Health Prevention Services, Arizona Department of Health Services (ADHS). In her role as Bureau Chief, Patricia functions as the Maternal & Child Health Director. A proud native of rural Arizona from Pinal County, she has dedicated her career to improving access to care for Arizona residents. Most recently Patricia provided leadership for the development of a comprehensive Maternal Health Action Plan, the Maternal Health Task Force and secured two federal grants dedicating resources to the Maternal Mortality Review Program and the Maternal Health Improvement Program. Patricia is a member of the Arizona Public Health Association, Arizona Rural Health Association and served previously as a community Representative on Chicano’s Por La Causa, Early Childhood Head Start Policy Council and the Arizona Medical Student Loan Program Board. Currently, Patricia serves as the ADHS Designee on the First Things First Board. Patricia holds an Associate degree from Central Arizona College, a Bachelor’s degree in Social Work from Arizona State University – Go DEVILS! — a Master’s degree in Health Administration from the University of St. Francis and holds Leadership certificates from Arizona State University, W.P. Carey College of Business and the Hispanic Leadership Institute, Arizona State University, Valle del Sol.
Breann Westmore is the Advocacy and Government Affairs Director at Centering Healthcare Institute (CHI). CHI is a non-profit organization with the mission is to improve health, transform care and disrupt inequitable systems through the Centering group model. As a Director of Advocacy & Government Affairs, Breann works to create and support evidence-based health policy, develop a pathway for access to care/payment reform, and mobilize advocates to expand the utilization of the Centering model. Prior to joining CHI, Breann served as the Maternal Infant Health & Government Affairs Director for March of Dimes for 8 years. Past policy wins including expanding access to care, newborn screening innovations, and enhanced data surveillance and monitoring of maternal morbidity and mortality. She lives in Phoenix, Arizona with her husband and two kids.
Due to the current social distancing recommendations, this program will be held via video conference through Cisco WebEx. This program will be $10 for members and $15 for non-members.
To register, please visit our website https://azsha.org/, click upcoming programs, on the right you will see a button that says “Register for Next Program Pay Now”. This button will take you to a screen with multiple payment options. Please select your membership level. If you are a member, please login and proceed with the payment process. If you are not a member, you will have to create a username and password to continue with the payment process.
Once you have registered online, you will receive a calendar invite containing the WebEx link. Please note, you don’t need to sign up for a WebEx Account to join a meeting.
The State Bar of Arizona does not approve or accredit CLE activities for the Mandatory Continuing Legal Education requirement. This activity may qualify for up to 1.5 hours of CLE credit, 0 hours of ethics, toward your annual requirement for the State Bar of Arizona.
SEPTEMBER 23, 2021 PROGRAM ANNOUNCEMENT
Got Data? : How the Health Data Rules are Changing
Time: 12:00 noon to 1:00 pm
Place: Cisco WebEx
The past year has been one of the most consequential for health privacy and data rules in decades – and not just because of COVID-19. Massive changes to rules governing health data uses and sharing have either already occurred or will go into effect shortly. Join us for a webinar on September 23, 2021 covering the recent and upcoming developments impacting health data. The presenters will address:
Joanne Charles, Principal Corporate Counsel, Privacy and Regulatory Counsel, Microsoft. Joanne Charles’s practice focus is on privacy and global data protection, assessing multi-jurisdictional legal and regulatory obligations and integrating compliance into emerging technologies.
Elliot Golding, Partner, Squire Patton Boggs. Elliot Golding (CIPP/US) is a member of Squire Patton Boggs’ Data Privacy, Cybersecurity & Digital Assets Practice and Healthcare Industry Group leadership team, where he provides business-oriented privacy and cybersecurity advice to a wide range of clients, with a particular focus on companies handling healthcare and other personal data. He has been selected as an honoree in Global Data Review’s inaugural 40 Under 40 list, representing the best of the data law bar around the world.
Melissa Soliz, Partner, Coppersmith Brockelman PLC. Mel Soliz’s regulatory health law practices focuses on compliance with data privacy and patient access laws, such as HIPAA, 42 C.F.R. Part 2, the ONC Information Blocking Rule, the CMS Interoperability and Patient Access Rule, and state laws. She is recognized by Best Lawyers© for her work in health law.
Due to the current social distancing recommendations, this program will be held via video conference through Cisco WebEx. This program will be $10 for members and $15 for non-members.
To register, please visit our website https://azsha.org/, click upcoming programs, on the right you will see a button that says “Register for Next Program Pay Now”. This button will take you to a screen with multiple payment options. Please select your membership level. If you are a member, please login and proceed with the payment process. If you are not a member, you will have to create a username and password to continue with the payment process.
Once you have registered online, you will receive a calendar invite containing the WebEx link. Please note, you don’t need to sign up for a WebEx Account to join a meeting.
The State Bar of Arizona does not approve or accredit CLE activities for the Mandatory Continuing Legal Education requirement. This activity may qualify for up to 1 hour of CLE credit, 0 hours of ethics, toward your annual requirement for the State Bar of Arizona.
Five Things Healthcare Providers Should know about Reporting Use of Provider Relief Funds
by: Miranda A. Preston and James R. Taylor, Milligan Lawless
The Provider Relief Fund (PRF) was created to reimburse healthcare providers for lost revenue attributable to COVID-19 or health-related expenses incurred to prevent, prepare for, and respond to COVID-19. Under the CARES Act, Congress appropriated $178B for the PRF, and to date, $118B has been paid to and attested by healthcare providers throughout the country. In Arizona, 7,813 healthcare providers have received PRF payments, totaling $1.64B.[1] Currently, 260 Arizona providers, including hospitals, skilled nursing facilities, assisted living facilities, surgery centers, medical practices, dentists, and hospices, have each received over $750,000 in PRF payments. In light of a substantial likelihood of future audits, this article summarizes five items providers should know regarding their mandatory reporting obligations to the U.S. Department of Health and Human Services (HHS).
1. Providers who Received PRF Payments during the First Half of 2020 Must Report by September 30, 2021.
Providers who received one or more payments exceeding $10,000 in the aggregate during a PRF Payment Received Period[2] are required to submit reports to HHS as to how they used the PRF funds. The PRF reporting portal is now open, and HHS recently issued new guidance on the use and reporting of PRF payments. In this guidance, HHS adopted a multiphase reporting system, pursuant to which the deadlines for the provider’s use and reporting of PRF funds are based on the specific dates on which the provider received the PRF payments. Providers who received payments under the first automatic distribution on April 10, 2020 must report on the payments they received between April 10, 2020 and June 30, 2020 (“Period 1”) by September 30, 2021. HHS has made it clear that it will not grant extensions for reporting.[3] Failing to report within the applicable time period(s) is a breach of the Terms and Conditions applicable to the recipient of the PRF distribution, and may result in recoupment of PRF funds received.[4]
2. Providers who received PRF payments after the initial automatic April 10, 2020 funding, have differing reporting requirements, as set forth in the chart below.
The reporting deadlines apply to all recipients who received one or more payments exceeding $10,000 in the aggregate during a Payment Received Period. Recipients who received PRF payments during multiple Payment Received Periods are required to submit multiple reports. Providers need to register a PRF reporting account before they can begin reporting. HHS has published a Registration User Guide, and Reporting Portal FAQs to assist providers with the registration process.
3. There are New Flexibilities For Providers in Calculating Lost Revenues
Providers can allocate the entirety of their PRF payments to Lost Revenue. In the use of funds calculation, PRF payments that are not first allocated to unreimbursed expenses are then allocated towards a provider’s lost revenue. It was previously unclear whether providers who had no unreimbursed expenses attributable to the coronavirus could allocate the entirety of the PRF payments they received towards lost revenue. In a July 1, 2021 FAQ, HHS clarified that PRF payments could be applied solely to a provider’s lost revenues.[5] However, lost revenues or expenses must only have been incurred during the period of availability correlating to the Payment Received Date. The FAQs clarify that a provider’s lost revenue is calculated on a quarterly basis. PRF recipients still have three options for calculating lost revenue:
Option i: The difference between actual patient care revenues;
Option ii: The difference between budgeted (prior to March 27, 2020) and actual patient care revenues.
Option iii: A calculation by any reasonable method of estimating revenues.
The FAQ clarify that “…for Option i and Option ii, lost revenues are calculated for each quarter during the period of availability as a standalone calculation, with 2019 quarters serving as a baseline. For each calendar year of reporting, the applicable quarters where lost revenue is demonstrated are totaled to determine an annual lost revenue amount. There’s no offset [of quarters during the period of availability where the provider didn’t experience lost revenue.]”[6]
Further, HHS clarified that for providers who have more lost revenue in a Payment Received Period than PRF payments for the same period, that portion of lost revenue can be carried forward and applied against payments received during later Payment Received Periods and included in the lost revenues reported for later reporting periods, provided expenses and lost revenues are not duplicated.[7]
4. Maintaining Detailed Documentation is Critical.
Pursuant to the Terms and Conditions that providers are bound by in connection with their receipt of PRF payments, providers are required to maintain supporting documentation demonstrating that costs were obligated/incurred during the Period of Availability. Providers aren’t required to submit that documentation when reporting, but HHS has clearly stated that it will audit the use of PRF payments and recoup payments if the provider’s expenses are not supported by adequate documentation.[8]
5. HHS is Developing an Appeals Process.
In recognition that providers may have questions regarding the accuracy of their PRF payments, HHS recently added a new FAQ stating that it will soon introduce a structured reconsiderations process to review and reconsider PRF payment uses based on the provider’s submitted supporting documentation.[9]
[1] https://taggs.hhs.gov/Coronavirus/Providers
[2] The Payment Received Period describes a specific time period when the recipient received one or more payments. The payment is considered received on the deposit date for automated clearing house (ACH) payments or the check cashed date. There are four Payment Received Periods during the time frame between April 10, 2020 to December 31, 2021. https://www.hhs.gov/coronavirus/cares-act-provider-relief-fund/reporting-auditing/index.html
[3] PRF FAQ regarding extensions (available at https://www.hhs.gov/sites/default/files/provider-relief-fund-general-distribution-faqs.pdf), states: “Are providers able to request extensions on submissions of their required reports for any of the required reporting periods? (Added 7/1/2021)” To which HHS’s reply is, “No. Providers that received one or more payments exceeding $10,000, in the aggregate, during a Payment Received Period are required to report in each applicable Reporting Time Period. Providers that are required to report and do not submit a completed report by the applicable deadlines will be deemed out of compliance with the program Terms and Conditions and may be subject to recoupment.”
[4] The Terms and Conditions applicable to the recipients of each type of PRF distribution require the recipient to submit reports as specified by HHS in future program instructions. The Terms and Conditions also provide that non-compliance with the Terms and Conditions is grounds for HHS to recoup PRF funds. To view the Terms and Conditions applicable to the various PRF distributions, click here.
[5] Id.
[6] Id.
[7] Id.
[8] Pursuant to HHS PRF FAQ available at https://www.hhs.gov/sites/default/files/provider-relief-fund-general-distribution-faqs.pdf, HHS states that “HHS reserves the right to audit Provider Relief Fund recipients now or in the future, and is authorized to collect any Provider Relief Fund payment amounts that have not been supported by documented expenses or revenue losses attributable to coronavirus or not used in a manner consistent with program requirements or applicable law. All payment recipients must attest to the Terms and Conditions, which require the submission of documentation to substantiate that these funds were used for health care-related expenses or lost revenues attributable to coronavirus.”
[9] Id.
August 17, 2021 PROGRAM ANNOUNCEMENT
Section 1557 of the Affordable Care Act: What Health Care Lawyers Need to Know
Time: 12:00 noon to 1:00 pm
Place: Cisco WebEx
Our August 17 program takes up Section 1557 of the Affordable Care Act and its regulations. Section 1557 was the first health care-specific anti-discrimination provision in federal law. Regulations promulgated in 2016 established the provision’s broad coverage, including requirements that health care entities provide signage and documents in various languages and a declaration that the term “sex discrimination” in the law extended to protect transgender individuals. The Trump Administration made changing the Section 1557 regulations a priority, narrowing the entities subject to the law, limiting the language requirements, removing transgender protections, and focusing on religious discrimination. Since then, the courts, including the U.S. Supreme Court, have weighed in on aspects of the law, and now the Biden Administration is actively addressing the scope of the regulation through enforcement positions and proposed revision to the regulations. Meanwhile, healthcare entities have pursued their own course, continuing to incorporate anti-discrimination provisions into their policies and culture.
This program will address the history, current status and course forward for Section 1557 and its regulations, including discussion of major court decisions and practical realities for providers.
Our speakers are:
Due to the current social distancing recommendations, this program will be held via video conference through Cisco WebEx. This program will be $10 for members and $15 for non-members.
To register, please click here, or click on the button to the right that says “Register for Next Program Pay Now”. This button will take you to a screen with multiple payment options. If you are a member, please login and proceed with the payment process. If you are not a member, you will have to create a username and password to continue with the payment process.
Once you have registered online, you will receive a calendar invite containing the WebEx link. Please note, you don’t need to sign up for a WebEx Account to join a meeting.
The State Bar of Arizona does not approve or accredit CLE activities for the Mandatory Continuing Legal Education requirement. This activity may qualify for up to 1 hour of CLE credit, 0 hours of ethics, toward your annual requirement for the State Bar of Arizona.
July 28, 2021 PROGRAM ANNOUNCEMENT
The Untenable Dilemma – The Department of Justice and Walmart Spar Over Both a Pharmacist and a Corporation’s Role Under the Controlled Substances Act
Time: 12:00 noon to 1:00 pm
Place: Cisco WebEx
In an increasingly demanding environment in which pharmacies may fill hundreds of prescriptions in a single day for patients, the U.S. Department of Justice has recently filed a number of lawsuits against corporations and individual pharmacists, taking an increasingly expansive view of their roles and responsibilities under the Controlled Substances Act. Two such cases have pitted Walmart Inc. against the DOJ. And the outcome of these cases is likely to have far-reaching implications for (1) a corporation’s responsibility to train and supervise pharmacists, as well as to institute safeguards to prevent drug diversion, and (2) an individual pharmacist’s duty to investigate suspicious prescriptions.
Vinnie Lichvar is an experienced litigator focused in healthcare law and criminal defense. He routinely represents corporations and individuals in government investigations, regulatory enforcement matters, and white-collar litigation. His healthcare law practice focuses on the representation of hospitals, pharmacies, laboratories and other healthcare facilities, physicians, nurses and other professionals in malpractice, credentialing and licensure board matters. He has represented private companies and individuals in regulations matters, including investigations by the Department of Justice and the Attorney General’s Office. His experience includes conducting internal investigations and responding to inquiries from state and federal government agencies. He also focuses on healthcare compliance, transactions and regulatory matters for healthcare organizations and physicians, including medical staff matters, HIPAA, Stark, ambulatory surgery centers, fraud and abuse, peer review, risk management, physician employment contracting, joint ventures, practice formation and separation.
Due to the current social distancing recommendations, this program will be held via video conference through Cisco WebEx. This program will be $10 for members and $15 for non-members.
To register, please click here, or click on the button to the right that says “Register for Next Program Pay Now”. This button will take you to a screen with multiple payment options. If you are a member, please login and proceed with the payment process. If you are not a member, you will have to create a username and password to continue with the payment process.
Once you have registered online, you will receive a calendar invite containing the WebEx link. Please note, you don’t need to sign up for a WebEx Account to join a meeting.
The State Bar of Arizona does not approve or accredit CLE activities for the Mandatory Continuing Legal Education requirement. This activity may qualify for up to 1 hour of CLE credit, 0 hours of ethics, toward your annual requirement for the State Bar of Arizona.
New Legislation Makes Telehealth More Accessible in Arizona
June 15, 2021 PROGRAM ANNOUNCEMENT
2021 Legislative and Regulatory Update
Time: 12:00 noon to 1:00 pm
Place: Cisco WebEx
This year’s program will focus on state measures from the 2021 legislative session and current federal health care initiatives. And it’s never too early to talk about elections, so the program will also provide some early insight on statewide elections for next year.
Jason Bezozo worked at the Arizona State Senate as the Senior Legislative Research Analyst for the Senate Health Committee and as Assistant Director for the Senate Research Staff. He joined the Arizona Hospital and Healthcare Association in 2002 as the Director of Government Affairs and Policy and then joined Banner Health in 2006 to manage government relations across the health care system. He has a history degree from ASU and a Master’s in business administration from University of Phoenix.
Greg Ensell is Vice President, Government Relations with the Arizona Hospital and Healthcare Association (AzHHA). In that capacity, he leads the organization’s lobbying and political engagement efforts. For more than twenty years, Mr. Ensell has held public affairs and government relations positions for organizations including, Cox Communications, the Arizona State Senate, and the Phoenix Chamber of Commerce.
Due to the current social distancing recommendations, this program will be held via video conference through Cisco WebEx. This program will be $10 for members and $15 for non-members.
To register, please visit our website https://azsha.org/, click upcoming programs, on the right you will see a button that says “Register for Next Program Pay Now”. This button will take you to a screen with multiple payment options. Please select your membership level. If you are a member, please login and proceed with the payment process. If you are not a member, you will have to create a username and password to continue with the payment process.
Once you have registered online, you will receive a calendar invite containing the WebEx link. Please note, you don’t need to sign up for a WebEx Account to join a meeting.
The State Bar of Arizona does not approve or accredit CLE activities for the Mandatory Continuing Legal Education requirement. This activity may qualify for up to 1 hour of CLE credit, 0 hours of ethics, toward your annual requirement for the State Bar of Arizona.