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How Telehealth Flexibility Driven By COVID-19 is Improving Mental Health Access

Stephanie Raborn

Despite Mental Health Parity laws, access to mental health services in the United States is limited.[1] A combination of cost, providers’ preferences for cash-based practices, and ongoing stigma about psychological and psychiatric services make it harder for individuals to access mental health services.[2] This problem is exacerbated by the global pandemic in terms of increased anxiety caused by physical and economic uncertainty and loss of income, including loss of health coverage benefits through employer-sponsored insurance.[3] But there is some good news—regulators’ and providers’ increased flexibility is making it easier to obtain mental health services through telemedicine.[4]

There are further improvements needed—like creating a pathway for individuals to obtain prescriptions currently blocked by the Ryan Haight Act[5]—but the legislative and regulatory response to access issues occurring as a result of the COVID-19 pandemic are a step in the right direction. For example, Pennsylvania has temporarily suspended program limits on the amount of services that can be provided through telehealth.[6] Maryland is allowing residential substance use disorder treatment programs to provide telehealth services to Medicaid patients and qualified uninsured Marylanders.[7] And Connecticut, while still requiring that participants be at Medicaid-enrolled originating sites to receive certain services­­—such as opioid treatment programs—via telemedicine, has removed limitations for originating sites for individual therapy, family therapy, or psychotherapy with medication management.[8]

Further, the Department of Health and Human Services as released guidance encouraging the use of telehealth for provision of various health services.[9] Insurers are getting on board, too. In July, Blue Cross Blue Shield of Massachusetts announced a plan to expand access to telehealth services by releasing a new incentive plan that reimburses child psychiatrists at a rate fifty percent higher than the standard rate schedule in exchange for agreeing to maintain availability in their practices for Blue Cross Blue Shield Members.[10] Cigna eliminated cost-sharing not only for telehealth visits from primary-care providers, but also for telehealth visits for behavioral health.[11] And Optum, a subsidiary of UnitedHealth Group, expanded availability of telehealth visits including growing its number of behavioral health providers.[12]

And indeed, there has been a dramatic increase in utilization of telehealth services overall amidst the pandemic.[13] Whether these measures take root and further expand access to mental health services remains to be seen, but they are a small victory, and as such are worth celebrating.

[1] New Study Reveals Lack of Access as Root Cause for Mental Health Crisis in America, National Council for Behavioral Health (Oct. 10, 2018), https://www.thenationalcouncil.org/press-releases/new-study-reveals-lack-of-access-as-root-cause-for-mental-health-crisis-in-america/#:~:text=These%20beliefs%20are%20driven%20by,for%20accessing%20mental%20health%20care..

[2]Mental Health in America: Access to Care Data, Mental Health America, https://www.mhanational.org/issues/mental-health-america-access-care-data  (last visited Aug. 2, 2020) (reporting that in 2020, 10.7%, or over 4.7 million, adults with mental illness remained uninsured).

[3] Alvin Powell, Feeling more anxious and stressed? You’re not alone, The Harvard Gazette (Apr. 16, 2020), https://news.harvard.edu/gazette/story/2020/04/rising-mental-health-concerns-in-the-coronavirus-era/ (highlighting individual responses reporting increased stress and anxiety being linked to the Covid-19 pandemic). See also Nirmita Panchal et al., The Implications of Covid-19 for Mental Health and Substance Use, Kaiser Family Foundation (Apr. 21, 2020), https://www.kff.org/coronavirus-covid-19/issue-brief/the-implications-of-covid-19-for-mental-health-and-substance-use/ (noting that in a Kaiser Family Foundation poll, forty-five percent of polled individuals reported a negative impact on their mental health “over worry and stress over the virus”).

[4] Madeline Guth and Elizabeth Hinton, State Efforts to Expand Medicaid Coverage & Access to Telehealth in Response to COVID-19, Kaiser Family Foundation (June 22, 2020),  https://www.kff.org/coronavirus-covid-19/issue-brief/state-efforts-to-expand-medicaid-coverage-access-to-telehealth-in-response-to-covid-19/.

[5] See Kierin Bernard, Telemedicine and the Ryan Haight Act: An Analysis of the Ryan Haight Act’s Statutory Purpose, its Inadvertently Negative Impact on the Telemedicine Industry, and the Future of Telemedicine, 10 Wake Forest J. L. & Pol’y 59, 64 (2019) (noting that “[o]ne of the most significant legislative limitations of telemedicine . . . is the requirement of the Ryan Haight Act that providers must conduct an in-person exam before they can prescribe controlled medications to their patients.”).

[6] Memorandum from the Pennsylvania Office of Mental Health and Substance Abuse Services (OMHSAS) (Mar. 15, 2020), https://www.dos.pa.gov/ProfessionalLicensing/Documents/OMHSAS-COVID-19-Telehealth-Expansion.pdf.

[7] Telehealth Guidance for SUD Residential Treatment Services During the COVID-19 Outbreak, Maryland Dep’t of Health (Apr. 15, 2020), https://maryland.optum.com/content/dam/ops-maryland/documents/provider/Alerts/april2020/Telehealth%20SUD%20Residential%20Treatment%20Guidance_041520.pdf.

[8] Connecticut Medical Assistance Program Provider Bulletin (Mar. 13, 2020), https://www.ctdssmap.com/CTPortal/Information/Get%20Download%20File/tabid/44/Default.aspx?Filename=pb20_09.pdf&URI=Bulletins/pb20_09.pdf.

[9] Telehealth: Delivering Care Safely During COVID-19, HHS.gov, https://www.hhs.gov/coronavirus/telehealth/index.html (last visited Aug. 2, 2020).

[10] Blue Cross Blue Shield of Massachusetts Announces Bold New Action To Expand Members’ Access to Mental Health Services, Blue Cross Blue Shield of Massachusetts (July 23, 2020),  http://newsroom.bluecrossma.com/2020-07-23-Blue-Cross-Blue-Shield-of-Massachusetts-Announces-Bold-New-Action-To-Expand-Members-Access-to-Mental-Health-Services.

[11] Cigna Expands and Extends its COVID-19 Relief for Medicare Advantage and Individual and Family Plans, Cigna Newsroom (June 1, 2020), https://www.cigna.com/newsroom/news-releases/2020/cigna-expands-and-extends-its-covid-19-relief-efforts-for-medicare-advantage-and-individual-and-family-plans.

[12] Optum Helping People Stay Connected with Needed Behavioral Health Support During COVID-19, BusinessWire (May 11, 2020), https://www.businesswire.com/news/home/20200511005259/en/Optum-Helping-People-Stay-Connected-Needed-Behavioral (discussing Optum’s expansion of behavioral health by adding more telehealth providers and expanding the availability of telehealth visits).

[13] Assistant Sec’y Plan. Educ., Medicare Beneficiary Use of Telehealth Visits: Early Data from the Start of the Covid-19 Pandemic, HHS.gov, 3 (July 2020) https://aspe.hhs.gov/system/files/pdf/263866/HP_IssueBrief_MedicareTelehealth_final7.29.20.pdf.

A Title IX Timing Conundrum

Manning Peeler

          This post discusses the timing of the recently released Title IX final regulation by the U.S. Department of Education.  For an in-depth consideration of cross-examination in campus Title IX hearings, see Manning’s forthcoming article in the Wake Forest Journal of Law & Policy Volume 10, Issue 3 entitled Seeking Clarity in the Title IX Confusion: Cross-Examination Requirement in Title IX Hearings Under Due Process.

As universities continue to deal with the significant changes to education and campus life caused by the novel coronavirus pandemic, the U.S. Department of Education (DOE) released the final version of a 2,033 page rule regarding how educational institutions can be in compliance with Title IX.[1]  Although schools had been looking forward to finally receiving official guidance on the topic, both the timing of the release and the date required for compliance lead to serious concerns.  Universities will need to comply with the new regulation by August 14, 2020, but as they deal with the fallout of COVID-19, university general counsels, Title IX offices, and other stakeholders need more time to make structural changes to policies and procedures in order to come into compliance with the new regulations.

The DOE released a Notice of Proposed Rulemaking regarding Title IX regulations on November 29, 2018, replacing the previously rescinded 2011 Dear Colleague Letter and 2014 Title IX Guidance Q&A.[2]  This proposed rule received significant feedback and criticism, setting the record for the highest number of comments ever made on a proposed rule at over 124,000 comments.  The influx of public comments demonstrated that there were significant issues with the proposed rule, so universities lacked clarity regarding how to prepare to adjust their Title IX programs to comply with the eventual final rule.   Almost eighteen months later on May 6, 2020, the DOE released the final version of the rule, which made significant changes to the original proposed rule.  These changes affected crucial aspects of a Title IX program such as the standard of proof in hearings, the minimal amount of Title IX claim investigators, and training requirements for the campus community.  According to the rule, universities must be in compliance with it by August 14, 2020.

While some of these changes were important and necessary to attempt to balance supporting sexual assault survivors with protecting the due process rights of the accused, universities need more than just a summer, especially a summer during a worldwide pandemic, to shape their Title IX programs to be in compliance with the new rule.  The August 14, 2020 date is not arbitrary.  It coincides with the starting date for many schools throughout the country and would allow for all Title IX claims during the 2020-2021 academic year to be handled under the same rules.  Although this is a respectable goal, it is not a feasible one.  Ted Mitchell, President of the American Council on Education, stated that the DOE usually gives schools at least eight months to adjust their operations to comply with new regulations, and he criticized the DOE’s timing by stating, “As a result of the pandemic, virtually every college and university in the country is closed. Choosing this moment to impose the most complex and challenging regulations the agency has ever issued reflects appallingly poor judgment.”[3]  Peter Lake, the Director of the Stetson University Center for Excellence in Higher Education Law and Policy, echoed Mitchell’s sentiment, pointing out that “[a] lot of people are going to be out of compliance for an entire academic year. The timing of this is really difficult for higher ed: late in the budget cycle, during a crisis and when they don’t have money.”[4]

With penalties such as loss of federal funding looming, universities must scramble to comply.   Difficulties associated with the pandemic include uncertainty about the opening of campuses, working from home, and budget issues.  Not all universities will have to make drastic changes to their Title IX programs in order to come into compliance, but any changes are significantly more difficult during a pandemic.  For example, the final rule requires at least three staff members to carry out different steps in the Title IX complaint process, so universities that do not have enough Title IX staff to meet this requirement will need to hire more staff or reorganize their staff structures.  As a result of the pandemic, universities already face difficult decisions regarding budgeting and staffing, and having to change their staffing organization in such a short time, especially in the period of stay-at-home orders, is an unnecessary burden to place on universities.  In order to ensure that universities have adequate time and resources to comply fully with the final rule and work toward Secretary Betsy DeVos’ goal of “support[ing] survivors of sexual misconduct, without sacrificing important safeguards to ensure a fair and transparent process,” the DOE needs to extend the timeline to comply with the final rule.[5]

[1] 34 C.F.R. pt. 106 (2020).  Although this regulation applies to all schools that receive federal funding, this post focuses on higher education institutions.

[2] See 83 Fed. Reg. 61,462, 61,497 (proposed Nov. 29, 2018) (to be codified at 34 C.F.R. pt. 106); Letter from Russlynn Ali, Assistant Sec’y for Civil Rights, Office for Civil Rights, U.S. Dep’t of Educ., Dear Colleague Letter: Sexual Violence 1, 4 (Apr. 4, 2011) (on file with the U.S. Dep’t. of Edu.); Memorandum from Catherine E. Lhamon, Assistant Sec’y for Civil Rights, Office for Civil Rights, U.S. Dep’t of Educ., Questions and Answers on Title IX and Sexual Violence iii (Apr. 29, 2014) (on file with the U.S. Dep’t. of Edu.).

[3] Greta Anderson, U.S. Publishes New Regulations on Sexual Assault, Inside Higher Education (May 7, 2020), https://www.insidehighered.com/news/2020/05/07/education-department-releases-final-title-ix-regulations.

[4] Id.

[5] Kathryn Stamm, New DeVos Title IX Rules to be Enacted by Mid-August, Leaving Colleges Scrambling to Comply, The Cornell Daily Sun (May 7, 2020), https://cornellsun.com/2020/05/07/new-devos-title-ix-rules-to-be-enacted-by-mid-august-leaving-colleges-scrambling-to-comply.

Constitution in Crisis: The Fourth Amendment and Combating COVID-19

Garret Stone

The right of the people to be secure in their persons, houses, papers, and effects, against unreasonable searches and seizures, shall not be violated, and no warrants shall issue, but upon probable cause, supported by oath or affirmation, and particularly describing the place to be searched, and the persons or things to be seized.

In response to national emergencies, the federal government has previously implemented many policies in violation of constitutional guarantees to the private citizen. During World War II, Executive Order 9066 ordered approximately 117,000 Americans of Japanese ancestry living in California, Washington, and Oregon to be relocated and interned in remote military camps to combat potential espionage and sabotage.[1] In the wake of September 11, 2001, American military installations and the Central Intelligence Agency were permitted to torture suspected terrorists.[2] Undoubtedly, these policies constitute constitutional violations, but they were still accepted and even championed by the American public as necessary action.

The current COVID-19 pandemic presents new threats to private constitutional protections. In Griswold v. Connecticut, the Supreme Court found that the Fourth Amendment implicitly includes the right to individual privacy from government intrusion, derived from “penumbras and emanations” of the Bill of Rights.[3] The right to privacy has since been expanded to include robust protections for the private citizen.[4] Effectively minimizing the spread of coronavirus requires the federal and state governments to identify infected persons and track their location. Law enforcement agencies have access to sophisticated surveillance systems, including precise location tracking and facial recognition,[5] but state governments have taken little time to empower themselves to take full advantage of surveillance technology. For example, the New York legislature enacted emergency legislation granting Governor Andrew Cuomo unlimited authority to rule by executive order to combat COVID-19.[6] The federal government has recently contacted Google, Facebook, and other major tech companies about potentially using “aggregated location data” taken from Americans’ mobile phones for public health surveillance.[7] What may result is an unprecedented gathering of private information used to track citizens long after this pandemic has subsided.

Once surveillance of private individuals becomes unnecessary, will the government relinquish its hold on location information, or will tracking the public become the new status-quo? Historically, once the federal government has assumed new roles or powers, it is reluctant to roll back policy directives. The American Patriot Act passed during the Bush Administration’s aptly named “War on Terror” illustrates the staying power of emergency policies.  The Patriot Act gives sweeping search and surveillance powers to domestic and foreign intelligence agencies and eliminates the power of review previously reserved for the courts.[8] Although American escalation in the Middle East has been quelled, parts of the Patriot Act remain in effect, and the government’s national security surveillance powers remain significantly increased.[9]

It is unlikely that the government would ever willingly release the identities and locations of COVID-19 patients, but this information is still at risk of publication by nefarious entities.  Cyber warfare is rampant between the world’s leading powers. In 2008, the Pentagon’s security network was breached by a foreign espionage network.[10] Information relating to national security was compromised, and the breach is considered the most significant breach of U.S. military networks to date.[11] The cyber front is constantly evolving, and the government cannot ensure that the data it has collected to combat COVID-19 will remain confidential.

The United States is navigating uncharted waters. COVID-19 has upended the very fabric of American society and long-held notions of community. There is no doubt that health care surveillance is a necessary tool, but how this information may be used and how long emergency powers will last are topics of constitutional concern. Albert Cahn, the executive director of the Surveillance Technology Oversight Project, warned that this pandemic has the potential to “fundamentally change the scope of American civil rights.”  Short of evoking the fears of Orwell and the watchful eye of “Big Brother,” it is not outside the realm of possibility that location surveillance may be repurposed to further controversial political agendas, like anti-immigration policies. Only time will tell if the impact of COVID-19 will be lasting or fleeting on the private lives of American citizens. Until the sputum has settled, we can only wait and see.

[1] Japanese Internment Camps, History (Feb. 21, 2020), https://www.history.com/topics/world-war-ii/japanese-american-relocation.

[2] Carl Rosenberg, What the C.IA.’s Torture Program Looked Like to the Tortured, New York Times (Dec. 4 2019), https://www.nytimes.com/2019/12/04/us/politics/cia-torture-drawings.html.

[3] Griswold v. Connecticut, 381 U.S. 479, 483 (1964).

[4] See generally William M. Beany, The Constitutional Right to Privacy in the Supreme Court, 1962 Supreme Court Review 212 (1962) (tracking the evolution of the right to privacy).

[5] Natasha Singer & Choe Sang-Hun, As Coronavirus Surveillance Escalates, Personal Privacy Plummets, New York Times (Mar. 23, 2020), https://www.nytimes.com/2020/03/23/technology/coronavirus-surveillance-tracking-privacy.html.

[6] Id.

[7] Id.

[8] Jake Laperruque, What to Expect for the PATRIOT Act Reauthorization, POGO (Feb. 11, 2020), https://www.pogo.org/analysis/2020/02/what-to-expect-for-the-patriot-act-reauthorization/.

[9] Id.

[10] Secret U.S. Military Computers ‘cyber attacked’ in 2008, BBC News (Aug. 25, 2010), https://www.bbc.com/news/world-us-canada-11088658.

[11] Id.

Panic Buying: Toilet Paper Today, What’s Tomorrow?

Nicole Arcodia

Videos of consumers fighting over toilet paper, pictures of people lining up outside of stores to buy toilet paper, and security guards protecting toilet paper have become commonplace in the last couple weeks.[1] Due to excessive overbuying by some consumers, many stores have been forced to limit toilet paper purchases to one package per customer.[2] Where does the hysteria for a lack of toilet paper come from?

This unexpected run on toilet paper has confused many people given that an increased need for toilet paper is unrelated to the symptoms of coronavirus.[3] This stockpiling and hoarding of an essential good like toilet paper, however, is not an uncommon reaction when people are scared.[4] Empty shelves cause people to panic: there is fear of running out, fear of the unknown, and fear of what is to come.[5] Social media, particularly Instagram videos of people panic-buying toilet paper, memes about the lack of toilet paper, and pictures of empty shelves around the world have just added to the hysteria.[6]

A run on toilet paper is just the start. It has been almost three weeks since shelter-in-place and social distancing orders were first instilled throughout the country.[7] These shelter-in-place orders require Americans to work from home, students to take classes remotely from home, and people to stay in their houses unless otherwise necessary.[8] It began in California, and as of April 3, 2020, 297 million people in 38 states are being urged to stay home indefinitely.[9] However, the peak of coronavirus is still an estimated two to three weeks away, as is the peak use of resources.[10] Therefore, as a country it is necessary that we do not let hysteria and fear drive us to overbuy. People are encouraged to stock up on water, canned food, frozen food, and medication for at most a few weeks,[11] while still realizing that they can return to stores to buy more essentials if they run out.[12]

Luckily, ninety percent of toilet paper consumed in the United States is produced within the United States.[13] Therefore, although there is a shortage now, toilet paper producers expect the surge to subside and the supply to continue to grow, fixing availability problems.[14] However, for the time being, hoarding unnecessary items like toilet paper depletes these items for everyone else.[15] In this unprecedented time, an excess of something as simple as toilet paper will not protect people against coronavirus; instead it will keep others from getting supplies, food, and products that they need.

Today, fear and uncertainty looms, but there must remain room for hope and unity. That starts with something as simple as toilet paper. Instead of joining the hysteria, making decisions based on fear, running to the store and hoarding food and supplies, only get what is necessary. Further, focus on positive stories such as the benefit that coronavirus is having on the environment.[16] In Venice, dolphins were seen in canals that used to be murky, nitrogen dioxide pollution over China has dropped significantly, and Seattle, New York and San Francisco have each seen a substantial drop in harmful pollution.[17]

As we endure the coming weeks and months in this frightening and unprecedented time, it is important to not let fear and uncertainty cloud our judgment and together we can come out of this pandemic more unified.

[1] Todd C. Frankel, The Toilet Paper Shortage is Real. But It Should be Brief, The Washington Post (March 13, 2020 3:36PM), https://www.washingtonpost.com/business/2020/03/13/toilet-paper-shortage/.

[2] Michelle Toh, It’s Crazy’: Panic Buying Forces Stores to Limit Purchases of Toilet Paper and Masks, CNN Business (March 6, 2020 6:13AM), https://www.cnn.com/2020/03/06/business/coronavirus-global-panic-buying-toilet-paper/index.html.

[3] Frankel, supra note 1.

[4] Id.

[5] Id. In 2011, after an earthquake and tsunami hit Japan, there was a rush for household products including toilet paper. Id.

[6] Adam Westbrook, People Around the World Are Panic-Buying… Toilet Paper?, The New York Times (March 12, 2020),  https://www.nytimes.com/2020/03/12/opinion/toilet-paper-coronavirus.html?action=click&module=RelatedLinks&pgtype=Article.

[7] Sarah Mervosh, Denis Lu, et. al, See Which States and Cities Have Told Residents to Stay Home, The New York Times (April 2, 2020), https://www.nytimes.com/interactive/2020/us/coronavirus-stay-at-home-order.html.

[8] Id. It allows people to leave their homes for necessities: to go to the grocery store, to go to the doctor, and to exercise. Id.

[9] Id.

[10] Anagha Srikanth, Changing America: Here’s When the Coronavirus Will Peak in Your States, The Hill (April 2, 2020),  https://thehill.com/changing-america/well-being/prevention-cures/490856-when-will-coronaviruses-cases-peak-in-your-state.

[11] Westbrook, supra note 6.

[12] Toh, supra note 2.

[13] Frankel, supra note 1.

[14] Id.

[15] Id.

[16] Denise Chow, Coronavirus Shutdowns Have Unintended Climate Benefits: Cleaner Air, Clearer Water, NBC News (March 31, 2020 4:34PM), https://www.nbcnews.com/science/environment/coronavirus-shutdowns-have-unintended-climate-benefits-n1161921.

[17] Id.

Proposed Changes to Stark Law and the Anti-Kickback Statute Highlight the Complexity of Compliance for Healthcare Providers

Stephanie Raborn

In October 2019, the Centers for Medicare and Medicaid (CMS) and the Department of Health and Human Services (HHS) announced several proposed changes to “modernize and clarify” existing complex regulations prohibiting physician self-referral.[1] These proposed changes to the Physician Self-Referral Law (“Stark”) and the Anti-Kickback Statute (“AKS”) could signal a welcomed relaxation of providers’ compliance burdens with regard to the HHS and the CMS. They further illustrate, however, the complexity and challenge healthcare providers of all sizes face in maintaining a compliant practice. HHS and CMS should continue to be responsive to providers’ feedback regarding the challenges of compliance and relieve some of the burden on the industry by providing a greater number of sample arrangements meeting the laws’ requirements. Although the comment period for these proposed changes closed on December 31, 2019,[2] providers should continue to engage with agencies during notice and comment periods and lobby regulatory bodies for simplification and clarification of an increasingly complex compliance burden.

There are two primary federal laws affecting health providers’ agreements: Stark and AKS. These fraud and abuse laws, enforced by the Department of Justice (DOJ), the Department of Health and Human Services Office of Inspector General (HHS OIG) and CMS, can present dangerous pitfalls for unwary providers. Stark prohibits physicians from referring patients seeking certain “designated health services,”[3] which are payable by Medicare and Medicaid to entities in which the physician has a financial relationship, unless an exception applies. The Anti-Kickback Statute is a criminal law that prohibits knowing and willful remuneration—payment of anything of value including not only money, but excessive compensation, expensive hotel stays, meals and more—to induce or reward patient referrals or business generation.[4] Penalties for violation of these laws can include monetary penalties of up to $15,000 and $50,000 per violation (for Stark and AKS respectively) plus the cost of the remuneration multiplied and in the case of the criminal statute potential imprisonment of up to five years per violation.[5] The AKS contains safe harbors that protect certain payment or business arrangements from implication, and Stark’s exceptions and AKS’s safe harbors have been the source of much inquiry and confusion.

Goals of Stark include “protecting patients from unnecessary services and being steered to less convenient, lower quality, or more expensive services because of a physician’s financial self-interest.”[6] Similarly, the goal of the AKS is to avoid overutilization, increased program costs, the adulteration of medical decisions and unfair competition.[7] Laudable and necessary as these goals are, ensuring compliance with these statutes contributes to the labyrinth of regulations that healthcare providers must navigate while simultaneously addressing patients’ healthcare needs. The Stark Law is a strict liability statute, meaning that enforcement officials need not even prove that the provider knowingly or willfully violated the statute in order to obtain a conviction.

HHS’s proposed changes to the AKS include new safe harbors and existing safe harbor modifications, specifically the introduction of new “Value-Based Enterprise” safe harbors, a Personal Services and Management Safe Harbor, and a Cybersecurity and Electronic Health Record Donation Safe Harbor.[8] CMS’s proposed Stark Law changes include the creation of new exceptions for value-based arrangements, including a Full Financial Risk exception, Value-Based Arrangements with Meaningful Downside Financial Risk to the Physician, and a Value-Based Arrangements exception.[9] The scope of these proposed changes is broad, and their publication by HHS and CMS precipitated a flurry of questions and conjecture from the healthcare industry. Potentially affected providers should respond by reviewing the CMS[10] and HHS[11] fact sheets and by consulting healthcare compliance attorneys about implications to their arrangements. Providers should also engage with both agencies by submitting inquiries when the finalized changes are announced, and HHS and CMS should create Q&As and dedicate additional staff to anticipate and respond to inquiries.

[1] HHS Proposes Stark Law and Anti-Kickback Statute Reforms to Support Value-Based and Coordinated Care, U.S. Dep’t of Health and Human Servs. (Oct. 9, 2019), https://www.hhs.gov/about/news/2019/10/09/hhs-proposes-stark-law-anti-kickback-statute-reforms.html.

[2] Modernizing and Clarifying the Physician Self-Referral Regulations Proposed Rules, Ctrs. for Medicare & Medicaid Servs. (Oct. 9, 2019), https://www.cms.gov/newsroom/fact-sheets/modernizing-and-clarifying-physician-self-referral-regulations-proposed-rule.

[3] A Roadmap for New Physicians: Fraud & Abuse Laws, U.S. Dep’t of Health and Human Servs. (last visited Mar. 27, 2020), https://oig.hhs.gov/compliance/physician-education/01laws.asp.

[4] Id.

[5] Comparison of the Anti-Kickback Statute and Stark Law, Health Care Fraud Prevention and Enf’t Action Team, Office of Inspector Gen. (last visited Mar. 27, 2020), https://oig.hhs.gov/compliance/provider-compliance-training/files/StarkandAKSChartHandout508.pdf.

[6] Ctrs. for Medicare & Medicaid Servs., supra note 2.

[7] U.S. Dep’t of Health and Human Servs., supra note 3.

[8] Billy Wynne et al., Proposed Stark Law, Anti-Kickback Reforms Aid to Facilitate Value-Based Care, HealthAffairs (Oct. 15, 2019), https://www.healthaffairs.org/do/10.1377/hblog20191014.13154/full/.

[9] Id.

[10] Ctrs. for Medicare & Medicaid Servs., supra note 2.

[11] HHS Office of Inspector General Fact Sheet, U.S. Dep’t of Health and Human Servs. (Oct. 2019), https://oig.hhs.gov/authorities/docs/2019/CoordinatedCare_FactSheet_October2019.pdf.

A Not-So-Silent Ending to the Silent Sam Saga

Manning Peeler

           After witnessing almost fifty years of vandalism and protests, Silent Sam fell from its pedestal at the University of North Carolina at Chapel Hill (“UNC-CH”) on August 20, 2018.  In the following months, much of the protest and debate surrounding the divisive statue subsided.  After the toppling, however, UNC-CH and the UNC Board of Governors (“UNC BOG”) still faced an important question: What to do with this fallen statue now? In a recent settlement with the Sons of Confederate Veterans (“SCV”), the UNC BOG sold the statue to the SCV and paid a significant sum of money to the SCV to limit potential future protests. On January 8, 2020, the Daily Tar Heel (“DTH”), the student newspaper at UNC-CH, sued the UNC BOG, claiming that it negotiated the settlement in violation of the Open Meetings Act and questioned the suspiciously silent ending to this saga.

            The North Carolina Open Meetings Act sets out standards under which public bodies of the state of North Carolina must conduct meetings to ensure that the public can access the information and discussions.[1] An exception to the open meetings requirement exists when a body consults with an attorney about a proposed settlement of a claim.[2] When meeting in closed session, the public body must keep an account of the discussion and reasonably later make it public record unless “public inspection would frustrate the purpose of a closed session.”[3]

            In a suit filed on January 8, 2020, the DTH sued the UNC BOG, claiming that the information regarding the SCV settlements was not properly released to the public as required by the Open Meetings Act.[4] In an open session, Chairman Harry Smith assigned five UNC BOG members to work with UNC-CH to revise the University’s plan for the monument. The Committee met almost entirely in closed session on November 27, 2019, and it approved a settlement of a lawsuit between the SCV, the UNC System, and the UNC BOG. This settlement included that (1) the monument would be transferred to the SCV, (2) the UNC BOG would create a $2.5 million trust for its preservation, and (3) the monument could not be located in any county containing a UNC constituent institution.

            The Committee members first released information about this settlement in a December 16, 2019 op-ed piece in the Raleigh News & Observer.[5] The op-ed also made the first public mention of another agreement with the SCV that limited the SCV’s ability to display banners on university campuses in exchange for $74,999 from the UNC BOG. The DTH argued that, because the Committee did not release any of its meeting’s contents until three weeks after the settlement’s completion, it violated the Open Meetings Act, and the Court should render the Committee’s actions void.

           Opponents of the settlement have been vocal. The UNC-CH faculty quickly expressed its opposition; students at UNC-CH began on-campus protests; and a group of eighty-eight prominent alumni and donors filed an amicus curiae brief urging the judge to set aside the settlement because it was a “misuse of university funds” that “seriously damages the reputation of the University, which should be committed to historical truth and opposed to modern-day white supremacy.”[6] A UNC-CH law professor noted that “[Judge Allen Baddour] clearly has been following what’s been going on in the public commentary about what he did a few weeks ago, and he appears to be somewhat concerned about it.”[7] After initially approving the settlement, Judge Baddour vacated the SCV-UNC BOG settlement on February 12, 2020 because of the SCV’s lack of standing to file suit and have a court-ordered settlement on this matter.[8] Without groups such as the DTH and the UNC-CH community questioning this settlement, the judge may not have reconsidered his initial approval. Now, the UNC BOG will have to find another solution under significantly increased criticism and scrutiny.


[1] See N.C. Gen. Stat. § 143-318.9-18 (2019).

[2] Id. at § 143-318.11(a)(3).

[3] Id. at § 143-318.10(e).

[4] Complaint at 13, DTH Media Corp. v. University of N.C., https://s3.amazonaws.com/snwceomedia/dth/f9fab47e-67ae-4207-9a98-c2aa0ecff218.original.pdf.

[5] Jim Holmes et al., We Created a Trust to Pay a Confederate Group to Take Silent Sam. It was the Best Solution., News & Observer (Dec. 16, 2019), https://www.newsobserver.com/opinion/article238369068.html.

[6] Kate Murphy, Prominent UNC Alumni Want to Stop the $2.5M Silent Sam Deal with Confederate Group, News & Observer (Jan. 29, 2020), https://www.newsobserver.com/news/local/education/article239768938.html.

[7] Matthew Burns and Laura Leslie, Judge May Reconsider Approval of ‘Silent Sam’ Deal, WRAL (Dec. 20, 2019) https://www.wral.com/judge-may-reconsider-approval-of-silent-sam-deal/18845716/.

[8] Matthew Burns and Sarah Krueger, Judge Throws Out ‘Silent Sam’ Deal, WRAL (Feb. 12, 2020), https://www.wral.com/judge-throws-out-silent-sam-deal/18948287/.

Human Rights Violations: From the Runways of New York Fashion Week to the Fast-Fashion Companies of Today

Henna Shah

Christopher John Rogers, Fe Noel, and Area. Do these names ring a bell? How about Oscar de la Renta, Kate Spade, Cynthia Rowley, or Vera Wang? Last week, designers like these came from around the world to showcase their recent masterpieces on runways across The Big Apple. Welcome to New York Fashion Week!

New York Fashion Week (“NYFW”) is known for its allure, catwalks, and most importantly, clothes. However, in the past decade, the fashion industry has been anything but glamorous. Rather, it has become the center of human rights abuses and allegations.

In 2011, NYFW made the unprecedented decision of canceling a designer’s show.[1] That designer was Gulnara Karimova, the daughter of late Uzbekistan dictator Islam Karimov. As the former Uzbekistan ambassador to Spain and the United Nations, Karimova’s advocacy for her father’s policies, including those that “imprison[ed] and tortur[ed] political opponents and right activists,” created controversy in the international human rights arena.[2] Specifically, it was Karimov’s policy of “forc[ing] up to two million Uzbek children to leave school for two months each year to pick cotton – a fabric woven throughout Karimova’s designs” that distressed the fashion community.[3] By canceling her show, NYFW publicly denounced the designer and her father’s tyrannical regime, and it became one of the first showcases to advocate for human rights in the fashion industry.

However, as the leaders of high-end fashion made promises to ensure humane garment production, allegations of human rights abuse rampantly emerged in the fast-fashion industry. The term “fast-fashion” refers to the “contemporary fashion trends that change quickly each season”[4] that have “resulted in faster production with lower costs.”[5] Leaders of the fast-fashion movement include companies like Zara[6] and H&M.[7] Although fast-fashion has been able to grow its market presence by presenting more than forty collections annually and selling clothes at low prices to consumers, the massive demand has driven companies to utilize “sweatshop” factory models that violate the International Labour Organization’s (“ILO”) standards.[8] However, due to loopholes in national laws and widespread government compliance deficits, “sweatshop” factories are able to fulfill the demands of fashion’s consumer and capitalistic culture while avoiding legal repercussions.[9]

One of the fundamental labor standards set by the ILO is the basic human right to a living wage.[10] However, for fast-fashion industry workers, wages often do not meet the legal standards.[11] In fact, workers frequently face threats of wage cuts and dismissal from managers demanding overtime.[12] Unfortunately, workers have very few remedies to combat these abuses. In some factories, workers are forced to work in unsafe, cramped spaces and are beaten by managers for failing to meet unrealistically high quotas. For instance, in the infamous 2013 Rana Plaza garment factory incident, workers were trapped and forced to continue production as the building collapsed on them.[13] This tragedy is the deadliest disaster in the fashion industry’s history, as it killed over 1,000 workers and injured about 2,500 more.[14]

Furthermore, the fast-fashion industry perpetuates gender discrimination.[15] Since women constitute the majority of the workforce in the garment industry, they are disproportionally affected by production-related human rights violations.[16] A survey by the German Institute for Human Rights found that fourteen percent of women workers in Bangalore reported previous incidents of sexual harassment or rape.[17] Additionally, sixty percent reported being intimidated or threatened with violence and forty to fifty percent reported experiences of humiliation and verbal abuse.[18]

Likewise, child labor remains a problem within the fashion industry. It is estimated that 16.7 million children in South Asia produce clothing.[19] The dismal working conditions of “sweatshops” have negatively affected these children’s development and health.

Fashion may not be everyone’s forte and we may not all agree with style icon Blair Waldorf when she says, “Fashion is art and culture and history and everything I love combined.”  Nevertheless, as the fashion industry continues to grow, it is paramount that we, as consumers, keep it socially conscious and accountable for its human rights abuses.


[8] The ILO highlighted eight fundamental labor standards: (1) 1948 Freedom of Association and Protection of the Right to Organise Convention; (2) 1949 Right to Organise and Collective Bargaining Convention; (3) 1930 Forced Labour Convention; (4) 1957 Abolition of Forced Labour Convention; (5) 1973 Minimum Age Convention; (6) 1999 Worst Forms of Child Labour Convention; (7) 1951 Equal Remuneration Convention; and (8) 1985 Discrimination (Employment and Occupation) Convention.

[12] A report found that ninety-four percent of Cambodian factories violated overtime regulations and dismissed workers who refused to work overtime.

Symposium Agenda – Right to Try Laws: The Benefits and Burdens

The 2019 Fall Symposium is right around the corner; check out our schedule of speakers and learn more about their backgrounds below.

November 1, 2019

9:15-9:45am—Breakfast and Registration

9:45-9:50am—Welcome by Dean Jane Aiken, Assoc. Dean Jonathan Cardi, Chris Coughlin & Melissa Temple Malone

9:50am-10:20am—Setting the Stage: Fifty Years of End-of-Life Care Debates

by Dr. John Moskop, Wake Forest University School of Medicine

Moderator:  Dr. Pat Lord, Wake Forest University, Department of Biology

10:25-10:55am—Keynote: Informed Consent in Right to Try:  A Dubious Assumption by Professor Rebecca Dresser, Daniel Noyes Kirby Professor Law Emeritus, Washington University in Saint Louis School of Law

Moderator:  Prof. Mark Hall, Director of the Wake Forest Health Law and Policy Program, Fred D. & Elizabeth L. Turnage Professor of Law

11:00-11:45am—Panel Discussion: Right to Try Issues in Pediatric Medicine and GeneticsDr. Ana Iltis, Professor, Carlson Professor of University Studies, Philosophy; Director, Center for Bioethics, Health and Society, Dr. Michael Kappelman ; Dr. Sumy Joseph

Moderator:  Wake Forest 2L, Madison Alligood, Wake Forest Journal of Law & Policy

11:50-12:25pm—Performable Case Study and Discussion on Pediatrics, Genetics, and the Right to Try by Prof. Richard Robeson, Wake Forest University, Communication and Center for Bioethics, Health & Society; and various members of the Wake Forest School of Law Journal of Law and Policy

Moderator:  Prof. Steve Friedland, Elon University School of Law

12:30-1:30pm—Lunch

1:30-2:05 pm— Perspectives on the Role of the Patient Advocate in FDA Regulation by Prof. Jordan Paradise, Georgia Reithal Professor of Law, Loyola University of Chicago School of Law

Moderator:  Prof. Bethany Corbin, Director of the Wake Forest Master of the Study in Law Program, LLM Health Law, Loyola University of Chicago School of Law

2:10-2:40—Payment Models for Access to Unapproved Drugs by Prof. Christopher Robertson, Associate Dean for Research and Innovation, University of Arizona, James E. Rogers College of Law

Moderator:  Professor Simone Rose, Associate Dean for Innovation and Entrepreneurship, Wake Forest University School of Law

2:45-3:25 pm—Panel Discussion: The Terms of Trying by Professor Nancy M. P. King, JD. Professor, Department of Social Sciences & Health Policy and Wake Forest Institute for Regenerative Medicine, Wake Forest School of Medicine; Co-Director, Center for Bioethics, Health, & Society and Graduate Program in Bioethics, Wake Forest University, & William Zoffer, JD, industry consultant, former Senior Vice President, U.S. Pharmaceuticals Legal Operations, GlaxoSmithKline and U.S. Department of Justice

Moderator: Suzanne F. Cook, Ph.D, Principal, Epidemiology Associates, LLC 

3:30-4:00—The Right to Try Debate by Wake Forest University Debate Team—consistently ranked one of the top debate teams in the country, the students will be performing a debate that will bring out many of the different arguments relevant to the Right to Try debate.  

4:00 pm—Closing by Prof. Chris Coughlin & Melissa Temple Malone

All registrants will receive a link to the footage from the event whether or not they are able to attend; register now!

Women’s Reproductive Rights: One Step Forward, Two Steps Back?

Women’s Reproductive Rights: One Step Forward, Two Steps Back?

Briana Whalin

The day Justice Kennedy announced his retirement, a sadness washed over many Americans. Kennedy’s retirement, for those who are not politically conservative, felt like the last pillar of hope falling. After losing the White House to our current administration, moderates and liberals looked more than ever to the Supreme Court to be the voice of reason; a saving grace. Now, Kennedy’s retirement threatens to transport America’s public policy back decades.

Kennedy was initially nominated as President Reagan’s second choice. Reagan’s first nomination, Robert H. Bork, was rejected during his Senate confirmation hearing after his personality and ideology became too divisive in the eyes of the Senate. Justice Kennedy stood juxtaposed to Bork as the less conservative and more amenable choice. Soon after his nomination, he was sworn in as a Supreme Court Justice on February 18, 1988.[1]

Throughout his years on the Court, Kennedy gained the reputation as the “swing-vote” Justice.[2] His record stands as a pattern of siding with liberal Justices on individual rights questions and with conservative Justices on everything else. For example, he voted with conservative Justices on issues concerning campaign finance restrictions and gun-ownership rights.[3] However, he sided with liberal Justices on more than one occasion and often on landmark and divisive individual rights cases. These cases include, but are not limited to, decisions such as Obergefell v. Hodges and Planned Parenthood of Southeastern Pennsylvania v. Casey. Kennedy’s decision in these particular cases made him into a personified judicial barrier and voice or reason in the Court for liberal­-leaning Americans by ensuring protections for LGBTQ and Women’s Reproductive rights.

Now, looking forward, we await a new appointee from an administration bent on appointing an ultra-conservative Justice who will help overturn Roe v. Wade and restrict individual rights in the name of conservative beliefs and religious freedom. As a result, many women are seriously concerned that the Casey “undue burden” standard[4] will be restricted to the point of a virtual ban on abortion or a true overturning of Roe. These fears are fully justified as Pro-Life outlets are praising Kennedy’s retirement as an opportunity to overturn Roe[5] until the Court becomes a liberal majority again, which in the context of the Supreme Court could mean decades.

Further, let us remember: reproductive rights issues are public health issues. I have been fortunate to meet one of the plaintiffs in Roe and their experience makes it clear that overturning a woman’s right to a safe and legal abortion means forcing women to have dangerous and life-threatening abortions. The plaintiff in Roe that I met was forced to go out of the country, to a place where they did not speak the language, with a piece of paper with an address scribbled on it, to meet a doctor they had never met, in a place they had never been. Forcing women into this position is dangerous and again, is a public health issue. Abortions will happen regardless of its legal status in the United States as it did before Roe. Regardless of whether it is a virtual ban or full ban that may happen, all we can hope for is that the Justices see this as a public health issue to protect women and not a religious or political crusade.

[1] Anthony M. Kennedy, Oyez, (July 1, 2018), https://www.oyez.org/justices/anthony_m_kennedy.

[2] Brent Kendall & Jess Bravin, Justice Anthony Kennedy Defined His Career at Center of Biggest Decisions, Wall St. J., (July 1, 2018), https://www.wsj.com/articles/supreme-court-justice-anthony-kennedy-announces-retirement-1530122570. (Kennedy himself has said that he hates this moniker, commenting at a Harvard Law School graduation that, “[t]he cases swing. I don’t.”).

[3] Id.

[4] Planned Parenthood of Se. Pa. v. Casey, 505 U.S. 833 (1992).

[5] In an interview with NPR, the President of Students for Life, Kristan Hawkins, praised Justice Kennedy’s retirement as “a day that we’ve been waiting for” and further commented that “[o]ur goal in the pro-life movement has always been to make abortion illegal and unthinkable.” Sara McCammon, What Kennedy’s Retirement Means For Abortion Rights, Nat’l Pub. Radio, (July 1, 2018), https://www.npr.org/2018/06/28/624319208/what-justice-kennedy-s-retirement-means-for-abortion-rights.