Health Law Journal a Peer Reviewed Law Journal a Publication of the Health Law Section of the New York State Bar Association

2021 | VOL. 26 | NO. 1 Health Law Journal A Peer Reviewed Law Journal A publication of the Health Law Section of the New York State Bar Association

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2021

Vol. 26, No. 1

THE HEALTH LAW SECTION NEW YORK STATE BAR ASSOCIATION

Contents Regular Features In the New York State Courts 6 Leonard M. Rosenberg In the Legislature 16 James W. Lytle New York State Fraud, Abuse and 19 Compliance Developments Edited by Melissa M. Zambri Cover Art - By Rembrandt - In the Law Journals Mauritshuis online catalogue., Public 33 Cassandra DiNova Domain, https://commons.wikimedia. org/w/index.php?curid=64281722 For Your Information 35 Claudia O. Torrey Young Lawyers Committee Health Law 36 Cassandra DiNova and Brenda Baddam Journal 2021 | Vol. 26 | No. 1 Featured Articles Regulars Legal and Ethical Concerns of Telehealth and 37 Telemedicine Message From Andrew Ko 5 the Chair Karen L. Illuzzi Gallinari Misbranded Drugs 101: What Attorneys 42 Need to Know Welcome New David F. Durso 70 Health Law Section Members General Considerations for Drafting 45 Successful Telehealth Contracts Section Committees Craig W. Anderson 72 and Chairs Chernobyl: Bridging the Gap Between 49 International Nuclear Law and Public Health Melissa Montoni Materiality in the Post-Escobar Era: An 56 Argument for Supreme Court Clarification of Materiality Kyle Madley Mandating the COVID-19 Vaccination: 65 A Legal Analysis Morgan Dowd, JD Publication and Editorial Policy HEALTH LAW JOURNAL Persons interested in writing for this Journal are wel Editor comed and encouraged to submit their articles for Brendan S. Parent consideration. Your ideas and comments about the NYU School of Medicine Journal are appreciated as are letters to the editor. 227 E 30th St, Ste 721 Publication Policy: New York, NY 10016 All articles should be submitted to: [email protected] Brendan S. Parent, J.D. Email: [email protected] Benjamin Sundholm Devevoise & Plimpton Benjamin Sundholm 919 3rd Ave Email: [email protected] New York, NY 10022-3902 Submitted articles must include a cover letter giv [email protected] ing permission for publication in this Journal. We will assume your submission is for the exclusive use of Section Officers this Journal unless you advise to the contrary in your Chair letter. Authors will be notified only if articles are Karen L. Illuzzi Gallinari rejected. Authors are encouraged to include a brief St. John’s Riverside Hospital biography with their submissions. Yonkers, NY 10701-1301 Editorial Policy: The articles in this Journal represent [email protected] the authors’ viewpoints and research and not that of the Journal Editorial Staff or Section Officers. The ac Chair-Elect curacy of the sources used and the cases cited in sub Anoush K. Scott missions is the responsibility of the author. Lippes Mathias Wexler Friedman LLP 54 State St., Fl 10 Subscriptions Albany, NY 12207-2540 [email protected] This Journal is a benefit of membership in the Health Law Section of the New York State Bar Association. Vice-Chair The Journal is available by subscription to non-attor Nathan G. Prystowsky neys, libraries and organizations. The subscription Axiom rate for 2021 is $160.00. Send your request and check 16 N Broadway, Apt 2N to Member Resource Center, New York State Bar White Plains, NY 10601-2223 Association, One Elk Street, Albany, NY 12207. [email protected]

Accommodations for Persons with Disabilities: Treasurer NYSBA welcomes participation by individuals with disabili Jane B. Burke ties. NYSBA is committed to complying with all applicable Hodgson Russ LLP laws that prohibit discrimination against individuals on 677 Broadway, St 301 the basis of disability in the full and equal enjoyment of its Albany, NY 12207-2986 goods, services, programs, activities, facilities, privileges, [email protected] advantages, or accommodations. To request auxiliary aids or services or if you have any questions regarding accessibility, Secretary please contact the Bar Center at 518-463-3200. Lisa D. Hayes The Brookdale Hospital Medical Center Publication Date: January 2021 1 Brookdale Plaza Katz 321 Brooklyn, NY 11212-3198 Copyright 2021 by the New York State Bar Association. [email protected] ISSN 1530-3926 ISSN 1933-8406 (online) NYSBA.ORG/HEALTH

4 NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 Message From the Chair By Karen L. Illuzzi Gallinari

Dear Health Law Section Report, the Our committees are listed at Members: latter of which the end of this Journal. Please email our Section Liaison, Catherine Carl I hope this note finds you and all was included at [email protected], indicating the yours well. in our Sum- mer Health Committee/s that interest you. Congratulations for taking a few Law Journal, minutes to enhance your professional are avail- This Health Law Journal Issue education and nurture your profes- able at this In this issue, we are proud to sional development through our link: https:// present scholarly articles contributed Health Law Journal. You are also to be nysba.org/ by some of our youngest Health commended for your membership healthlawsec- Law Section members. The wisdom in the Health Law Section. Through tioncovid19/. and passion they bring to the table, your continued support of our Sec- The NYSBA Government Relations at the beginning of their careers, tion, you are making a difference in team is convening the final Resolu- shines a bright light on the future the lives of countless individuals who tions to appropriate parties within of our industry. The future leaders need assistance during these chal- state leadership. who have contributed to this issue lenging times, even when you are During the November Sections’ address a wide range of important attending to your other priorities. The topics including vaccinations, nuclear Report of our COVID-19 Task Force Caucus and House of Delegates meetings, several individuals commented energy, misbranded drugs, telehealth reflects some of the areas where our and how the courts determine mate- members are hard at work making a that the process that evolved over the past many months, during which we riality when evaluating false claims difference. These include advocating allegations. for the protection of health care work- collaborated more than ever before with our colleagues from many other ers and vulnerable populations, such Annual Meeting as the elderly, disabled and communi- Sections, was an example of how ties of color. our Bar Association should function. Your next opportunity to benefit The productive dialogues this effort from local and national expertise on As background, please recall has facilitated will continue through a similarly wide variety of hot health that earlier this year, Immediate the work of our Health Law Section care topics will take place during our Past NYSBA President Hank Green- committees and two Bar-wide Task Annual Meeting, on January 19 and berg charged Hermes Fernandez, Forces, which were created to address January 27, 2020. This rich program our Immediate Health Law Section long-term care issues and ongo- will be available on demand after- Past Chair, with appointing a Task ing issues relating to immunity and wards. I also encourage you to join at Force of the Health Law Section to liability. least one of our committees as well. examine COVID-19 legal issues. The Full participation will ensure you en- Task Force was created and worked Section Committees joy all the benefits of being a member tirelessly over a compressed period of While you are contributing to our of the Health Law Section. time to identify and analyze the key industry and our fellow New York- The chairs of each of our com- legal and related ethical issues, and ers by simply being a member of our it prepared Resolutions recommend- mittees and I are at your service for Section, we encourage each of you any information and assistance you ing action steps to New York State who are not yet members of any of leadership. may need to support your interest our Health Law Section committees and success in health law. You can On November 7, 2020, the to become more actively engaged by reach us by emailing Catherine Carl NYSBA House of Delegates adopted joining the committee most relevant at [email protected], or through the the Health Law Section’s COVID-19 to your practice and your interests. “Contact Us” links on our Section’s Resolutions. They incorporate Through your active involvement, and committees’ web pages. amendments suggested by our col- you can ensure that our efforts and leagues in other Sections. These rec- resources are directed to the topics We look forward to hearing from ommendations address serious issues most important to you. You will also you! impacting the health and livelihoods work directly with and will develop of all New Yorkers. relationships with local health law Karen L. Illuzzi Gallinari experts. The final Resolutions and the underlying COVID-19 Task Force

NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 5 In the New York State Courts By Leonard M. Rosenberg

Court of Appeals Accepts existence of a private right of action[.]” sion” of the Certified Question from Second In addition, the court noted that other issue in Feder Circuit: Does the Public Health provisions of the Public Health Law, v. Staten Island Law Provide a Private Right of namely Sections 12 and 13, expressly Univ, Hosp., Action for Damages Where a provide for enforcement remedies. 273 A.D.2d In particular, Section 12 imposes 155 (1st Dep’t, Health Care Provider Charges in civil penalties, payable to the state, in 2000), which Excess of 75 Cents Per Page for cases of willful violations of the Public perfunctorily Copies of Medical Records? Health Law, while Section 13 allows recognized a Ortiz v. Ciox Health LLC, 961 F.3d private citizens, the Department of private right of 155 (2d Cir., 2020). In October 2016, Health, or any local board of health to action under Ms. Vicky Ortiz requested copies of enforce compliance by filing an action Section 18, did her medical records from New York pursuant to Article 78 of the CPLR. not constitute “clear guidance.” Presbyterian Hospital (NYPH). Upon receipt of the records from IOD, Inc., Further, the court noted that, Moreover, the court found that Ciox’s predecessor, she was charged under New York Law, plaintiffs must the plain language of the statute was $1.50 per page, double the maximum clear a three-part test before seeking silent on the issue, that the issue was permissible fee under Section 18(2)(e) civil relief based on the violation of a dispositive, and most importantly, of the New York Public Health Law: statute that does not expressly grant a that the issue involved delicate policy “[t]he provider may impose a reason- private right of action. In making this considerations better suited for the able charge for all inspections and determination, courts must consider state Court of Appeals. The court copies … [provided that] the reason- (1) whether plaintiff is a member of reasoned that by enacting Section able charge for paper copies shall the class for whose benefit the statute 18, the legislature balanced several not exceed seventy-five cents per was enacted, (2) whether creation competing interests, including the page.” In need of immediate access of a private right of action would right of patients to access their infor- to the records, Ms. Ortiz paid the bill promote the legislative purpose, and mation, and the burdens and costs and later filed a putative class action (3) whether creation of a private right imposed on medical providers as a suit in state court alleging, inter alia, of action would be consistent with result of that access. Thus, creating unjust enrichment and violations of the legislative scheme. a private right of action, in addition the Public Health Law. Shortly after to the various enforcement remedies Here, the court stopped short of already available under Sections 12 Ms. Ortiz commenced litigation, Ciox balancing these factors. Instead, it refunded the overcharge. and 13, could “affect the balance the deferred the question to the New York legislature endeavored to strike,” and In May 2017, the case was State Court of Appeals, finding that was better left to the state Court of removed to the Southern District of all relevant considerations weighed Appeals. Accordingly, on June 5, 2020 New York, and both Ciox and NYPH in favor of certification. Specifically, the Court certified the question to the moved to dismiss. The District Court the court found that the issue had not Court of Appeals as follows: “Does been decided by the Court of Appeals, granted dismissal of all claims except Section 18(2)(e) of the New York Pub- for the claim arising under Section and that existing precedent from other lic Health Law provide a private right 18(2)(e). While the case was pending New York courts was insufficient to of action for damages when a medical in the Southern District, Ms. Ortiz predict how the state Court of Ap- provider violates the provision limit- passed away, and the temporary peals would rule. In doing so, the ing the reasonable charge for paper administrator of her estate was sub- court took the position that the First copies of medical records to $0.75 per stituted in her place. In October 2018, Department’s “one-sentence discus- both Ciox and NYPH again moved to dismiss the Section 18 claim. The Compiled by Leonard Rosenberg, Esq. Leonard Rosenberg is a sharehold- court granted their motions, holding er in the firm of Garfunkel Wild, P.C., a full service health care firm repre- that Section 18(2)(e) does not grant senting hospitals, health care systems, physician group practices, individual a private right of action to those practitioners, nursing homes and other health-related businesses and orga- charged in excess of $0.75 per page nizations. Rosenberg is Chair of the firm’s litigation group, and his practice for copies of medical records. includes advising clients concerning general health care law issues and On appeal, the Second Circuit litigation, including medical staff and peer review issues, employment law, found that Section 18 “is silent as to the disability discrimination, defamation, contract, administrative and regulatory issues, professional discipline, and directors’ and officers’ liability claims.

6 NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 page?” On June 23, 2020, the Court of for summary judgment and asked the and did not anywhere take on, a duty Appeals accepted the certified ques- parties to brief two questions: (1) does to limit the fees it received for its tion, and the issue will be decided Section 18(2)(e) impose a legal duty services to its costs incurred.” after additional briefing and oral on an entity other than a health care Next, the court addressed Beth argument. Ortiz v. Ciox Health LLC, 35 provider—such as an ROI vendor—to Israel’s motion, which asserted that N.Y.3d 1001 (2020). cap its charges at its “costs incurred”? Section 18(2)(e) “does not give rise to and, (2) if not, does the nature of the a private right on the part of a records Southern District Grants contractual arrangement between requester to bring a damages action,” Beth Israel and HealthPort create a Summary Judgment to Health thereby raising a question substan- duty, under Section 18(2)(e), barring Care Provider and ROI Vendor tially similar to the one recently certi- HealthPort from charging more than Accused of Engaging in fied to the Court of Appeals in Ortiz, its costs incurred? In March 2018, the Deceptive Business Practices by supra. Beth Israel also argued that the court ruled in favor of HealthPort $0.75 per-page charge imposed by Overbilling for Medical Records on both questions, holding that the HealthPort was properly attributed to Ruzhinskaya v. HealthPort Technolo- statutory obligation to cap charges Beth Israel, and that requesters were gies LLC, 2020 WL 3791881 (S.D.N.Y., at “costs incurred” applied only to therefore not charged in excess of Beth July 7, 2020). In a case closely related health care “providers,” not to a third- Israel’s “costs incurred.” The court to Ortiz, supra, the Southern Dis- party ROI vendor. The Court further ruled in favor of Beth Israel on both trict of New York granted summary held that the contractual arrangement issues, and added that plaintiff’s claim judgment to both Beth Israel Medical at issue, whereby HealthPort invoiced Center and HealthPort Technologies, requesters directly, on behalf of Beth for deceptive business practices under Section 349 of the General Business a release of information (ROI) vendor, Israel, did not shift the provider’s Law must also fail, since it was “whol- in a putative class action stemming statutory duties to HealthPort. Rather, ly derivative” of the other claims. from alleged violations of Section it was merely a “mechanical arrange- 18(2)(e) of the Public Health Law Sec- ment” designed to streamline the With respect to the defendants’ tion and Section 349 of the General billing process, and carried “no legal billing arrangement, the court once Business Law. consequence.” again found that the fee due to HealthPort from Beth Israel for its Ms. Ruzhinskaya requested cop- Ruzhinskaya appealed, and in services was indeed a “cost incurred” ies of the medical records from her May 2019, the Second Circuit an- by Beth Israel. Thus, because Ru- deceased mother’s admission to Beth nounced its intention to certify two zhinskaya was not billed in excess of Israel. The request was processed by questions to the New York Court that fee, she was “neither billed more HealthPort at the rate of $0.75 per of Appeals: (1) whether HealthPort than Beth Israel’s ‘costs incurred’ nor page, the maximum charge permit- can be sued directly under Sec- above the statutory maximum charge ted by statute. Ruzhinskaya filed suit tion 18(2)(e), and (2) how to calculate of 75 cents per page of paper cop- against both Beth Israel and Health- the “costs incurred” in producing and ies.” With respect to the existence, or Port, claiming that their practice of transmitting medical records. Instead non-existence, of a private right of charging a fixed rate of $0.75 per page of certifying the questions, the Sec- action, the court explicitly adopted violated Section 18(2)(e) of the Public ond Circuit opted to remand the case the District Court’s “persuasive Health Law, which dictates that that a for Beth Israel to rejoin as a party, rea- reasoning” in Ortiz v. Ciox Health LLC, health care “provider” may impose a soning that rendering a substantive 386 F. Supp. 3d 308 (S.D.N.Y. 2019), “reasonable charge for all inspections decision on Beth Israel’s direct-billing appeal docketed, No. 19-1649 (2d Cir. and copies, not exceeding the costs arrangement, in Beth Israel’s absence, June 1, 2019), finding that “a private incurred by such provider,” but that would present a risk of “multiple un- right of action cannot be implied “the reasonable charge for paper cop- necessary proceedings.” ies shall not exceed seventy-five cents from § 18(2)(e).” In doing so, the per page.” Ruzhinskaya dropped her On remand, after additional dis- court recognized that the question of claims against Beth Israel in the hope covery and the filing of several joint whether a private right of action is of obtaining certification of a large, stipulations of fact, both defendants available where a provider violates statewide class. Instead, the court cer- again moved for summary judgment the $0.75 per-page limit had recently tified a class consisting only of persons in May 2020. In a two-part decision, been certified to the state Court of who, between “March 12, 2011 and the the court first reaffirmed its March Appeals, and that, in all likelihood, present, had requested records from 2018 grant of summary judgment “the answer to that certified ques- Beth Israel, whose requests had been in favor of HealthPort, ruling that tion will resolve the similar question serviced by HealthPort, and who had Ruzhinskaya could not maintain a presented here: whether § 18(2)(e) been charged 75 cents per page.” claim against HealthPort under Sec- affords a private right of action for tion 18(2)(e) because HealthPort “is damages where the charge imposed In March 2017, with trial ap- not a healthcare provider within the on the requester allegedly exceeds the proaching, the court invited motions meaning of § 18, and does not have, medical provider’s costs incurred?”

NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 7 Accordingly, both Ortiz and Ru- Court issued a consolidated decision regulatory fees, which asks courts to zhinskaya will turn on the state Court in which it denied the state’s mo- consider: (1) the nature of the entity of Appeals’ answer to the certified tions and held that the pass-through imposing the assessment, (2) the question accepted on June 23, 2020, provision was unconstitutional. The population subject to the assessment, in Ortiz v. Ciox Health LLC, 35 N.Y.3d District Court also struck down the and (3) the ultimate use or alloca- 1001 (2020). remainder of the OSA, finding that tion of the revenues generated. The the pass-through provision was not court noted that most federal circuits Second Circuit Finds That severable. agree that the third factor is the most important: If the funds are used to Under the Tax Injunction Act, Subsequently, the Legislature Federal District Court Lacked benefit the general public, then the amended the OSA to contain a new assessment is likely a tax. If the funds Jurisdiction To Strike Down New payment mandate that did not York’s Opioid Stewardship Act more narrowly benefit the regulated include a pass-through provision. In companies or defray an agency’s Ass’n for Accessible Meds. v. James, light of that development, the state costs of regulation, then it is more 974 F.3d 216 (2d Cir., 2020). Plaintiffs chose not to challenge the District likely a regulatory fee. are two trade associations represent- Court’s ruling that the pass-through ing manufacturers and distributors provision is unconstitutional, but The Second Circuit then found of pharmaceutical products and one sought reversal of the ruling invali- that the OSA’s legislative purpose, developer, manufacturer, and seller of dating the remainder of the statute. which was to raise $600 million to opioid medications. Plaintiffs sepa- respond to a public health crisis, The court began its decision with “strongly suggests” that the opioid rately brought suit against the New an overview of the opioid crisis and York Attorney General and the New stewardship payments serve general the legislative purpose of the OSA. The revenue-raising purposes. The court York Commissioner of Health (col- court observed that opioid addiction lectively, the “State”) in the United noted that the opioid stewardship and abuse had an economic toll on the fund could be used only on programs States District Court, Southern District state and its residents that had risen to of New York, alleging that the Opioid that conferred a benefit on the general over $200 million dollars per year by public and thus could not be used for Stewardship Act (OSA) violates the 2017. The Legislature enacted the OSA dormant Commerce Clause. the narrow benefit of opioid manu- in 2018 to raise $600 million over six facturers and distributors or to offset The OSA requires opioid manufac- years to address this cost. the DOH’s costs of regulating the turers and distributers to pay an annual The court next turned to the TIA, industry. “opioid stewardship payment.” The which provides that federal district total payment each year is fixed at $100 The court also found that the courts shall not “enjoin, suspend or million and divided among the licens- other factors weighed in favor of restrain the assessment, levy or collec- ees based upon their market share, as treating the opioid stewardship pay- tion of any tax under state law where calculated by the Department of Health ment as a tax. The court found that a plain, speedy and efficient remedy (DOH). The revenue is collected by the payment was assessed by the Leg- may be had in the courts of such State.” the DOH and deposited into a special islature, and that the DOH “played The purpose of this statute, the court “opioid stewardship fund” jointly little substantive role in imposing noted, was to prevent district courts maintained by the Comptroller and the it.” Although Plaintiffs emphasized from interfering with states’ ability to Commissioner of Taxation and Finance. that the assessment fell on only 97 levy taxes, which Congress considered Monies deposited in the opioid steward- companies, the court found that the to be an important local concern. As ship fund may be used only for specific category of entities identified by the there was no dispute that there is a suf- programs related to opioid abuse and statute—which encompasses “[a]ll ficient remedy in New York courts to prescription monitoring. The statute manufacturers and distributors . . . challenge state taxes, the only question initially imposed a “pass-through provi- that sell or distribute opioids in the before the Second Circuit was whether sion,” which barred licensees from pass- state of New York”—was sufficiently the opioid stewardship payment is a ing the cost of the opioid stewardship broad and open-ended to qualify the “tax” under the TIA. The court held payments on to their customers. payment as a tax. that the payment is a tax, and that the Plaintiffs each moved for sum- District Court lacked jurisdiction to The court rejected Plaintiffs’ mary judgment or for a preliminary rule on its validity. insistence that the opioid stewardship injunction, and the state cross-moved payment is a regulatory fee. The court While there is no bright-line rule, to dismiss each lawsuit. The state held that public health initiatives serve the court stated, a tax is primarily contended that the opioid steward- the general welfare of state residents, made for revenue-raising purposes ship payment is a tax that the District even if their purpose is narrowly as opposed to regulatory or puni- Court lacks jurisdiction to enjoin or targeted. The court was unpersuaded tive purposes. The court turned to invalidate in accordance with the by Plaintiffs’ argument that the pay- the three-factor test used by the First Tax Injunction Act (TIA). The District ments are made to the DOH and Circuit to distinguish taxes from

8 NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 deposited into a special fund, rather ticket, Governor Cuomo issued the preventing the spread of COVID-19, than the state’s general fund. The Order. Since travelers from Arizona but argued that the quarantine restric- court held that the use of the funds, were subject to the self-quarantine tion was not narrowly tailored to and not where they are maintained, is requirement, Plaintiff cancelled her achieve that goal. Plaintiff pointed dispositive. The court also observed trip to New York. Plaintiff sought out that the Order forces a healthy that the funds are “functionally and le- a preliminary injunction, arguing person who flies in from a restricted gally maintained by the state’s taxing that the self-quarantine require- state to quarantine for 14 days, while authorities,” and not by DOH. Lastly, ment violated her right to interstate a COVID-19 infected person arriving the court found it “less significant” to travel under the Equal Protection from a non-restricted state can travel its analysis that the Legislature did not Clause, the Citizenship Clauses of the freely. Plaintiff further alleged that the label the payments as a tax, as taxing Fourteenth Amendment and Article Order deprived her of the chance to go authorities may tend to avoid the term IV, and the Due Process Clause of sightseeing and delayed plans to pack for political purposes. the Fourteenth Amendment. Judge up belongings in a prior residence. Hurd granted Defendants’ motion to The court similarly rejected dismiss, finding that Plaintiff failed to The court ruled that under Plaintiffs’ argument that the opioid satisfy the requirements for a prelimi- either standard, Plaintiff failed to stewardship payments are a punitive nary junction and failed to state any demonstrate that the cancellation of fine. The court asserted that the Leg- Constitutional claims. her trip to New York or the restric- islature may tax an industry because tions imposed by the 14-day self- it believes it to impose an unusual The court first addressed Plain- quarantine requirement constituted cost on society, and that such moti- tiff’s motion for a preliminary injunc- irreparable harm. The court then vation would not turn the tax into a tion, discussing the two applicable delved into a discussion of Jacobson regulatory fine. The court also found standards for evaluating such re- v. Massachusetts, 197 U.S. 11 (1905). it irrelevant to the analysis under the quests in the Second Circuit. The In Jacobson, the Supreme Court held TIA that the opioid stewardship pay- court first highlighted the standard that “when faced with a society- ment is a fixed amount rather than a applied in Corbett v. Cuomo, 2020 WL threatening epidemic, a state may percentage. Finally, the court rejected 3483479 (S.D.N.Y. June 24, 2020), a implement emergency measures that Plaintiffs’ argument that the pass- “virtually identical constitutional curtail constitutional rights so long as through provision, which bars them challenge” decided in the Southern the measures have at least some ‘real from passing the burden of the pay- District of New York. In Corbett, the or substantial relation’ to the public ments on to consumers, was meant court held that to obtain a prelimi- health crisis and are not ‘beyond all to be punitive, as the Legislature nary injunction, a party must demon- question, a plain, palpable invasion of removed that provision and the state strate: (1) a likelihood of irreparable rights secured by [the Constitution].’” was not defending it on appeal. harm; (2) either a likelihood of success on the merits or sufficiently seri- Acknowledging that courts and legal scholars have criticized the Federal District Court Dismisses ous questions as to the merits and a Jacobson standard, the court none- Constitutional Challenge To balance of hardships that tips in their favor; (3) that this balance tips in their theless recognized that the majority Executive Order 205’s 14-Day Jacobson favor regardless of the likelihood of of federal courts rely on in Self-Quarantine Requirement analyzing the constitutionality of for Out-of-State Travelers success; and (4) that an injunction is in the public interest. The Corbett coronavirus-oriented public health Jacobson Page v. Cuomo, 2020 WL 4589329 court declined to apply the height- efforts. Applying , the court (N.D.N.Y., Aug. 11, 2020). Plaintiff, an ened standard for preliminary injunc- held that Plaintiff has “no chance of Arizona resident, sued Governor An- tion recognized by the Second Circuit. success on the merits of any of her drew Cuomo and Howard A. Zucker, This alternative standard, applied in claims” and denied the request for a M.D., J.D., in their official capacities Page, applies where the movant seeks preliminary injunction. as Governor and Commissioner of an injunction that is either “mandato- The state established that CO- Health of the State of New York. She ry” or “will provide the movant with VID-19 is a highly infectious and challenged the constitutionality and substantially all of the relief sought, potentially deadly disease that sought to halt enforcement of Execu- and that relief cannot be undone even spreads easily from person to person, tive Order 205. The Order imposes a if the defendant prevails at a trial on with an incubation period of up to 14-day self-quarantine requirement the merits.” Under the heightened 14 days. Fourteen days was selected on those persons traveling to New standard, the moving party must as the quarantine period because if York from states where the COVID-19 show a clear or substantial likelihood no symptoms appear after 14 days, positive test rate exceeds 10%. of success on the merits and make a it is unlikely the person was infected Plaintiff had planned to travel to strong showing of irreparable harm. at the time of entry into the state. Accordingly, Plaintiff failed to show New York for a two-week vacation, Plaintiff acknowledged that the that the Order bears “no real or but before she could purchase her state has a compelling interest in

NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 9 substantial relation” to public health. Sept. 10, 2020). In Luke’s Catering Ser- The court first determined that The court also held that “plain, pal- vice v. Cuomo, Plaintiffs, a group of six Plaintiffs could not show that the pable” standard cannot be satisfied event, banquet, and catering facilities, Executive Order had “no real or by merely alleging violation of the sought to enjoin and invalidate Exec- substantial relation” to protecting fundamental right to travel. utive Order 202.45. The Order places public health. Although Plaintiffs a 50-person limit on “non-essential” conceded that the coronavirus poses As to Plaintiff’s constitutional gatherings in order to reduce the risk a significant threat to public health challenges, the court first held that of spreading coronavirus. Plaintiffs and welfare, they contended that the Order did not violate the Equal argued that the Order has left them the Order has no real or substantial Protection Clause or the Citizenship “unable to conduct any meaningful relation to the coronavirus pandemic, Clause of the Fourteenth Amend- business…and has placed them on and challenged “the premise that ment, nor did it violate the Citizen- the brink of insolvency.” Plaintiffs large gatherings present a risk of ship Clause of Article IV. The court alleged violations of the Equal Protec- COVID-19 transmission.” held that the Order did not burden tion Clause and the Takings Clause of the right to interstate travel since, the United States Constitution, and Plaintiffs also argued that New under the “plain terms” of it, indi- sought a preliminary injunction. York’s focus on large gatherings is viduals from restricted states were “overreactive,” suggesting that New still able to travel to and enter New Typically, to obtain a preliminary York follow other states and adopt York. The court also determined that injunction, a party must demonstrate: capacity-based regulations instead. because the Order applied equally to (1) he or she is likely to succeed on However, the court ruled that New both residents and non-residents, it the merits; (2) he or she will suffer York’s choice to adopt the 50-person does not discriminate between resi- irreparable harm absent injunctive limitation is entitled to deference, dents and non-residents of New York, relief; (3) the balance of equities tip and Jacobson review does not permit but rather between “individuals with in his or her favor; and (4) the issu- courts to pass judgment on or second- and without a mathematically height- ance of the injunction is in the public guess the wisdom and efficacy of the ened risk of spreading COVID-19.” interest.” However, since Plaintiffs emergency measures implemented. sought a “mandatory” preliminary Finally, the court ruled that injunction, the issuance of which al- The court summarized state’s jus- Plaintiff failed to allege a violation of ters the status quo, the court applied tification for the Orders. Howard A. either substantive or procedural due a heightened standard. Plaintiffs Zucker, M.D., J.D., the Commissioner process. In holding that no substan- were required to demonstrate both of the New York State Department of tive due process claim was alleged, (1) a clear or substantial likelihood of Health, explained that the Order was the court emphasized that substan- success on the merits and (2) a strong developed in consultation with a team tive due process does not protect showing of irreparable harm. Judge of epidemiologists in direct response against government action that is in- Skretny held that Plaintiffs failed to to the COVID-19 threat, to reduce the correct or ill-advised, but rather gov- meet the burden of the heightened risk of person-to-person transmis- ernment action that is arbitrary and standard and denied the request for sion during “super-spreader” events, capricious, conscience-shocking, or preliminary injunction. particularly at indoor venues. oppressive in a constitutional sense. The court also found that Plaintiff did With respect to the first element, A “super-spreader” event is one not allege a violation of procedural the court ruled that Plaintiffs must in which a single person infects a due process. Recognizing that due demonstrate that there is a clear or disproportionate number of other individuals. The hallmarks of such process is “flexible and calls for such substantial likelihood of success procedural protections as the par- on the merits of their claims under an event are its size, the length and ticular situation demands,” the court Jacobson v. Massachusetts, 197 U.S. 11 nature of expected interactions, and noted that even if the Order does (1905). The Supreme Court held in the length of the event itself. The infringe on Plaintiff’s fundamental Jacobson that, pursuant to the Tenth more people with whom an indi- rights, the coronavirus pandemic is Amendment, a state can exercise vidual interacts, and the longer those “precisely” the situation in which its police powers to restrict consti- interactions, the higher the risk of such infringement is justified. tutional rights while combatting a transmission. Transmission risks also public health emergency. When such increase when large groups arrive together, join for communal pur- Federal District Court Dismisses statutes are reviewed under Jacobson, courts are only permitted to deter- poses, share facilities, spend many Constitutional Challenge hours together, and depart together. To Executive Order 202.45’s mine whether the statute either (1) “has no real or substantial relation Scientists believe that such “super- 50-Person Restriction on “Non- spreader” events play an oversized Essential” Gatherings to [public health, public morals, or public safety]” or (2) “is, beyond all role in the transmission of COVID-19, Luke’s Catering Service, LLC, v. question, a plain palpable invasion of with some estimating that 10% of Cuomo, 2020 WL 5425008 (W.D.N.Y., rights secured by [the Constitution.].” the cases may be responsible for 80%

10 NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 of the transmissions. Limiting large The court also ruled that the serting claims for unjust enrichment events therefore reduces the risks of Order is not “beyond all question, a and conversion on the basis that it, transmission, which is why the Order plain palpable invasion of rights,” and not the defendants, was entitled placed size restrictions on gatherings. and rejected Plaintiffs’ Equal Protec- to cash consideration generated pur- tion and Takings Clause claims. For suant the demutualization of malprac- Plaintiffs also contended that the the reasons noted above, the court tice insurer Medical Liability Mutual Order is arbitrary and unreasonable disagreed with Plaintiffs’ argument Insurance Company (MLMIC). because there is no rational basis for that treating them differently from them to be treated differently from In 2016, MLMIC announced that restaurants violated the Equal Protec- restaurants. Since their facilities oper- National Indemnity Company, a sub- tion Clause. The court also rejected ate similarly to restaurants, which are sidiary of Berkshire Hathaway, would Plaintiffs’ argument that the Order permitted to operate at 50% capacity, acquire MLMIC and that, as part of deprives them of “all meaningful Plaintiffs argued that that not allow- that transaction, MLMIC would be use” of their facilities and thus consti- ing them to operate under the same converted or “demutualized” from a tute an unconstitutional taking, point- conditions creates “inequity.” How- mutual insurance company to a stock ing to Plaintiffs’ concession that the ever, the court rejected this argument, insurance company. Pursuant to this Order does not completely preclude noting crucial distinctions between transaction, MLMIC agreed to distrib- them from hosting any events on their the operations of Plaintiffs’ facilities ute certain cash consideration received premises, just those with more than and restaurants. from NICO, in an amount approxi- 50 persons in attendance. For example, the large gatherings mately 1.9 times the sum of premiums Plaintiffs typically host, such as wed- Turning to the second element of that were timely paid during a defined dings, religious celebrations, family the heightened standard, the court three-year period, to eligible policy- reunions, funeral breakfasts, gradu- held that Plaintiffs did not make holders or their “Designees.” a “strong showing” of irreparable ation parties and political events, The disputed funds in Maple-Gate harm, nothing the Order’s tempo- are different from typical restaurant Anesthesiologists were generated pur- rary nature and Plaintiffs ability to outings. Guests at such events arrive suant to MLMIC malpractice policies still operate their businesses. The and depart at the same time; while by which the defendants were insured court also ruled that Plaintiffs did restaurant goers arrive and depart at while employed by the anesthesiol- not demonstrate that the balance of varying times; guests at such events ogy practice. As the policyholders, equities and public interest weigh are generally family and friends the employees claimed that they were in their favor. An injunction would who know each other and closely the proper recipients of the associ- undermine New York’s coronavirus interact; restaurant goers, other than ated cash consideration. The practice response and prevent it from enforc- the immediate party, are generally disagreed, asserting that since it paid ing measures meant to protect public strangers who do not interact with the entirety of the premiums for the health. Plaintiffs’ interest in hosting each other; guests at such events stay policies, it was the proper recipient of gatherings with more than 50 people for extended periods of time, while the demutualization funds. restaurant goers generally stay only did not outweigh the State’s inter- as long as their meal lasts. Thus, the est in protecting the general welfare The employees moved to dis- court agreed that unlike the Plain- and, ultimately, “the pressing need to miss the practice’s claims, and the tiffs, restaurants do not host the type eradicate this insidious disease.” Supreme Court, Erie County, granted of “super-spreader” events that the the employees’ motion in its entirety. epidemiologists, upon whom the state The Appellate Division for the Third and Fourth Departments The court affirmed, finding that relied, believe pose a heightened risk the former employees were entitled Holds That Physician of COVID-19 transmission. The court to the cash proceeds. In reaching this noted as another significant distinc- Policyholders Are Entitled to conclusion, the court relied on New tion that the State has deemed the Receive MLMIC Demutualization York Insurance Law § 7307, which restaurant industry “essential,” recog- Funds, While the Supreme governs how mutual insurance nizing it as a major food resource for Court, Kings County, Finds companies convert to stock insur- New Yorkers, unlike catering services. That the Employers That Paid ance companies, and MLMIC’s plan Plaintiffs also argued that the the Premiums for the MLMIC of conversion. The court found that Order is no longer necessary, given Policies Are the Proper Recipient these authorities “provided that cash the improvements in infection rate of the Funds distributions were required to be and continued re-opening of other made to those policyholders who had Maple-Gate Anesthesiologists, P.C. sectors. However, the court rejected coverage during the relevant period v. Nasrin, 182 A.D.3d 984, 122 N.Y.S.3d that argument, noting that the reach prior to demutualization,” absent an 840 (4th Dep’t 2020). Plaintiff, an of Jacobson extends until the end of assignment of that right to a policy anesthesiology practice, brought this the coronavirus pandemic—and “the administrator. Since the documentary action against former employees as- end is not in sight.” evidence established that the defen-

NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 11 dants were the policyholders for the the First Department’s decision in tue of having paid the premiums for MLMIC policies and that they had In re Schaffer, Schonholz & Drossman, the policy in question, while the phy- not designated the practice to receive LLP v. Title, 171 A.D.3d 465, 465, 96 sician asserted that she had a legal the demutualization proceeds, the N.Y.S.3d 526 (1st Dep’t, 2019), the right to the funds as the policyholder. court held that the former employees Supreme Court, Saratoga County, Both parties moved for summary were the proper recipients of the cash denied the employee’s motion and judgment, and the court found in consideration. declared that the practice was entitled favor of the hospital. The physician to the cash consideration. The court also declined to fol- subsequently moved to reargue her low In re Schaffer, Schonholz & Dross- The Appellate Division reversed, motion following the Fourth De- man, LLP v. Title, 171 A.D.3d 465, 465, ruling that the employee was the partment’s decision in Maple-Gate 96 N.Y.S.3d 526 (1st Dep’t, 2019), in proper recipient of the funds. Follow- Anesthesiologists. which the Appellate Division for the ing the Fourth Department’s rationale The court began its analysis by ac- First Department found that em- in Maple-Gate Anesthesiologists, the knowledging that “a clear split” exists ployers that paid the premiums for court held that the employee, as the between the Appellate Division courts MLMIC policies, and not policyhold- policyholder for the relevant MLMIC regarding entitlement to MLMIC er-employees, were entitled to the policy, had a legal right to the cash demutualization funds, with the Third resulting demutualization proceeds consideration under the New York and Fourth Departments, in Schoch and under the principles of unjust enrich- Insurance Law § 7307 and MLMIC’s Maple-Gate Anesthesiologists, finding ment. Even if the practice “could be plan of conversion. entitled to the demutualization pay- that policyholders are entitled to the ments without the express designa- The court also rejected the proceeds, and the First Department, in Schaffer, determining that employers tion,” the Fourth Department found, practice’s contention that its former that paid the policy premiums were “[t]he mere fact that [the practice] paid employee would be unjustly enriched the proper recipients of those funds. the annual premiums on the policies if she were to receive the cash con- As a trial court in the Second Depart on defendants’ behalf does not entitle sideration and declined to follow - it to the demutualization payments.” the First Department’s holding in ment, the court noted that it was free Schaffer. Specifically, the court found to engage in a “fresh analysis.” Schoch v. Lake Champlain OB-GYN, that: (1) the cash consideration was Next, the court found that the P.C., 184 A.D.3d 338, 126 N.Y.S. 3d a windfall to both parties, as neither physician did not have a legal right to 532 (3d Dep’t, 2020). Three weeks of them anticipated its distribution; the cash consideration under the Insur- after the Appellate Division for the (2) the employee’s receipt of the ance Law simply because she was the Fourth Department issued its deci- funds would not be due to a factual named policyholder. Specifically, the sion in Maple-Gate Anesthesiologists, mistake, as she was legally entitled to court rejected the Fourth and Third De- the Appellate Division for the Third them as the policyholder; (3) neither partments’ interpretation of N.Y. Insur- Department issued a similar decision. party changed position based on the ance Law § 7307(e)(3), finding that the Plaintiff, a certified nurse midwife demutualization; and (4) the employ- statutory language assumed that the and obstetrics/gynecology nurse ee’s conduct was neither tortious nor policyholder and the party that paid practitioner, brought a declaratory fraudulent. Under these circumstanc- the policy premiums are necessarily the judgment action against her former es, the court held that the employee same person. Since the statute “did not employer, an obstetrics and gynecol- would not be unjustly enriched at the contemplate a demutualization plan ogy practice, to establish that she, practice’s expense were she to receive and accompanying cash compensa- as the policyholder, was entitled to the demutualization funds. receive cash consideration generated tion payment where the policyholder Wyckoff Heights Medical Center v. pursuant to MLMIC’s demutualiza- did not pay the premiums herself,” the Leonora Monroe & MLMIC Insurance tion for the MLMIC policy under court found that the Insurance Law did Company which plaintiff was insured while , No. 526139/18, 2020 WL not give policyholders a legal right to she was employed by the practice. 4561195 (N.Y. Sup. Ct., Kings Cty., receive the funds and was “unhelpful Wyckoff Heights The practice asserted a counterclaim August 7, 2020). In , in this context.” a hospital sued a former employee- for unjust enrichment, claiming The court also noted that physician seeking to establish its that it would be against equity and MLMIC’s demutualization plan entitlement to MLMIC demutualiza- good conscience for the employee to anticipated competing claims by tion funds that were issued for the receive the funds when the practice policyholders and those who paid insurance policy under which the paid the entirety of the premiums for the premiums, and established a physician was insured while she was the policy in question. dispute resolution process. The court employed by the hospital. As was the reasoned that there is no point to The parties both moved for sum- case in Maple-Gate Anesthesiologists a dispute resolution process if the em- mary judgment. Finding that it was and Schoch, the hospital claimed that ployee is automatically entitled to the bound by the Appellate Division for it was entitled to those funds by vir-

12 NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 cash consideration merely because account records and ledgers, dates, “pursuant to this rule.” In determin- she was the policy holder. procedure codes, descriptions of ing the scope of that clause, it noted services, copies of patient checks, and that the only CPLR “rule” that is In the absence of controlling correspondence with their patients. referred to in the immediately pre- authority, the court turned to “the No patient authorizations were pro- ceding text that governs service of a specific facts of the case.” The court vided. The Group refused to comply, subpoena duces tecum to obtain med- found that (1) the hospital paid the contending that CPLR 3122(a)(2) ical records, is CPLR 3120. This rule is premiums for the physician’s policy, requires such authorizations. The incorporated in CPLR 3122(a)(1). And (2) those premium payments were Comptroller offered to compromise that section is concerned with objec- not part of the physician’s compensa- by accepting records with patient tions to pretrial discovery. Therefore, tion package, and (3) the parties had names redacted and replaced by the Court concluded that the patient not previously bargained for the de- unique identifiers. In response, the authorization requirement in CPLR mutualization funds. Under these cir- Group moved to quash the subpoena. 3122(a)(2) applies only to subpoenas cumstances, the court concluded that served pursuant to CPLR 3120; rule it would be “… unjust to award the CPLR 3122(a)(2) requires that 3120 applies to subpoenas served cash compensation to the defendant certain subpoenas seeking patient after litigation has commenced. who never paid for the premiums at medical records be accompanied by any time during her employment.” a written patient authorization. The The Group’s second argument statute expressly provides that the re- attempted to expand the scope of New York Court of Appeals quirement applies to subpoenas duces the “pursuant to this rule” clause Holds That Comptroller May tecum served “pursuant to this rule.” by asserting that it is self-referential Subpoena Medical Billing The Group argued that (1) under and therefore subject to the patient Records Without Providing CPLR 3122(a)(2), it was not obligated authorization requirement. The Court Patient Authorizations to respond to the subpoena; (2) the disagreed, reasoning that CPLR subpoena improperly requested pa- 3122(a)(2) is not itself a rule, but it Plastic Surgery Group, P.C. v tient information protected by HIPAA; “[d]elineates a circumstance which a Comptroller of State, 34 N.Y.3d 507, 121 and (3) the subpoena was overbroad medical provider need not respond N.Y.S.3d 723 (2019). The issue before and unduly burdensome. The Comp- or object to a subpoena.” The Court the New York State Court of Appeals troller cross-moved to compel compli- stated that it is “required to consider was whether the New York State ance, contending that CPLR 3122(a)(2) a statute as a whole, reading and Comptroller, in the course of auditing applies only to discovery subpoenas construing all its parts. . . together to health care providers who were paid issued by a party in litigation. determine legislative intent.” by the state, can subpoena patient billing records without written pa- The trial court granted the The Court noted that in 2011, tient authorizations. Group’s motion to quash, but the the legislature amended CPLR 3122 Appellate Division reversed. The to clarify that the patient authoriza- Petitioner Plastic Surgery Group, Court of Appeals then granted the tion requirement did not apply to a P.C. (“the Group”) is an out-of-net- Group leave to appeal and affirmed trial subpoena issued by a court. This work provider with the Emipre Plan, the Appellate Division’s holding. (On change moved the patient authori- part of the New York State Health appeal, the Group did not challenge zation requirement into a separate, Insurance Program. As an out-of-net- the Appellate Division’s determina- numbered paragraph and added a work provider, the Group has a legal tions that the Comptroller’s subpoena clear exception for trial subpoenas. duty to collect patient co-payments. was not improper under HIPAA and Additionally, the Court noted, that Failure to do so inflates a claim’s cost was not overbroad or unduly burden- “[i]f it were the intent of the legis- and can result in civil and criminal some. Therefore, the Court did not lature to set forth a rule, governing penalties. The Comptroller com- address those issues). the operation of all subpoenas duces menced an audit of certain claims paid tecum served on medical provid- to the Group for services rendered to The Court began its analysis by ers, it would not have placed such a Empire Plan members. The audit was looking toward the broader context statute in the article of the CPLR that to determine whether the Group had of CPLR Article 31. It noted that Rule governs ‘Disclosure’. . . .” The Court routinely waived patient copays, thus 3122 is preceded by Rule 3120 and stated that application of the Group’s inflating the costs paid by the State. Section 3121. Its analysis concluded theory would have an absurd result: that both CPLR 3120 and CPLR 3121 the Comptroller’s subpoenas would Because the Practice Group was expressly govern practice after an ac- uncooperative, the Comptroller is- be governed by provisions that are tion has been commenced. The Court only applicable to subpoenas served sued a subpoena duces tecum pursu- then turned to the Group’s arguments. ant to CPLR 2302(a). The subpoena in a pending civil judicial proceeding. sought names and addresses of the The Court first noted that CPLR Lastly, the Court turned to the Group’s Empire Plan members, their 3122(a)(2)’s patient authorization re- Group’s policy argument, which it quirement applies only to subpoenas

NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 13 also found unpersuasive. The Court Hospital physicians, neither of whom With regard to Plaintiff’s § 740 noted that CPLR 3122(a)(2) does not agreed. The physicians believed that claim, the court stated that not only apply by its own terms. Therefore, placement of the drain posed a risk must a plaintiff establish an actual it cannot be construed to further the of intracranial hemorrhage. Plaintiff violation of a law or regulation, but policy interest within the physician- believed that failure to place the drain must also demonstrate the violation patient privilege set forth in CPLR would lead to the infant’s death. presented a “substantial and specific 4504. Also, the Group did not argue danger to the public health or safety.” that the privilege is a separate basis Frustrated with what he per- The court noted that neglecting an for quashing the subpoena. The Court ceived to be indifference and inaction individual patient does not threaten also rejected this argument because on the part of the two physicians, the health or safety of the public at New York Public Officer’s Law 92 Plaintiff emailed his manager at large and such disclosures are gener- prohibits the Comptroller from pub- the Hospital. In the email, Plaintiff ally insufficient to make a requisite licly disclosing any patient records implied that the physicians had not showing under § 740. it received for purposes of an audit, done enough for the patient, and The court held that as Plaintiff’s without the patient’s consent. reiterated his recommendation for placement of an extra-ventricular email to his manager did not reveal drain. He also made a note of his any inherently dangerous practice Federal District Court Holds That recommendation and concerns in ongoing or liable to recur at the Hos- Nurse’s Note in Medical Record the patient’s medical record, and pital, it did not address a violation Was Not a Protected Disclosure also wrote in the medical record that presenting a substantial and specific Under New York Labor Law the patient’s great-grandmother had danger to public health or safety. §§ 740 or 741, and Subjective mentioned speaking with an attor- Thus, Plaintiff’s email disclosure Criticism of Physician’s Plan of ney. Shortly thereafter, the Hospital’s could not sustain a claim under § 740. Care Failed to State a Claim liason with the staffing agency told The court next addressed Plain- Under § 741 Plaintiff that he was “wildly inap- tiff’s § 741 claim. § 741, unlike § 740, propriate,” “way out of line,” and Villarreal v. Montefiore Medical does afford protection to employees operating “outside the scope of his Center, 2020 WL 5518382 (S.D.N.Y., who disclose violations that present “a practice.” Plaintiff’s contract with the Sept. 14, 2020). Plaintiff, a registered significant threat to the health of a spe- Hospital was terminated. nurse, sued Montefiore Medical Cen- cific patient.” Accordingly, the issue ter (the “Hospital”) and Fastaff, LLC, In addressing the Defendants’ before the court was whether Plaintiff a staffing agency, alleging violations motion to dismiss, the court limited reasonably believed that the treatment of New York Labor Law §§ 740 & 741. its analysis of Plaintiff’s alleged dis- plan for the patient was so deficient The Defendants moved to dismiss closures to only the email exchange that it violated a law or regulation. Plaintiff’s complaint for failure to with his supervisor, which criticized Plaintiff’s complaint alleged state a claim under Rule 12(b)(6), the Hospital’s treatment plan for the that the failure to place an extra- arguing Plaintiff did not plausibly patient. In doing so, the court noted ventricular drain may have consti- allege that he was terminated after that §§ 740 and 741 are concerned tuted professional misconduct as making a disclosure protected under only with disclosures that lead to defined in New York Education Law either § 740 or § 741. retaliatory personnel actions, not § 6530, which proscribes practicing with disclosures that postdate such Plaintiff secured a short-term medicine “with gross negligence on a actions. Thus, although the complaint placement at the Hospital as a particular occasion.” Plaintiff’s basis alleged other supposed violations of registered nurse in the Hospital’s for believing the treatment plan to be New York laws and regulations at pediatric intensive care unit, during grossly negligent was his “profession- the Hospital, there was no indication which time he was assigned to care al knowledge and work experience.” that Plaintiff raised these issues with for an infant born with serious health The court observed that although Defendants prior to his termination. complications, which were addressed Plaintiff maintained that his recom- by surgery. Following the patient’s The court further noted that the mendation was the proper treatment discharge, the patient returned to the disclosures protected under §§ 740 plan, despite the fact that two physi- Hospital after contracting bacterial and 741 are those made to supervi- cians disagreed with his assessment meningitis. MRI testing revealed the sors and “public bodies,” defined in (one of whom voiced his disagree- patient had sustained brain tissue §§ 740(1)(d) and 741(1)(e) as government only after assessing the patient damage and a build up of excess ment bodies like courts and adminis- himself), the Plaintiff did not allege fluid in the brain. Plaintiff believed trative agencies. Thus, Plaintiff’s note that the physicians’ decision was the patient should be treated with an in the patient’s medical record, which made too hastily or that their expla- extra-ventricular drain to address the was neither a disclosure to a super- nation conflicted with leading medi- excess fluid in the brain. He dis- visor nor a public body, was not a dis- cal treatises. Rather, the court found cussed his recommendation with two closure protected by the Labor Law. Plaintiff’s alleged disclosure to be a personal critique of the physicians.

14 NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 As Plaintiff’s basis for his allega- The Appellate Division affirmed. Public Health Law does not permit tion of gross negligence was nothing The court noted that Petitioner’s al- the imposition of punitive damages more than his personal judgment on legations regarding unethical employ- against municipalities. how the patient should have been ment practices by certain medical Section 2801-d(2) permits puni- treated, and the two physicians, with professionals did not fall under the tive damages against medical facilities whom he consulted, explained their purpose of the Education Law, which where the deprivation of a patient’s disagreement with Plaintiff’s judg- protects patients, not physicians. This, rights is willful or in reckless disre- ment before he emailed his manager, according to the court, was evidenced gard of the patient’s rights. In this the court found that Plaintiff’s com- by the Education Law’s focus on fraud, action, the Plaintiff sought punitive plaint failed to allege that Plaintiff negligence and incompetence by a damages against Monroe Commu- reasonably believed the Hospital or physician, impairment of the physi- nity Hospital (MCH) under § 2801-d, its staff violated any law or regula- cian, and the impact on the general after its executive director deprived tion. Therefore, Plaintiff’s § 741 claim welfare of the patient. While the Peti- Plaintiff’s decedent of his manual also failed. tioner cited to the definition of professional medical misconduct under the wheelchair, which resulted in the deterioration of the decedent’s health Third Department Rejects Education Law as the failure to comply and later his death. MCH moved for Psychiatrist’s Efforts To Have with applicable laws, the court noted that Petitioner did not specify what partial summary judgment dismissal OPMC Investigate Non-Medical of the claim for punitive damages, ar- Misconduct Claim laws the medical institutions and its leadership allegedly violated. guing that § 2801-d(2) does not permit Meyer v. Zucker, 185 A.D. 3d 1265, punitive damages against municipali- 128 N.Y.S.3d 291 (3d Dep’t, 2020). Moreover, the court held that the ties. The trial court granted MCH’s Petitioner Dr. Jill Meyer, a licensed Public Health Law does not require motion. psychiatrist, sought to have the Of- OPMC to investigate non-medical On appeal, the court observed fice of Professional Medical Conduct misconduct. To that end, the court that New York State and its political (OPMC) investigate her allegations found unpersuasive Petitioner’s focus subdivisions are not generally liable that several medical institutions and on the phrase “shall investigate” in for punitive damages. According to their leadership colluded to prevent Public Health Law § 230(10)(a)(1)(A). the court the “twin justifications” for her from obtaining employment as The court reasoned that rather than punitive damages—punishment and a psychiatrist. OPMC denied Peti- imposing a general duty to investi- deterrence—are not advanced when tioner’s request on the basis that the gate all claims, the language of the applied to government entities. allegations did not constitute medical Public Health Law allows the OPMC misconduct as defined by Education to investigate medical misconduct on Moreover, the court noted that Law § 6530. Petitioner commenced a its own or upon receipt of a com- since statutes conflicting with the CPLR article 78 proceeding seeking plaint, regardless of the source. general presumption of sovereign to invalidate OPMC’s determination immunity must be strictly construed, Accordingly, the court held denying her request and to compel it waiver of this immunity by inference that since OPMC is not required to to investigate her claims. is disfavored. With that in mind, the investigate a non-medical misconduct court held that § 2801-d(2) does not The Commissioner of Health claim, a writ of mandamus to compel “clearly, expressly, or specifically,” moved to dismiss, asserting that she such investigation was unwarranted. waive sovereign immunity, nor is lacked standing to challenge OPMC’s Additionally, the court held that there any indication that the legisla- determination, and that the peti- OPMC’s decision not to investigate ture contemplated exposing munici- tion failed to state facts necessary to the Petitioner’s claims for not being palities to punitive damages. support the issuance of a mandamus medical misconduct as defined by the to compel OPMC to investigate. The Education Law § 6530 had a rational The court also dismissed Plain- motion court granted the Respon- basis, and was therefore not arbitrary tiffs’ reliance on other sections of the dent’s motion, finding that since and capricious. Public Health Law. According to the Petitioner’s claims did not fall under court, reliance on other sections of Education Law § 6530, OPMC was Fourth Department Holds the statute only rendered § 2801-d(2) not under any legal duty to investi- That Plaintiffs Cannot Recover ambiguous with respect to the impo- gate, and its refusal to do so was not Punitive Damages Against sition of punitive damages against arbitrary and capricious. Municipalities for Violations of MCH. As such, the court held that § 2801-d(2) could not be considered to On appeal, Petitioner asserted Public Health Law § 2801-d expressly authorize municipal liabil- that OPMC had a mandatory duty Cornell v. County of Monroe , 2020 ity for punitive damages or abrogate to investigate her claims, and that by WL 5867735 (4th Dep’t, October the well-settled principle of sovereign refusing to do so, it acted in an arbi- Cornell 2, 2020). In , the Appellate immunity. trary and capricious manner. Division held that § 2801-d(2) of the

NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 15 In the Legislature By James W. Lytle

In the last edition of this publi- bills passing and applies the protection only cation, I had reported on the initial both houses to COVID-19-related services steps taken by the New York State in 2019 and rendered to such persons; Legislature and the Governor’s office 641 and 606 when the COVID-19 pandemic first during 2018 • While the original law extend- prevention arrived in New York. It seemed likely, and 2017, ed to the diagnosis, even then, that the 2020 Legislative respectively. or treatment of COVID-19, the Session would be like no other—and Only one of amendment deletes “preven- everything that has transpired since the 2020 bills tion” and limits protections to has borne that out. has thus far the actual care and not to “ar- been vetoed ranging for” care; and The emergency authority es- by the Gover- tablished in legislation described in • The amendment conditions nor—but he typically defers taking liability limitations to services that prior column has spawned 70 adverse actions on the bills that may executive orders, as of this writing, rendered “in accordance with be in the tentative veto pile until later applicable law or where appro- with the likelihood that many more in the year. executive actions will be forthcoming priate pursuant to a COVID-19 before the pandemic becomes history. While the volume of legislation emergency rule.” While close attention to those execu- may have dwindled, a number of The Governor signed these tive orders—which relaxed certain important bills have either been en- amendments on August 3. professional scopes of practice, acted or are awaiting the Governor’s expanded the use of telehealth, man- review:1 Contact tracing: A. 10500-C/S. dated the closure and then reopening 8450-C would protect the confiden- of businesses, schools and health care COVID-19-related bills tiality of contract tracing, while two other bills (S. 8362-A/A. 10447-A and facilities, among many other things— COVID immunity: One of the pro- is highly recommended, a full A.10567-A/S. 8829) would require visions enacted as part of the budget that contact tracers (in New York City, exposition is outside of this column’s (Part GGG of Chapter 56 of the Laws legislative jurisdiction. Without ques- in the first bill, and in the rest of the of 2020) provided civil and criminal state, in the second) be hired who tion, the emergency has further tilted immunity to health care professionals the balance of power and the locus represent the cultural and linguistic and facilities for certain acts or omis- diversity of the affected communities. of health care policy-making toward sions during the COVID emergency, the Executive—a phenomenon that except where the acts or omissions Whistleblower protections for health- preceded the pandemic under several constituted intentional criminal mis- care workers: S. 8397-A/A. 10326-A gubernatorial administrations but conduct, gross negligence, reckless protects health care employees from has accelerated during this crisis. misconduct or intentional infliction employer retaliation if they report Whether that balance may be restored of harm. Staff or resource short- violations of workplace safety to vari- when the current emergency recedes ages would not be considered gross ous parties, including the news media remains to be seen. negligence or satisfy any of the other and social media. exceptions to the grant of immunity. With more than a handful of state COVID and public employees: After some criticism of the scope of legislators infected by the virus, even S. 8427/A. 10528 established a corona- the immunity accorded to health care convening the Legislature proved virus death benefit for public employ- providers during the crisis, the Legis- challenging: the Capitol was closed to ees and S. 8617-B/A. 10832 requires lature passed subsequent legislation the public, many legislators attended public employers to develop a plan (S. 8835/A. 10840) to fine tune the legislative hearings and sessions for continued operations in the event original proposal: remotely and, not surprisingly, the of a public health emergency. output of the Legislature declined • The amendment limits liability precipitously. With no additional protection only to services ren- session yet scheduled for the balance dered to persons with confirmed of the year, only 413 bills passed both or suspected cases of CO- houses as of mid-October and only VID-19—and not to “the care of James Lytle is a partner in the 249 have been acted upon by the any other individual who pres- Albany office of Manatt, Phelps & Governor. That total compares to 935 ents” during the emergency— Phillips, LLP.

16 NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 Nursing home pandemic emergency • A. 5370-A/S. 6705, which Organ Donation planning: S. 8289-B/A. 10394-A re- would require the Department A. 7915-A/S.7318 mandates that quires residential health care facili- of Health to develop and make applicants for hunting and fishing ties to submit an annual pandemic available information regard- licenses be asked and be required emergency plan to the Commissioner ing bone marrow donation and to respond whether they wish to be of Health, which must include a com- registries. enrolled in the Donate Life (organ munication plan with families, plans donor) registry. to protect staff, residents and families • A. 2770-C/S. S. 8525, which against infection, and plans to pre- directs the commissioner of S. 6941/A. 9523 amended a law serve a resident’s place at the facility health to require hospitals to enacted in 2019 that generally con- if he or she is hospitalized. provide pre-term labor patients formed New York anatomical gift with information regarding the laws to the Uniform Anatomical Gift Infectious disease in prisons: potential health effects of pre- Act. The bill made technical changes A. 10463-A/S. 8315-A would require term labor and pre-term deliv- to the 2019 chapter, restored some a review of policies and procedures ery on an expectant mother and provisions relating to the responsi- relating to infectious disease in cor- on her fetus. bilities of hospitals and procurement rectional facilities. • A. 6986-A/S. 6707 and A. 6987- organizations and clarified provisions COVID-19 impact on minorities: A/S. 6662, which require the relating to the execution, amendment S. 8245-A/A. 10517 would require the Department of Health to con- and revocation of anatomical gifts. Department of Health to conduct a duct studies and report upon study on the health impacts of COV- the effects of racial and ethnic Opioid and Substance ID-19 on racial and ethnic minorities. disparities on breastfeeding Use-Related rates and on infant mortality, COVID-19 vaccine administration: A. 7812-A/S. 8259 expanded the respectively. S. 8182-A/A. 10508 would add a yet entities that may possess, distribute and administer opioid antagonists to to be approved COVID-19 vaccine • A. 10470-A/S. 8719-A would reverse overdoses to include restau- to the immunizations that may be direct the Health Commis- rants, bars, retail stores, shopping administered by pharmacists. sioner to conduct a study of the malls, barber shops, beauty parlors, delivery of ambulatory care on theaters, sporting or event venues, Telehealth Staten Island. inns, hotels or motels. While executive orders gener- • S. 7173/A. 9520 requires hos- S. 3159-A/A. 5952-A prohibits ally removed barriers to the use of pital to adopt obstetric hemor- discrimination in the issuance of telehealth during the pandemic, the rhage protocols; Legislature addressed telehealth life insurance policies or annuity through these bills: • S. 7175/A. 9133 requires the contracts against individuals solely Department of Health to de- because the individual had been Dental telehealth: A. 10034/S. 7879 velop and update information prescribed medication to block the would require that the provision of on possible complications from effects of opioids, such as Naloxone dental services through telehealth pregnancy that might endanger and Narcan. adhere to the same standards of care the life or health of the new- S. 4741-B/A. 9536 requires sub- that otherwise apply to the provision born or mother and to post stance use certified treatment proof dental services. that information on its website grams to notify patients of their right to facilitate the furnishing of Audio-only telehealth services: to identify individuals who should be that information to patients S. 8416/A 10404-A includes audio contacted in cases of emergency. only telephonic telehealth services to by hospitals, clinics, obstetri- be incorporated within the definition cians, primary care providers, midwives and other health care Hospital Policies and of telehealth services, provided that Responsibilities the Medicaid and Childrem’s Health programs. Hospitals offering Insurance Programs’ coverage of such maternity or women’s wellness A. 9134/S. 7192 amends a 2019 services will be subject to Department services and clinics providing law to clarify that the hospital em- of Health regulations. prenatal services must make ployees required to undergo domestic this information available to violence training are nursing, medi- Public Health Reporting patients. cal, social work and other clinical personnel, as well as security person- • S. 7172/A. 9132 requires the De- A number of bills require reports nel at the hospital. or studies of various matters, as set partment of Health to convene forth below: a workgroup on rare diseases. S. 7185/A. 9135 strengthens existing requirements governing hospital

NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 17 discharge planning requirements Health Care Consumer Advocacy • A. 5240-A/S. 6479-A requires to clarify that, where an identified and Assistance that single-occupancy bath- caregiver is unwilling or unable to S. 6492-B/A. 8533-B would rooms in public places (includ- “confidently provide proper care,” establish a drug assistance program ing bars, restaurants, mercan- the hospital must assess whether in New York that would be intended tile facilities, factories, schools, other services, such as home care, to provide access to insulin and other SUNY and CUNY facilities and may be necessary and, if so, to order life-sustaining medications if they community colleges) must be those services. are otherwise without health cover- designated as gender-neutral. age. The Commissioner of Health is S. 6937/A. 8974, a chapter Professional Roles and directed to issue a report within three amendment to a bill enacted in Responsibilities months of the effective date of the 2019, clarifies the state agencies that are subject to the A. 7991-A/S. 6678-A requires the legislation as to how this program same requirement of gender- Office of Professional Medical Con- might be established. The bill would neutrality for single-occupancy duct (OPMC) to post on its website also authorize prescribers to issue bathrooms. information relating to the reporting a non-patient-specific prescription of professional misconduct, including for insulin and related supplies that sexual harassment and assault, and may be dispensed by a pharmacist to an individual who had been previ- requires physician practices to post Endnote information informing patients of the ously prescribed the medication and 1. The bills are referenced by their Senate OPMC website. requires it on an emergency basis. (S. XXXX) and Assembly (A. XXXX) bill S. 7190/A. 9521 clarifies the rights numbers and the bill numbers of those A. 10634-B/S. 8641-A makes a bills signed by the Governor as of this series of technical amendments to of residents of adult care facilities to writing are indicated in bold. a 2019 statute that authorized oph- select their own health care providers. thalmologists and optometrists to A. 9530/S. 7304 would require delegate to certain unlicensed per- that at least three members of the sons the instillation of dilating eye Public Health & Health Planning drops. The amendments clarify that Council represent health care con- these persons must be under the sumer advocacy organizations. supervision of the ophthalmologist or optometrist and satisfy certain other A. 9538/S. 7241 would require requirements. managed care plans to provide written notice of the name and contact in- S. 7115/A. 9034 would allow a formation of the designated indepen- patient or prescriber to request that dent consumer assistance program a prescription for a controlled sub- and the independent substance use stance be partially filled, with the disorder mental health ombudsman remainder available to be dispensed on all notices of adverse determina- separately in conformity with the tions, grievances and appeals. directions for use. S. 6952/A. 9648 conditions Medic- Bathroom Accessibility aid coverage for lactation counseling A number of bills addressed bath- services on the order of a physician, room access, which may be applicable physician assistant, nurse practitioner to health care facilities: or midwife. • A. 8146/S. 6226 creates a S. 7524/A. 9097 would require Crohn’s and Colitis Identifica- the Department of Health to convene tion card that can be utilized a work group to assess the impact of to access to restroom facilities recent changes to the grant process as necessary and A. 8821/S. under the Doctors Across New York 7211 authorizes the consumer program on the ability of individual protection division to enforce applicants to access funding under previously enacted laws that the program. prohibit denying access by persons with these medical conditions from accessing employee bathrooms.

18 NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 New York State Fraud, Abuse and Compliance Developments Edited by Melissa M. Zambri

New York State Department of With those charges dismissed, OMIG found Health Medicaid Decisions1 only the allegations of unacceptable these disal- Compiled by Margaret M. Surowka practices related to record-keeping lowances to be remained. Despite Appellant showing improper. David A. Petti, D.D.S. (Decision that the record-keeping at his former On a After Hearing July 3, 2020, James F. practice was out of his control, the conference Horan, ALJ) ALJ sustained the violations. As the dental practice had already pro- call with the This matter involved the review vided the recoupment of $20,936, the ALJ, Appel- of a decision by the New York State only remaining determination was lant claimed Office of the Medicaid Inspector whether an exclusion was warranted that no factual General (OMIG) to exclude Appel- based on the findings. In this regard, issues existed lant, David A. Petti, D.D.S, from the the ALJ noted that the exclusion had for a hear- Medicaid Program for three years. been largely based on the allegations ing, and made an initial request for OMIG’s decision was based on a that Appellant had violated profes- a decision without a hearing. This Notice of Final Agency Action seek- sional standards, which he dismissed. initial request was denied based on ing recoupment from Appellant and The ALJ also noted that Appellant OMIG’s assertion of factual issues to his former employer, Wilson Dental, had no prior disciplinary actions, be determined. Thereafter, a hearing P.C., for allegedly failing to: (1) com- that record-keeping violations are was scheduled and Appellant made a ply with Medicaid Dental Manual far less severe than providing sub- formal motion for a decision without requirements; (2) meet professionally standard care, and that the recoup- a hearing. recognized dental standards; (3) ad- ment for those services was sufficient equately document services rendered; During the pendency of the mo- for record-keeping violations. The and (4) adequately document the tion, Appellant’s attorneys brought a ALJ rejected OMIG’s argument that need for the services. The services at similar motion before another ALJ in Appellant’s removal from private issue involved wisdom teeth extrac- a separate matter involving a facility insurers should lead to an exclu- tion, sinus closures, and sedation under the same ownership with simi- sion, concluding that 18 N.Y.C.R.R. times. lar facts and findings. ALJ Gayle re- § 515.4(b) does not provide for ac- ferred to and attached the decision in As to OMIG’s finding that Ap- tions by private insurers as grounds that matter—The New Jewish Home, pellant failed to comply with profes- for determining a penalty. Therefore, Manhattan (May, 2020), summarized sional standards, OMIG presented ALJ Horan reversed the exclusion. below—and cited to ALJ Terepka’s its “expert witness” and Appellant decision sustaining OMIG’s audit testified on his own behalf. Adminis- Sarah Neuman Center for trative Law Judge (ALJ) Horan noted Healthcare and Rehabilitation that Appellant was a dental surgeon, (Decision Without Hearing May 21, Melissa M. Zambri is the Man- commonly known as an oral surgeon, 2020, Ann H. Gayle, ALJ) aging Director of the Albany Of- with years of experience in extrac- This decision was issued without fice of Barclay Damon LLP and the tions and working with anesthesia. hearing at Appellant’s request pursu- Co-Team Leader of the firm’s Health OMIG’s witness was a general sur- ant to 18 N.Y.C.R.R. § 519.23, and per- Care and Human Services teams, geon who did not specialize in and tained to a Final Audit Report issued focusing her practice on enterprise had never performed surgical sinus by OMIG disallowing reimbursement development and regulatory guid- closures. Based on this, ALJ Horan for office rentals and interest paid on ance for the health care industry. She refused to recognize OMIG’s witness a line of credit reported by Appellant. also teaches Legal Aspects of Health as an expert with respect to oral sur- Specifically, Appellant, the operator Care for Clarkson University and is gery procedures. That fact, coupled of a Nursing Facility (NF) and Adult an Adjunct Professor at Albany Law with the evidence that every service Day Health Care program (ADHC), School. at issue had prior approval, resulted noted reimbursements for “Equip- The editor wishes to thank Bar- in the ALJ concluding that OMIG was ment Rental Expense Disallowance” clay Damon LLP law clerks Jennifer not able to meet its burden of show- in the amount $66,685 (NF) and Cruz and Benjamin Wisher, who ing that unacceptable professional $49,573 (ADHC) and “Working Capi- assisted in the summaries of these standards had been violated. tal Interest Expenses” in the amounts decisions and press releases. of $35,556 (NF) and $35,336 (ADHC).

NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 19 determination that the reported costs the technology adopted by Appel- Instead, Appellants were the individ- were incorrect. As such, ALJ Gayle lants met the requirements of the uals who applied for the payments granted the request for a decision EHR Incentive Program. Appellants and as such, were responsible for the without a hearing and concluded that admitted that the EHR certification accuracy of their attestations. There- Appellant failed to meet its burden of identification numbers identified on fore, the OMIG determination to proving that the OMIG determination their attestations were neither ad- recover the $170,000 in EHR Technol- was incorrect. opted in 2014, nor at any other time. ogy Incentive Program payments was Seven of the eight dentists listed affirmed. Dental Specialty Associates, P.C. Amazing Charts Version 8, and one (Decision After Hearing May 14, listed DentiMax EHR Version 6, on The New Jewish Home, Manhattan 2020, John Harris Terepka, ALJ) their attestations. Appellants did, (Decision Without Hearing May 11, This decision is another in a long however, adopt a certified EHR Tech- 2020, John Harris Terepka, ALJ) line of decisions involving OMIG’s nology—Dentrix Enterprise Version Appellant is a residential health determination to seek restitution of 7—in 2017, a year for which Appel- care facility (RHCF) licensed under payments under the Medicaid Elec- lants both did not attest, and the Article 28 of the Public Health Law, tronic Health Records (EHR) Incen- incentive payment was not available operating in New York City. At issue tive Program from dentists. Here, for. Nevertheless, Appellants argued was a post-payment audit of the capi- Appellants—eight Medicaid provider that they substantially complied with tal portion of the RHCF’s cost reports dentists and their dental practice, the intent of the EHR Incentive Pro- (RHCF-4), which were considered in Dental Specialty Associates, P.C.—in- gram with the technology they had determining Appellants’ Medicaid dividually applied for and submit- in 2014, Dentrix Enterprise Version 5, Reimbursement Rates for the period ted attestations for payment under and that the version was the “func- of January 1, 2013 through Decem- the EHR Incentive Program. In 2015, tional equivalent” of the certified ber 31, 2016. A motion for a decision Dental Specialty was paid $21,250 for Version 7. ALJ Terepka rejected Ap- without a hearing was brought by each of the eight dentists who at- pellants’ argument, concluding that it Appellant, pursuant to 18 N.Y.C.R.R. tested to the adoption of technology is not “the function of this proceeding § 519.23. Property expense disallow- products eligible for the payments in to decide whether an uncertified EHR ance one, “related company expense 2014, totaling $170,000. technology of the Appellants’ choos- disallowances,” in the amount of ing is close enough to, or substan- $362,553 and property expense The EHR Incentive Program tially complies with, the certification disallowance four, “working capital requires the eligible professional to criteria and so is good enough to interest expense disallowance,” in the demonstrate that during the payment qualify for an incentive payment.” See amount of $60,716, were specifically year, the eligible professional either Decision at 8. ALJ Terepka noted that at issue. adopted, implemented, or upgraded the only question to be determined certified EHR Technology, or is a was whether Appellants met the In regards to the related compa- meaningful user of certified EHR requirement and adopted a certified ny expense disallowance, pertaining Technology. See 42 CFR § 495.314(a). EHR Technology, and rejected that to depreciation and rental expenses As an initial argument, Appellants this was form over substance. for Appellant’s offsite administra- asserted that: (1) OMIG was barred tive offices, Appellant explained that by the three-year statute of limitation Finally, Appellants argued that Jewish Home Lifecare, Corporate for negligence actions; and (2) the six- they were “meaningful users” of Services Inc. was incorporated in year statute of limitation for contracts EHR Technology, an argument that 2009, and serves as an offsite “home was not applicable in the matter. was again rejected as the question of office” that provides administra- Appellants’ argument was rejected, meaningful use only applies if the tive services to the facilities under as the overpayment of Medicaid technology was certified. Indeed, its corporate umbrella, including funds, rather than negligence, was the fact that Dentrix did not have the Appellant RHCF, as well as at issue, and the statute of limitation its technology, Enterprise Version 7, several other nursing homes and applicable to Medicaid overpayments certified until 2017 was undisputed. other health care and social services is six-years, as enrollment in the ALJ Terepka noted that there also programs. As such, the administra- Medicaid Program is contractual in was no explanation for the misrepre- tive services previously performed nature. Moreover, Parts 504 and 517 sentations and inaccuracies on both in-house at the Appellant RHCF of 18 N.Y.C.R.R. expressly provide Appellants’ attestations and in their were moved to this offsite loca- that OMIG has six years to initi- response to the Draft Audit Report, tion for which the related company ate an audit and require identified other than Appellants’ assertions expense disallowances were claimed. overpayments. that they may have been misled or ALJ Terepka noted that under the received questionable guidance from relevant regulations, an RHCF may After reaching a decision on the the EHR consultant who assisted receive reimbursement from Med- statute of limitation, ALJ Terepka them in preparing the attestations. icaid for costs that are chargeable turned to the primary issue: whether

20 NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 to necessary patient care, and that regulations. See 10 N.Y.C.R.R. §§ 86- Suffolk Center for Rehabilitation these allowable costs can include a 2.17(a), (d), 86-2.19(f), 401.3, 710.1 and Nursing (Decision After component of capital costs including et seq. Importantly, a RHCF may be Hearing April 27, 2020, Ann H. deprecation and rental and neces- eligible for reimbursement for offsite Gayle, ALJ) sary interest on current and capital office space, but in this case, “the Appellant, a RHCF, sought a indebtedness. See 10 N.Y.C.R.R. property costs associated with an hearing to appeal a fee-for-service §§ 86-2.10(a)(9), 86-2.17, 86-2.20(a). additional building . . . [were] already audit conducted by OMIG’s contrac- However, these allowable costs may being reimbursed in its rate for hous- tor, Health Management Systems, Inc. not include expenses that are found ing these administrative services in (HMS), identifying Medicaid over- to not be reasonably related to the ef- its existing building[,]” and as such, payments in the amount of $97,219.65 ficient production of services. See 10 “Medicaid [was] paying twice for plus interest calculated from the date N.Y.C.R.R. § 86-2.17(d). Importantly, the same function.” See Decision at 9. of payment. The audit identified Appellant’s per diem rate, set by the ALJ Terepka also noted that under 10 four categories of findings, based on Department of Health, is based on N.Y.C.R.R. § 86-2.19(f)(1), “[i]ncur- a review of Medicaid claims paid to cost reports which are subject to au- ring additional realty property costs Appellant for dates of service from dit, retroactive rate adjustment, and for an offsite building as a result of January 1, 2007 through January 31, repayment of overpayments, and moving administrative functions to 2011. Appellant, however, only con- unless otherwise provided in Part an offsite building is a realty transac- tested the findings in category one, 86-2m, the reporting costs for RHCFs tion for this nursing home for which which included disallowances for Ap- are primarily found in 42 CFR Chap- a change in the capital component of pellant’s alleged failure to reduce its ter IV and the Medicare Provider its rate is not permissible.” See Deci- payments, in whole or in part, by net Reimbursement Manual (PRM-1). sion at 11. Additionally, Appellant’s available monthly income (NAMI) See N.Y. Soc. Serv. Law § 368-c; 10 argument that the fact that it was not payments. N.Y.C.R.R. § 86-2.7; 18 N.Y.C.R.R. given notice that the costs would not §§ 504.8, 517.3(a), 518.1. be reimbursed when the Department ALJ Gayle noted that the only re- of Health was aware of these costs sponse to the Draft Audit Report was In determining whether these from its RHCF-4 was a deprivation of Appellant’s analysis of the uncollected were allowable costs, ALJ Terepka its due process rights was rejected, as NAMIs that it suffered ($345,680.12), first looked at the real property costs such an argument ignored the process and Appellant’s assertion that this associated with the offsite adminis- provided for by post-payment audit amount should be used as an offset of trative services. Appellant argued procedures. repayment. As such, the only issues to that the costs should be allowable, as be decided at hearing were whether they resulted in more efficient service As to the disallowance for the the NAMI overpayments were correct delivery and a reduction in overall working capital interest expense, and whether interest from the date spending. ALJ Terepka noted that no necessary interest on both current of the overpayments was proper. As evidence was offered showing these and capital indebtedness are allow- additional background, prior to the efficiencies, reduced spending, or able costs under 10 N.Y.C.R.R. § 86- Draft Audit Report and Final Audit why it was economical to relocate 2.20(a). Here, however, OMIG found Report being issued, Appellant com- these administrative functions to that the line of credit failed to meet menced an action in Supreme Court justify the several hundred thousand the definition of “current liability,” (Index 305755/12), which was dis- dollars in additional reimbursement which is defined as a short term missed for failure to exhaust adminis- from Medicaid that Appellant sought. debt usually paid within one year or trative remedies. See Concourse Rehab. Most importantly, by requesting a less. See PRM-1 § 202.1. Importantly, & Nursing Ctr. v. Shah, 78 N.Y.S.3d 60 decision without a hearing, Appellant Appellant offered no documentation (1st Dep’t 2018). was not entitled to a factual determi- showing a method of repayment or nation such as this. due date for the borrowed funds, ALJ Gayle set forth the relevant and failed to show that the interest legal standards, reiterating that Although ALJ Terepka agreed expense was properly chargeable to RHCFs are obligated to reduce claims with Appellant that the move to an necessary patient care notwithstand- for Medicaid payments by residents’ offsite location did not require a Cer- ing the fact that generally accepted NAMI amounts, the NAMI obliga- tificate of Need (CON), or any other accounting principles (GAAP) re- tion is the resident’s responsibility, notice or approval, he noted that Ap- porting was followed. ALJ Terepka and the facility has the burden of pellant’s current CON for the RHCF concluded that the costs did not collecting that amount. See Nursing includes administrative space within qualify as capital indebtedness under Home Dear Administrator Letter the building, and as such, OMIG’s 10 N.Y.C.R.R. § 86-2.20(e). As a result, dated October 26, 2001; Administra- determination requiring Appellant to ALJ Terepka upheld the OMIG’s tive Directive 6 dated July 17, 2000. seek approval for reimbursement for findings and affirmed the property As Medicaid is the payor of last offsite property costs was both rea- expense disallowances. resort, it need not pay any amount sonable and consistent with relevant

NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 21 that is the patient’s responsibility. See in 11 of the 100 claims constituting required information. Nevertheless, Florence Nightingale Nursing Home v. the random audit sample for claims for these eight claims, OMIG deter- Perales, 782 F.2d 26 (2nd Cir. 1986). for services from January 1, 2014 mined that the documentation failed Appellant argued that it is entitled through December 31, 2016. The total to demonstrate that at least three to Medicaid reimbursement for “bad Medicaid payments for claims in the members of the multi-disciplinary debts” from the uncollected NAMIs audit universe was $82,093,297.20. team had engaged in a timely re- of its residents and sought a dollar- view. In response, Appellant argued for-dollar offset or prepayment. ALJ After the Exit Conference and that OMIG’s disallowing claims for Gayle rejected this argument, finding removal of several claims based on these issues was improper, as it is a that it was “inconsistent with Med- documentation submitted in re- “programmatic requirement,” not a icaid reimbursement methodology sponse thereto, a Draft Audit Report payment requirement. ALJ Bordeaux and regulations, and even on its own was issued citing 12 alleged viola- disagreed, and cited 14 N.Y.C.R.R. terms is not supported by evidence.” tions of the Medicaid requirements § 822.6(d), which requires services to See Decision at 9. ALJ Gayle noted in 11 of the submitted claims for a meet the standards of Parts 822 and that there was no testimony offered sample overpayment of just $407.90. 841 in order to “qualify for reim- to show any “good faith efforts” After reviewing the response to the bursement.” ALJ Bordeaux similarly to collect payments and how those Draft Audit Report, OMIG issued rejected Appellant’s argument that efforts were related to the specific its Final Audit Report upholding its the existing documentation, taken residents involved in the audit. More- draft findings and seeking overpay- together, contained all of the required over, although “bad debts” may be ments totaling $7,745,764, which was elements. Upon review, each sample reported as allowable costs in a rate the amount at issue at hearing. The was missing a plan/review that was determination, there is no author- findings, which primarily involved timely signed by at least three mem- ity for applying “bad debt” to offset documentation inadequacies, were bers of the multi-disciplinary team. overpayments in a fee-for-service categorized as: (1) Missing/Late Indi- claim audit such as the one at issue vidual Treatment/Recovery Plan Re- The second category, Failure here. See Eden Park Health Servs., Inc. view (8 samples); (2) Failure to Meet to Meet Brief Individual Counsel- v. Axelrod, 494 N.Y.S.2d 524 (3d Dep’t Brief Individual Counseling Require- ing Requirements, was based on a 1985). As such, ALJ Gayle determined ments (1 sample); (3) Missing/Late showing the service documentation that the NAMI-related overpayments Signature on Individual Treatment/ reflected a 10 minute session, rather were proper, and therefore, were due Recovery Plan Review (1 sample); than the required face-to-face contact and payable overpayments. (4) Missing Signed Written Consent with the patient of at least 25 min- Form (1 sample); and (5) Physician utes. Appellant conceded this find- In regards to the payment of Examination not Updated Annually ing. As to Missing/Late Signature on interest, ALJ Gayle dismissed Appel- (1 sample). the Individual Treatment/Recovery lant’s argument that the date of the Plan Review, the third category, ALJ calculation was incorrect, concluding ALJ Bordeaux summarized that Bordeaux again rejected Appellant’s that Appellant failed to present any Medicaid providers are required to argument that the violation was not evidence that the date of the pay- prepare and maintain contempora- a basis for denying payment of the ments were incorrect and confused neous documentation demonstrat- claim. As to category four, Miss- the fee-for-service audit pursuant to ing the provider’s right to receive ing Signed Written Consent Form, 18 N.Y.C.R.R. § 518.4(b) - (c) with a payment, and that Medicaid has the Appellant argued that progress cost report audit in which interest authority to audit these records and notes detailing the discussion of the See is calculated from the date the audit use sampling, at its discretion. 18 treatment risks should be considered is issued pursuant to 18 N.Y.C.R.R. N.Y.C.R.R. § 504.3(a), (g), 517.3(b), equivalent to a signed consent. ALJ § 518.4(e). As such, the overpayments 540.7(a)(8). Importantly, OTPs are Bordeaux rejected this argument and and OMIG’s calculation of interest also subject to requirements of 14 expressly indicated that an informed, were affirmed. N.Y.C.R.R. Part 822. The largest written consent signed by the patient finding, Missing/Late Individual is required. As to the final category, Beth Israel Medical Center Treatment/Recovery Plan Review, Physician Examination not Updated (Decision After Hearing April 24, included eight instances where OMIG Annually, Appellant confirmed that it 2020, Natalie J. Bordeaux, ALJ) determined that the required treat- could not locate the required document/recovery plan review was not Appellant, a hospital and health mentation, but asserted that periodic in place on the audited date of ser- care center that operated an opioid nurse reviews should be considered vice. ALJ Bordeaux noted that OMIG treatment program (OTP), requested sufficient and pointed out that it had did not limit its review to documents a hearing to appeal a Final Audit not billed for the physician examina- formally identified as treatment/ Report seeking overpayments in the tion. Rather than finding that this lack recovery plans and reviews, but that extrapolated amount of $7,745,764 of billing alone was enough, ALJ Bor- instead, OMIG was willing to accept based on alleged disallowances found deax concluded that the service must other documents that contained the

22 NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 also be disallowed for the failure to David S. Gavlin, D.D.S. (Decision submitted for ambulette services from conduct the examination. After Hearing April 20, 2020, January 1, 2008 through December 31, Kimberly A. O’Brien, ALJ) 2010. The universe of claims paid for In regard to all of the disallow- the audit period totaled $6,152,169. ances, Appellant argued that OMIG’s Appellant, an individual dentist, appealed from an OMIG audit identi- After reducing the audit findings fol- audit protocols were improper and lowing the Exit Conference and Draft constituted proposed rulemaking for fying overpayments in the amount of $21,250 for failure to meet the require- Audit Report, OMIG’s Final Audit which it should have been informed. Report disallowed 100 of the 150 The ALJ rejected this contention and ments of the EHR Incentive Program. The overpayment was based on sampled claims and sought extrapo- found that Appellant failed to iden- lated overpayments in the amount tify any provision of the protocols OMIG’s determination that Appel- lant failed to provide documentation of $2,503,088. The 100 claims fell that were inconsistent with the regu- into two categories of disallowances: lations. In response to Appellant’s demonstrating that he adopted a certified EHR system and that he had the (1) Driver Is Not Taxi and Limou- testimony as to the substantial costs sine Commission (TLC) licensed (76 (at least $300,000) necessary to im- required minimum Medicaid patient volume as stated in his attestation. claims); and (2) Missing/Incomplete prove its document storage processes, Documentation (24 claims). ALJ Bordeaux noted that providers Appellant appeared pro se and have an “ongoing and independent testified on his own behalf at the hear- Prior to the hearing, OMIG obligation to correct any inadequate ing. OMIG provided data from the revised its findings and withdrew compliance with documentation Medicaid Data Warehouse for Medic- all but 28 of the category one claims, requirements.” See Decision at 26. As aid encounters during a 90-day period and 23 of the category two. As such, such, these efforts do not excuse the selected by Appellant, which showed the revised findings challenged at violations. a Medicaid patient volume that was hearing included a total of 51 claims significantly lower than the attested with overpayments of $1,179,603.65, Finally, as to extrapolation, representing a 50% reduction of the Appellant argued that the use of a to number (1,056 as opposed to 2,880). Appellant indicated that the numbers original Final Audit Report. As to statistical sampling methodology is category one, Driver Is Not TLC unfair and amounts to a penalty that were skewed due to failure to account for patients who receive coverage Licensed, ALJ Bordeaux noted that is inappropriate. However, Appel- since at least 2004, the Medicaid lant produced no expert testimony through Medicaid Health Mainte- nance Organizations (HMOs), but Transportation Provider Manual has challenging the methodology con- required that ambulette transporta- tained in OMIG’s expert certifica- failed to provide any documentation substantiating his assertions regarding tion only be provided by lawfully tion by Dr. Karl W. Heiner. The ALJ authorized ambulette providers. rejected these arguments, noting that patient volume. Appellant also failed to provide documentation that he had Moreover, for ambulette services extrapolation has been upheld in a operating in New York City, the Yorktown an EHR certified system in 2012, as long line of cases including driver must be licensed by the TLC. Medical Laboratory, Inc. v. Perales only the name of the vendor, without , 948 See 18 N.Y.C.R.R. § 505.10(e)(6)(ii). It Mercy any verification, had been submitted. F.2d 84 (2nd Cir. Cir. 1991), and was noted that according to the New Hospital of Watertown v. New York State Appellant testified that he and York City Regulations, ambulettes Dep’t of Social Services , 79 N.Y.2d 197 his practice had fallen victim to are paratransit vehicles, otherwise (1992). ALJ Bordeaux also noted that identity theft and that the changes known as a wheelchair accessible the disallowance rate of 11% (based to emails and passwords and closing van equipped with a hydraulic lift or on 11 samples out of 100) was greater of accounts were the reason for his ramp. See 35 RCNY § 4-01. than the total overpayments sought, failure to provide documentation. which amounted to 9.4% of the total ALJ O’Brien found that this expla- For the remaining claims, Appel- amount of Medicaid payments for nation did not excuse his failure to lant provided copies of the drivers’ the audit period. Appellant’s asser- maintain records demonstrating his Department of Motor Vehicles (DMV) tion that the overpayments will result entitlement to the payment. As such, licenses, but failed to provide proof in closure of at least one of its OTP OMIG’s determination that it was en- of their TLC licenses. ALJ Bordeaux clinics was noted as irrelevant to the titled to recover $21,250 in Medicaid noted that a DMV license is separate ALJ’s holding. Finally, ALJ Bordeaux overpayments was affirmed. and distinct from a TLC license. Al- found that the overpayment was not though Appellant presented verifica- abusive and OMIG was authorized to Ema’s Ambulette, Inc. (Decision tion from the TLC of the licensing recover overpayments in this manner After Hearing January 29, 2020, status of some of the drivers who without a finding of fraud. As such, Natalie J. Bordeaux, ALJ) rendered services for the disallowed the Final Audit Report was affirmed Appellant, a non-emergency med- claims, Appellant failed to provide in all respects. ical transportation provider, requested proof of TLC licensing for the drivers a hearing to appeal an audit of claims in 26 claims. Therefore, the disallowances for those claims were upheld.

NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 23 Moreover, in some instances, OMIG provided its expert’s certifications, forces women to appear in person disallowed only one-half of round and Appellant failed to offer expert in a clinical setting to receive Mife- trips upon Appellant providing proof testimony or an accounting to rebut pristone, a drug used in early abor- of a TLC license for the driver of one the presumption of accuracy. There- tions. The AG coalition argued in its leg of the round trip claim. In support fore, OMIG’s determination was amicus brief that Mifepristone should of its position, Appellant also argued affirmed in its entirety. be accessible through telehealth and that TLC licensure was not required mail delivery so that women are not since the vehicles did not qualify as New York State Attorney unnecessarily exposed to coronavirus paratransit vehicles. This argument General Press Releases disease (COVID-19) when attempting was dismissed by the ALJ, who in- to secure access to the drug, https:// Compiled by Brenda Baddam, Mary dicated that if this were the case, the ag.ny.gov/press-release/2020/ Connolly, Dena DeFazio, and Bridget vehicles would not qualify as ambu- attorney-general-james-continues- Steele lettes and, therefore, Appellant would fight-maintain-access-reproductive- not be entitled for reimbursement for Attorney General James Seeks health-care. ambulette services. to Immediately Halt Trump Ad- Attorney General James Wins ministration from Allowing Health As to category two, the disal- Court Argument Against Martin Care Discrimination to Move For- lowed claims were all based on Shkreli and Company, Antitrust ward—September 10, 2020—Attorney Appellant’s inability to produce Lawsuit Will Continue—August General (AG) James filed a motion documentation relating to the second 19, 2020—The United States Dis- for summary judgment in a lawsuit leg of round trips as required. The trict Court for the Southern District seeking to immediately stop a Trump requirements for documentation per- of New York rejected a motion to Administration rule that a group of taining to the second leg of the round dismiss a lawsuit brought by AG AGs claim would make it easier for trip were effective May 5, 2009, and James against Vyera Pharmaceuticals health care providers and insurance were published in an August 2010 and its two former CEOs, includ- companies to discriminate against Medicaid Update. The ALJ dismissed ing Martin Shkreli, after Shkreli certain classes of Americans, includ- Appellant’s objections, finding that and his company sought to dismiss ing lesbian, gay, bisexual, transgen- the disallowed claims at issue were the lawsuit. AG James’ case alleges der, and queer (LGBTQ+) individu- only those that took place after the that Vyera, Shkreli, and his business als, non-English speaking people, and May 5, 2009 effective date. ALJ Bor- partner stifled competition and raised women. AG James and a coalition of deaux noted that OMIG disallowed the price of the drug Daraprim by 23 attorneys general filed this lawsuit only one-half of the total amount of more than 4,000 percent overnight in July against the U.S. Department of the claims due to Appellant’s failure to $750 per pill after they purchased Health and Human Services (HHS), to document the driver of the second the rights to the drug in August 2015. HHS Secretary Alex Azar, and the leg of the trip. Daraprim and its generic equivalents head of HHS’ Office of Civil Rights are the only FDA-approved drugs (OCR), Roger Severino, arguing that In regards to all of the claims, Ap- that treat toxoplasmosis, a parasitic the new rule stripped away express pellant argued that it should be given disease that can be life-threatening nondiscrimination protections under “some credit” due to the five-year to individuals with compromised the Patient Protection and Affordable delay between the audit’s commence- immune systems. AG James and a Care Act (ACA), https://ag.ny.gov/ ment in September of 2011 and the coalition of six other attorneys gen- press-release/2020/attorney-general- Final Draft Report issued in 2016, and eral seek to enjoin Vyera’s conduct james-seeks-immediately-halt-trump- asserted that due to the delay and the and to obtain the return of unjust administration-allowing. fact that it ceased operations in 2012, profits to be distributed to impacted the production of the required docu- Attorney General James Con- individuals, https://ag.ny.gov/press- mentation was made more difficult. tinues Fight to Maintain Access to release/2020/attorney-general-james- ALJ Bordeaux noted that providers Reproductive Health Care at Supreme wins-court-argument-against-martin- are obligated to maintain documenta- Court—September 8, 2020—AG shkreli-and-company. tion for a minimum of six years and James and 23 attorneys general filed that the document retention period is AG James Secures Court Win an amicus brief in support of the tolled once the provider receives no- Against Trump Administration for plaintiffs in U.S. Food and Drug Ad- tice of the intent to audit, obligations Unlawful Regulations Restrict- ministration et al. v. American College of which are not affected by the decision ing Coronavirus-Based Paid Sick Obstetricians and Gynecologists et al. to to cease operations. See 18 N.Y.C.R.R. Leave—August 3, 2020—The United encourage the court to reject a request §§ 504.3(a), 517.3(b)-(c). States District Court for the Southern from the Trump Administration to District of New York granted por- halt a preliminary injunction and Finally, Appellant objected to tions of AG James’ motion for sum- reinstate a U.S. Food and Drug Ad- OMIG’s extrapolation of the disal- mary judgment requesting that New ministration (FDA) requirement that lowed claims. At hearing, OMIG York block a Trump Administration

24 NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 rule that narrowed workers’ rights Surgical Solutions (“IMPACT Medi- confusion and reduced health care to paid sick leave and emergency cal”), from selling personal protective coverage in contravention of the family leave during the COVID-19 equipment (PPE)and COVID-19 relat- ACA’s purposes, https://ag.ny.gov/ pandemic. AG James’ lawsuit was ed test kits until at least January 2023. press-release/2020/attorney-general- filed in April 2020 and challenged Additionally, Borgese and IMPACT james-wins-suit-stops-trump-admin- U.S. Department of Labor regula- Medical will be required to post a istration-raising-costs. tions on grounds that they contra- $100,000 bond to resume selling these Attorney General James Sues dicted the Families First Coronavirus products. The proposed consent Trump Administration for Allowing Response Act (FFCRA) by unlawfully order and judgment follows a lawsuit Health Care Discrimination restricting eligibility for paid sick and filed last month by AG James alleging —July family leave during the public health that Borgese and IMPACT Medical 20, 2020—AG James and a coalition crisis, https://ag.ny.gov/press- obtained purchase orders and large of attorneys general filed a lawsuit release/2020/ag-james-secures-court- up-front payments from hospitals to stop a new Trump Administration win-against-trump-admin-unlawful- and health care systems for PPE and rule promulgated by HHS on the regulations-restricting. then failed to deliver the products. grounds that the new rule makes it The consent order and judgment easier for providers and insurers to Attorney General James Secures pending court approval states that discriminate against LGBTQ+ in- $1.85 Million Following Medicaid Borgese and IMPACT Medical were dividuals, individuals with limited Fraud by Global IT Company —July never authorized 3M distributors, English proficiency, women, and 30, 2020—As a result of a coordinated did not possess the N95 or KN95 others by attempting to eliminate effort by the Office of the Attorney respirator masks they advertised to anti-discrimination provisions found General (OAG) and the U.S. Attor- sell, and could not meet the delivery in the ACA. In the lawsuit, AG James ney’s Office for the Southern District times they promised with respect to and the coalition argued that the rule of New York, AG James reached an these sales, https://ag.ny.gov/press- is arbitrary, capricious, and contrary agreement with former multinational release/2020/attorney-general-james- to law under the Administrative internet technology company Com- stops-fraudulent-broker-selling-ppe. Procedure Act, and that it violates puter Sciences Corporation (CSC) the equal protection guaranteed by for violating state and federal laws Attorney General James Wins the Fifth Amendment, https://ag.ny. by improperly processing Medicaid Suit, Stops Trump Administration gov/press-release/2020/attorney- claims for services rendered as a from Raising Costs of Abortion general-james-sues-trump-adminis- part of New York’s Early Interven- Coverage—July 21, 2020—The United tration-allowing-health-care. tion Program. Under the settlement States District Court for the North- Attorney General James’ State- agreement, CSC admitted it per- ern District of California granted ment on Supreme Court Decision formed insurance claims handling AG James’ motion for summary Stripping Women of Their Right to and processing services for New York judgment concluding that a Trump Birth Control Coverage Under the City to assist the City in administer- Administration rule that would have ACA ing the Early Intervention Program. made it more difficult for women —July 8, 2020—In a released In addition, CSC admitted it used in New York and across the country statement, AG James stated that the Little billing codes that resulted in Med- to access abortion services under Supreme Court’s decision in Sisters of the Poor v. Pennsylvania icaid making improper payments the ACA departed from prior HHS was a to the City. The investigation was policy and was arbitrary and capri- “loss to women across the nation, and triggered by a whistleblower lawsuit cious. In January 2020, AG James allows President Trump to move for- filed under the qui tam provisions and California AG Xavier Becerra ward with his efforts to control wom- Little of the federal and New York False co-led a coalition of eight attorneys en’s reproductive freedoms.” In Sisters of the Poor Claims Acts. New York State will general in filing a lawsuit to stop , the Supreme Court receive $989,565, and the whistle- HHS from implementing the Trump held that the ACA does not forbid the blower will receive $416,250, under Administration’s rule that would Trump Administration from creat- the settlement, https://ag.ny.gov/ have required qualified health plans ing an exemption to its contraceptive press-release/2020/attorney-general- that participated in state exchanges mandate. AG James and a coalition james-secures-185-million-following- to send consumers two separate of attorneys general had previously medicaid-fraud-global-it. monthly bills for certain abortion filed an amicus brief in the Supreme services. The U.S. District Court for Court supporting the suit by Pennsyl- Attorney General James Stops the Northern District of California vania and New Jersey defending the Fraudulent Broker from Selling threw out this rule as arbitrary and contraceptive coverage and counsel- PPE —July 28, 2020—AG James an- capricious, as it departed from prior ing requirement mandated under nounced a proposed consent order HHS policy without providing a the ACA, https://ag.ny.gov/press- and judgment pending court approv- reasoned explanation, and would release/2020/attorney-general-james- al that would prohibit Frank Borgese have resulted in increased costs and statement-supreme-court-decision- and his company, IMPACT Medical & stripping-women-their.

NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 25 Attorney General James Helps meant “to provide consumers with against banks and other entities Win Supreme Court Case Guarantee- reliable, cost-effective alternatives that have managed the money of ing Women’s Access to Abortion Cov- to name-brand medication” but that the Sackler family—co-founders of erage—June 29, 2020—AG James an- these companies “put profits over Purdue Pharma—over the last 15 nounced that a recent Supreme Court public health,” https://ag.ny.gov/ years. Following the court’s deci- decision in June Medical Services v. press-release/2020/attorney-general- sion, AG James announced that the Gee will protect the ability of women james-challenges-anticompetitive- New York OAG would be issuing across the nation to maintain access conduct-generic-drug-industry. new subpoenas to multiple banks to safe, legal abortions. In June Medi- and financial institutions in order to Attorney General James Leads cal Services, a medical provider sought determine where the Sacklers stored Coalition Fighting for Abortion to overturn a decision by the U.S. their money over the years and how Access During Coronavirus Pan- Court of Appeals for the Fifth Circuit much was stored, https://ag.ny.gov/ demic upholding a Louisiana law requiring —June 5, 2020— AG James led press-release/2020/attorney-general- abortion providers to maintain ad- a multistate coalition of 23 attorneys james-statement-after-us-bankruptcy- mitting privileges at local hospitals. general against the FDA and HHS to court-allows-subpoenas-move. AG James stated that this law was halt a FDA requirement that forces identical to a Texas law previously women to appear in person to a clini- AG James Sues Trump Adminis- invalidated by the Supreme Court in cal setting in order to receive a drug tration for Limiting Enforcement of Whole Woman’s Health v. Hellersedt in known as Mifepristone for an early Federal Environmental and Public 2016. The Supreme Court reaffirmed abortion or for miscarriage care. The Health Laws—May 13, 2020—AG its ruling and held that the Louisiana coalition took the position that the James led a coalition of nine attorneys law was unconstitutional because it drug should be readily accessible general in challenging a new policy of infringed on women’s reproductive via telehealth so as to not poten- the Environmental Protection Agency freedoms and right to access an abor- tially expose women to COVID-19 (EPA) to stop enforcing requirements tion under Roe v. Wade. In December by requiring unnecessary travel. AG under a number of federal environ- 2019, AG James and 22 attorneys gen- James stated that “control over one’s mental laws due to the COVID-19 eral filed an amicus brief in support reproductive freedom should not be crisis, including the Clean Air, Clean of plaintiffs in June Medical Services ar- limited to those who are able to leave Water, and Safe Drinking Water Acts, guing that the Louisiana law was an their homes as we battle the coronavi- provided that the companies cite CO- unnecessary and onerous burden that rus” and that many women will need VID-19 for their non-compliance. The failed to promote women’s health to travel long distances—sometimes policy applies retroactively to March and would limit the number of abor- up to 200 miles—in order to reach a 13, 2020 and has no end date. In the tion providers available to women clinic that dispenses Mifepristone. lawsuit, the coalition contends that in Louisiana, https://ag.ny.gov/ AG James reinforced that, even as the EPA lacks legal authority to waive press-release/2020/attorney-general- phased reopening of the states occur, monitoring and reporting obliga- james-helps-win-supreme-court-case- “telehealth should be used wherever tions that inform regulators and the guaranteeing-womens-access. possible . . . because it maximizes public of pollution hazards, and that the number of capable health care the agency has failed to consider the Attorney General James Chal- workers providing necessary medi- adverse impacts on public health that lenges Anticompetitive Conduct in cal treatment, while protecting health the policy will have in the middle the Generic Drug Industry—June 10, care staff” and that “the counseling of the COVID-19 pandemic, such as 2020—AG James and 51 attorneys required prior to a medication abor- increased pollution and lack of avail- general from around the country tion is routinely provided through able public information about that have filed an antitrust complaint in telehealth in order to reduce in-clinic pollution, https://ag.ny.gov/press- federal court alleging that key indi- interactions,” https://ag.ny.gov/ release/2020/ag-james-sues-trump- vidual executives and manufactur- press-release/2020/attorney-general- administration-limiting-enforcement- ers of dermatological, generic drugs james-leads-coalition-fighting-abor- federal-environmental-and. engaged in a widespread conspiracy tion-access-during. to artificially inflate and manipu- Attorney General James Fights late prices, reduce competition, and Attorney General James’ State- to Defend ACA in Supreme Court— unreasonably restrain trade of generic ment After U.S. Bankruptcy Court May 6, 2020—AG James, along with drugs sold across the United States. Allows Subpoenas to Move Forward a coalition of 19 attorneys general The complaint also alleges systematic Against Sackler Family Banks and and the governor of Kentucky, have antitrust violations, including market Financial Institutions in Opioid brought an action to defend the allocating, price-fixing, and rigging Case—May 13, 2020—AG James ACA to the U.S. Supreme Court. The of bids for more than 80 different announced that the U.S. Bankruptcy Supreme Court agreed to review a topical, generic drugs. AG James Court for the Southern District of recent decision by the U.S. Court of emphasized that generic drugs are New York issued a ruling that al- Appeals for the Fifth Circuit that held lows subpoenas to move forward that the ACA’s individual mandate

26 NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 was unconstitutional and questioning where residents, families, or members risks for some women and denying whether the remaining provisions of of the public can share complaints access to others,” https://ag.ny.gov/ the law could stand. A Texas-led co- about nursing homes that have not press-release/2020/attorney-general- alition that initially filed the lawsuit, provided required communica- james-leads-coalition-fighting-tennes- contends that the ACA’s individual tions with families about COVID-19 sees-unconstitutional. mandate was rendered unconstitu- diagnoses or fatalities. The hotline Attorney General James Leads tional when Congress reduced the will also accept complaints about Coalition Fighting Alabama’s Uncon- penalty for foregoing coverage to $0, abuse and neglect, including failure stitutional Abortion Ban During CO- and that the rest of the ACA should to follow rules to keep residents safe. VID-19 Pandemic be held invalid as a result of that AG James expressed gratitude to —April 21, 2020— change. AG James and the coalition the workers in nursing homes who AG James led a multistate coalition of of attorneys general seek to defend serve and support the vulnerable 18 attorneys general to stop Alabama the ACA in its entirety and assert residents, and emphasized that the from banning all procedural abor- that while the Fifth Circuit held the OAG will continue to work hard to tions in the State, citing COVID-19 individual mandate to be unconstitu- protect nursing home residents and as the justification for the ban. The tional, the court failed to rule on the make sure their rights are preserved coalition filed an amicus brief in the validity of the remaining provisions during the COVID-19 crisis. In ad- U.S. Court of Appeals for the Elev- of the law, https://ag.ny.gov/press- dition to the hotline, confidential enth Circuit in support of plaintiffs Robinson v. Marshall release/2020/attorney-general-james- complaints may also be filed with in , in response fights-defend-aca-supreme-court. the OAG online, https://ag.ny.gov/ to the State’s appeal of a decision by press-release/2020/attorney-general- the U.S. District Court for the Middle Attorney General James and james-statement-protecting-nursing- District of Alabama to issue a tempo- Pharmacy Executives Applaud New home-residents. rary restraining order (TRO) blocking York’s Expansion of COVID-19 the State from enforcing the abortion Testing to Pharmacies—April 28, Attorney General James Leads ban, which was part of an Executive 2020—AG James released a statement Coalition Fighting Tennessee’s Un- Order issued on March 17, 2020. The applauding New York’s expansion of constitutional Abortion Ban Dur- coalition’s amicus brief alleges that “ COVID-19 tests to local pharmacies, ing COVID-19 Pandemic—April 23, . . . the ban on abortions will irrepa- and expressed gratitude for the fact 2020—AG James led a multistate rably injure any woman who reaches that “New York will begin to take coalition of 19 attorneys general to the legal limit for an abortion during advantage of its vast system of phar- stop Tennessee from banning all the ban,” resulting in some women macies to provide COVID-19 tests to procedural abortions in the State, cit- losing their constitutional right to a more New Yorkers than ever before.” ing COVID-19 as the justification for legal abortion and that a prohibition AG James was joined by Steve Moore, the ban. The coalition filed an amicus on abortions, even for a short period President of the Pharmacists Society brief in the U.S. Court of Appeals for of time, would harm some women by of the State of New York (PSSNY), the Sixth Circuit in support of plain- requiring more invasive and lengthier who commended pharmacists for tiffs in Adams & Boyle, P.C. v. Slatery. terminations, https://ag.ny.gov/ playing a key role in the health and When the U.S. District Court for the press-release/2020/attorney-general- wellbeing of the country and show- Middle District of Tennessee granted james-leads-coalition-fighting-ala- ing that they are able “to step in a preliminary injunction enjoining the bamas-unconstitutional. when needed most.” Representa- ban on procedural abortions in the Attorney General James Leads tives of CVS Health and Rite Aid State, Tennessee appealed the order Coalition Fighting Arkansas’ Uncon- also recognized the critical role that the same day. The case challenges stitutional Abortion Ban During CO- pharmacies play in local communities two Executive Orders issued by Ten- VID-19 Pandemic and that expansion of testing capa- nessee’s governor, Bill Lee, on March —April 20, 2020— bilities will help to slow the spread of 23 and April 8, 2020. The coalition’s AG James led a multistate coalition COVID-19, https://ag.ny.gov/press- amicus brief in support of plaintiffs of 19 attorneys general in seeking to release/2020/attorney-general-james- noted that, “characterization of the stop Arkansas from banning almost and-pharmacy-executives-applaud- ban as a few weeks’ postponement of all procedural abortions in the State new-yorks-expansion-covid. an ‘elective and non-urgent’ pro- during the COVID-19 pandemic. The cedure fails to recognize how the coalition filed an amicus brief in the Attorney General James’ State- time-sensitive nature of abortion care U.S. Court of Appeals for the Eighth ment on Protecting Nursing Home distinguishes that care from services Circuit, in support of plaintiffs in Residents Little Rock Family Planning Services v. —April 23, 2020—AG James that can be deferred without patient Rutledge announced that, while the Medicaid harm during the current public health . The U.S. District Court for Fraud Control Unit (MFCU) contin- crisis” because procedural “abortions the Eastern District of Arkansas is- ues to investigate allegations of abuse cannot be deferred indefinitely or sued a TRO blocking the State from and neglect in the nursing home sys- for long stretches without increasing shutting down Little Rock Family tem, the OAG has launched a hotline Planning Services’ (LRFPS) procedur-

NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 27 al abortion services, and an appeal james-demands-health-insurance- women infected with the disease and was filed in the Eighth Circuit seek- providers-obey-law-protect-womens. individuals with the Human Immu- ing to halt the lower court’s order. nodeficiency Virus (HIV). The lawsuit State Attorneys General Call Following a March 21, 2020 public further contends that, as a result of on EPA to Rescind Policy Limiting statement by the Arkansas Depart- Vyera’s anticompetitive conduct, a Enforcement of Federal Civil Envi- ment of Health and an April 3 direc- generic version of Daraprim is yet to ronmental and Public Health Laws tive, LRFPS—the only clinic in Arkan- — be sold in the United States, causing sas currently licensed to perform April 15, 2020—AG James and 13 hospitals, physicians, and patients to procedural abortions—was served attorneys general submitted a letter either pay exorbitant prices or make with a cease-and-desist order stating to the EPA denouncing the agency’s difficult treatment decisions without that the April 3 “prohibition applies March 26, 2020 memorandum which affordable access to the most effective to surgical abortions that are not announced a nationwide policy on treatment, https://ag.ny.gov/press- immediately necessary to protect the the civil enforcement of federal envi- release/2020/attorney-general-james- life or health of the patient” and that ronmental laws during the COVID-19 adds-states-suit-against-convicted- “[a]ny further violations of the April crisis. The policy states that the EPA criminal-martin-0. 3 Directive will result in an immedi- does not intend to take enforcement Attorney General James’ State- ate suspension of [LRFPS’] license.” action against companies that, for ex- ment on Nursing Home Condition in Despite citing the April 3 directive as ample, violate existing reporting and Crown Heights the basis for ordering LRFPS to stop monitoring requirements, provided —April 10, 2020—In a performing procedural abortions but that the companies draw a nexus released statement, AG James an- for very limited circumstances, the between COVID-19 and their non- nounced that the Crown Heights Department of Health has reportedly compliance. The coalition of attorneys Center for Nursing and Rehabilita- permitted other non-urgent medical general contends that, among other tion is being closely monitored fol- services to be performed, https:// things, the policy ignores the connec- lowing multiple complaints alleging ag.ny.gov/press-release/2020/attor- tion between air pollution and cardio- troubling conditions at the site, and if ney-general-james-leads-coalition- vascular and respiratory conditions warranted, actions would be taken as fighting-arkansas-unconstitutional. which may increase risk of serious appropriate to protect nursing home harm for individuals who contract residents, https://ag.ny.gov/press- Attorney General James De- the COVID-19 virus, https://ag.ny. release/2020/attorney-general-james- mands Health Insurance Providers gov/press-release/2020/state-attor- statement-nursing-home-condition- Obey the Law, Protect Women’s neys-general-call-epa-rescind-policy- crown-heights. Access to Birth Control—April 19, limiting-enforcement-federal. Attorney General James Leads 2020—AG James has demanded that Attorney General James Adds Coalition Fighting Oklahoma’s three health insurance companies States to Suit Against Convicted Unconstitutional Ban on Abortion immediately provide coverage for Criminal Martin Shkreli and Vyera During COVID-19 Pandemic 12-month supplies of contraceptives —April Pharmaceuticals in accordance with the Comprehen- —April 14, 2020— In 10, 2020—AG James announced the sive Contraception Coverage Act a released statement, AG James an- formation of a multistate coalition of (CCCA), a New York law which took nounced that six additional States are 19 attorneys general seeking to stop effect on January 1, 2020 that requires joining the federal government’s law- Oklahoma from banning almost all health insurance providers to cover suit against Vyera Pharmaceuticals abortions in the State, citing CO- 12-month supplies of contraception (previously known as Turing Phar- VID-19 as justification for the ban. at one time. The demand came after maceuticals) and two of its former The coalition filed an amicus brief it came to the OAG’s attention that CEOs, including convicted criminal in the U.S. Court of Appeals for the Aetna, MetroPlus Health, and Oscar Martin Shkreli. California, Illinois, Tenth Circuit in support of plaintiffs Southwind Women’s Center LLC v. Health refused to provide patients North Carolina, Ohio, Pennsylvania, in Stitt with coverage for 12-month sup- and Virginia have joined AG James . Under Executive Order 2020-07, plies of contraceptives. The CCCA and the Federal Trade Commission in Oklahoma’s governor, Kevin Stitt, also requires health plans to cover all the suit seeking repayment of illegal- sought to postpone all elective sur- forms of contraception without de- ly obtained profits due to monopolis- geries and minor medical procedures ductible, coinsurance, copayment, or tic prices set for the drug Daraprim, in the State, including abortion ser- any other cost-sharing requirements, which at one point reached up to vices not otherwise deemed a medical ensures access to emergency contra- $750 per pill. Daraprim is the only emergency or necessary to prevent ception, and prohibits any coverage FDA-approved drug for the treat- serious health risks. Several repro- restrictions or delays, such as pre- ment of toxoplasmosis, a parasitic ductive health care providers filed a authorizations, https://ag.ny.gov/ disease which may pose serious and lawsuit challenging the Executive Or- press-release/2020/attorney-general- often life-threating consequences for der in the U.S. District Court for the those with compromised immune Western District of Oklahoma. The systems, including babies born to court issued a TRO halting portions

28 NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 of the Oklahoma ban, and the State increased costs and unintended preg- the court to immediately issue a TRO of Oklahoma appealed. The coali- nancies nationwide, https://ag.ny. blocking the ban. Shortly thereafter, tion’s amicus brief calls for a stay of gov/press-release/2020/attorney- District Court Judge Lee Yeakel is- the lower court’s TRO, https://ag.ny. general-james-fights-trump-admin- sued a temporary restraining order gov/press-release/2020/attorney- efforts-strip-women-their-right-birth. that stopped the abortion ban from general-james-leads-coalition-fight- taking effect. The very next day, fol- Attorney General James Leads ing-oklahomas-unconstitutional-ban. lowing a request by the State of Texas, Multistate Coalition Calling on the U.S. Court of Appeals for the Attorney General James Urges Trump Administration to Halt Fifth Circuit halted the district court’s Action to Protect Communities of Anti-Abortion Rule as Coronavirus decision, effectively reinstituting the Color from COVID-19 Pandemic Rages On —April 8, —April 7, 2020— ban on abortions in the State due to 2020—In response to preliminary AG James is co-leading a multistate a need to conserve limited personal data released showing a dispropor- coalition of eight attorneys general protective equipment and hospital tionate correlation between people of asking HHS to delay implementing services. The amicus brief argues that color and fatalities from COVID-19 a final rule that would unlawfully reproductive health care is an “essen- in New York City, AG James issued reinterpret Section 1303 of the ACA tial medical service” that should be a call to action regarding long-term and require qualified health plans available to women, despite the ongo- inequities in our health care system, that participate in State exchanges to ing public health emergency, and that and calling for expanded treatment send separate bills and collect sepa- the “prohibition blocks the exercise and tracking of marginalized commu- rate payments for abortion services. of a woman’s constitutional right to nities, rapid testing, increased hospi- In a letter to HHS Secretary Alex access abortion,” https://ag.ny.gov/ tal capacity, and expanded language Azar, the coalition argued that the press-release/2020/attorney-general- access to ensure those communities rule threatens women’s access to james-leads-fight-stop-texas-block- hit hardest have access to needed in- abortion coverage during a public ing-abortions-during. formation. AG James also highlighted health crisis, and that the final rule’s the need to protect essential workers, implementation would be incon- Attorney General James Orders as many are people of color, https:// sistent with the Office of Manage- 78 Transport Providers to Immediate- ag.ny.gov/press-release/2020/ ment and Budget Directive M-20-16, ly Stop Endangering New Yorkers— attorney-general-james-urges-action- which instructed federal agency April 3, 2020—In a released statement protect-communities-color-covid-19. heads to “prioritize all resources to regarding a statewide investigation slow the transmission of COVID-19” conducted by the MFCU, AG James Attorney General James Fights and otherwise focus exclusively on announced an immediate mandate Trump Admin. Efforts to Strip “mission-critical activities,” arguing calling on 78 medical transport Women of their Right to Birth Con- that implanting the final rule would providers to discontinue conducting trol Coverage Under the ACA —April unnecessarily detract from the States’ prohibited group rides in violation 8, 2020—In a released statement, AG ability to prioritize responding to the of orders issued by the Department James announced that a coalition of COVID-19 crisis, https://ag.ny.gov/ of Health on March 21, 2020. While 21 attorneys general have filed an press-release/2020/attorney-general- supplying medical transportation to amicus brief in the U.S. Supreme james-leads-multistate-coalition-call- Medicaid recipients in and around Court supporting Pennsylvania and ing-trump-administration. Albany, Buffalo, Rochester, and Syra- New Jersey in the States’ lawsuit cuse, dozens of transportation pro- Attorney General James Leads defending the contraceptive coverage viders failed to follow the State’s ban Fight to Stop Texas from Block- and counseling requirements con- on medical transports with more than Trump v. ing Abortions During Coronavirus tained in the ACA. The case, one occupant per vehicle, which was Pennsylvania Pandemic , stems from Trump Ad- —April 3, 2020—AG James issued by the Department of Health ministration Rules issued in 2017 and announced the filing of an amicus in an effort to facilitate social distanc- 2018 ignoring the ACA’s birth control brief in the U.S. Court of Appeals for ing measures, https://ag.ny.gov/ coverage requirement and allowing the Fifth Circuit supporting plaintiffs press-release/2020/attorney-general- Planned Parenthood v. Abbott employers to deny coverage to em- in , and james-orders-78-transport-providers- ployees based on religious or moral opposing Texas’ directive banning immediately-stop-endangering. objections. Many States, including nearly all abortion services in the New York, sought and obtained in- State unless the life of the mother is in AG James Orders CBD Company junctions against the rules. The coali- jeopardy due to COVID-19. The amic- to Stop Marketing Products as Effec- tion’s amicus brief argues that States us brief was filed in a lawsuit filed by tive Coronavirus Treatments—April have a vested interest in ensuring the Center for Reproductive Rights, 2, 2020—AG James announced an that women have access to seamless Planned Parenthood Federation of immediate order requiring Finest contraceptive coverage and that this America, and the Lawyering Project Herbalist, a company specializing loss of coverage will result in reliance in the U.S. District Court for the West- in the sale of Cannabidiol (CDB), to on State-funded programs, leading to ern District of Texas, which called on cease and desist the marketing of its

NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 29 product Pure Herbal Total Defense general-james-continues-fight-halt- abortions, https://ag.ny.gov/press- Immunity Blend as a means of curing trump-administrations-attack. release/2020/attorney-general-james- or treating COVID-19. Finest Herb- pushes-increase-abortion-access-med- Attorney General James Ap- alist is one of many companies to ication-during. plauds Courts for Standing Up for receive a cease and desist letter from Women’s Reproductive Rights During Attorney General James to Lead the OAG for selling or marketing Coronavirus Pandemic Coalition of States Fighting to Stop products as treatments or cures for —March 30, Texas from Blocking Abortions Dur- COVID-19, https://ag.ny.gov/press- 2020—In a statement following a ing Coronavirus Pandemic release/2020/ag-james-orders-cbd- federal order which ensured women’s —March company-stop-marketing-products- continued access to reproductive 27, 2020—AG James announced that effective-coronavirus. care in Texas, AG James commended she will be building and leading a Judge Lee Yeakel of the U.S. Dis- multistate coalition of attorneys gen- Attorney General James’ State- trict Court for the Western District eral to ensure women have continued ment on Central Park Field Hospi- of Texas for issuance of a TRO in access to abortion services during the tal—March 31, 2020—In a released Planned Parenthood v. Abbott, stopping COVID-19 public health crisis. AG statement concerning reports that the ban on nearly all abortions in James plans to file an amicus brief in Samaritan’s Purse, the group funding the State, https://ag.ny.gov/press- support of plaintiffs in Planned Parent- and building the overflow facility for release/2020/attorney-general-james- hood v. Abbott. The suit by the Center Mount Sinai Hospital, has a record applauds-courts-standing-womens- for Reproductive Rights, Planned of asking volunteers to sign a “state- reproductive-rights-during. Parenthood Federation of America, ment of faith,” AG James announced and the Lawyering Project, filed in Attorney General James Pushes that there would be no volunteers the U.S. District Court for the Western to Increase Abortion Access by present at the overflow site and that District of Texas, seeks a TRO block- Medication During Coronavirus the OAG would remain vigilant to ing Texas’ directive banning nearly Pandemic ensure that discrimination did not —March 30, 2020—AG all abortion services in the State due occur, https://ag.ny.gov/press- James, as part of a multistate coalition to COVID-19, https://ag.ny.gov/ release/2020/attorney-general-james- of 21 attorneys general, requested press-release/2020/attorney-general- statement-central-park-field-hospital. that the Trump Administration waive james-lead-coalition-states-fighting- or utilize its discretion to not enforce stop-texas-blocking. Attorney General James Contin- its Risk Evaluation and Mitigation ues Fight to Halt Trump Administra- Strategy (REMS) designation for the AG James Orders Companies to tion’s Attack on Reproductive Health prescription drug Mifepristone (or Stop Selling Bogus “Coronavirus- Care Access—March 31, 2020—In a RU-486). In a letter to HHS and the Killing” Devices—March 26, 2020— statement regarding a new Trump FDA, the attorneys general allege AG James has ordered AllerAir Administration rule that would raise that the REMS designation dictates Industries, Airpura Industries, and abortion costs and place onerous and and impedes women’s access to the Sylvane Inc., companies that sell air confusing requirements on access medical-abortion prescription, and purifiers, to immediately cease and to abortion services, AG James an- call on the Trump Administration to desist marketing their products as nounced the formation of a multistate ensure that women can more easily tools that can prevent the spread and coalition of seven attorneys general access this health care service while contraction of COVID-19. The com- arguing for an immediate ruling the COVID-19 pandemic leaves many panies’ marketing has been based on a case involving access to abor- unable to seek in-person care. Mife- on misrepresentations about CO- tion services under the ACA. The pristone is the only drug approved in VID-19, including that it is primarily case challenges the December 2019 the United States for pregnancy ter- an airborne disease and that these HHS final rule reinterpreting Section mination. Under the REMS, the FDA air purifiers can effectively prevent 1303 of the ACA to require qualified requires that: (1) patients be handed people from contracting the virus health plans that participate in State the medication at a clinic, medical of- by removing virus particles from exchanges to send separate bills and fice, or hospital under the supervision the air, https://ag.ny.gov/press-re- collect separate payments for abor- of a health care provider; (2) health lease/2020/ag-james-orders-compa- tion services of at least $1. A consum- care providers be registered with the nies-stop-selling-bogus-coronavirus- er who misses the $1 payment could drug manufacturer; and (3) patients killing-devices. lose all coverage on the exchange. sign a “Patient Agreement” form Attorney General James Fights to The coalition of attorneys general confirming that they received coun- Ensure Women Nationwide Are Able filed a motion for summary judg- seling on the risks associated with the to Obtain Abortions During Corona- ment, calling on the court to issue an medication. The American College of virus Pandemic immediate ruling declaring the final Obstetricians, the American Medical —March 26, 2020— rule unconstitutional, https://ag.ny. Association, and the American Asso- AG James released a statement call- gov/press-release/2020/attorney- ciation of Family Physicians all sup- ing on the federal government and port removal of the REMS on medical States across the country to ensure

30 NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 that women have access to safe, legal Judge for Courts Outside New York james-announces-change-nys-health- abortions during the COVID-19 crisis. City, the Honorable Vito C. Caruso’s policy-allowing-transgender. The statement asserts that “the coro- announcement that the trial against Attorney General James Takes navirus is not an excuse for federal, multiple opioid manufacturers and Action Against Coronavirus Health state, or local governments to curtail distributors set to begin on March Scams, Issues Guidance to New women’s reproductive freedoms or 20, 2020 would be delayed due to the Yorkers limit their choices,” https://ag.ny. ongoing risk posed by COVID-19. A —March 5, 2020—AG James gov/press-release/2020/attorney- controlled date conference on April issued guidance to New Yorkers general-james-fights-ensure-women- 14, 2020, to determine next steps and highlighting available resources and nationwide-are-able-obtain-abortions. set a more concrete schedule for trial, potential consumer scams related to was scheduled by Judge Jerry Gar- COVID-19. Additionally, the OAG is Attorney General James Urges guilo, who will oversee the trial. The actively monitoring retailers for po- President Trump to Immediately suit was filed in March 2019, against tential incidents of price gouging of Prioritize Production of Protective Purdue Pharma, its affiliates, and the necessary goods and entities selling Gear and Testing Supplies —March Sackler family; Janssen Pharmaceu- bogus medical treatments purporting 24, 2020—AG James joined a coali- ticals and its affiliates (including its to treat or cure COVID-19, https:// tion of 16 attorneys general urging parent company Johnson & Johnson); ag.ny.gov/press-release/2020/ the Trump Administration to fully Mallinckrodt LLC and its affiliates; attorney-general-james-takes-action- utilize the Defense Production Act to Endo Health Solutions and its affili- against-coronavirus-health-scams- respond to the ongoing threat of CO- ates; Teva Pharmaceuticals USA, Inc. issues. VID-19. In a letter to President Don- and its affiliates; Allergan Finance, Opioid Manufacturers and ald Trump, the attorneys general urge LLC and its affiliates; and distributors Distributors Denied in Effort to the President to invoke the full pow- including McKesson Corporation, Push Back Opioid Trial ers of the Defense Production Act to: —March 4, Cardinal Health Inc., Amerisource 2020—AG James released a statement (1) allow factories around the United Bergen Drug Corporation, and Roch- States to immediately prioritize the after the request of multiple opioid ester Drug Cooperative Inc., https:// manufacturers and distributors to production of personal protective ag.ny.gov/press-release/2020/ equipment needed by health care delay the trial on claims brought by out-abundance-caution-opioid-trial- the OAG, set to begin on March 20, workers, first responders, and law delayed-due-coronavirus. enforcement; (2) increase health care 2020, were denied. After multiple capacity; and (3) increase COVID-19 Attorney General James An- attempts by defendants to delay the testing capacity, https://ag.ny.gov/ nounces Change to NYS Health trial were denied by the trial court, press-release/2020/attorney-general- Policy Allowing Transgender Minors a four-judge panel of the Appellate james-urges-president-trump-imme- to Correct Sex Designation on Birth Division, Second Department, issued diately-prioritize-production. Certificates—March 10, 2020—AG a unanimous decision rejecting the James announced a change in policy defendants’ latest effort to delay the Attorney General James Marks at the DOH, Vital Records, that al- trial. The panel of judges ordered 10 Year Anniversary of ACA by Con- lows transgender minors born in proceedings to begin on March 20, tinuing to Fight to Protect Health New York to correct the sex designa- 2020. In March 2019, AG James filed Reform Law —March 23, 2020—AG tion on their birth certificates, resolv- a lawsuit against manufacturers James released a statement mark- ing a suit filed on behalf of M.H.W., a Purdue Pharma, its affiliates, and the ing the 10-year anniversary of the transgender minor. The policy change Sackler family; Janssen Pharmaceu- passage of the ACA. The ACA was ensures that transgender youth do ticals and its affiliates (including its signed into law by President Barack not need to wait until they are 18 parent company Johnson & Johnson); Obama on March 23, 2010. Despite years old to make the change, and Mallinckrodt LLC and its affiliates; many challenges through Congress that they can obtain a certified copy Endo Health Solutions and its af- and in the courts, the health care of their birth certificate accurately filiates; Teva Pharmaceuticals USA, reform law remains largely intact and reflecting their sex, consistent with Inc. and its affiliates; and Allergan has ensured coverage for millions their gender identity. Requests for a Finance, LLC and its affiliates; and of Americans, https://ag.ny.gov/ correction to a minor’s birth certifi- distributors McKesson Corporation, press-release/2020/attorney-general- cate must be made by the minor’s Cardinal Health Inc., Amerisource james-marks-10-year-anniversary- parents or legal guardian(s). Ad- Bergen Drug Corporation, and aca-continuing-fight-protect. ditionally, medical affidavits are no Rochester Drug Cooperative Inc. The March 20 trial date covers the AG’s Out Of Abundance Of Cau- longer required to correct the sex lawsuits against all manufacturers tion, Opioid Trial Delayed Due to designation on the birth certificate of and distributors, except for Purdue Coronavirus—March 10, 2020—AG an adult or minor, https://ag.ny.gov/ press-release/2020/attorney-general- Pharma and the Sackler family, which James released a statement follow- is moving separately through U.S. ing Deputy Chief Administrative Bankruptcy Court, https://ag.ny.

NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 31 gov/press-release/2020/opioid-man- to the State. In separate pleas, three dramatic department policy, https:// ufacturers-and-distributors-denied- of Wego’s drivers were convicted of ag.ny.gov/press-release/2020/attor- effort-push-back-opioid-trial. Medicaid Assistance Provider Pro- ney-general-james-condemns-federal- hibited Practices, a class E felony, for proposals-roll-back-critical-anti. Supreme Court Grants Review of paying Medicaid recipients to falsely ACA Repeal Case AG James Voices Support for —March 2, 2020— report their addresses to Medical Legalization of Surrogacy in New The U.S. Supreme Court has agreed Answering Services as substantially York—February 13, 2020—AG James to review a Fifth Circuit decision that further away, allowing Wego to re- released a statement in support of held the ACA’s individual mandate ceive a higher monetary reimburse- New York’s legalization of gestational unconstitutional, and called into ment based on the increased mileage. surrogacy. The AG joined a broad question whether the law’s remain- Each driver was sentenced to a three coalition of advocates in support of ing provisions could stand. New York year conditional discharge, and or- the proposed legislation, including is joined by the attorneys general of dered to pay $127,395.56, $98,421, and the Human Rights Campaign, Family California, Colorado, Connecticut, $260,574.46 in restitution. In total, res- Equality, RESOLVE: The National Delaware, Hawaii, Illinois, Iowa, titution ordered for this matter was Infertility Association, National Massachusetts, Michigan, Minnesota more than $1.2 million, https://ag.ny. Council of Jewish Women New York, (by and through its Department of gov/press-release/2020/operation- American Society for Reproductive Commerce), Nevada, New Jersey, ghost-ride-ag-james-announces-con- Medicine, Academy of Adoption & North Carolina, Oregon, Rhode Is- victions-niagara-falls-taxi-company. land, Vermont, Virginia, Washington, Assisted Reproduction Attorneys, and the District of Columbia, along Attorney General James Con- and Men Having Babies, https:// with the governor of Kentucky, in demns Federal Proposals to Roll ag.ny.gov/press-release/2020/ag- its petition to the Supreme Court for Back Critical Anti-Discrimination james-voices-support-legalization- review of the decision, https://ag.ny. Protections For Patients and Stu- surrogacy-new-york. gov/press-release/2020/supreme- dents—February 18, 2020—AG court-grants-review-aca-repeal-case. James sent two multistate comment New York State Office of the letters to the Trump Administration Operation Ghost Ride: AG Medicaid Inspector General opposing federal proposals roll- James Announces Convictions of Update ing back critical anti-discrimination Niagara Falls Taxi Company Owner Compiled by Dena M. DeFazio protections for patients and students, and Drivers for Defrauding Medic- stemming from an Executive Order Download the Free COVID Alert aid—February 26, 2020—Wego Taxi allowing faith-based organizations to NY App and Help Fight The Spread Tours, Inc. (“Wego”), its owner, and deny services to various groups. The of COVID-19—October 4, 2020— corporate secretary, were convicted first comment letter opposes a HHS https://omig.ny.gov/news/2020/ for stealing thousands of dollars from proposal that would eliminate trans- download-free-covid-alert-ny-app- Medicaid by billing New York State parency requirements for faith-based and-help-fight-spread-covid-19. for rides that were never provided. providers that help patients under- According to plea agreements, the stand their rights and access referrals Let’s Get Counted!—April owner and secretary falsely attested to care from alternative providers. 1, 2020—https://omig.ny.gov/ that they drove Medicaid recipients The letter contends that the proposal news/2020/lets-get-counted. to and from false addresses, and bills fails to safeguard the rights of women were submitted to Medicaid for these and LGBTQ+ individuals, and is arbi- trips, resulting in Medicaid payments trary and capricious because it fails to Endnote to Wego that it was not entitled to consider the evidence or adequately receive. The owner and secretary both 1. Please note that these decisions are justify the proposed changes. The summarized after they are posted on the pleaded guilty to Grand Larceny in second comment letter objects to a Department of Health’s website, which is the Fourth Degree, a class E felony, often many months after the date of the proposal by the U.S. Department decision. were sentenced to a three year condi- of Education expanding the defini- tional discharge, and were ordered to tion used to claim religious exemp- pay $143,610.70 and $39,568.56 in res- tions under Title IX of the Education titution, respectively. Wego pleaded Amendments Act of 1972, alleging guilty to Grand Larceny in the Fourth that the expansion could give schools Degree for knowingly submitting free rein to discriminate against claims to Medicaid falsely represent- students or faculty on the basis of ing that transportation services had sex, and that the proposal is arbitrary been provided in accordance with and capricious because the federal Medicaid rules and regulations, and government failed to provide any will forfeit $602,338.28 in withheld substantive reasoning justifying the Medicaid payments as restitution

32 NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 In the Law Journals By Cassandra DiNova

#METOO Medicalization and New Civil Rights, Policies, Elizabeth Pendo, Robert Meets the Craig Konnoth, 72 Stan. L. Rev. 1165 Gatter, and Seema Mohapatra, 80 Emergency (May 2020). Maryland Law Review Online 1 Room: (2020). Providing and Mental-Health Courts: Expanding the Paying for Model in an Era of Criminal Justice So Much to Comment On, So Care After A Reform, 63 Wash. U. J.L. & Pol’y 299, Little Time: Notice-and-Comment Sexual Assault, Courtney Black (2020). Requirements in Agency Informal Rulemaking Under the Administrative Stacey L. Patients as Peers: Blockchain Based EHR Procedure Act, Kadie Martin, 61 B.C. Worthy, Shruti and Medical Information Commons L. Rev. E-Supplement II.-132 (April R. Kulkarni, Models for HITECH Act Compliance , 2020). Taylor J. Kelly, Zachary L. Catanzaro and Robert and Jessica Johnson, 13 St. Louis U. J. Kain, 44 Nova L. Rev. 289 (Spring Somebody Call My Doctor: Repeal of Health L. & Pol’y 175 (2020). 2020). the Treating Physician Rule in Social Security Disability Adjudication, Complicated Lives: A Look into the Parity Is Not Enough! Mental Health, Charles Terranova, 68 Buff. L. Rev. Experiences of Individuals Living with Managed Care, and Medicaid , Matthew 931 (May2020). HIV, Legal Impediments, and Other B. Lawrence, 48 The J. of Law, Social Determinants of Health, Margaret Medicine & Ethics 480 (Oct. 2020). The Antitrust Impact of Venture B. Drew, Jason Potter, and Caitlin Capital Firms on Concentration in the Private Equity Investment in the Stover, 23 Quinnipiac Health L.J. 81 Technology Sector, Bushra Samimi, Physician Practice: Has Its Time Finally (2020). 11 Hastings Sci. & Tech. L.J. 155 Come or Will the Mistakes of the Past (Summer 2020). ERISA Reform as Health Reform: The be Repeated?, Patrick D. Souter and Case for an ERISA Preemption Waiver, Andrew N. Meyercord, 13 J. Health & The Dynamism of Health Law: Expanded Elizabeth Y. McCuskey, 48 The J. of Life Sci. L. 84 (June 2020). Insurance Coverage as the Engine of Law, Medicine & Ethics 450 (Oct. Regulatory Reform, Gabriel Scheffler, Profiting on Your Pulse: Modernizing 2020). 10 UC Irvine L. Rev. 729 (March HIPAA To Regulate Companies’ Use of 2020). Family Rehabilitation, Inc. v. Azar: Patient-Consumer Health Information, Caring for the Caretakers – A Path Anna Mizzi, 88 Geo. Wash. L. Rev. The Great American Health Care for Providers Trapped in the Medicare 481 (March 2020). System and the Dire Need for Change: Appeals Backlog, Matthew Morris, 23 J. Stark Law Reform as a Path To a Vital Providing Adolescents with Independent Health Care L. & Pol’y 67 (2020). Future of Value-Based Care, Marilyn L. and Confidential Access To Childhood Uzdavines, 7 Tex. A&M L. Rev. 573 Health Policy by Litigation, Katie Keith Vaccines: A Proposal To Lower the Age of (Spring 2020). and Joel McElvain, 48 The J. of Law, Consent, Lois A. Weithorn and Dorit Medicine & Ethics 443 (Oct. 2020). Rubinstein Reiss, 52 Conn. L. Rev. 771 The Medicare Innovation Subsidy, Mark In or Out: Calculation of the Medical (July 2020). A. Lemley, Lisa Larrimore Ouellette, and Rachel E. Sachs, 95 NYULR 75 Loss Ratio and its Effect on the Psychological Distress, Mental Disorder, (April 2020). Affordable Care Act, Cynthia Yi, 61 B.C. and Assessment of Decisionmaking L. Rev. E-Supplement II.-377 (May Capacity Under U.S. Medical Aid in The Winter Takes It All, but Who Gets 2020). Dying Statutes, Lois A. Weithorn, 71 To Play? The False Claims Act’s First Generic But Expensive: Why Prices Hastings L.J. 637 (April 2020). To File Rule and Jurisdiction, Jonathan Lester, 61 B.C. L. Rev. E-Supplement Can Remain High For Off-Patent Regulating Care Robots , Valarie K. II.-410 (June 2020). Drugs, Frazer A. Tessema, Aaron S. Blake, 92 Temp. L. Rev. 551 (Spring Kesselheim, and Michael S. Sinha, 71 2020). “To Infinity and Beyond”: A Limitless Hastings L.J. 1019 (May 2020). Approach to Telemedicine Beyond State Reproducing Inequality Under Title Living in the Gray: Why Today’s IX, Deborah L. Brake and Joanna L. Supported Decision-Making-Type Grossman, 43 Harv. J. L. & Gender Cassandra DiNova is an Associ- Models Eliminate Binary Solutions 171 (Summer 2020). ate Attorney of Rivkin Radler LLP, To Court-Ordered Guardianships, part of their Health Services Group. Alexandra Wallin, 57 San Diego L. Resolving Tensions Between Disability Rev. 433 (Spring 2020). Rights Law and COVID-19 Mask

NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 33 Borders, Kate Nelson, 85 Brook. L. of Life Among Mental Health Court What States Can Do to Address Out- Rev. 1017 (Summer 2020). Participants, Jason Matejkowski, of-Network Air Ambulance Bills, Erin Woojae Han, and Aaron Conrad, 26 C. Fuse Brown, Alex McDonald, and Treating Poverty: Legal Tools for Health- Psychol. Pub. Pol’y & L. 185 (May Ngan T. Nguyen, 48 The J. of Law, Harming Needs, Alice Setrini, 69 2020). Medicine & Ethics 462 (Oct. 2020). DePaul L. Rev. 777 (Spring 2020). Victims of Introspection: Insufficient Workplace Wellness Programs: Empirical (Un)Common Law and the Female Body, Legal Protections for At-Risk Users of Doubt, Legal Ambiguity, and Conceptual Lolita Buckner Inniss, 61 B.C. L. Rev. Automated Mental Health Apps, Jena Confusion, Camila Strassle and E-Supplement I.-95 (May 2020). M. Richer, 44 Vt. L. Rev. 893 (Summer Benjamin E. Berkman, 61 Wm. & Voluntariness of Treatment, Mental 2020). Mary L. Rev. 1663 (May 2020). Health Service Utilization, and Quality

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34 NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 For Your Information By Claudia O. Torrey

Greetings! Hoping this issue of the Health Law Journal information extraction took place remotely via a finds you and yours safe and well!! I trust you will find private network. the following couple items of interest: OCR’s investigation of CHSPSC yielded systemic 1) On September 23, 2020 the Office of Civil Rights noncompliance of HIPAA Privacy and Security (OCR) of the United States Department of Health Rules, including failures to implement information and Human Services announced a $2.3million system procedures and reviews as well as required settlement with Community Health Systems, Inc. security protections. At the time of the settlement (CHSPSC,LLC/CHSPSC) of Franklin, Tennessee announcement, OCR Director Roger Severino not- (https:www.hhs.gov/news); as a business associ- ed the failure of CHSPSC to implement the HIPAA ate under the Health Insurance Portability and Ac- required security protections, after being notified countability Act (HIPAA), CHSPSC also agreed to by the FBI of a security breach, is/was inexcusable! adopt a corrective action plan (https://www.hhs. gov/sites/default/files/CHSPSC-ra-cap.pdf [the 2) Another irony, October is Cybersecurity Awareness plan included two years of monitoring]) to settle Month (www.healthitanswers.net). 2020 marks a alleged HIPAA Privacy and Security violations partnership between the National Cybersecurity affecting over six million people. The irony for this Alliance and the Cybersecurity and Infrastructure columnist is as an out-of-state New York State Bar Security Agency. The goal of the partnership is to Association member from Tennessee, CHSPSC is heighten the awareness of protecting connected in my proverbial backyard! devices, as we engage in more and more health IT! Each week in October has a dedicated theme: CHSPSC provides a number of services to physi- first week—”If You Connect It, Protect It,” second cian clinics and hospitals including health infor- week—”Securing Devices at Home and Work,” mation management and (IT). It is asserted by the third week—”Securing Internet-Connected Devices Federal Bureau of Investigation (FBI) that CHSPSC in Healthcare,” and the fourth week—”The Future was informed in April 2014 about persistent cyber- of Connected Devices” (for example the increased hacking by an “outside entity.” Cyber-hacking use of 5G). continued until August 2014, which allowed the outside entity to access and extract protected health information from more than six million Claudia O. Torrey, Esq. is a Charter Member of the individuals within the CHSPSC systems. The Health Law Section.

NEW YORK STATE BAR ASSOCIATION

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NYSBA Health Law Journal | 2020 | Vol. 26 | No. 1 35 Young Lawyers Committee By Cassandra DiNova and Brenda Baddam, Co-Chairs

The Young Lawyers Committee is focused on the summer in 2017 the Young Lawyers Committee spon- advancement of young health law lawyers in their sored a special edition in the Health Law Journal entitled careers. The committee offers unique opportunities only “Provocative Topics in Health Law,” giving an opportu- for young lawyers, including the ability to network with nity for young lawyers to publish their work. Finally, the fellow peers. The committee hosts monthly teleconfer- Young Health Lawyers Committee rounded out its events ence calls as an open forum to discuss any issues a young for 2017 by organizing a joint networking event with the lawyer may face and current issues in health law. The American Bar Association following a collaborative panel conference calls also include discussions of upcoming discussion covering topics such as health care apps, AI NYSBA events and ideas for future events. and big data and their legal implications. This special issue is the second time the Young If you are interested in joining the Committee or have Lawyers Committee has sponsored a special issue of any questions, please contact Cassandra DiNova at cas- the Health Law Journal. In early 2016, the Young Lawyers [email protected]. Committee co-sponsored a CLE entitled “Health Care Cybersecurity in a HIPAA Compliant World.” Over the

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36 NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 Legal and Ethical Concerns of Telehealth and Telemedicine By Andrew Ko

Technological advancements have benefited our provide telemedicine services. Specifically, physicians society in various ways. The invention of smartphones practicing telemedicine will need to understand when and advent of video and audio communication platforms there is the creation of a physician-patient relationship have changed the way that individuals communicate in the telemedicine setting and the prescription require- with each other. Increased ease of access of web cam- ments across state lines. eras and similar technologies that can transmit real-time This article provides an overview of the legal and reg- video and audio permit individuals to contact each other ulatory landscape for telemedicine. Specifically, it address- anywhere mobile data or an internet connection is avail- es telemedicine licensing requirements, the establishment able. What seemed impossible two decades ago is now of a physician-patient relationship in the telemedicine reality. Both physicians and patients may benefit from the context, regulations on prescribing through telemedicine, use of telemedicine. Telemedicine services are provided when a duty of care arises in telemedicine, ways that phy- through, among other methods, the use of two-way audio sicians can mitigate liability when practicing telemedicine, and video connections, stethoscopes, digital blood pres- and disclosure and notification requirements involving sure machines, and magnifying lenses.1 Telemedicine has patient data obtained through the practice of telemedi- the potential to change the way that primary care is prac- cine.2 Health law attorneys should be familiar with these ticed. This same technology creates an opportunity for aspects of telemedicine before advising their clients. patients who cannot physically travel to their health care professionals’ offices to obtain care. Many states have New York’s Law on Telehealth and Telemedicine passed laws and implemented regulations to ensure telehealth and telemedicine are practiced in a safe manner. New York defines telehealth and telemedicine separately. Under New York law the practice of telehealth is Technology permits a primary care physician to per- defined as “the use of electronic information and com- form basic consultations through the use of a web cam- munication technologies by telehealth providers to deliver era or smartphone. Such technology also permits physi- health care services, which shall include the assessment, cians and patients who move to continue treatment. For diagnosis, consultation, treatment, education, care man- example, physicians may continue to serve their patient agement and/or self-management of a patient.”3 Tele- base even after their patients move to a different state medicine is defined as “the use of synchronous, two-way or retire to a warmer climate. Also, physicians have the electronic audio visual communications to deliver clinical option of expanding their own practices if they decide health care services, which shall include the assessment, to relocate. Technology may even allow physicians to diagnosis, and treatment of a patient, while such patient take on pro-bono work involving regular monitoring of is at the originating site and a telehealth provider is at chronically ill patients. Telemedicine can benefit a patient a distant site.”4 Some states define telehealth and tele- who has difficulty with travel because it enables physi- medicine separately while other states only define either cians to furnish services without having to be with their telehealth or telemedicine.5 patients. However, the ability for physicians to provide services to their patients without being face-to-face with The COVID-19 pandemic has increased the flexibility their patients raises ethical issues. The appropriateness of the provision of telehealth and telemedicine services. of telehealth must be determined on a case-by-case basis. For example, New York providers of mental health services via telehelth may use telephonic means to deliver such While telemedicine takes advantage of the nearly universal availability of modern technology, it creates myriad legal and ethical issues for physicians practicing in different states, under different statutory and regula- Andrew Ko is an associate in the Health Law De- tory systems. There are fundamental questions that arise partment at O’Connell & Aronowitz in Albany, New from the practice of telemedicine. At the most basic level, York. Prior to joining O’Connell and Aronowitz, he physicians must determine what steps must be taken to was an Appellate Court Attorney at the State of New comply with the requirements of practicing telemedicine. York Supreme Court, Appellate Division, Third Judicial Physicians must also determine which statutes and regu- Department. lations must be followed and in what ways their practice must be changed to fit the other state’s requirements. This article would not have been possible without Medical malpractice, which is on the mind of every phy- the research of Alexander H. Wynkoop, a former law sician, will be a significant concern for physicians who clerk at O’Connell & Aronowitz.

NYSBA Health Law Journal | 2020 | Vol. 26 | No. 1 37 services. However, it is unclear whether such flexibility will practice and to authorize the use of certain remain after the pandemic ends.6 technologies for the delivery of health care services to established patients, pursu- Licensing Requirements ant to such limitations as the commis- Generally, for a physician to provide telemedicine sioners of such agencies may determine 17 services within a state, he or she has to meet the traditional appropriate. 7 licensing requirements of each individual state. How- Physicians providing telemedicine services must be ever, other states, such as Louisiana and Minnesota, offer licensed in multiple states, either through the IMLC or 8 alternatives to practitioners licensed in their home state. through traditional licensure processes, and must comply Physicians wishing to practice telemedicine in multiple with each state’s statutes and regulations on telemedicine. states may view traditional licensure requirements as Additional restrictions “may be found in the rules, poli- burdensome. cies, and procedures of the state licensing boards.”18 This One way states have attempted to simplify licensing complicates the practice of telemedicine and it makes com- physicians who want to provide telemedicine services is pliance with a new state’s system difficult for out-of-state the implementation of the Interstate Medical Licensure practitioners. For example, the way in which a physician- Compact (IMLC). The IMLC is an interstate agreement patient relationship, which will be discussed in further whereby a state’s various licensing boards recognize the detail below, is created is inherently different when it is requirements met by physicians in other states and allow formed via telemedicine. Health law attorneys should re- them to register for licensure, so long as they meet the search how physicians become licensed in each state where IMLC criteria.9 The IMLC’s goal is “to increase access to their clients will practice. health care for patients in underserved or rural areas and allow[ ] them to more easily connect with medical experts The Physician-Patient Relationship through the use of telemedicine technologies.”10 “While It is also important to determine how the physician- making it easier for physicians to obtain licenses to practice patient relationship is established in the telemedicine in multiple states, the Compact strengthens public protec- setting. Because telemedicine examinations are not physi- tion by enhancing the ability of states to share investigative cal or in-person, there are questions as to what constitutes and disciplinary information.”11 Currently, there are 29 a physician-patient relationship and when one is created. states, the District of Columbia and the Territory of Guam Moreover, because telemedicine is still relatively new, not participating in the IMLC.12 all state regulatory schemes provide clear guidance. New York is listed as “Introduced” because a bill is cur- Some states have incorporated provisions for telemedi- rently in the Senate Committee of Higher Education Com- cine in their general regulation pertaining to the practice mittee which would enact the interstate medical licensure of medicine. For example, New Hampshire defines a compact.13 On February 12, 2020, New York introduced physician-patient relationship as “a medical connection legislation to join the IMLC.14 New York had legislation between a licensed physician and a patient that includes pending regarding the intrastate practice of telemedicine,15 an in-person or face-to-face 2-way real-time interactive which is not related to participation in the IMLC, but it was communication exam,” as well as the collection of other ultimately stricken. “Under this agreement licensed phy- pertinent history, diagnosis, and treatment information sicians can qualify to practice medicine across state lines required by a traditional examination.19 New Hampshire within the Compact if they meet the agreed upon eligibility further regulates telemedicine by requiring licensure in requirements.”16 New Hampshire, excluding audio-only, or facsimile-only, communication and creating the same standard of care for Due to the COVID-19 pandemic, states such as New practitioners of telemedicine as those practicing “in-person York have temporarily relaxed out of state licensure encounter[s].”20 A physician practicing telemedicine would requirements. be more readily able to comply with this regulatory scheme Executive Order 202.1 which temporarily because it places the practice of telemedicine squarely Suspended and modified Section 2999-cc within the regulation of the practice of medicine with very of the Public Health Law and any regula- little additional restriction.21 tory provisions promulgated thereunder Other states view telemedicine as a tool for the prac- by the Department of Health, the Office tice of medicine, and not as a separate form of practice. of Mental Health, the Office of Addiction For example, California has “no legal prohibitions to Services and Supports, and the Office for using technology in the practice of medicine, as long as People with Developmental Disabilities, the practice is done by a California licensed physician.”22 to the extent necessary to allow additional Under California law, “[t]elehealth is not a telephone con- telehealth provider categories and modali- versation, email/instant messaging conversation, or fax; it ties, to permit other types of practitioners typically involves the application of videoconferencing or to deliver services within their scopes of

38 NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 store and forward technology to provide or support health Mitigating Liability 23 care delivery.” Pursuant to California’s law, “the standard Physicians must be careful not to inadvertently practice of care is the same whether the patient is seen in-person, medicine without authorization. Physicians may be liable through telehealth or other methods of electronically for the unauthorized practice of medicine where they are enabled health care,” and “[p]hysicians need not reside in providing telemedical services to patients who are physi- California, as long as they have a valid current California cally in a state that the physicians are not licensed in. Lia- 24 license.” Therefore, in practice California’s regulatory bility for unauthorized practice of medicine can be avoided scheme is similar to that of New Hampshire. by obtaining licensure in states where physicians provide Each state’s different restrictions make practice in care, whether through traditional means or through an multiple states difficult. States regulate beyond the creation interstate compact such as the IMLC. Such liability can be of the physician-patient relationship—for instance, with further mitigated by complying with each state’s regulatory respect to what and how a physician can prescribe—which system through continued rigorous study or retention of will be discussed in further detail below. While the Ameri- legal counsel specializing in compliance with telemedicine can Medical Association has compiled a 50-state survey on rules, regulations, and policies. These two steps will help establishing physician-patient relationships through the use ensure that physicians, who want to extend their practice of telemedicine, which is a useful resource, physicians with or the services they offer, smoothly transition into this questions related to establishing a physician-patient relation- largely unfamiliar practice. ship should seek the advice of an attorney. This is particu- Unlike when mitigating liability for unauthorized prac- larly true where the physician practices in multiple states. tice of medicine, when it comes to mitigation of liability for breach of the physician’s duty of care, the solutions become The Duty of Care more complex. As described above, the dataset available to Further, it is important to know when a duty of care physicians providing telemedicine services is not necessar- is established in the telemedicine setting. Notably, to raise ily inclusive of all information a physician would typically a viable medical malpractice there must be an established rely on to make a diagnosis. One clear solution, though duty of care owed by a physician to a patient.25 The duty of largely impracticable, would be for a physician to limit his care begins when a physician-patient relationship is created or her practice to individuals who have access to technol- and continues until that relationship is properly ended. ogy that can provide temperature, range of motion and During this time, if the physician causes the patient to be blood pressure. However, such a limitation contradicts a injured by breaching this duty, the physician is liable for purpose of telemedicine; that is, to bring access to medical the damage he or she caused.26 To determine whether the treatment to a wider group of patients. physician breached his or her duty of care, the finder of fact The position that many teledermatologists are tak- must determine “whether a reasonably prudent physician ing may be illustrative for the model that physicians may confronting similar circumstances would not have acted as implement for telemedicine. “[M]any [Direct-to-Consumer] the defendant physician did.”27 DTC teledermatology services treat only acne and do not Misdiagnosis and improper prescription are com- prescribe medications that are associated with higher mon breaches of this duty,28 which is of particular concern malpractice risk . . . . Additionally, DTC telemedicine ser- to practitioners of telemedicine. The level of technology vices often have stated policies not to prescribe controlled required to obtain every imaginable form of data obtained substances.”30 Using this practice model, physicians could from a traditional in-person examination would be cost limit what they diagnose to conditions that are non-life prohibitive in a primary care setting; therefore, there is in- threatening or readily discernable by the dataset available. herently data missing from what a physician uses to diag- Further, physicians could limit what they prescribe to treat- nose and prescribe while conducting telemedicine. Factors ments and medications without serious adverse effects or such as temperature, accurate range of motion, blood pres- opportunity for abuse. In practice, the physicians would de- sure, and visual examination are beyond the capabilities of scribe the scope of their practice to patients, so the patients a web camera or cellphone. However, as outlined above, understand at the outset that the scope of the care they will often the duty of care is not modified for telemedicine de- receive may be more basic than if they were visiting a physi- spite these limitations. The danger, then, is that physicians cian in person. By providing such disclosure, this ensure that provide telemedicine services may rely heavily on the that the patients are properly treated, or rather not improp- limited dataset available from an audio-video call. In doing erly treated, thereby reducing the physician’s liability. The so, such physicians may make different diagnoses than if foregoing is an example of how physicians could provide they had the full scope of information provided by a tradi- telemedicine services while also limiting their liability. tional in-person examination. As a solution, the American Medical Association (AMA) suggests keeping the patient Prescribing Through Telemedicine informed of the technological limitations, and “tak[ing] ap- Similar to New Hampshire’s regulation for the creation 29 propriate steps to overcome those limitations.” of a physician-patient relationship, the New Hampshire regulatory system for prescribing in the telemedicine context

NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 39 is fairly comprehensive. First, practitioners are generally For example, New Jersey requires that where a patient prohibited from “prescribe[ing] by means of telemedicine a is provided with telemedicine or telehealth services, his controlled drug classified in schedule II through IV.”31 For or her medical information must be made available upon schedule V or non-controlled substances, a physician must request.40 New Jersey also provides that with the patient’s have established a physician-patient relationship, as de- consent, the medical information obtained from the practice scribed above, except “for medication on a short-term basis of telemedicine may be forwarded directly to the patient’s for a new patient prior to the patient’s first appointment.”32 primary care provider or health care provider of record.41 In order to prescribe non-opioid schedule II through IV The patient may also request that such information be sent drugs, there must be a pre-existing in-person physician- to other health care providers.42 Where the patient does patient relationship for monitoring and follow-up care.33 For not have a primary care provider, the health care provider opioid schedule II through IV, initial and post-prescription providing the telemedicine services may advise the patient in-person examinations are generally requried.34 to contact a primary care provider and if requested by the patient, help the patient locate a primary care provider or Other states, such as Ohio, draw a strict controlled/ other in-person medical assistance, to the extent possible, non-controlled substance line. A physician who has never that is located within reasonable proximity to the patient.43 conducted a physical examination of the patient may pre- In New Jersey, the consent “may be oral, written, or digital scribe non-controlled substance subject to certain criteria in nature, provided that the chosen method of consent is obtained through traditional practice, but otherwise obtain- 44 35 deemed appropriate under the standard of care.” As you able through telemedicine. This criteria includes confir- can see, New Jersey’s disclosure and consent requirements mation of patient’s identity and location, informed consent, are more specific than New York’s requirements. Where a referral to an in-person exam with a health care provider if state does not provide specific guidance on disclosure and appropriate, follow-up care, and proper records available consent requirements of patient data obtained in the tele- to the patient including their diagnosis and necessity for 36 medicine setting, physicians must adhere to Federal Health the prescription. For controlled substances, however, the Insurance Portability and Accountability Act (HIPAA) regulation is so restrictive that an out-of-state primary care disclosure and notification requirements.45 Under the physician would likely not be able to prescribe. Prescribing circumstances where federal and state laws are in disagree- such a substance requires that: the physician be a colleague ment, the more stringent requirement must be followed.46 of a physician who has performed an in-person examina- Moreover, physicians may need guidance on the sufficiency tion within the past 24 months; the patient is physically of their written consent which must comply with state and located in a licensed medical facility; the physician has a federal law. Due to the complexity of the disclosure and special federal registration allowing such prescription; or notification requirements, it is imperative attorneys are the physician is the medical director or attending physician well-versed in such requirements. at a licensed hospice or medical facility.37 Not all states have extensive and detailed, laws and Conclusion regulations on prescribing through telemedicine. Rhode Particularly, with the changes brought about by the Island allows prescription of non-controlled substances COVID-19 pandemic, telemedicine allows physicians to ex- through telemedicine without an in-person examination, pand their practice, to continue to treat patients who move but only allows prescription of controlled substances in away, or allow physicians to move and maintain patients short duration pursuant to an established coverage agree- or treat patients while they are out of town temporarily. But ment.38 Similar to the formation of the physician-patient telemedicine can also allow those same physicians to pro- relationship, the regulations on prescribing under tele- vide services to others in rural or underserved areas, all at a medicine practices are not insurmountable but require competitive cost. Laws and regulations will continue to be persistent attention to the details of each individual state’s adopted and evolve as the practice of telemedicine becomes requirements. more widespread. It is important for health care attorneys to understand and keep up to date on the legal and regula- Disclosure and Notification Requirements tory requirements that must be met by physicians provid- Another important aspect of telemedicine is compli- ing telemedicine services. ance with the disclosure and notification requirements for patient data obtained through telemedicine services. States Endnotes may have laws or regulations that dictate the disclosure 1. See NY PUB HEALTH § 2999-cc(5). and notification requirements of protected health informa- 2. See Hilary Daniel and Lois Snyder Sulmassy, Policy Recommendations tion obtained during the practice of telemedicine. New to Guide the Use of Telemedicine in Primary Care Settings: An American York currently only has a specific regulation for disclosure College of Physicians Position Paper, Annals of Internal Medicine n.20 and notification in the context of telemental health servic- (September 8, 2015). 39 es. Other states have specific telemedicine regulations and 3. NY PUB HEALTH § 2999-cc(4). laws which provide guidance on the disclosure and notifi- “Telehealth shall not include delivery of health care services by cation requirements. means of facsimile machines, or electronic messaging alone, though use of these technologies is not precluded if used in conjunction

40 NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 with telemedicine, store and forward technology, or remote patient 21. For another example of a plainly regulated scheme, requiring at least monitoring. For purposes of this section, telehealth shall be limited the standard of care of traditional in-person practice, see Chapter 24, to telemedicine, store and forward technology, remote patient Telemedicine, of the Wisconsin Administrative Code. monitoring and audio-only telephone communication, except that 22. http://www.mbc.ca.gov/Licensees/Telehealth.aspx. with respect to the medical assistance program established under 23. https://www.speechandhearing.ca.gov/licensees/telehealth.shtml. section three hundred sixty-six of the social services law, and the child health insurance plan under title one-A of article twenty- 24. http://www.mbc.ca.gov/Licensees/Telehealth.aspx. five of this chapter, telehealth shall include audio-only telephone 25. See Joseph S. Kass, MD, JD and Rachel V. Rose, JD, MBA, Medical communication only to the extent defined in regulations as may be Malpractice Reform: Historical Approaches, Alternative Models, promulgated by the commissioner.” and Communication and Resolution Programs, AMA Journal of 4. NY PUB HEALTH § 2999-cc(5). Ethics, https://journalofethics.ama-assn.org/article/medical- malpractice-reform-historical-approaches-alternative-models-and- 5. For purposes of this article, except where states use the term communication-and-resolution/2016-03 (March 2016). telehealth, the term telemedicine will be used to generally describe 26. See id. services provided via electronic means that allow physicians to see and talk real time with patients. 27. Id. 6. https://health.ny.gov/health_care/medicaid/covid19/faqs.htm. 28. See id. 7. For example, under OKLA. ADMIN. CODE § 435:10-7-13, “[p] 29. American Medical Association, Ethical Practice in Telemedicine, hysicians treating patients in Oklahoma through telemedicine must https://www.ama-assn.org/delivering-care/ethics/ethical-practice- be fully licensed to practice medicine in Oklahoma.” telemedicine (last visited September 29, 2019). 30. Kevin Kunzmann, No Medical Malpractice Found in Direct Telemedicine 8. LA. ADMIN. CODE tit. 46, § 7507 (2017). Louisiana allows for Cases, MD Part of the HCP LiveNetwork, https://www.mdmag. practice where a physician licensed in their home state obtains a com/medical-news/no-medical-malpractice-found-in-direct- telemedicine permit from the Louisiana State Board of Medical telemedicine-cases (April 3, 2019). Examiners. MN. STAT. § 147.032 (2019). Minnesota allows limited practice where the physician is located outside of the state at all 31. N.H. Rev. Stat. § 329:1-d(iii). times, with the requirement that the physician registers with the 32. N.H. Rev. Stat. § 329:1-c. Minnesota Board of Medical Practice. 33. See N.H. Rev. Stat. § 329:1-d. 9. https://imlcc.org/do-i-qualify/. 34. N.H. Rev. Stat. § 329:1-c. 10. https://imlcc.org/. 35. See Ohio Administrative Code 4731-11-09(c)(1)-(9). 11. Id. 36. See id. 12. See id. 37. See id. 13. See id. 38. See http://www.health.ri.gov/healthcare/about/telemedicine/. 14. See https://www.nysenate.gov/legislation/bills/2019/S7732. 39. See 14 NYCRR 596.5(c)(2)(iii). 15. https://www.nysenate.gov/legislation/bills/2019/S888. 40. NJ Stat 45:1-62. 16. https://imlcc.org/ 41. Id. 42. Id. 17. http://www.op.nysed.gov/COVID19_Telepracticeguidance.html#. 43. Id. 18. Marcie M. Damisch, JD, Telemedicine Licensure and Related Challenges for Physicians, My Life Sciences, Vol. 95 Issue 07 (April 10, 2018), 44. Id. https://www.medicaleconomics.com/health-law-and-policy/ 45. See 42 C.F.R. § 2.31. telemedicine-licensure-and-related-challenges-physicians. 46. United States Department of Health and Human Services, HIPAA, 19. N.H. Rev. Stat. § 318:1(XV-a). Does the HIPAA Privacy Rule preempt state laws?, https://www.hhs. gov/hipaa/for-professionals/faq/399/does-hipaa-preempt-state- 20. N.H. Rev. Stat. § 329:1-d. laws/index.html (last visited December 8, 2019).

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NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 41 Misbranded Drugs 101: What Attorneys Need to Know By David F. Durso

Recently, the Food and Drug Administration (FDA), cer medications to them, they were likely getting nothing along with the Department of Justice (DOJ), have in- more than saline solution. creased enforcement against health care providers and Health care providers are often approached by over- drug distributors who introduce misbranded drugs seas distributors offering “the same drugs” at a lower imported from overseas. As this conduct can have both price. The benefit of the lower price is that providers can civil and criminal penalties, providers and their attorneys make additional profits on the reimbursement for the should review purchasing agreements and drug inven- drugs. It is important to note that, for some drugs and tory lists to ensure compliance with all applicable laws. biologicals, reimbursement by payors, including Medi- care, is set at a fixed rate based upon the average sales Background price plus a small percentage to account for profit.10 Av- Drugs that are purchased for use in the United States erage sales price is based on quarterly data submitted to are approved for use by the FDA. The manufacture, label- CMS by drug manufacturers.11 Because these misbranding, and distribution of all drugs and drug components ed drugs are purchased through non-FDA approved are regulated by, amongst other laws, the Food Drug channels, the price of the drugs is not reported to CMS 1 and Cosmetic Act (FDCA). The FDCA defines drugs as and, therefore, is not included in the average sales price articles intended for use in the diagnosis, cure, mitiga- calculation. Thus, by purchasing the drugs at a lower 2 tion, treatment or prevention of disease. Drugs can be cost, the provider stands to make additional profit when 3 classified as misbranded for any number of reasons. submitting claims for reimbursement. As discussed Some examples include (1) if the drug was imported more fully below, the government does not look kindly by a commercial importer not duly registered with the on providers who make additional profits through this 4 FDA under the FDCA; (2) if the label does not bear the arrangement. Rx Only symbol;5 (3) if any words, statements, or other information that appear on the labeling or insert are not Criminal Penalties in English;6 and (4) if the packaging does not bear the unique National Drug Code (NDC) number. Receipt of misbranded drugs exposes individuals to significant criminal penalties. Any person introducing These misbranded drugs are often sold under the or delivering into interstate commerce any drug that is same name and manufactured by the same manufacturer misbranded, and the receipt in interstate commerce of as the version approved for sale and use in the United misbranded drugs, are both strict liability misdemean- States. Indeed, the drugs can be the biological equiva- ors.12 Therefore, even without knowledge that the drugs lent, i.e., chemically identical, to the version of the drug were purchased from an overseas distributor and were approved for sale in the United States while still being misbranded, an individual can be convicted of a misde- misbranded. However, in some instances, providers have meanor. If convicted, the crimes are punishable by a fine purchased misbranded drugs that do not contain an ac- of not more than $1,000, imprisonment for not more than tive ingredient. This is obviously the biggest concern with one year, or both. misbranded drugs, and the basis for enforcement actions undertaken by the FDA and DOJ. Regardless of whether The consequences of introducing misbranded drugs become more severe when the individual commits the the misbranded drugs are the biological equivalent of the 13 drugs approved for sale in the United States, significant crime “with intent to defraud or mislead.” In that criminal and civil exposure exists for the mere possession instance, the individual faces a felony charge and can be of misbranded drugs. The administration of misbranded drugs poses a serious risk to patients that should not be understated. In 2018, after a lengthy FDA investigation and subse- David F. Durso. Esq. is an Associate at Ruskin quent prosecution, Canada Drugs, a Canadian company, Moscou Faltischek, P.C. where he is a member of the admitted to the illegal sale of misbranded and counterfeit Health Law Department and White Collar Crime and prescription drugs in the United States.7 Canada Drugs Investigations Practice Group. He represents health distributed counterfeit versions of the cancer drugs care professionals and companies in a variety of mat- Avastin and Altuzan.8 Upon testing the drugs, the FDA ters including Medicare or Medicaid fraud investiga- discovered that the vials of drugs recovered from certain tions, medical staff proceedings, government investiga- shipments contained no active ingredient.9 Thus, while tions and prosecutions and professional disciplinary patients believed that physicians were administering can- proceedings.

42 NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 sentenced to a period of imprisonment of not more than Enforcement Actions three years or a fine of not more than $10,000, or both. The DOJ has brought a number of civil and criminal The “intent to defraud or mislead” mens rea contained in actions over the past few years that provide insight into the felony level offense requires that the individual have how the DOJ views misbranded drugs cases. In U.S. v. Sen, knowledge that the drugs are misbranded. The government Dr. Sen and Mrs. Sen were indicted by a federal grand jury can take the position that because of the misbranding itself, for the introduction of misbranded drugs with intent to (for example, language other than English on the label), the defraud and mislead and related charges.21 The allegations practitioner was on notice that the drugs were imported in the indictment were that in 2009 the practice obtained from overseas. foreign drugs that were misbranded and thus not approved for use by the FDA.22 The drugs the defendants purchased Civil Liability were misbranded because they were not manufactured by In addition to the criminal exposure that individuals facilities registered with the FDA and the packaging con- face described above, the government utilizes the False tained foreign languages. After trial, the jury convicted the Claims Act to seek monetary penalties for reimburse- Sens of the strict liability misdemeanor counts of causing ment by federally funded health care programs for claims the introduction of misbranded drugs into interstate com- submitted for misbranded drugs. Litigations based on the merce.23 The judge ultimately dismissed the charges upon False Claims Act result in billions of dollars of settlements a motion by the United States Attorney’s Office for the and judgments every year. In 2018 alone, the government Eastern District of Tennessee.24 In its moving papers, the recovered more than $2.8 billion in settlements and judg- government alluded to the fact that the charges were being ments from civil cases involving fraud and false claims.14 dismissed because the Sens were not convicted of knowingly introducing misbranded drugs into interstate commerce.25 A False Claims Act violation occurs when an individual Thus, it appears as though the DOJ is not interested, or at “knowingly presents, or causes to be presented, a false or 15 least less interested, in pursuing cases where the defendant fraudulent claim for payment or approval.” An individual can establish that he or she did not possess the mens rea acts knowingly when that individual has actual knowledge required for the felony level crime. of the information, acts in deliberate ignorance of the truth or falsity of the information, or acts with reckless disregard In 2016 a number of orthopedic clinics located within of the truth or falsity of the information.16 The statute does the U.S. Attorney’s Office for the Eastern District of Cali- not require that the individual possess the specific intent to fornia settled False Claims Act allegations related to the defraud the government.17 reimportation of various viscosupplements and the subsequent billing to federal and state health care programs.26 A claim is defined as any request or demand for money The three clinics paid a combined $2.39 million to resolve or property presented to an officer, employee, or agent of the False Claims Act allegations.27 In these cases, the gov- the United States or made to a contractor, if the money or ernment contended that the clinics knowingly purchased property is to be spen or used on the government’s behalf reimported foreign versions of the viscosupplements.28 or to advance a government program or interest, and if These viscosupplements were misbranded in that the label- the United States provides any portion of the money or ing was in foreign languages.29 property requested or demanded or will reimburse such contractor any portion of that money.18 Finally, material is Health care providers are not the only target of enforce- defined as “having a natural tendency to influence, or be ment. As discussed above, Canada Drugs, a distributor, capable of influencing, the payment or receipt of money or admitted to widespread illegal sales of misbranded and property.”19 counterfeit drugs. In the end, the corporation forfeited $29 million as proceeds, paid a fine of $5 million and was sen- False Claims Act violations can result in a civil penalty tenced to five years probation.30 per false claim, plus three times the amount of damages to the government by the false claims. The civil penalty Finally, in 2015, U.S. v. Mark Heinicke, M.D., the defen- that can be imposed is not less than $11,181 and not more dant pleaded guilty to treating patients with misbranded than $22,363 per claim.20 In bringing a False Claims Act medications and was sentenced to one year probation case, the government could, and often does, consider each and $176,000 in restitution.31 The defendant admitted to claim submitted for reimbursement to be a separate false purchasing drugs from a foreign distributor in the United claim. Thus, the individual could face the civil penalties Kingdom which were not approved by the FDA.32 These described above for each claim submitted for reimburse- drugs were used to treat cancer, rheumatoid arthritis and ment. For healthcare providers who submit hundreds, if osteoporosis. In a separate civil agreement, he agreed to not thousands of claims, these penalties can add up very pay $338,000 in addition to court ordered restitution to quickly. settle the False Claims Act allegations.33

NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 43 Conclusion 18. 31 U.S.C. § 3729(b)(2)(A). The government has a number of enforcement mecha- 19. 31 U.S.C. § 3729(b)(4). nisms to ensure that all drugs purchased and administered 20. 31 U.S.C. § 3729(a)(1). in the United States are approved by the FDA. Given the 21. United States v. Sen, 24 F. Supp. 732, 734 (E.D. Tenn. 2014). substantial penalties, both civil and criminal, for the pos- 22. Id. session and importation of misbranded drugs, providers 23. Id. at 735 (“After a jury trial, Dr. Sen was convicted on December 12, and their attorneys must give heightened scrutiny to drug 2013, of the charges in Counts One through Twenty Nine of the third distributors offering drugs for lower prices. superseding indictment. Mrs. Sen was convicted of a lesser included offense in Counts One through Twenty Nine, that is, the same misdemeanor offenses as her husband, Dr. Sen.”). Endnotes 24. See United States v. Sen, Gov’t. Mot. to Dismiss, No. 2:13-CR-00056 (Feb. 9, 2015); see also Jamie Satterfield, Judge: Greenville doctor, wife 1. 21 U.S.C. §§ 301 et seq. wrongly convicted, Knoxville News Sentinel (Feb. 13, 2015), http:// 2. 21 U.S.C. § 321(g)(1). archive.knoxnews.com/news/crime-courts/judge-greeneville- 3. 21 U.S.C. §§ 301-399. doctor-wife-wrongly-convicted-ep-930677481-353564551.html/. 4. 21 U.S.C. § 352(o). 25. United States v. Sen, Gov’t. Mot. to Dismiss, No. 2:13-CR-00056 (Feb. 9, 2015). 5. 21 U.S.C. § 353(b)(4)(A). 26. Press Release, Department of Justice, U.S. Attorney’s Office, Eastern 6. 21 C.F.R. § 201.15(c)(1). District of California, Orthopedic Clinics to Pay $2.39 Million to Settle 7. Press Release, Department of Justice, U.S. Attorney’s Office, District Allegations of Billing Federal Health Care Programs for Reimported of Montana, Canadian Drug Firm Admits Selling Counterfeit and Products (Oct. 3, 2016) https://www.justice.gov/usao-edca/pr/ Misbranded Prescription Drugs Throughout the United States orthopedic-clinics-pay-239-million-settle-allegations-billing-federal- (Apr. 13, 2018), https://www.fda.gov/inspections-compliance- health-care. enforcement-and-criminal-investigations/criminal-investigations/ 27. Id. april-13-2018-canadian-drug-firm-admits-selling-counterfeit-and- misbranded-prescription-drugs. 28. Id. 8. Id. 29. Id. 9. Id. 30. Press Release, Department of Justice, U.S. Attorney’s Office, District of Montana, Canadian Drug Firm Admits Selling Counterfeit and 10. 42 U.S.C. § 1395w-3a. Misbranded Prescription Drugs Throughout the United States (Apr. 13, 11. Department of Health and Human Services, Centers for Medicare 2018) https://www.fda.gov/inspections-compliance-enforcement- and Medicaid Services, Pub. 100-04 Medicare Claims Processing, and-criminal-investigations/criminal-investigations/april-13-2018- Transmittal 856 (Feb. 15, 2006). canadian-drug-firm-admits-selling-counterfeit-and-misbranded- prescription-drugs. 12. 21 U.S.C. §§ 331, 333(a)(1). 31. Press Release, Department of Justice ,U.S. Attorney’s Office, Western 13. 21 U.S.C. § 333(a)(2). District of Kentucky, Louisville Physician Pays $515,408.85 For Treating 14. Press Release, Department of Justice, Justice Department Recovers Over Patients With Misbranded Drugs and Fraudulently Charging Medicare $2.8 Billion From False Claims Act Cases in Fiscal Year 2018 https:// (Jan. 29, 2015) https://www.justice.gov/usao-wdky/pr/louisville- www.justice.gov/opa/pr/justice-department-recovers-over-28- physician-pays-51540885-treating-patients-misbranded-drugs-and- billion-false-claims-act-cases-fiscal-year-2018. fraudulently. 15. 31 U.S.C. § 3729(a)(1). 32. Id. 16. 31 U.S.C. § 3729(b)(1)(A). 33. Id. 17. 31 U.S.C. § 3729(b)(1)(B).

44 NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 General Considerations for Drafting Successful Telehealth Contracts By Craig W. Anderson

Even those who have significant experience in draft- to understand in this regard well as the entities involved, ing contracts may overlook some of the fundamentals and the applicable payor(s). For example, under federal of telehealth practice that need to be addressed within Medicare conditions of participation for Critical Ac- the contract. Telehealth agreements are not vastly differ- cess Hospitals may partner with providers who are not ent from agreements where the same services would be enrolled with Medicare,3 there is no similar permission provided face-to-face, but may require an added measure expressed in the conditions of participation for Hospi- of attention and detail. This article provides a general tals.4 For Medicaid, under New York’s Telemental health outline for attorneys who are called on to review or draft regulations which govern OMH facilities, reimbursement telehealth contracts. Please note that for purposes of is governed largely by contract and the Distant Site is this article the term “telehealth” is used generically and not entitled to reimbursement separate/apart from what applies to all subdivisions of the term (like telemedicine, is stated in the contract. As the list of what qualifies as telemental health, etc.).1 telehealth continues to expand, it is necessary to check the regulations and guidance on a regular basis. The Background of the Telehealth Arrangement Office of the Inspector General and CMS will continue Contracts for telehealth services will typically to closely monitor claims billed for telehealth services to 5 include two or three parties. Absolutely essential to the protect against fraud and waste. transaction are the Originating Site(s) and the Distant One common practice is to push the billing and reim- Site(s). The Originating Site is the physical location bursement issues to the party operating the Originating where the individual/patient is located at the time that Site, and for the Distant Site party to simply collect a fee services are delivered. Originating Sites can include for the services provided by the Distant Site physician, general hospitals, physician’s offices, nursing homes, much like any other vendor. This is often the approach adult care facilities, as well as the patient’s private used in nursing home or hospital settings, where Medi- residence. The Distant Site refers to the location of where care would otherwise provide reimbursement for the the provider is physically located. In addition to these services, but will—for whatever reason—not reimburse a essential parties operating the Distant Site and Originat- physician for providing said services via telehealth (and, ing Site, some health care providers establish and/or therefore, the Distant Site physicians don’t want to both- coordinate with a third party, a special corporate partner er trying to request reimbursement). In such situations, that handles the administrative aspects of billing and one thing that should be clearly stated in the agreement technology (“Administrative Entities”). A strong agree- is that the Originating Site will be responsible for billing ment will include language that clarifies the obligations the government or third-party payor and that the Dis- of these parties with respect to billing, data exchange, tant Site providers must provide any appropriate docu- cyber security and liability insurance, patient consent, mentation needed. Further, the Originating Site should and credentialing. obtain appropriate authorizations/assignments from the Distant Site Providers, so that it is abundantly clear that Billing and Reimbursement the Originating Site—and not the Distant Site—will be Given the extensive additional compliance required, seeking reimbursement of the services through the third- the first considerations should be how or whether the party payor. services are covered by Medicare and/or Medicaid, as the answer to that question will impact the entire Corporate Practice of Medicine (CPOM) and Fee structure of any contract. Of course, those familiar with Splitting the history of Medicare and Medicaid restrictions will New York prohibits any person from sharing in the sympathize with providers who remain confused as to fees for professional services, unless that person is: whether telehealth services can be reimbursed through the Medicare and/or Medicaid programs. Medicare a partner, employee, associate in a and Medicaid have set definitions of telehealth and ap- professional firm or corporation, profes- plicable proscriptions on reimbursing services that do not fit within these definitions.2 Assuming the services qualify as telehealth services, the Agreement will need to comply with additional regulations and specific pay- Craig Anderson is an Associate Attorney with Bond, ment/reimbursement structuring. The important thing Schoeneck & King, practicing health care law.

NYSBA Health Law Journal | 2020 | Vol. 26 | No. 1 45 sional subcontractor or consultant autho- The following diagram may be helpful in understand- rized to practice the same profession, ing the problematic structure: or a legally authorized trainee practicing under the supervision of a licensed prac- Services titioner. This prohibition shall include Admin./Management any arrangement or agreement whereby Company of Distant Site Originating Site Provider the amount received in payment for Money furnishing space, facilities, equipment or personnel services used by a professional licensee constitutes a percentage of, or is Money Services otherwise dependent upon, the income or receipts of the licensee from such practice, except as otherwise provided by law with respect to a facility licensed Distant Site Providers pursuant to article 28 of the Public Health Law or article 13 of the Mental Hygiene Law.6 In this structure, the management company is an LLC and either employs or directs the Distant Site physicians. New York’s CPOM/fee splitting prohibitions were The LLC receives payments based on the services pro- recently reviewed by the Court of Appeals, serving as a vide. The problem with this arrangement is that, under reminder that New York State law, non-licensees like the Administrative Entity are not permitted to receive compensation for the New York law prohibits unlicensed indi- services provided by physicians to patients.9 Additionally, viduals from organizing a professional as warned against by the case cited above, there is a risk of service corporation for profit or exercising fraudulent practices or poor services if the Administrative control over such entities. In the medical Entity exercises control over the health care services being context, the underlying policy concern is offered/provided. “that the so-called ‘corporate practice of medicine’ could create ethical conflicts There are ways to eliminate or reduce risk of non- and undermine the quality of care af- compliance, one of which is for the Distant Site and LLC to forded to patients” (State Farm Mut. Auto. change their corporate structure to ensure against corporate Ins. Co. v Mallela, 372 F.3d 500, 503 (2d Cir. practice of medicine and fee splitting issues. However, in 2004)). Control of medical service corpora- the event that the LLC/Distant Site Provider is unwilling to tions by unlicensed individuals leads to do so, the originating site could potentially contract directly higher costs, less effective medical treat- with the Distant Site for services; the agreement between ment, and mistrust of the no-fault insur- the Originating Site and the Distant Site would, however, ance system.7 need to set forth additional, clarifying requirements to provide guidance on any transaction that could run afoul Telehealth contracts have given rise to a somewhat of New York’s CPOM or fee splitting laws in order to better novel application of New York’s Corporate Practice of protect the Originating Site. Medicine and Fee Splitting prohibitions. These issues typically arise where the contract is structured in a way that Many attorneys are already aware of this dilemma, an Administrative Entity has substantial involvement or as well as methods for resolving it, but it is important to control over the health care providers or where the pay- be mindful of this, as it is a frequent obstacle in telehealth ments go through the Administrative Entity. Although not contracts. The arrangement for telehealth services must wholly unique to telemedicine, it seems that the signifi- be carefully drafted to avoid CPOM and Fee Splitting cant increase in the use of telemedicine has brought with prohibitions. it enterprising companies that are not familiar with New York’s CPOM prohibitions. When an arrangement is done Insurance and Cybersecurity properly, the use of the Administrative Entity frees up Cybersecurity has become an increasingly regulated the providers to focus on the provision of care while also issue.10 Along with this is increased exposure to risk and limiting liability. However, when the arrangement is done the need to meet national and international privacy stan- improperly, this can lead to a host of problems, including dards (like the EU’s GDPR). Each party should be aware corporate practice of medicine.8 of the need to be able to identify and correct security vulnerabilities. One step towards added protection is that, in addition to standard insurance requirements, the telehealth services agreement needs to address requirements of cyber insurance. These policies offer unique coverage for

46 NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 incidents involving privacy, security, and performance of regard to the health care practitioners equipment. While cyber liability insurance isn’t unique to providing telemedicine services, the telehealth realm, it becomes more necessary given the fact that people’s health and privacy are at stake. For one, (iii) itemize the credentialing in- engaging in telehealth requires the exchange of information formation to be collected and the to one or more individuals who will now be storing infor- required verification activities to be mation; it is not reasonable to allow another entity to store performed by the distant site hospital your information when they have no coverage. Addition- and relied upon by the originating ally, weaknesses in cyber security may lead to inoperability hospital in considering the recommen- of systems/programs, and may in turn render useless the dations of the distant site hospital, intended communications. (iv) require each distant site . . . practi- Good insurance policies will cover an entity’s ex- tioner . . . to be licensed to practice in penses related to negligence, errors in performance, this state and privileged at the distant destruction of data, and improper disclosures of personal site hospital, information, and reimburse for fines incurred by lost data (v) require the distant site hospital to and the costs incurred for investigation. Attorneys need to provide to the originating hospital a make sure that they—and their clients—understand what current list of each distant site health is actually covered by the policy. Failure to do so leaves care practitioner’s privileges at the them open to very real and very costly risks. distant site hospital, and

Credentialing (vi) require the distant site hospital to conduct a periodic review . . . at least Credentialing ensures that the physicians at the Dis- every two years, and as otherwise tant Site meet requirements of the Originating Site. Article warranted . . . , the credentials, privi- 28 facilities are required to review the background and leges, . . . and competence in deliver- experience of physicians, dentists, and podiatrists and ing health care services of each health are essential to ensuring the quality of care. In providing care practitioner providing telemedi- telemedicine services, however, the Originating Site can cine services; to provide the originat- utilize or rely upon the credentialing of the Distant Site in ing hospital with the results of such certain situations. review; and to notify the originating Although 2805-u states that the Originating Site is not hospital immediately upon any sus- authorized to “delegate its authority over and respon- pension, revocation, or limitation of sibility for decisions concerning the credentialing and such privileges.11 granting staff membership or professional privileges,” the Similar are the requirements of federal regulations. Originating Site may, nevertheless, “rely on the credential- For example, 42 CFR Part 482, which sets forth condi- ing and privileging decisions made by the distant site,” tions of participation of the governing body of hospitals provided that a number of requirements. Among other participating in Medicare, states that the governing body things, these include requirements that the Distant Site may choose to rely upon the credentialing and privileging participates in Medicare and Medicaid, that each practitio- decisions made by the Distant Site.12 ner is licensed in New York, and that Distant Site conduct periodic, outcome-based reviews concerning those who Quality and Standard of Care have been granted privileges. 2805-u also contains specific language that must be in the underlying services agree- The careful attorney will also take into consideration ment. Specifically, whether the physicians providing the requested services will be able to perform care at the same quality and to the (f) the agreement entered into between the same extent as a face-to-face or “in-person” encounter originating site hospital and distant site between the physician and the patient. In spite of numer- hospital shall be in writing and shall, at a ous claims from telehealth vendors and even attorneys, minimum: there is an inherent difference in the interactions; the fact (i) provide the categories of health remains that the Distant Site practitioner does not have care practitioners that are eligible the same access to the patient. The practitioner will not be candidates for appointment …, able to directly touch the patient and may not be able to view all of the patient’s body. Although New York State (ii) require the … distant site hospital has long held that the standard and quality of care to be to comply with the Medicare condi- provided via “telepractice” must be the same as in-person tions of participation governing the visits,13 meeting these requirements is not always pos- appointment of medical staff with sible. This is perhaps most clearly identified in the cur-

NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 47 rent regulations and guidance pertaining to telemental Endnotes health, which does not allow providers to use telemental 1. Note that, while applicable for general purposes, this article was health services for purposes of ordering medication over drafted prior to the COVID-19 public health emergency and does not the patient’s objections, nor may an assessment or evalu- take into consideration changes in regulations or laws that may have occurred since that time. ation provided through telemental health serve as the basis for the involuntary removal of an individual from 2. See, e.g., 42 CFR § 410.78; N.Y. Pub. Health Law § 2999-cc. the community.14 The issues of standard of care remain a 3. “In the case of distant-site physicians and practitioners providing telemedicine services to the CAH’s patients under a written significant conundrum for physicians trying to perform agreement between the CAH and a distant-site telemedicine entity, the services the “old fashioned way.” the distant-site telemedicine entity is not required to be a Medicare- participating provider or supplier.” 42 CFR § 485.635(c)(5). To be clear, this is not always an obstacle to provid- 4. See generally, 42 CFR § 482. ing the care needed by the patient. Studies have shown that telehealth services, including telemental health, are 5. See Department of Health and Human Services, Office of Inspector 15 General, CMS Paid Practitioners for Telehealth Services That Did “unquestionably effective in most regards.” Still, these Not Meet Medicare Requirements (2018), https://oig.hhs.gov/oas/ issues should be carefully considered with the providers reports/region5/51600058.pdf (DHHS OIG found that CMS had who may be responsible for the patient receiving care, to improperly reimbursed for services that did not meet the Medicare ensure that the contract can adequately plan for or avoid requirements). any potential shortcomings that may result in the absence 6. N.Y. Comp. Codes R. & Regs. tit. 8 § 29.1(b)(4). of an in-person visit. At a minimum, the contract should 7. Andrew Carothers, M.D., P.C. v. Progressive Ins. Co., 128 N.E.3d 153 include requirements that physicians refer patients for an (2019). in-person visit when the practitioner does not believe that 8. Also of concern would be potential implications of: the Federal the care can be sufficiently provided through a televisit. Anti-Kickback Statute; the Physician Self-Referral (or “Stark”) Law; and various state regulations prohibiting or restricting management arrangements of health care facilities. Patient Consent 9. See N.Y. Educ. Law § 6509-a.; N.Y. Comp. Codes R. & Regs. tit. 8 § While patient consent is obviously required in the 29.1(b)(4). contest of establishing a relationship between the tele- 10. See, e.g., US Cyber Security Act of 2015, the recent enactment of health provider and the patient, there are also potential the NY SHIELD Act, and additional guidance being offered by government agencies on reporting, e.g., DOH’s Dear Administrator contract issues related to patient consent. One example Letter issued August 12, 2019; OHIM DAL 19-01. of how consent can be overlooked is overzealous con- 11. N.Y. Pub. Health Law § 2805-u (emphasis added). tract language that requires—as oppose to permits—the Distant Site to perform a particular services. Without 12. See 42 CFR §§ 482.12(a)(9); 482.22(a)(3), (a)(4). additional language referencing the need to obtain patient 13. Item for Discussion from Johanna Duncan Poitier, New York State Education Department, to The Board of Regents Committee on consent, or that services are only offered pursuant to pa- Professional Practice (Nov. 16, 1999), http://www.op.nysed.gov/ tient consent, this could lead to a failure by the Originat- reports/telepractice.pdf . ing Site to properly inform/educate their patient(s) on the 14. These, and other restrictions set forth in N.Y. Comp. Codes R. & benefits or drawback of the arrangement; thereby leading Regs. tit. 14 § 596.6(a)(10), are regulatory acknowledgments of the to problems with informed consent. inherent weaknesses, if not skepticism, of not being able to observe a patient in person. In ensuring that the patient is properly notified, the 15. Donald M. Hilty, et al., The Effectiveness of Telemental Health: A 2013 New York State Department of Health requires that poli- Review, 19 Telemedicine J. & E-Health 444 (2013), https://www.ncbi. cies to ensure that patients are aware of their rights to re- nlm.nih.gov/pmc/articles/PMC3662387/. fuse to participate in services delivered via telehealth and 16. New York State Department of Health, Medicaid Update, Special to be informed of all parties who may be present at “each Edition: Expansion of Telehealth (2019), https://www.health. end” of the telehealth transmission.16 Contracts should ny.gov/health_care/medicaid/program/update/2019/feb19_mu_ speced.pdf. reference (and incorporate) policies regarding patient consent to ensure that each party is aware of the need to comply with this requirement.

Summary In conclusion, telehealth can provide a cost-effective, meaningful method of providing health care. However, as telehealth continues to grow in both supply and demand, health care providers and their attorneys must be careful to keep up with the regulatory issues that impact reimbursement, quality of care, and overall compliance.

48 NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 Chernobyl: Bridging the Gap Between International Nuclear Law and Public Health By Melissa Montoni

Introduction to have the CNPP running by 1977.10 Pressured for time, Nuclear energy is a relatively new addition to the and lacking the necessary finances and resources, Soviet scientific world. Since the splitting of the atom during engineers hastily built the power plant. On September 29, 1977 the CNPP was officially on the Ukrainian electrical World War II, nuclear energy has become an integral part 11 of society, for better or worse. This integration is evident grid. by the nuclear power plants that give cities electricity, to At the time of commission, CNPP had four reactors nuclear weapons that could alter life forever. Although running with two more being built at a later date. The re- nuclear energy plays a prominent role in society, there actors used in the CNPP were RBMK reactors, which was is little legal framework when it comes to nuclear acci- the Russian acronym for “high-power channel reactor.”12 dents. The insufficiency of stronger laws raises significant These graphite reactors were a uniquely Soviet design and public health issues. The impact is best observed in the came with their own set of unique flaws. Three main flaws 1986 Chernobyl disaster in the former Union of Soviet in particular played a crucial role in the 1986 disaster. First 1 Socialist Republics (USSR). The health impact of the flaw was the fact that the reactors were graphite moder- Chernobyl disaster brought forth significant changes and ated, because graphite simply slows the speed of excited reforms in nuclear law. In order for the international legal neutrons in a nuclear chain reaction but does not cool the framework to become even more useful, there must be reactor.13 Compare this to western nuclear reactors, which adoption and implementation of nuclear liability among use water as both a moderator and coolant.14 Another flaw nuclear-powered countries. that the RBMK reactors had was that they were missing a containment seal.15 The purpose of a containment seal is Chernobyl: A Disaster the World Will Never to prevent the release of any radioactive materials into the Forget environment if there were ever to be an accident.16 Most A. Building Chernobyl reactors, especially American reactors, cannot receive a license to run if there is a missing seal; however, there was Distant and secretive; probably two common adjec- no law in the USSR to ensure that the reactors had a seal.17 tives to describe life behind the Iron Curtain.2 However, Last is a technical flaw with the RBMK reactors. the world was given an exclusive glimpse into Soviet life when faulty reactor design, human error, and a corrupt After gaining access to Chernobyl from the Ukrainian government led to the worst nuclear disaster human his- government, scientists realized there were two major tory has ever seen. On April 26, 1986, the fourth reactor defects in the RBMK: speed of the control rods and time at the Chernobyl Nuclear Power Plant (CNPP) suffered a standby for the diesel generators.18 The control rods at power surge, releasing tons of toxic radioactive particles the Chernobyl Power Plant were designed in such a way into the environment and forever changing the face of the that it took them “20 seconds to reach contact with the small Soviet village of Pripyat.3 reactor.”19 The insertion speed was far too slow to stop a runaway nuclear reaction in the case of a meltdown.20 Although what occurred that very night the reac- Not only were the control rods too slow, but there were tor exploded is often referred to as an accident, what also problems with the backup diesel generators.21 These occurred at Chernobyl was foreseeable and far from an generators were supposed to serve the function of provid- accident. Plans for building a nuclear power plant in the ing power to the cooling system and reduce temperature Soviet Socialist Republic of Ukraine began in 1970.4 The reactivity within the reactor.22 Unfortunately, the diesel head of the Ministry of Energy and Electrification (MEE) generators at Chernobyl required about 60-75 seconds of the USSR gave orders to start building a new nuclear to reach their full capacity.23 By the time the generators power plant along the Ukrainian and Belarusian border.5 The CNPP was to house six reactors, which would have made it the largest nuclear power plant in the world at Melissa Montoni is a third-year law student at the that time.6 The purpose was to create a large enough Elisabeth Haub School of Law at Pace University in nuclear power plant that could supply energy to all of White Plains, New York, pursing a Certificate in Public Ukraine.7 With permission granted by the MEE, official Health Law. Her undergraduate education was at Ford- construction began in 1972.8 While the ambitions of the ham University where she studied pre-med and minored Soviet government were high, their resources and financ- in Russian language and history. Montoni is expected to es to actually build the plant were not.9 Adding to these graduate May 2021 and plans to practice in the field of problems, was that the MEE imposed construction dead- medical and health law. lines as to when the reactors were to be built and aimed

NYSBA Health Law Journal | 2020 | Vol. 26 | No. 1 49 were fully charged, the reactor temperature would be too and firefighters, suffered from “vomiting, diarrhea, skin high to control.24 The MEE and Soviet authorities were well lesions, fevers, seizures […] and internal bleeding.”43 Many aware of these flaws.25 Soviet records indicate that in 1983, of those who suffered from ARS died within hours or the newly built CNPP already failed a series of initiation weeks after the disaster.44 and safety tests.26 However, the Soviet government never Another danger of radiation exposure is the increased took any action to address these issues. Instead, the Soviet 45 government intentionally allowed these defective reac- likelihood of developing cancer. Estimates show that “an tors to keep running only relying on the slim chance that estimated 25,000 people living within the vicinity of the these flaws would not escalate into a nuclear meltdown. Of CNPP” have or will have cancer caused by the 1986 disaster.46 In the estimated 25,000, around “16,000 of those can- course, the Soviet government’s presumptions came to a 47 harsh reality on April 26, 1986. cer cases will be thyroid cancer.” The reason behind this is because one of the most radioactive elements released from B. April 26th, 1986 the reactor core is Iodine-131.48 The thyroid gland naturally absorbs iodine in humans; the gland responsible for hor- The MEE scheduled a required safety test for all RBMK mone regulation.49 However, when exposed to Iodine-131, reactors during the day of April 26, 1986. The test started the thyroid gland absorbs the radioactive particles which right on time (13:00) where one of the turbo-generators to interfere with healthy thyroid cell DNA resulting in cell reactor 4 was shut off and caused the thermal power of the death and the formation of cancer cells.50 reactor to go down to 1,600 megawatts (MW).2728 Due to the decrease in reactor power, the Ukrainian Electric Grid D. Pripyat: Chernobyl’s Environmental Scar System notified Chernobyl that electricity was needed that day and scheduled the test for night.29 The test began Chernobyl did not just cause adverse medical effects. with the control rods being lowered into the reactor which The disaster also left a significant impact on the environ- slowly reduced the reactor’s power and supply to spin ment which can lead to more harm to public health. The the turbo-generator.30 In order to prevent any emergency nearby town of Pripyat suffered the most for this negli- system interference with the test, the crew deactivated all gence. After the first days of the accident, the damaged systems including the most crucial one: the emergency reactor released about a total of measurements of about cooling system.31 It was at this step of the test that the “20 million curies of radioactive gases blown into the atmosphere […] and nearly 10 million curies of radioactive de- operator made a critical human error: forgetting to reset the 51 parameters of the control rods, which caused the rods to go bris from the damaged reactor fell to the ground.” A year too deep into the reactor during the test.32 after the accident, measurements of background radiation were taken around Pripyat revealing that any land near the The deep insertion of the control rods reduced the reactor was “about 50-100mR/h and those at the perimeter power down to 30 MW.33 The operator continued the test of the village had about 0.5-1.0mR/h […] still higher than while he struggled to get the reactor power to 200 MW.34 the natural background radiation of 0.015 mR/h.”52 However, the reactor was at such an unstable level that the power rose too rapidly.35 In order to reduce this sudden Today, the town of Pripyat is known as a ghost town. power surge, the operator ordered all the control rods to be Only visited by the occasional scientists the town remains injected into the core at once. This caused the rods to melt the way it was left with faded posters reading, “We’ll give upon contact with the reactor core.36 The pressure even- the motherland bread! and Glory to the Soviet worker- peoples!”53 Buildings that once housed families lie empty, tually built up so much that a steam explosion occurred 54 within the reactor.37 A second explosion resulted from the decaying and overtaken by the vines of nature. The infamous Ferris Wheel that was meant to open for May hydrogen build-up of the over heated graphite columns in 55 the reactor that sent “burning lumps of material and sparks Day celebration now stands still with rusty seats. Visita- 38 tion to the town of Pripyat is limited due to the levels of to shoot into the air above the reactor.” On that night of 56 April 26, 1986, the USSR caused the world’s first nuclear radiation. catastrophe. Shortly after the disaster, Soviet engineers built a structure known as a sarcophagus to house the radiation C. Health Effects from the Chernobyl Disaster that leaked from the exposed reactor.57 In the mid 2000s, With such large doses of radiation into the environ- scientists began to notice a slight increase of radiation into ment, it is not hard to overstate the detrimental health ef- the atmosphere.58 In order to prevent any more leakage, sci- fects that followed the Chernobyl disaster.39 The most com- entists and engineers erected a new structure.59 The project mon injury from the disaster was Acute Radiation Sickness was named the New Confinement Structure and, with the (ARS).40 ARS is a broad term that refers to the numerous help of international financing from other countries, was effects radiation can have on the human body.41 Depend- completed in 2017.60 This structure covers any remaining ing on the dosage amount, “ARS can range from gastroin- decaying radiation preventing any leaks into the environ- testinal problems, skin deterioration, and even death.”42 ment.61 The structure will remain over the damaged reactor Sources report that many of those who suffered from ARS, until the waste inside is no longer considered a health haz- such as engineers in the building at the time of explosion ard; this is estimated to be around 6,570 years from now.62

50 NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 Legalizing the Atom means that the responsible party shall be held liable for failing to assure safe conditions. A. What Is Nuclear Law? The first step into understanding the relationship Environmental justice aims to not only create healthy between nuclear energy and public health law is to under- and safe conditions for all but to also impose liability upon stand nuclear law. Nuclear law is “the body of special legal those who injure the public via means of environmen- norms created to regulate the conduct of legal or natural tal hazards. The legality around lead contamination is a persons engaged in activities” of nuclear material. 63 The notorious example of environmental justice coming into 79 purpose of nuclear law is to promote the development play. During the late 1990s in the United States, various of nuclear science and technology while simultaneously legal steps were taken to hold parties liable for known and 80 protecting society against any hazards.64 Nuclear law first intentional lead exposure. The Department of Housing became a topic in 1955 with the International Conference and Urban Development (HUD): on the Peaceful Uses of Atomic Energy convention held attempted to resolve the conflict between 65 in Geneva, Switzerland. A year later, the International housing affordability and lead poisoning Atomic Energy Agency (IAEA) was created, which to this by two strategies: lowering the standards day, is the leading international legislating body when it for abating lead paint hazards and induc- 66 comes to nuclear law. ing property owners preventative ac- The IAEA is the only international organization that tions in return for insulation against civil 81 regulates nuclear laws. As of 2019, there are a total of 171 liberties. 67 countries which are member States to the IAEA. In order Property owners were held liable for any injury caused to unify the vast and dynamic laws surrounding nuclear by the property’s lead contamination if they failed to follow energy, the IAEA created the IAEA Handbook on Nuclear and take certain preventative actions.82 The aim of such 68 Law. The Handbook is a legislative guideline, updated regulations were to hold individuals liable for the harm regularly, which serves as a foundation for countries desir- caused by his or her property and encouraged property ing to use nuclear power to assess when creating their owners to ensure that their property was safe before rent- 69 national legal framework for nuclear energy usage. The ing or selling it to other parties.83 Applying environmental Handbook has five parts, which each deal with different justice to the nuclear field would mean that member States subject matters ranging from critical concepts in the field would need to find not only a balance between nuclear of nuclear law and legislation to nuclear and radiation laws, public health, and liberty interests but also the health 70 safety. Countries that use nuclear power joined the IAEA and safety of the environment. convention as member States in the late 1950s.71 However, while the IAEA is the main legislating body for nuclear However, the IAEA does acknowledge that finding a law, it cannot force member States to adopt legislation on balance between nuclear law, public health and also pro- nuclear law.72 Instead, the IAEA nuclear laws are to serve tecting the environment can be a challenge.84 The IAEA as guidelines, but it is up to the member States to create Handbook does state that member States are to ensure and adopt nuclear laws into their legislation.73 that public health laws, safety and environment are the top three considerations to look at when drafting nuclear B. Public Health Law and Nuclear Law laws.85 The Handbook also mentions that when member Based on the adverse effects Chernobyl caused to both States are creating legal framework for nuclear activities, the the public and environment, it is not hard to see why nucle- member State laws should adequately protect individuals 86 ar energy is considered a health law matter. Public health and the environment. Yet, the Handbook gives no specific 87 law is a legal field that focuses on government authorities guidance for this. Although it is true that the IAEA and and duties to ensure public safety while also balancing its Handbook, though not explicitly, encompass the idea of liberty interests.74 There must be a balance between nuclear environmental justification, there is no legal framework for 88 laws, ensuring public safety, and liberty interests.75 Achiev- member States to follow. Member States are instead given 89 ing such a balance also calls for there to be a relationship full discretion when creating nuclear laws. The result is between nuclear law and public health law.76 One example often vague nuclear laws that do little to compensate indi- 90 of how there can be a relationship between public health viduals and the environment in cases of nuclear accidents. law and nuclear law is the topic of environmental justice.77 Fortunately, there is a solution: nuclear liability.

C. Environmental Justice The Solution: Bridging the Gap Between Law and Environmental justice is the “argument that the gov- Science ernment, or any private party, has a moral obligation A. Nuclear Liability in Nuclear-Powered Countries to assure reasonably healthy and safe conditions for all The Chernobyl disaster brought significant changes neighborhoods.”78 Taking the argument of environmental in the field of nuclear science and the legal framework for justice and applying it to the definition of public health law nuclear law. One of the main areas of the legal framework significantly developed was the area of nuclear liability.91

NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 51 Specifically, nuclear liability is a type of “civil liability damaging the drums and releasing toxic chemicals above which would hold a third party liable for damages” done ground and into the groundwater.113 Chemicals continued to those injured from the usage of nuclear material.92 The to leak into the environment for decades.114 In the winter term damages is to refer to any damages done to person of 1977, heavy snow raised the water tables underground, or property; private and or public.93 At the time of the raising the elevation of the exposed drums.115 Residents Chernobyl disaster, there were no laws regarding nuclear soon took note of an “odd black liquid” that came from the liability, and therefore no way to award damages to injured canal along with “odd odors and substances appearing in individuals and states.94 However, the IAEA responded private and public property.”116 With complaints high, the by creating the Convention on Third Party Liability in the village council took action to investigate in 1978.117 Field of Nuclear Energy in 1988.95 The Convention led to the creation of the Joint Protocol that later became effec- Investigations by the village council revealed alarming tive in 1992.96 The wording of the Joint Protocol states that discoveries. Reports of water containing human carcino- gens in people’s own homes was a common discovery “such liability will be triggered when a nuclear installation 118 causes a nuclear disaster.”97 The Joint Protocol made sure during this investigation. With reports of such hazardous to define the term disaster broad enough so that liability materials present, essentially all over the neighborhood, the state Department of Environmental Conservation began to will be triggered in the cases of disasters that are either 119 intentional or unintentional (i.e. accidents).98 The liability conduct their own investigations. The New York State that the Protocol implements is strict liability and holds Department of Health and Environmental Conservation that there would be compensation for the victims regard- revealed an abundance of chemical waste lying exposed on less of nationality, domicile, or residence.99 Hypothetically numerous surfaces, obnoxious chemical fumes and vapors, and children returning from playing outside with burns on speaking, if such legislation were in place at the time of the 120 Chernobyl disaster, it would have been possible for mem- their hands and faces. ber States of the IAEA to hold the Soviet Union liable for C. Comprehensive Environmental Response, the damages they did to their people, the environment and Compensation and Liability Act (CERCLA) the world.100 As a result from numerous investigations and the ac- B. Case Study: The Love Canal Disaster tive push by the residents to hold the Hooker Company accountable for their actions, the federal government stepped While nuclear liability can definitely serve as a solution 121 for compensating persons and property damage to nuclear in. In 1978, President Jimmy Carter announced Love disasters, one question still remains: how would nuclear Canal as a federal health emergency, ordering federal funds and the Federal Disaster Assistance Agency to aid in rem- liability work in the case of a disaster? The case of the Love 122 Canal disaster can answer of this question. The Love Canal edying the site. In addition, Congress passed the Com- disaster refers to a neighborhood in Niagara Falls, New prehensive Environmental Response, Compensation and 101 Liability Act (CERCLA) in 1980, or more commonly known York. As the American industrial age of the 1920s car- 123 ried on, it became apparent to many industrial companies as the Superfund Act. The agency in charge of adminis- 102 trating CERCLA was the Environmental Protection Agency that they needed to properly dump hazardous wastes. 124 Twenty years later, Hooker Chemical Company decided to (EPA). CERCLA was to provide liability, compensation, designate Love Canal as its waste storage.103 The Hooker cleanup and emergency response for any hazardous material released into the environment that could pose a public Chemical Company was known for producing chloralkali 125 products.104 The process of creating chloralkali products health issue. results in large quantities of hazardous chemical waste.105 CERCLA functions under 42 U.S. Code § 9606, Love Canal served as the perfect location as the canal could which allows the President of the United States to de- be drained, lined with clay and ultimately turned into termine whether or not there is an “imminent and sub- a chemical waste landfill.106 The Hooker Company pur- stantial endangerment to public health, welfare or the chased the canal in 1947.107 The Hooker Company contin- environment.”126 If the President determines there is a dan- ued to dump hazardous waste into the canal until the mid ger, there is to be an investigation conducted by the EPA, to 1950s.108 find the accountable parties.127 CERCLA’s liability clause allows any responsible party to be brought and tried in In 1954, the Hooker Company sold the canal to the 128 town as the village board desired to purchase property to federal court. CERCLA has a broad scope of liability. Spe- build new schools.109 Construction began that year lead- cifically, the Potentially Responsible Party (PRP) provision, through retroactivity, allows current, past and even future ing excavators to find large quantities of sealed drums 129 buried in the ground.110 There was no record or indica- operators of a company to have liability. If found liable, tion what was inside these drums; however, construction the responsible party is to pay damages for the clean-up. 111 Congress was well aware that funding would be a chal- continued. By 1955, the neighborhood of Love Canal had 130 various new schools to accommodate its growing popula- lenge. In response, Congress decided to enact a federal 112 tax on any industry which produces hazardous material as tion. Construction of the new schools, homes and play- 131 grounds disrupted the concrete foundation over the drums a byproduct. This taxation on industries allowed there

52 NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 to be funding for clean-up and other legal remedies to the that have the potentiality of creating hazardous byproducts areas affected by the release of the hazardous chemicals.132 are present in that certain member State. For example, the more nuclear power plants a member State has the higher The Love Canal was one of the first sites on CERCLA’s 133 the tax. This could also serve as an incentive for member list of contaminated areas. The EPA found evidence States to find alternatives for energy production other than that showed the Hooker Company, now known as Occi- nuclear energy. An IAEA compensation fund would allow dental Petroleum Company, was the responsible party for 134 there to be an international source of money member States the Love Canal Disaster. Numerous residents, as either could have access to when compensating victims. In return, plaintiffs or joint plaintiffs, brought civil action against Oc- 135 this would ensure that member States have the capability cidental. The process was time consuming and as of the and resources to clean up after hazardous disasters. 1990s, there were still pending and open cases. However, by 2004 Occidental was to pay for all the liability damag- The IAEA makes an attempt to hold parties responsible es.136 That year, Love Canal received enough funding, via in the case of nuclear accidents. Yet, the law as it currently the federal taxation provision in CERCLA, to go through stands is not developed enough. Implementing CERCLA complete cleanup.137 As of today, Love Canal is no longer provisions into IAEA laws will help develop nuclear liabil- the toxic waste dump it once was. ity further by ensuring that there are both measures and resources to compensate those effected by nuclear accidents. D. The IAEA’s CERCLA: Holding Nuclear Companies Liable for Damages Conclusion Perhaps if the IAEA implemented legislation similar The Chernobyl disaster was a horrific event that altered to CERCLA, Chernobyl would not be the hazardous ghost the field of science and raised important public health is- site it is today. The IAEA Handbook’s section on nuclear sues. The disaster exposed the flaws in nuclear laws, specif- liability does hold a party strictly liable for any intentional ically, a lack of nuclear liability legislation, and exposed the or unintentional cases of nuclear disasters.138 Yet, the IAEA gap that exists between nuclear energy and public health law on nuclear liability fails to provide details and guid- law. While the damage is done, it is hard not to wonder ance on how to go about holding a party liable. Looking at what the outcome would have been if nuclear liability ex- CERCLA for inspiration, the IAEA could possibly imple- isted at the time of the 1986 disaster. While the IAEA made ment a similar approach method. CERCLA allows the great efforts to fix these flaws, it is now the responsibility of President of the United States to make the final decision the member States to take it upon themselves to adopt and on whether there is any danger to the environment or the fully implement such legislation. Holding governments public.139 If the President finds there is danger, the EPA will liable for the damages done to individuals and the envi- begin an investigation to find the responsible parties.140 ronment could, perhaps, bridge the gap between nuclear Since the IAEA is an organization that consists of member energy and public health law. Such laws could serve as a States, it would be practical to make the member States the motivation for stricter nuclear power plant safety require- body that determines whether or not there is any danger to ments to prevent another Chernobyl. the environment or public in the case of a nuclear disaster. Once it is determined that there is a potential danger, the member State in which the accident occurred will be Endnotes responsible for conducting investigation for the liable par- 1. Specifically, in the former Ukrainian Soviet Socialist Republic Zhores ties; similar to how the EPA investigates. It should be the Medvedev, The Legacy of Chernobyl 12 (1990). discretion of the affected member State on how to go about 2. Iron Curtain refers to the political, military and ideological barrier the investigation and how to fund the investigation. which separated the countries which made up the Soviet Union and Western Europe after WWII. Erik Richardson, NATO, The Warsaw Following CERCLA’s provisions, when a nuclear disas- Pact, and the Iron Curtain 15 (2017). ter occurs, the party responsible (most typically the com- 3. Zhores Medvedev, The Legacy of Chernobyl 12 (1990). pany who owns the nuclear power plant) is found liable 4. Adam Higginbotham, Midnight in Chernobyl 29 (2019). for the environmental damages and compensation to those 5. Id., at 30. 141 affected by the disaster. However, the IAEA does not 6. Id. explain how to actually compensate the victims. CERCLA, 7. Id. on the other hand, specifically states that the liable party 8. The Legacy of Chernobyl 22. 142 is to compensate the victims through cleanup efforts. In 9. Midnight in Chernobyl 31. addition, CERCLA also creates a source of funding for the 10. Id. clean-up efforts through federal taxation on any industry 11. Id., at 33. which produces a hazardous byproduct.143 As a result, the 12. Actual Russian translation is “реактор большой мощности liable party can then retrieve money from the fund created канальный, РБМК.” The Legacy of Chernobyl 13 (1990). by CERCLA for cleanup efforts. The IAEA can follow a 13. The Legacy of Chernobyl 15. similar path. The IAEA could create a provision that states 14. Id. any participating member States are to pay a tax to the 15. Richard Rhodes, Nuclear Renewal 1 (1993). IAEA. The tax could be dependent on how many industries

NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 53 16. Id. 60. Id. 17. The Legacy of Chernobyl 18. 61. Id. 18. Id. 62. Id. 19. Id., at 22. 63. Handbook on Nuclear Law, International Atomic Energy Agency (Apr. 20. Nuclear Renewal 5. 5, 2020), https://www-pub.iaea.org/MTCD/publications/PDF/ Pub1160_web.pdf. 21. The Legacy of Chernobyl 18. 64. Id. 22. Nuclear Renewal 8. 65. History of the IAEA, International Atomic Energy Agency (Apr. 23. Id., at 10. 5, 2020) https://www.iaea.org/services/technical-cooperation- 24. Id. programme/history. 25. The Legacy of Chernobyl 33. 66. David Fishcer, History of the IAEA 9 (1997). 26. Id. 67. Member States of the IAEA, International Atomic Energy Agency (Sep. 27. Megawatts is the scientific unit for measuring power output by 6, 2020) https://www.iaea.org/about/governance/list-of-member- nuclear reactors. Robert Gale, Radiation: What It Is, What You Need to states. Know 3 (2013) 68. Handbook on Nuclear Law. 28. Robert Gale, Radiation: What It Is, What You Need to Know 3 (2013). 69. Id. 29. The Legacy of Chernobyl 25. 70. Id. 30. Id. 71. Id. 31. Id., at 27. 72. Id 32. Id. 73. Id. 33. Id., at 28. 74. Richard Bonnie and Ruth Bernheim, Public Health Law, Ethics & 34. Id. Policy (2015) 1. 35. Id., at 32. 75. Id. 36. Id., at 34. 76. Id. 37. Id. 77. Id., at 349. 38. Id. 78. Id. 39. Id., at 99. 79. Public Health Law, 999. 40. Id., at 100. 80. Id. 41. Radiation Sickness, Mayo Clinic (Apr. 5, 2020), https://www. 81. Id. mayoclinic.org/diseases-conditions/radiation-sickness/symptoms- 82. Id. causes/syc-20377058. 83. Id. 42. Id. 84. Handbook on Nuclear Law. 43. Sources & Effects of Ionizing Radiation, United Nations Scientific 85. Id. Committee on the Effects of Atomic Radiation (UNSCEAR) (Apr. 5, 2020) http://www.unscear.org/docs/reports/2008/11-80076_ 86. Id. Report_2008_Annex_D.pdf. 87. Liability and Compensation for Nuclear Damage, Nuclear Energy 44. Id. Agency (1994) 118. 45. Radiation: What It Is, What You Need to Know 67. 88. Id. 46. Health Effects of the Chernobyl Disaster: An Overview, World Health 89. Id. Organization (Apr. 5, 2020) https://www.who.int/ionizing_ 90. Id. radiation/chernobyl/backgrounder/en/. 91. Handbook on Nuclear Law. 47. Id. 92. Id. 48. Radiation: What It Is, What You Need to Know, 110. 93. Liability and Compensation for Nuclear Damage, 81. 49. Id. 94. International Nuclear Law in the Post Chernobyl Period, Organization 50. Id. for Economic Co-Operation and Development (OECD) 187 (2006). 51. The Legacy of Chernobyl, 105. 95. Id. 52. Id., at 108. 96. Id. 53. Svetlana Alexievich, Voices from Chernobyl 48 (2005). 97. Id., at 154. 54. The Legacy of Chernobyl, 106. 98. Liability and Compensation for Nuclear Damage, 93. 55. Shengli Niu, Chernobyl 20 Years After: From Disaster, Breeding a New 99. Id. Safety Culture, International Labour Organization (Sept, 4, 2020) 100. Id., at 190. https://www.ilo.org/global/about-the-ilo/newsroom/features/ WCMS_069141/lang--en/index.htm. 101. Love Canal: Public Health Time Bomb, New York State (Sep. 7, 2020), https://www.health.ny.gov/environmental/investigations/love_ 56. Id. canal/lctimbmb.htm. 57. Legacy of Chernobyl, 105. 102. Id. 58. Aria Bendix, Chernobyl’s Sarcophagus Is Getting Dismantled Because It 103. Id. Is Teetering on Collapse, Business Insider (Sept. 4, 2020), https://www. businessinsider.com/chernobyl-disaster-sarcophagus-construction- 104. An industrial process which uses an electric current to stimulate a dismantling-2019-9. chemical reaction in sodium chloride (NaCl) solutions to produce chlorine (Cl) and sodium hydroxide (NaOH); commodity chemicals 59. Id.

54 NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 in the industry business. Norman Greenwood, Chemistry of the 123. Thomas Voltaggio, A Half Century of Progress, EPA Alumni Elements (1997) 100. Association (Sep. 7, 2020), https://www.epaalumni.org/hcp/ 105. Id. superfund.pdf. 106. Id. 124. Id. 107. Id. 125. Id. 108. Id. 126. Id. 109. Actions at the Love Canal Site, The New York Times (Sep. 7, 2020), 127. Superfund: 20th Anniversary Report: A Series of Firsts, Environmental https://www.nytimes.com/1983/02/23/us/actions-at-the-love- Protection Agency (Sep. 7, 2020), https://web.archive.org/ canal-site.html. web/20100909035122/http://www.epa.gov/superfund/20years/ ch3pg1.htm. 110. Id. 128. Id. 111. Id. 129. Id. 112. Id. 130. Id. 113. Id. 131. Id. 114. William Glaberson, Love Canal: Suit Focuses on Records from the 1940s, The New York Times (Sep. 7, 2020), https://www.nytimes. 132. Id. com/1990/10/22/nyregion/love-canal-suit-focuses-on-records- 133. The Love Canal Tragedy. from-1940-s.html. 134. Id. 115. Id. 135. Id. 116. Id. 136. Id. 117. Id. 137. Id. 118. The Love Canal Tragedy, Environmental Protection Agency (Sep. 7, 138. Liability and Compensation for Nuclear Damage, 93. 2020), https://archive.epa.gov/epa/aboutepa/love-canal-tragedy. html. 139. A Half Century of Progress. 119. Id. 140. Id. 120. Id. 141. Id. 121. Id. 142. Id. 122. Id. 143. Id.

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NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 55 Materiality in the Post-Escobar Era: An Argument for Supreme Court Clarification of Materiality By Kyle Madley

Introduction History of the False Claims Act In June of 2016, the Supreme Court passed down a In relevant part, the current text of the False Claims unanimous decision endorsing the implied false certifica- Act imposes liability on any person who knowingly pres- tion theory as a basis for False Claims Act (FCA) liability, ents a false statement or record to the government that is answering a divisive split in the circuits below.1 More material to a claim for payment.5 importantly, however, the Supreme Court established a set of factors to guide the analysis of the materiality The Act defines “knowing” or “knowingly” as when requirement of the FCA.2 In describing these factors, the a person has actual knowledge of the information, acts in Court stated: “deliberate ignorance” of the truth, or acts recklessly with regard to the truth or falsity of the knowledge. 6 A “claim” [A] condition of payment is relevant but comprises any request or demand, whether under a con- not automatically dispositive. […] Proof tract or otherwise, for money or property that is presented of materiality can [also] include, but is to the United States or a contractor.7 The statute states not necessarily limited to, evidence that that a claim is “material” when it has a natural tendency the defendant knows that the Govern- to influence, or is capable of influencing, the payment or ment consistently refuses to pay claims. receipt of money or property.8 […] If the Government pays a particular claim in full despite its actual knowledge The False Claims Act was enacted in 1863 during the that certain requirements were violated, Civil War to address concerns that some organizations sold supplies to the Union Army that were not as they that is very strong evidence that those 9 requirements are not material. Or, if the were represented, thereby defrauding the government. Government regularly pays a particular Congress amended the modern FCA in 1986 to enhance the government’s ability to recover losses due to alleged type of claim in full despite actual knowl- 10 edge that certain requirements were fraud. However, the FCA was not created to serve as violated, and has signaled no change in an all-purpose vehicle to prosecute “garden-variety” frauds, but instead, severe frauds perpetrated against the position, that is strong evidence that the 11 requirements are not material.3 government. While the Court did use the wording “very strong” to Congress amended the FCA again in 2009 as part of the Fraud Enforcement and Recovery Act (FERA) to denote the importance of government payment, ambigu- 12 ity remains among the courts below with regard to how resolve ambiguities surrounding the materiality element. to weigh the factor of continued government payment. Specifically, in FERA, Congress imposed liability on one Gilead Sciences, Inc. v. United States, ex rel. Campie, coming who “knowingly makes, uses, or causes to be made or used, a false record or statement material to a false or out of the Ninth Circuit, would give the Supreme Court 13 the opportunity to address the discrepancies in the courts fraudulent claim.” Previously absent from the statute, below and describe more clearly how continued govern- the addition of the word “material” did not create a new ment payment is to be interpreted.4 materiality standard, but instead “merely made explicit and consistent that which had previously been a judi- Justice Thomas correctly articulated that the standard cially-imposed, and oftentimes conflicting, standard.”14 for the materiality determination of a false claim is a bal- As the First Circuit noted in U.S. ex rel. Loughren v. Unum ancing test of a number of factors. Continued government Group, “under both versions, [Relator] was required to payment is noted as being very strong evidence; how- prove falsity, materiality, and scienter.” Therefore, the ever, the circuits below are misusing this factor. In several requirements were unchanged; however, after 2009 it was instances, the circuits are ignoring the circumstances sur- explicit from the statute that this was the method of in- rounding the payment and therefore failing to account for additional reasons why the government might continue Kyle Johnson Madley is an associate with the firm to pay in the face of a potential false claim. The Supreme Curcio, Mirzaian, Sirot, LLC., in their litigation group. Court should articulate more clearly the weight attrib- Generally, he practices commercial and corporate litiga- uted to government payment, while accounting for a full tion. While working on this article, Madley was an inquiry into the circumstances as to why the government intern at the New Jersey Attorney General’s Office in the has still paid in the face of a potential fraudulent claim. Healthcare/Government Fraud Department.

56 NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 quiry under the FCA.15 The real issue with the FCA prior to lated the growing confusion over the materiality standard 2009 was not that the materiality requirement was absent, in the FCA.27 The Second Circuit joined the Fourth, Fifth, but rather, that without an express definition, the circuits Ninth, and D.C. Circuits in finding that a claim is legally had to guess at its meaning.16 false only where a party certifies compliance with a statutory condition to payment.28 In reference to materiality under Prior to FERA, the two controlling fraud cases passed the FCA, the court stated in dicta that: down by the Supreme Court were United States v. Wells and Neder v. United States. In 1997 the Court in Wells held […] although materiality is a related that, when it came to knowingly making false statements concept, our holding is distinct from a to federally insured banks, after a “natural reading of the requirement imposed by some courts that full text,” materiality was not explicitly written, and thus a false statement or claim must be material not an element of a claim.17 Two years later, the Court in to the government’s funding decision. A Neder held that it was not incorrect when it concluded in materiality requirement holds that only a Wells that materiality was not a written element of many subset of admittedly false claims is subject fraud statutes; however, when the statute included the to False Claims Act liability. We rule simply wording “fraud” as opposed to “false statement,” it was that not all instances of regulatory non- correct to impose a common law materiality requirement compliance will cause a claim to become to that fraud.18 The synthesis of these two cases led to false. We need not and do not address the general finding that statutes using the word “false,” whether the Act contains a separate materi- if lacking an express materiality requirement, presump- ality requirement.29 tively did not have such a standard, while statutes using the word “fraud” were interpreted to include a materiality Although not a holding of the case, this statement requirement, unless the clear language of the statute said echoed nationwide confusion on when, and if, the mate- otherwise.19 Prior to FERA, no iteration of the False Claims riality requirement applied in all FCA claims. A statement Act ever included the word materiality.20 Therefore, using that the Supreme Court took the opportunity to answer in Escobar. the Wells/Neder framework, the “natural reading of the text” did not include materiality as an element. Further, the FCA used neither the words “false statement” nor “fraud,” Universal Health Services, Inc. v. U.S. (Escobar) but instead, “false claim.” This led many courts below to While addressing the viability of the implied certifica- struggle with the Wells/Neder framework when determin- tion theory for an FCA claim, the Supreme Court in January ing whether the FCA included an “inherent common-law of 2016, articulated a decisive standard with regard to the materiality” or instead no “presumption of materiality.” function of the materiality requirement in a false claims This illustrates the importance of Congress’ enacting FERA inquiry, answering a divisive split in the circuits below.30 in 2009, in order to offer clarity on the materiality divide.21 Justice Thomas articulated a set of factors to use for a balancing test when determining the materiality of a false Pre-Escobar claim. Much like the pre-FERA materiality ambiguities caused In Escobar, a young girl’s parents brought a qui tam suit a rift among the circuits in their FCA enforcement, so did under the False Claims Act after their daughter died of a the theory of “implied false certification.” This theory holds seizure following treatment at a Universal Health Services that “when a defendant submits a claim, it impliedly certi- mental health clinic by several unlicensed and unsuper- fies compliance with all conditions of payment. But if that vised doctors and aides in violation of Medicaid regula- claim fails to disclose the defendant’s violation of a mate- tions.31 She received counseling services for approximately rial statutory, regulatory, or contractual requirement, so the five years, and after being diagnosed with bipolar disorder, theory goes, the defendant has made a misrepresentation a “doctor” at the facility prescribed her medication for her that renders the claim false or fraudulent under § 3729(a) disease.32 Rivera’s condition declined until she died of a (1)(A).”22 Specifically, Universal Health Svcs. Inc., v. United seizure caused by an adverse reaction to the medication.33 States ex rel. Escobar rejected the holding from the Seventh It was later revealed that few of the Arbour employees Circuit in Sanford-Brown that expressly rejected the implied were actually licensed to administer mental health counsel- certification theory.23 ing or authorized to prescribe medication.34 The “doctor” Historically, liability under the FCA arose from allega- who diagnosed Yarushka as bipolar represented herself as a tions that claims were factually false, or one of two theories psychologist with a Ph.D. to the Escobars, but did not men- of false certification: express false certification, or implied tion that her degree came from an unaccredited internet college and that Massachusetts had denied her applica- false certification. The implied certification theory is a ju- 35 dicially created theory first addressed in Ab–Tech Construc- tion to be a licensed psychologist. The practitioner who tion, Inc. v. United States, in 1994.24,25 An important decision prescribed medicine to Yarushka was actually a nurse who lacked authority to prescribe medications without doctor by the Second Circuit in Mikes v Straus rejected the implied 36 certification theory.26 More importantly, however, it articu- supervision.

NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 57 The Escobars brought the claim in the District Court of punishing garden-variety breaches of contract or regula- Massachusetts alleging that Universal Health defrauded tory violations.”51 The Court emphasized that the FCA is a the Medicaid program by seeking reimbursement for vehicle only for claims of serious fraud, unlike its common- services rendered by professionals without disclosing that law ancestors.52 Once the Court was clear on the nature of these professionals were unlicensed.37 The District Court the standard, the Court then articulated “factors” that are granted defendants’ motion to dismiss on the basis that relevant when reviewing a claim for materiality.53 there is no liability when the licensing requirements were not a “condition of payment.”38 The Escobars then ap- The Court rejected reliance on an express statement pealed to the First Circuit, which reversed in relevant part that a requirement is a condition of payment by stating, and remanded, holding that every claim impliedly repre- “[a] misrepresentation cannot be deemed material merely sents that the facility had complied with the required regu- because the Government designates compliance with a 39 particular statutory, regulatory, or contractual requirement lations, so an undisclosed violation makes the claim false. 54 The First Circuit held that those regulations were a material as a condition of payment.” A government decision to put condition of payment.40 a provision in a statute or government contract is relevant to the inquiry, but not the end of the inquiry.55 The Supreme Court attempted to clarify the confusion among the Circuits about the test for determining material- Justice Thomas then articulated his materiality stan- ity under the False Claims Act by stating: dard as: False Claims Act liability for failing to [P]roof of materiality can include, but is disclose violations of legal requirements not necessarily limited to, evidence that does not turn on whether those require- the defendant knows that the Government ments were expressly designated as condi- consistently refuses to pay claims in the tions of payment [....] [w]hat matters is mine run of cases based on noncompliance not the label the Government attaches to with the particular statutory, regulatory, a requirement, but whether the defendant or contractual requirement. Conversely, if knowingly violated a requirement that the the Government pays a particular claim defendant knows is material to the Gov- in full despite its actual knowledge that ernment’s payment decision.41 certain requirements were violated, that is very strong evidence that those require- The Court noted, “liability does not depend on whether ments are not material. Or, if the Govern- the regulatory or contractual requirements were expressly ment regularly pays a particular type of designated as a condition for payment.”42 The deciding claim in full despite actual knowledge that factor is whether the misrepresentation was material to the certain requirements were violated, and payment decision.43 In evaluating materiality for purposes has signaled no change in position, that is of the FCA, express identification of a condition of payment strong evidence that the requirements are is not “automatically dispositive” although it is relevant.44 not material.56 It is, “whether the defendant knowingly violated a requirement known to be material to the payment decision.”45 Although the Court did designate certain factors as The Court described the materiality standard as “rigor- “strong evidence” or “very strong evidence,” the ultimate holding was that these were simply factors, none of which ous” and “demanding” noting that it is insufficient that the 57 government merely would have had the option to decline was strong enough to be dispositive by itself. Justice payment with knowledge of noncompliance.46 Ultimately, Thomas never claimed that this list was exhaustive, high- Escobar “what matters is not the label the government attaches to a lighting the point that the materiality standard is requirement, but whether the defendant knowingly vio- a nuanced one that requires the courts below to engage lated a requirement that the defendant knew [was] material in an evaluation of the full breadth of the circumstances to the payment decision.”47 to determine if the alleged false claim was material to the government’s decision. The Court held that the materiality Justice Thomas quoted the Neder Court in explicating standard under the FCA still looked to the natural tendency the concept of materiality, “[T]he term ‘material’ means and likely or actual effect a false claim would have on the having a natural tendency to influence, or be capable of in- government’s decision to pay the claim, which is a highly fluencing, the payment or receipt of money or property.”48 fact-sensitive determination.58 Moreover, the Court held, “under any understanding of the concept, materiality ‘look[s] to the effect on the In addition to concluding what materiality was, Justice likely or actual behavior of the recipient of the alleged Thomas was also clear that materiality should not rest misrepresentation.”’49 However, the Court was clear that solely on the fact that the government deems something a the FCA materiality standard was not as easy to satisfy as condition of payment, or that the government would have option its common law equivalent.50 Holding specifically, “[t]he the to decline payment should it find out about a vio- materiality standard is demanding. The False Claims Act lated condition. Contrary to what the First Circuit held, the relevant is not an all-purpose antifraud statute, or a vehicle for Supreme Court said although these factors are to

58 NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 the materiality inquiry, those factors are not the end of the condition precedent. Therefore, if there is an initial fraudu- inquiry.59 The Supreme Court’s primary objective in articu- lent inducement against the FDA to get the drug or device lating the new materiality standard was to directly over- approved, then there are practical obstacles that restrict the turn the First Circuit and moderate what is an “extraordi- ability of the government to stop payment. narily expansive view of materiality.”60 The Court sought One of leading the cases regarding misrepresentations to disallow situations where noncompliance is minor or in the context of FDA approval is D’Agostino v. ev3, Inc.64 insubstantial, otherwise noncompliance would always be material, and a violation of a condition of payment would The relator alleged that ev3 made three different fraudu- always trigger FCA liability.61 lent representations to the FDA in order to secure FDA approval of ev3’s Onyx device.65 The defendants allegedly Despite the Supreme Court’s clear admonition to disclaimed certain uses for the device, overstated training the contrary, the circuits below have misused the factors it provided for the device, and omitted safety informa- elicited by Justice Thomas by over-emphasizing continued tion that was vital to the function of the device.66 The First government payment without considering the breadth of Circuit struggled with the fact that CMS reimbursed the the circumstances. Campie presents the perfect opportunity surgeons that used the device and not the FDA themselves; for the Supreme Court to clarify that, although continued therefore, the court was searching for a causal link between government payment is a factor, the courts below cannot the claims to the FDA and the CMS payments.67 The court ignore the circumstances surrounding that continued pay- was unreceptive to the argument that FDA approval was a ment. This test was intended to be a nuanced balancing pre-condition for CMS payment stating that, test, using the whole picture of the facts; therefore, it is improper to rely on one factor without reference to the others. alleging that fraudulent representations could have influenced the FDA to approve Onyx falls short of pleading a causal link Post-Escobar Split between the representations made to the The circuit courts are divided in their analysis of FDA and the payments made by CMS. If materiality on what sort of weight should be applied to the representations did not actually cause continued government payment when it knows that the the FDA to grant approval it otherwise claimant violated some law or regulation, about which the would not have granted, CMS would still vendor may or may not have made a representation in con- have paid the claims.68 nection with the claim for payment, and which may or may not be relevant to the services or product provided to the In response, plaintiff argued that, “as long as [defen- government.62 The majority of the circuits hold that when dant’s] representations at issue could have influenced the the government continues to pay, despite the fact that it has FDA to grant approval, then that would be material.”69 knowledge a vendor violated some law while certifying Once again, the court dismissed the argument stating compliance with all laws, in regard to its claim for payment, that the fraudulent representation must be material to the that usually ends the inquiry. However, recently, circuits government’s payment decision itself.70 The court bol- have begun to hold in the alternative, finding that not every stered this conclusion by observing that CMS continued to instance of continued government payment is decisive evi- pay for the device, even after learning of relator’s claims, dence of materiality, which supports the correct balancing thereby undermining the suggestion that the misrepresen- standard articulated by Justice Thomas that accounts for the tations were material to CMS’ reimbursement decision.71 entire circumstance of the alleged false claim.63 Explaining its holding, the court stated, “[t]o rule otherwise would be to turn the FCA into a tool with which a jury of This issue is very common in the context of fraudulent six people could retroactively eliminate the FDA approval inducement, where the provider either misleads or omits and effectively require that a product largely be withdrawn relevant information in order to secure government pay- from the market even when the FDA sees no reason to do ment. Omissions are relevant when the vendor certifies so.”72 In the wake of D’Agostino, many courts have used or implies compliance with standards, despite the fact the this quote to dismiss claims pleading materiality in the face vendor is no longer in compliance with said standards. of continued government payment. Therefore, although the vendor is not affirmatively making misrepresentations, the failure to include that the vendor One such case is United States ex rel. Harman v. Trinity is no longer in compliance with requirements could lead Industries, Inc., from the Fifth Circuit.73 Plaintiff brought an to false claim liability. In sum, if a misrepresentation or an action against a rival manufacturer of highway guardrails omission has the natural tendency to influence the govern- claiming that the defendant misrepresented conformance ment’s decision to pay then that that false claim is material. with federal regulations.74 The federal government subsi- dizes the cost of highway construction and improvements Frequently these cases involve products approved by through grants given to the states.75 During the periods the Food and Drug Administration (FDA). The FDA does relevant to the facts of the Harman case, acceptance by the not make payments; however, the agency approves drugs Federal Highway Administration (FHWA) of the products or devices, for which the government will then reimburse used in the state highway improvements was a prerequisite through various programs for which FDA approval is a to eligibility for reimbursement.76 The plaintiff claimed that

NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 59 the defendant failed to disclose revisions in the guardrail and sale in the United States, a manufacturer must submit design in a report to the FHWA.77 Plaintiff alleged that this a “new drug application” to the FDA, in which it states the design revision was a defect that led to several highway chemical composition of a drug and specifies the facilities deaths.78 After significant back-and-forth between defendant where it will be made, as well as “methods and controls” and the FHWA, including extensive testing, it was found used in the manufacturing process.94 Acceptable facilities that, despite the failure to disclose the change, the guardrail must meet federal standards, known as “good manufac- complied with regulations and thus the government contin- turing practices.”95 The FDA may refuse an application or ued making guardrail cost reimbursements to states.79 withdraw a previously approved application if the methods or facilities “are inadequate to preserve [the drug’s] identity, Even though the court had relatively stark facts to strength, quality, and purity.”96 For consideration under the show the defect was not material, the court remained 80 Act, the facility must be “acceptable”, meaning it must meet true to the nuanced materiality balancing test. The court certain federal standards, known as “good manufacturing stated, “the FCA requires proof only that the defendant’s practices.”97 Finally, once approved, the drug maker must false statements ‘could have’ influenced the Government’s seek FDA approval to make any “major changes” to the pro- pay decision or had the ‘potential’ to influence the Govern- cess for the making of the drug before distributing it.98 All ment’s decision, not that the false statements actually did 81 of these requirements entail certification in order to receive so [...].” The court turned to its sister circuits, identifying and maintain FDA approval.99 the decisions from the First, Seventh, Ninth, D.C, and Third circuits82 all holding that continued government payment In the mid-2000s Gilead submitted new drug applica- is enough to dismiss the FCA allegation.83 Eventually opin- tions and received FDA approval for three HIV drugs.100 In ing that “[t]he lesson we draw from these well-considered these drug applications, Gilead certified that the active in- opinions is that, though not dispositive, continued payment gredient in the drugs came from “specific registered facto- by the federal government after it learns of the alleged ries” located in Canada, Germany, United States, and South fraud substantially increases the burden on the relator in Korea.101 Relators alleged that as early as 2006, Gilead establishing materiality.”84 Of note, however, is the fact that contracted with Synthetics China to make unapproved FTC the Harman court, unlike many of its sister courts, recog- at unregistered facilities, and masked this fact by bringing nized the “gravity” and “clarity” of governmental deci- the FTC into the United States through its Canadian and sions, in certain payment decisions.85 In reference to their South Korean factories.102 Gilead ultimately successfully own facts though, the court was bound by the fact that this sought approval from the FDA to use Synthetics China’s particular decision “risked the lives on our nation’s high- FTC in October 2008, but according to relators, Gilead had ways, not just undue expense.”86 been including products from Synthetics China in its fin- ished drug products for at least two years before obtaining Even in the face of such an important government deci- approval in 2010.103 More importantly, relators also alleged Harman sion, risking life and limb, the court still iterated that Gilead falsified or concealed data in support of its ap- that, “there are and must be boundaries to government 104 87 plication to get Synthetics China approved by the FDA. tolerance of a supplier’s failure to abide by its rules.” Relators contend that one specific representation regarding The defendant still argued that when the government drug testing was false, as two of three batches had failed learns of alleged false claims, investigates said claims, and internal testing.105 Further, Gilead never acknowledged or still formally approves the product, there is no material- 88 notified the FDA about the bad test results or the contami- ity argument. Plaintiff countered with the argument that nation issues.106 Ultimately, the three claims asserted by “post-revelation actions” by the government are not de- relators were that (1) Gilead actively concealed its use of terminative in an FCA action, and that the materiality test 89 illicit FTC products by bringing it in through its registered is “holistic” and no single element is dispositive. Hand- Canada factory and changing the labels; (2) augmenting cuffed by the deliberate inaction of the government, in light paperwork in order to conceal the source of the FTC; and of years of FHWA approval, the court had to decide on be- 90 (3) crediting its approved factories with the product from half of defendant, finding a lack of materiality. However, Synthetics China.107 the court was receptive to the fact that under different facts, wherein the FHWA acted unaware of the facts of the fraud, In this instance, the Ninth Circuit determined that FDA the decision to continue payment could be undermined.91 approval was the “sine qua non” of federal funding; if the FDA approved the drug then Medicaid would reimburse Harman The case that gave the Fifth Circuit pause in it.108 Further, contrary to D’Agostino, the Campie court was United States ex rel. Campie v. Gilead Scis., Inc., from the 92 emphasized that the FDA and CMS were part of a single Ninth Circuit. Relators, two former Gilead employees, agency, Health and Human Services (HHS).109 The court qui tam filed a suit against their former employer alleging noted the fact that the government was still paying for it violated the False Claims Act by making false statements the drugs created an uphill battle for proving materiality, about its compliance with Food and Drug Administration however, the court was receptive to practical arguments.110 regulations regarding the manufacture of certain HIV drugs, Specifically, the court stated when fraudulent FDA approv- resulting in the receipt of billions of dollars from the gov- al deceives HHS: ernment.93 In order to get a drug approved for manufacture

60 NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 [T]o read too much into the FDA’s con- For example, in United States ex rel. Kelly v. Serco, Inc., tinued approval—and its effect on the the Ninth Circuit grappled with materiality again.117 How- government’s payment decision—would ever, in that case the court relied heavily on Justice Thom- be a mistake. First, to do so would allow as’s “option to not pay” wording about possible violations, Gilead to use the allegedly fraudulently- while at the same time dismissing the fact that the govern- obtained FDA approval as a shield against ment relied on defendant’s reports to make its payment liability for fraud. Second, as argued by decisions.118 Therefore, if the reports omitted certain details Gilead itself, there are many reasons the or misrepresented facts, the government would be rely on FDA may choose not to withdraw a drug those reports and make payments above and beyond what approval, unrelated to the concern that the was actually required.119 This is not the type of fact that government paid out billions of dollars Justice Thomas envisioned discarding so easily when he for nonconforming and adulterated drugs. established his materiality requirement. The Ninth Circuit Third, unlike Kelly, where the government essentially considered the government’s reliance on said continued to accept noncompliant vouch- reports as irrelevant, in direct contrast with how Thomas ers, Gilead ultimately stopped using FTC from instructed courts to view payment options.120 Perhaps the Synthetics China. Once the unapproved and court still might have decided in the same manner, but still contaminated drugs were no longer being used, the government’s reliance on the reports is relevant, as per the government’s decision to keep paying for Justice Thomas’s instructions. compliant drugs does not have the same sig- Miller nificance as if the government continued to pay The Supreme Court could cite as a way of show- despite continued noncompliance.111 ing how government reliance on contractual provisions functions in a manner that respects the relevancy of all of The court stated that these very issues are “matters of Justice Thomas’s factors. In Miller, while it was true that the proof,” and therefore it would be inappropriate to dismiss government did continue to pay defendant’s claims, it was the claim using 12(b)(6), addressing a stated concern in relevant that the government relied heavily on the academic D’Agostino regarding the nature of “proofs” needed to reports the school was required to submit as a pre-condition clarify an FDA approval decision.112 This case is currently of payment.121 Keenly aware of the importance of these re- pending a Writ of Certiorari, asking the Supreme Court to ports, the court was vigilant to include them in the analysis, address what significance continued government payment keeping in mind that Justice Thomas said these types of pre- should have.113,114 conditions, while not dispositive, were still relevant.122 The Court in Miller exercised the proper type of balancing Justice Argument for Supreme Court Acceptance of the Thomas envisioned.123 If the court were to have over-empha- Writ for Campie sized continued government payment, the court would have missed a key factor of materiality in this case, highlighting Campie presents the exact circumstances where, al- the importance of Justice Thomas’s holistic test. though the government did continue to pay in light of potential false claims, there are other reasons for the decision, D’Agostino presents another case in which a lower sufficient to survive a 12(b)(6) motion. Unlike many of its court misused the Escobar materiality test. This is prob- sister circuits, the Ninth Circuit correctly viewed continued lematic because D’Agostino is one of the most highly cited government payment as but a factor of a larger balancing cases when it comes to interpreting the Escobar standard. test. The majority of circuits have been less receptive to the The First Circuit failed to recognize that the FDA and CMS other factors and have put an over-emphasis on continued are actually one agency of the government.124 Therefore, government payment. There is an ambiguity below as to a fraud on the FDA is not independent from the govern- when, and if, continued government payment is rebuttable. ment’s decision as the FDA and CMS function as one, HHS, The majority of circuits seem to say that this rebuttal is near in making payment decisions. From the outset, the First impossible, however practically this is not true, as articu- Circuit’s interpretation is flawed. However, what is more lated by Campie, Miller, and Harman. egregious is the fact that the court was highly dismissive of the fact that by defrauding the FDA into granting ap- When describing the factors in Escobar Justice Thomas proval, the defendant effectively guaranteed payment by stated, “Continued payment or acceptance by the Gov- the government.125 If the FDA approves the drug then CMS ernment of the fraudulent claim is very strong evidence will pay for it. It is not within CMS’s purview to investi- against materiality.”115 Many of the circuits below that gate drugs if the FDA has approved them. Therefore, until dismiss almost all claims where the Government continues the FDA pulls approval the government will continue to to pay are misusing this quote.116 Many of these Circuits, pay. This set of facts highlights the importance of Justice like the Third Circuit in Petratos, have had facts that make Thomas’s factors, as a whole, deciding materiality, not just the continued payment a relatively clear statement of im- continued government payment alone. One factor cannot materiality. However, there are circumstances where courts tell the whole story of materiality; therefore, it is vital that should be more receptive to practical and public policy the Supreme Court accept the writ in Campie, and reinforce limitations for the government to stop payment. the premise that no one factor is dispositive, or else the

NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 61 courts below will continue to over-emphasize continued allows companies to commit a fraud until caught, then sim- government payment. ply come into compliance, and use the continued payment after their re-conformance as a sword against materiality. In Campie, the Court acknowledged the fact that the Gilead was content to continue its fraudulent activity, until FDA may have many different reasons for pulling, or not the FDA finally realized that something with the drugs pulling a drug’s approval, and until that time comes, the manufacturing process was amiss. While it is true that Gil- government will have a hard time denying payment for a ead ultimately came into conformance with regulations, the drug that is FDA approved.126 The drugs made by Gilead fraud promulgated upon the FDA initially should not be were vital drugs for the treatment of HIV.127 There is a ignored simply because Gilead changed their misdoings. significant community of individuals afflicted with HIV, on Medicaid or Medicare, reliant on these drugs. Gilead The Supreme Court can also use the holding from the provided the only three makes of this particular HIV First Circuit in Escobar, to reinforce how their balancing test drug, so with its drug off the CMS list, the patients had no works when it comes to misrepresentations in general, out- alternatives. If the FDA approves a drug, and it is medically side of the FDA context.130 While it is true that the govern- necessary with no adequate alternative, then CMS will au- ment continued to reimburse Universal Health Services, the tomatically pay for that drug, until the FDA either pulls the government only did so because of the misrepresentations approval or approves a new, cheaper alternative. As stated made by the workers at the facility.131 Had it not been for in Campie, the FDA approval is the sine qua non of receipt of those misrepresentations the government would not have state funding.128 Therefore, if while the FDA investigated paid.132 Further, the government relied on the billing report these potential fraudulent misrepresentations, the govern- as being accurate and in compliance with the standards ment pulled reimbursement of these drugs, then a large proscribed by the program and thus continued to pay the population of very sick individuals might be without vital claims.133 The First Circuit faithfully used the factors as just medication until the potential false claim is resolved. that, factors, all weighed in reference to the whole of the circumstance, not simply just looking at continued govern- If the Supreme Court were to allow the lower courts to ment payment. misuse Justice Thomas’s test and over-emphasize government payment then it would force agencies, like CMS, The above argument shows why this is a standard, to change their reimbursement procedures. In order to in some circumstances, best left for decision at a later maintain an FCA claim, CMS would need to start pulling stage than at a 12(b)(6) motion to dismiss. To answer this funding when the FDA gains knowledge of a potential question, it is vital to prove what “actual knowledge” the false claim. Otherwise, if the government continues to pay, government had.134 This position receives support from as it currently does, while the FDA is investigating, de- the premise that many times the communication between fendant’s will always have a claim that the government’s the government and its agencies responsible for regulation continued payment while it had knowledge of a potential in various industries is not always efficient. It might take violation shows the violation was not material. This would some time for the government to become aware of an FDA, be a problematic procedure for any government agency to or another agency’s investigation, and then even more time abide by, especially CMS where it involves the health of for them to decide, and actually have the ability to pull our nation. In the event that the FDA finds the fraud to be funding. There are several steps of proofs in order to say negligible, all that irreparable harm upon those patients definitively the government had “actual knowledge” neces- was for naught. Perhaps Justice Thomas contemplated this sary to decide if a violation is material or not. scenario when creating his balancing test, but in any event, the Justice’s balancing test is still that; a balancing test. The The Court can use a combination of Campie, Harman, courts below, in decisions like D’Agostino and Kelly, are act- and Miller to provide clarity for the courts below when ing in direct contravention of the Supreme Court’s directive it interprets cases involving continued government pay- and are thus, promulgating poor case law. ment. The Supreme Court can use Campie to explain how the circumstances behind continued government payment Second, in Campie, Gilead was able to use the FDA ap- might say more as to why the government continued to proval as a shield against the materiality argument, in that pay. Campie, D’Agostino, and Petratos all showed that if the FDA approval was the starting point for government there were a misrepresentation made to the FDA to secure payment. The strict materiality standard, in that instance, approval fraudulently then CMS would pay for that drug allowed Gilead to promulgate a fraud on the FDA to secure automatically. The Supreme Court will need to address the approval, and then in turn receive funding from HHS issue in Circuits’ interpretations that allows defendants based on that initial fraud on the FDA, while avoiding a to plead a lack of materiality because CMS continued to materiality argument.129 This is inapposite to the purpose pay while the FDA was investigating whether it should of the materiality standard of the FCA as iterated in Esco- pull a drug’s approval. Practically, it would be very prob- bar. Especially in light of the fact that, once the FDA began lematic for CMS to pull funding at the beginning of every investigating Gilead, it ceased using Synthetics China, and investigation by the FDA. The Supreme Court could relate thus came into conformance with the FDA’s initial approv- a spectrum of facts ranging from Petratos to Campie, the al. To allow Gilead to escape in this instance, essentially former leading to a finding of no materiality and the latter

62 NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 a finding of materiality. In Petratos, the FDA investigated Federal Rules of Civil Procedure, 4 GEO. MASON L. Rev., 327, 340 the drug and found the misrepresentation to be negligible, (1996). so obviously the false claim was not material to the gov- 11. Escobar, 136 S.Ct at 1998. 12. Pub. L. No. 111-21, 123 Stat. 1617 (2009) (codified as amended in ernment’s decision. The Supreme Court could use those scattered sections of 18 and 31 U.S.C.). facts as one end of the spectrum. Contrast those facts with 13. United States ex rel. Spay v. CVS Caremark Corp., 875 F.3d 746, 761 (3d Campie, where Gilead directly violated the FDA agree- Cir. 2017) (emphasis added). ments, changed ingredients and failed to disclose failed 14. Id. drug tests. It is clear there that if the FDA had known of 15. Loughren, 613 F.3d at 316 n.7. such serious violations; the agency would have pulled the 16. Spay, 875 F.3d at 762. approval, therefore pulling the government payment as 17. United States v. Wells, 519 U.S. 482, 483 (1997)(citation omitted). well. With that spectrum of facts established it would give 18. Neder v. United States, 527 U.S. 1, 22-23(1999). the lower courts a clear articulation on how to view mis- 19. See Wells, 519 U.S. at 483; see also, Neder, 527 at 23-25. 20. See Act of Mar. 2, 1863, ch. 67, 12 Stat. 696 (1863); U.S. Rev. Stat. tit. representations made to secure payments and clear up the 36 §§ 3490-3494 (1865); Id. §§ 3490-3494 (1875); 31 U.S.C. §§ 231-235 over-emphasis on continued payment. (1926); Id. §§ 231-235 (1935); Id. §§ 231-235 (1943); Id. §§ 3729-3731 (1982); Id. §§ 3729-3733(1986); Id. §§ 3729-3733 (1988). Moreover, the Court could use Miller to emphasize how 21. See Wells, 519 U.S. at 483; see also, Neder, 527 at 23-25. in certain instances bargained for contractual provisions 22. Escobar, 136 S.Ct. at 1994. could be highly relevant to materiality despite the fact that 23. Id. at 1989, see also United States v. Sanford-Brown, 788 F.3d 696, 711-12 the government continued to pay. In Miller, it was clear (7th Cir. 2015). how important the bargained-for requirements for academ- 24. Ab–Tech Construction, Inc. v. United States, 31 Fed.Cl. 429 (Fed. Cl. ic reporting’s were. The government made it exceedingly 1994), aff’d, 57 F.3d 1084 (Fed. Cir.1995) (unpublished table decision); See 31 U.S.C.A. § 3729. clear that it would rely on those reports in making its pay- 25. In Ab-Tech, The Court of Federal Claims held that the defendants’ ment decisions. While it is true that Justice Thomas stated submission of payment vouchers, although containing no express these pre-conditions are merely “relevant and not disposi- representation as to what, implicitly certified their adherence to the tive” in some instances, the Court should remain true to requirements of a federal small business program. The defendants’ failure to adhere to rules did not directly preclude payment, but the “natural tendency” test also articulated by Thomas. If submitting a claim while knowingly not being in compliance with parties take such painstaking efforts to create contractual said rules nonetheless constituted a false statement in connection to provisions, like in common law, those provisions should a claim for payment, resulting in False Claims Act liability. hold some weight. Further, when it is clear the govern- 26. Mikes v. Straus, 274 F.3d 687 (2d Cir. 2001). ment is relying on them, so if the defendant has falsified 27. Id. those provisions then the government would obviously 28. Id. at 697 (citing United States ex rel. Siewick v. Jamieson Sci. & Eng’g, Inc., 214 F.3d 1372, 1376 (D.C. Cir. 2000); United States ex rel. pay. Therefore, the Court can use Miller to illustrate how Thompson v. Columbia/HCA Healthcare Corp., 125 F.3d 899, 902 in some cases, the contractual provisions can hold weight (5th Cir. 1997); United States ex rel. Hopper v. Anton, 91 F.3d 1261, beyond continued government payment. 1266–67 (9th Cir. 1996); Harrison v. Westinghouse Savannah River Co., 176 F.3d 776, 786 (4th Cir. 1999)). When there are ambiguities among the circuits, it is 29. Id. at 697 (citing Harrison, 176 F.3d at 785; United States ex rel. vital for the Supreme Court to answer that ambiguity, and Cantekin v. Univ. of Pittsburgh, 192 F.3d 402, 415 (3d Cir. 1999), cert. provide clarity. Campie provides the platform for the Court denied, 531 U.S. 880 (2000))(internal citations omitted). to address the discrepancy head on. The Supreme Court 30. Escobar, 136 S.Ct. 1996. 31. Id. at 1989. here can remain true to its standard created by Justice 32. Id. Thomas, and use circuit cases to show the courts how to 33. Id. faithfully apply that balancing standard. 34. Escobar, 136 S.Ct. at 1989. 35. Id. at 1997. 36. Escobar, 136 S.Ct. at 1997. 37. United States ex rel. Escobar v. Universal Health Serv., 2014 WL 1271757 Endnotes (D. Mass. Mar. 26, 2014). 1. Universal Health Svcs., Inc. v. United States ex rel. Escobar, 136 S.Ct. 38. Id. 1989, 1996, _ U.S. _ (2016). 39. United States ex rel. Escobar v. Universal Health Serv., 780 F.3d 504, 517 2. Id. (1st Cir. 2015). 3. Id. at 2003-04. 40. Id. 4. Gilead Sciences, Inc. v. United States, ex rel. Jeffrey Campie, et al., 41. Id. at 1996. Petition for Writ of Certiorari 17-936 (January 3, 2018). 42. Escobar, 136 S.Ct. at 1994. 5. 31 U.S.C.A. § 3729. 43. Id. 6. Id. at (iii)(1). 44. Id. 7. Id. at (iii)(2). 45. Id. 8. Id. at (iii)(4). 46. Id. at 2003. 9. Escobar, 136 S.Ct at 1998. 47. Escobar, 136 S.Ct at 1994. 10. Todd B. Castleton, Compounding Fraud: The Costs of Acquiring Relator 48. Id. at 2002. Information Under the False Claims Act and the 1993 Amendments to 49. Id. (citing 26 R. Lord, Williston on Contracts § 69:12, p. 549 (4th ed. 2003) (Williston)).

NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 63 50. Id. at 2003. 91. Id. 51. Escobar, 136 S.Ct. at 2003)(citing Allison Engine Co., Inc., v. U.S. ex rel. 92. Id. at 664, 668. Sanders, 553 U.S. 662, 672 (2008))(internal quotation omitted). 93. Campie, 862 F.3d at 895. 52. Id. 94. Id. (citing 21 U.S.C. § 355(a), (b)(1); 21 C.F.R. § 314.50(d)(1)). 53. Escobar, 136 S.Ct. at 2003. 95. Id. 54. Id. 96. Id. 55. Id. 97. Id. 56. Id. at 2003-4. 98. Campie, 862 F.3d at 895. 57. See id. 99. Id. 58. Escobar, 136 S.Ct. at 2003 100. Id. 59. Id. 101. Id. at 896. 60. Id. 102. Id. 61. Id. 103. Campie, 862 F.3d at 896. 62. See, e.g., 41 U.S.C. § 7103(c)(1) (This section does not authorize 104. Campie, 862 F.3d at 896. an agency head to settle, compromise, pay, or otherwise adjust 105. Id. at 896. any claim involving fraud.); 48 C.F.R. § 33.210(b) (The authority 106. Id. to decide or resolve claims does not extend to… The settlement, compromise, payment or adjustment of any claim involving fraud.); 107. Id. at 897. Medicare Program Integrity Manual § 3.7.3.3 (2017), http://go.cms. 108. Id. at 905 (citing U.S. ex rel. Hendow v. Univ. of Phoenix, 461 F.3d 1166, gov/2iUyMKx (If it is believed that the overpayment resulted from 1176 (9th Cir. 2006). potential fraud, a refund may not be requested from the provider 109. Campie, 862 F.3d at 905 until the potential fraud issue is resolved.). 110. Id. at 906. 63. United States ex rel. Harman v. Trinity Indus. Inc., 872 F.3d 645 (5th Cir. 111. Id. at 906 (internal citation omitted). 2017); United States ex rel. Campie v. Gilead Scis., Inc., 862 F.3d 890 (9th 112. Campie, 862 F.3d at 906. Cir. 2017). 113. Gilead Sciences, Inc. v. United States, ex rel. Jeffrey Campie, et al., 64. D’Agostino v. ev3, Inc., 845 F.3d 1, 7 (1st Cir. 2016). Petition for Writ of Certiorari 17-936 (January 3, 2018). 65. Id. at 7. 114. The final main case in the series of post-Escobar materiality cases 66. Id. is United States ex rel. Miller v. Weston Educ., Inc., 840 F.3d 494 (8th 67. Id. Cir. 2016). Like Sanford-Brown, cited above, Miller involved false 68. Id. certification of school records in violation of the Higher Education 69. D’Agostino, 845 F.3d at 7. Act. In Miller, the court placed significant weight on a pre-condition of payment because this specific condition certified in three separate 70. Id. ways, therefore overcoming the fact that the Government continued 71. Id. to pay the school. If the Government were to rely on these falsely 72. Id. certified records then there would be no reason for them not to pay 73. United States ex rel. Harman v. Trinity Indus. Inc., 872 F.3d 645, 661 n. claims by the school. The court found it important that this condition 61 (5th Cir. 2017). was so heavily bargained for, stressing the importance of the school’s 74. Id. at 648. honest record keeping, with regard to the Government’s payments. 75. Id. 115. Escobar, 136 S.Ct. at 1995. 76. Id. 116. D’Agostino, 845 F.3d 1 (1st Cir. 2017); Sanford-Brown, 840 F.3d 445 (7th 77. Id. Cir. 2016); United States ex rel. Kelly v. Serco, Inc., 846 F.3d 325 (9th Cir. 2017); United States ex rel. McBride v. Halliburton Co., 848 F.3d 1027 78. Harman, 872 F.3d at 648. (D.C. Cir. 2017); United States ex rel. Petratos v. Genentech Inc., 855 79. Id. at 648-49. F.3d 481, 490 (3d Cir. 2017). 80. Id. 117. Kelly, 846 F.3d at 334. 81. Id. at 661. 118. Id. 82. United States ex rel. Petratos v. Genentech Inc., 855 F.3d 481, 490 (3d 119. Id. Cir. 2017) is one of the main cases interpreting the post-Escobar 120. Id. materiality standards. In Petratos, the court relied heavily on the fact that plaintiff failed to show any set of facts to establish, 121. Miller, 840 F.3d at 504. and effectively conceded that, the drug makers deficiency was 122. Id. not material because the Government had full knowledge of the 123. Id. violation, yet still paid in full and the FDA certified 3 subsequent 124. D’Agostino, 845 F.3d at 7 drugs from Defendant Genetech. Therefore, if the Government had 125. Id. full knowledge of the violation, the court refused to substitute its 126. Campie, 862 F.3d at 905. decision for that of the Government and could not find materiality. 127. Id. at 896. 83. Harman, 872 F.3d at 661 (citing D’Agostino, 845 F.3d 1 (1st Cir. 2017); Sanford-Brown, 840 F.3d 445 (7th Cir. 2016); United States ex rel. Kelly 128. Id. at 905. v. Serco, Inc., 846 F.3d 325 (9th Cir. 2017); United States ex rel. McBride 129. Id. at 899. v. Halliburton Co., 848 F.3d 1027 (D.C. Cir. 2017); United States ex rel. 130. United States ex rel. Escobar v. Universal Health Servs., Inc., 842 F.3d Petratos v. Genentech Inc., 855 F.3d 481, 490 (3d Cir. 2017). 103, 109 (1st Cir. 2016). 84. Id. at 663. 131. Id. at 110. 85. Harman, 872 F.3d at 663. 132. Id. 86. Id. 133. Id. 87. Harman, 872 F.3d at 664. 134. Campie, 862 F.3d at 905-6. 88. Id. 89. Id. 90. Id. at 665.

64 NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 Mandating the COVID-19 Vaccination: A Legal Analysis By Morgan Dowd, JD

Introduction Mandatory vaccination for children was also recognized by the Supreme Court.11 In Prince v. Massachusetts, The devastation surrounding the Novel Coronavi- the Court declared that “[plaintiff] cannot claim freedom rus (COVID-19) outbreak has been felt worldwide. New from compulsory vaccination for the child more than for York started self-isolation on March 12, 2020 in order to himself on religious grounds. The right to practice religion slow the spread.1 Many other states followed, especially freely does not include liberty to expose the community or after President Trump announced the 15 Days to Slow the child to communicable disease or the latter to ill health the Spread guidelines.2 As this virus confronts the human or death.”12 race worldwide, the next question becomes: will a CO- VID-19 vaccination become available and how will it be A later Supreme Court case, Cruzan by Cruzan v. Direc- distributed? Although uncertain if and when a vaccina- tor Missouri Dept. of Health, determined that a competent tion will become available, the Centers for Disease Con- person has a liberty interest in Due Process in refusing trol and Prevention (CDC) has already issued a National unwanted medical treatment, relying in part on Jacobson.13 Pandemic Strategy to address distribution, specifically by Chief Justice Rehnquist said: breaking up the American people into tiers due to need.3 In addition, Congress has introduced a vaccination devel- But determining that a person has a opment bill.4 “liberty interest” under the Due Process Clause does not end the inquiry, whether If the vaccine becomes available, a majority of Ameri- respondent’s constitutional rights have cans may want the vaccination5 but some may push back been violated must be determined by for religious, philosophical or personal reasons. This balancing his liberty interests against the article will outline why every American could be required relevant state interests.14 to receive a COVID-19 vaccination, regardless of their claimed exemptions. The court found the State of Missouri had sufficient interests in maintaining human life of incompetent per- Current Legal Standard for Vaccinations sons, finding the procedural requirements established the “relevant state interests” necessary to deny plaintiff’s A. Federal Case Law claim.15 The landmark Supreme Court case regarding vaccinations is Jacobson v. Massachusetts.6 Under Jacobson, B. Federal Administrative Law the State of Massachusetts required and enforced the The federal government created an administrative vaccination of inhabitants for smallpox.7 The Supreme body that assists in vaccination production, distribution Court stated: “The authority of the state to enact this and education. The Department of Health and Human statute is to be referred to what is commonly called the Services developed the National Vaccine Program, which police power.”8 Jacobson argued that the mandatory annually issues a National Vaccine Plan.16 The National vaccination for smallpox infringed on his “inherent right Vaccine Program of every freeman to care for his own body and health in such a way as to him seems best; and that the execution [Studies] the availability of adequate of such a law against one who objects to vaccination, supply of safe and effective vaccination no matter for what reason, is nothing short of an as- products in the states and territories, sault upon his person.”9 However, the Court snaps back, recommends research priorities and declaring: other measures the Director of the Na- tional Vaccine Program should take to But the liberty secured by the Constitu- enhance the safety and efficacy of vac- tion of the United States to every person cines, advises the Director of the Program within its jurisdiction does not import an absolute right in each person to be, at all times and in all circumstances, wholly freed from restraint….This court has more than once recognized it as a fundamental principle that ‘persons and Morgan Dowd, J.D., Elisabeth Haub School of Law property are subjected to all kinds of at Pace University, 2020; B.S., Business Administration, restraints and burdens in order to secure University of Colorado-Boulder, 2017. The author would the general comfort, health, and prosper- like to thank Professor Karen Gallinari for her support ity of the state.’10 with the editing of this article.

NYSBA Health Law Journal | 2020 | Vol. 26 | No. 1 65 in implementation of sections 2102 and tory vaccination requirement violated their substantive 2103 of the Public Health Service Act, and due process rights.33 The plaintiff’s argument was that the identifies the most important areas of gov- growing scientific evidence suggests that vaccines cause ernment and non-government cooperation more harm than good to society; however, the Court did that should be considered in implementing not find this argument convincing.34 The court cited Jacob- sections 2102 and 2103 of the Public Health son and stated, “Plaintiff’s substantive due process chal- Service Act.17 lenge to the mandatory vaccination regime is therefore no more compelling than Jacobson’s was more than a century Its National Vaccine Program has already addressed ago.”35 The Plaintiff in Phillips also challenges under the the development of a COVID-19 vaccine in its February 18 Free Exercise of Religion clause but the court clearly states 2020 meeting. In addition, the Center for Disease Control in response, “New York could constitutionally require (CDC), through its Public Health Law Program, compiles that all children be vaccinated in order to attend public lists of “State Healthcare Worker and Patient Vaccination school.”36 Laws” as well as “State School and Childcare Vaccination Laws.”19 In Caviezel v. Great Neck Public Schools, the plaintiff challenged the mandatory vaccination law in New York, argu- Further, Representative Rick Larsen introduced bill ing she and her child had a valid religious exemption.37 The H.R.5729, called the “Protecting Americans from Seasonal 20 District Court dismissed the plaintiff’s First Amendment Influenza Act of 2020.” This bill provides grants to a state claim since neither Supreme Court precedent nor Second health agency if their influenza rate is below the recom- 21 Circuit jurisprudence suggested that a valid First Amend- mended CDC rate. As a condition of this grant, the state ment claim could survive against a mandatory vaccination health agency must include a preventive care element to law.38 their program, including outreach to vulnerable populations, employer-based programs, reducing out-of-pocket Plaintiffs have also challenged compulsory vaccination costs, or public awareness campaigns.22 Senator Markey under administrative law grounds. New York health care also introduced a bill to provide funding for research into workers challenged the New York law requiring health care a “universal coronavirus vaccine.”23 The House and the staff to vaccinate each year for influenza or wear a mask Senate have also introduced the “Vaccine Awareness Cam- when at work.39 This rule was adopted through admin- paign to Champion Immunization Nationally and Enhance istrative rulemaking by the New York State Department Safety Act of 2019” or the “VACCINES Act,” which proof Health.40 The court in Spence found that the regulation poses a national vaccine surveillance system to be adminis- requiring health care workers to receive an influenza vac- tered by the CDC.24 cination or wear a face mask was not “arbitrary, capricious, irrational or contrary to law.”41 Plaintiffs have also chal- C. New York State lenged administrative rulings made specifically for New Mandatory vaccinations have widely been accepted York City.42 In both cases,43 the court ruled in favor of the in the State of New York. The key provision of New York New York City Department of Health and Mental Hygiene State law is Public Health Law § 2164, which mandates reasoning that each decision to require measles and influ- vaccination of children that attend school in the State enza vaccinations for children to attend school in New York of New York.25 The state requires that every child must City were proper exercises of its authority.44 have a vaccination for poliomyelitis, mumps, measles, diphtheria, rubella, varicella, Hemophilus influenzae Discussion type b (Hib), pertussis, tetanus, pneumococcal disease, Based on the current case law precedent,45 all states and hepatitis B.26 The law requires that a child without a have legal authority to require a mandatory vaccination certificate of vaccination for a 14-day period must be kept in response to COVID-19, if their public health authorities home from school.27 Most notable to this section of the determine a mandate is necessary. Jacobson supports the use law is the new repeal made in 2019,28 when the New York of state police power for the benefit of public health for citi- State legislature repealed section 9 of 2164, which allowed zens within that state.46 In addition to state police power, a religious exemption for vaccination.29 The legislature the Due Process clause creates a legal foundation for vac- also developed laws that require health care personnel cination challenges where plaintiffs succeed if their indi- to receive the influenza vaccination each year.30 If health vidual liberty interest outweighs the government interest.47 care personnel are unvaccinated, then they must wear a In addition, courts have not found the freedom of religion surgical or procedure mask while in areas where patients a persuasive argument either.48 In New York, the courts or residents are typically present.31 Along with the State of have found that neither the New York State Department of New York, New York City has also issued laws to require Health nor the New York City Department of Health and vaccination.32 Mental Hygiene violated the constitutional separation of powers and did not make vaccination rules that were arbi- The New York State courts have responded by sup- trary and capricious.49 porting a strong vaccination policy. In Phillips v. City of New York, plaintiffs argued that the New York’s manda-

66 NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 In regard to the Freedom of Religion argument, the merce clause has been construed to include marijuana, plaintiffs in Phillips and Caviezel argued that they possessed the National Labor Relations Act, and waterways.63 It a valid religious exemption under New York law (prior to certainly could be construed to include a vaccine, since the the repeal in 2019).50 However, as shown under Caviezel, a American people themselves are so involved in interstate plaintiff with a legitimate religious belief that qualifies un- commerce. But perhaps, such as they have encouraged der the religious exemption statute does not outweigh the vaccinations in the past, HHS, the CDC and Congress state’s interest in public health.51 First Amendment cases should work together to encourage COVID-19 vaccination are analyzed through the strict scrutiny standard, which nationwide, while leaving the power of enforcing vaccina- requires that a constitutionally valid law “must be justified tion to the states. by a compelling governmental interest and must be narrowly tailored to advance that interest.”52 In fact, Congress has already proposed widespread legislation regarding vaccination for COVID-19. There are Philosophical and personal exemptions do not re- 12 proposed bills and resolutions by the 116th Congress receive the same level of scrutiny as religious exemptions.53 garding vaccination and immunization since the COVID-19 In states that recognize exemptions for philosophical or outbreak began.64 But even before the COVID-19 outbreak, personal reasons, the public health and government inter- widespread vaccination was proposed for certain vulner- est takes precedence over the individuals reasons.54 This is able populations.65 Even amongst the chaos of COVID-19, especially true in the State of New York.55 The seriousness the House and Senate introduced resolutions supporting and devastation surrounding COVID-19 warrants some ac- the GAVI Alliance, which supports vaccines and immuni- tion by every American to protect each other, regardless of zations in developing countries.66 an individual’s beliefs. Some of the bills and resolutions proposed provide The particular administrative law challenges that immediate insurance coverage for treatment of COVID-19, may arise from a state or city vaccination rule may differ including a vaccination when one becomes available.67 depending on the rulemaking process used by the admin- Proposed resolutions generally support widespread vac- istrative bodies. In light of the current challenges in New cination across the United States.68 Most notably, however, York State and New York City, the courts have found that are the bills proposed offering widespread vaccination they exercised proper administrative procedures in devel- programs that are subsidized by the federal government for oping their vaccination rules.56 The courts also found the seniors and children.69 In the “Protecting Seniors Through rules to be an appropriate response to a communicable Immunization Act of 2019,” the Medicare program will disease outbreak or prevention of an outbreak.57 Provided encourage and provide free vaccinations to seniors already that the rulemaking is created within procedure and us- covered by Medicare.70 The “Vaccinate All Children Act ing proper justifications, the state and local agencies have of 2019” will require vaccinations for every student at a legal authority to regulate COVID-19 vaccinations in their public elementary and secondary school to be vaccinated in area. order to receive federal grants, with only medical exemptions allowed.71 It is clear by these proposals that vaccina- In response to COVID-19, laws and regulations for tion distribution and funding can be heavily influenced by vaccinations should follow past precedent. The state has Congress. It can be expected that the federal government the authority to require a mandatory vaccination, especially 58 will be involved in COVID-19 vaccinations nationwide due when it concerns children and health care workers. Once to the widespread effect from this national emergency and responsible scientific studies are completed which confirm pandemic. that a sufficiently safe and effective vaccine is available, New York State, at the very least, should consider adding Conclusion the COVID-19 vaccination to those required for children who attend school in New York59 and those required annu- An integral part of the United States is the individual ally for healthcare workers.60 rights afforded to each citizen. But when it comes to the public health of the country, those rights and liberties Federally, HHS’s National Vaccine Program is work- must be weighed against the risk of spreading disease. ing on the development, production and manufacturing of The devasting impact COVID-19 has had, the univer- the COVID-19 vaccination. But could Congress do more to sal desire for solutions which will return our society to support a nationwide mandated COVID-19 vaccination? normalcy, and the history of unsuccessful attempts to According to Tim Dare, “[a]ll of the states of the United challenge mandatory vaccinations may reduce the extent States require vaccination for school entry, and despite of opposition if a mandate is deemed necessary by public a number of challenges, no court has held mandatory health authorities. That possibility elevates the impor- vaccination laws unconstitutional.”61 In fact, one could tance of ensuring scientists and legislators cautiously and argue that immunization in the United States is practi- quickly move to provide safe and effective vaccines and cally compulsory.62 The logical question becomes: would treatments. Mandatory vaccination can only be justified if it be constitutional to require a nationwide vaccination? scientists and physicians remain committed to safety and Congress could pass legislation to require a vaccination effectiveness.72 under the interstate commerce clause. The interstate com-

NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 67 Endnotes to Champion Immunization Nationally and Enhance Safety Act of 2019, S.1619, 116th Cong. (introduced by Sen. Gary C. Peters on May 1. State of New York, Exec. Order No. 202.1 Continuing Temporary 22, 2019). Suspension and Modification of Laws Relating to the Disaster Emergency (March 12, 2020), https://www.governor.ny.gov/sites/ 25. Public Health Law § 2164. governor.ny.gov/files/atoms/files/EO_202_1.pdf. 26. Public Health Law § 2164(2a). 2. The White House & the Centers for Disease Control and Prevention, 27. Public Health Law § 2164(7a). The President’s Coronavirus Guidelines for America, 15 Days to Slow the Spread, https://www.justice.gov/doj/page/file/1258511/download. 28. NY LEGIS 35 (2019), 2019 Sess. Law News of N.Y. Ch. 35 (A. 2371-A). 3. Centers for Disease Control and Prevention, National Pandemic 29. Public Health Law § 2164(9) (repealed June 13, 2019). See also NY Strategy, Allocating and Targeting Pandemic Influenza Vaccine (2018) LEGIS 35 (2019), 2019 N.Y. Sess. Laws Ch. 35 (A. 2371-A). https://www.cdc.gov/flu/pandemic-resources/national-strategy/ 30. 10 N.Y. Code § 2.59 (2014). planning-guidance/pandemic-severities-tier-1.html (Tier 1 31. 10 N.Y. Code § 2.59(d) (2014). includes: deployed and mission critical personnel, critical health care (inpatient, outpatient, long-term care, pharmacists, pharmacy 32. See New York State Bar Association, New York State Public Health technicians), public health personnel, emergency medical services Legal Manual §§ 1.62, 1.64 (2d ed. 2020), https://s3.us-east-1. (EMS), law enforcement, fire services, manufacturers of vaccine and amazonaws.com/fonteva-customer-media/00D1U000001361rUAA/ antivirals, pregnant women, and infants and toddlers.). mdjUHvsf_New_York_State_Public_Health_Legal_Manual_2nd_ Ed_417920E_pdf. 4. Take Responsibility for Workers and Families Act, H.R. 6379, 116th Cong. (introduced Mar. 23, 2020 by Rep. Nita Lowey) (proposing $6 33. Phillips v. City of New York, 775 F.3d 538, 542 (2d. Cir. 2015). billion in COVID-19 vaccination development). 34. Id. 5. Centers for Disease Control and Prevention, National Center for 35. Id. Health Statistics: Immunization (2018) https://www.cdc.gov/nchs/ fastats/immunize.htm (70.4% of children aged 19-35 months 36. Id. at 543 (New York State constitutionally repealed the religious receiving all 7 major vaccines). exemption in 2019, see infra). 6. Jacobson v. Massachusetts, 197 U.S. 11 (1905). 37. Caviezel v. Great Neck Public Schools, 739 F.Supp.2d 273, 274-75 (E.D.N.Y. 2010) (affm’d by Caviezel v. Great Neck Public Schools, 500 7. Id. at 12. Fed.Appx. 16 (2d Cir. 2012). 8. Id. at 24-25. 38. Id. at 284-85. 9. Id. at 25. 39. Spence v. Shah, 136 A.D.3d 1242, 1246 (App. Div. 3d 2016). 10. Id. at 26 (quoting Hannibal & St. J. R. Co. v. Husen, 95 U.S. 465, 471 40. Id. See also 10 N.Y. Code §2.59(d) (2014). (1877). 41. Spence, 136 A.D.3d at 1246. 11. Prince v. Massachusetts, 321 U.S. 158, 167 (1944). 42. Garcia v. New York City Dept. of Health and Mental Hygiene, 31 12. Id. (citing People v. Pierson, 176 N.Y. 201, 211 (1903)). N.Y.3d 601, 621 (N.Y. 2018). C.F. v. New York City Dept. of Health 13. Cruzan by Cruzan v. Director Missouri Dept. of Health, 497 U.S. 261, 262 and Mental Hygiene, 2019 NY Slip Op. 31047, at 4-6 (Apr. 18, 2019) (1990). (administrative ruling). 14. Id. at 279. 43. Id. 15. Id. at 282. 44. Garcia, 31 N.Y.3d at 621 (NYC Dept. of Health and Mental Hygiene was acting “…pursuant to its legislatively-delegated and long- 16. 42 U.S.C. § 300aa-1 (2020). U.S. Dept. of Health & Human Services exercised authority to regulate vaccinations” of children for National Vaccine Program, The National Vaccine Program Office influenza). C.F., 2019 NY Slip Op. 31047, at 4-6 (NYC Dept. of Health Mid-Course Review of the 2010 National Vaccine Plan, https:// and Mental Hygiene regulation requiring any person who lives or www.hhs.gov/sites/default/files/nvpo-midcourse-review-final.pdf. works in “designated zip codes” to be vaccinate for MMR (measles)). 17. U.S. Dept. of Health & Human Services National Vaccine Program, 45. See supra Part III. National Vaccine Advisory Committee (NVAC), https://www.hhs.gov/ vaccines/nvac/index.html. 46. Jacobson, 197 U.S. at 12. 18. U.S. Dept. of Health & Human Services National Vaccine Program, 47. See generally Cruzan by Cruzan, 497 U.S. at 262. February 13-14, 2020 NVAC Meeting, Agenda https://www.hhs. 48. See supra Part III. gov/vaccines/nvac/meetings/2020/02-13/index.html (in the 1:15pm slot, Dr. Alan Embry presented the “Coronavirus Vaccine 49. Garcia, 31 N.Y.3d at 621. C.F., 2019 NY Slip Op. 31047, at 4-6. Development: Opportunities and Potential Pitfalls https://www. 50. Phillips, 775 F.3d at 542. Caviezel, 739 F.Supp.2d at 274-75. hhs.gov/sites/default/files/nvac_feb2020_day1_panel2.pdf). 51. Caviezel, 739 F.Supp.2d at 284. 19. Centers for Disease Control and Prevention, State School and Childcare Vaccination Laws, https://www.cdc.gov/phlp/publications/topic/ 52. Church of the Lukami Babalu Aye, Inc. v. City of Hialeah, 508 U.S. 520, vaccinations.html. Centers for Disease Control and Prevention, State 531-32 (1993). Healthcare Worker and Patient Vaccination Laws, https://www.cdc. 53. See Richard J. Bonnie & Ruth Gaare Bernheim, Public Health Law, gov/phlp/publications/topic/vaccinationlaws.html. Ethics, and Policy Cases and Materials 716 (Robert Clark, et. al eds.) 20. Protecting Americans from Seasonal Influenza Act of 2020, H.R.5729, (Foundation Press 2015) (citing Hanzel v. Arter, 625 F.Supp. 1259 (S.D. 116th Cong. (introduced on Jan. 30, 2020). Ohio 1985) (“the minimum scrutiny which the Supreme Court has deemed applicable to economic and social legislation is thus the 21. Id. proper standard of review.”)). 22. Id. 54. National Conference of State Legislatures, States With Religious and 23. Coronavirus Vaccine Act, S.3370, 116th Cong. (introduced by Sen. Philosophical Exemptions from School Immunization Requirements, Edward Markey on Mar. 2, 2020). https://www.ncsl.org/research/health/school-immunization- exemption-state-laws.aspx (The New York section is out of date 24. VACCINES Act of 2019, H.R. 2862, 116th Cong. (introduced by since there is no longer a religious exemption). Rep. Kim Schrier on May 21, 2019). Vaccine Awareness Campaign

68 NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 55. National Conference of State Legislatures, States With Religious and United States in helping save the lives of children and protecting the Philosophical Exemptions from School Immunization Requirements, health of people in poor countries with vaccines and immunization https://www.ncsl.org/research/health/school-immunization- through the GAVI Alliance, H.Res.861, 116th Cong. (introduced by exemption-state-laws.aspx (The New York section is out of date Rep. Betty McCollum on Feb. 21, 2020). since there is no longer a religious exemption). 67. Ensuring Coverage in Public Health Emergencies Act of 2020, H.R. 56. See Spence, 136 A.D.3d at 1246. Garcia, 31 N.Y.3d at 621. C.F., 2019 6317, 116th Cong. (introduced by Rep. Lloyd Doggett on Mar. 23, NY Slip Op. 31047, at 4-6. 2020). Ensuring Treatment for COVID Act, S.3564, 116th Cong. 57. Id. (introduced by Sen. Robert P. Casey, Jr. on Mar 22, 2020). Care for COVID-19 Act, H.R.6311, 116th Cong. (introduced by Rep. Raul Ruiz 58. Jacobson, 197 U.S. at 24. on Mar. 19, 2020). Ensuring Coverage in Public Health Emergencies 59. Public Health Law §2164. Act of 2020, S.3536, 116th Cong. (introduced by Sen. Robert P. Casey, Jr. on Mar. 19, 2020). Rapid Coverage of COVID-19 Vaccine Act of 60. 10 N.Y. Code §2.59 (2014). 2020, H.R. 6299, 116th Cong. (introduced Mar. 19, 2020 by Rep. Joe 61. Tim Dare, Mass Immunization Programs: Some Philosophical Issues, 12 Courtney). Rapid Coverage for Coronavirus Vaccines Act, S.3505, Bioethics 125-49 (Blackwell Publishers 1998) (reprinted in Richard 116th Cong. (introduced by Sen. Doug Jones on Mar. 17, 2020). J. Bonnie & Ruth Gaare Bernheim, Public Health Law, Ethics, Ensuring Affordable COVID-19 Preventive Care Act of 2020, H.R. and Policy Cases and Materials 693-701 (Robert Clark, et. al eds.) 6222, 116th Cong. (introduced by Rep. Janice Schakowsky on Mar. (Foundation Press 2015)). 12, 2020). Ensuring Access to COVID-19 Preventive Care Act of 2020, H.R. 6231, 116th Cong. (introduced by Rep. Larry Bucshon on Mar. 62. Id. 12, 2020). Care for COVID-19 Act, S.3442, 116th Cong. (introduced by 63. See generally Gonzales v. Raich, 545 U.S. 1 (2005). NLRB v. Jones & Sen. Cory A. Booker on Mar. 11, 2020). Laughlin Steel Corp., 301 U.S. 1 (1937). Gibbons v. Ogden, 22 U.S. 1 68. Recognizing the importance of vaccinations and immunizations in (1824). the United States, H.Res.179, 116th Cong. (introduced by Rep. Adam 64. Take Responsibility for Workers and Families Act, H.R. 6379, 116th Schiff on Mar. 5, 2019). A resolution recognizing the importance of Cong. (introduced Mar. 23, 2020 by Rep. Nita Lowey). Ensuring vaccinations and immunizations in the United States, S.Res.165, Coverage in Public Health Emergencies Act of 2020, H.R. 6317, 116th Cong. (agreed to in the Senate on Apr. 11, 2019). 116th Cong. (introduced by Rep. Lloyd Doggett on Mar. 23, 2020). 69. Vaccinate All Children Act of 2019, H.R. 2527, 116th Cong. Ensuring Treatment for COVID Act, S.3564, 116th Cong. (introduced (introduced on May 3, 2019 by Rep. Frederica Wilson). Protecting by Sen. Robert P. Casey, Jr. on Mar 22, 2020). Care for COVID-19 Seniors Through Immunization Act of 2019, S.1872, 116th Cong. Act, H.R.6311, 116th Cong. (introduced by Rep. Raul Ruiz on Mar. (introduced by Sen. Mazie K. Hirono on Jun. 13, 2019). Protecting 19, 2020). Rapid Coverage of COVID-19 Vaccine Act of 2020, H.R. Seniors Through Immunization Act of 2019, H.R. 5076, 116th Cong. 6299, 116th Cong. (introduced Mar. 19, 2020 by Rep. Joe Courtney). (introduced by Rep. Donna Shalala on Nov. 13, 2019). Ensuring Coverage in Public Health Emergencies Act of 2020, S.3536, 116th Cong. (introduced by Sen. Robert P. Casey, Jr. on Mar. 19, 70. Protecting Seniors Through Immunization Act of 2019, S.1872, 2020). Rapid Coverage for Coronavirus Vaccines Act, S.3505, 116th 116th Cong. (introduced by Sen. Mazie K. Hirono on Jun. 13, 2019). Cong. (introduced by Sen. Doug Jones on Mar. 17, 2020). Ensuring Protecting Seniors Through Immunization Act of 2019, H.R. 5076, Access to COVID-19 Preventive Care Act of 2020, H.R. 6231, 116th Cong. (introduced by Rep. Donna Shalala on Nov. 13, 2019). 116th Cong. (introduced by Rep. Larry Bucshon on Mar. 12, 2020). 71. Vaccinate All Children Act of 2019, H.R. 2527, 116th Cong. Ensuring Affordable COVID-19 Preventive Care Act of 2020, H.R. (introduced on May 3, 2019 by Rep. Frederica Wilson). 6222, 116th Cong. (introduced by Rep. Janice Schakowsky on Mar. 12, 2020). Care for COVID-19 Act, S.3442, 116th Cong. (introduced 72. Maschke & Gusmano, supra note 86 (“Covid-19 interventions by Sen. Cory A. Booker on Mar. 11, 2020). Coronavirus Vaccine Act, [joining] the list of others that entered the clinic on the basis of S.3370, 116th Cong. (introduced by Sen. Edward Markey on Mar. 2, limited or contested evidence of effectiveness and then harmed 2020). Protecting Americans from Seasonal Influenza Act of 2020, patients or proved to be ineffective[, strategies] can be developed H.R.5729, 116th Cong. (introduced by Rep. Rick Larsen on Jan. 30, to minimize this from happening, but they will only work with 2020). commitment from scientists, physicians, policymakers, patients, and the general public.”). See also FDA Guidance, supra note 88. 65. Recognizing the importance of vaccinations and immunizations in the United States, H.Res.179, 116th Cong. (introduced by Rep. Adam Schiff on Mar. 5, 2019). A resolution recognizing the importance of vaccinations and immunizations in the United States, S.Res.165, 116th Cong. (agreed to in the Senate on Apr. 11, 2019). Vaccinate All Children Act of 2019, H.R. 2527, 116th Cong. (introduced on May 3, 2019 by Rep. Frederica Wilson). VACCINES Act of 2019, H.R.2862, 116th Cong. (introduced by Rep. Kim Schrier on May 21, 2019). Vaccine Awareness Campaign to Champion Immunization Nationally and Enhance Safety Act of 2019, S.1619, 116th Cong. (introduced by Sen. Gary C. Peters on May 22, 2019). Protecting Seniors Through Immunization Act of 2019, S.1872, 116th Cong. (introduced by Sen. Mazie K. Hirono on Jun. 13, 2019). Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, S.1379, 116th Cong. (became law on June 24, 2019 as Public Law 116-22). Supporting Older Americans Act of 2020, H.R.4334, 116th Cong. (introduced by Rep. Suzanne Bonamici on Sept. 16, 2019). Protecting Seniors Through Immunization Act of 2019, H.R. 5076, 116th Cong. (introduced by Rep. Donna Shalala on Nov. 13, 2019). 66. A resolution supporting the role of the United States in helping save the lives of children and protecting the health of people in developing countries with vaccines and immunization through GAVI, the Vaccine Alliance, S.Res.511, 116th Cong. (introduced by Sen. Marco Rubio on Feb. 27, 2020). Supporting the role of the

NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 69 Welcome New Health Law Section Members The following members have joined the Section since September 5, 2020 to January 12, 2021.

Monice Barbero Jason S. Madden Mark Barnes Brigid M. Maloney Alexandra T. Berke Stacey Lipitz Marder Felicia Binkis Michael A. Marinaccio Michelle Bravo Edward F. McArdle Nancy Brenna DeLea Ryan J. McDonald Daniel R. Brice Jonathan A. Moskowitz Julian David Buffa Paul O’Brien Johan Paul-Marie Byssainthe Evelina E. G. Padilla Jill E. Clayton Teresa Piccolo June C.M. Colthirst Jamie Alison Rosen John J. Cooney Rebecca Nicole Russo Thomas A. Cullen Megan C. Ryan Thomas S. D’Antonio Lois S. Saltzman Gil DeLaura Nora Lawrence Schmitt Brett Edward Farrow Tania Seaburg Margaret J. Fowler David M. Tang Ross A. Frommer Jenifer Turriziani Victoria Elissa Garel V. Jonas Urba Daniel M. Goldberg Maya Ureño-Dembar Hillel Goldman Kimberly Strauchon Verner Mark D. Goodwin John F. Von Ahn George T. Griffith Timothy Michael Ward Jessica Lee Gustafson Michael J. Weiner Kathleen Keery Hogan Stewart L. Weisman Sui Jim Carrie A. Wenban Lisa Ann Kechijian Mark G. White Cody Richard Keetch Kristen Kim Moira Schneider Laidlaw Audrey A. Lark Jerry Lee Lynch

70 NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 Thank You! For your dedication, For your commitment, and For recognizing the value and relevance of your membership.

As a New York State Bar Association member, your support helps make us the largest voluntary state bar association in the country and gives us credibility to speak as a unified voice on important issues that impact the profession.

Scott M. Karson Pamela McDevitt President Executive Director

Section Committees and Chairs* The Health Law Section encourages members to participate in its programs and to volunteer to serve on the Committees listed below. Please contact the Section Officers or Committee Chairs for further information about these Committees.

Diversity Health Law Legislative Issues Professional Discipline Lillian P. Mosley Mark R. Ustin Douglas M. Nadjari Community Service Society of New York Farrell Fritz, P.C. Ruskin Moscou Faltischek, PC 633 3rd Ave, Fl 10 Albany, NY 1425 Rxr Plz New York, NY 10017-6701 [email protected] Uniondale, NY 11556-1425 [email protected] [email protected] Long-Term Care E-Health and Information Systems Jane B. Burke John. J. Barbera Daniel Meier Hodgson Russ LLP Martin Clearwater & Bell LLP Benesch Friedlander Coplan & Aronoff 677 Broadway, Ste 301 245 Main St Continental Plaza II Albany, NY 12207-2986 White Plains, NY 10601-2411 411 Hackensack Ave, Fl 3 [email protected] [email protected] Hackensack, NJ 07601-6323 [email protected] Medical Research and Biotechnology Public Health Alex C. Brownstein Thomas Merrill Nathan G. Prystowsky BioScience Communications New York, NY Axiom 250 Hudson St, Fl 9 [email protected] 16 N Broadway Apt 2N New York, NY 10013-7634 White Plains, NY 10601-2223 [email protected] Dr. Mary Beth Quaranta Morrissey [email protected] Fordham University GHIMC Samuel J. Servello 400 Westchester Ave Ethical Issues in the Provision West Harrison, NY 10604-2908 of Health Care New York, NY 10003 [email protected] Lawrence R. Faulkner [email protected] The ARC Westchester Young Lawyers 265 Saw Mill River Rd, Fl 3 Membership Hawthorne, NY 10532-1509 Lisa D. Hayes Brenda Baddam [email protected] The Brookdale Hospital Medical Center Barclay Damon 1 Brookdale Plaza Katz 321 80 State St Brendan S. Parent Brooklyn, NY 11212-3198 Albany, NY 12207-2541 NYU School of Medicine [email protected] [email protected] 227 E 30th St, Ste 721 New York, NY 10016 Jorge Luis Rivera Cassandra Rivais DiNova [email protected] Northwell Health Rivkin Radler LLP 27005 76th Ave, Ste B305 66 S Pearl St, Fl 11 Health Care Litigation New Hyde Park, NY 11040-1402 Albany, NY 12207-1533 Linda J. Clark [email protected] [email protected] Barclay Damon LLP 80 State St Payment, Enforcement & Compliance Albany, NY 12207-2541 William P. Keefer [email protected] Phillips Lytle LLP Buffalo, NY Jeffrey J. Sherrin [email protected] O’Connell & Aronowitz PC 54 State St, Fl 9 Sandra C. Maliszewski Albany, NY 12207-2527 Maimonides Medical Center [email protected] Brooklyn, NY [email protected] Health Care Providers and In House Counsel Margaret J. Davino Fox Rothschild LLP 101 Park Ave, Fl 17 New York, NY 10178-1700 [email protected] * To update your information, contact NYSBA’s Member Resource Center at 1-800-582-2452.

72 NYSBA Health Law Journal | 2021 | Vol. 26 | No. 1 New York State Bar Association New York

NYSBA Membership 2021 Renewal Is Now Open NYSBA membership grants you access to exclusive benefits and to be part of monumental change. Whether it’s adapting to the new virtual environment, participating in health law discussions, or speaking out on racial injustice, we are always looking to increase involvement via leadership and task force opportunities. Here’s a list of existing benefits and partners…with additional ones added throughout the year! • Complimentary CLE programs included with select Membership • 25%+ discount on all additional CLE programs offered • 25%+ discount on all NYSBA published books & forms • Complimentary copies of the NYSBA Journal, State Bar News, CasePrepPlus and NY Law Digest NYBSA Partners ABA Retirement Funds JDL Group Renew Online USI Affinity Insurance Ruby Receptionists ABACUSLAW UPS NYSBA.ORG/RENEW2021 Clio Digital Age Marketing Group or by phone 800.582.2452 LawPay Fastcase

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New York State Bar Association ANNUAL MEETING A TWO-WEEK VIRTUAL CONFERENCE

JANUARY 19 – 29, 2021 HEALTH LAW SECTION TUESDAY, JANUARY 19, 2021 9:00 a.m. – 12:45 p.m. WEDNESDAY, JANUARY 27, 2021 9:00 a.m. – 1:15 p.m. NYSBA.ORG/AM2021

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