Health Law Journal a Publication of the Health Law Section of the New York State Bar Association NEW YORK STATE BAR ASSOCIATION

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NYSBA SPRING/SUMMER 2015 | VOL. 20 | NO. 2 Health Law Journal A publication of the Health Law Section of the New York State Bar Association NEW YORK STATE BAR ASSOCIATION

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Order multiple titles to take advantage of our low ﬂ at rate shipping charge of $5.95 per order, regardless of the number of items shipped. $5.95 shipping and handling offer applies to orders shipped within the continental U.S. Shipping and handling charges for orders shipped outside the continental U.S. will be based on destination and added to your total. Prices do not include applicable sales tax. Mention code: PUB3092N when ordering. HEALTH LAW JOURNAL

Spring/Summer 2015

Vol. 20, No. 2

THE HEALTH LAW SECTION NEW YORK STATE BAR ASSOCIATION

Regular Features In the New York State Courts ...... 5 In the New York State Legislature ...... 13 In the New York State Agencies ...... 16 New York State Fraud, Abuse and Compliance Developments ...... 19 In the Law Journals ...... 25 For Your Information ...... 27

Feature Articles Medical, Ethical and Legal Obligations to Honor Individual Preferences Near the End of Life ...... 28 Patricia A. Bomba and Jonathan Karmel A Quarter-Century Since Baby M: Why New York Should Reconsider Its Surrogacy Law ...... 34 Shawna Benston Mitochondrial Replacement: Changing the Family Structure ...... 49 Caitlin Davie Franken-Food or Scare Tactics? The Science, Law and Policy of Genetically Modified Food Excerpts from an Expert Panel Discussion ...... 57 The Tension Between the Affordable Care Act and EMTALA and Its Potential Legal Implications ...... 62 Daniel Shapiro OMIG Reminds Providers That Compliance Officer Must Be an Employee of the Provider ...... 66 Philip Rosenberg, Laurie T. Cohen and Brooke A. Lane Out-of-Network Law Frequently Asked Questions ...... 67 Healthcare Association of New York State (HANYS)

Section Matters Newsflash: What’s Happening in the Section ...... 71

Cover artwork: The Rocket by Edward Middleton Manigault,1909

NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 3 Message from the Section Chairs On June 1, Margie Davino’s term as Section Chair ended, and Ken Larywon’s term as Section Chair commenced.

We are proud to say that We also have a number of the Health Law Section has CLEs being planned, under the been growing and busy. We guidance of Bob Borsody, Chair encourage all members of the of the CLE Committee. These Section to join a committee include: and get involved. We have some committee changes to • Senior Housing program, allow persons with interests in by the Section’s CLE these areas to get to know each Committee in NYC— other and become aware and September 25 in NYC. involved with topics affecting • Half-day program by the their clients. The ﬁ rst is the re- E-Health and Informa- constitution of the Long-Term tion Systems Committee—to be held in October in Care Committee, which will be chaired by Jane Bello NYC. Burke at Hodgson Russ. The Long-Term Care Committee will focus on legal issues relating to skilled nursing, as- • Health Law Section Fall Meeting—to be held Octo- sisted living, home care and other providers of long-term ber 30 in Albany. care. It will provide a forum to discuss laws, regulations, and policies and developments relating to the operation • Aid in Dying program, proposed by the Committee and oversight of long-term care providers; offer mem- on Ethics in the Provision of Health Care (date to be bers opportunities to comment on proposed statutory determined). and regulatory developments relating to long-term care; • Medical Marijuana in New York State—(date to be undertake initiatives to educate members, other attorneys determined). and the public on legal issues relating to long-term care; and provide opportunities for member networking. • Special Education and the Law: NYSBA CLE Department, co-sponsored by the Health Law Sec- Secondly, the Mental Hygiene and Developmental tion—date to be determined in the fall. Disabilities Committee is splitting into two committees: the Mental Health Law and Substance Abuse Com- Please get involved with the Section, and we look for- mittee will be chaired by Carolyn Wolf from Abrams ward to seeing you at one of the committee meetings and/ Fenstermann, and the Developmental Disabilities Com- or above meetings! mittee will be chaired by Hermes Fernandez, from Bond Schoeneck and King. This split recognizes the sometimes Margaret J. Davino different focuses of mental health law and development Outgoing Chair disabilities law, although several members are serving on both committees. Kenneth R. Larywon Incoming Chair If you are interested in any of the above committees (or any of our committees), please contact the above chairs, or sign up through the bar.

CHHECKECK US OUUTT OONN TTHEHE WEEBB hhttp://www.nysba.org/Healthttp://www.nysba.org/Health

4 NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 In the New York State Courts By Leonard M. Rosenberg

Second Circuit Holds Constitutional based upon to mandate vaccination. Regarding New York’s Vaccination their Catholic the argument that vaccines do more Requirement and Exclusion of Non- beliefs. Howev- harm than good, the Court held that Vaccinated Children from Public er, they brought any such determination is a question School During Outbreak of Vaccine- suit when the for the legislature rather than for in- Preventable Disease children were dividual objectors. excluded from Phillips v. City of New York, 775 Turning to the Free Exercise F.3d 538 (2d Cir. 2015). Appellants, school, pursuant to 10 N.Y.C.R.R. Clause, the Court cited persuasive parents of minor unvaccinated chil- Prince v. Massachusetts § 661.10, after a classmate was diag- dictum from dren, appealed from the U.S. District and other Supreme Court cases, hold- Court for the Eastern District of New nosed with chicken pox. Phillips and Mendoza-Vaca’s complaint was con- ing that the right to freely practice York’s dismissal of their constitu- one’s religion does not include the tional challenge to New York State’s solidated with that of Appellant Dina Check, who sought a preliminary freedom to expose the community requirement that all children be vac- or a child to communicable disease, cinated to attend public school. Ap- injunction to compel the Department of Education to allow her daughter to ill health, or death. Signifi cantly, pellants claimed that the vaccination the Court also noted that NYPHL § requirement violated: (i) substantive attend school unvaccinated. The preliminary injunction application was 2164(7)(a) affords greater protection due process; (ii) the Free Exercise than the U.S. Constitution requires Clause of the First Amendment; (iii) addressed by a Magistrate Judge who recommended that the request be de- by allowing an exemption for parents the Equal Protection Clause of the with genuine and sincere religious Fourteenth Amendment; and (iv) nied, fi nding that Check’s testimony showed that her views on vaccination beliefs. The Court reasoned that be- the Ninth Amendment. Appellants cause the State could constitutionally also alleged violations of state and were primarily health-related rather than based on genuine and sincere bar Phillips and Mendoza-Vaca’s municipal law. Under the same legal unvaccinated children from public theories, Appellants also challenged religious belief. In particular, Check testifi ed that she did not know of any school entirely, a limited exclusion as unconstitutional a New York State of such children during the outbreak regulation (10 N.Y.C.R.R. § 661.10) tenets of Catholicism that prohibited vaccinations and, instead, focused her of vaccine-preventable illness was that allows school offi cials to tempo- “clearly constitutional.” rarily exclude from attendance those testimony on her daughter’s previous students who are exempt from the adverse reactions to inoculations. The Addressing the Equal Protection vaccination requirement (for religious Eastern District adopted the Magis- Clause, the Court held that there was or medical reasons) during an out- trate’s Report and Recommendation no discrimination against Catholics, break of vaccine-preventable disease. and denied injunctive relief. as both Phillips and Mendoza-Vaca The Eastern District granted are Catholic and received religious Pursuant to the New York Public exemptions for their children. Be- Health Law § 2164(7)(a), “[n]o prin- Defendants’ motions to dismiss or for summary judgment as to the cause Appellants failed to challenge cipal, teacher, owner or person in the District Court’s fi nding that charge of a school shall permit any consolidated cases. Affi rming the District Court’s decision, the Court Check’s approach to vaccinations child to be admitted to such school, was not based on genuine religious or to attend such school, in excess of of Appeals addressed substantive due process, the free exercise of reli- beliefs, the Court rejected the argu- fourteen days” without a certifi cate ment that Check was treated differ- of immunization. The statute has two gion, equal protection, and the Ninth Amendment. The Court held that the ently from her similarly situated co- exceptions: (i) where a licensed phy- Appellants. The Court further noted sician has certifi ed that an immuniza- vaccination statute and regulation allowing children’s exclusion from that Appellants alleged nothing to tion may be detrimental to the child’s suggest that Phillips and Mendoza- health; and (ii) where the child’s school were constitutionally permissible exercises of the State’s police Vaca shared similar religious beliefs parent, parents or guardian “hold to Check’s. genuine and sincere religious beliefs power and did not infringe upon the which are contrary” to the vaccina- Free Exercise Clause. As to substan- Finally, the Court held that the tion requirement. tive due process, the Court cited the Ninth Amendment was unavailable, standard articulated by the Supreme as it is not an independent source Appellants Phillips and Mendo- Court in 1905 in Jacobson v. Common- of individual rights and Appellants za-Vaca successfully obtained reli- wealth of Massachusetts, holding that failed to “plausibly…allege a viola- gious exemptions for their children it is within the police power of a state tion of any other constitutional right.”

NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 5 Federal Law Preempts Personal pension of petitioner’s medical li- (“NIH”). During his postdoctoral Injury Claims Based on Child’s cense, and permanently prohibited research program Plaintiff was al- Reaction to Vaccination him from owning or administering a legedly exposed to the herpes virus, Stenberg v. Kalansky, 122 A.D.3d group medical practice or a medical and thereafter brought suit against 611, 996 N.Y.S.2d 306 (2d Dep’t 2014). facility licensed under Article 28 of the Defendant in Supreme Court. Infant plaintiff and her mother (to- the Public Health Law (“PHL”); how- The Defendant moved for summary gether, Appellants) appealed from ever, petitioner is permitted to oper- judgment, arguing that Plaintiff was the grant of Respondents’ CPLR § ate a solo offi ce practice. The penalty an employee of the medical school 3211(a) motions to dismiss the com- was sustained by the Administrative at the time of the exposure and thus plaint alleging medical and nursing Review Board, and petitioner com- his exclusive remedy was workers’ malpractice and lack of informed con- menced an Article 78 proceeding to compensation benefi ts. The Supreme sent. Respondents were West Sayville challenge the penalty as unauthor- Court found that the existence of an Children’s Medical Services, P.C. and ized by statute. employer-employee relationship was three individual parties. a question of fact for the Board to The Court held that although a resolve, stayed the proceedings, and Appellants alleged that the infant penalty that clearly is not authorized remanded the parties to the Board plaintiff sustained personal injuries by statute is subject to amendment, in for a ruling on this issue. Ultimately, following Respondents’ administra- this case the restrictions on petition- the Board determined that Plaintiff tion of certain vaccines. Specifi cally, er’s license fall “within a reasonable was an employee of the Defendant Appellants claimed that the injuries interpretation of the penalty autho- medical school. Plaintiff appealed the stemmed from the infant plaintiff’s rized by Public Health Law § 230- decision. loss of consciousness and fall in a(3).” [PHL§230-a(3) permits “limita- which she struck her chin after receiv- tion of the license to a specifi ed area The Appellate Division, Third ing the vaccinations. or type of practice.”] The Court noted Department, affi rmed the Board’s that the penalty was tailored to per- determination. Plaintiff argued that The Appellate Division affi rmed mit petitioner to continue providing federal law preempted the Board’s the Supreme Court’s dismissal of the medical care to patients while avoid- jurisdiction over the fellow and claims as preempted by Federal law, ing the type of administrative duties substantial evidence did not exist to under the National Childhood Vac- that led to his conviction. support the Board’s fi nding that an cine Injury Act of 1986 (42 U.S.C. §§ employer-employee relationship ex- 300aa-1-300aa-34). Postdoctoral Research Fellow isted between him and the Defendant Exposed to Virus Is Limited to medical school. The Appellate Divi- Barring a Physician from Owning Workers’ Compensation Benefi ts, sion was not persuaded by Plaintiff’s or Administering a Medical Facility as University Exercised Control arguments. The Court did not fi nd Due to Conviction for Conspiracy Over the Terms and Conditions of any explicit or implicit indication in to Commit Bribery While Employed Researcher’s Employment any federal statute or regulation that as Hospital CEO Is a Penalty Schwenger v. NYU School of preempted New York workers’ com- Authorized by the Public Health Medicine, 126 A.D.3d 1056 (3d Dep’t pensation laws. The Court opined Law 2015). Plaintiff, a postdoctoral fel- that, absent any clear evidence, Con- Aguino v. Shah, 4 N.Y.S.3d 563 (3d low conducting research funded by a gress did not intend to preempt state Dep’t 2015). Petitioner Roberto Aqui- federal grant, appealed the Workers’ law in areas where states have tradi- no, a licensed physician, owned and Compensation Board’s (the “Board”) tionally exercised their police powers, was the Chief Executive Offi cer of determination that an employer-em- such as workers’ compensation laws. Parkway Hospital, which the Berger ployee relationship existed between However, Plaintiff argued that pre- Commission had recommended for the fellow and the Defendant medical emption can be found in a program closure. Petitioner pled guilty to one school. Affi rming the Board’s deci- announcement circulated by the NIH. felony count of conspiracy to commit sion, the Appellate Division, Third He cited to a program announcement bribery, based on payments he made Department, held that substantial which stated that individuals “sup- to a state senator for efforts to infl u- evidence supported the fi nding that ported under the [grant program] are ence the state to keep the hospital an employer-employee relationship not considered to be in an employee- open. As a result of the felony convic- existed. employer relationship with NIH or tion, the State Board for Professional the awardee institution,” and that in- Medical Conduct charged petitioner After obtaining his doctorate stitution could not apply grant funds with professional misconduct pursu- degree in 1998, Plaintiff, a research to workers’ compensation expenses. ant to Education Law § 6530(9)(a). scientist, began laboratory research The Court held that the program an- at the Defendant medical school. nouncement did not justify the pre- A hearing committee sustained Plaintiff’s salary was funded by a emption of state workers’ compensa- the charge and imposed a penalty federal grant, administered through tion laws, as the announcement was that included a one-year stayed sus- the National Institutes of Health

6 NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 made in the context of explaining the Plaintiff and her co-defendants, an- and (iii) Plaintiff continued to work at tax liability of individuals receiving other obstetrician and the hospital the hospital after the verdict was is- grant funds, and it expressly stated that employed them, did not con- sued and was offered a new contract that the taxability of stipends does stitute legal malpractice given that on the same terms as the other phy- not alter the relationship between Plaintiff did not have to pay any part sicians despite the verdict, Plaintiff those individuals and institutions. of the judgment, which was covered failed to establish that she suffered by insurance, and was not entitled to actual and ascertainable damages. With respect to Plaintiff’s claim recover non-pecuniary damages for Accordingly, the Court held that the regarding the existence of an employ- alleged reputational injuries resulting trial court properly dismissed the er-employee relationship, the Appel- from media coverage of the verdict. legal malpractice claim and affi rmed late Division noted that to determine the decision of the trial court. whether an employer-employee rela- Plaintiff, along with another ob- tionship exists, it must consider the stetrician, Dr. Nguyen, and their em- Plaintiffs Lack Standing to Sue for following factors: “method of pay- ployer, Nathan Littauer Hospital and Alleged Overcharges for Copies ment, right to discharge, furnishing of Nursing Home, were sued for medi- of Medical Records Pursuant to equipment and relative nature of the cal malpractice by a former patient Public Health Law § 18 Absent work.” Here, the Court considered after the patient developed a serious Direct Payment or Obligation to the following facts in making its de- infection shortly after giving birth at Reimburse Attorney termination: (1) Plaintiff was super- the hospital. Plaintiff, Dr. Nguyen, Spiro v. Healthport Techs., LLC, vised by a professor employed by the and the hospital were all insured by 2014 WL 4277608 (S.D.N.Y. Aug. 29, Defendant; (2) Plaintiff used equip- defendant Medical Liability Mutual 2014). Plaintiffs are individuals and ment provided by the Defendant; (3) Insurance Company (“MLMIC”), putative representatives of a class of the Defendant was listed as the payor who assigned the defense of the case personal injury plaintiffs who, in con- on Plaintiff’s paycheck; (4) the Defen- to the defendant law fi rm Carter, nection with their underlying law- dant provided Plaintiff with vacation, Conboy. A jury found in favor of the suits, sought medical records from sick leave and health insurance; and patient, apportioning liability be- Defendants pursuant to N.Y. Public (5) the professor set Plaintiff’s work tween Plaintiff (35%) and Dr. Nguyen Health Law § 18. Defendants Mon- schedule, exercised broad control (65%) and awarding damages in an tefi ore Medical Center, Mount Sinai over his research, and had authority amount that was reduced to $3.2 mil- Hospital, and Beth Israel Medical to discipline or fi re him. lion. Plaintiff thereafter commenced Center are hospitals that outsourced this action against MLMIC, alleging their copying and furnishing of medi- Contrary to Plaintiff’s assertion deceptive business practices and cal records to Defendant Healthport that he was not an employee because breach of contract, and against the Technologies, LLC (“Healthport”). his salary and benefi ts were funded law fi rm, asserting that the law fi rm’s Plaintiffs were all represented by by federal grant money, the Appel- joint representation of all defendants the same counsel, Simonson Hess late Division held that the foregoing in the medical malpractice action Liebowitz & Goodman, P.C. (“Simon- constituted substantial evidence to and use of a “united front” defense son”), in their underlying personal uphold the Board’s determination. resulted in a confl ict of interest to the injury lawsuits. For each Plaintiff, Furthermore, the Court opined that detriment of Plaintiff and constituted Simonson requested medical records that source of the monies used to pay legal malpractice. Plaintiff was not determinative of and was issued a bill from Healthport whether an employer-employee rela- In an earlier decision, the court for 75 cents per page for copying tionship existed. dismissed Plaintiff’s claims against expenses. Simonson paid each bill MLMIC (92 A.D.3d 1057, 938 N.Y.S.2d directly, and after each case settled, Physician Did Not Suffer 367). On this appeal, the Court held Plaintiffs reimbursed Simonson for Damages from Law Firm’s Joint that Plaintiff failed to submit suf- disbursements, including the cost Representation of Her, Another fi cient proof to raise a triable issue of of obtaining medical records from Physician and the Hospital That fact that her attorney was negligent, Defendants. Employed Them; Legal Malpractice that but for such negligence she On March 12, 2014, Plaintiffs Claim Dismissed would have prevailed, and that she brought this action in Supreme Kaufman v. Medical Liability Mutu- sustained actual and ascertainable Court, New York County, alleging al Insurance Company damages. The Court held that be- , 121 A.D.3d 1459 that Defendants charged them fees cause (i) Plaintiff did not have to pay (3d Dep’t 2014). Plaintiff appealed for the medical records in excess of any portion of the judgment, which from the dismissal of her legal mal- those permitted by law. Defendants was covered entirely by the insurer practice claim against a law fi rm that removed the case to the Southern and the hospital; (ii) Plaintiff is barred defended her in a medical malprac- District of New York under the Class from recovering her alleged reputa- tice action. Affi rming the dismissal, Action Fairness Act and moved to tional damages, which are not recov- the Appellate Division held that the dismiss. In response, Plaintiff fi led an law fi rm’s joint representation of erable in a legal malpractice action;

NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 7 amended complaint, which sought fendants contended that they could dants had knowledge of the alleged damages for violation of N.Y. Public not be subject to liability for violation discrepancy between the charges that Health Law § 18 and N.Y. General of N.Y. Public Health Law § 18 be- they imposed and their actual costs Business Law § 349, restitution for cause they did not charge more than of copying medical records, the court unjust enrichment, and injunctive re- the maximum “reasonable charge” of found that a reasonable consumer lief. Defendants then fi led a renewed 75 cents per page. However, the court would be led to believe that the ac- motion to dismiss, claiming that held that this was a misreading of the tual costs were in fact 75 cents per Plaintiffs lacked standing to assert statute, which states that health care page. Accordingly, the court held that their claims, that the complaint failed providers may impose a charge for Plaintiffs had stated a cause of action to state a cause of action, and that cer- the copying of medical records not to for violation of GBL § 349(a). Further, tain claims were time-barred. exceed the costs that they actually in- because of Defendants’ alleged fail- curred in making such copies, and in ure to disclose that their costs were The court fi rst addressed the is- no event to exceed 75 cents per page. less than 75 cents per page, the court sue of standing. Defendants argued The court asserted that the statute rejected Defendants’ argument that that only Simonson was entitled to does not give health care providers Plaintiffs voluntarily paid for the challenge the alleged overcharges the authority to profi t by providing medical records as billed. because Simonson, rather than Plain- medical records, and does not estab- As for Plaintiffs’ unjust enrich- tiffs, requested the medical records, lish 75 cents per page as a per se rea- ment claim, the court held that received bills from Healthport, and sonable cost of copying. rendered payment. Plaintiffs coun- Plaintiffs had stated a claim against tered that they suffered an injury-in- The court also rejected Defen- Healthport, but not against the other fact when, after settling their law- dants’ argument that it is immune Defendants. The court noted that suits, they reimbursed Simonson for from civil liability under N.Y. Public Plaintiffs alleged only that Healthport the cost of medical records. Therefore, Health Law § 18(12), which states received payments in excess of its they asserted, they had standing to that no health care provider shall be expenses, not that any of the three assert their claims. subject to civil claims “arising solely hospitals benefi ted from the alleged from granting or providing access overcharging. Because the amended complaint to any patient information in accor- Finally, the court addressed De- did not state that Plaintiffs were ob- dance with this section.” The court fendants’ motion to dismiss Plaintiffs’ ligated to reimburse Simonson for stated that Defendants’ interpretation claims as barred by the statute of the fees paid to Healthport, the court of this provision would read the cost limitations. The court fi rst noted that held that Plaintiffs lacked standing limitation out of the statute entirely. Plaintiffs’ claims were all governed to seek damages or restitution. The Further, upon reviewing the legisla- by a three-year statute of limitations. court stated that absent such obliga- tive history, the court determined that The court then determined that both tion, Plaintiffs’ payment to Simon- the New York Legislature intended of Plaintiff’ ‘statutory claims ac- son for the cost of medical records this provision to be applied narrowly crued when all of the elements were would merely be a volitional act. This to protect health care providers for satisfi ed – namely, when Defendants would not be “fairly traceable” to their release of patient information in received and accepted payment from Defendants’ purportedly wrongful good faith. conduct, but to their decision to reim- Simonson in excess of their costs. The burse Simonson’s expenses. The court The court then turned to Plain- court also stated that Plaintiffs’ un- recognized, however, that Plaintiffs tiffs’ cause of action for violation of just enrichment claim accrued upon could revive their claims by pleading N.Y. General Business Law (“GBL”) Defendants’ acceptance of payment, that the reimbursement was manda- § 349(a). Plaintiffs alleged that Defen- as such was the alleged wrongful act tory, provided that it was refl ected in dants engaged in a deceptive act or giving rise to a duty of restitution. Simonson’s engagement letters. The practice by charging 75 cents per page Applying these determinations to the court also dismissed Plaintiffs’ claim for the copying of medical records facts at bar, the court held that the for injunctive relief, holding that they while failing to disclose to consum- claims of all but one of the Plaintiffs did not adequately establish that ers (1) that they are not allowed to were time-barred. The court rejected Defendants would likely cause them charge an amount greater than their Plaintiffs’ argument that the claims further injury by overcharging them actual costs and (2) that their actual accrued when they reimbursed for medical records. costs were less than 75 cents per page. Simonson for the charges paid to The court noted that parties are not Healthport, asserting that such a Anticipating that Plaintiffs might obligated to disclose all relevant in- holding would impermissibly give amend their complaint to establish formation under the statute, but that plaintiffs the power to toll the statute standing for their damage and resti- they are obligated to disclose relevant of limitations simply by having a tution claims, the court then turned and material information that only third party pay the costs up front and to Defendants’ motion to dismiss for they possesses. Because only Defen- then delaying reimbursement. failure to state a cause of action. De-

8 NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 Hospital’s Directive Barring prerequisite to bringing a complaint Khan, and Dr. Garro. Drs. Ihenacho Physician from Its Premises to the courts. and Kahn moved under Federal Suffi ciently Diminished Physician’s Rules of Civil Procedure 12(b)(1) and Clinical Privileges so as to Plaintiff Stated Federal Civil 12(b)(6) to dismiss the federal claims Require the Physician to File an Rights Claims Against Private against them for lack of subject mat- Administrative Complaint Prior to Physicians for Actions Arising from ter jurisdiction and/or failure to state Filing Suit Involuntary Hospitalization a claim upon which relief can be Raggi v. Wyckoff Heights Med. Ctr., Bryant v. Steele, No. 13-CV-5234 granted. ADS GRB, 2015 WL 1345376 (E.D.N.Y. 123 A.D.3d 1044, 1045, 999 N.Y.S.2d The Court began its inquiry with Mar. 21, 2015). Having allegedly re- 174 (2d Dep’t 2014). Petitioner Robert the standard for a 42 U.S.C. § 1983 ceived anonymous and threatening Raggi, M.D. (“Dr. Raggi”), and Robert claim, wherein a plaintiff must allege phone calls, Plaintiff sought police Raggi, M.D., P.C., the professional that the defendants violated his or assistance, and a month later, made corporation through which Dr. Raggi her federal rights while acting under complaints about the lack of progress provided medical care (collectively color of state law. The Court stated into the investigation. Perceiving his “Petitioners”), brought an Article 78 that private entities can commit acts behavior as manifestations of mental proceeding against Wyckoff Heights under color of state law if their con- illness, the police contacted a social Medical Center (the “Hospital”) duct is fairly attributable to the state. worker to assess the need for an seeking reinstatement of Dr. Raggi’s This occurs when the private conduct emergency mental health evaluation. clinical privileges, and to recover is compelled by the state, the private When the social worker and two po- damages for breach of contract and conduct has a suffi ciently close nexus lice offi cers met with Plaintiff at his in quantum meruit after the hospital to the state, or the private conduct home, Plaintiff mentioned hunting placed him on a mandatory, invol- has traditionally been the exclusive rifl es in his home. Thereafter, the so- untary 90-day leave of absence, pre- prerogative of the state. vented him from entering the Hospi- cial worker reported to the Directors tal, and subsequently terminated his of Community Services that Plaintiff Drs. Ihenacho and Kahn argued employment. suffered from a mental illness, for that forcible hospitalization by pri- which immediate care and treatment vate health care providers cannot Affi rming the decision of the Su- in a hospital was appropriate. be attributed to the state. The Court preme Court, Kings County, dismiss- found that Plaintiff properly stated Plaintiff was involuntarily trans- ing Petitioners’ Article 78 proceeding a claim. Initially, the Court noted ported to Stony Brook University seeking reinstatement, the Appellate various cases involving involuntary Medical Center (“Stony Brook”) un- Division, Second Department, held hospitalization, such as Doe v. Rosen- der New York Mental Hygiene Law that Petitioners were required to fi le berg, which held that the hospital and § 9.45 and involuntarily hospitalized an administrative complaint with the physician conduct could not be attrib- and transferred to defendant Bruns- New York State Public Health and uted to the state. It also examined the wick Hospital Center, Inc. (“Bruns- Health Planning Council (“PHHPC”) terms of New York Mental Hygiene wick”) under New York Mental and exhaust their administrative rem- law § 9.37, which suggested the ab- Hygiene Law § 9.37. At Stony Brook, edies before seeking redress from the sence of state action due to its use of a psychiatrist, Dr. Garro, examined courts. permissive language. Plaintiff, allegedly for three minutes, On appeal, the Second Depart- and applied to involuntary hospital- However, the Court then evalu- ment rejected Petitioners’ contention ize Plaintiff. Stony Brook then trans- ated Tewksbury v. Dowling, wherein a that PHHPC review was unnecessary ferred Plaintiff to a private hospital, private physician involuntarily hos- because Dr. Raggi’s clinical privileges Brunswick, where he was admitted pitalized a patient under New York were not technically “terminated” by a psychiatrist, defendant Dr. Mental Hygiene Law § 9.37 based on when he was prevented from exercis- Ihenacho, and evaluated by a non- an examination performed by a state ing his privileges as a result of being psychiatric physician. Defendant Dr. actor, a physician at a separate hospi- barred from accessing the Hospital’s Khan certifi ed the need for involun- tal. It found these facts were similar premises. The Court reasoned that tary care. Plaintiff maintained that he to those in Plaintiff’s complaint be- the Petitioners were required to fi le never suffered from a mental illness cause Plaintiff alleged Drs. Ihenacho an administrative complaint with the necessitating involuntary hospitaliza- and Kahn relied upon the assessment PHHPC because the Hospital’s direction, and he was not properly evalu- of a state actor, Dr. Garro, in decid- tive, which did not technically termi- ated by a psychiatrist. ing to involuntarily hospitalize him. nate his privileges, “diminish[ed]” Their alleged reliance on the recom- Plaintiff brought claims of medi- Dr. Raggi’s clinical privileges within mendation of a state actor constituted cal malpractice and violation of his the meaning of New York Public suffi cient state action because, under civil rights under 42 U.S.C. § 1983 Health Law § 2801-b(1), which re- New York Mental Hygiene Law quires an administrative appeal as a against Brunswick, Dr. Ihenacho, Dr.

NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 9 § 9.37, defendants could not involun- aid reimbursements. In administer- care workers and, in turn, improve tarily admit Plaintiff without the state ing the moratorium, DOH has the the recruitment and retention of high- actor’s recommendation. Accord- discretion to prioritize appeals based quality home care aides. The United ingly, the Court found a suffi ciently upon its consideration of which facili- State District Court for the Northern close nexus existed between defen- ties are facing “signifi cant fi nancial District of New York granted the dants and a state actor, and Plaintiff hardship” and other factors deemed Commissioner’s motion to dismiss in adequately pleaded his federal claims appropriate. Additionally, Petitioner part and denied the motion in part. against Drs. Ihenacho and Kahn. argued that it will suffer irreparable Plaintiffs argued that the WPL harm because its rates will remain interferes with the labor-management Administrative Delay in Deciding incorrectly calculated until the end of bargaining process, makes an “imper- a Medicaid Rate Appeal Is Not the moratorium in 2015. a Suffi cient Ground to Avoid missible reference to” an ERISA plan, Requirement of Exhaustion of The Court rejected Petitioner’s violated their fundamental right to Administrative Remedies Prior to futility and irreparable harm argu- political representation, and thus is Seeking Judicial Relief ments. First, it held that it would not preempted by the NLRA and ERISA, entertain a claim of futility based on and violates their Fourteenth Amend- Schenectady Nursing & Rehab. delay because “adjudicatory delay by ment and Due Process rights. The Ctr., LLC v. Shah, 124 A.D.3d 1023, 2 an agency does not authorize a court District Court dismissed all but one N.Y.S.3d 249 (3d Dep’t 2015). Peti- to intervene in an administrative proof Plaintiffs’ claims. tioner-Appellant, a residential health ceeding before a fi nal determination care facility, commenced a CPLR Subdivision Four of the WPL absent extraordinary circumstances.” Article 78 proceeding to annul what (New York Public Health Law § 3614- The Court also held that the backlog it claimed to be an erroneous rate cal- c(4)), provides that of appeals and imposition of a mora- culation, and asked the court to direct torium did not constitute an “extraor- the Department of Health (“DOH”) [a]ny portion of the mini- dinary circumstance.” To the contrary, to recalculate its Medicaid reimburse- mum rate of home care Petitioner was merely subject to the ment rates. Before fi ling the Article aide total compensation same process and delay as other nurs- 78 proceeding, Petitioner fi led an ad- attributable to health ben- ing homes seeking to appeal their re- ministrative appeal of Respondent’s efi t costs or payments in imbursement rates. Second, the Court determination. That administrative lieu of health benefi ts, and rejected Petitioner’s claim of irrepa- process, however, had not concluded paid time off,…shall be rable harm because it did not seek an at the time the Article 78 Petition was superseded by the terms expedited review of its administrative commenced. As a result, the Albany of any employer bona appeal based on alleged fi nancial dis- County Supreme Court granted Re- fi de collective bargaining tress, and also because such assertion spondent’s pre-answer motion to agreement in effect as of was conclusory. dismiss the petition based on, among January 1, 2011, or a suc- cessor to such agreement, other things, Petitioner’s failure to Second Circuit Rules That New which provides for home exhaust its administrative remedies. York’s Wage Parity Law Is care aides’ health benefi ts Petitioner then appealed, and the Ap- Constitutional and Not Preempted through payments to pellate Division affi rmed. by the NLRA or ERISA jointly administered labor- The Court noted that an adminis- Concerned Home Care Providers, management funds. trative agency’s determination must Inc. v. Cuomo, 2015 WL 1381380 (2d be challenged through every avail- Cir. Mar. 27, 2015). Plaintiffs, a trade The District Court held that sub- able administrative remedy before it association of home care agencies and division 4 of the WPL ran afoul of can be challenged in court, except for fi ve licensed home care service agen- ERISA’s express preemption provi- two narrow exceptions. First, where cies, brought suit against the Com- sion as it singled out only one type of an administrative challenge would missioner of the State Department ERISA plan for unique treatment. The be futile; second, where the petitioner of Health, seeking to invalidate and subdivision excused grandfathered can demonstrate irreparable harm. permanently enjoin enforcement of collective bargaining agreements that Here, Petitioner argued that the ad- the New York Wage Parity Law (the included Taft-Hartley plans from ministrative appeal would be futile “WPL”). The WPL sets the minimum complying with certain provisions of because of the voluminous backlog amount of total compensation that the law, which is expressly prohibited of appeals pending before the DOH, employers must pay home care aides by ERISA. Given the express sever- and also due to a statutorily imposed in order to receive Medicaid reim- ability clause in the WPL, the District payment moratorium. Pursuant to bursements for care provided in New Court eliminated the subdivision Public Health Law § 2808(17)(b), the York City and surrounding counties. rather than invalidating the entire moratorium imposes an $80 million The WPL was created to address the law. Plaintiffs appealed. limit per fi scal year on gross Medic- inconsistency in wages among home

10 NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 The Court of Appeals affi rmed erenced collective bargaining agree- the WPL applies only to the payment the District Court’s fi nding that the ment establishes and governs several of state Medicaid funds, and there WPL was not preempted by the ERISA plans, Plaintiffs argued that is no property interest in or contract NLRA. The Court noted that the this is an “impermissible” reference. right to reimbursement at any specifi c NLRA does not have an express pre- The Court found that any connection rate, or for continued participation emption provision but applied one between the WPL and ERISA to be in the Medicaid program, Plaintiffs form of implied preemption known tenuous at best, and thus would not failed to adequately plead a violation as Machinists preemption, which constitute a “reference” that warrants of their due process rights. Moreover, forbids states and localities from in- preemption. The Court held that in the Court noted that the WPL did not truding upon the labor-management order to trigger ERISA preemption, delegate decision making authority to bargaining process. This preemp- a statute must not merely mention the SEIU 1199, as the statute pegs the tion applies only to the process for or allude to an ERISA plan, but must prevailing rate of compensation to determining terms and conditions of also have some relationship to ERISA that in existence as of January 1, 2011. employment; it does not extend to the plans or affect ERISA plans in some Because the union has no authority to particular substantive terms of the manner. alter the agreement, and any future bargain that is struck. As such, the negotiations would have no bearing Finally, Plaintiffs’ argued that the Court noted that states possess broad on the prevailing rate of compensa- WPL is unconstitutional as it violates authority under their police powers tion, the Court held that even if Plain- their Fourteenth Amendment and to regulate the employment relation- tiffs had a property interest in future Due Process rights. They alleged that ship and the substantive labor stan- Medicaid reimbursements, their due by relying on a rate set by a legisla- dards, to set a baseline for employ- process challenge would fail. tive body outside the affected coun- ment negotiations. Accordingly, the ties, the WPL infringes upon the Court held that the WPL was a valid Physician’s Factual Findings Are fundamental right to representation exercise of the State’s authority to cre- Necessary for Court to Evaluate in the legislative process and thus ate such a standard. Furthermore, the Denial of Physician’s Application to warrants strict judicial scrutiny. The Second Circuit opined that despite Become Workers’ Compensation Court held that social and economic the WPL’s effects on the package of Health Care Provider legislation, such as the WPL, does benefi ts over which employers and Matter of Cohen v. New York State not employ “suspect classifi cations” employees can negotiate, it “does not Workers’ Compensation Bd., 122 A.D.3d or impinge on fundamental rights. limit the rights of self-organization 1222, 997 N.Y.S.2d 822 (3d Dep’t Accordingly, the Court noted that the or collective bargaining protected by 2014). Appellant, a licensed doctor of WPL must be upheld against an equal the NLRA.” The Court remarked that osteopathy, appealed the dismissal of protection attack when the legisla- both union and non-union employees his Article 78 proceeding to review tive means are rationally related to were not treated differently under the Respondent’s denial of his request to a legitimate governmental purpose. WPL as they are free to bargain about become an authorized workers’ com- Here, the Court found that setting the how to allocate total compensation pensation health care provider. minimum rate of home care aide total between wages and other benefi ts. compensation was rationally related The Court also held that Machinists Pursuant to Workers’ Compen- to the New York Legislature’s goal preemption does not eliminate the sation Law § 13-b, a physician must of providing high quality home care State’s authority to create minimum obtain Respondent’s approval before services. labor standards for particular geo- treating patients who receive workers’ compensation benefi ts. Based graphic regions or areas of the labor Plaintiffs also argued that the upon the existence of a non-disci- market. WPL violated the Due Process Clause plinary order of conditions imposed of the Fourteenth Amendment as it With respect to Plaintiffs’ claim on Appellant’s license by the Offi ce delegated authority to a private enti- that the WPL is preempted by ERISA, of Professional Medical Conduct, ty, namely the SEIU 1199, as it was the the Court affi rmed that only Subdivi- Respondent rejected Appellant’s current largest collective bargaining sion Four of the statute violated the application without further explana- agreement, which set the prevailing provisions of ERISA. Plaintiffs argued tion. Agreeing with Appellant that rate of total compensation. The Court that all of the provisions of the WPL the rejection was improper because it noted that governmental action may make an “impermissible reference was based solely upon the existence be challenged as a violation of due to” an ERISA plan, as the law sets of the order of conditions, the Court process only when it may be shown the minimum rate of compensation annulled the denial and remitted the that it deprives a litigant of a prop- based on the “prevailing rate of to- matter for reconsideration. erty or a liberty interest. Plaintiffs tal compensation,” which is the rate claimed a property right in the future from the largest collective bargaining The Court noted that the purpose revenues generated by their busi- agreement covering home care aides of § 13-b is “to insure the quality of nesses. The Court held that because in New York City. Because the ref- the medical care and treatment ren-

NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 11 dered to injured claimants by limiting trative determination was “justifi ed” physician group practices, payment to lawfully qualifi ed per- or “without foundation in fact,” the individual practitioners, nursing sons.…” The Court then noted that Court held that it was unable to “con- homes and other health-related the non-disciplinary order “did not duct a meaningful review” of the de- businesses and organizations. Mr. constitute an admission to or fi nding termination based solely on Respon- Rosenberg is Chair of the fi rm’s of misconduct”; was no longer in ef- dent’s mere reference to the order of litigation group, and his practice fect; and did not include any factual conditions, or the content of the order includes advising clients concerning fi ndings as to Petitioner’s capabilities of conditions. general health care law issues and as a physician. The Court emphasized litigation, including medical staff that its review of Respondent’s dis- and peer review issues, employment Compiled by Leonard cretionary determination was limited law, disability discrimination, Rosenberg, Esq. Mr. Rosenberg to ascertaining whether such deter- defamation, contract, administrative is a shareholder in the fi rm of mination was (i) arbitrary and capri- and regulatory issues, professional Garfunkel Wild, P.C., a full service cious or (ii) an abuse of discretion. discipline, and directors’ and health care fi rm representing Because this standard required the offi cers’ liability claims. hospitals, health care systems, court to decide whether the adminis- There are millions of reasons to do Pro Bono. (Here are some.)

Each year in communities across New York State, indigent people face literally millions of civil legal matters without assistance. Women seek protection from an abusive spouse. Children are denied public benefi ts. Families lose their homes. All without benefi t of legal counsel. They need your help. If every attorney volunteered at least 20 hours a year and made a fi nancial contribution to a legal aid or pro bono program, we could make a difference. Please give your time and share your talent.

Call the New York State Bar Association today at 518-487-5640 or go to www.nysba.org/probono to learn about pro bono opportunities.

12 NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 In the New York State Legislature By James W. Lytle

Health Policy Legislation in the enacted this year agencies or hospices. The corpora- 2015-16 State Budget: What Didn’t at the April 1 tion’s board would have to consider Get Done budget deadline. a range of factors as it exercised its It is accepted wisdom in Albany As noted below, fi duciary obligations, including the that if you want to get the Legis- many of these impact of its actions on the corpora- lature to enact legislation quickly, proposals are tion itself, its shareholders, employ- you should try to get it inserted in the subject of ees, the interests of patients of the the Governor’s proposed Executive ongoing consid- hospital, the community and societal Budget. While so-called Article VII eration by the considerations, local and global envi- legislation (named for the provi- Legislature and may ultimately be ronmental issues, and the short- and sions of the State Constitution that enacted, either in a similar or revised long-term interests of the corporation. govern the budget-making process) form, either during this legislative To overcome prior year’s objec- is supposed to be included in the session or a subsequent one. tions, the 2015 proposal would have required assurances that the inves- budget only to the extent the legisla- Private Equity Ownership of tors would remain for at least three tion is deemed “necessary to provide Hospitals: For several years, the moneys and revenues suffi cient to years, would mandate disclosure of Administration has sought to enact any opportunity for the not-for-profi t meet” the proposed expenditures in a proposal that would, on a limited the State Budget (State Constitution, hospital to buy out the investors, and basis, alter New York’s long-standing would require the establishment of a Art. VII, §2), governors have, for prohibition on corporate ownership many years, used the budget-making local advisory board to make recom- of hospitals. And, for several years, mendations regarding issues such as process to obtain approvals of policy the Legislature has refused to enact it. proposals that may have only the the mission statement, approving the vaguest connections to fi scal impera- This year’s proposal would have chief executive offi cer, and approving tives. The combination of the April 1 established a pilot program to “assist policies related to charity care. deadline for budget adoption and the in restructuring healthcare delivery Notwithstanding these “sweeten- extraordinary budgetary powers of systems” that would allow for the ers,” the proposal was not adopted. the Governor (see Pataki v. New York establishment of up to fi ve business State Assembly et al. and Silver v. Pa- corporations to operate hospitals. The Certifi cate of Need Reform: taki, 4 N.Y.3d 75 (2004)) were thought stock of the hospitals would not be Perhaps more surprisingly, relatively to guarantee enactment of budget publicly traded. The business corpo- modest reforms of the State’s Cer- legislation in short order, even when ration would affi liate with at least tifi cate of Need (CON) process were the legislation had only a tangential one academic medical institution that also rejected by the Legislature. The relationship to the proposed spend- is approved by the Commissioner proposal would have streamlined the ing plan. of Health, and the entity would be CON program by: eligible to participate in Dormitory • Eliminating the necessity of es- That conventional wisdom may Authority, the Local Development tablishing “public need” when have to be reconsidered. Corporation, or other Empire State general hospitals or diagnostic Development Corporation debt In the 2015-16 State Budget, Gov- and treatment centers profi nancing. The business corporations ernor Cuomo advanced a substantial pose to construct primary care would be relieved of various require- package of health-related legislation, facilities; addressing a host of policy objectives ments that would otherwise apply to (each with fairly minimal budgetary them under the Public Health Law, • Expressly authorizing PHHPC implications). Many of these propos- relating to stockholders, disposition to approve primary care diag- als were rejected by the Legislature— of voting rights, and other provi- nostic and treatment centers some for the second and third time. sions, although the Public Health and without regard to their public Health Planning Council (PHHPC) need or fi nancial feasibility; While this column might more would be authorized to impose re- typically (and usefully) review what quirements relating to the disclosure • Reducing the “look back” pe- actually did get enacted in the State of shareholders. riod for review of the character Budget, I thought it might be interest- and competence of proposed ing to focus on a number of the policy The corporations would only op- sponsors or directors of health proposals that did not ultimately erate the specifi cally named hospital, care entities from ten to seven make their way into the legislation as well as any affi liated home care years; and

NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 13 • Standardizing the review of Value-Based Payments: The information relating to physicians in transfers of less than 10% of the movement toward value-based New York State, including criminal voting rights or ownership in payments in the health care sys- convictions, professional medical Article 28 facilities. tem seems inexorable. The State’s conduct fi ndings and license limi- Delivery System Reform Incentive tations, loss of hospital privileges, For at least the last two years, this Program (DSRIP) requires 90% of medical malpractice judgments or or a similar proposal failed to secure Medicaid payments be value-based settlements, and a host of other back- passage. in fi ve years and Medicare and ground information. Retail Clinic Legislation: private payors are heading in the An- Although DOH contended that same direction. The budget proposed other proposal would have autho- the information is otherwise available authorized value-based purchasing rized DOH to license and regulate through other public sources, citing through a series of provisions that the growing number of diagnostic WebMD, the Legislature from the allowed managed care organizations and treatment centers that operate in outset appeared very much commit- to enter into value-based payments retail establishments, which are vari- ted to the continuation of the profi le with providers, that authorized DOH ously known as “limited services clin- program, which it argued uniquely to enter into value-based payments ics,” “retail clinics” or “minute clin- made this information accessible in with performing provider systems ics.” The proposal was premised on one place and did so in a more defi ni- (PPS) that are participating in DSRIP, the risk that there may be confusion tive or “offi cial” manner. Although and that authorized DOH to “utilize among consumers as to what services the proposed discontinuation of the methodologies of reimbursement that are offered, as well as concerns over physician profi ling initiative would are value based.” continuity of care. The legislation have saved $1.2 million a year, the would have established operating While the Legislature rejected all Legislature declined to repeal the standards, oversight mechanisms, of the value-based payment provi- program. and licensing requirements—and this sions that had been advanced in the Collaborative Drug Therapy year’s proposal further required the budget, the Legislature’s actions Management: Four years ago, a clinics to meet accreditation require- may not necessarily refl ect hostility demonstration project was enacted ments, employ a medical director, to the concept, but instead may have that permitted pharmacists in teach- establish regular operating hours and been motivated by the view that the ing hospitals to engage in the man- accept walk-ins, as well as mandated legislation was not necessary, since agement of drug therapy—including that patients may not be required to managed care organizations and the adjusting and altering the drug thera- buy supplies or fi ll prescriptions at DOH already had the authority to in- pies for patients in these settings—in the retail establishment. corporate value-based methodologies accordance with protocols with Urgent Care Centers: into their payment policies. Legisla- Likewise, a participating physicians. A May 2014 tors also expressed the view that the separate budget proposal would have report by the State Board of Pharma- ultimate shape of state policy on the provided for the regulatory oversight cy declared the demonstration project subject may require some further de- of urgent care centers and require a success, noting that pharmacist bate and discussion. Shortly after the that all entities that hold themselves interventions avoided adverse drug budget was enacted, Senate Health out as urgent care facilities are either reactions, reduced re-hospitalization Committee Chair Kemp Hannon Article 28 certifi ed entities or fully rates, reduced cost and increased hosted a roundtable discussion of key accredited health care providers. patient satisfaction. Last year, the pro- stakeholders to discuss the move- Each clinic would also need to meet gram’s “sunset” (or expiration date) ment toward value-based payments, a minimum scope of practice limited was extended through September, refl ecting the continued interest of the to treatment for acute episodic illness 2015 and the Governor’s 2015-16 bud- Legislature in the topic. and minor trauma. This year’s ver- get proposed to extend the demon- sion clarifi ed accreditation require- Repeal of the Physician Pro- stration for another three years. ments and would have authorized fi le Program: The Executive Budget The Senate and Assembly reject- PHHPC to determine the minimum proposed to repeal section 2995-a ed the Governor’s proposal—but not services that an urgent care center of the Public Health Law to relieve because they opposed the program. must provide. DOH of the obligation to collect and Both houses have bills introduced to post individual physician profi les Each of these proposals were in- that would extend the program for dissemination to the public—and cluded in one of the two houses’ one permanently and would extend it to to eliminate the obligation of New house budget proposals—but, in the a host of additional settings, includ- York’s physicians to supply the end, the Senate rejected the urgent ing all Article 28 facilities (including necessary information. The Physi- care proposal and the Assembly re- nursing homes) and to community jected retail clinic legislation. Nothing cian Profi le program requires DOH passed. to assemble a substantial amount of

14 NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 practices. Debate on those proposals vanced training and certiﬁ cation, be could not only facilitate the provi- is ongoing. supervised by a registered nurse and sion of certain medication regimens practice under the limitations of a to home health patients, but would Advanced Home Health Aides: plan of care developed by an autho- provide an important career ladder A proposal to create a broader scope rized practitioner, which may involve for home health aides. Debate on the of practice for home health aides was a greater medication role. The precise proposal is continuing. also rejected by the Legislature— scope of practice would be developed although substantial progress was by the Commissioners of Health Jim Lytle is a partner in the made on the issue that may bode well and Education in consultation with Albany ofﬁ ce of Manatt, Phelps & for consideration during the balance stakeholders. A broad coalition of Phillips, LLP. of the legislative session. Under the health care entities and associations proposal, Advanced Home Health have coalesced around the bill, which Aides (AHHAs) would undergo ad-

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NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 15 In the New York State Agencies By Francis J. Serbaroli

Disclosure of Medical Assistance Rates of Payment Supplementary Reports of Quality and for Residential Treatment Facilities Certain Congenital Anomalies for Surveillance- for Children and Youth Epidemiological Surveillance; Filing Related Notice of Adoption. The Offi ce of Notice of Proposed Rulemaking. Information Mental Health amended Part 578 of The Department of Health proposed Notice of Title 14 NYCRR to eliminate the trend amending sections 22.3 and 22.9 of Adoption. The factor effective July 1, 2014 through Title 10 NYCRR to increase the maxi- Department of June 30, 2015. Filing date: January 13, mum age of reporting certain birth de- Health added 2015. Effective date: January 28, 2015. fects to the Congenital Malformations section 400.25 to Title 10 NYCRR to See N.Y. Register January 28, 2015. Registry. See N.Y. Register February 25, disclose identifi ed nursing quality 2015. indicator information upon request to Amendments to Rate Setting any member of the public. Filing date: Methodology: Rates for Residential Immediate Needs for Personal Care December 22, 2014. Effective date: Habilitation Delivered in IRAs and Services January 7, 2015. See N.Y. Register Janu- CRs and for Day Habilitation Notice of Revised Rulemaking. ary 7, 2015. Notice of Adoption. The Offi ce for The Department of Health amended People With Developmental Disabili- sections 360-3.7 and 505.14 of Title 18 Rate Rationalization—Intermediate ties amended Subpart 641-1 of Title 14 NYCRR to provide for meeting the Care Facilities for Persons with NYCRR to amend the new rate setting immediate needs of Medicaid appli- Developmental Disabilities methodology that was effective in July cants and recipients for personal care Notice of Emergency Adoption. 2014. Filing date: January 13, 2015. Ef- services. See N.Y. Register February 25, The Department of Health amended fective date: January 28, 2015. See N.Y. 2015. Subpart 86-11 of Title 10 NYCRR to Register January 28, 2015. amend the new rate methodology ef- Physician Assistants and Specialist fective November 1, 2014. Filing date: Amendments to Rate Setting for Assistants December 30, 2014. Effective date: Non-State Providers: Intermediate Notice of Adoption. The Depart- December 30, 2014. See N.Y. Register Care Facilities for Persons with ment of Health amended Part 94 of January 14, 2015. Developmental Disabilities Title 10 NYCRR to allow LPAs to pre- Notice of Adoption. The Offi ce for scribe controlled substances (including Rate Rationalization for Community People With Developmental Disabili- Schedule II) to patients under the care Residences/Individualized ties amended Subpart 641-2 of Title 14 of the supervising physician. Filing Residential Alternatives Habilitation NYCRR to amend the new rate setting date: February 24, 2015. Effective and Day Habilitation methodology that was effective July date: March 11, 2015. See N.Y. Register Notice of Emergency Adoption. 2014. Filing date: January 13, 2015. Ef- March 11, 2015. The Department of Health amended fective date: January 28, 2015. See N.Y. Subpart 86-10 of Title 10 NYCRR to Register January 28, 2015. Transgender Related Care and amend the new rate methodology ef- Services fective November 1, 2014. Filing date: Telepsychiatry Services in OMH- Notice of Adoption. The Depart- December 30, 2014. Effective date: Licensed Clinics ment of Health amended section December 30, 2014. See N.Y. Register Notice of Adoption. The Offi ce of 505.2(l) of Title 18 NYCRR to authorize January 14, 2015. Mental Health added section 599.17 Medicaid coverage for transgender- to Title 14 NYCRR to establish basic related care and services. Filing date: Vital Access Program and Providers standards and parameters to approve February 24, 2015. Effective date: Notice of Adoption. The Offi ce of telepsychiatry in OMH-licensed clinic March 11, 2015. See N.Y. Register Mental Health added Part 530 to Title programs choosing to offer service. March 11, 2015. 14 NYCRR to establish a process by Filing date: January 27, 2015. Effective which providers may be designated date: February 11, 2015. See N.Y. Regis- Patients Committed to the Custody as Vital Access Providers to receive ter February 11, 2015. of the Commissioner Pursuant to supplemental funding. Filing date: CPL Article 730 January 9, 2015. Effective date: January Notice of Proposed Rulemaking. 28, 2015. See N.Y. Register January 28, The Offi ce of Mental of Health pro- 2015. posed amending Part 540 of Title 14

16 NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 NYCRR to conform regulatory provi- the provision of continuous PC and Substance Abuse Services added Part sions to statute with respect to the continuous CDPA services. Filing date: 805 to Title 14 NYCRR to enhance performance of competency reports. March 6, 2015. Effective date: March 6, protections for service recipients in the See N.Y. Register March 11, 2015. 2015. See N.Y. Register March 25, 2015. OASAS system. Filing date: March 16, 2015. Effective date: March 16, 2015. Consolidated Fiscal Report Penalty Amendment of Certifi cate of Need See N.Y. Register April 1, 2015. Amendments (CON) Applications Notice of Proposed Rulemaking. Notice of Adoption. The Depart- Incident Reporting in OASAS The Offi ce for People With Develop- ment of Health amended sections 600.3 Certifi ed, Licensed, Funded or mental Disabilities proposed amend- and 710.5 of Title 10 NYCRR to elimi- Operated Programs ing section 635-4.4 of Title 14 NYCRR nate requirement for Public Health Notice of Emergency Rulemaking. to change requirements for imposing a and Health Planning Council review of The Offi ce of Alcoholism and Sub- penalty on providers that fail to meet certain types of amendments to CON stance Abuse Services repealed Part fi ling deadlines for cost reports. See applications. Filing date: March 10, 836 and added new Part 836 to Title 14 N.Y. Register March 11, 2015. 2015. Effective date: March 25, 2015. NYCRR to enhance protections for ser- See N.Y. Register March 25, 2015. vice recipients in the OASAS system. Standards for Individual Onsite Filing date: March 16, 2015. Effective Water Supply and Individual Onsite Direct Care and Clinical date: March 16, 2015. See N.Y. Register Wastewater Treatment Systems Compensation Payments April 1, 2015. Notice of Proposed Rulemaking. Notice of Adoption. The Offi ce The Department of Health proposed for People With Developmental Dis- Patient Rights amending Part 75 of Title 10 NYCRR abilities amended Part 641 of Title Notice of Emergency Rulemaking. to establish minimum water quality 14 NYCRR to amend rate-setting for The Offi ce of Alcoholism and Sub- standards for individual onsite water eligible services in order to implement stance Abuse Services repealed Part supply systems. See N.Y. Register increases in direct care and clinical 815 and added new Part 815 to Title 14 March 18, 2015. compensation. Filing date: March 10, NYCRR to enhance protections for ser- 2015. Effective date: March 25, 2015. vice recipients in the OASAS system. School Immunization Requirements See N.Y. Register March 25, 2015. Filing date: March 16, 2015. Effective Notice of Proposed Rulemaking. date: March 16, 2015. See N.Y. Register The Department of Health proposed Updates to SSI Offset and SNAP April 1, 2015. amending Subpart 66-1 of Title 10 Benefi t Offset NYCRR to update regulations to en- Notice of Adoption. The Offi ce for Establishment, Incorporation sure children entering grades kinder- People With Developmental Disabili- and Certifi cation of Providers of garten through 12 receive adequate ties amended sections 671.7, 686.17 Substance Use Disorder Services number of required immunizations. and Subpart 641-1 of Title 14 NYCRR Notice of Emergency Rulemaking. See N.Y. Register March 18, 2015. to adjust reimbursement to affected The Offi ce of Alcoholism and Sub- providers for rent and food costs. stance Abuse Services repealed Part Medical Assistance Rates of Payment Filing date: March 10, 2015. Effective 810 and added new Part 810 to Title 14 for Residential Treatment Facilities date: March 25, 2015. See N.Y. Register NYCRR to enhance protections for ser- for Children and Youth March 25, 2015. vice recipients in the OASAS system. Notice of Proposed Rulemaking. Filing date: March 16, 2015. Effective The Offi ce of Mental Health proposed Credentialing of Addictions date: March 16, 2015. See N.Y. Register amending Part 578 of Title 14 NYCRR Professionals April 1, 2015. to amend the date of trend factor elimi- Notice of Emergency Rulemaking. nation to December 31, 2014 instead of The Offi ce of Alcoholism and Sub- Children’s Camps June 30, 2015. See N.Y. Register March stance Abuse Services repealed Part Notice of Emergency Rulemaking. 18, 2015. 853 and added new Part 853 to Title 14 The Department of Health amended NYCRR to enhance protections for ser- Subpart 7-2 of Title 10 NYCRR to Personal Care Services Program vice recipients in the OASAS system. include camps for children with (PCSP) and Consumer-Directed Filing date: March 16, 2015. Effective developmental disabilities as a type of Personal Assistance Program date: March 16, 2015. See N.Y. Register facility within the oversight of the Jus- (CDPAP) April 1, 2015. tice Center. Filing date: March 13, 2015. Notice of Emergency Rulemaking. Effective date: March 13, 2015. See N.Y. The Department of Health amended Criminal History Information Register April 1, 2015. sections 505.14 and 505.28 of Title 18 Reviews NYCRR to establish defi nitions, crite- Notice of Emergency Rulemak- ria and requirements associated with ing. The Offi ce of Alcoholism and

NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 17 Standards for Adult Homes and cal marijuana. Filing date: March 31, Supported Employment Services Adult Care Facilities Standards for 2015. Effective date: April 15, 2015. See (SEMP) Redesign Enriched Housing N.Y. Register April 15, 2015. Notice of Proposed Rulemaking. Notice of Emergency Rulemaking. Rate Rationalization—Intermediate The Offi ce for People With Develop- The Department of Health amended Care Facilities for Persons with mental Disabilities proposed amend- Parts 487 and 488 of Title 18 NYCRR to Developmental Disabilities ing Subparts 635-10, 635-12 and 635-99 revise Parts 487 and 488 in regards to of Title 14 NYCRR to redesign SEMP the establishment of the Justice Center Notice of Adoption. The Depart- by establishing requirements for the for Protection of People with Special ment of Health amended Subpart provision and funding of Intensive Needs. Filing date: March 17, 2015. 86-11 of Title 10 NYCRR to amend and Extended SEMP. See N.Y. Register Effective date: March 17, 2015. See N.Y. the new rate methodology effective April 22, 2015. Register April 1, 2015. July 1, 2014. Filing date: April 7, 2015. Effective date: April 22, 2015. See N.Y. Emergency Medical Services Implementation of the Protection of Register April 22, 2015. Notice of Adoption. The Depart- People With Special Needs Act and ment of Health amended Part 800 of Reforms to Incident Management Rate Rationalization for Community Residences/Individualized Title 10 NYCRR to clarify terminology, Notice of Emergency Rulemaking. Residential Alternatives Habilitation eliminate vagueness, address legal The Offi ce of Mental Health amended and Day Habilitation statutes/crimes and incorporate mod- Parts 501 and 550, repealed Part 524 ern professional, ethical and moral and added new Part 524 to Title 14 Notice of Adoption. The Depart- standards. Filing date: April 21, 2015. NYCRR to enhance protections for ment of Health amended Subpart Effective date: May 6, 2015. See N.Y. people with mental illness served in 86-10 of Title 10 NYCRR to amend Register May 6, 2015. the OMH system. Filing date: March the new rate methodology effective 11, 2015. Effective date: March 11, 2015. July 1, 2014. Filing date: April 7, 2015. Opioid Overdose Programs See N.Y. Register April 1, 2015. Effective date: April 22, 2015. See N.Y. Notice of Adoption. The Depart- Register April 22, 2015. ment of Health amended section Clinic Treatment Programs Rate Rationalization—Prevocational 80.138 of Title 10 NYCRR to modify Notice of Adoption. The Offi ce of Services, Respite, Supported the rule consistent with new statutory Mental Health amended Part 599 of Employment and Residential language and with the emergency Title 14 NYCRR to amend reimburse- Habilitation nature of opioid overdose response. ment structure for delivery of psycho- Filing date: April 21, 2015. Effective therapy services and eliminate utili- Notice of Proposed Rulemaking. date: May 6, 2015. See N.Y. Register zation threshold for court-mandated The Department of Health proposed May 6, 2015. services. Filing date: March 11, 2015. adding Subpart 86-13 to Title 10 Effective date: April 1, 2015. See N.Y. NYCRR to establish new rate meth- Computed Tomography (CT) Quality Register April 1, 2015. odology effective July 1, 2015. See N.Y. Assurance Register April 22, 2015. Notice of Proposed Rulemaking. Implementation of the Protection of Prevention of Infl uenza Transmission The Department of Health proposed People with Special Needs Act and amending section 16.25 and adding Reforms to Incident Management Notice of Adoption. The Offi ce of section 16.59 to Title 10 NYCRR to pro- Notice of Emergency Rulemaking. Mental Health amended Part 509 of tect the public from the adverse effects The Offi ce for People With Develop- Title 14 NYCRR to provide clarifi cation of ionizing radiation. See N.Y. Register mental Disabilities amended Parts 624, and fl exible system for documentation. May 6, 2015. 633, 687 and added Part 625 to Title Filing date: April 2, 2015. Effective 14 NYCRR to enhance protections for date: April 22, 2015. See N.Y. Register Compiled by Francis J. Serbaroli, people with developmental disabilities April 22, 2015. who is a shareholder in the Health & served in the OPWDD system. Filing FDA Business Group of Greenberg Site Based and Community date: March 13, 2015. Effective date: Traurig’s New York offi ce. He is the Prevocational Services March 15, 2015. See N.Y. Register April former Vice Chairman of the New 1, 2015. Notice of Proposed Rulemaking. York State Public Health Council, The Offi ce for People With Develop- writes the “Health Law” column for Medical Use of Marijuana mental Disabilities proposed amend- the New York Law Journal, and is the former Chair of the Health Law ing Subparts 635-10 and 635-99 of Title Notice of Adoption. The Depart- Section. The assistance of Caroline B. 14 NYCRR to distinguish requirements ment of Health added Part 1004 and Brancatella, Associate, of Greenberg for site-based prevocational services amended Subpart 55-2 of Title 10 Traurig’s Health and FDA Business and community prevocational servic- NYCRR to comprehensively regulate Group, in compiling this summary is es. See N.Y. Register April 22, 2015. the manufacture, sale and use of medi- gratefully acknowledged.

18 NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 New York State Fraud, Abuse and Compliance Developments Edited by Melissa M. Zambri

New York State Department of argument that the error was a billing Medicaid claims Health OMIG Audit Decisions or computer “glitch.” The ALJ also during the Compiled by Margaret Surowka rejected the provider’s argument period January Rossi that the overpayments of $26,862.59 2007 through would result in a “death penalty” to December 2009. Island Wide Ambulette Service the provider. The infusion (DOH administrative hearing pharmacy is Coalo Ambulette Service, Inc. decision dated February 15, 2015, not patronized and Azaire Paul (AKA Paul Azaire) William J. Lynch, Administrative by the public, (DOH administrative hearing Law Judge). This was an audit of but rather decision dated November 10, 2014, transportation services for the period only serves between four and seven James F. Horan, Administrative July 1, 2003 through December 31, patients at any particular time. At Law Judge). 2008 with alleged overpayments of This was a review issue were refi lls of prescriptions $1,708,489. The provider who made a of an OMIG determination to which admittedly did not have refi lls timely request for a hearing failed to exclude the transportation provider noted on the prescription but were appear. The provider notifi ed OMIG and owner and to recover for required companion prescriptions that it had recorded the date of the overpayments for services from to those that did have refi lls noted. hearing incorrectly and asked that January 1, 2008 to January 23, 2011. The prescription course was routine the failure to appear be excused. The Provider’s TLC license had expired and had been dispensed previously provider did not make an application in 2007 and provider failed to on other occasions for this patient to vacate the default. As such, the maintain workers’ compensation and the pharmacy admittedly missed ALJ determined that the request for a and disability insurance. Provider that no refi lls were authorized hearing to challenge the recovery had conceded that certain services by the prescriber. The pharmacy been abandoned. billed and purportedly referred by admitted that no call was made to one physician were in fact never the prescriber and there was nothing M.J. Trans. Corp. (DOH provided. The ALJ found that administrative hearing decision noted on the prescription to indicate the OMIG proved that provider that an oral authorization for the dated January 27, 2015, James F. engaged in unacceptable practices. Horan, Administrative Law Judge). refi ll had been obtained pursuant to The provider tried to argue that the Education Law § 6801(4)(a). The ALJ This was an audit of transportation failure to renew its TLC license was services for the period from January sustained the audit fi ndings noting, not Medicaid fraud, but the ALJ “[i]t is a signifi cant error for a 1, 2008 until December 31, 2011. At noted that fraud was not alleged or issue were payments for services pharmacist/pharmacy to refi ll a necessary for there to be a fi nding prescription when no refi lls have where the required driver’s license of unlawfully furnished services. number fi le contained a number been ordered.” The ALJ noted that The ALJ found that and the absence OMIG had not alleged that these with all zeros. This error was made of the TLC license, compensation during data entry. OMIG disallowed were anything more than errors, but and disability insurance were the ALJ noted that they were “errors all such claims. The provider did unacceptable practices. As such, adjust certain of the claims and those for which the Pharmacy should not the ALJ found that the OMIG was have been paid.” adjustments were allowed. OMIG entitled to overpayments. Moreover, indicated that adjustment of claims, the false billings alone, and here Devendra Kumar Shrivastava, though usually allowed within where coupled with unacceptable M.D. (DOH administrative hearing two years from claim submission, practices, warranted the three-year decision dated October 28, 2014, is not supposed to occur during an exclusion of both the owner and the Denise Lepicier, Administrative Law audit. In this case, however, OMIG provider. Judge). This was an audit of physician decided not to seek the repayment claims for services provided to Lifeline Infusion Services, for those claims that were adjusted. patients who were eligible for Inc. (DOH administrative hearing Thus, that issue was not before the both Medicare and Medicaid. The decision dated October 28, 2014, ALJ. As to those claims that were not OMIG reviewed 467 claims that it Denise Lepicier, Administrative adjusted and for which OMIG did alleged had inaccurate information Law Judge). seek repayment, the ALJ upheld the This was an audit of about the existence of or extent of overpayments despite the provider’s infusion pharmacy for all 235 paid Medicare coverage. The ALJ noted

NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 19 that a provider must bill Medicare to appear. The ALJ deemed that the schneiderman-announces-charges- or other insurance fi rst for covered School had abandoned the request against-herkimer-county-certifi ed- services prior to submitting a claim for a hearing and upheld the lower nurse%E2%80%99s-aide. to Medicaid and is responsible overpayment recovery with interest. Bronx Home Health Care Agency for maintaining the Medicare Owners and Consultant Who Failed Explanation of Benefi ts. Since the New York State Attorney General to Pay Workers Pled Guilty—April appellant offered no evidence to Press Releases 23, 2015—Owners of a home health dispute OMIG’s calculations, the ALJ Compiled by Aubrey Roman, Colm care agency and a consultant for upheld its overpayment fi ndings in Ryan and Karen S. Southwick the agency pled guilty to charges the amount of $63,716. $1.025 Million Settlement with for failing to pay 63 home health Ambulette P.R.N., Inc. (DOH Trustees of Nonprofi t—April 29, aides employed by the company. administrative hearing decision 2015—The trustees and former The plea requires the owners to pay dated May 1, 2014, Denise Lepicier, trustees of a fund benefi ting more than $80,000.00 in restitution Administrative Law Judge). This was underprivileged children reached to their former employees. http:// an audit of transportation services. a settlement with the Attorney www.ag.ny.gov/press-release/ The Final Audit Report was issued General’s offi ce to return $1.025 ag-schneiderman-announces-guilty- November 8, 2013 and received at million. The Fund’s leader depleted pleas-bronx-home-health-care- the provider’s mailing address on the nonprofi t’s entire investment agency-owners-and. November 12, 2013. Over 60 days portfolio and shifted the nonprofi t’s Lawsuit Against Board of elapsed and on January 21, 2014, focus to fund his, and a fellow Directors Alleging Mismanagement OMIG received a letter, postmarked trustee’s, personal interests resulting of Two Brooklyn-Based Nonprofi ts January 18, 2014 requesting a hearing. in the Fund’s purchase of a million- Serving Vulnerable Families— At issue was the timeliness of the dollar Southampton home. Prior April 9, 2015—A lawsuit has been request. The provider argued that it to the leader taking offi ce, the commenced against the board of did not receive the Final Audit Report Fund’s focus was making grants directors of two not-for-profi ts for and that OMIG gave it additional to settlement houses and other alleged mismanagement of certain time to request the hearing. OMIG institutions serving children in New properties and gross negligence. had the signed return receipt of York City, providing approximately These organizations were created to the mailing to the address of the $250,000.00 per year in grants. The provide housing and support services provider and the United States Postal Attorney General’s offi ce will turn for pregnant women, young mothers Service online tracking. The Final over the settlement payments, less and their children. An investigation Audit Report was never returned to costs, to the Fund whose entire board by the Attorney General’s offi ce OMIG. In light of this, the provider will be replaced by new trustees, revealed that board members listed cannot overcome the presumption acceptable to the Attorney General’s certain townhouses jointly operated of delivery. As to additional time to Charities Bureau. http://www.ag.ny. by the nonprofi ts for sale without request the hearing, although OMIG gov/press-release/ag-schneiderman- necessary approval from the Charities acknowledged that the provider announces-1025-million-settlement- Bureau or a state court after being called after the time to request a trustees-nonprofi t-squandered-assets. “[l]ured by a lucrative real-estate hearing, the provider was advised Charges Against Herkimer market in Brooklyn” for personal to contact the legal department. County Certifi ed Nurse’s Aide gain. The lawsuit has been fi led in Without proof that OMIG granted Accused of Striking a Nursing Brooklyn County Supreme Court. an extension, the time to request the Home Resident—April 28, 2015—A http://www.ag.ny.gov/press- hearing would not be extended. The Certifi ed Nurse Aide was arrested release/ag-schneiderman-announces- ALJ therefore denied the provider’s and arranged on charges of lawsuit-against-board-directors- request for a hearing. Endangering the Welfare of an alleging-mismanagement-two. Lake Grove, Durham and Maple Incompetent or Physically Disabled EMT Who Stole from Queens Valley Schools (DOH administrative Person in the First Degree and at least Volunteer Ambulance Corps hearing decision dated April 30, one other charge after she allegedly Sentenced to Jail—April 3, 2015—A 2014, David Lenihan, Administrative struck a resident. A second defendant volunteer emergency medical Law Judge). This was an audit of a in the action was charged with technician who was convicted of school seeking restitution of over $1.1 making a false statement to protect stealing more than $300,000.00 from million. The Final Audit Report had the Nurse and for failing to promptly a volunteer ambulance service was sought over $1.4 Million but after the report the incident. The maximum sentenced to serve four months request for a hearing, OMIG removed penalty for the endangerment charge in jail and fi ve years probation, in several fi ndings. The School failed is three years in prison. http:// addition to paying full restitution. to reschedule the hearing and failed www.ag.ny.gov/press-release/ag-

20 NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 The individual pled guilty to Grand GNC. The agreement will outline to pay for personal expenses Larceny in January 2015. http:// and implement new standards in including her school taxes and pet www.ag.ny.gov/press-release/ authenticating herbal supplements, and farm supplies. She faces 1 1/3 to ag-schneiderman-announces-jail- ensure the purity of herbal 4 years in prison if convicted. http:// sentence-emt-who-stole-queens- supplements, and increase consumer www.ag.ny.gov/press-release/ volunteer-ambulance-corps. education about herbal supplements’ ag-schneiderman-announces- chemical content. http://www.ag.ny. arrest-former-not-profi t-director- Arrest of Aide Accused of gov/press-release/ag-schneiderman- defrauding-medicaid-and. Assaulting Queens Nursing Home announces-agreement-gnc- Resident— Settlement with Health Plan April 2, 2015—A certifi ed implement-landmark-reforms-herbal- to End Wrongful Denial of Mental nurse aide was arrested on felony supplements. charges in Queens County, accused Health and Addiction Services— of assaulting an 80-year-old resident. Arrest of Nurse for Stealing March 18, 2015—A Health Plan It is alleged that in August of 2014, Narcotics from Nursing Home— agreed to cover residential treatment the nurse pushed and hit the resident March 26, 2015—A former employee for behavioral health conditions and multiple times, and caused her face of a nursing home was arrested reform its procedures for evaluating to hit the bed rail. Ultimately the for allegedly stealing several pills behavioral health treatment claims. resident required treatment at a local containing oxycodone from the In addition, the settlement agreement hospital to treat her resulting injuries. nursing facility’s emergency pain requires the Health Plan to provide The nurse no longer works at the medication supply between January notice of a new appeal right to facility. If convicted of the top count, 23, 2013 and February 2, 2013. It is 3,300 members whose requests the nurse will face up to seven years alleged that the theft was concealed for inpatient substance abuse in state prison. http://www.ag.ny. when the accused falsifi ed records rehabilitation and eating disorder gov/press-release/ag-schneiderman- and forged the signatures of residential treatment were previously announces-arrest-aide-accused- medication nurses, indicating that denied. The estimated value of the assaulting-queens-nursing-home- the medications were administered denial of these requests is up to $9 resident. to residents at the facility. The nurse million. http://www.ag.ny.gov/ faces up to four years in prison press-release/ag-schneiderman- Fishkill Nonprofi t Serving for the Class E felony of falsifying announces-settlement-excellus- New Yorkers with Disabilities to business records in the fi rst degree health-plan-end-wrongful-denial- Repay Medicaid $363,000 for Using and up to one year in jail for several mental. Unqualifi ed Staff— April 1, 2015—A other Class A misdemeanor charges. Indictment of Nonprofi t and Its Fishkill-based nonprofi t providing http://www.ag.ny.gov/press- Top Executives for Participating in services to disabled New York release/ag-schneiderman-announces- an Organized Crime Ring—March residents and their families used arrest-nurse-stealing-narcotics- 18, 2015—The chief executive unqualifi ed individuals to provide nursing-home. services to Medicaid recipients offi cer, former chief executive who participated in the Home and Arrest of Former Not-for-Profi t offi cer and controller of a nonprofi t Community Based Services Program Director for Defrauding Medicaid substance abuse treatment provider offered by the New York State Offi ce and Stealing from a Developmentally were arrested and indicted in of Persons with Developmental Disabled Individual—March a superseding indictment that Disabilities (“OPWDD”). As a result 19, 2015—A former executive expanded on an earlier indictment of utilizing an underqualifi ed staff director of a not-for-profi t serving from October 2014. The Attorney to provide services to Medicaid developmentally disabled individuals General alleges that the provider recipients, the agency agreed to defrauded Medicaid for services stole $27 million from the Medicaid reimburse Medicaid $363,643.00. rendered to the not-for-profi t’s program by providing excessive http://www.ag.ny.gov/press- consumers and stole funds of a services, operating an unregulated release/ag-schneiderman-announces- developmentally disabled person. residential treatment program and agreement-fi shkill-nonprofi t-serving- The executive director provided violating patient rights. http:// new-yorkers. group services to the same consumers www.ag.ny.gov/press-release/ag- of two entities on overlapping dates schneiderman-announces-indictment- New York Attorney General and times resulting in Medicaid nonprofi t-narco-freedom-and-its-top- Announced Agreement to paying the not-for-profi t $2,207.79 executives. Implement Landmark Reforms for for services that should not have Herbal Supplements— Kickback Settlement with March 30, been paid. She also used over Pharma Manufacturer—March 16, 2015—A landmark agreement was $1,000 from the bank account of a 2015—A global pharmaceutical announced between New York and developmentally disabled consumer the Pennsylvania-based retailer company agreed to a settlement with

NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 21 all fi fty states to resolve allegations of Scheme to Defraud in the First reform its claims review process and it violated the False Claims Act by Degree and agreed to six months pay a $900,000 penalty. The Attorney using lavish meals and speaker of incarceration and fi ve years of General’s Health Care Bureau found programs to induce physicians to probation. http://www.ag.ny.gov/ that the company issued denials twice prescribe its drugs. The company press-release/ag-schneiderman-and- as often for behavioral health claims agreed to pay the United States and ig-scott-announce-guilty-plea-oneida- as insurers did for other medical or state Medicaid programs $39 million. county-individual-who-engaged. surgical claims and four times as The New York State Medicaid often for addiction recovery services. Settlement with Rockland program will receive $2,339,671. In addition to overhauling its claim County Mental Health Facility That http://www.ag.ny.gov/press- review process, the company agreed Altered Records Prior to a Medicaid release/ag-schneiderman-announces- to cooperate with an independent Audit—March 9, 2015—A mental kickback-settlement-pharma- appeal process for claims that had health facility agreed to pay $304,000 manufacturer-daiichi-sankyo. been previously denied due to lack of to resolve claims that its managers medical necessity or lack of coverage Agreement with Pharmacy altered records in advance of a for residential treatment. http:// Ensuring Accessibility for Deaf Medicaid audit. The facility admitted www.ag.ny.gov/press-release/ag- and Hard-of-Hearing Customers— that over forty handwritten changes schneiderman-announces-settlement- — March 12, 2015 A Pharmacy agreed were made to records prior to the valueoptions-end-wrongful-denial- to install an assistive listening audit so that they would appear mental-health. system and implement new policies to support claims that the facility concerning communication with submitted for reimbursement. http:// Sentencing of Oral Surgeon who customers who are deaf or hard of www.ag.ny.gov/press-release/ag- Stole Over $14,000 from New York hearing to improve access to services schneiderman-announces-settlement- State—February 26, 2015—An oral and ensure effective communication rockland-county-mental-health- surgeon who contracted with DOCCS with pharmacists. http://www.ag.ny. facility-altered. to provide specialty dental care for gov/press-release/ag-schneiderman- inmates at correctional facilities pled Sentencing of Former Offi ce secures-agreement-kinney-drugs- guilty to billing DOCCS for surgical Manager for Stealing $11,828 from ensuring-accessibility-deaf-and-hard. procedures that he did not perform Residents of an Assisted Living by “upcoding” lower rate procedures Agreement with Health Plan Facility— — March 5, 2015 A joint at a higher reimbursement rate. The to Boost Coverage for Preventative investigation between MFCU and the oral surgeon pled guilty to Offering Services— — March 11, 2015 A Health Newark Police Department found a False Instrument for Filing in the Plan agreed to send nearly $400,000 that the offi ce manager of a senior Second Degree and was sentenced to its members for anesthesiology living center stole $11,828 from in Albany County Court to six services provided in connection three residents by failing to deposit months’ incarceration and ordered with an in-network preventative money a family sent a resident, to pay $14,640 in restitution. http:// colonoscopy. The Plan should stealing a check from a resident www.ag.ny.gov/press-release/ not have required its members to and using forged checks to illegally ag-schneiderman-and-ig-scott- make a copayment, coinsurance or obtain money. The offi ce manager announce-sentencing-oral-surgeon- deductible for these services because pled guilty to one count of Criminal who-stole-over-14000-new. the Affordable Care Act requires Possession of a Forged Instrument in health plans to cover recommended the Second Degree and two counts $800,000 Settlement With Bronx preventative services without of Petit Larceny and was sentenced Nonprofi t That Diverted Money member cost-sharing. http:// to “shock probation” which includes Intended for Services for Elderly— www.ag.ny.gov/press-release/ag- six months’ incarceration, fi ve years’ February 25, 2015—A downstate schneiderman-announces-agreement- probation, an order of restitution nonprofi t has agreed to pay the emblemhealth-boost-coverage- and an order of protection in favor Medicaid program $800,000 after preventive-services. of the victims. http://www.ag.ny. allegedly spending Medicaid funds gov/press-release/ag-schneiderman- in violation of the organization’s Individual Enters Guilty Plea for announces-sentencing-former-offi ce- funding agreement with the NYC Engaging in Scheme to Defraud for manager-stealing-11828-residents. Human Resource Administration. Hospital Visits— — March 10, 2015 The Attorney General’s investigation Settlement to End Wrongful An individual who made frequent revealed that these funds were used Denial of Mental Health and hospital visits received $201,335 to make mortgage payments on the Substance Abuse Treatment from his insurance company over organization’s headquarters. http:// Services— — approximately fi ve years, but failed March 5, 2015 A managed www.ag.ny.gov/press-release/ag- to utilize these funds to pay bills care company that administers schneiderman-announces-800000- relating to his hospital treatment. The behavioral health benefi ts for about settlement-bronx-nonprofi t-diverted- individual pled guilty to one count 2.7 million New Yorkers agreed to money-intended.

22 NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 $6 Million Settlement with Utica Nurse Arrested for over the costs. The individual and Bronx For-Profi t Hospice Provider Allegedly Failing to Provide the nonprofi t are each charged Following Joint Investigation Notifi cation of Patient’s Panic-High with one count of Grand Larceny Between Attorney General and Potassium Level in Laboratory in the Second Degree, a Class C U.S. Attorney Bharara—February Results—February 17, 2015—A Utica felony; fi ve counts each of Criminal 18, 2015—A Bronx County hospice Licensed Practical Nurse was arrested Possession of a Forged Instrument in agency agreed to pay $1.68 million and charged with Endangering the Second Degree, a Class D felony, to Medicaid and $4.32 million to the Welfare of an Incompetent or and Offering a False Instrument for Medicare in response to state and Physically Disabled Person in the Filing in the First Degree, a Class E federal government allegations that it Second Degree and Willful Violation felony; and ten counts of Falsifying submitted claims for reimbursements of Health Laws for allegedly failing Business Records in the First Degree, and received payment for hospice to report panic-high potassium levels a Class E felony. The individual faces services not rendered or inadequately appearing in a patient’s laboratory up to fi fteen years in prison. http:// provided. As part of the settlement, test results. Panic-high potassium www.ag.ny.gov/press-release/ the hospice provider admitted that levels can cause arrhythmia and ag-schneiderman-announces-arrest- it did not treat patients according to cause the heart to stop. The nurse westchester-nonprofi t-executive- an individualized plan of care, did allegedly failed to follow protocol by scheme-involving. not ensure that plans of care were not reporting the laboratory results being followed for each patient, failed to a doctor or a nursing supervisor, Erie County Nurse Aide Pleads to make nursing services routinely placing the patient’s health at serious Guilty for Taking and Exchanging available, failed to ensure that risk. The patient was given another Compromising Photograph of nursing services were provided in medication to lower his potassium Incontinent Patient Via Snapchat— accordance with a plan of care, failed level. http://www.ag.ny.gov/press- February 3, 2015—A former to maintain adequate clinical records release/ag-schneiderman-announces- employee pled guilty to the charge and failed to ensure that compliance arrest-utica-nurse-allegedly-failing- of Willful Violation of Health Laws audit results refl ected adherence to provide-notifi cation. and was sentenced to one year all applicable regulations. http:// conditional discharge with 100 hours Westchester Nonprofi t Executive www.ag.ny.gov/press-release/ag- of community service for taking Arrested for Alleged Involvement in schneiderman-announces-6-million- and exchanging a compromising Scheme Involving State Program to settlement-bronx-profi t-hospice- photograph of an elderly patient in Assist Seniors and the Disabled— provider-following. a state of undress and sharing it via February 4, 2015—The executive Snapchat. A manager for the aide Capital Region Nursing director of a Yonkers-based nonprofi t stated the photograph was taken Home Aide Arrested for Allegedly that specialized in securing state- for no legitimate purpose and the Injuring 83-Year-Old Nursing Home funded service contracts that resident lacked the mental capacity Resident—February 17, 2015—A provided construction and moving to consent to the taking of the Glens Falls Certifi ed Nurse Assistant services to the elderly and disabled photograph. The aide surrendered his was arrested and arraigned on when moving from nursing homes CNA certifi cate. http://www.ag.ny. charges that she endangered the into the community was charged gov/press-release/ag-schneiderman- welfare of a nursing home resident with falsifying bids to the Nursing announces-arrest-and-guilty-plea- by failing to provide appropriate care Home Transition and Diversion erie-county-nurse-aide-taking-and. to an 83-year-old woman, resulting Program (“NHTD Program”), a in the resident fracturing her hip. New York State Department of Settlement Reached With Health The nurse is accused of failing to Health program. The individual Plan Over Excessive Co-Pays— follow the resident’s plan of care that allegedly falsifi ed and submitted January 12, 2015—An agreement required the assistance of two people bids for NHTD Program projects. was reached with a health plan and left the resident unattended. By falsifying the bids, the individual requiring that its contracted health The nurse was arraigned on charges controlled which contractor won the care providers issue refunds to nearly of Endangering the Welfare of an bid. He then used the falsifi ed bid to 3,000 customers in the Rochester Incompetent or Physically Disabled infl ate the amount Medicaid paid the area for charging excessive co- Person in the Second Degree, a class nonprofi t as its share of the project. pays. The plan had issued incorrect A Misdemeanor, and Willful Violation In addition, he allegedly demanded Explanations of Benefi ts, which of Health Laws, a Misdemeanor. and received kickbacks from a NHTD imposed an additional specialty http://www.ag.ny.gov/press- Program project contractor and fi led co-payment for member visits to a release/ag-schneiderman-announces- claims in the transition program for primary care provider. Upon inquiry, arrest-capital-region-nursing-home- moving expenses that were never the plan acknowledged the erroneous aide-over-injury-83-year. provided or signifi cantly infl ated Explanations of Benefi ts and explained the issue stemmed from the

NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 23 changing of certain tax identifi cation the resident from her wheelchair to Complete List of Posted Audit numbers. http://www.ag.ny.gov/ her bed without the assistance of Protocols—http://www.omig. press-release/ag-schneiderman- another staff person. Documents fi led ny.gov/audit/audit-protocols. announces-settlement-health-insurer- in the case allege that as a result of over-excessive-copays-customers. the transfer, the resident sustained Ms. Zambri is a partner in the a laceration to her right leg that the Manhattan Dentist Arrested and Albany Offi ce of Barclay Damon aide and another uncharged aide Charged With Filing False Claims for LLP and the Chair of the Firm’s attempted to cover up by bandaging Dental Services— Health Care and Human Services January 8, 2015—A the wound and failing to report Practice Area, focusing her practice Manhattan dentist was arrested for the injury. The felony complaint on enterprise development and fi ling false claims and stealing $11,479 fi led in the Suffolk County First regulatory guidance for the health from Medicaid for providing services District Court charges the aide with care industry. She is also an to patients he never met or treated felony Falsifying Business Records Adjunct Professor of Management only in prior years. The complaint in the First Degree, misdemeanor at the Graduate College of Union alleges that a patient of the defendant Endangering the Welfare of an University, teaching Legal Aspects was unaware of the dentist and never Incompetent or Physically Disabled of Health Care. received the services for which the Person, and misdemeanor Willful dentist billed Medicaid. The dentist Violation of Health Laws. http:// Ms. Rossi is Counsel to Barclay was charged with one count of Grand www.ag.ny.gov/press-release/ Damon LLP in its Albany Offi ce, Larceny in the Third Degree, a Class ag-schneiderman-announces-arrest- focusing her practice on health care D Felony, and one count of Offering aide-accused-endangering-suffolk- law, advising health care providers a False Instrument For Filing in the nursing-home. on federal and state statutory First Degree, a Class E Felony. http:// and regulatory compliance, and www.ag.ny.gov/press-release/ New York State Offi ce of the representing health care providers ag-schneiderman-announces-arrest- Medicaid Inspector General Update in response to audits, investigations dentist-medicaid-theft. Compiled by the Editor and disciplinary matters. $300K Settlement Reached Performing Provider System Ms. Roman is a litigation with Queens-Based Transportation Lead Guidance Posted—April 6, associate in the Albany Offi ce of Provider Resolving Allegations of 2015—http://www.omig.ny.gov/ Barclay Damon LLP. Her practice Overbilling—January 5, 2015—A latest-news/847-the-new-york-state- includes health care litigation, Queens-based transportation offi ce-of-the-medicaid-inspector- commercial litigation, labor and company will pay $300,000 to settle general-omig-has-posted-new- employment, and torts defense. claims that it overbilled Medicaid compliance-guidance. for transportation services. Apple Colm Ryan is an associate in the admitted that between January Holding Company and Joint Healthcare Controversies Practice 1, 2004 and October 30, 2008, it Venture Structures Compliance Area of Barclay Damon LLP. He has frequently billed Medicaid for Guidance Posted—April 3, 2015— represented health care providers ambulette services even though no http://www.omig.ny.gov/latest- in administrative proceedings, personal assistance was provided to news/844-compliance-guidance- hearings and appeals involving Medicaid recipients, which resulted posted. various state agencies including in Medicaid paying for ambulette the New York State Department 2015-2016 Budget Testimony— services at rates that were higher than of Health and the Offi ce of the February 3, 2015—http://www. the applicable livery rates. http:// Medicaid Inspector General. www.ag.ny.gov/press-release/ omig.ny.gov/latest-news/841-omig- ag-schneiderman-announces- budget-testimony. Ms. Southwick is a litigation associate in the Syracuse Offi ce of 300k-settlement-queens-based- Medicaid Providers Revalidating Barclay Damon LLP, focusing her transportation-provider. Enrollment: Mandatory Compliance practice on white collar defense, Program Obligations and Certifi ed Nurse Aide Arrested including representing health care Certifi cation Requirement Upon and Charged with Endangering providers in response to audits and Revalidation—January 27, 2015— the Welfare of a Nursing Home investigations. Resident—December 15, 2014—A http://omig.ny.gov/images/ certifi ed nurse aide was arrested on stories/compliance_alerts/20150127_ charges she endangered the welfare Compliance_Guidance_2015_01_ of a 92-year-old wheelchair-bound fi nal_1_27_15.pdf. resident for allegedly illegally moving

24 NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 In the Law Journals

A Compelling Interest? Using Old Kickbacks and Contradictions: The Anti- Separation Of Powers— New York Court Conceptions Of Public Health Law To Kickback Statute and Electronic Health Of Appeals Affi rms Invalidation Of Soda Challenge The Affordable Care Act’s Records, Daniel E. Rheiner 17 Vand. J. Portion Cap, 128 Harv. L. Rev. 1508 Contraceptive Mandate, Joshua Joel, 31 Ent. & Tech. L. 493 (2015). (2015). Ga. St. U.L. Rev. 613 (2015). Narrow Networks, the Very Sick, and the Something Catchy: Nursing Home Are Physician-Patient Communications Patient Protection and Affordable Care Liability in the Senior Sexually Protected By The First Amendment?, Act: Recalling the Purpose of Health Transmitted Disease Epidemic, Martha Swartz, 2015 Cardozo L. Rev. Insurance and Reform, Valarie Blake, 16 Alexander Warso, 22 Elder L.J. 491 De Novo 92 (2015). Minn. J.L. Sci. & Tech. 63 (2015). (2015). Bankruptcy And Health Insurance Navigating The Law Of Defense Substance Use Disorder Parity Under Proceeds: Why Health Care Providers Counsel Ex Parte Interviews Of Treating the Patient Protection and Affordable Should Not Be Subject To The Automatic Physicians, Joseph Regalia and V. Care Act: Improvements Made, but Stay Provision, Kenneth N. Schott III, Andrew Cass, 31 J. Contemp. Health Further Government Action Needed to 53 Duq. L. Rev. 279 (2015). L. & Pol’y 35 (2015). Guarantee Full Parity in the Private Insurance Market, Amanda Flood, 10 J. Enforcement Overdose: Health Care Physician Assistant Scope Of Practice , Health & Biomed. L. 363 (2015). Fraud Regulation In An Era Of Ann Davis, Stephanie M. Radix, Overcriminalization And Overtreatment, James F. Cawley, Roderick S. Hooker The Future Of Direct-To-Consumer Isaac D. Buck, 74 Md. L. Rev. 259 and Carson S. Walker, Ann. Health L. Genetic Testing: Regulation And (2015). 286 (2015). Innovation, Chelsea Weiermiller, 16 N.C. J.L. & Tech. On. 137 (2015). Enforcing Mental Health Parity Through Piercing The Veil: The Limits Of Brain the Affordable Care Act’s Essential Death As A Legal Fiction, Seema K. The Hospital Readmission Reduction Health Benefi t Mandate, Kathleen G. Shah 48 U. Mich. J.L. Reform 301 Program: Fraud And Abuse Concerns, Noonan and Stephen J. Boraske, 24 (2015). Courtney Mathews, 17 Depaul J. Ann. Health L. 252 (2015). Health Care L. 31 (2015). Protecting Our Herd: How A National Free Speech, Free Press, Free Religion? Mandatory Vaccination Policy Protects When Will CMS “Pull the Trigger?” The Clash Between the Affordable Public Health By Ensuring Herd The Independent Payment Advisory Care Act and the For-Profi t, Secular Immunity, Ellen C. Tolsma, 18 J. Board and the Future of Medicare Corporation, Elizabeth M. Silvestri, 48 Gender Race & Just. 313 (2015). Cost-Containment Policy: A Coming Suffolk U. L. Rev. 257 (2015). Constitutional Clash, Nicholas Sumski, Removing Access To Health Care From 10 J. Health & Biomed. L. 441 (2015). FTC Orders In Health-Related Employer And State Control: The ACA Advertising Cases: From A New As Anti-Subordination Legislation, W. Who Defi nes “Healthy”? Ethical Approach To The New Normal, Eric David Koeninger, 44 U. Balt. L. Rev. Dilemmas Across Competing Interest Berman, 29 Antitrust ABA 98 (2015). 201 (2015). Groups On Genetic Manipulation And Gene Patents, Haley Guion, 17 Depaul Health Care: The Globalization Of Health Removing The Menacing Specter Of J. Health Care L. 47 (2015). Care, Sara Rosenbaum, 50 Tulsa L. Elder Abuse In Nursing Homes Through Rev. 607 (2015). Video Surveillance, Katherine Anne Symposium: 2014 Public Health Law Meier, 50 Gonz. L. Rev. 29 (2015). Conference: Intersection Of Law, Policy Holding Health Insurance Marketplaces And Prevention, 43 J.L. Med. & Ethics Accountable: The Unheralded Rise And Rethinking The Childhood-Adult Divide: 1 (2015). Imminent Demise Of Structural Reform Meeting The Mental Health Needs Of Litigation In Health Care, Sarah L. Emerging Adults, Barbara L. Atwell, 25 • Letter From The Editor, Courtney Grusin, 24 Ann. Health L. 337 (2015) . Alb. L.J. Sci. & Tech. 1 (2015). McClellan Implementing Health Reform In An Rule Of Reason Without A Rhyme: • Introduction: Putting Law to Era of Semi-Cooperative Federalism: Using “Big Data” To Better Analyze Work to Improve Public Health: Lessons from the Age 26 Expansion, Accountable Care Organizations Under A National Convening, Donna E. Sara Rosenbaum, Alexander B. Blum, The Medicare Shared Savings Program, Levin Amanda Giordano, M. Jane Park Shaun E. Werbelow, 90 N.Y.U.L. Rev. • Community Experiments in and Claire D. Brindis, 10 J. Health & 361 (2015). Public Health Law and Policy Biomed. L. 327 (2015). ,

NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 25 Angela K. McGowan, Gretchen • Hospitals, Collaboration, and • Emergency Preparedness and G. Musicant, Sharonda R. Wil- Community Health Improvement, Response for Disabled Individuals: liams and Virginia R. Niehaus Martha H. Somerville, Laura Implications of Recent Litigation, Seeff, Daniel Hale, and Daniel Lainie Rutkow, Holly A. Taylor, • Domestic Legal Preparedness And J. O’Brien and Lance Gable Response To Ebola, James G. Hodge, Jr., Matthew S. Penn, • Tribal Water Rights: Explor- • Bridging the Gap between Science Montrece Ransom, and Jane E. ing Dam Construction in In- and Law: The Example of Tobacco Jordan dian Country, Jerilyn Church, Regulatory Science, Micah L. Chinyere O. Ekechi, Aila Hoss, Berman and Annice E. Kim • Lessons Learned from the Expan- and Anika Jade Larson sion of Naloxone Access in Mas- • From Beginning to End: The sachusetts and North Carolina, • State Health Department Employ- Importance of Evidence-Based Corey S. Davis, Alexander Y. ees, Policy Advocacy, and Politi- Policymaking in Vaccination Walley, and Colleen M. Bridger cal Campaigns: Protections and Mandates, Daniel G. Orenstein Limits Under the Law, Shannon and Y. Tony Yang • E-Cigarettes: Policy Options and Frattaroli, Keshia M. Pollack, Legal Issues Amidst Uncertainty, • Legal Challenges to the Interna- Jessica L. Young, and Jon S. Nancy Kaufman and Margaret tional Deployment of Govern- Vernick Mahoney ment Public Health and Medical • Harnessing the Public Health Personnel during Public Health Creating Legal Data for Public • Power of Model Codes to Increase Emergencies: Impact on National Health Monitoring and Evalua- Drinking Water Access in Schools and Global Health Security, Brent tion: Delphi Standards for Policy and Childcare, Cara L. Wilking, Davidson, Susan Sherman, Surveillance, David Presley, Angie L. Cradock, and Steven Leila Barraza, and Maria Julia Thomas Reinstein, Damika L. Gortmaker Marinissen Webb-Barr, and Scott Burris • Adventures in Nannydom: Symposium: Keeping It Fresh?: Lessons from the Residual New- • Reclaiming Collective Action for Exploring The Relationship Between born Screening Dried Blood the Public’s Health, Lindsay F. Food Laws And Their Impact On Public Sample Litigation, Michelle Wiley, Wendy E. Parmet, and Health And Safety, 5 Wake Forest J. L. Huckaby Lewis Peter D. Jacobson & Pol’y 39 (2015). • Shared Use and Safe Routes to • Mental Health Emergency Deten- • Lessons From The Demise Of The School: Managing the Fear of tions and Access to Firearms, Jon Sugary Drink Portion Cap Rule, Liability, Benjamin D. Winig, S. Vernick, Emma E. McGinty, Katherine Pratt John O. Spengler, and Alexis M. and Lainie Rutkow Etow • Public Policy & Obesity: Over- • Human Health Impacts of Climate view And Update, Rogan Kersh • Defi ning Commercial Speech Change: Implications for the Prac- and Brian Elbel in the Context of Food Market- tice and Law of Public Health, Jill ing, Jennifer L. Pomeranz and • Exploring The Relationship Krueger, Paul Biedrzycki, and Sabrina Adler Between Food Laws And Their Sara Pollock Hoverter Impact On Public Health And • Navigating the Incoherence of Big • Is Sharing De-identifi ed Data Safety: Article: The Obesity Gene Data Reform Proposals , Nicolas Legal? The State of Public Health And The (Misplaced) Search For Terry Confi dentiality Laws and Their A Personalized Approach To Our • The Role of Law in Supporting Interplay with Statistical Dis- Weight Gain Problems, Timothy Secondary Uses of Electronic closure Limitation Techniques, Caulfi eld Health Information Courtney McClellan, Assistant , Tara Ram- “Yes, In Your Backyard!” Model Editor Victor Richardson, Sallie • anathan, Cason Schmit, Ak- Legislative Efforts To Prevent Milam, and Denise Chrysler shara Menon, and Chanelle Fox Communities From Excluding • The Health in All Policies (HiAP) • The Four Stages of Youth Sports Cafos, Vanessa Zboreak Approach and the Law: Prelimi- TBI Policymaking: Engagement, • Food Policy And Cognitive Bias, nary Lessons from California and Enactment, Research, and Reform, Paul F. Campos Chicago, Claudia Polsky, Ken- Hosea H. Harvey, Dionne L. dall Stagg, Maxim Gakh, and Koller, and Kerri M. Lowrey • Ppaca Wellness Regulations: The Christine T. Bozlak Destruction Of Plan-Sponsored Tobacco Programs, Stephen Frost

26 NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 Symposium: The Law of Medicare and Medicaid at Fifty, 15 Yale J. Health For Your Information Pol’y L. & Ethics 1 (2015). By Claudia O. Torrey • Introduction: Abbe R. Gluck Dear Colleagues, • Keynote Speech: Obamacare, As I pen this message to you, it has unfortunately been one month since Medicare, and Baseball’s Greatest one of my parents suffered a stroke; at this writing, it appears that the progno- Pitchers, Jonathan Cohn sis is a “long,” but hopefully productive Summer in rehab. Thus, the absence • Medicare Advantage, Account- of the usual “FYI” column; the plan is to return in the next Journal issue. able Care Organizations, and I share this information with you for two reasons: (1) you are “like extend- Traditional Medicare: Synchroni- ed family” that I interact with and (2), because as health lawyers we know that zation or Collision?, Thomas L. at some point on this journey called life we will all be patients! We also know Greaney that sometimes we have to be a non-controversial patient advocate, wherein • The Universality of Medicaid at “a little bit of medical knowledge” is a good thing (smiles). Fifty, Nicole Huberfeld Thank you in advance for your prayers and/or positive thoughts. Best • Multiple Medicaid Missions: wishes for a reﬂ ective Fourth of July holiday and a good Summer! Targeting, Universalism, or Both?, John V. Jacobi Claudia O. Torrey, Esq. is a Charter Member of the Health Law Section. • The Accidental Administrative Law of the Medicare Program, Eleanor D. Kinney • Medicare at 50: Why Medicare- for-all Did Not Take Place, Theodore R. Marmor and Kip Sullivan Follow NYSBA on Twitter • Medicaid at 50: No Longer Lim- ited to the “Deserving” Poor?, David Orentlicher, MD, JD visit www.twitter.com/nysba • Clash of the Titans: Medicaid and click the link to follow us and Meets Private Health Insurance, Sara Rosenbaum stay up-to-date on the latest news from the Association • Out of the Black Box and Into the Light: Using Section 1115 Med- icaid Waivers to Implement the Affordable Care Act’s Medicaid Expansion, Sidney D. Watson • Social Insurance Is Missing a Piece: Medicare, Medicaid, and Long-Term Care, Judy Feder • 1332 Waivers and the Future of State Health Reform, Heather Howard and Galen Benshoof • Medicare, Medicaid, and Pharma- ceuticals: The Price of Innovation, Daniel J. Kevles • Challenges for People with Dis- abilities within the Health Care Safety Net, Michael R. Ulrich

NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 27 Medical, Ethical and Legal Obligations to Honor Individual Preferences Near the End of Life By Patricia A. Bomba and Jonathan Karmel

I. Introduction the patient is not able to do so and there is no HCA.4 In The Patient Self-Determination Act1 affi rms an in- addition, the Surrogate’s Court Procedure Act (SCPA) sec- dividual’s right to accept or refuse treatment. This right tion 1750-b permits a SCPA Article 17-A guardian or an does not end when a person is near the end of life. Specif- actively involved family member to make medical decisions for individuals with developmental disabilities (DD) ically, an individual has the right to accept or refuse any 5 or all life-sustaining treatment near the end of life. Deci- who lack the ability to make these decisions. sions to forgo life-sustaining treatment may change in the HCAs and Public Health Law (PHL) surrogates may fi nal year of life as the person’s health status, prognosis not undo health care decisions the patient already made and personal goals for care transition from focusing on before losing capacity.6 Nor can they disregard the prefer- longevity, to functionality, to quality of life. A seriously ill ences and values of the patient, including the patient’s person who might die in the next year, and has the abil- religious and moral beliefs, and substitute their own pref- ity to make medical decisions regarding life-sustaining erences or values when making new health care decisions treatment, should discuss goals, values and wishes with a after the patient loses capacity.7 Health care professionals physician, and complete the New York State Department also have an ethical obligation to honor individual prefer- of Health (NYSDOH) Medical Orders for Life-Sustaining ences and cannot disregard the values, preferences and 2 Treatment (MOLST) form (DOH-5003). prior decisions made by the patient in favor of requests for treatment made by the HCA, PHL surrogates, family Based upon the individual’s goals for care, the patient 8 may choose to allow natural death and forgo an attempt or other loved ones. at cardiopulmonary resuscitation (CPR). For example, Both FHCDA and SCPA1750-b have explicit guide- an individual may request a Do Not Resuscitate (DNR) lines and special requirements for making decisions to medical order, while still wishing to have a trial of intu- withhold and/or withdraw life-sustaining treatment. In bation and mechanical ventilation, and hospitalization. all cases, the statutes affi rm “person-centered” care and As the health status worsens, the patient may consent require that treatment decisions be based upon the indi- to a Do Not Intubate (DNI) medical order in addition to vidual’s personal values, beliefs and goals for care and not the DNR order. When this individual’s condition further those of the decision-maker. deteriorates, having no further hospitalizations may be requested by the patient. At each stage, no matter the II. The Ethical-Legal Framework for Making decision, this individual has a right to be treated with Medical Decisions dignity and respect. A. Health Care Proxy Law Health care providers will always offer comfort A HCA may make medical decisions on behalf of a measures (palliative care) despite the medical orders to patient (principal), after two physicians concur that the discontinue certain treatment contained in the MOLST. patient lacks medical decision-making capacity. A HCA Comfort measures have the primary goal of relieving is generally authorized to make decisions as if the HCA pain and other symptoms and reducing suffering. Food were the principal. Occasionally, the health care proxy and fl uids will be offered by mouth. Medications, reposi- document may limit the authority of the HCA. A HCA is tioning, wound care, and other measures such as oxygen, required to make decisions according to the principal’s suctioning and manual treatment of airway obstruction wishes, including religious and moral beliefs. If these will also continue to be used to relieve pain and suffering. wishes are not reasonably known and cannot with reason- There are several statutes governing the ethical able diligence be ascertained, the HCA may make deci- framework for withholding and/or withdrawing life- sions according to the principal’s best interests, except sustaining treatment, if an individual loses the capacity for a decision to withhold or withdraw artifi cial nutrition to make these decisions. The Health Care Proxy Law or hydration. A HCA is authorized to make a decision to empowers an adult to appoint a health care agent (HCA) withhold or withdraw artifi cial nutrition or hydration to make treatment decisions based on known wishes or only if the HCA has reasonable knowledge of the princi- best interests.3 The Family Health Care Decisions Act pal’s wishes regarding the administration of artifi cial nu- (FHCDA) enables a patient’s family member or close trition and hydration.9 “Clear and convincing evidence” friend (Public Health Law surrogate) in a hospital or of the principal’s wishes is NOT needed for a HCA to nursing home setting to make health care decisions when make decisions about life-sustaining treatment. However,

28 NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 a HCA cannot override a principal’s prior instructions The FHCDA surrogate must be fully informed about to health care professionals or the principal’s advance the patient’s medical condition and the risks, benefi ts, directive.10 burdens and alternatives of possible life-sustaining treatment. The FHCDA surrogate must then consent to with- Before choosing a HCA, there are very important is- holding or withdrawing life-sustaining treatment, for sues for the principal to consider. This person must, or at which medical orders are written. The surrogate’s assess- least should:11 ment must be based upon the consideration of: • Meet legal criteria (be a competent adult, at least 18 • the dignity and uniqueness of every person; years old); • the possibility and extent of preserving the patient’s • Be willing to speak on behalf of the principal; life; • Be willing to act on the principal’s wishes; • the preservation, improvement or restoration of the • Be able to separate the HCA’s own feelings from patient’s health or functioning; those of the principal; • the relief of the patient’s suffering; and • Live near the principal or be willing to come to that • any medical condition and such other concerns geographical location if needed; and values that a reasonable person in the patient’s • Know the principal well; circumstances would wish to consider. • Understand what values, goals and morals are C. Surrogate’s Court Procedure Act § 1750-b important to the principal; SCPA1750-b allows an Article 17-A Guardian or ac- • Be willing to discuss sensitive wishes; tively involved family members to make medical decisions, including end-of-life decisions related to the with- • Be willing to listen to wishes expressed by the holding and/or withdrawing life-sustaining treatment principal; for individuals with developmental disabilities (DD) who • Be willing and able to work with those providing lack the ability to make these decisions. A person with DD care to the principal to carry out those wishes; who has capacity can make end-of-life decisions. A person with DD who has capacity to choose a HCA can com- • Intend to be reasonably available in the future; plete a health care proxy and choose a HCA. If the person with DD subsequently loses capacity to make medical • Be able to handle potential confl icts between the decisions, the HCA then can make decisions in accor- family and close friends of the principal; dance with Health Care Proxy Law. If the person with DD • Be willing and able to handle the responsibility of lacks the capacity to make decisions and does not have a carrying out end-of-life wishes; and HCA, the provisions of SCPA 1750-b apply. In that case, the guardian shall base all advocacy and health care de- • If chosen as an alternate, be willing and able to act cision-making solely and exclusively on the best interests if the primary HCA is unwilling or unable to act. of the person with DD and, when reasonably known or ascertainable with reasonable diligence, on the person’s B. Family Health Care Decisions Act wishes, including moral and religious beliefs.14 Clear and Under FHCDA, a surrogate is selected from the sur- convincing evidence of the patient’s wishes is also not rogate list when there is no HCA to make all medical needed in order for a surrogate to consent to MOLST de- decisions in a hospital, nursing home or hospice after the cisions in accordance with FHCDA and SCPA 1750-b. attending physician and another health or social services practitioner at the facility have concurred that the patient D. Medical Orders for Life-Sustaining Treatment lacks capacity. For decisions to withhold or withdraw Preferences for treatment and decisions about the life-sustaining treatment, there are specifi c clinical criteria care of seriously ill persons near the end of life are acutely which must be satisfi ed. Additionally, the facility’s ethics needed in an emergency. More often than not, a seriously review committee must agree with the decision in certain ill individual lacks the capacity to make these decisions 12 situations. when chronic medical conditions acutely decompen- The FHCDA surrogate is also required to make treat- sate. MOLST orders provide health care professionals ment decisions “in accordance with the patient’s wishes, with clear direction for the life-sustaining treatment including the patient’s religious and moral beliefs,” or, if the individual wishes to receive, as well as those to be the patient’s wishes are not reasonably known and can- avoided, based upon current, not future, health status and not be ascertained, “in accordance with the patient’s best prognosis. interests.”13

NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 29 MOLST is a clinical process that emphasizes the dis- A. An Example of What Should Happen with MOLST cussion of the patient’s goals for care and shared medical A nursing home resident indicated that he wished decision-making between health care professionals and to meet a life goal—e.g., attend a grandson’s wedding. patients who are seriously ill or frail, for whom the phy- Because of that, he requested to receive full treatment, sician would not be surprised if they might die within including CPR, on his MOLST. His daughter was his the next year. The completion of the MOLST form results HCA. She was aware of his goals for care based upon in a standardized set of documented medical orders that his current health status. He then had a catastrophic refl ect a patient’s preferences for life-sustaining treat- stroke, which precluded the possibility he could attend ment. MOLST, however, is not an advance directive. his grandson’s wedding. This major change in his health NYSDOH approved MOLST for use in all health care status triggered a review of his MOLST orders. Since his facilities throughout New York State in October 2005. A HCA stood in the principal’s shoes, she had to establish Dear Administrator Letter (DAL) was sent to hospitals, new goals for his care and treatment based upon his nursing homes and EMS in January 2006. Upon comple- prior preference that he did not wish to live hooked up to tion of a successful community MOLST Pilot Project in machines like his late brother. Therefore, a palliative ap- Monroe and Onondaga Counties from 2005-2008, leg- proach was discussed with the HCA with the focus on the islation enacting MOLST was passed and then signed quality and not the longevity of his life. The HCA could by Governor David Paterson. This law also changed the then request the change in the MOLST orders in accor- scope of practice for EMS responders across New York dance with the principal’s wishes based upon the change State to permit MOLST orders for DNR to be honored in circumstances and the determination of new goals for in nonhospital settings in addition to non-hospital DNR care. orders and non-hospital DNI orders only on the MOLST If, however, this same resident had previously conform. sented to DNR/DNAR/Accept Natural Death on page In 2010, MOLST became a NYSDOH form. This is the 1 and Limited Medical Interventions on page 2 of the ONLY form approved by NYSDOH for both DNR and MOLST, the HCA could not “undo” the DNR order, be- DNI orders in the community. All health care profession- cause the MOLST had provided a clear statement of the als, including EMS, must follow the MOLST orders in all resident’s wishes and represented clear and convincing evi- clinical settings, including the community. dence. There was in that instance no reason to believe that the resident’s wishes would have changed or would not On January 21, 2011, the Offi ce for People with De- have been applicable in the event of a catastrophic stroke. velopmental Disabilities (OPWDD) approved use of the The MOLST DNR order provides more than just “reason- DOH-5003 MOLST form for individuals in the OPWDD able knowledge” of the principal’s wishes; it provides system in all clinical settings, including the community. clear documentation of those wishes. However, the individual’s physician must follow certain legal requirements before a MOLST can be signed for a B. One of the Most Frequently Asked MOLST DD person. Further, the OPWDD MOLST Legal Require- Questions ments Checklist must be attached to the MOLST form. One of the most frequently asked questions with respect to MOLST is whether a HCA or a PHL surrogate can III. Authority to Make MOLST Decisions demand life-sustaining treatment and hospitalization for When a patient has properly consented to MOLST a nursing home resident, when the resident loses capacity orders via a shared, informed medical decision-making and the resident’s health status worsens. If that request process and has made decisions regarding life-sustaining confl icts with the resident’s prior decisions, made when treatment, the MOLST form will document the patient’s the resident had capacity and the medical orders were wishes, given the patient’s current health status and issued by the attending physician on the MOLST, the an- prognosis. swer is NO. Yet this situation continues to occur.

A HCA CANNOT overrule the clear wishes of the C. An Example of What Should Not Happen with principal as expressed in the MOLST, unless the agent MOLST has a good faith basis for believing that the principal’s A 77-year-old female with multiple medical condi- wishes have changed or do not apply to the present cir- tions, including agoraphobia, was admitted to a nursing cumstances (e.g., the principal’s condition has changed, facility approximately six years ago, when she was no and he or she would have made a different decision, had longer able to manage her activities of daily living. Her he or she known about the change). Similar logic is ap- family rarely, if ever, visited or communicated with her. plied when a surrogate makes MOLST decisions in accor- Her grandson served as her HCA. At the time of her ad- dance with FHCDA and SCPA1750-b.15 mission, she had the capacity to make medical decisions.

30 NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 About four years ago, she began to refuse to leave her • The resident’s legal rights and decisions as bed with very rare exceptions. As a result, she developed evidenced by her MOLST orders were violated. severe pressure sores due to her refusal of bathing, turn- She was transferred against her will and without ing, and positioning. Serial psychiatric consultations were her consent, and her right to refuse treatment was obtained. These confi rmed that the patient still had the violated. capacity to understand the risks and benefi ts associated • From a medical perspective, the medical staff with her refusal of care. erroneously failed to follow her documented Approximately two-and-a-half years later, her attend- wishes, in part due to the agitation of the HCA. ing physician and the psychiatrist both agreed she con- • The nursing home staff felt immense moral distress. tinued to have the capacity to make decisions regarding They felt they had failed their ethical obligations to life-sustaining treatment. A MOLST form was completed. the resident. Her goals for care were to focus on the quality of her life. She specifi cally wished to avoid aggressive interven- • From a regulatory perspective, there were also tions, and wanted to die a natural death in the nursing violations. CMS Clinical Standards and Quality for home, being cared for by the staff who had served as her Advance Care Planning Survey Defi ciency F tag surrogate family. Her MOLST refl ected DNR, DNI, no 155 states clearly that the failure to follow MOLST feeding tubes, no hospitalization and Comfort Measures orders by allowing hospitalization results in Only. Her goals and preferences for care and treatment “Immediate Jeopardy.”16 remained unchanged with the passage of time, when the MOLST orders were reviewed and renewed in accor- Unfortunately, the provisions of the Public Health Law dance with the nursing home’s policies and procedures. are not always suffi cient to ensure that patient rights will be respected. The resident became acutely ill with symptoms of sepsis, a diffuse infection likely due to the pressure IV. Why There Are Failures in Following MOLST sores. The nurse practitioner (NP) contacted her HCA Orders to review her acute deterioration in health status and to • Clinicians, patients, families and medical decision review the treatment plan, which was consistent with his makers are unaware of their moral, ethical and grandmother’s previously made decisions and goals. Her legal obligations to follow MOLST orders and grandson stated he understood his grandmother’s wishes the implications of their failure to follow MOLST and was supportive of the palliative care plan of care. orders. The resident was treated with antibiotics and comfort measures. • Unfortunately, advance care planning is not recognized by everyone as a dynamic However, over the next three days, her oral intake communication process. Too often, the emphasis is diminished. She ultimately stopped eating and drink- placed on the completion of the forms rather than ing and appeared to be imminently dying. The NP again the communication process. Many clinicians have called the grandson to update him of her continuing de- diffi culty with having the discussion and have cline. He subsequently arrived at the facility and insisted inadequate training in confl ict resolution. that the resident be transferred to the hospital for acute care, violating his grandmother’s known wishes and al- • Sometimes when the attention of the physician is ready executed medical orders. The NP spoke with him primarily directed on the conversation, appropriate to try to help him deal with the reality of the situation. legal documents and/or medical orders may not be She refused to call 911, because she and all the facility completed or may be completed incorrectly. staff knew what the resident wanted and didn’t want. However, the grandson called 911. When EMS arrived, • One of the most serious problems is that family the grandson allegedly became quite agitated. He insisted members tend to avoid having conversations that his grandmother be transported to the hospital. After centered on the personal values, beliefs and goals reviewing the MOLST, the EMS staff called Medical Con- for care. Thus, they do not really understand what trol for guidance. Because of the grandson’s agitation, the matters most to the individual seeking MOLST resident was transferred to the Emergency Department. orders. She was then admitted to the facility’s intensive care unit, • Sometimes the patient has chosen the wrong HCA. where she had a stormy and painful medical course and ultimately died. An analysis of this case revealed the fol- • There is also a lack of understanding by both health lowing due to the failure to follow the resident’s MOLST care professionals and family of the difference orders: between a traditional advance directive (health care proxy and/or living will) and medical orders (MOLST).

NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 31 • The assessment of capacity determinations and Advance care planning helps ensure that the patient’s documentation of capacity as well as the patient’s treatment preferences are documented, regularly updated, personal values, beliefs and goals for care and the and respected. statutory requirements may either be absent or Early initiation of advance care planning is relevant inadequate. Therefore, all of these problems may at all ages. No age group is immune from acute illness or affect whether a MOLST is or can be honored. injury, complex chronic conditions or death. Improving • Unfortunately, the health care system is communication and advance care planning is critically fragmented. Therefore, key information may not be important for persons of all ages who are facing the end consistently accessible when there are transitions of life, including adults, adolescents and children. Fact- in patient care. Further, health care professionals based public education that encourages advance care are not always able to easily access advance planning and shared medical decision-making that is well directives and/or MOLST orders in the patient’s informed should be made available along the life cycle. medical record. New York State has developed and implemented a V. Recommendations community approach to advance care planning with two complementary programs that were highlighted in the A. Clinician Training Should Be Strengthened IOM Report: The programs were Community Conversa- In 2014, the Institute of Medicine (IOM) released tions on Compassionate Care (CCCC)19 and MOLST. Posi- “Dying in America: Improving Quality and Honoring tive outcomes were achieved and lessons were learned Individual Preferences Near the End of Life,” a com- from more than a decade’s experience.20 prehensive review of end-of-life care in the U.S.17 The IOM report concluded that the U.S. health care system C. The Use of eMOLST Should Be Expanded was poorly designed to meet the needs of patients near eMOLST21 is a web-based application that allows the end of life and that major changes to the health care eMOLST orders and documentation of the conversation system were needed to meet end-of-life care needs and to be accessed from anywhere with Internet access. New informed patient preferences in a high-quality, afford- York’s eMOLST system is accessible to all users at all able, and sustainable manner. The report proposed a high times at www.NYSeMOLSTregistry.com. eMOLST helps national priority for a patient-centered, family-oriented health professionals follow a standard clinical process approach to care near the end of life. for the MOLST discussion and guides them through all necessary documentation of the ethical framework and The Committee recommended the development of legal requirements. The system includes programming quality standards for clinician-patient communication to prevent errors and allows physicians to sign MOLST and advance care planning. They also recommended the orders electronically. At the end of the eMOLST process, development of appropriate provider training, certifi ca- both a DOH-5003 MOLST form22 and the appropriate tion and licensure to strengthen palliative care knowl- MOLST Chart Documentation Form for Adult Patients23 edge and skills for all clinicians. Because advance care or Minor Patients24 (aligns with NYSDOH Checklists)25 planning and MOLST are key elements of palliative care, or the OPWDD MOLST Legal Requirements Checklist for they must be integrated into the curricula of all medical, Individuals with Developmental Disabilities26 are created. nursing, social work and chaplaincy schools. eMOLST works for all patients: adults, children and per- B. Public Education and Engagement in Advance sons with developmental disabilities. Care Planning Should Be Encouraged New York’s MOLST forms can be completed online in “Most people nearing the end of life are not physi- eMOLST and are automatically included in the registry. cally, mentally, or cognitively able to make their own A copy can be printed for the patient. eMOLST does not decisions about care. The majority of these patients will require or rely on an EHR system and can be used with receive acute hospital care from physicians who do not paper records. eMOLST is operational statewide and cur- know them. Therefore, advance care planning is essential rently operates in all browsers and all devices, including to ensure that patients receive care refl ecting their values, on tablets. eMOLST ensures quality and patient safety, re- goals, and preferences.”18 duces patient harm and helps achieve the triple aim, improving the care experience, health outcome and reducing However, many people do not understand the need cost. Use of eMOLST is important, since key policy rec- for advance care planning, which is the process of plan- ommendations in the IOM Report include certain specifi c ning for future medical care in the event individuals lose relevant actions. These include: the capacity to make their own medical decisions. Lack of capacity can occur suddenly due to unexpected ill- • The encouragement of all states to develop and ness or injury, from which an individual may or may not implement a Physician Orders for Life-Sustaining recover. In either case, when an acutely ill person is near Treatment (POLST) paradigm program in ac- death or actively dying, end of life decisions are needed.

32 NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 cordance with nationally standardized core MOLST Checklist 3 – adult with FHCDA surrogate (3/2012), requirements. available at https://www.health.ny.gov/professionals/patients/ patient_rights/molst/docs/checklist_3.pdf. • The requirement to use interoperable electronic 13. PHL § 2994-d(4)(a). health records that incorporate advance care plan- 14. SCPA 1750-b(2). ning to improve the communication of individuals’ 15. Indeed, a health care provider need not seek the consent of a wishes across time, settings, and providers, docu- surrogate under FHCDA when the patient has already made a menting (1) the designation of a surrogate/decision decision about the proposed health care. PHL § 2994-d(3)(a)(ii). maker, (2) patient values and beliefs and goals for 16. Center for Clinical Standards and Quality/Survey & Certifi cation care, (3) the presence of an advance directive, and Group F tag 155, http://www.cms.gov/Medicare/Provider- (4) the presence of medical orders for life-sustain- Enrollment-and-Certifi cation/SurveyCertifi cationGenInfo/ Downloads/Survey-and-Cert-Letter-13-16.pdf. Hospital patients ing treatment for appropriate populations. and nursing home residents have a right to refuse medical treatment. 10 NYCRR §§ 405.7(b)(10); 415.3(e)(1)(ii). Fortunately, the New York State MOLST is a national- 17. IOM Report Dying in America: Improving Quality, Honoring ly endorsed POLST Paradigm Program. Further, eMOLST Individual Preferences Near the End of Life, http://www.iom.edu/ is the only such model in the country and was cited in the Reports/2014/Dying-In-America-Improving-Quality-and- IOM Report.27 Honoring-Individual-Preferences-Near-the-End-of-Life.aspx. 18. IOM Report Dying in America: Improving Quality, Honoring VI. Conclusion Individual Preferences Near the End of Life Key Findings and Recommendations, https://www.iom.edu/~/media/Files/ As the populations of both New York State and the Report%20Files/2014/EOL/Key%20Findings%20and%20 United States of America age, the importance of the Recommendations.pdf. implementation of advance care planning is signifi cant. 19. Community Conversations on Compassionate Care, http://www. Encouraging the completion of advance directives such compassionandsupport.org/index.php/for_patients_families/ as the Health Care Proxy, discussions by physicians with advance_care_planning/community_conversations. patients about their values, wishes and goals and imple- 20. Bomba, P. and Orem, K. Lessons Learned from New York’s Community menting the use of eMOLST to facilitate the completion Approach to Advance Care Planning and MOLST. Annals of Palliative of MOLST forms is crucial. Finally, end-of-life wishes Medicine, 2015; 4(1):10-21, http://www.amepc.org/apm/article/ view/5641. of patients must be honored by all parties and greater 21. NYS eMOLST Registry, https://www.NYSeMOLSTregistry.com. efforts must be made to educate both the general population and all health care professionals. 22. DOH-5003 MOLST Form, https://www.health.ny.gov/forms/ doh-5003.pdf. 23. MOLST Chart Documentation Form for Adult Patients, http:// Endnotes www.compassionandsupport.org/index.php/for_professionals/ molst/checklists_for_adult_patients. 1. Patient Self-Determination Act of 1990, P. L. 101-508, § 4206 (codifi ed in 42 USC § 1395cc(f)). 24. MOLST Chart Documentation Form for Minor Patients, http:// www.compassionandsupport.org/index.php/for_professionals/ 2. NY Public Health Law (PHL) § 2994-dd(6); 10 NYCRR § 400.21(b) molst/checklist_for_minor_patients. (6); New York State Department of Health (NYSDOH) Medical Orders for Life-Sustaining Treatment (MOLST). https://www. 25. NYSDOH MOLST Legal Requirements Checklists for Adults health.ny.gov/professionals/patients/patient_rights/molst/. and Minors, http://www.health.ny.gov/professionals/patients/ patient_rights/molst/. 3. PHL § 2982(2). Under PHL Article 29-C, the term “health care proxy” refers to the document; the term “health care agent” refers 26. OPWDD MOLST Legal Requirements Checklist for Individuals to the person appointed. PHL § 2980(5), § 2980(8). with Developmental Disabilities, http://www.opwdd.ny.gov/ opwdd_resources/information_for_clinicians/MOLST. 4. PHL Article 29-CC. 27. IOM Report Dying in America: Improving Quality, Honoring 5. SCPA 1750-b(4). Individual Preferences Near the End of Life, http://www.iom.edu/ 6. PHL §§ 2981(4); 2982(1); 2989(2); 2994-d(3)(a)(ii). Reports/2014/Dying-In-America-Improving-Quality-and- 7. PHL §§ 2982(2); 2994-d(4). Honoring-Individual-Preferences-Near-the-End-of-Life.aspx 3-50, Box 3-3. 8. PHL §§ 2964(2)(c); 2994-f; 2994-ee. 9. NYSDOH MOLST Checklist 2 – adult with health care proxy any setting (5/1/13), available at https://www.health.ny.gov/ Patricia Bomba, MD, FACP, is Vice President and professionals/patients/patient_rights/molst/docs/checklist_2. Medical Director, Geriatrics at Excellus BlueCross pdf. BlueShield, Chair of the MOLST Statewide 10. Burke, K., Herb, A. and Swidler, R. Three Stubborn Misconceptions Implementation Team and eMOLST Program Director. About the Authority of Health Care Agents, NYSBA Health Law J., 10(3):63-70 (Summer/Fall 2005). Jonathan Karmel, Esq., has been Associate Counsel 11. Choose a Spokesperson (Choose the Right Health Care at the New York State Department of Health since Agent), http://www.compassionandsupport.org/index.php/ for_patients_families/advance_care_planning/choose_a_ 2000. He is the attorney for the MOLST and eMOLST spokesperson. programs at the New York State Department of Health. 12. Deciding About Health Care: A Guide for Patients and Families, http://www.health.ny.gov/publications/1503.pdf. NYSDOH

NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 33 A Quarter-Century Since Baby M: Why New York Should Reconsider Its Surrogacy Law By Shawna Benston

I. Introduction II. Surrogacy-Related Terms Alex Kuczynski feared she’d never see her and her There are two types of surrogacy: traditional and husband’s faces refl ected in their child’s. Indeed, “[a]fter gestational. Traditional surrogacy fi nds the surrogate serv- a total of 11 failed I.V.F. cycles and four failed pregnan- ing as both carrier and genetic mother of the baby after cies, stretched out over fi ve years, actual hope becomes a having undergone artifi cial insemination, which can be mawkish pretense.”1 She had long desired to be a mother, done with or without fertility drugs to boost the surro- and, viewing this role as “the natural outgrowth of a lov- gate’s egg production.6 Since the advent and proliferation ing relationship” since marrying her husband, 39-year- of physicians able to perform in vitro fertilization (IVF), old Alex remained determined and was rewarded when “surrogacy agencies report that the numbers have shifted gestational surrogacy “found its way into [her] brain” markedly away from traditional surrogacies toward after yet another miscarriage.2 As she would learn—and gestational surrogacies.”7 As Alex vividly demonstrates, share with her New York Times Magazine audience in No- the desire for motherhood is not necessarily uncondi- vember 2008—gestational surrogacy offered the Kuczyn- tional—indeed, Alex herself rather matter-of-factly states skis the chance to welcome a biological child into their that “[i]f [she had] never met the man, [she] would [have] lives. Embarking on her search for the ideal surrogate, skip[ped] the baby”8: the latter would serve as a symbolic Alex acquired a rather extensive knowledge base about outgrowth of Alex and her husband’s preexisting relation- what surrogacy entails, who offer themselves as potential ship. Therefore, gestational surrogacy, which would offer surrogates, and what it means for the role of carrier to be the chance of the couple’s genetic intertwining and fused shifted from the biological mother to a paid third party. resemblance, was Alex’s clear last resort. Surrogacy is generally unnerving: “like abortion, Gestational surrogacy entails the use of IVF, an in- [surrogacy] is controversial precisely because it evokes vasive and intensive process. First, hormonal treatment and often contradicts basic concepts about family, moth- is administered to the surrogate to suppress her natural erhood, and gender roles.”3 One author has even as- monthly cycle and stimulate development of a recep- serted that “at the very least, one ought to be especially tive uterine lining. Then, laboratory-fertilized embryos concerned with any process that disrupts the important (created from the genetic mother’s eggs and the genetic bond between mother and child, which derives from both father’s sperm) are implanted into the surrogate’s uterus.9 biological and cognitive/psychological aspects of human IVF, while continuously honed by scientists, has proved nature, beginning during gestation and continuing after to be “a procedure with few guarantees”10 because “one birth.”4 The act of being a surrogate and the decision to in three embryos resulting from IVF have chromosomal lend one’s body and time to aid the intended parents are abnormalities that prevent the development into a full- even more diffi cult to comprehend than the more general term pregnancy.”11 (Recently, a promising, and even notion of surrogacy: “While it is easy to understand the relatively affordable,12 new test to determine successful unhappiness and despair that motivate an infertile, child- embryos was introduced. While this new test is beyond less couple, who desire children, to enter into a surrogacy the purview of this article, it is worth mentioning simply arrangement, the motives of women who choose to be for the recognition that assisted reproductive technol- surrogate mothers, despite general public disapproval of ogy is continually refi ned and expanded.) Furthermore, third party assisted reproduction, are more puzzling and because a woman, such as Alex, could have a healthy13 more suspect.”5 uterus and have miscarried a fetus that had “no sign of genetic defect,”14 making her an ostensibly promising IVF This article strives to humanize and expand on the candidate, she might still have an unexplained reason for notions of surrogacy, the surrogate herself, and the inher infertility15 that renders the retrieval portion of IVF tended parents: what is each party’s reason(s) for entering applicable to her, and the implantation portion applicable into such a delicate and important relationship in order to a surrogate. Thus, gestational surrogacy allows the to produce a baby, and why does each party need legal intended parent to be the biological parent, while the sur- protection not yet provided in New York? Finally, what rogate has no genetic link to the baby. considerations must the New York legislature include in its potential restructuring of the New York surrogacy This article explores the relationship between surro- law? gate and intended parents, informed consent, surrogates’ altruism narrative, and the debated right to procreate.

34 NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 Intended parents are the parents for whom the surrogate Baby M reignited debate concerning procreative liber- is carrying the baby. Such parents might be homosexual ties within the penumbra28 of privacy rights derived from or heterosexual, married or unmarried, a couple or an the Due Process Clause of the Fourteenth Amendment.29 individual, and either the biological or adoptive parents While “[s]urrogacy proponents argue that contractual of the baby.16 Alex was the heterosexual, married, biologi- agreements that enable couples to procreate should be a cal intended parent of the baby her surrogate carried for constitutionally protected liberty under the [F]ourteenth her. Informed consent, defi ned by the American Medical [A]mendment,”30 the Supreme Court has “never recog- Association as “a process of communication between a nized a right to procreate via contract.”31 Thus, debate patient and physician that results in the patient’s au- since Baby M has found proponents of surrogacy contracts thorization or agreement to undergo a specifi c medical asserting their “logical extension of procreative liberty” intervention,”17 requires full disclosure by the physi- deserving protection under the Griswold-Roe rationale,32 cian about risks and benefi ts of, and alternatives to, the and opponents emphasizing such contracts’ “inher- proposed treatment in order to protect “[the] patient’s ent enforceability diffi culties because of public policy right to self-determination, bodily integrity, and…his considerations.”33 or her voluntariness in the health care decisionmaking Indeed, the New York legislature did address this process.”18 Finally, the surrogate’s altruism narrative is a rather complex mode of discussion in which the surro- debate, after the New York State Task Force on Life and Baby M gate emphasizes her desire to help others rather than ben- the Law, in direct response to , recommended that efi t monetarily from the service. Due to a long history of all surrogacy contracts, including gestational surrogacy 34 The conclusion aversion to baby-selling,19 our cultural rhetoric surround- contracts, be void and unenforceable. ing surrogacy is couched in philanthropic diction, with was that “the practice could not be distinguished from references to fi nances conspicuously absent. However, as the sale of children and placed children at signifi cant risk 35 The resulting law in New York, NY Domestic Alex’s story starkly demonstrates, fi nances—and, specifi - of harm.” Relations Law Article 8, “declare[d] all surrogate parent- cally, fi nancial disparities—continue to fuel surrogacy ing contracts ‘contrary to the public policy of this state’… arrangements between intended parents and previously [and] prohibit[ed] the payment of fees other than reason- unknown surrogates. able medical expenses incurred because of pregnancy and III. Current Perspectives on Surrogacy childbirth and fees to individuals who ‘act as brokers for the arrangements.’”36 The law provided that enforcement A. American Culture’s Reception and Interpretation would range from civil penalties for fi rst-time violations of Surrogacy since Baby M by the surrogate carrier, her spouse, and/or the genetic The landmark Baby M case centered on a traditional- parent(s), to conviction of a felony for repeat violation surrogacy contract that Mrs. Whitehead, the carrier—and (e.g., for paying a prohibited fee more than once). Impli- biological mother—wanted to violate by maintaining cations of this law are New York’s fl at prohibition of both custody of the baby.20 The contract provided that Mrs. genetic and gestational surrogacy, and its classifi cation of Whitehead would surrender her parental rights upon the repeat offenders as felons (after having imposed substan- baby’s birth and that the Sterns, the intended parents, tial civil penalties).37 would become the baby’s legal parents,21 with Mrs. Stern During and immediately after Baby M, concern38 adopting the baby.22 Mrs. Whitehead’s biological connec- about litigation between surrogates and intended parents tion to the baby was the dominant impetus in her quest fl ared. For example, scholarly commentary on the case to keep the baby: “She talked about how the baby looked prior to the New Jersey Supreme Court’s ruling included like her other daughter, and made it clear that she was the assertion that “surrogacy should be permitted to experiencing great diffi culty with the decision.”23 infertile couples only if conducted for altruistic pur- The trial court, using a “best interests of the child” poses.”39 This concern has declined: “[T]he politics and standard, concluded that custody with the Sterns was social meaning of surrogacy have slowly changed, and preferable to custody with the Whiteheads and upheld the alarm and hostility have diminished substantially,” the terms of the contract.24 However, the Supreme Court allowing for “[a]n alternative framework…in which of New Jersey invalidated the contract, basing its reason- altruistic surrogates (contractually bound and compen- ing on the contract’s divergence from both state statutes sated nonetheless) provide the ‘gift of life’ to deserving and public policies.25 The court found the use of money couples.”40 As will be discussed below, this narrative of for the purpose of adoption “illegal and perhaps crimi- altruism is itself a double-edged sword; but for now, we nal” and the biological mother’s pre-birth and pre-con- can recognize a swift cultural shift away from fear of leg- ception contractual commitment to surrender the baby islation against surrogacy agreements and toward a more coercive.26 Equally objectionable, the court found, was the open-ended discussion that—although in need of legisla- biological mother’s agreement not to contest proceedings tive change to refl ect society’s new perspective—allows to terminate her parental rights.27 for a more nuanced understanding of the relationships among surrogates, intended parents, and the babies born via surrogacy.

NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 35 The reframing of surrogacy expanded concerns increase in the number of surrogacies and in society’s im- from solely coercion of the surrogate and corruption and plicit acceptance of the practice. Indeed, once the practice degradation of procreation to women’s autonomy (with was more culturally accepted, explorations of surrogates’ respect to both surrogates and intended mothers) and actual experiences have been made possible in an effort to services protected by contract. Thus, the current surroga- reveal and diminish their psychological, physical, and in- cy debate centers primarily on the balancing of women’s terpersonal problems associated with surrogacy. Further- autonomy against their need for protection from abuse. more, “[a]lthough regulatory legislation arguably legiti- However, both of these analytic strains concern women’s mizes the practice of surrogacy, it is necessary to protect protection—the former from paternalistic and overcom- more fully the interests of the parties and to inject greater pensating protection,41 and the latter from the very real predictability into the process.”50 Therefore, a wider cul- threat of coercion. tural acceptance—even that which is revealed incongru- ously through criticism—of surrogacy, along with some Another related strain of the surrogacy discussion states’ updated regulatory legislation, demands further centers on the right to contract—itself an outgrowth of scrutiny of the many facets of the surrogates’ experience individual autonomy. While scholarly commentators so as to render the process healthier and more uniformly have explored whether to evaluate surrogacy within the understood. However, many concerns linger and even family law or contract law context, they nearly univer- fester in American society. sally determine that the latter is preferable.42 Because “[j]udicial resolution pursuant to family law standards B. The New Normal: Societal Refl ections on seeks to safeguard the fetus by settling disputes in ac- Procreation cordance with the best interest of the child,”43 presump- While society is generally more accepting of sur- tions made under such standards “come at the expense rogacy (see supra, “American Culture’s Reception and of women’s autonomy and freedom to contract.”44 One Interpretation of Surrogacy since Baby M”), many remain recommendation is that New York “amend its Domestic uneasy with it. Indeed, the Comments and subsequent Relations Law and combine aspects of other states’ laws Letters section relating to Alex Kuczynski’s article reveal to allow for, and enforce, gestational surrogacy con- mixed feelings inspired in Alex’s readers. One commenter tracts.”45 While this particular recommendation aims to jumps to Alex’s defense, wondering whether the com- protect intended parents, those looking to protect sur- ments would be as “scathing” had “the author been, say, rogates include the same goal of contract enforcement: a woman who had survived cancer yet left infertile due “Acknowledging the legal validity of contracts that are to chemotherapy”; furthermore, this commenter suggests consistent with the surrogate’s interests advances the no- that “the greatest ‘failure’ of the article (or the blindness tion that women are competent to act as rational agents caused by the assumptions, biases, and stereotypes of with regard to their reproductive capacities.”46 the readers) was not conveying the emotional turmoil of Beyond the recognition of a general right to contract, infertility.”51 However, Alex’s story elicited far more out- women in particular are seen now, as opposed to during rage than support. Many readers found abhorrent Alex’s Baby M, as empowered by contract, a choice emblematic unfi ltered honesty concerning her and her husband’s of individual autonomy and self-determination. Just as seemingly bottomless wealth, which allowed the couple “[f]eminist advancements allowed women to pursue op- the freedom to try IVF eleven times. Then, of course, portunities which caused them to postpone childbearing the couple’s surrogacy—a process that included hiring and suffer age-related declines in fertility,” so, too, have a lawyer, retrieving and fertilizing Alex’s eggs, transfer- they “provide[d] the basis for the argument that women ring the embryo into the surrogate, and a $25,000 fee to must be empowered to retain control over their own the surrogate—proved costlier than most individuals or bodies.”47 The frequently unaligned trajectories of biol- couples could afford.52 However, what readers reacted to ogy and career demand a greater acceptance of women’s most viscerally was Alex’s rather brazen depiction of her need to approach procreation more creatively.48 In turn, “exploit[ing] [her] last few months of nonmotherhood by the suggestion is that women who are able to carry a white-water rafting down Level 10 rapids on the Colo- child for those who cannot should be permitted to do so rado River, racing down a mountain at 60 miles per hour as an exercise of autonomy. at ski-racing camp, drinking bourbon and going to the Su- per Bowl.”53 While it might appear to some readers that Perhaps paradoxically, the proliferation of literature these actions, and Alex’s deliberate commitment of them concerning potential and actual problems suffered by to paper, represent her overcompensation for feelings of surrogates indicates a wider acceptance of the practice. inadequacy and deprivation due to her inability to carry a Such literature essentially acknowledges that surro- baby to term, other readers deplored Alex’s starkly unma- gate agreements will be made and alerts us to potential ternal—perhaps even unwomanly, as will be discussed— dangers that must be systematically eradicated. Some- approach to the time of her baby’s gestation. For example, what analogous to other medical and scientifi c advance- one reader sent a letter that expressed her “revulsion” ments, as “technology has made [surrogacies] safer and aroused by Alex’s story and specifi cally at her having 49 more likely to succeed,” our country has witnessed an paid another woman to have her baby when there are “so

36 NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 many children who cannot fi nd homes”; this reader even mid- to late-thirties when their chances of becoming preg- asserted that the baby is the surrogate’s, not Alex’s.54 nant have declined signifi cantly.63 Some readers’ wariness and disapproval of Alex’s So, is surrogacy becoming a “new normal”?64 Certain- pursuance of surrogacy even led them to view Alex as a ly parenthood—and, particularly, motherhood—remains masculine onlooker to a real woman’s pregnancy. Stirred front-and-center in our society’s ongoing conversation by the article’s very title and by Alex’s stark assertion about and struggle with achieving normalcy. In addi- that her surrogate was “[s]trictly speaking…a vessel, tion to the television show “The New Normal,” seem- the carrier, the biological baby sitter, for [her] baby,” one ingly countless shows and movies center on the familial reader fi nds “the author as the stand-in life-force impreg- structure and parental problems in particular.65 With nator, situated outside the nine-month process of creat- respect specifi cally to mothers, a new genre is emerging a child but claiming responsibility for and complete ing: the “momance.”66 While “[t]he decision to have—or ownership of the result.”55 This comment invites discus- not have—children has been a perennial obsession that sion beyond the confi nes of this article concerning gender blooms in a thousand blog posts and talk show debates identity, especially in light of the same reader’s allusion every time science pushes a new boundary or The New to “Aristotle’s view that a woman is a receptacle for the England Journal of Medicine prompts a new scare,”67 the life force implanted by a man through intercourse.”56 modern “24-hour tabloid culture,”68 including exposure to celebrity older mothers and gay adoptions, is “in vogue Within the purview of this article, Alex’s readers and in the news.”69 Indeed, “[t]he topic doesn’t grow old, embody this cultural struggle to comprehend, accept, and mothers do.”70 The topic of fertility, or lack thereof, has adapt to a woman’s role within what might be termed the become culturally normalized—perhaps because of medi- “new normal”: family structures that veer away from the cine’s expansion to include viable solutions to infertility, traditional one containing two married heterosexual par- at least for those who can afford them. Societal interest 57 welcomed into the family by more ents and 2.5 children in—even fascination with—so-called alternative family varied means. We must recall that Alex was 39 years structures has resulted in a natural progression toward old when she fi rst thought of gestational surrogacy and greater acceptance of difference and the needs for repro- lunged toward it. She thus found herself in a dual cross- ductive assistance that accompany it. roads: One was personal, as she struggled against her own biology to reconcile booming professional success Even the traditional family structure is frequently with elusive fertility. The other crossroads was cultural, redefi ned. While women continue to be bombarded by as she, perhaps inadvertently, found herself epitomizing images touting the joys of motherhood, they struggle to a conundrum arguably born of feminism: the pressure on determine whether and how best to approach this phase women to “lean in”—to take the greatest advantage of in their lives. This often-wrenching dichotomy of societal career-building years before fulfi lling the goal of woman- opinions and pressures and personal decision-making is hood itself, baby-making—simultaneously encourages embodied by the physical juxtaposition of a Johnson & professional achievement and neglects to adequately Johnson advertisement with the online iteration of a New advise women on how best to incorporate motherhood. York Times Magazine article71 penned by the author of the book Perfect Madness: Motherhood in the Age of Anxiety.72 The “lean in” jargon, coined by Sheryl Sandberg The ad asserted, “Love is the Most Powerful Thing on the Lean In: Women, Work, and the Will to in her 2013 book, Planet: Enjoy and Share Caring Stories Now,” depicting Lead 58 is offered to young female professionals to encour- , simply an adult hand holding a baby’s hand. The article, age them to achieve the greatest possible professional meanwhile, explored the diffi culties mothers experience success—to “aspire to leadership”59—before engaging in trying to reinsert themselves into the workforce after maternal duties. This jargon attempts to respond to the having voluntarily removed themselves a decade prior to inadvertent pressure, derived from feminism’s call for serve as stay-at-home moms. While money was at issue workforce equality, on women to “have it all” by raising a for some women, especially due to the recession, which family while climbing the corporate ladder. While strong occurred after their decisions to “opt out” of the work- encouragement of women’s efforts to rise to the top of the force, the more pervasive problem was one of self-identi- workforce is welcome—especially in a country in which ty: “what haunted many of them, as they reckoned with women make 77 cents for every dollar a man makes60— the past 10 years of their lives, was a more unquantifi able Sandberg’s advice is “at best half a loaf.”61 With the sense of personal change.”73 “maternal wall”62 rearing itself in the middle of a typical professional’s career trajectory, and with slow progress at While none of the women interviewed for the New workplaces to accommodate motherhood, most women York Times Magazine article voiced regrets about having are still faced with a diffi cult choice—made consciously had children when they did, most encountered extreme or unwittingly, the latter due to natural career develop- diffi culty reclaiming their intellectual selves after having ment inertia—between young motherhood and solid devoted a decade to children-oriented obligations. These professional success. Many choose the latter and fi nd women embody a post-recession recognition that things themselves, like Alex, struggling to have children in their just don’t always go as planned—career, family, or the

NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 37 combination thereof—and there needs to be a softer place spouses’ particular risks as to take their own; as one such for them to fall should they need help. Young women wife stated, “I think that being married to someone in the today fi nd themselves surrounded by “lean in” advice military embeds those values [going to extremes, fi ghting and admonitions of women who opted out. But in our for your country, risking your life] in you. I feel I’m taking choose-your-own-adventure, American-dream cocktail, a risk now, in less of a way than he is, but still a risk with how are they to know and pursue the best route to per- my life and body to help someone.”83 sonal and professional success? Is Alex Kuczynski, who chose never to abandon her successful career but wait What is diffi cult to read between these lines of be- to have her baby, a more accurate depiction of a woman nevolence is many surrogates’ coercion into proclaiming “having it all,” and, if so, why doesn’t the New York such altruistic sentiments at their own expense. Indeed, legislature support such a vision of success? “surrogates often express their motivations in what Ra- gone refers to as a ‘scripted’ manner to refl ect culturally IV. The Surrogate’s Experience accepted ideals of motherhood, female reproduction, and family.”84 A general cultural, and specifi cally feminist, A. The Altruism Narrative of Surrogates concern that women not be commodifi ed or babies sold “It is an act of love, but also a fi nancial transaction, has resulted in surrogates’ insistence, often to their own that brings people together like this.”74 Surrogacy neces- autonomy’s detriment, that they have little to no mon- sarily involves selfl essness and a sacrifi cial inclination etary interest when agreeing to serve as surrogates. They on the part of the surrogate, but must also confront the thereby lose the ability to contract honestly and fairly. issue of monetary compensation. Indeed, compensation With the understanding that the adoption of an is crucial for surrogates’ sense of fairness and ability to altruistic model of motivation necessarily weakens and contribute fi nancially to their own families. While many, even threatens surrogates, one must determine how best if not all, surrogates do cite the desire to help others to broach regulation of payment. While it might seem as a driving force to act as surrogate, our cultural nar- obvious that “[to deny women payment for their labor] rative of pure altruism has become “one of the most is an unfair denial of the valuable service that a surrogate effective blocks to women’s self-awareness and demand provides as well as the risks she faced when she bears a for self-determination”75 by silencing surrogates’ other, child,”85 the issue of regulation is not so clear-cut: equally valid concerns. One danger of continuing to view surrogacy through the lens of altruism is surrogacy On the one hand, not to regulate com- agencies’ “exploit[ing] this perception in their online pensation is inappropriate because it material by reassuring prospective parents of the sur- will likely lead to increased commer- rogates’ willingness to participate (‘You will soon have cialization of the process. But, to allow that beautiful bundle of joy safe and sound at home!’) as unlimited compensation would make well as making reference to surrogates’ feelings of altru- surrogacy even more inaccessible to ism.”76 Tangentially, a persistent “social devaluation” of the non-wealthy than it already is and childless women—especially those who are childless by exacerbate concerns about surrogacy’s choice—renders such agencies’ offer of hope coercive.77 exploitative potential.86 A delicate balance in the regulation of payment must respond to concerns about commodifi cation of “individual Furthermore, assigning a monetary value to one’s characteristics such as weight, race, health, and diet”78 “willingness to engage in procedures such as prenatal and about the commercialization of the process, and also testing, termination, multifetal pregnancy reduction 87 to the potential for the surrogate’s exploitation. (MFPR) or selective reduction” arouses ethical concern. Therefore, policy changes must refl ect the need for sur- This is not to say that altruism does not play a funda- rogate payment and protection from exploitation. It has mental role in the surrogacy process. One surrogate stat- been argued that such policy should err on the side of ed that “[b]eing a surrogate is like giving an organ trans- payment: “[e]ven if the surrogate is vulnerable to some plant to someone…only before you die, and you actually exploitation, respect for her autonomy means not wholly get to see their joy.”79 Surrogates can feel that the “sense removing paid surrogacy as one of her options.”88 Indeed, of empowerment and self-worth is one of the greatest one recommendation is that while New York should fol- rewards surrogate mothers experience.”80 They might low Washington State’s lead in implementing provisions enjoy the actual experience of pregnancy—“the natural that “defi n[e] compensation as any payment of money high that comes from ‘all those rushing hormones’”81— ‘except payment of expenses incurred as a result of the while being free from the commitment to another person pregnancy,’” there are “some circumstances [in which] upon his or her birth. The knowledge that one is “doing fees in addition to medical expenses are appropriate.”89 something good for somebody else”82 might be a driv- A more nuanced approach to codifying compensation for ing force. Military wives, a demographic in which many surrogacy would greatly enhance the process for every- surrogates can be found, might be so infl uenced by their one involved.

38 NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 B. Informed Consent any confl ict arise between the surrogate and the intended If, as has been recommended,90 surrogacy contracts parents. are to be considered permissible and enforceable, such Some suggestions have been made as to how best policy must consider how best to ensure surrogates’ in- to regulate surrogacy contracts. One involves a “soft formed consent. The issue of informed consent pervades law” approach that would require potential surrogates literature on surrogacy; some obvious issues in this arena to participate in a “short class on contract pregnancy.”96 should be addressed if new policy is to be successful and Analogous to getting a driver’s license prior to driv- enduring. ing or a medical license prior to practicing, taking such One specifi c example of surrogates’ inadequate a class would be a prerequisite for serving as a contract comprehension of the surrogacy process can be found surrogate. This soft law approach to paid surrogacy “can within the military wives demographic. One surrogate address the vulnerability arguments…while guarding 97 interviewed in an article for The Daily Beast reported her a woman’s reproductive freedom.” An assertion con- devastation upon giving up a baby, saying “she thinks cerning the regulation of the contract itself is that “[a] things would have been different had she been counseled surrogate-focused contract model would shift the balance more by the agency on attachment issues.”91 Because the of power during negotiations and preclude the appear- 98 operation was “small and less than professional (and ance of involuntary servitude.” Indeed, the same article there are plenty of those in the unregulated world of sur- states that “[in] the absence of legislation delineating rogacy agencies),”92 this surrogate suffered psychological the rights and obligations of the contracting parties, the repercussions that could have been avoided. Military foremost consideration should be protection of the party 99 wives are, one might argue, particularly baited by fertil- most vulnerable to exploitation—the surrogate.” With ity agencies that “may offer a potential surrogate with respect to New York specifi cally, it has been suggested [Tricare health insurance, which has some of the most that New York courts should monitor surrogacy contracts comprehensive coverage for surrogates in the industry] to “ensure the parties understand what they are agreeing 100 an extra $5,000.”93 Such agencies’ aggressive, cash-laden to,” and that the legislature should include a provision approach to attractive surrogate candidates understand- “requiring the surrogacy contract to specify child custody ably piques such candidates’ interest: the husbands earn in the event of a ‘change of circumstances’ and to state the 101 very little,94 and the wives want to contribute to the fam- responsibilities of the parties to the contract.” ily funds, too. As mentioned above (see supra, “The Altru- Indeed, most literature post-Baby M seems to have ism Narrative of Surrogates”), such payment helps surro- shifted the focus from the rare possibility of surrogate gates contribute fi nancially to their own families; indeed, misbehavior (e.g., trying to keep the baby) and toward because surrogates are universally required to have had surrogates’ general vulnerability; such literature empha- a baby prior to engaging in surrogacy, they inextricably sizes the need to consider the surrogates’ position fi rst so have at least one other person for whom to provide. This that they don’t become ensnared in a potentially damag- need, coupled with surrogates’ natural desire to share the ing or exploitative contract with the intended parents. provider role with their husbands, renders military wives especially vulnerable to the arguably predatory approach C. Surrogates’ Psychological and Physical of surrogacy agencies. Experience The combination of coercion and lack of adequate A better understanding of what surrogates endure information prior to consent indicates the need for can reveal the need for more protective legislative provi- regulation of surrogacy agreements: these agreements, if sions for surrogacy contracts. Perhaps due, at least in adopted, should cap the amount of non-medical com- part, to the aforementioned altruism narrative of surro- pensation to avoid coercion. Furthermore, they should gates, “[v]ery little is understood about the world of the 102 indicate procedures prior to agreement so that potential surrogate.” surrogates can fully understand the transaction and emo- i. Surrogates’ Relationship with Intended Parents tions that accompany it. If surrogacy agreements remain unregulated in New York, they will clearly continue to The relationship between surrogates and intended be made—as Alex’s story demonstrates—but will lack parents is necessarily a delicate one, but one that can be the protections for both the intended parents and the mutually rewarding. Indeed, one study examining this surrogates: the intended parents won’t have legal re- relationship ten years after the baby’s birth revealed course if the surrogate tries to keep the baby (a rare but that although frequency of contact decreased over time, real possibility),95 and the surrogate won’t be protected the majority of intended parents who did remain in against repercussions from a lack of informed consent contact with their surrogates “reported…harmonious or the equally rare, yet possible, rejection of the child by relationship[s] with [them].”103 the intended parents. Finally, and most importantly, the Such a positive report notwithstanding, better and children born from surrogacy won’t be protected should more in-depth preparation for the relationship with the

NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 39 intended parents would likely render the surrogate’s surrogates endure even more than do traditional surro- experience more emotionally manageable. Indeed, gates, often being required to undergo a hysterosonogram “pre- and post-birth experiences, relationship with the or hysterosalpinogram, or both, which investigate uterine contracting couple, and whether expectations about sur- health prior to embryo implantation.114 Risks associated rogacy are met are important infl uences on the surrogate with these tests—beyond pain and discomfort, which can mothers’ level of satisfaction.”104 As confi rmed by several include cramping, bleeding, dizziness, nausea, or vomit- studies, “the surrogate mother generally forms a relation- ing—include bacterial infections, bleeding, cervical and ship with the couple rather than the child,”105 and so it is other trauma, allergic reactions, fainting, and radiation the sudden deprivation of that relationship—and gener- exposure.115 Even the mildest potential side effects, such ally not the baby itself—that can cause a sort of postpar- as fainting, infection, and allergic reaction can, in rare tum depression in the surrogate. Ultimately, “it is the circumstances, lead to major surgery and tissue loss.116 quality of the relationship with the couple that largely Intended parents’ potential desire to cut costs might determines the surrogate mother’s satisfaction with her motivate them to choose “low-quality medical facilities, experience”106 and that informs a surrogate’s decision 117 Furthermore, multiple whether to act as a surrogate again.107 where the risks are greater.” pregnancies common to surrogacy augment the risk asso- Notably, “as contact with the couple begins to taper ciated with any pregnancy.118 Finally, contractual provi- off, [some surrogates] become increasingly dissatisfi ed sions mandating surrogates’ strict adherence to “certain with the surrogacy arrangement”108; it appears that while risky medical protocols that enhance the probability of intended parents might view the arrangement as the time a birth, such as fertility treatment and multiple embryo period between the agreement is made and the baby is transfer,” as well as the “unfavorable allocation of fi nan- given to them, at least some surrogates have expectations cial burden in the event of a medical emergency during of a longer friendship that lasts signifi cantly beyond the pregnancy,” render surrogate pregnancy radically more birth. Because some couples will choose not to extend hazardous than typical pregnancy.119 their relationship with their surrogate beyond the baby’s birth, and because “[c]ouple interaction with the surro- iii. Surrogates’ Psychological Experience gate immediately post birth appears important,”109 both Perhaps the most complex element of the surrogacy the intended parents and the surrogate should be coun- experience is the psychological one: how well are poten- seled in how best to approach their relationship—or lack tial surrogates prepared to engage in surrogacy, and how thereof—following the birth. do they feel after giving the baby to the intended parents? We see the altruism narrative emerge as a socially accept- ii. Surrogates’ Physical Experience ed explanation for the surrogate’s sacrifi ce120—but as we Surrogates risk not only complications associated have seen above, adhering to this narrative prevents us with all pregnancies, but also unique dangers that from fully understanding who the surrogate is and what emerge within the surrogacy process. The risks are not she endures. Furthermore, “[s]mall, non-representative identical for all surrogates, since such risks vary depend- samples; lack of control groups; and ambiguous or fl awed ing on “the health and age of the woman serving as a comparisons with test norms make it diffi cult to reach surrogate, the type of surrogacy (gestational or tradition- any conclusions about the personal traits of women who al), what hormones or drugs the surrogate is instructed become surrogate mothers.”121 to take, how many IVF or AI cycles a surrogate under- What has been uncovered is that “the majority of sur- goes before reaching a successful pregnancy, the number rogates felt well informed about the practical and medical of embryos implanted, the age of the woman providing aspects of surrogacy, but knowledge of the legal, psycho- her eggs, whether the eggs and/or embryos are frozen or logical and social aspects was not good.”122 Furthermore, fresh, whether the individuals providing gamete material so-called traditional surrogates’ grasp of their own per- have any infectious diseases.”110 Furthermore, because “the medical risk begins before the intended parents ception of genetic importance is not universally strong. have even agreed to hire the surrogate,”111 a surrogate For example, while one surrogate in a study expressed might easily receive no compensation for at least some her “emotional discomfort with the…‘child which is half 123 generally “the sur- physical and emotional discomfort or even anguish. mine walking around somewhere,’” rogate de-emphasizes her biogenetic tie to the child.”124 This pre-agreement risk-taking involves agencies’ in- Again, this is emblematic of inadequate informed-consent vasive screening process comprised of both physical tests efforts and follow-up care after the birth within the intan- and the provision of a “highly personal”112 medical and gible realm of emotional and psychological response to sexual history. This screening process risks violating sur- the surrogacy process.125 While this particular issue—tra- rogates’ right to privacy and confi dentiality by request- ditional surrogates’ inconsistent perceptions of biologi- ing “the names of several references with whom the sur- cal importance—is essentially moot due to the modern rogate’s intention [is] discussed.”113 Potential gestational penchant for gestational surrogacy, it serves as a not-too-

40 NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 distant reminder that, generally, surrogates remain at a search for self-realization. The perhaps unwitting desire distinct informational disadvantage when compared to to create an entity with a self-consciousness of its own intended parents, who educate themselves thoroughly motivates some to engage in procreation.132 A more com- during the often drawn-out period of their infertility monly recognized motivation for biological procreation discovery. is the strengthening of a partner relationship by means of the partners’ genetic fusion.133 Still another force fueling Indeed, research has indicated that, in addition to the urge to reproduce is the desire for a genetic link to the a positive relationship with the intended parents, as future, which in turn could secure one’s legacy.134 Finally, discussed above, “[surrogates’] satisfaction was in- the experiences of pregnancy, childbirth, and/or child creased due to access to competent professionals who rearing impel many to attempt biological reproduction.135 helped guide them through the process and deal with emotional issues and any problems that arose.”126 More- Alex made clear her desire to manifest her marital over, because of intended parents’ noted “awkwardness love in the form of a biological baby. Indeed, she focused of maintaining contact with the surrogate”127 after the on “motherhood as the natural outgrowth of a loving birth, surrogates’ need for continued professional therapy relationship,”136 asserting that she had never thought seems especially crucial. Even though this need for of “raising a child as a goal in itself.”137 Still, because continued therapeutic help is not universal among sur- Alex did not carry her baby in pregnancy or give birth to rogates,128 it seems that the safer approach is to provide him, she was haunted by the questions, “Would I really it to all surrogates and allow them to decide whether to be his mother? Was the key to motherhood carrying the avail themselves of it. baby?”138 She “worried that [she] was missing out on some great and essential preparation,”139 wondering what V. The Intended Parents’ Experience it meant to not have this experience and whether “a ge- 140 A. The Debated Right to Procreate netic connection [was] enough[.]” Was Alex’s thinking in accordance with Kantian ethics, which would admon- Was Alex Kuczynski exercising an intuitive or even ish against treating a baby, or even the idea of a future a constitutional right to procreate when she enlisted the biological child, as anything but an end in itself? Argu- help of—and contracted with—her surrogate? Regard- ably, not. However, it seems nearly impossible to choose less of the answer to this question—if such an answer surrogacy and comply with Kantian ethics, especially in a can ever be conclusively arrived at—another, arguably country in which far too many children live precariously more important, question arises: once someone procre- in foster care.141 With respect to children engendered by ates, what duties do parents, and even society, owe to the means of surrogacy, the risk threatens their landing in the offspring? foster-care system in states that are silent on the issue of 142 The debate surrounding the right to procreate, and surrogacy, and of their suffering “in limbo” perhaps its converse right not to procreate, has been a perpetually even until they reach the age of 18. divisive one in the United States. The line of Supreme However, since surrogacy will inevitably continue— Court cases starting with Roe v. Wade embodied a rela- as Alex demonstrates in her contracting with a Pennsylva- tively recent history of abortion legislation (prior to 1821, nia-based surrogate despite New York’s lack of surrogacy 129 English common law controlled the realm of abortion ). recognition143—especially as medical science improves, The Court’s focus on the Fourteenth Amendment’s right states’ active recognition of surrogacy agreements can to privacy would sharpen in subsequent cases involving be enormously benefi cial to the children. Indeed, while abortion and contraception, such as Eisenstadt v. Baird perhaps people lack a fundamental right to reproduce by and Planned Parenthood v. Casey, in which liberty was also means of surrogacy (discussed below), “other important cited as encompassing “the right to defi ne one’s own concepts in moral discourse, including harms, benefi ts, concept of existence, of meaning, of the universe, and responsibilities, virtues, and features of human relation- 130 of the mystery of human life.” Indeed, it is these dual ships such as caring and fi delity”144 should guide us in concerns about privacy and liberty, and their inextricable determining how best to protect the most innocent parties link to individuals’ notions of selfhood and meaningful- to surrogacy: the children. ness, that drive the parallel debates surrounding abortion and the right to procreate. Fundamentally, the question remains: regardless of the foster care situation, or any other concerns surround- Many of the comments to Alex’s New York Times ar- ing the decision to procreate, did Alex have the right to ticle questioned her dedication to biological procreation, procreate? The notion of a right to procreate is intrinsi- suffering eleven rounds of IVF and, fi nally, surrogacy cally problematic: if we do, in fact, have such a right, instead of adopting one of many children in need. Carson where lies the corresponding duty to help us achieve Strong, author of Ethics in Reproductive and Perinatal Medi- procreation? Or, is this a negative right—i.e., one that 131 cine: A New Framework, offers many compelling reasons demands simply a lack of interference, rather than active for biological reproduction that shed light on the despera- help, as with a positive right?145 It seems most likely that tion many people (both men and women) can feel in the

NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 41 a right to procreate, if one exists, is a negative one, re- B. Full Faith and Credit quiring no direct, positive help from others but, instead, It bears repeating that Alex acted within the law with non-interference. Indeed, if we return to the parallel her surrogacy arrangement: although a New York resi- abortion-rights debate, the argument presented in the Roe dent, she was able to fi nd a suitable surrogate in Pennsyl- v. Wade line of cases is not that any given individual has vania, where the baby was ultimately born. Alex was then a duty to provide an abortion to a woman seeking one, able to bring the baby home to New York, where her and but that the decision to have an abortion should be legal her husband’s legal parentage would remain recognized, and made by the woman and an individual who is will- despite the baby’s Pennsylvania birth. This recognition is ing to provide the abortion. Thus, it can be argued that legally codifi ed in the U.S. Code in Title 28, Part V, Chap- individuals have the right to try to procreate biologically, ter 115, Section 1738A, which explains how full faith and but that they do not have the right to actually success- credit is given to child custody determinations. There is fully reproduce. This is what was refl ected in Skinner v. comity for custody determinations (with limited modifi - Oklahoma (see supra, note 48), which essentially concludes cation exceptions),151 which means that when an individ- that one’s physical potential for procreation cannot be ual is found to be the legal parent of a baby in one state, taken away against one’s will. Thus, Skinner asserts the all of the other states must recognize that legal parentage. negative right to be allowed to attempt procreation, but not the positive right to become a biological parent. While this might seem rather obvious to a casually interested citizen, this comity provision has wide-ranging Of importance is what constitutes a negative right. implications in the rare event that a surrogate brings a If one applies a Kantian framework, one recognizes a custody suit against the intended parents. The crucial negative right as one that, when violated by interference, defi nition in this statute is that of “home State,” which 146 affects an individual’s treatment as an end in herself. “means the State in which, immediately preceding the As discussed above and further by Strong, the quest for time involved, the child lived with his parents, a parent, self-realization and self-identity can be manifested in or a person acting as parent, for at least six consecutive biological procreation. It follows that interference with months, and in the case of a child less than six months biological procreation can rupture individuals’ sense of old, the State in which the child lived from birth with any self and amount to disrespect for a person as an end in of such persons.”152 In states that recognize surrogacy 147 herself. Indeed, psychological reactions to infertility contracts, when questions of parentage arise, the court can be enormously burdensome: “It is typical for infer- will likely look at the parties’ intentions as indicated in tile couples to experience a grief response involving one the contract; the likely result, therefore, will be to enforce or more features, including shock, denial, anger, guilt, the contract and maintain the intended parents’ legal 148 and depression.” Furthermore, couples might retreat parentage and custody. from normal social interaction in order to avoid others’ probing questions about their inability to conceive, This is precisely what happened in In re Doe,153 which and to avoid glimpses at others’ growing families. Alex involved the determination of whether certain individu- harbored an acute self-awareness of this “self-enforced als engendered by gestational surrogacy could be ben- secrecy of the infertile,”149 consciously rejecting this ap- efi ciaries of a trust established by a family member who proach in a perhaps unusual über-public account of her specifi ed that no adopted children could do so.154 After own battle with infertility. Individuals might fear resent- fi nding that the settlor did not intend to exclude children ment and even abandonment by their partners, and sink born to a surrogate,155 the New York Surrogate’s Court into a depression laced with feelings of inferiority.150 explored the issue of parentage, ultimately giving full faith and credit to California’s judgment that the intended Ultimately, it appears clear that while one lacks an parents were, in fact, the children’s parents. The Court absolute right to reproduce, one maintains the right of stated: noninterference with one’s attempts at procreation. If sexual intercourse fails to result in a viable pregnancy, It is clear that in California the twins or if a couple is homosexual and simply cannot repro- were not adopted, and recognizing this duce without medical intervention of some sort, or if an result in New York is appropriate.… individual wants to become a single parent, the couple [I]n gestational surrogacies, as here or individual must be allowed to seek medical interven- where the birth mother is implanted with tion if it is desired. While Alex might have been shunned a fertilized ovum genetically unrelated to by many readers due to her ostentatious account of her her the basic question of who should be seemingly endless fi nancial capacity for multiple rounds considered the natural mother must be of IVF followed by surrogacy, she nevertheless was answered in light of the advanced tech- merely exercising the right to use her money in this way. nologies that permit such a procedure. In She broke no laws—choosing to contract out of state in Johnson, California developed an analysis order to skirt New York’s lack of recognition and enforce- that has become known as the intent test: ment of surrogacy—and was working to fulfi ll a more those who intended to be parents, absent complete sense of self by means of biological procreation. other compelling circumstances, should

42 NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 be considered the parents. Applying essential, basic civil rights of man, and rights far more that test, the Johnson court declared the precious…than property rights.”158 It appears that this genetic mother, who intended from the decision exemplifi es the New York courts’ likely support beginning to be the mother, instead of for, or at least inclination toward, legalizing commercial the gestational surrogate mother, to be surrogacy agreements. the natural mother.… New York also has a separate article, article 8 (§§ 120-124) of C. Implications of Current New York Law on Parties the Domestic Relations Law, dealing with to New York-Based Surrogacy Agreements surrogate parenting. Unlike California, it Now that we can recognize New Yorkers’ continuing forbids recognition of surrogate parent- ability to engage in surrogacy contracts without fear of ing contracts, and considers them void losing their legally granted parental rights and custody, and unenforceable. Nonetheless, New we should ask: what price do they pay for doing so? And York courts entertain petitions for decla- what about those who still choose to engage in surrogacy rations of maternity, and do not require agreements within the bounds of New York? We must parents to go through an adoption pro- turn our attention to the implications of New York’s cur- ceeding in cases of in vitro fertilization rent lack of recognition and enforcement of surrogacy and gestational surrogacy agreements.… contracts for New York-resident surrogates and intended Finally, no reasoning justifi es a denial parents. of full faith and credit to the California judgment. Where a judgment of a sister As discussed above (supra “Informed Consent”), state is issued with jurisdiction of all surrogates are more likely to be uninformed about and parties, New York must afford it full faith fi nancially unequipped for legal representation. Even and credit.… Although New York forbids if they can afford legal representation, New York-based enforcement of surrogacy contracts, the surrogates are especially vulnerable to potential coercion enforcement of the contract is not at issue and exploitation due to their inability to record their own here. More importantly, the legislature intentions in a legally recognizable agreement. Ultimately, did not punish or prejudice the rights of crude as the semantics are, surrogacy has a market- 159 children born from such arrangements. place, and the weakest surrogates are those who remain Instead, the statutory scheme explicitly at a legal disadvantage without the protection of a valid contemplates full and fair proceedings contract. to determine ‘parental rights, status and A New York case that arose not long after Baby M obligations’ (Domestic Relations Law § found the traditional surrogate petitioning the Fam- 156 124). ily Court for consent to the adoption of her baby by the 160 Therefore, when another state has engaged in an inten- intended parent. These parties had written a 49-page tion-based analysis of parentage and has issued a judg- “Surrogate Parenting Agreement” that provided that ment thereon, New York will recognize and honor that the surrogate would surrender custody of the baby in 161 judgment, giving it full faith and credit. The implications exchange for $10,000. This $10,000 was in addition to of this comity and granting of full faith and credit are pregnancy-related expenses, and the agreement specifi - substantial: intended parents like Alex and her husband cally indicated that this fee “is in no way to be construed can legally contract out of state with a surrogate (who as a fee for termination of parental rights by [the surro- then gives birth to the baby out of state), and thereby ac- gate] or a payment or exchange for a consent to surrender quire legal parentage in states that recognize surrogacy the child for adoption or to assist in the adoption of the agreements; then such intended parents—and newly child or as payment of any expenses for living or mater- legal parents—can return with the baby to New York and nity care between the birth of the child and the adoption 162 be recognized legally as the baby’s parents. Ultimately, of the child by [the intended parent].” The court found this means that New York’s prior decision not to recog- payments pursuant to a surrogacy contract in violation nize or enforce surrogacy contracts has little to no effect of New York law, without a constitutional protection that 163 on those New York residents who have the resources for would override the state law; ultimately, the surrogate and dedication to gestational surrogacy. had to swear under oath that she had not requested, accepted, or received, and would not request, accept, or Further underscoring New York-resident genetic par- receive the $10,000 in order for the court to terminate her ents’ ability to cement their legal parentage is the decision parental rights.164 Thus, the surrogate did not receive her in the recent case T.V. (Anonymous), et al. v. New York State promised consideration for her promise to surrender the Department of Health.157 This case recognized the right of a baby to the intended parent. genetic mother using a gestational surrogate to have her name on the baby’s birth certifi cate. This decision cited This case is rather confusing: both the surrogate and Stanley v. Illinois, in which it was stated that “[t]he rights the intended parent wanted the same thing—namely, for to conceive and to raise one’s children have been deemed the baby to be surrendered by the former and adopted by

NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 43 the latter. However, the surrogate paid a hefty price—the keep the baby. New York would do well to adopt the pre- forced abandonment of a promised $10,000—while the birth-order provision but not the 72-hour change-of-heart intended parent, through no fault of his own, came out one. A small handful of states’ liberal policies concerning ahead. Indeed, this case serves as precedent for potential who can procure a pre-birth order would also serve as a ill-intentioned intended parents to similarly bait and positive infl uence.172 In those states, there are no restric- switch their New York-resident surrogates; regardless of tions as to who can get such an order: married couples whether any such scenario has occurred, the current New using their own egg and sperm, married couples using a York law leaves surrogates vulnerable to agreements donor, unmarried couples, single parents, and same-sex conducted in bad faith by intended parents. couples all can procure pre-birth orders.173 Furthermore, although this case occurred in 1990, be- The more open and accepting the state policy, the fore gestational surrogacy became the preferred method more protective of all parties to a surrogacy arrangement of surrogacy, the law has not been adapted to account and the resulting baby. New York would do well to con- for scientifi c and societal development. As two relatively sider the above-mentioned policy provisions if it reevalu- recent articles published in The Huffi ngton Post rather ates its surrogacy law. passionately assert, New York has failed, thus far, to carve out a consistent, clear, legal path for gestational VI. Conclusion surrogacy.165,166 Although New York has legalized gay We can see that New York should recognize and marriage, gay couples (as well as single individuals and enforce surrogacy contracts to protect all parties involved. infertile heterosexual couples) must fi nd a surrogate in a In not doing so thus far, New York—perhaps inadver- ‘“friendly’ state”167 and engage in the quest for biological tently—allows for a greater “potential for exploitation parenthood rendered costlier than ever due to “the need and coercion of parties to surrogate arrangements”174 by to travel across state lines for medical procedures and denying parties standing to bring a contract claim. More legal representation.”168 A journalist assigned to cover specifi cally, recognition and enforcement of surrogacy the Baby M case asserts that “[i]t is far past time for states contracts would help empower the weaker parties—the to pass laws that create a clear cut, irrevocable path for surrogates—who are at a distinct disadvantage: “a sur- participants in surrogate arrangements to follow. Failure rogate generally occupies an inferior bargaining position to do that is an open invitation to more and very painful in surrogacy arrangements.”175 This is due to surrogates’ legal battles. It can also create lifelong scars for the child relative lack of comprehension of what surrogacy entails everyone professes to love.”169 (since intended parents have likely become well-versed Encouraging anything akin to baby selling would be in assisted reproduction technology, while the surrogates have not), and likely fi nancial and educational inability both illegal and immoral. Equally immoral, however, is 176 entrapment—whether inadvertent or deliberate—of an to hire legal representation. Regulation of surrogacy uninformed surrogate in New York through a potentially contracts should consider “economic compensation, access to medical treatment, psychological support, and bad-faith offer of monetary compensation. Rather than 177 fl atly refuse to recognize or enforce surrogacy contracts, informed consent.” Surrogates’ access to independent therefore, New York should consider a more tempered counsel has been cited as crucial due to potential confl icts approach. of interest, surrogates’ relatively weak position, and the “intensely emotional nature of the process.”178 Whether such a tempered approach means requiring a judge to approve a surrogacy contract before the New York’s refusal to recognize or enforce surrogacy actual surrogacy is executed or providing a ceiling for contracts is outdated: it does not align with other policy extra-pregnancy-related monetary gifts from intended decisions adopted by New York—for example, the legal- parents to surrogates, New York would be wise to protect ization of gay marriage—or with more universal lifestyle potential surrogates by not turning a blind eye to what changes chosen by American women. New York’s stance they reasonably believed would be their benefi ts. Some on surrogacy—a tremendous sacrifi ce that apparently other states offer examples of different policies that should go uncompensated—hurts both intended parents seem to work well and that New York might emulate. and surrogates. Intended parents, whether infertile, sin- For example, many states allow for a pre-birth order of gle, or homosexual, suffer from being unable to exercise parentage,170 which helps all parties avoid post-birth cus- their right to contract with willing potential surrogates tody controversy. New Hampshire serves as a pertinent and know that the resultant contract is legally viable. example of how to fuse a liberal provision with court Such prospective parents are also denied a protected right supervision: under this state’s surrogacy statute, a court to procreate—specifi cally, the right to attempt biologi- must issue such a pre-birth order “before the procedure cal procreation—by being left with essentially no legal to impregnate the surrogate.”171 However, where New recourse should a surrogate breach agreement terms. Sur- Hampshire takes a problematic turn is in allowing the rogates, meanwhile, are left vulnerable to potentially un- gestational surrogate to maintain the right to take up to reliable intended parents. In New York, there is no clear 72 hours after the baby’s birth to change her mind and legal recourse, for anyone involved, in the (rare) event

44 NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 that the agreement is not abided by one party or another; 7. Kuczynski, supra note 1. all parties involved are at a stark disadvantage compared 8. Id. See also Judith Newman, Letters: Her Body, My Baby, THE to those residing in states that do recognize and enforce NEW YORK TIMES MAGAZINE, LETTERS (Dec. 14, 2008), available at surrogacy contracts. The recognition and enforcement http://www.nytimes.com/2008/12/14/magazine/14letters-t- HERBODYMYBAB_LETTERS.html?pagewanted=all (“Kuczynski of surrogacy contracts would allow all parties to have a had the audacity to write honestly about wanting to replicate her clear direction for how to approach such contracts, which own DNA at any cost, and for that she was punished.”). would, ideally, provide guidance as to monetary compen- 9. Richard Sherbahn, Gestational Surrogacy: Using IVF and Having a sation caps, what to do in case of a medical emergency Surrogate Mother Carry the Child for You, Advanced Fertility Center that endangers the surrogate’s life, and whom to entrust of Chicago, http://www.advancedfertility.com/surrogacy.htm care of the baby in the event of the intended parents’ (last visited Jul. 3, 2013). deaths. Most important, the children born from surrogacy 10. Lisa Belkin, Connor Levy, Baby Born After ‘Next-Generation would not be left at the mercy of legally questionable cus- Sequencing,’ May Be The Future of IVF, THE HUFFINGTON POST (Jul. 8, 2013), available at http://www.huffi ngtonpost.com/2013/07/08/ tody arrangements or at risk of falling between the cracks connor-levy-next-generation-sequencing-ivf_n_3562394.html?utm_ into the foster care system. hp_ref=healthy-living&ir=Healthy%20Living (last visited Jul. 8, 2013). Furthermore, the legislature should consider the modern penchant for gestational, rather than tradi- 11. Id. tional, surrogacy. While not its foremost goal, one result 12. James Gallagher, Baby Born Using New IVF Screening Technique, BBC NEWS (Jul. 7, 2013), available at http://www.bbc.co.uk/news/ of gestational surrogacy is surrogates’ more successful health-23205638 (last visited Jul. 8, 2013) (“What our technique avoidance of a strong emotional attachment to the baby, does is it gives you the number of chromosomes and other an attachment normally fueled during pregnancy by an biological information about the embryo at a low cost—probably acute awareness of a biological connection. Therefore, about two thirds of the price of existing methods of screening any remaining fears of the Baby M situation, itself ex- [which can cost $6,000].”). tremely rare and feared only during and immediately 13. Kuczynski, supra note 1. after this case, should be quelled by the knowledge that 14. Id. gestational surrogacy is the surrogacy mode of choice, 15. See, e.g., Female Infertility: Causes, Tests, Signs, Treatments, with surrogates generally feeling that the babies are “not WEBMD, available at http://www.webmd.com/infertility-and- [theirs] to give.”179 reproduction/guide/female-infertility (last visited Jul. 8, 2013) (“Unexplained infertility. The cause of infertility in approximately Beyond the legal diffi culties posed by New York’s 20% of couples will not be determined using the currently current stance on surrogacy contracts, varied new—or, available methods of investigation.”). at least, newly accepted—lifestyle choices and biologi- 16. See Intended Parents, Inc., About Us, available at http:// cal needs run perpendicular to the solitary vision of the intendedparents.com/About_Us.asp (last visited Jul. 8, 2013). surrogacy-engendered family imagined by the legisla- 17. American Medical Association, Informed Consent, available at ture, namely, a heterosexual couple hiring a surrogate, http://www.ama-assn.org//ama/pub/physician-resources/ legal-topics/patient-physician-relationship-topics/informed- who threatens—and perhaps wins—a fi ght for the baby consent.page (last visited Jul. 8, 2013). after its birth. Today is a time of slow-forming yet true 18. Id. acceptance—of gay marriage and rights, of single parenthood, of parenthood begun after the typical fertile years, 19. See, e.g., Nancy W. Machinton, Surrogate Motherhood: Boon or Baby-Selling—The Unresolved Questions, 71 MARQ. L. REV. 115 and of women working to achieve professional success (1987); Steven M. Recht, ‘M’ is for Money: Baby M and the Surrogate prior to motherhood. The law should refl ect and support Motherhood Controversy, 37 AM. U. L. REV. 1013, at 1026–28. such acceptance, but the New York surrogacy law does 20. In the Matter of Baby M, a pseudonym for an actual person, 537 neither. A.2d 1227 (1988), at 1236–1237. 21. Id. at 1235. Endnotes 22. Id. at 1237. 1. Alex Kuczynski, Her Body, My Baby, THE NEW YORK TIMES (Nov. 23. Id. at 1236. 28, 2008), available at http://www.nytimes.com/2008/11/30/ magazine/30Surrogate-t.html?pagewanted=all&_r=0 (last visited 24. Id. at 1239–1240. Jul. 8, 2013). 25. Id. at 1240. 2. Id. 26. Id. 3. Id. at 23. 27. Id. 4. Matthew Tieu, Oh Baby Baby: The Problem of Surrogacy. BIOETHICS 28. Griswold v. Connecticut, 381 U.S. 479, 484–85 (1965). RESEARCH NOTES. Vol. 19, No. 1 (March 2007), at 2. 29. See, e.g., Recht, supra note 19, at 1028–1031. 5. Janice C. Ciccarelli and Linda J. Beckman, Navigating Rough Waters: An Overview of Psychological Aspects of Surrogacy, J. SOC. 30. Id. at 1028. ISSUES, Vol. 61, No. 1 (2005), at 29–30. 31. Id. at 1030. 6. What is intrauterine insemination (IUI) and how does it work? Human 32. Id. at 1031. Fertilisation and Embryology Authority, http://www.hfea.gov. uk/IUI.html (last visited Jul. 3, 2013). 33. Id.

NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 45 34. Brittnay M. McMahon, The Science Behind Surrogacy: Why New nytimes.com/2013/03/10/books/review/sheryl-sandbergs-lean- York Should Rethink its Surrogacy Contracts Laws, 21 ALB. L. J. SCI. & in.html?pagewanted=all. TECH. 359, 360 (2011). 60. National Committee on Equal Pay, http://www.pay-equity.org/. 35. Id. at 365. 61. Slaughter, supra note 59. 36. Id. at 366. 62. Id., quoting law professor Joan Williams. 37. Id. at 367. 63. See, e.g., How Age Affects Fertility, FERTILITYFACTOR.COM 38. Abby Brandel, Colloquium: Gender, Law and Health Care: Legislating (“Statistically speaking, the changes of pregnancy for women Surrogacy: A Partial Answer to Feminist Criticism, 54 MD. L. REV. over 30 start to decline by about 3.5% per year.”), http://www. 488, 516 (1995). fertilityfactor.com/age_and_fertility.html. 39. Recht, supra note 19, at 1044 (emphasis in the original). 64. See, e.g., Fred Silberberg, Is Surrogacy on Its Way to Becoming ‘The New Normal’? THE HUFFINGTON POST (June 20, 2012), 40. Elizabeth S. Scott, Surrogacy and the Politics of Commodifi cation, 72 available at http://www.huffi ngtonpost.com/fred-silberberg/ LAW AND CONTEMPORARY PROBLEMS 109 (2009). surrogacy_b_1610804.html (last visited Aug. 2, 2013). 41. Catherine London, Advancing a Surrogate-Focused Model of 65. Just a couple examples of television shows, in addition to “The Gestational Surrogacy Contracts, 18 CARDOZO J.L. & GENDER 391, 392 New Normal” (NBC, 2012-2013), are “Parenthood” (NBC, 2010- (Winter 2012). 2015), which follows a family’s various parent-child relationships 42. See, e.g., Yehezkel Margalit, In Defense of Surrogacy Agreements: A across generations and includes issues of foster care, adoption, Modern Contract Law Perspective (March 10, 2013), at 4. Available infertility, and single-parenthood; and “Modern Family” (ABC, at SSRN: http://ssrn.com/abstract=2231089 (“There is presently 2009-present), which involves different familial structures, much scholarly literature that endorses the understanding that including so-called traditional (heterosexual parents with three when faced with the dilemma of which system of law should children) and untraditional (homosexual parents adopting a govern surrogacy contracts—family law or contract law—the foreign baby; older man marrying a younger woman who is latter should prevail.”). the mother of a young son). A small sample of relevant movies includes “The Family Stone” (2005), which involves various 43. London, supra note 41, at 411. familial and romantic relationships, including a homosexual and 44. Id. interracial couple who adopt a baby; “Baby Mama” (2008), a comedy about surrogacy; and “The Back-Up Plan” (2010), which 45. McMahon, supra note 34, at 373. involves artifi cial insemination. 46. London, supra note 41, at 410. 66. Alessandra Stanley, Tina Fey’s ‘Admission’ and Other Comedies Eye 47. Id. at 402–403. Maternity, THE NEW YORK TIMES (Mar. 15, 2013), available at http:// www.nytimes.com/2013/03/17/movies/tina-feys-admission-and- 48. Recall that the right to procreation is constitutionally protected as other-comedies-eye-maternity.html?pagewanted=all&_r=1& (last seen in Skinner v. Oklahoma Ex. Rel. Williamson, 316 U.S. 535, 536 visited Aug. 3, 2013). (1942) (“Oklahoma deprives certain individuals of a right which is basic to the perpetuation of a race—the right to have offspring.”). 67. Id.

49. Lorraine Ali, The Curious Lives of Surrogates, THE DAILY BEAST (in 68. Id. NEWSWEEK MAGAZINE), available at http://www.thedailybeast. 69. Id. com/newsweek/2008/03/29/the-curious-lives-of-surrogates. html, Mar. 29, 2008. 70. Id. 50. Brandel, supra note 38, at 515. 71. Judith Warner, The Opt-Out Generation Wants Back In, The New York Times Magazine (Aug. 7, 2013), available at http://www. 51. “AML,” in Kuczynski, supra note 1, at Readers’ Comments, #404. nytimes.com/2013/08/11/magazine/the-opt-out-generation- 52. Kuczynski, supra note 1. wants-back-in.html?pagewanted=4&_r=1&hp (last visited Aug. 8, 2013). 53. Id. 72. JUDITH WARNER, PERFECT MADNESS: MOTHERHOOD IN THE AGE OF 54. Shira Saperstein, Letters: Her Body, My Baby, THE NEW YORK ANXIETY, Riverhead Books: New York (2005). TIMES MAGAZINE, LETTERS (Dec. 14, 2008), available at http:// www.nytimes.com/2008/12/14/magazine/14letters-t- 73. Warner, supra note 71, at p. 4 (online iteration). HERBODYMYBAB_LETTERS.html?pagewanted=all. 74. Ali, supra note 49. 55. Janet Benton, Letters: Her Body, My Baby, THE NEW YORK 75. Brandel, supra note 38, at 521. TIMES MAGAZINE, LETTERS (Dec. 14, 2008), available at http:// www.nytimes.com/2008/12/14/magazine/14letters-t- 76. Katherine Drabiak et al., Ethics, Law, and Commercial Surrogacy: A HERBODYMYBAB_LETTERS.html?pagewanted=all. Call for Uniformity, 35 J. L. MED & ETHICS 300, 305 (2007). 56. Id. 77. Brandel, supra note 38, at 496. 57. See, e.g., Misty Harris, ‘Domestic Dream’ of 2.5 Children Per Woman 78. Ethics Committee of the American Society for Reproductive Long Gone as Fertility Rate Declines for Third Year in Row, NATIONAL Medicine, Consideration of the Gestational Carrier: A Committee POST, available at http://news.nationalpost.com/2013/07/09/ Opinion, Fertility and Sterility (2013), at 1839. domestic-dream-of-2-5-children-per-woman-long-gone-as- 79. Ali, supra note 49. fertility-rate-declines-for-third-year-in-row/ (last visited Aug. 8, 2013) (commenting on the declining fertility rate in Canadian 80. Id. women). 81. Id. 58. SHERYL SANDBERG, LEAN IN: WOMEN, WORK, AND THE WILL TO LEAD 82. Id. (2013). 83. Id. 59. Anne-Marie Slaughter, Yes, You Can: Sheryl Sandberg’s ‘Lean In,’ THE NEW YORK TIMES (Mar. 7. 2013), available at http://www. 84. Drabiak, supra note 76, at 305.

46 NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 85. Brandel, supra note 38, at 521. choose to bear children for others primarily out of altruistic concerns.…Rather, the women have empathy for childless couples 86. Id. at 522. and want to help others experience the great joy of parenthood.”). 87. Ethics Committee of the American Society for Reproductive 121. Id. at 31. Medicine, supra note 78, at 1839. 122. Akker, supra note 107, at 152. 88. Jennifer Damelio and Kelly Sorensen, Enhancing Autonomy in Paid Surrogacy, BIOETHICS, Vol. 22, No. 5 (2008), at 274. 123. Id. at 147. 89. McMahon, supra note 34, at 377. 124. Id. at 156. 90. See, e.g., McMahon, supra note 34, at 360. 125. Id. at 159. 91. Ali, supra note 49. 126. Ciccarelli & Beckman, supra note 5, at 34. 92. Id. 127. Id. at 35. 93. Id. 128. Id. at 34.

94. See Ali, supra note 49 (“Military wives who do decide to become 129. GEORGE COLE & STANISLAW FRANKOWSKI, ABORTION AND PROTECTION surrogates can earn more with one pregnancy than their OF THE HUMAN FETUS: LEGAL PROBLEMS IN A CROSS-CULTURAL husbands’ annual base pay (which ranges for new enlistees from PERSPECTIVE 20 (1987). $16,080 to $28,900)”). 130. Planned Parenthood of Southeastern Pa. v. Casey, 505 U.S. 833, 851 95. Ethics Committee of the American Society for Reproductive (1992). Medicine, supra note 78, at 1840. 131. CARSON STRONG, ETHICS IN REPRODUCTIVE AND PERINATAL MEDICINE: 96. Damelio & Sorensen, supra note 88, at 269. A NEW FRAMEWORK, 18–22 (1997). 97. Id. at 275. 132. Id. at 18. 98. London, supra note 41, at 414. 133. Id. at 18–19. 99. Id. at 410. 134. Id. at 20. 100. McMahon, supra note 34, at 374. 135. Id. at 20–22. 101. Id. at 375. 136. Kuczynski, supra note 1. 102. Ali, supra note 49. 137. Id. 103. V. Jadva et al., Surrogacy families 10 years on: relationship with the 138. Id. surrogate, decisions over disclosure and children’s understanding of their 139. Id. surrogacy origins, HUM. REPROD., Vol. 27, Issue 10 (2012), at 3011. 140. Id. 104. Ciccarelli and Beckman, supra note 5, at 32. 141. U.S. Department of Health and Human Services; Administration 105. Id. for Children and Families; Administration on Children, Youth 106. Id. and Families; Children’s Bureau, Child Welfare Outcomes 2007- 2010: Report to Congress, available at http://archive.acf.hhs.gov/ 107. Olga Van Den Akker. Genetic and Gestational Surrogate Mothers’ programs/cb/pubs/cwo07-10/cwo07-10.pdf: Despite a 22-percent Experience of Surrogacy. JOURNAL OF REPRODUCTIVE AND INFANT decrease in the number of children in foster care between 2002 PSYCHOLOGY. Vol. 21, No. 2 (May 2003), at 154 (“The main reason and 2010, “[n]ationally, there were approximately 415,000 children for wishing to be a surrogate again was the importance they in foster care on the last day of FY 2010. During that year, an attached to the intended mother’s friendship….The most positive estimated 250,000 children entered foster care, and 248,000 feelings about the surrogacy were the deep and meaningful children exited foster care,” for a net increase of children in foster friendships they felt they had developed with the intended care of approximately 2,000. Furthermore, cause of the decrease couples and the hope they can give people with no other between 2002 and 2010 “currently [is] not possible to determine” options.”). (i). Moreover, of the 213,000 children who exited foster care in 108. Ciccarelli & Beckman, supra note 5, at 32. 2010, 52,000 were discharged to adoption, while 7,000 left for reasons other than permanent homes or emancipation, “such as 109. Id. transfer to another agency or to another State” (ii). 110. Magdalina Gugucheva, Surrogacy in America. Council for 142. Stephanie Saul, Building a Baby, With Few Ground Rules, THE NEW Responsible Genetics (2010), at 17. YORK TIMES (Dec. 12, 2009), available at http://www.nytimes. 111. Id. at 19. com/2009/12/13/us/13surrogacy.html?pagewanted=1&_ r=1&fta=y, at 2. 112. Id. 143. Kuczynski, supra note 1. 113. Id. 144. STRONG, supra note 131, at 23–24. 114. Id. at 19–20. 145. See, e.g., STRONG, supra note 131, at 23. 115. Id. at 20. 146. STRONG, supra note 131, at 24. 116. Gugucheva, supra note 110, at 20. 147. Id. 117. Id. 148. Id. at 15. 118. Id. at 23. 149. Kuczynski, supra note 1. 119. Id. at 24. 150. STRONG, supra note 131, at 15. 120. Id. at 30 (“Contrary to popular beliefs about money as a prime motive, surrogate mothers overwhelmingly report that they 151. 28 U.S.C. 1738A(f) and (h).

NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 47 152. Id. at (b)(4). case law) and pre-birth orders of parentage include Arkansas, California, Colorado, Connecticut, Georgia, Illinois (which 153. In re Doe, 793 N.Y.S.2d. 878 (2005). actually has an easier process that skips the court process), Kansas, 154. Id. at 879. Kentucky, Maine, Maryland, Massachusetts, Montana, New Hampshire, North Dakota, Oregon, Pennsylvania, Rhode Island, 155. Id. at 880–81. South Dakota, Utah, and West Virginia. 156. Id. at 880–81. 171. Id. at 6. 157. T.V. (Anonymous), et al. v. New York State Department of Health, 172. Id. (California, Connecticut, Maine, Maryland, Rhode Island, and 88 A.D.3d 290 (2011). South Dakota). 158. Stanley v. Illinois, 405 U.S. 645, 651 (1972). 173. Id. at 2. 159. See, e.g., Diane Dimond, Surrogacy on Upswing: Laws Still in 174. Drabiak, supra note 76, at 302. Infancy, THE HUFFINGTON POST (June 19, 2013), available at http:// www.hufﬁ ngtonpost.com/diane-dimond/surrogacy-on- 175. London, supra note 41, at 414. upswing_b_3465120.html (last visited Jul. 31, 2013). 176. Gugucheva, supra note 110, at 23. 160. Matter of Adoption of Paul, 550 N.Y.S.2d 815 (1990). 177. Ethics Committee of the American Society for Reproductive 161. Id. at 815. Medicine, supra note 78, at 1839. 162. Id. at 816. 178. Id.

163. Id. at 818. 179. Kerri MacDonald, Letting Go of a Baby, but Not the Emotions, THE NEW YORK TIMES (May 10, 2013), available at http://lens.blogs. 164. Id. at 818–19. nytimes.com/2013/05/10/letting-go-of-a-baby-but-not-the- 165. Dimond, supra note 159. emotions/ (last visited Aug. 5, 2013).

166. Lila Sutphen, Surrogacy Soapbox, THE HUFFINGTON POST (June 19, 2013), available at http://www.hufﬁ ngtonpost.com/lilah- Shawna Benston holds a BA from Yale University, sutphen/surrogacy-soapbox_b_3467493.html (last visited Jul. 31, 2013). an MLitt (Classics) from the University of St Andrews, a Masters of Bioethics from the University of Pennsylva- 167. Id. nia, and a JD from the Benjamin N. Cardozo School of 168. Id. Law, where she served as Editor-in-Chief of the Cardozo 169. Dimond, supra note 159. Journal of Conﬂ ict Resolution. Sincere appreciation goes 170. Diane S. Hinson, State-by-State Surrogacy Law: Actual Practices, out to Stuart Sherman and the late Adrienne Asch for FAMILY ADVOCATE (Fall 2011). States that clearly allow for both their feedback on this article. surrogacy contracts (by statute, lack of prohibitory law, or

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48 NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 Mitochondrial Replacement: Changing the Family Structure By Caitlin Davie

The family dynamic has evolved over the last sev- which affects mainly infants and causes patches to form eral decades. In vitro fertilization (IVF) techniques, on the brain that in turn cause loss of mental function and surrogacy and other scientifi c advances have played a movement abnormalities.13 Leigh syndrome is deadly; signifi cant role in that changing dynamic. But scientifi c those affl icted often die within a few years, typically due advancements and surrogacy do more than just change to respiratory failure.14 Defects in the mitochondrial DNA the family structure, they also create unique ethical and have also been linked to deafness, diabetes, and some legal consequences. The legal and ethical consequences cancers.15 of some IVF treatments and surrogacy arrangements are Mothers who are carriers of mitochondrial diseases well known and have played out on the pages of newspa- have various options to avoid passing the disease on to pers and magazines. But the ethical and legal implications their children. These options include adoption, in vitro of some scientifi c advances, such as the one discussed in fertilization (IVF) with donor eggs, pre-implantation this article, have not yet been addressed by the courts and genetic diagnosis (PGD), and prenatal diagnosis (PND). 16 legislatures. Adoption and IVF with donor eggs may not be a desir- Most parents select IVF procedures because their able option for mothers who prefer to have a genetic health issues prevent the natural conception and birth of connection to their children.17 These options are also very a child. One particular subset of diseases that has driven expensive. PGD allows women to increase their chances the creation of an entirely new type of IVF treatment is of having a healthy child by fi rst creating an embryo, mitochondrial diseases. through the use of IVF, and then testing the embryos for the presence of mitochondrial diseases.18 Not all mito- Mitochondria are present in all cells and reside in chondria will necessarily be affected, so those embryos 1 Mitochondria have DNA, the fl uid around the nucleus. with the least amount of unhealthy mitochondria will be which is referred to as mitochondrial DNA or mtDNA.2 implanted.19 PGD reduces, but does not eliminate, the Mitochondrial DNA is necessary to carry out mitochon- chance the child will develop the disorder.20 PGD may drial functions such as converting food energy into a form also create ethical issues for some parents regarding what 3 A mito- that becomes the cell’s main source of energy. to do with the embryos that were not chosen. PND is per- chondrial disease or disorder results from a defect in the formed by testing a fetus that has been conceived natural- mitochondrial DNA. ly to determine whether or not the fetus has the disease.21 The DNA contained in the nucleus is nuclear DNA.4 If the fetus tests positive for a mitochondrial disease, Mitochondrial DNA is separate from the DNA contained parents are left with the diffi cult decision of whether or in the nucleus.5 Mitochondrial DNA contains 37 genes not to abort the fetus.22 that carry the instructions for the creation of enzymes and Researchers at Newcastle University in the United molecules that are necessary for healthy mitochondrial Kingdom have developed two innovative techniques 6 Genes that make up the nuclear DNA give each function. that could help prospective parents avoid mitochondrial person his or her unique features.7 An individual receives disorders while remaining the biological parents of their two copies of most genes, one from each parent. 8 Most children. Both innovative techniques are called mito- DNA is contained in the nucleus; the DNA found in the chondrial replacement. Simply put, these processes allow mitochondria is only a “small fraction of the total DNA in scientists to replace the unhealthy mitochondria with cells.”9 healthy mitochondria. Mitochondrial diseases occur when there is a change There are two ways that this can be accomplished.23 in the mitochondrial DNA caused by mutation, dele- One is the Maternal Spindle Transfer (MST).24 MST tion, or rearrangement of the segments of mitochondrial requires an egg from the intended mother and a donated 10 Because only the egg cells supply mitochondria to DNA. egg from another woman.25 The maternal spindle, which the embryo, the biological mother passes on mitochondri- houses the egg’s nuclear DNA, is removed from the 11 Although only females can pass mitochon- al diseases. donor egg and is replaced with the intended mother’s drial diseases to their children, these diseases affect both maternal spindle.26 This procedure creates an egg that 12 males and females. has the intended mother’s nuclear DNA and the donor Mitochondrial diseases can have devastating effects mother’s mitochondrial DNA.27 Following the procedure, on those who are affl icted. For example, a mutation in the egg can be fertilized by the intended father.28 mitochondrial DNA is responsible for Leigh syndrome,

NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 49 The second procedure is called Pro-Nuclear Transfer hinges on extensive cross-talk between genes dispersed (PNT).29 This procedure requires an embryo from the across the nucleus and the mitochondria. Because phe- intended parents and a donated embryo.30 Each embryo notypes with less-than-ideal cross-talk are disfavored contains one pronucleus from the sperm and one pro- by natural selection, coordinated mitochondrial-nuclear nucleus from the egg, and each pronucleus contains the interactions become highly specifi c over evolutionary nuclear DNA of the respective parent.31 The procedure time. If [mitochondrial replacement] disrupts such spe- involves the removal of the pronuclei, the pronucleus cifi c, highly coordinated mito-nuclear allelic interactions, from the egg and the pronucleus from the sperm, from adverse health outcomes might occur.”47 Indeed, in stud- the donor embryo and replacing it with the pronuclei ies involving male mice and mitochondrial replacement, of the intended parents.32 The nuclear material that was the mice had reduced learning, performance and explor- removed from the donor embryo will be destroyed.33 atory capacity.48 The study of mitochondrial replacement This procedure creates an embryo that has the intended in humans is limited and the serious consequences in parents nuclear DNA and the donor mother’s mitochon- mice highlight the potential adverse consequences in drial DNA.34 humans.49 The most important difference between these two There is also a more philosophical concern regard- procedures is that MST requires the destruction of an ing a possible change in the personality of the child who egg,35 whereas PNT requires the destruction of an em- undergoes this procedure. A child who grows up with a bryo.36 Both of these procedures produce a child that has mitochondrial disease will have very different life experi- the nuclear DNA of the intended parents and the mito- ences than a child who grows up healthy.50 While genet- chondrial DNA of the donor mother. Thus, the child will ics plays an important role in forming an individual’s have three biological parents. personality, life experiences are also signifi cant.51 Thus mitochondrial replacement may not only affect the Ethical Considerations child’s disease state, but also other aspects of the child’s personality.52 While these procedures will provide families with new and potentially life-changing options, they are not Mitochondrial replacement also has the unique risk without ethical concerns. The destruction of an egg in the that it will negatively impact researchers’ abilities to MST procedure and the destruction of an embryo in the study demographic and migration patterns, and ancestral PNT procedure are of particular ethical concern to fami- lines using mitochondrial DNA.53 Mitochondrial DNA is lies with certain religious beliefs and to certain religious often used to determine a person’s direct female ancestral organizations. For some religions, eggs and embryos line.54 And because mitochondrial DNA is only passed have aspects of personhood.37 For example, Catholics are to offspring through the mother, this type of mapping opposed to the destruction of embryos because in Cathol- allows researchers to fi nd female ancestors who might icism life begins at conception, which is the fertilization not have been found because of changes in surnames.55 of the egg.38 Some in the Buddhist and Hindu religions The procedure could also confuse the genealogical links also oppose the destruction of embryos.39 However, between individuals, making it more diffi cult for future many people of the Jewish faith, as well as other religious generations to accurately trace their ancestry and fi nd groups, do not believe embryonic life is sacred.40 Similar- important information related to their background and ly in the Islamic religion, there generally is no opposition familial history.56 41 to the destruction of an embryo. The gravity of these risks leads to the argument that There are other concerns worth noting. The effects prospective parents should just adopt. However, that is of mitochondrial replacement on future generations are simply not the reality of the society we live in. Adoption largely unknown and there is evidence that the proce- can be expensive, time consuming and unsuccessful for dure itself is not without risks.42 For example there are any number of reasons. Even if adoption was a viable risks to the donor.43 The egg donor risks psychological option for every family, genetics is often important to par- and physical injuries such as injury to organs, decreased ents. A genetic connection is what drives some people to fertility or infertility, ovarian, breast and colon cancer, as seek alternatives that would allow for at least a partial ge- well as hemorrhage and thromboembolism from the do- netic link between the parents and the child. This is often nation process itself.44 However, women undergo these done through the use of a surrogate. Surrogacy is hardly a risks everyday when they donate their eggs in standard simple or easy solution. Surrogacy agreements are fraught egg donation cases.45 It should also be noted that these with legal complications and are expensive. Surrogates risks are relatively low. So while these risks should not can cost anywhere between $30,000-35,000 plus medical be ignored or taken lightly, they should not prevent the and legal costs and many people require private fi nanc- donation of mitochondrial DNA. ing to undergo surrogacy.57 For some, the costs reach six digits and costs also increase with complex pregnancies.58 Additional concerns exist regarding the potential ad- Despite these shortcomings, the number of gestational 46 verse effects on health. “[E]nergy production critically surrogacy59 arrangements has been increasing.60 People’s

50 NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 willingness to undertake such potentially heartbreaking the wife carried the pregnancy and was the gestational and bank-breaking risks just so that they can have a child mother, she did not have genetic ties to their children.69 that is genetically related to them clearly shows the value The Court held that this was a “true egg donation” situ- society puts on genetics in parental relationships. ation as envisioned by the California Supreme Court and because the gestational mother intended to the raise the 70 Legal Considerations children as her own she was the natural mother. Beyond these important ethical considerations are the These cases are instructive in determining a child’s legal ramiﬁ cations associated with mitochondrial replace- legal parents in cases involving mitochondrial replacement. The children born using this procedure will have ment.71 The intent test can be used if the woman who three biological parents. If the child has three biological donates the mitochondrial DNA agrees to forgo any pa- parents, theoretically all of these parents should have rental rights. The couple that initiated the mitochondrial rights to visitation and custody, and a corresponding replacement would be the natural parents, not the donor, obligation to provide child support. However, the law because they intended to raise the child as their own.72 generally recognizes only two parents for each child. Without the intended parents decision to have the child, Stepparents only assume parental rights and obligations this child would not have been born, so the intended par- when they replace one of the parents. ents are the ones who should have parental rights.73

Genetic Donors Issues involving the donor mother’s decision to assert parental rights can be avoided with mitochondrial Historically, the law has presumed that a child can DNA by using anonymous donations. If donors are 61 only have two legal parents. Traditionally, genetic ties aware from the outset that they are making anonymous or legal adoption have determined the parents of a child. donations and that once they have donated their DNA Technological advances have confused these traditional they no longer have parental rights, controversies over 62 assumptions. For example, egg donation and surrogacy parental rights should be avoided. Issues concerning have forced the legal system to consider whether the parenthood should also be less of an issue with mitochon- genetic or gestational mother should have legal rights drial replacement than with donor eggs because donors and responsibilities to the resulting child. Courts have of mitochondrial DNA will not have the same physical looked to the intent of the parties to determine whether traits as the child. The nuclear DNA, which the child will the gestational or genetic mother should be regarded as receive from the intended parents, almost exclusively the legal mother. In the particular situation of mitochon- determines physical characteristics.74 The donor’s limited drial replacement, genetics cannot be used as determina- genetic connection to the child, paired with the fact that tive because all three parities are genetically related to the the donor mother does not carry the child, also makes it child. unlikely that the donor mother would later attempt to as- In Johnson v. Calvert, a couple entered into a surrogacy sert parental rights. agreement in which the surrogate would be implanted Anonymous donation also helps protect donors from with an embryo that was created from the egg of the parents who might later attempt to collect child support 63 wife and the sperm of the father. After the relationship from donors. However, donors would likely be protected between the couple and the surrogate deteriorated, the from claims for child support anyway because the donor surrogate claimed that she was the legal parent of the did not intend to raise the child as her own and therefore, 64 child. The Supreme Court of California held that while under the intent test, would not be liable for the child’s gestation and genetic ties could both establish maternity, support. in cases where the genetic and gestational mother are not the same person then “she who intended to procreate the Where the courts have been unable to rely on the child—that is, she who intended to bring about the birth intent of the parties—for example, where there has been of a child that she intended to raise as her own—is the a mistake by a fertility clinic—the courts have relied on natural mother.”65 By contrast, “in a true ‘egg donation’ genetic relationships rather than gestation to determine situation, where a woman gestates and gives birth to a the child’s legal parents. For example, in Perry-Rogers v. child formed from the genetic material of another woman Fasano, a mix-up at an IVF clinic resulted in Mrs. Fasano with the intent to raise the child as her own, the birth being implanted with embryos that were formed using mother is the natural mother.”66 her eggs and her husband’s sperm and embryos that were formed using another couple’s eggs and sperm.75 Mrs. In McDonald v. McDonald, the New York State Appel- Fasano had two children, one that was genetically hers late Division, Second Department followed the ruling in and one that was genetically the Perry-Rogers’.76 Johnson and also adopted the intent test.67 In McDonald, a couple ﬁ led for divorce and the father sought custody of The appellate court treated the case as analogous to a their children.68 He claimed that he was the “only genetic surrogacy situation. However, Ms. Fasano did not con- and natural parent available” because the couple used an sent to carry a child for another person, but rather used egg donor when conceiving their children and, although the IVF clinic so that she could have children of her own.

NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 51 Therefore, this case is as similar to an egg donation case dren.86 For example, in Arkansas a grandparent can rebut as it is to a surrogacy situation. The court also attempted the presumption that a parent’s choice to deny visitation to apply the intent test noting that the Perry-Rogerses is in the child’s best interest by proving that “(A) [the intended to have and raise their own genetic child.77 grandparent] has established a signifi cant and viable However, this case cannot be solved so easily. While it relationship with the child…and (B) [v]isitation with the is true that the Perry-Rogerses wanted a child and they [grandparent] is in the best interest of the child.”87 Many were using an IVF clinic to accomplish this purpose, Mrs. states have similar visitation laws for siblings. For ex- Fasano also intended to have a child and certainly never ample, in Maryland, if siblings are separated in foster care agreed to be a surrogate. Mrs. Perry-Rogers did not con- or by adoptive placements, they have standing to petition sent to donate her egg and Mrs. Fasano did not consent for visitation. 88 to be a surrogate. The court wrote that it wasn’t relying Some jurisdictions such as the District of Columbia solely on genetics in fi nding in favor of the Perry-Rogers- and Delaware, have explicitly recognized multiple par- es78 but neither the intent test nor the surrogacy analogy completely explains the decision. ents even if there are more than two by allowing “de facto parents.” In the District of Columbia a de facto parent is Three Intended Parents an individual (A) Who: (i) Lived with the Mitochondrial replacement creates the possibility child in the same household at the time of three genetic parents and also the potential for three of the child’s birth or adoption by the intended parents. Why shouldn’t the legal system accom- child’s parent; (ii) Has taken on full and modate three parents? Society already recognizes paren- permanent responsibilities as the child’s tal arrangements that involve stepparents, but generally parent; and (iii) Has held himself or stepparents do not have the legal rights of a parent.79 herself out as the child’s parent with the agreement of the child’s parent or, if there A New Trend are 2 parents, both parents; or (B) Who: (i) Has lived with the child in the same Courts and legislatures are beginning to recognize household for at least 10 of the 12 months that limiting parental rights to two-parent families is not immediately preceding the fi ling of the always best for the children. Sometimes there are oth- complaint or motion for custody; (ii) Has ers who should have rights to visitation, custody, and formed a strong emotional bond with the decision-making on the child’s behalf. Judge Kaye, in child with the encouragement and intent her dissenting opinion in Allison D., calls attention to the of the child’s parent that a parent-child importance of recognizing unique family structures. She relationship form between the child and emphasizes that a child’s welfare, happiness, and best the third party; (iii) Has taken on full interests should be most important in determining who a and permanent responsibilities as the 80 child’s parents are. Judge Kaye argues that by limiting child’s parent; and (iv) Has held himself children’s familial choices, we are “limiting their op- or herself out as the child’s parent with portunity to maintain bonds that may be crucial to their the agreement of the child’s parent, or if 81 development.” there are 2 parents, both parents.89 Legislatures have recognized the importance of In D.C., a person who has established that he or she is a allowing persons other than parents to have visitation de facto parent will be considered a parent when deter- rights by enacting grandparent and sibling visitation mining custody and child support.90 laws. In Troxel, the Supreme Court examined the constitutionality of a Washington State law that permitted any Delaware has a similar statute that allows for de facto person to petition for visitation.82 The Court found the parents. In Delaware a de facto parent statute unconstitutional because it was too sweeping and is established if the Family Court deter- did not give enough deference to the parents’ decision.83 mines [that the individual]: (1) Has had The court stated that “there is a presumption that fi t par- the support and consent of the child’s ents act in the best interests of their children”; thus if the parent or parents who fostered the forma- parents deny visitation, there is a presumption that the tion and establishment of a parent-like decision was in the best interest of the child and gener- relationship between the child and the ally the state should not intervene.84 As a result of the de facto parent; (2) Has exercised paren- ruling in Troxel, visitation laws must be limited and give tal responsibility for the child…and (3) deference to the parents’ decision that visitation is not in Has acted in a parental role for a length the best interest of the child.85 of time suffi cient to have established a Several states have legislation granting grandparents bonded and dependent relationship with standing to petition for visitation with their grandchil- the child that is parental in nature.91

52 NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 Once it has been established that a person is a de facto the parties because “recognizing the intending parents parent, that person has the same rights and responsibili- as the child’s legal, natural parents should best promote ties as the child’s other established parents.92 certainty and stability for the child.”109 The courts and legislatures should work together to allow the families Some courts have been unwilling to hold that there themselves to decide how many parents their particular are more than two parents without an express directive family will have. from the legislature. In In re M.C., M.C. was raised by her biological mother, Melissa, and her mother’s domestic Where three parents have decided to have a child partner, Irene.93 After the relationship ended, Melissa using mitochondrial replacement and raise the child to- conspired with her then-boyfriend to murder Irene, but gether, then all three parents should be able to assert their they were unsuccessful.94 With Melissa in jail, the future parental rights. If any of these three people were unable of M.C. was left to the courts.95 The possible parents were to be legally considered a parent to that child, it would Melissa, Irene, or M.C.’s biological father.96 The California signifi cantly affect that person’s ability to adequately care court ultimately determined that all three were presump- for the child. The excluded parent may be left out of daily tive parents, but rejected the lower court’s decision that decisions for the child that can only be made by a parent, all three could be the child’s parents.97 The court made it such as health care decisions. More important, if one or clear in its decision that it would not use this case as an more of the three parents decide that they no longer want opportunity to recognize “novel parenting relationships,” to continue with this arrangement, the parent that was but the court did invite the legislature to do so.98 excluded from having parental rights could be denied visitation and custody rights to their own child. Three- The California Legislature acted on the court’s parent families can provide signifi cant benefi ts to a child suggestion. On October 3, 2013, Governor Jerry Brown when all three adults are able to provide emotional and fi - signed legislation allowing a child to have three or more nancial support. Additionally, having three parents might legal parents.99 The legislation allows a court to fi nd that ensure that a child is provided with a well-rounded up- a child has more than two legal parents when limiting a bringing. Disagreements caused by souring relationships child to two parents would be detrimental to the child.100 or signifi cant disagreements over the child’s well-being The Legislature found that “[s]eparating a child from a can be resolved in the same manner as when a child’s two parent has a devastating psychological and emotional parents disagree. The foregoing reasons underscore the impact on the child” and the explicit purpose of the law importance of allowing of three parent families in the case was to abrogate the holding in In re M.C..101 of mitochondrial replacement. Unlike the California Court in In re M.C., the Supe- In cases where there are only two people who intend rior Court of Pennsylvania held in Jacob v. Shultz-Jacob to raise the child, the two-parent paradigm should be that there could be three legal parents, even though the followed. Those who intended to raise the child as their legislature had not expressly recognized such arrange- own should be the parents. Giving a third party donor ments.102 In Jacob, a dispute arose as to who should have parental rights in this situation could be potentially dam- custody and responsibility for child support for two chil- aging to the child. Unsuspecting families may not have dren, Co.J. and Ca.J., who were raised by a lesbian couple vetted the donor prior to the procedure for attributes since birth.103 The non-biological mother was arguing for that would make the donor an adequate parent and the sole custody of the children but the trial court ruled that family unit may be dysfunctional. Unless the parties have all parties—the sperm donor father, the non-biological agreed prior to the procedure that all three would be the mother and the biological mother—should have shared legal parents, then only the intended parents should have custody.104 The non-biological mother was required to parental rights. pay child support, while the sperm donor was not.105 The trial court found that the law did not allow three Thus, the intent of the parties should be the ultimate parents to be responsible for child support.106 The sperm determinative factor when deciding who the legal parents donor, despite his designation as such in the case, was are. These considerations are unique to mitochondrial in fact active throughout the children’s lives, provid- replacement because prior to this medical advancement, ing fi nancial support as well as suggesting that they call genetics could always be used as a determinative fac- him “Papa.”107 The Superior Court affi rmed the custody tor when intent was unclear. Mitochondrial replacement decision, but determined that all three parents should be changes this equation because now all three parents are responsible for child support.108 genetically related and all three should have the opportunity to parent if that arrangement works best for the Conclusion family. Advancements in medical technology that further the societal goal of having healthier children will contin- Mitochondrial replacement creates a child that has ue, and the law must be able to adapt to these changes to the DNA of three different people. Whether three-parent ensure that these children will be well cared for and have families should be allowed comes down to the intent of a stable family life.

NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 53 Endnotes 38. Id. at 553. 1. Cells and DNA, National Library of Medicine, (Feb. 10, 2014), 39. Andrew Dutney, Religion, Infertility and Assisted Reproductive http://ghr.nlm.nih.gov/handbook/basics?show=all. Technology, 21 Best Practice & Research Clinical Obstetrics and Gynaecology 169, 175-176 (2007). 2. Id. 40. John H. Evans, Kathy Hudson, Religion and Reproductive Genetics: 3. Id. Beyond Views of Embryonic Life? Vol. 46, Journal for the Scientifi c 4. Id. Study of Religion, at 567 (2007). 5. Id. 41. See Frazzetto, supra note 37, at 554; see also Dutney, supra note 39, at 6. Id. 176. 7. Id. 42. Françoise Baylis, The ethics of creating children with three genetic parents, 26 Reproductive BioMedicine Online, 531, 532-34 (2013). 8. Id. 43. Id. at 532-33. 9. Mitochondrial DNA, National Library of Medicine (Feb. 10, 2014), http://ghr.nlm.nih.gov/mitochondrial-dna. 44. Id. 10. Id. 45. Id. 11. Inheriting Genetic Conditions, National Library of Medicine, 46. Klaus Reinhardt et al., Mitochondrial Replacement, Evolution, and the (Feb. 10, 2014), http://ghr.nlm.nih.gov/handbook/ Clinic, 341 SCIENCE 1345, 1345-46 (2013). inheritance?show=all. 47. Id. at 1346. 12. Id. 48. Id. 13. Leigh syndrome, National Library of Medicine (February 10, 2014), 49. See id. http://ghr.nlm.nih.gov/condition/leigh-syndrome. 50. Baylis, supra note 42, at 532. 14. Id. 51. Id. 15. Mitochondrial DNA, supra note 9. 52. Id. 16. Current treatment options, Human Fertilisation Embryology 53. Id. at 533. Authority, http://mitochondria.hfea.gov.uk/mitochondria/what- is-mitochondrial-disease/current-treatment-options/ (Last visited 54. What is genetic ancestry testing? National Library of Medicine, Feb. 16, 2014). (Feb. 10, 2013), http://ghr.nlm.nih.gov/handbook/testing/ ancestrytesting. 17. Id. 55. Id. 18. Id. 56. Baylis, supra note 42, at 533. 19. Id. 57. Deborah L Cohen, Surrogate pregnancies on rise despite 20. Id. cost hurdles, Reuters: US Edition, (March 18, 2013), http:// 21. Id. www.reuters.com/article/2013/03/18/us-parent-surrogate- 22. Id. idUSBRE92H11Q20130318. 23. Maternal Spindle Transfer (MST), Human Fertilisation Embryology 58. Id. Authority, http://mitochondria.hfea.gov.uk/mitochondria/ 59. See infra note 62 (defi nition of gestational surrogacy). what-is-mitochondrial-disease/new-techniques-to-prevent- 60. Id. mitochondrial-disease/maternal-spindle-transfer/ (last visited February 6, 2014); Pro-nuclear transfer (PNT), Human Fertilisation 61. Megan S. Calvo, NOTE: UNIFORM PARENTAGE ACT —Say Embryology Authority, http://mitochondria.hfea.gov.uk/ Goodbye to Donna Reed: Recognizing Stepmothers’ Rights, 30 W. New mitochondria/what-is-mitochondrial-disease/new-techniques-to- Eng. L. Rev. 773, 785 (2008). prevent-mitochondrial-disease/pro-nuclear-transfer/ (last visited 62. Traditional surrogacy involves a surrogate who has been February 6, 2014). artifi cially inseminated with the sperm of the intended father with 24. Maternal Spindle Transfer, supra note 23. an agreement that the surrogate will give up the child and rights to it (Anthony Miller, ARTICLE: Baseline, Bright-line, Best Interests: A 25. Id. Pragmatic Approach for California to Provide Certainty in Determining 26. Id. Parentage, 34 McGeorge L. Rev. 637, 671 (2003)). Traditional 27. Id. surrogacy carries a larger risk of having the surrogate mother claim parental rights because the surrogate has genetic ties to the 28. Id. child (see Abigail Lauren Perdue, ARTICLE: For Love or Money: An 29. Pro-nuclear transfer, supra note 23. Analysis of the Contractual Regulation of Reproductive Surrogacy, 27 J. Contemp. Health L. & Pol’y 279, 284-85 (2011)). 30. Id. Gestational surrogacy involves a donated egg that is fertilized 31. Id. and the resulting an embryo is placed in the woman who will be 32. Id. carrying the child but who will not be the mother (34 McGeorge L. Rev. at 671-72). Gestational surrogacy is medically and legally 33. Id. complicated (id.). Its legal complexity stems from the fact that 34. Id. there can be as many as fi ve potential parents: two intended but 35. Maternal Spindle Transfer, supra note 23. unrelated parents, the egg donor, the gestational carrier, and the sperm donor (id.). However, gestational surrogacy allows one or 36. Pro-nuclear transfer, supra note 23. both intended parents to be genetically related to their child when 37. Giovanni Frazzetto, Embryos, Cells and God, 5 European Molecular normal conception and/or gestation is not an option (see id.). Biology Organization 553 (2004).

54 NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 In the context of this article, surrogacy refers to gestational 84. Id. at 68-69. surrogacy unless stated otherwise because the goal of the intended 85. See id. parents considering mitochondrial replacement is to maintain a genetic connection with their child. 86. See Ala. Code § 30-3-4.1(d) (“the court shall determine if visitation by the grandparent is in the best interests of the child. Visitation Johnson v. Calvert 63. , 5 Cal 4th 84, 87 (1993). shall not be granted if the visitation would endanger the physical 64. Id. at 87-88. health of the child or impair the emotional development of the child. If the child is living with one or both biological or adoptive 65. Id. at 93. parents, there shall be a rebuttable presumption for purposes 66. Id. at note 10. of this section that the parent or parents with whom the child is 67. McDonald v. McDonald, 196 A.D.2d 7, 12 (2d Dep’t 1994). living know what is in the best interests of the child.”); see N.J. Stat. § 9:2-7.1(a) (“A grandparent or any sibling of a child residing 68. Id. at 9. in this State may make application before the Superior Court, in 69. Id. accordance with the Rules of Court, for an order for visitation. It shall be the burden of the applicant to prove by a preponderance 70. Id. at 12. of the evidence that the granting of visitation is in the best interests 71. See also In re Marriage of Buzzanca, 61 Cal. App. 4th 1410 (1998). of the child.”). (In Buzzanca the couple used a surrogate, egg donor, and sperm 87. Ark. Code § 9-13-103(c). donor (id. at 1412). After the couple divorced the intended father attempted to disclaim any parental rights or responsibilities to 88. Md. Family Law Code Ann. § 5-525.2(b); see also R.I. Gen. Laws § the child (id.). The court cited Johnson and held that the intended 15-5-24.4 (“(a) The family court, upon miscellaneous petition of father was in fact the father of the child because this child would a brother, sister, half-brother or half-sister, stepbrother, stepsister, not have been born without his intention to be a father (id. at 1412- or on behalf of any of those persons by his or her legal guardian, 13). for visitation rights for the petitioner’s sibling, half-sibling or stepsibling …may grant reasonable rights of visitation of the 72. See Johnson, 5 Cal 4th at 93. sibling to the petitioner. The court, in order to grant reasonable 73. See id. at 93-94. rights of visitation, must fi nd and set forth in writing the following 74. Supra note 1. fi ndings of fact: (1) That it is in the best interests of the child that the petitioner [petitioning sibling] is granted visitation rights 75. Perry-Rogers v. Fasano, 276 A.D.2d 67, 69 (1st Dep’t 2000). with the child; (2) That the petitioner is a fi t and proper person 76. Id. (Initially, the Perry-Rogerses and the Fasanos agreed that the to have visitation rights with the child; (3) That the petitioner Perry-Rogeres’ genetic child was legally theirs and the Perry- has repeatedly attempted to visit his or her sibling, half-sibling Rogerses agreed to visitation by the Fasanos (id. at 70). The lower or stepsibling during the thirty (30) days immediately preceding court granted the Perry-Rogerses sole and exclusive custody but the date the petition was fi led and was not allowed to visit the gave visitation to the Fasanos (id. at 71). However, the Perry- child during the thirty (30) day period as a direct result of the Rogeres later objected to the visitation order (id.). The Appellate actions of either, or both, parents of the child; (4) There is no other Court held that because the Perry-Rogerses are the legal and way that the petitioner is able to visit his or her sibling, half- genetic parents to the child, this particular situation is akin to sibling or stepsibling without court intervention; and (5) That giving the wrong child to the wrong mother at the hospital (id. the petitioner, by clear and convincing evidence, has successfully at 74). This was based on the fact that the implantation was a rebutted the presumption that the parent’s decision to refuse the mistake and Fasanos were aware soon after the implantation that petitioner’s visitation with the child was reasonable.”); see also NY the “nominal parenthood over Akeil [the Perry-Rogeres’ child] Dom Rel § 71 (“…a brother or sister or, if he or she be a minor, a should have been treated as a mistake to be corrected at soon as proper person on his or her behalf of a child, whether by half or possible, before the development of a parental relationship”(id.)). whole blood, may apply to the supreme court by commencing a special proceeding or for a writ of habeas corpus to have such Id. 77. child brought before such court, or may apply to the family court 78. Id. at 73. pursuant to subdivision (b) of section six hundred fi fty-one of the family court act; and on the return thereof, the court, by order, 79. Bryce Levine, Note: Divorce and the Modern Family: Providing in Loco Parentis Stepparent Standing to Sue for Custody of their Children after due notice to the parent or any other person or party having the care, custody, and control of such child, to be given in such in a Dissolution Proceeding, 25 Hofstra L. Rev. 315, 323 (1996) (The manner as the court shall prescribe, may make such directions as author argues in favor of providing stepparents with parental the best interest of the child may require, for visitation rights for rights after the marriage between a stepparent and parent such brother or sister in respect to such child.”). dissolves when it is in the best interest of the child (id. at 340- 41.)); Ruth Padawer, Who Knew I Was Not the Father?, New York 89. D.C. Code § 16-831.01. Times (Nov. 17, 2009), http://www.nytimes.com/2009/11/22/ 90. D.C. Code § 16-831.03. magazine/22Paternity-t.html?pagewanted=all&_r=0.html (The article explores how different fathers handle issues of custody and 91. Del. Code tit. 13, § 8-201(c). child support after fi nding out the children they have been raising 92. Del. Code tit. 13 § 8-203. as their own biological children are not genetically related to them. Several of the men chose to continue paying child support 93. In re M.C., 195 Cal. App. 4th 197, 204 (2011). and fought to remain in their children’s lives. One of the men 94. Id. Tanner Pruitt, was awarded full custody of his daughter even 95. Id. at 204-206. though he was not genetically related to her). 96. Id. at 216-17. 80. Alison D. v. Virginia M., 77 N.Y.2d 651, 659 (1991). 97. Id. at 223 (The court ultimately remanded the case to the juvenile 81. Id. at 658. court to fi rst determine which of the two out of the three would be 82. 530 U.S. 57, 60 (2000). M.C.’s parents and then determine who should receive custody (id. 83. Id. at 67. at 224)). 98. Id. at 214.

NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 55 99. The amended version of Cal Fam Code § 7601, which defi nes a “natural parent” and a “parent and child relationship,” also states NEW YORK STATE in subsection (c) that “[t]his part does not preclude a fi nding that BAR ASSOCIATION a child has a parent and child relationship with more than two parents” and in subsection (d) that “[f]or purposes of state law, administrative regulations, court rules, government policies, common law, and any other provision or source of law governing the rights, protections, benefi ts, responsibilities, obligations, and duties of parents, any reference to two parents shall be interpreted CONNECT to apply to every parent of a child where that child has been found to have more than two parents under this part.” WITH NYSBA 100. The amended Cal Fam Code § 7612(c) states that “[i]n an appropriate action, a court may fi nd that more than two persons with a claim to parentage under this division are parents if the court fi nds that recognizing only two parents would be Visit us on the Web: detrimental to the child. In determining detriment to the child, the court shall consider all relevant factors, including, but not limited www.nysba.org to, the harm of removing the child from a stable placement with a parent who has fulfi lled the child’s physical needs and the child’s psychological needs for care and affection, and who has assumed that role for a substantial period of time. A fi nding of detriment Follow us on Twitter: to the child does not require a fi nding of unfi tness of any of the parents or persons with a claim to parentage.” The act became www.twitter.com/nysba effective on Jan 1, 2014 (2013 Cal AB 1403). 101. 2013 Legis. Bill Hist. CA S.B. 274. 102. Jacob v. Shultz-Jacob, 923 A.2d 473, 482 (2007). 103. Id. at 476. (The court also ruled on the custody of two other Like us on Facebook: children in the family (id.). The other two children, A.J. and L.J., were adopted by Appellee who was the biological mother of Co.J. www.facebook.com/ and Ca.J (id.). A.J. and L.J. had no relationship with the sperm donor and he was not granted custody or required to make child nysba support payments (id.). Their custody dispute is not discussed further because the dispute was only between the non-biological mother and the biological mother, and not all three parents.). 104. Id. Join the NYSBA 105. Id. (The trial court ruled that the non-biological mother and sperm donor should have partial custody of the children, while the LinkedIn group: biological mother should have primary physical custody (id. at 476)). www.nysba.org/LinkedIn 106. Id. at 482. 107. Id. at 476, 481. 108. Id. 109. Johnson, 5 Cal. 4th at 95.

Caitlin Davie is a member of the Albany Law School class of 2014. The author thanks Professor Ev- elyn Tenenbaum for her generous assistance and guidance with this article, and her family.

56 NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 Franken-Food or Scare Tactics? The Science, Law and Policy of Genetically Modiﬁ ed Foods Excerpts from an Expert Panel Discussion

Contributors Moderator: Beth E. Roxland, J.D., M.Bioethics Panelists: David O. Carpenter, M.D.; Cathleen Enright, Ph.D.; Gregory Jaffe, J.D.; Patty Lovera Panel/Article Working Group, NYSBA Health Law Section, Committee on Medical Research and Biotechnology: Alex C. Brownstein, J.D. (article editor); Margaret J. Davino, J.D.; Randall J. Hirsch, M.D., J.D. (article editor); Sandra C. Maliszewski, J.D. (article editor); Roshni Persaud, J.D.; Beth E. Roxland, J.D.; Samuel J. Servello, J.D., Joyce Tichy, J.D.

Introduction engineered crops as new GMO crops may be entering the On September 10, 2013, the NYSBA Health Law Sec- market soon (such as engineered apples and potatoes). tion’s Committee on Medical Research and Biotechnol- There have been recent calls to strengthen legislation and ogy1 held a public symposium to explore the scientifi c, regulations regarding GMOs from measures to ban the legal and public health issues involved with genetically growing of GM crops to require mandatory labeling of modifi ed organisms (GMOs). The goal of the symposium foods using ingredients made from GMOs. was to start a public dialogue in light of the signifi cant The symposium addressed the following topics: legislative activity and proposals surrounding GMOs particularly in the states of California and New York. • GMO safety, environmental impact, and impact on food production; Genetically modifi ed foods have been marketed and consumed for many years in the United States. Farmers • Perspectives on the benefi ts and risks of GMOs; have been selecting for particular strains of plants or ani- • The current state and federal regulatory frame- mals for thousands of years through selective breeding, works regarding labeling and other legal issues that a technique that crosses plants and animals from related apply to GMOs; species. Another method of producing crops with useful traits is genetic engineering, the product of which we • The European Union’s approach to GMOs. call GMOs. These are plants or animals that have deoxy- ribonucleic acid (DNA) from other organisms (such as The program panelists and moderator for the evening bacteria or viruses) intentionally introduced into that crop included: or animal using recombinant DNA laboratory techniques. • David O. Carpenter, M.D., (Panelist) Director, In- The combining of genes from those different species stitute for Health and the Environment, University doesn’t usually occur in nature or through traditional at Albany School of Public Health. Previously, he breeding methods. In the United States, crops that have was the Director of the Wadsworth Laboratories for been engineered includes soybeans, cotton, canola, corn, the New York State Department of Health. Dr. Car- sugar beets, Hawaiian papaya, alfalfa, and squash (zuc- penter has an active research program focusing on chini and yellow). Food manufacturers estimate that over the study of human diseases in relation to exposure 70% of the food products consumed in the U.S. today to environmental contaminants. contain at least one ingredient made from a GMO crop. In addition, GMOs (e.g., bacteria, fungi) are widely used • Dr. Cathleen Enright, Ph.D., (Panelist) Executive by food manufacturers as processing agents to produce Vice President of the Food and Agriculture Section specifi c ingredients. Common ingredients derived from in The Biotechnology Industry Organization (BIO), GMOs include corn oil, soybean oil, cottonseed oil, high- a 1,100+ member organization in the United States fructose corn syrup, table sugar, and soy lecithin. With the and abroad. increased prevalence of genetically modifi ed (GM) ingre- • Mr. Gregory Jaffe, J.D., (Panelist) Biotechnol- dients in food, there is much debate regarding the safety ogy Project Director at the Center for Science in of those ingredients on human health and the impact of the Public Interest (CSPI), a nonprofi t consumer GM crops on the environment. For consumers, it can be organization located in Washington, D.C. working diffi cult to determine which ingredients are made from on food and nutrition issues. He was previously at

NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 57 the Department of Justice and EPA as an environ- be sold are very, very loose and nobody is informing the mental civil litigator. CSPI originally petitioned the consumer about that when they buy fi sh from the Great FDA in 1995 to mandate the labeling of trans-fat, Lakes, for example. One can talk about the plasticizers in which is now in place. all of our plastic products that are endocrine disrupters that feminize little boys and increase the risk of breast • Ms. Patty Lovera, (Panelist) Assistant Director of cancer. This may be a debate, makes great press, but it’s Food & Water Watch, a consumer advocacy organi- not really regulated. So, I think one has to put the GMOs zation focusing on food policies ranging from the in the context of other things that our government does Farm Bill to food labeling and safety standards as not regulate. well as water issues. Ms. Roxland: Who else in the federal government is • Ms. Beth Roxland, J.D., M. Bioethics, (Moderator) looking at this? Adjunct Professor, New York University School of Law and Associate of the Division of Medical Mr. Jaffe: The USDA, under the Plant Protection Act Ethics, New York University Medical School, who (PPA), regulates any crop that could be a plant pest.2 If a provided an overview of the legal issues. She was developer or a researcher wants to do a fi eld trial of GMO previously Executive Director of the New York crops, they will need a permit from USDA. At the end of State Task Force on Life and the Law and Special their fi eld trials, the developer must prove to the USDA’s Advisor to the Commissioner on Stem Cell Re- satisfaction that there are no plant pest characteristics search Ethics. with that crop so it can obtain “nonregulated” status and be freely planted by farmers. The EPA regulates pesticides Following is an edited transcript from the meeting. under the Federal Insecticide, Fungicide, and Rodenticide Ms. Roxland: With all the concerns surrounding Act. If the engineered crop produces a biological pesti- GMOs, how are they currently regulated in this country? cide (such as a gene from Bacillus Thuringiensis (Bt) that produces a biological toxin) the engineered crop needs Mr. Jaffe: The federal regulation of these crops is a to be registered under FIFRA, which requires both the little convoluted. Depending on the crop and the trait, it performance of an environmental risk assessment and the can fall under the Food and Drug Administration (FDA), setting of a food safety tolerance for any potential pesti- the Environmental Protection Agency (EPA), and/or the cide residues. U.S. Department of Agriculture (USDA). Dr. Enright: Interestingly, none of the products of Ms. Lovera: While the federal government has the other breeding technologies (i.e., selective breeding, oversight over what is or is not included in an ingredi- hybridization, mutagenesis, somaclonal variation) goes ent list, there has been tremendous lobbying activity in before the FDA because genetic engineering was consid- the area of GMOs. So, it has been the FDA’s policy for ered an extension of traditional breeding. Because of a over 15 years not to include GMO in those labels. To- concern about public acceptance, companies voluntarily day, there is an increasing groundswell of public inter- submit safety information to the FDA for review. est for lots of reasons which build on the predecessor controversy surrounding the use of recombinant bovine Ms. Roxland: Is it correct that the FDA requires a growth hormone (rBGH), an artifi cial growth hormone voluntary submission on the part of the developer when given to dairy cows to promote more milk production. reviewing the food safety of a GE plant or crop entering In both instances, these products are controversial in our food supply? If so, how is it different from what is go- terms of health questions, generating much conversation ing on in other countries? about safety and whether they should be approved. Like Mr. Jaffe: Generally the burden of proof as to whether GMOs, rBGH usage was approved with no mandatory a product, a drug or pesticide, for example, is safe, is on labeling and no disclosure that it was used on the cows. the developer of that product. Once the developer over- So while we would prefer that the federal government comes that burden, the product is approved. Though the list genetically engineered (GE) ingredients on a product FDA oversees the safety of our food supply, including the label, we don’t think that the feds will lead on this right safety of foods produced from plants, there’s no formal now. As a result, we’re talking to state legislatures. But approval process for GMOs. Under the Food, Drug and the question is where will this information be placed if Cosmetic Act, only food additives require mandatory not on the label? premarket approval from FDA. The FDA made a scientifi c Dr. Carpenter: A bigger issue, in my judgment, that and factual determination in 1992 that introducing new is the government (federal or state) doesn’t regulate a DNA and proteins generally does not make an existing lot of things that are very much more dangerous than crop a food additive. It is instead generally recognized GMOs, in particular the presence of known carcinogens as safe (GRAS). Under these circumstances, companies in our food supply. Certain foods may contain high developing GMO crops can self-affi rm GRAS. GMO doses of chlorinated pesticides like DDT, or dioxins or developers can voluntarily provide the FDA with safety PCBs. The FDA standards for allowing these foods to data through a voluntary consultation process. The FDA

58 NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 reviews that data package to make sure that the devel- ing. The last thing that I’ll say is we haven’t yet talked oper hasn’t missed anything, and asks questions as they about genetically engineered animals. There has been see fi t. Ultimately, the responsibility for safety rests on the one in the pipeline: genetically engineered salmon. These developer. So far, this voluntary process has been fol- animals are being regulated as a veterinary drug, which is lowed for all commercialized GMO crops. The European incredibly not a transparent process for the public. What Union, on the other hand, has developed a more rigorous we have now, after three years of very public debate on mandatory regulatory process. So, if we want to sell corn this, is our summary charts and that which the FDA made and soybeans to Europe or Japan, we must satisfy their public. We don’t have access to the data though. Much regulatory requirements. like a drug approval, that information will not be public until it has been approved. Dr. Enright: Even though the system at the FDA is voluntary, the companies don’t pick and choose what Ms. Roxland: The FDA issued guidelines on labeling data is required for submission. As a result, there is a in 1992 and later in 2001 issued for notice and comment mandatory system similar to our voluntary system. One a draft set of guidelines on voluntary labeling of GMO of the questions I am asked is: “Well, what if there’s data products.3 To date, the FDA never fi nalized the guidance that’s not favorable to the product?” The information and there are now calls to fi nalize that guidance. that our companies provide to USDA, EPA and FDA is Mr. Jaffe: FDA has draft guidance on labeling of largely the same information that they’ve presented to foods made from GMO crops. FDA said that because the European scientifi c body, the European Food Safety there is no difference between the safety of a genetically Association (EPSA). modifi ed crop and a non-genetically modifi ed crop, there Mr. Jaffe: In the case of GMOs, the international is no mandatory requirement to label GMOs. The guid- standards are set forth by the Codex Alimentarius, and ance states GMO ingredients need to be labeled if there is the required data submission in Canada, Europe and a nutritional change or different functional characteristics Japan mirror the data that’s generally submitted by the for the ingredient produced by the GMO (e.g., high oleic companies to FDA here in the U.S. The difference is that soybean oil instead of soybean oil). I think that one of FDA does not tell the American public its opinion on the the biggest reasons behind the whole labeling debate is safety of the GMO crop. My criticism with this system is that many members of the public are not convinced that there needs to be a change in the burden of proof. Under GMOs are safe. In my opinion, the most important public the current system, the law allows the FDA to go after policy to address that concern would be to have a manda- companies that market “adulterated” food. It’s the FDA’s tory FDA premarket approval for GMOs prior to allowing burden to show that it’s adulterated, as opposed to the them to enter our food supply. Ensuring safety before developer showing it’s safe before it enters the food sup- marketing the crop is much better than putting GMOs out ply. In other countries, before it even gets on the market, there, identifying them with a label, and letting the public they have to get approval from the regulatory body. To choose based on whatever they may or may not know me, that’s a difference in burden of proof even if the data about those foods. We’d make our regulatory system that’s submitted or the actual safety is not any different. similar to Canada’s, Japan’s and other countries around the world where our consumers would hear from FDA Ms. Lovera: The European Union looks at this as about whether the GMO is safe, see the relevant data in a a novel food technology. Our regulatory system is not transparent process with public participation, and under- equipped to deal with what is a new technology. We stand FDA’s analysis and reasoning behind their determi- have a patchwork that doesn’t really step up and give the nation of safety. This should be the number one legislative public an independent objective look at it. This comes up priority. Labeling should not be a surrogate for safety. The not just for transgenic animals or other biotech but also in other point I’d like to make concerning labeling is this. many food technologies. Accountability is currently an is- There are over 65 countries that have mandatory label- sue as well related to who is supplying this data, whether ing regulations but those national requirements are not anyone else is able to look at it, can it be replicated and uniform. For example, China exempts soybean oil totally whether there is any non-industry funded work. This is from GMO labeling while Japan requires a GMO label not the FDA’s job under the existing regulatory scheme. only if one of the fi rst three ingredients came from a GMO Our government does not provide grants to study the crop. So, any labeling should be based on science and hazards of GMOs so we are dependent on industry- facts and must be both accurate and not misleading. funded reports. That’s not to say it’s all wrong, but there should be a counterbalance of independent investigation. Ms. Roxland: Based on our discussion, it seems that We think that it’s time to have that conversation about the federal government won’t mandate labeling based an adequate way to regulate this. The Pew Charitable on a “right to know” premise, but only perhaps if there Trust is doing a big project about how [the current system are safety concerns or nutrients or allergens. What can is] really not adequate to protect the public health on citizens focus on if they want their state to pass a labeling anything you’re adding to food, let alone something that law? we think brings in lots new issues like genetic engineer-

NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 59 Ms. Lovera: This issue continues to evolve. We have that people have been consistently demanding based on changed the laws on labeling because debate leads to that polling over the years. This seems very basic to people change. Why? Because what consumers need to know to that they should get to know what we think is a basic make an informed decision about what they are buying difference. It’s not just over health concerns. We haven’t is evolving. We didn’t always get ingredient labels or nu- really talked about the rest of the real social and economic trition facts. We have country of origin labeling on foods impacts of this technology. Consumers are waking up to because the public said that they wanted it. There are a this. They want to vote on this but they need information lot of conversations about whose job it is to fi x this. We to do that. think the federal government has failed on this. People Dr. Enright: The biotech industry supports a con- have been beating their heads against the wall at the FDA sumer’s right to know. We’re very proud of the products for a long time trying to get them to listen to what most we make. We have full confi dence in their safety. The people want to know. This year, there were bills intro- foods grown from those crops grown from our seeds are duced in approximately 26 states. In the public health the most tested agricultural product in the history of food arena we’re missing an opportunity to see what happens manufacturing and agriculture. We understand that calls to people who eat GMOs and trace it back by not affi rma- for legislation around this topic won’t be going away. But tively including GMOs in labels. We know where GMOs we also understand that it’s not necessarily just based are not found because certain food certifi cations, such as on a right to know but also a desire to move away from “certifi ed organic” and other third party certifi cations, biotechnology, our technology and our seeds. Because don’t allow it. we believe in the technology, we believe in the seeds and Ms. Roxland: New York State actually has proposed stand by the safety of the food made from it. As such, we a bill which is similar to the California initiative. Un- cannot support efforts to try to, in some way, use a label der the proposed bill, a GMO product would be mis- to convey to consumers that this food is less good, less branded/mislabeled if it did not carry a “genetically nutritious, less safe, or has a health concern associated engineered” or “genetically modifi ed” label on the front with it. The science doesn’t support it. of the package or above/below the ingredients. This GE Mr. Jaffe: One of the principles that FDA ensures for label would not be specifi c to the actual ingredients that all labeling is that it must be “accurate and not mislead- were modifi ed. The GE label would not be specifi c to the ing.” For labeling required by a state or the federal gov- actual ingredients that were modifi ed, such that a con- ernment, I think that’s a really good principle. I think you sumer would not necessarily know which component of have to look at the details of each state GMO labeling bill their package was genetically engineered. There are also and fi gure out whether or not the information the con- multiple exemptions listed in the bills. The issue here is sumer is going to get from these labels is accurate and not whether or not these terms are suffi ciently educational. misleading. For example, do you need to use words such Would it be more helpful to provide GE information else- as “derived from genetically engineered corn” instead where (such as on a website)? Do these terms belong on a of “made with genetically modifi ed organisms” to make label to begin with? the label accurate? Is labeling appropriate if there is no Ms. Lovera: With some slight variations, all these physical—or biological—difference between the GMO in- bills talk about labels that say either “Contains geneti- gredients and its non-GMO equivalent, such as with high cally engineered ingredients,” or “Made with genetic fructose corn syrup? The same could be said for sugar engineering.” They aren’t warnings. They’re statements made from GMO sugar beets, which doesn’t contain any of fact. Yet, despite their outward statements of support, DNA or protein. While those highly processed ingredi- there has been active opposition from trade associations ents might require a label under a state labeling law, it like BIO and biotech companies in every state capital would be misleading because the products are identical. trying to stop these bills which would require these types On the other hand, requiring a label on the engineered of food labels. As an example, Pennsylvania’s Depart- sweet corn you are consuming would at least be factually ment of Agriculture had proposed a rule making it illegal accurate because each corn kernel has both the introduced for dairy producers to state they were not using GE. A new DNA and the protein made from that DNA. So one few months later, it popped up in another state and then of the things to think about in all these labeling debates by January 2013, it popped up in state legislatures all is not just whether it’s mandatory or voluntary, but what over the place. Suddenly we were in ten states trying to will be labeled. Is that going to be accurate or misleading maintain the right for dairy producers to say that they to the consumer, and what useful information will the weren’t using this technology with the asterisks. That’s consumer receive? The New York law prohibits actually already been established by the FDA that people were putting which ingredient is genetically engineered in going to put that caveat on there, so it’s a little hard for the ingredient list, which in my opinion might be a more us to reconcile that with statements about how interested factually accurate way to label. If you have a salad dress- this industry is in having us know when they’re actively ing and it has a little soybean oil in it, it would be more fi ghting what we think are common sense disclosures accurate to write in the ingredient list “genetic engineered

60 NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 soybean oil” than to say on the front of the package that The bill does not require restaurants or other food the salad dressing is “genetically engineered” (assuming retailers to label their menu items, nor does it require of course that oil with no DNA or protein is required to individual ingredients to be labeled as GM on a product be labeled at all). That soybean oil might be ingredient label. number 20 in terms of its percentage in the salad dressing. The N.Y. bill would require “genetically modifi ed” Current status somewhere on the package but that could be misleading The bill was, in a surprising development, voted because the engineered ingredients are a really small down in the Consumer Protection Committee at the very component of that food. I think one needs to think about end of the 2013 session, resulting in allegations that lob- these things. byists for Monsanto and other manufacturers had suc- ceeded in shifting members’ votes. Afternote: Where Does that Leave the NY Reintroduced for the 2015 session, the NY GMO Consumer? Labeling bill (A.617) was successfully voted out of the Proposed 2015 Bills: S485-2015 and A617-2015 Assembly Consumer Affairs and Protection Committee on March 3, 2015 in a 9 to 6 vote. As of this writing, it is Democratic Assemblywoman Linda Rosenthal of under review by the Assembly Codes Committee.5 Manhattan, and her co-sponsor, Republican Sen. Ken LaValle of Suffolk, drafted a bill in 2013 (re-introduced in Passage of a labeling law in Vermont 2014 and 2015) providing for the labeling of seeds, food Notably, Vermont passed a labeling law, effective or food products that contain a genetically engineered July 1, 2016. It is the fi rst state to do so. It is currently material or that are produced with a genetically engi- being sued by the industry, which seeks to have the law neered material. invalidated. The labeling requirement can be met in a variety of ways. While the manufacturer must label the food, in a Endnotes clear and conspicuous manner on the package of such 1. The NYSBA Health Law Section, Committee on Public Health, food, it can choose to use the words “produced with Health Law Committee of the New York City Bar Association, genetic engineering” or any other derivative of those and the NYSBA Food, Drug and Cosmetic Law Section also words, or the initials “ge,” “gm,” “gmo,” or derivative of participated in sponsoring this symposium. those phrases. 2. “Pursuant to that grant of authority [the PPA], the Animal and Plant Health Inspection Service (APHIS) promulgated regulations The bill also anticipates some of the most diffi cult that presume genetically engineered plants to be “plant pests”— questions about labeling. For example, for livestock, it and thus “regulated articles” under the PPA—until APHIS determines otherwise. However, any person may petition APHIS exempts: for a determination that a regulated article does not present a plant pest risk and therefore should not be subject to the applicable Food consisting entirely of, or derived regulations. APHIS may grant such a petition in whole or in part.” entirely from, an animal that has not Monsanto Co. v. Geertson Seed Farms, 570 F.3d 1130 (2010). itself been produced by genetic engineer- 3. Food Drug Administration (2001) DRAFT Guidance ing, regardless of whether the animal has for Industry: Voluntary Labeling Indicating Whether been fed with any food produced with Foods Have or Have Not Been Developed Using genetic engineering or treated with any Bioengineering. (FDA Maryland). Last accessed Feb. 2, 2015 at http://www.fda.gov/Food/GuidanceRegulation/ drug or vaccine that has been produced GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ with genetic engineering.4 ucm059098.htm. And for processed foods, it exempts from labeling 4. S485-2015 and A617-2015 §15(D)(I). Last accessed Feb. 4, 2015 at open.nysenate.gov/legislation/bill/A617-2015. products that include genetically engineered materials 5. For up to date status of the bill, see: http://assembly.state.ny.us/ as long as the genetically engineered materials do not ac- leg/?default_fl d=&bn=A00617&term=&Summary=Y&Actions=Y. count for more than 9/10ths of 1% of the total weight of the processed food.

NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 61 The Tension Between the Affordable Care Act and EMTALA and Its Potential Legal Implications By Daniel Shapiro

I. Introduction federal penalties.9 Hence, while EMTALA literally opened Even with the Supreme Court’s rejection of the latest the doors of the emergency room to any individual who constitutional challenge to the Patient Protection Afford- required emergency treatment, regardless of his or her able Care Act (ACA), it remains apparent that there are fi nancial status, national origin, insurance status and race, still several politically infl uential groups that oppose a it exposed hospitals to new forms of liability outside the law that seeks to create universal access to health care realm of the standard malpractice and negligence claims for all citizens.1 However, long before this country began they were accustomed to defending. debating the constitutionality of the ACA and its “indi- Under EMTALA, hospitals and both treating and vidual mandate”—which requires individuals to acquire on-call physicians face federal fi nes of up to $50,000 per health insurance or else face federal tax penalties—emer- violation.10 The law also provides patients with a private gency departments across the nation have been grappling right of action against the hospital (but not physicians) 2 with their own mandate. for injuries they sustain as a result of EMTALA non-com- 11 The Emergency Mandate Treatment and Active Labor pliance. In this regard, EMTALA plaintiffs may “obtain Act (EMTALA) was enacted by Congress in 1986.3 Com- those damages available for personal injury under the law of the state in which the hospital is located, and such monly referred to as the “anti-patient dumping law,” 12 EMTALA is designed to prevent hospitals from discrimi- equitable relief as is appropriate.” nating against uninsured or Medicaid patients by trans- While EMTALA does not serve as a replacement for ferring them to public hospitals before providing minimal a plaintiff’s state law malpractice claim, it does serve treatment and necessary screening to ensure that they are as vehicle to have the claims heard in federal court and 4 stable for transfer. Specifi cally, the law requires hospitals adjudicated before a federal jury. This is signifi cant to: (1) screen any individual who comes to an emergency because some federal courts have held that EMTALA room and; (2) treat that patient until his or her medical preempts procedural and substantive limitations imposed 5 condition is resolved or until the patient is stabilized. If by state law, sending the message that plaintiffs may the facility is not capable of treating the condition, it must be better served by pursuing EMTALA-based claims in transfer the patient to another hospital that has the capac- federal court (where the court may retain supplemental 6 ity to treat the patient. Under EMTALA, the qualifi ed re- jurisdiction over their state law-based malpractice claim) ceiving hospital is obligated to accept the transfer. Thus, rather than proceeding with their cases in state court. For at its core, EMTALA guarantees all individuals access to example, courts have refused to apply state notice statutes a certain level of emergency care whether or not they are and malpractice damage caps to EMTALA-based claims.13 7 insured or can otherwise afford the cost of treatment. Further, plaintiffs are in a far better position to leverage a fruitful settlement with hospital defendants that may be II. Hospital and Physician Liability Under forced to not only reimburse the complainants for their EMTALA personal injuries, but also may be subject to onerous fi nes An unintended yet foreseeable consequence of EM- imposed by the federal government when the facts of TALA’s passage was that indigent or uninsured patients their EMTALA-based noncompliance are fl eshed out at began fl ocking to local emergency rooms to seek treat- trial.14 ment for unmet health needs, including those that did As a result of an infl ux of EMTALA-based cases, fed- not call for emergency treatment.8 Over time, emergency eral courts have sought to narrowly restrict the types of rooms (especially those serving densely populated urban claims that truly fall within the law’s purview. The Circuit areas) were forced to adapt by perfecting their triage pro- Courts of Appeal routinely dismiss lawsuits on jurisdic- cedures as waiting rooms overfl owed with patients who tional grounds where plaintiffs have disguised medical presented with both emergent and non-emergent medical malpractice claims as EMTALA claims in an attempt to conditions. obtain EMTALA-based relief.15 Courts have repeatedly Since EMTALA expressly dictates that “[a] partici- cautioned: “EMTALA is not a federal medical malpractice pating hospital may not delay provision of an appropri- statute.”16 Nevertheless, where the plaintiff’s claims are ate medical screening examination…in order to inquire actually grounded on the emergency department’s failure about [an] individual’s method of payment or insurance to adequately screen and stabilize the patient, the claims status,” emergency room overcrowding has made hospi- will withstand Federal Rule 12(b)(6) and Rule 56 motions. tals far more vulnerable to EMTALA-based lawsuits and

62 NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 The success of an EMTALA-based claim generally In New York, the consequences are particularly dire. hinges on whether a plaintiff is able to prove that he According to ACEP, New York State has the highest or she was not screened and/or stabilized in a manner hospital occupancy rate in the nation, and the fourth few- commensurate with his or her medical condition and est emergency departments per capita.24 New York also that the hospital’s failures resulted in further quantifi able suffers from the fourth longest average time that patients harm.17 Naturally, defenses based on emergency room spend in the ER (366 minutes) before being transferred to overcrowding, lack of resources, limited staffi ng or poor their hospital bed or discharged.25 The national average is funding are not valid affi rmative defenses even though 272 minutes.26 Given these fi gures, it is not surprising that such impediments are often the cause of the hospital’s patients have died while awaiting treatment in ER wait- EMTALA violation. ing rooms in New York.27 However, it does bear noting that the state remains focused on addressing these issues III. Early Interaction Between EMTALA and the and has implemented a Delivery System Reform Incen- ACA tive Payment (DSRIP) program as a preemptive measure. Before the ACA was enacted in 2010, its proponents, Through this program, the state has allocated eight billion including President Barack Obama, argued that with dollars for distribution to Medicaid providers over the more people insured, fewer would turn to the emergency next fi ve years, with the funds being tied to projects and 28 room for treatment as their fi rst line of defense.18 The reforms focused on reducing avoidable hospital use. The idea was that patients would schedule appointments state’s expressed goal is ambitious. It intends to achieve a with their newly assigned primary care physicians or 25% reduction over this period. with in-network specialists who would provide necessary Regarding the question of whether more patients who treatment and preventative care, which would also serve were not previously insured will be more likely to seek to minimize the likelihood that those patients would treatment in the emergency room given the ACA’s man- require emergency care later. Such a conclusion seemed date, a 2013 landmark study performed by the Oregon logical. However, early studies reveal that the intended Health Insurance Experiment proves illustrative.29 In results have yet to materialize. In fact, the current num- short, the study concluded that the expansion of Medicaid bers contradict the theories espoused by the ACA propo- to low-income individuals increased both their visits to nents who saw the law as a panacea to emergency room primary care centers and to emergency rooms. The study overcrowding. reviewed records from 25,000 low income patients, some An April 2014 survey conducted by the American with Medicaid access and some without, and determined College of Emergency Physicians (ACEP) found that 46% that those with insurance ended up in the emergency of emergency physicians had experienced a rise in pa- room with a 40% greater frequency while many of the tients presenting to the emergency room since the enact- conditions that brought them there were deemed non- 30 ment of the ACA, while 23% reported a decrease and 27% emergent. Also, in February 2015, the American Journal reported no change.19 Additionally, 45% of emergency of Emergency Medicine published a related study based on physicians expect a “slight” infl ux in emergency room research performed by the Wayne State University School patients over time, while 41% expect that they will face of Medicine in Detroit, Michigan. This study found that a far greater increase in the next three years.20 Strikingly, Americans who receive public insurance under the ACA 77% of the physicians polled think that their facilities use the emergency department more frequently than be- 31 are not suffi ciently prepared to handle the infl ux they fore they were insured. Although there are many groups anticipate.21 Although the fi gures cited in ACEP’s survey in the medical community that do not subscribe to the are by no means conclusive—as they are entirely based theory that emergency room overcrowding is tied to hos- upon the voluntary online submissions of emergency pitals still having to provide non-urgent care to Medicaid medicine physicians—the American Hospital Association and other low income patients in the emergency room, it (a national non-profi t organization that represents nearly is diffi cult to deny that there exists a relationship between 32 5,000 hospitals, health care systems and network provid- the two. ers) has defended the survey’s fi ndings.22 IV. Public Policy vs. Strict Interpretation of The problem of emergency room overcrowding is EMTALA’s Provisions also compounded by the fact that the nation’s population The implications of these reports, (as they relate to continues to grow at an increasing rate. With the demand hospital overcrowding and EMTALA liability), are clear. for physicians on the rise and the projections revealing On the legal front, hospitals have a multitude of reasons that we will face a shortage of primary care physicians to be concerned as their exposure to liability will surely in the future, demand for non-emergency based care is 23 be impacted if these trends hold. And based on a recent expected to exceed supply by 2025. The impact that this newsworthy case in which a court denied whistleblower shortage will have on emergency rooms is potentially protections to a physician who complained that his hospi- devastating. tal was not properly screening patients in its overcrowded

NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 63 emergency room, it appears the judiciary is doing little to Endnotes help calm the storm that looms overhead. 1. The Supreme Court granted cert in the case titled King v. Burwell, 759 F.3d 358 (4th Cir. 2014), cert. granted, No. 14-114, 2014 U.S.

In the Tenth Circuit case titled Genova v. Banner LEXIS 7428, at *1 (U.S. Nov. 7, 2014) to resolve the issue of whether Health, et al., a doctor plaintiff whose staff privileges at the IRS may extend tax subsidies to states that had not set up the private hospital where he worked had been termi- their own health care exchanges under the ACA. The case raised constitutional issues related to state sovereignty and state’s rights. nated, alleged that he had been retaliated against for A decision was issued on June 25, 2015 upholding the ACA. reporting that the hospital was “hoarding” emergency 2. The ACA generally requires people living in the United States room patients for fi nancial reasons rather than transfer- to obtain health insurance or pay a tax penalty called a “shared ring them to another facility where they could be treated responsibility payment.” 26 U.S.C. § 5000A and 26 C.F.R. § more expeditiously.33 EMTALA contains a whistleblower 1.5000A-1. provision which provides that: 3. 42 U.S.C. § 1395dd. 4. Offi ce of the Inspector Gen., Dep’t. of Health & Human Servs., The A participating hospital may not penal- Emergency Medical Treatment and Labor Act: Patient Dumping ize or take adverse action [1] against a Archive, available at https://oig.hhs.gov/fraud/enforcement/ qualifi ed medical person…or a physician cmp/patient_dumping.asp. because the person or physician refuses 5. 42 U.S.C. § 1395dd(a) requires hospital emergency department to authorize the transfer of an individual to provide for an “appropriate medical screening examination” with an emergency medical condition to determine whether an “emergency” medical condition exists. 42 U.S.C. § 1395dd(e)(3)(A) defi nes “stabilize” as “provid[ing] that has not been stabilized or [2] against such medical treatment of the condition as may be necessary to any hospital employee because the em- assure, within reasonable medical probability, that no material ployee reports a violation of a require- deterioration of the condition is likely to result from or occur ment of this section.34 during the transfer of the individual from a facility, or, with respect to an emergency medical condition described in paragraph (1)(B), Even though EMTALA bars hospitals from disci- to deliver (including the placenta).” plining physicians who refuse to transfer unstabilized 6. 42 U.S.C. § 1395dd(b)(1)(B). patients suffering from emergency medical conditions, 7. Because EMTALA applies to all Medicare-participating hospitals the Court determined that the doctor’s actions did not with emergency departments and because hospitals are dependent 35 on Medicare reimbursement payments and subsidies as an income qualify for whistleblower status. The Court strictly source, the law’s mandate has a global application. interpreted the language of the statute and held that 8. Although commentators continue to debate whether this surge because the doctor neither claimed that he had been in ED usage is primarily attributable to EMTALA or is multi- harmed as a result of an EMTALA violation nor had he factorial—attributable to hospital closures, increased population, been discharged for reporting a EMTALA violation aris- hospital implementation of cost cutting measures, etc.—since the ing out of the hospital’s failure to screen or stabilize a law’s enactment, emergency department use has surged from 85 million visits per year to almost 140 million visits per year. patient or based on its transfer of an unstable patient, his See Laura D. Hermer, The Scapegoat: EMTALA and Emergency 36 claims failed as a matter of law. Notwithstanding, the Department Overcrowding, 14 J.L. & POLY 695 (2006); see also Court did note that patient “hoarding” could ultimately Centers for Disease Control, Dep’t of Health & Human Servs., lead to the type of patient dumping that EMTALA was Emergency Dep’t. Visits Archive, available at http://www.cdc. 37 gov/nchs/fastats/emergency-department.htm; Cindy Mann, enacted to prevent. But it also reasoned that the law CENTERS FOR MEDICARE AND MEDICAID SERVICES, INFORMATIONAL permits a suit only where a plaintiff was harmed “by BULLETIN: REDUCING NONURGENT USE OF EMERGENCY DEPARTMENTS or reported an existing EMTALA violation, not an im- AND IMPROVING APPROPRIATE CARE IN APPROPRIATE SETTINGS, pending one.”38 Parenthetically, the American Academy available at http://www.medicaid.gov/Federal-Policy-Guidance/ Downloads/CIB-01-16-14.pdf; Lynne D. Richardson, et al., of Emergency Medicine fi led an amicus brief with the Emergency Department Crowding as a Health Policy Issue: Past

Tenth Circuit on behalf of the plaintiff urging it to pro- Development, Future Directions, 40 ANN. EMERGENCY MED. 388, 388- tect physicians who voice concerns related to EMTALA 93 (2002). violations, whether they presently exist, are imminent or 9. 42 U.S.C. § 1395dd(b)(1)(B). 39 appear foreseeable. Evidently, the Court did not adopt 10. 42 U.S.C. § 1395dd(d). this public policy argument. 11. It is generally settled that plaintiffs may prosecute EMTALA claims against the hospital for damages they sustained, but several courts As our country enters into a new health care age, the have held that EMTALA does not create a private cause of action problems that we will assuredly face will run the gamut. against individual physicians. See e.g. Eberhardt v. Los Angeles, 62 One thing that is clear is that emergency rooms will be F.3d 1253, 1256 (9th Cir. 1995), King v. Ahrens, 16 F.3d 265, 271 (8th forced to navigate new roadblocks as the mandates set Cir. 1994); Delaney v. Cade, 986 F.2d 387, 393-94 (10th Cir. 1993); Baber v. Hospital Corporation of America, 977 F.2d 872, 876-878 (4th out in EMTALA and the ACA appear to be headed for Cir. 1992); Gatewood v. Washington Healthcare Corp., 933 F.2d 1037, a collision course. Absent adequate government fund- 1040 n.1 (D.C. Cir. 1991); Fisher by Fisher v. New York Health & ing, universal emergency department guidelines and a Hosps. Corp., 989 F. Supp. 444 (E.D.N.Y. 1998). greater supply of quality physicians, Congress may be 12. 42 U.S.C. § 1395dd(d)(2)(A). forced to take on the health care debate down the road, 13. See e.g. Cox v. Cabell Huntington Hosp., Inc., 2012 WL 685870, yet again. Unfortunately, taking up the debate is far sim- No. 3:110843 (S.D. W.V. Mar. 2, 2012) (plaintiff permitted to ﬁ le an pler than enacting effective legislation. EMTALA claim despite failing to provide the state law required

64 NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 notice of claim to health care providers and/or a verifi cation of 23. Association of American Medical Colleges, Physician Supply and merit to the court as required under state law); Godwin v. Memorial Demand Through 2025: Key Findings (March 2015), available at Medical Center, 25 P.3d 273, 281-282 (N.M. App. 2001) (Court https://www.aamc.org/download/153160/data/physician_ held that New Mexico’s 90-day notice-of-claim requirement for shortages_to_worsen_without_increases_in_residency_tr.pdf. tort claims was preempted by EMTALA’s two-year statute of 24. American College of Emergency Physicians, America’s Emergency Jackson limitations with respect to EMTALA causes of action); Care Environment: A State-by-State Report Card (2014 Ed.), v. East Bay Hospital , 980 F. Supp. 1341, 1348-1350 (N.D. Cal. available at http://www.emreportcard.org/uploadedFiles/ 1997) (state’s damage cap for malpractice claim did not apply to EMReportCard2014.pdf. EMTALA claim); Cooper v. Gulf Breeze Hospital, Inc., 839 F. Supp. 1538, 1541-1543 (N.D. Fla. 1993) (same); Bird v. Pioneers Hosp., 121 25. Id. F.Supp.2d 1321 (D.C. Colo. 2000) (Colorado’s notice statute does 26. Id. not apply to EMTALA claims). 27. In June 2008 a woman died on the fl oor of the psychiatric 14. Both the Centers for Medicare & Medicaid Services (CMS) and emergency room at Kings County Hospital Center after waiting the Offi ce of the Inspector General (OIG) have administrative for more than 24 hours for treatment. See Sewell Chan, City to Pay enforcement powers with regard to EMTALA violations. There is a $2 Million in Death After Hospital Wait, The New York Times, at 2-year statute of limitations for civil enforcement of any violation. http://www.nytimes.com/2009/05/28/nyregion/28settle.html See American College of Emergency Physicians, News Media, (May 27, 2009). In January 2014, a 30 year old man was found EMTALA, available at http://www.acep.org/News-Media-top- dead in the waiting room of Saint Barnabas Hospital in the Bronx banner/EMTALA/. eight hours after he arrived to the ER complaining of a rash. 15. See e.g. Eberhardt v. City of Los Angeles, 62 F.3d 1253 (9th Cir. 1995); See Rich Schapiro, Man, 30, found dead after 8-hour wait in Bronx Repp v. Anadarko Municipal Hosp., 43 F.3d 519 (10th Cir. 1994); Emergency Room For Rash, New York Daily News, at http://www. Holcomb v. Monahan, 30 F.3d 116 (11th Cir. 1994). nydailynews.com/new-york/bronx/man-30-dies-8-hour-wait- bronx-emergency-room-article-1.1591629 (Jan. 26, 2014). 16. Repp v. Anadarko Municipal Hospital, 43 F.3d 519, 522 (10th Cir. 1994); Power v. Arlington Hospital Ass’n, 42 F.3d 851, 856 (4th Cir. 28. New York State Dep’t of Health, Redesigning New York’s 1994); Gatewood v. Washington Healthcare Corp., 933 F.2d 1037, 1039 Medicaid Program: Delivery System Reform Incentive Payment (D.C. Cir. 1991); Cleland v. Bronson Health Care Group, Inc., 917 F.2d (DSRIP) Program, available at https://www.health.ny.gov/health_ 266, 271-72 (6th Cir. 1990); Brenord v. Catholic Med. Ctr. of Brooklyn care/medicaid/redesign/dsrip/. & Queens, Inc., 133 F. Supp. 2d 179, 185 (E.D.N.Y. 2001). 29. Sarah L. Taubman et al., Medicaid Increases Emergency Department 17. See e.g. Brooks v. Maryland Gen. Hosp., 996 F.2d 708 (4th Cir. 1993) Use: Evidence from Oregon’s Health Insurance Experiment, (patient complaining of acute weakness and a sudden inability 343 SCIENCE 263 (2014). to walk who presented to the emergency room and experienced 30. Id. at 265. excessive delays in treatment and evaluation, could assert a screening claim under EMTALA); Scruggs v. Danville Regional 31. Alexander T. Janke, et al., Access to Care Issues and the Role of EDs in Medical Center of Virginia, LLC, No. 08-00005, 2008 U.S. Dist. LEXIS the Wake of the Affordable Care Act, 33 AM. J. EMERG. MED. 181, 181- 68630, *10-12 (W.D. Va. Sept. 5, 2008) (denying motion to dismiss 185 (2015). plaintiff’s EMTALA screening claim, where plaintiff asserted 32. American College of Emergency Physicians, Newsroom, The that over 11½ hours had elapsed between the time he presented Uninsured: Access to Medical Care Fact Sheet, available at http:// himself to the emergency room and the time that he was examined newsroom.acep.org/index.php?s=20301&item=30032#footnote_ix by a doctor); Byrne v. Cleveland Clinic, 684 F. Supp. 2d 641 (E.D. (Jan. 4, 2009). Pa. 2010) (dismissal of plaintiff’s EMTALA claim that it took 33. Genova v. Banner Health, 734 F.3d 1095 (10th Cir. 2013). two hours after his arrival for an ED physician to attend to his condition denied). 34. 42 U.S.C. § 1395dd(i). 18. Brandy Zadrozny, Obamacare Has a New Problem: It Won’t Fix 35. Genova, 734 F.3d at 1103. Emergency Rooms, The Daily Beast, Jan. 2, 2014, available at http:// 36. Id. at 1098–1101. www.thedailybeast.com/articles/2014/01/02/obamacare-has-a- new-problem-it-won-t-fi x-emergency-rooms.html. 37. Id. at 1098. 19. American College of Emergency Physicians, 2014 ACEP Polling 38. Id. at 1099. Survey Results (April 2014), available at http://newsroom.acep. 39. Brief of Amicus Curiae American Academy of Emergency Medicine org/ACEP-Emergency-Visits-Up-Since-Implementation-of-ACA; in Support of Appellant, Genova v. Banner Health, 734 F.3d 1095 see also Brett Logiurato, Doctors Think Emergency Room Visits Are (10th Cir. 2013) (NO. 12-1314), available at http://www.aaem.org/ Going To Explode Under Obamacare, Business Insider, at http:// UserFiles/Genovaamicuscuriaefi ling.pdf. www.businessinsider.com/obamacare-emergency-room-visits- study-2014-5#ixzz3TXQr5bfn (May 22, 2014). 20. Id. at http://newsroom.acep.org/ACEP-Emergency-Visits-Up- Daniel Shapiro is partner with Jaspan Schlesinger Since-Implementation-of-ACA. LLP located in Garden City, New York and is a member 21. Id. of the fi rm’s litigation and appellate practice groups. 22. American Hospital Association, Always There Ready to Care: The Mr. Shapiro represents both private and corporate 24/7 Role of America’s Hospitals (March 2015), available at http:// clients, which include physician-owned professional www.aha.org/research/policy/2015.shtml. corporations, and provider and management service organizations.

NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 65 OMIG Reminds Providers That Compliance Ofﬁ cer Must Be an Employee of the Provider By Philip Rosenberg, Laurie T. Cohen and Brooke A. Lane

New York State law requires certain Medicaid pro- If the subsidiary is not wholly owned by the parent viders, including hospitals, home care agencies, mental company, however, the OMIG will not consider a parent health clinics, Article 16 clinics and other providers that company to have “unity of ownership and control” over derive a substantial portion of their business from the the subsidiary. That means that an employee who is the Medicaid program, to operate and maintain an effective compliance offi cer of a subsidiary will not be deemed to compliance program. Pursuant to that law, one of the es- be an employee of the parent holding company. The same sential components of an effective compliance program is individual, however, may serve as the compliance offi cer to vest an employee of the provider with the responsibil- for the parent company and individual subsidiaries if the ity of overseeing the day-to-day operations of the compli- individual has separate employment relationships with ance program. each entity. The New York State Offi ce of the Medicaid Inspec- The compliance guidance applies the same rule to tor General (“OMIG”) has released guidance reminding joint ventures that are participating in the Medicaid pro- those Medicaid providers of their obligation to employ gram. Because a joint venture does not involve unity of such a person. To be considered an employee, an indi- ownership and control between the joint venture and its vidual must qualify as an employee for state or federal owners, a compliance offi cer employed by either owner tax purposes. Independent contractors, consultants and will not be considered to be an employee of the joint volunteers are not considered employees. venture itself. A joint venture required to have a compliance program will thus have to separately employ an The compliance guidance also addresses the situa- employee who is vested with the day-to-day operation of tion where multiple corporate entities are controlled by the compliance program. But, again, that individual may a parent holding company. In that situation, the holding enter into separate employment arrangements with the company may operate or coordinate a compliance pro- joint venture and one or more owners. gram throughout the enterprise. The guidance explains that, even though the parent holding company may not Similarly, providers that choose to delegate respon- actually be participating in the Medicaid program, it may sibility for carrying out compliance activities to a man- employ a compliance offi cer on behalf of wholly owned agement company will have to ensure that a provider subsidiaries that are participating in the Medicaid pro- employee is the compliance offi cer vested with the gram because there is a unity ownership and control. responsibility for the compliance program. Similarly, the compliance guidance states that a whol- Providers should examine their compliance pro- ly owned subsidiary may employ the compliance offi cer gram and ensure that the designated compliance of- on behalf of the parent holding company if the employee fi cer’s employment status complies with the regulatory of the subsidiary: requirements. a. is vested by the parent company with responsibility for the day-to-day operation of the parent Philip Rosenberg and Laurie T. Cohen are partners company’s compliance program; in Nixon Peabody LLP and practice health law from the fi rm’s Albany offi ce. Brooke A. Lane is an associate b. satisfactorily carries out all of the compliance at Nixon Peabody LLP and practices health law in the responsibilities; fi rm’s Long Island offi ce.This ar ticle originally appeared c. reports directly to the parent company’s chief in the fi rm’s publication Health Law Alert, and is re- executive offi cer or other senior administrator; and printed with permission d. periodically reports directly to the parent company’s governing body on the activities of the parent company’s compliance program.

66 NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 Out-of-Network Law Frequently Asked Questions Healthcare Association of New York State (HANYS)

On March 31, New York’s out-of-network (OON) law General Questions went into effect. The law is the result of negotiations be- 1. What health plans are subject to the Out-of- tween the Department of Financial Services (DFS), Depart- Network (OON) Law? ment of Health (DOH), the legislature, hospitals, physicians, and health plans. It follows years of debate over the The law applies to all state-regulated insurance prod- adequacy of out-of-network reimbursement and the outcry ucts, including health maintenance organizations (HMOs), over surprise balance bills sent to consumers. preferred provider organizations (PPOs), exclusive provider organizations (EPOs), municipal health beneﬁ t plans, The law intends to hold patients harmless for emer- student health plans, and Medicaid managed care plans. gency services and surprise bills; creates new disclosure requirements for hospitals, physicians and health plans; Medicaid fee-for-service, Employee Retirement Income creates an independent dispute resolution (IDR) process Security Act (ERISA)-preempted, Medicare Advantage, for patients, plans, and physicians who disagree about Medicare fee-for-service, and self-insured health plans are out-of-network reimbursement for emergency and surprise not required to comply with state law. However, there are bills; and bolsters network adequacy requirements and the other rules and requirements regarding out-of-network state’s authority to enforce such standards. services that apply for Medicare and Medicaid patients. This following Frequently Asked Questions (FAQ) rep- 2. When does the out-of-network law take effect? resent HANYS’ initial analysis of the law to date based on The law is effective for dates of service on and after statutory language, regulations, and guidance issued by the March 31, 2015. Speciﬁ c effective dates for all components Department of Health (DOH) and Department of Financial of the law are listed below: Services (DFS). The answers provided may change over time as the law takes effect and state agencies issue updated guidance.

NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 67 Disclosure Requirements advance of non-emergency hospital services, in registration 3. What does the law specifi cally state regarding or admission materials. hospital disclosure requirements for charges? Hospitals must provide a statement advising the A hospital must post on its website, to the extent patient to check with the physician arranging the hospital required by federal guidelines, a list of the hospital’s services to determine the name, practice name, mailing ad- standard charges for items and services provided by the dress, and telephone number of any other physician whose hospital, including for Diagnosis Related Groups (DRGs). services will be arranged by the physician; and whether it is anticipated that physicians who are employed or contracted In the federal fi scal year (FFY) 2015 Inpatient Prospec- by the hospital will provide services to the patient (includ- tive Payment System fi nal rule, the Centers for Medicare ing anesthesiology, pathology, and/or radiology). Hospitals and Medicaid Services (CMS) reminds hospitals of their must also provide the patient with information on how to obligation to comply with this provision and is providing timely determine the health plans with which the other fl exibility as to how hospitals should make their charges physicians participate. public. CMS states that hospitals should either make public a list of their standard charges (whether that be the charge- 6. Is there a template that hospitals can use to fulfi ll master or in another form of their choice), or their policies its disclosure requirements? for allowing the public to view a list of those charges in Yes, HANYS and Greater New York Hospital Associa- response to an inquiry. tion (GNYHA) created a Hospital Disclosure Template to 4. What other information must a hospital post on help members comply with the new hospital disclosure its website? requirements. Both DOH and the Department of Financial Services (DFS) have stated that they will accept the tem- The hospital must post the following information on plate disclosure form from hospitals that use it to satisfy its website: both the website and registration material requirements, • a list of the health plans in which the hospital which take effect March 31, 2015. participates; 7. What information must a physician disclose to • the name, mailing address, and telephone number of patients? the physician groups that the hospital has contracted with to provide services, including anesthesiology, Physician disclosure requirements come in two parts: pathology or radiology; and instructions on how to • For referrals and coordination of services: The physi- contact these groups to determine the health plan cian must provide the patient with the name, practice participation of the physicians in these groups; and name, mailing address, and telephone number for • the name, mailing address, and telephone number any health care provider scheduled to perform those of physicians employed by the hospital and whose services specifi cally referenced in the law (anesthe- services may be provided at the hospital, and the siology, laboratory, pathology, radiology, or assistant health plans in which they participate. surgeon services) in connection with care provided in the physician’s offi ce; as coordinated by the physi- 5. What information must the hospital provide to its cian; or as referred by the physician. patients in registration/admission materials? • For scheduled hospital admissions or outpatient In addition to the website disclosure requirements, hospital services: The physician must provide the hospitals must provide written information to patients in

68 NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 patient and the hospital with the name, practice Surprise Bills name, mailing address, and telephone number of 12. What is a surprise bill? any other physician whose services will be arranged by the physician and are scheduled at the time of Financial Services Law 603(h) defi nes a surprise bill as pre-admission testing, registration or admission, and a bill for health care services, other than emergency ser- information how to determine in which health plans vices, received by: the physician participates. • an insured for services rendered by a non-participat- 8. How does the law defi ne physician and provider? ing physician at a participating hospital or ambulato- ry surgical center, where a participating physician is A provider is defi ned as an appropriately licensed, unavailable, or a non-participating physician renders registered or certifi ed health care professional pursuant to services without the insured’s knowledge, or unfore- Education Law Title 8, or comparably licensed, registered seen medical services arise at the time the health care or certifi ed by another state, or a facility licensed or certi- services are rendered; provided, however, that a sur- fi ed pursuant to Public Health Law Articles 5, 28, 36, 44 or prise bill shall not mean a bill received for health care 47, or Mental Hygiene Law Articles 19, 31 or 32, or compa- services when a participating physician is available rably licensed by another state. and the insured has elected to obtain services from a A physician is defi ned as an individual licensed to non-participating physician; or practice medicine pursuant to Education Law Article 131 or • an insured for services rendered by a non-partici- as provided under the law of the state where the individual pating provider where the services were referred practices medicine. by a participating physician to a non-participating provider without the explicit written consent of the Emergency Bills insured acknowledging that the participating physician is referring the insured to a non-participating 9. Are OON emergency bills for hospital charges provider and that the referral may result in costs not subject to the independent dispute resolution covered by the health plan. process? No, the independent dispute resolution process for 13. When does a referral to a non-participating emergency services applies only to physician services in provider occur? a hospital. Emergency bills for hospital charges are not A referral to a non-participating provider occurs when: eligible for independent dispute resolution. • the health care services are performed by a non- 10. If an OON emergency bill for hospital charges is participating health care provider in the participating not eligible for the independent dispute resolution physician’s offi ce or practice during the course of the process, how do those charges get paid? same visit; Beginning on March 31, 2015, Insurance Law 3241(c) • the participating physician sends a specimen taken requires insurers to hold insureds harmless for charges in from the patient in the physician’s offi ce to a non- excess of the in-network deductible, copayments or coin- participating laboratory or pathologist; or surance for OON emergency services. This hold-harmless requirement for OON emergency services applies both • for any other health care services when refer- to physician services in a hospital and hospital charges. rals are required under the insured’s contract (i.e., For disputes involving OON emergency hospital services gatekeeper). that are not eligible for the independent dispute resolu- 14. How does the state defi ne an “available” tion process, health plans may need to pay more than the provider? reimbursement required under the Affordable Care Act to ensure that an insured is held harmless. For the participating physician to be considered “available,” the insured should have a meaningful opportunity to 11. If an emergency room physician requests that choose an in-network physician in advance of the services. a specialist provide a patient in the emergency room a consultation and the specialist does not 15. Does the hold-harmless provision apply to surprise participate with the patient’s health plan, would bills? this be considered part of the emergency service? Financial Services Law 606 requires providers to hold Yes, according to guidance issued by the Department insured patients that have completed an assignment of of Financial Services (DFS), in this scenario a bill from a benefi ts form harmless for a surprise bill. HMOs and gate- specialist would be considered a bill for emergency services keeper EPOs are also required to hold insureds harmless and could be subject to the independent dispute resolu- for a surprise bill pursuant to hold-harmless requirements tion process because it fl ows directly from the emergency imposed under the Public Health Law and regulations. The service. provider shall not bill or seek payment from the insured ex-

NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 69 cept for any applicable copayment, coinsurance, or deduct- care, Medicare, and Medicaid fee-for-service. Additionally, ible that would be owed if the insured utilized a provider Medicaid managed care is exempt from IDR if the bill is for in-network. emergency services, and is not exempt from IDR if the bill is a surprise bill. 16. An insured is admitted to a participating hospital following emergency services and during that 21. Once an application for review is submitted, does hospital stay a non-participating specialist the dispute automatically qualify for an IDRE? provides consultation services. Would this qualify No. Once an application for dispute is submitted, the as a surprise bill? IDRE has three business days to screen the application for This would qualify as a surprise bill if: eligibility (assuming no confl icts of interest exist). The IDRE • a participating physician is unavailable; is responsible for determining if the dispute qualifi es as an emergency or surprise bill. • a non-participating physician renders services without the insured’s knowledge; or 22. What factors does the IDRE take into consideration when reviewing disputes? • unforeseen services arise at the time other services are rendered. The IDRE shall have the dispute reviewed by a neutral and impartial reviewer with training and experience in 17. If an insured is admitted to a non-participating health care billing, reimbursement, and usual and custom- hospital and during that stay consultation services ary charges. All determinations shall be made in consul- are provided by a non-participating specialist, tation with a neutral and impartial licensed reviewing would this qualify as a surprise bill? physician in active practice in the same or similar specialty No, this would not be considered a surprise bill be- as the physician providing the service that is subject to the cause the patient is already OON and cannot reasonably dispute. To the extent practicable, the reviewing physician expect that physicians at an OON hospital are in-network. shall be licensed in the state of New York. 23. How long does the IDRE have to make a fi nal Independent Dispute Resolution (IDR) Process determination? 18. How do you submit a dispute for review by an The IDRE shall make a determination within 30 days of independent dispute resolution entity (IDRE)? receiving the request for dispute resolution. Emergency bills: A health care plan, a non-participating physician, or a patient who is not an insured or self-in- 24. Who is responsible for paying the fee for the sured may submit a dispute regarding emergency services dispute resolution process? to the Superintendent of DFS for review by an IDRE. If the IDRE determines that the health plan’s payment is reasonable, payment for the dispute resolution process Surprise bills: A health care plan, a non-participating shall be the responsibility of the provider or physician. physician, a non-participating referred provider, an insured who does not assign benefi ts, or a patient who is not If the IDRE determines that the provider or physician’s an insured or self-insured may submit a dispute regard- fee is reasonable, the health plan shall be responsible for the ing a surprise bill to the Superintendent for review by an fee of the dispute resolution process. IDRE. If good faith negotiations directed by the IDRE result in 19. How do the OON law and the IDR process apply a settlement between the health plan and provider or physi- to the uninsured and patients who are insured cian, the prorated fee for the dispute resolution process under ERISA or self-funded plans? shall be split evenly between the two parties. Employee Retirement Income Security Act (ERISA) For disputes that are rejected as ineligible or due to and self-funded plans are not state-regulated; therefore the requesting provider, physician, or health plan’s failure state laws do not extend to these plans. Patients insured to submit information, an IDRE may charge an applica- under ERISA or self-funded plans will be treated as un- tion processing fee, which shall be the responsibility of the insured for the purposes of emergency and surprise bills. requesting provider, physician, or health plan. The patient may submit his or her remaining portion of the bill, if not the entire bill, to DFS for independent dispute For disputes involving an uninsured patient, if the resolution and the dispute resolution process will involve IDRE determines that the physician’s fee is reasonable, the the patient and the physician. patient will be responsible for the fee for the dispute resolution process. However, if the Superintendent determines 20. Are any physician bills for emergency services or that that payment would pose a hardship to the patient, the surprise bills exempt from the IDR process? IDRE shall waive payment. Yes, when physician fees are subject to schedules or Reprinted with permission of the Healthcare Association of New other monetary limitations under any other law, includ- York State (HANYS). HANYS is seeking further clarifi cation on ing Workers Compensation, no-fault, managed long-term some of these matters, and may revise these answers on its website.

70 NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 ing staff credentialing matters. On over 100 occasions, Mr. Larywon has lectured on risk management issues to physicians, nurses, and other health care professionals at many hospitals in the metropolitan area. Mr. Larywon co- authored a series of articles about managed care issues for the New York Law Journal. Previously, Mr. Larywon was Chair of the Profes- What’s Happening in the Section sional Discipline Committee of the Health Law Section. That Committee addresses issues related to agencies such as OPMC and OPD. He has also served as the Secretary and Vice-Chair of the Section. Kenneth R. Larywon Mr. Larywon earned his law degree in 1978 from Kenneth R. Larywon took offi ce Notre Dame Law School. as Chair of the Health Law Section on June 1, 2015. He is a senior part- Offi cers ner and trial attorney with Martin, The other section offi cers who took offi ce on June 1 Clearwater & Bell, and practices are: out of the fi rm’s New York City offi ce. He focuses his practice on the Chair-Elect: Raul A. Tabora, Jr., Bond Schoeneck & defense of professional liability cases King, PLLC (Albany) and health care law matters. For Vice-Chair: Lawrence Faulkner, ARC of over 30 years, Mr. Larywon has defended physicians and Westchester (Hawthorne) hospitals in claims arising out of the delivery of medical care. He has also represented health care professionals in Secretary: Robert A. Hussar, Manatt, Phelps & disciplinary proceedings before the Offi ce of Professional Phillips (Albany) Medical Conduct and the Department of Education. Treasurer: Julia C. Goings-Perrot, Catania, Mahon, Mr. Larywon has extensive experience in counseling Milligram (Newburgh) and defending hospitals, and in physician and nurs-

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NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 71 Section Committees and Chairs

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CLE Legislative Issues Mental Hygiene, Law and Substance Robert P. Borsody James W. Lytle Abuse Robert P. Borsody, PC Manatt, Phelps & Phillips, LLP Carolyn Reinach Wolf 666 Fifth Avenue, 29th Floor 30 S. Pearl Street Abrams, Fensterman, Fensterman, New York, NY 10103 Albany, NY 12207 Eisman, Formato, Ferrara [email protected] [email protected] & Wolf, LLP 1111 Marcus Avenue, Suite 107 Developmental Disabilities Managed Care and Insurance Lake Success, NY 11042 Hermes Fernandez Ross P. Lanzafame [email protected] Bond, Schoeneck & King, PLLC Harter Secrest & Emery LLP 22 Corporate Woods, Suite 501 1600 Bausch and Lomb Place Professional Discipline Albany, NY 12211 Rochester, NY 14604 Peter T. Crean [email protected] [email protected] Martin Clearwater & Bell LLP 220 East 42nd Street, 13th Fl. E-Health and Information Harold N. Iselin New York, NY 10017-5806 Charles C. Dunham, IV Greenberg Traurig, LLP [email protected] Epstein Becker & Green, P.C. 54 State Street 250 Park Avenue Albany, NY 12207 Carolyn Shearer New York, NY 10177 [email protected] Bond, Schoeneck & King, PLLC [email protected] 22 Corporate Woods Blvd., Suite 501 Medical Research and Albany, NY 12211-2374 Daniel Meier Biotechnology [email protected] Benesch Friedlander Coplan & Aronoff Samuel J. Servello Continental Plaza II New York Genome Center Public Health 411 Hackensack Avenue, 3rd Flr. 101 Avenue of the Americas Jason M. Brocks Hackensack, NJ 07601-6323 New York, NY 10013 Benecard [email protected] [email protected] 1200 Route 46 West Clifton, NJ 07013 Ethical Issues in the Provision of Alex C. Brownstein [email protected] Health Care BioScience Communications Alice H. Herb 250 Hudson Street Publications and Web Page SUNY Downstate Medical Center New York, NY 10013 Robert N. Swidler 450 Clarkson Avenue, Box 116 [email protected] St. Peter’s Health Partners Brooklyn, NY 10011 5 Cusack [email protected] Membership 315 S. Manning Blvd. James F. Horan Albany, NY 12208 Lawrence R. Faulkner New York State Health Department [email protected] ARC of Westchester Bureau of Adjudication 265 Saw Mill River Road, 3rd Fl. Riverview Center Reimbursement, Enforcement, and Hawthorne, NY 10532 150 Broadway, Suite 510 Compliance [email protected] Albany, NY 12204-2719 Melissa M. Zambri [email protected] Barclay Damon LLP Health Care Providers and Networks 80 State Street David A. Manko Karen L.I. Gallinari Albany, NY 12207-2207 Rivkin Radler LLP Bronx Lebanon Health Care System [email protected] 926 RXR Plaza 15 Wilcox Avenue Uniondale, NY 11556-0926 Yonkers, NY 10705 Young Lawyers [email protected] [email protected] Nicole R. Ozminkowski Harris Beach P LLC Reginald Bullock, Jr. 99 Garnsey Road 155 Wyckoff Street Pittsford, NY 14534 Brooklyn, NY 11217 [email protected] [email protected]

72 NYSBA Health Law Journal | Spring/Summer 2015 | Vol. 20 | No. 2 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 con- Robert N. Swidler sid er ation. Your ideas and comments about the Journal St. Peter’s Health Partners are ap pre ci at ed as are letters to the editor. 5 Cusack Publication Policy: 315 S. Manning Blvd. All articles should be submitted to: Albany, NY 12208 (518) 525-6099 Robert N. Swidler [email protected] St. Peter’s Health Partners 5 Cusack 315 S. Manning Blvd. Section Officers Albany, NY 12208 Chair (518) 525-6099 Kenneth R. Larywon [email protected] Martin Clearwater & Bell LLP Submitted articles must include a cover letter giving 220 East 42nd St. permission for publication in this Journal. We will as- New York, NY 10017 sume your submission is for the exclusive use of this [email protected] Journal unless you advise to the contrary in your letter. Authors will be notifi ed only if articles are rejected. Chair-Elect Authors are encouraged to include a brief biography Raul A. Tabora, Jr. with their submis sions. Bond, Schoeneck & King, PLLC 22 Corporate Woods, Suite 501 Editorial Policy: The articles in this Journal rep re sent Albany, NY 12211 the authors’ viewpoints and research and not that of [email protected] the Journal Editorial Staff or Section Offi cers. The accu- racy of the sources used and the cases cited in submis- Vice-Chair sions is the re spon si bil i ty of the author. Lawrence R. Faulkner Dir. of Corp Compliance & Gen’l Counsel Subscriptions ARC of Westchester This Journal is a benefi t of membership in the Health 265 Saw Mill River Road, 3rd Floor Law Section of the New York State Bar Association. Hawthorne, NY 10532 [email protected] The Journal is available by subscrip tion to non-attorneys, libraries and organizations. The sub scrip tion rate Secretary for 2015 is $150.00. Send your request and check to Robert A. Hussar Newsletter Dept., New York State Bar Association, One Manatt Phelps & Phillips LLP Elk Street, Albany, NY 12207. 30 South Pearl Street Albany, NY 12207 Accommodations for Persons with Disabilities: [email protected] NYSBA welcomes participation by individuals with disabilities. NYSBA is committed to complying with all applicable laws that prohibit discrimination against individuals on the Treasurer basis of disability in the full and equal enjoyment of its goods, Julia C. Goings-Perrot services, programs, activities, facilities, privileges, advantag- Associate General Counsel es, or accommodations. To request auxiliary aids or services HealthQuest or if you have any questions regarding accessibility, please Legal Services Department contact the Bar Center at (518) 463-3200. 1351 Route 55, Suite 200 Lagrangeville, NY 12540 Copyright 2015 by the New York State Bar Association. [email protected] ISSN 1530-3926 ISSN 1933-8406 (online)

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