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IN THIS ISSUE UNLAWFUL, UNFAIR AND UNWISE: CONSTITUTIONAL AND RULEMAKING Unlawful, Unfair and Unwise: Constitutional and Rulemaking INFIRMITIES IN CMS’s ENROLLMENT Infirmities in CMS’s Enrollment Revocation Regulations and REVOCATION REGULATIONS AND HOW How to Challenge Them...... 1 TO CHALLENGE THEM Chair’s Column...... 2 Donald H. Romano, Esq. a proposed revocation for which you Section News...... 22 Foley & Lardner LLP would be offered the opportunity to Washington DC respond, or any other warning from Supreme Dilemma: Handling your Medicare contractor, you receive Conflicts Between State Medical a notice stating your billing privileges Privacy Laws and Federal Welcome to the Medicare are revoked for a period of three years. Investigative Subpoenas...... 24 Program – Now Get Out To make matters worse, the contractor Imagine you are a physician who notifies you that it is recouping Medi- Lessons Learned From a New has been convicted of a minor felony, care payment for all of the services Medical-Legal Partnership: from the date of your conviction Patient Screening, Information such as one count of possession of a through the date of the notice, which and Communication...... 34 controlled substance, which was not a crime of dishonesty or had anything to amounts to several hundreds of thou- Section Calendar...... Back Cover do with Medicare or any other health- sands of dollars. care program. You report the felony Or imagine that you are a physi- conviction to your Medicare contrac- cian practice that employs someone tor within 30 days, as required. You who is listed as a managing employee also report the conviction to the state on the practice’s enrollment form. The licensing board, which decides to take employee does not tell you that he has no action against your license. You been excluded from participation in wait to see what happens with Medi- the federal healthcare programs by the care, because, after all, revocation of Department of Health and Human billing privileges for a felony convic- Services’ Office of Inspector General tion is not automatic. Revocation due (“OIG”) and despite your routine to a felony conviction is supposed to searches of OIG’s listing of excluded be based on a determination that a individuals and entities (“LEIE”) you provider’s or supplier’s continued par- fail to find that he has been excluded.2 ticipation in the Medicare program is You discover he has been excluded “detrimental to the best interests of when you receive a notice from the the Medicare program and its Centers for Medicare & Medicaid beneficiaries”1 (whatever that means). Services (“CMS”) informing you that Two years later, without any notice of your billing privileges have been Volume 31, Number 6, continued on page 3 August 2019 Chair’s Corner E HEALTH H

T LAWYER the aba health law section

The Health Lawyer (ISSN: 0736-3443) is published by the American Bar Association Health Law Section, 321 N. Clark Street, Chicago, IL 60654-7598. Address corrections should be sent to the American Bar Association, c/o Member Records. Requests for permission to reproduce any material from The Health Lawyer should be addressed in writing to the editor. The opinions expressed are those of the authors and shall not be construed to represent the policies or positions of the American Bar Association and the ABA Health Law Section. Copyright © 2019 American Bar Association.

2019-2020 Officers and Council of the ABA Health Law Section are as follows: Chair Vice Chair Budget Officer Alexandria Hien McCombs Hal Katz Adrienne Dresevic Signify Health Husch Blackwell LLP The Health Law Partners Dallas, TX Austin, TX Farmington Hills, MI Chair-Elect Secretary Immediate Past Chair John H. McEniry IV Clay Countryman Hilary H. Young Fagron North America Breazeale Sachse & Joy & Young, LLP Fairhope, AL Wilson LLP Austin, TX Baton Rouge, LA

Section Delegates to the House of Delegates William W. Horton Robyn S. Shapiro Jones Walker, LLP Health Sciences Law Group LLC Birmingham, AL Fox Point, WI

Council Christi J. Braun W. Andrew H. Gantt III Kathy L. Poppitt Vanderbilt University Gantt Law LLC King & Spalding LLP Medical Center Baltimore, MD Austin, TX Nashville, TN Kathleen DeBruhl Denise Hanna Julian Rivera Kathleen L DeBruhl & Locke Lord LLP Husch Blackwell LLP Associates LLC Washington, DC Austin, TX New Orleans, LA Matthew Fisher William Hopkins Donald H. Romano Mirick O’Connell DeMallie Shackelford Bowen Foley & Lardner & Lougee LLP McKinley & Norton, LLP Washington, DC Worcester, MA Austin, TX

Board of Governors Liaison Government Attorney-at-Large Howard T. Wall Alec Alexander Franklin, TN Centers for Medicare & Medicaid Services Washington, DC

Young Lawyer Division Liaison Law Student Division Liaison Muthuramanan Rameswaran Michael C. Nolan Katten Muchin Rosenman, LLP University of Houston Law Center Washington, DC Houston, TX

Section Director The Health Lawyer Editor Simeon Carson Marla Durben Hirsch American Bar Association Potomac, MD 321 N. Clark Street 301/299-6155 Chicago, IL 60654-7598 [email protected] 312/988-5824 [email protected] continued on page 2

2 The Health Lawyer Volume 31, Number 6, August 2019 Unlawful, Unfair and Unwise: Constitutional and Rulemaking Infirmities continued from page 1 revoked for three years for having an judicial review as other Medicare squarely on the side of providers and excluded individual as a managing appeals processes do and by prohib- suppliers as to whether a protected employee.3 Although CMS’s regula- iting providers and suppliers from liberty interest can exist. tions allow it to rescind a revocation appealing the length of the reen- Is there a protected property where the provider or supplier fires rollment bar? interest? the managing employee (or if is an • Does CMS’s reinterpretation of the owner who is the subject of the In Board of Regents of State Col- regulations to provide for a reenroll­ 5 adverse action terminates the owner’s leges et. al v. Roth, the Supreme Court ment bar for certain deactivations ownership interest) within 30 days of clarified that determining whether (while still denying appeal rights the revocation,4 and although you do someone has a property interest for the deactivation determination) so within a matter of days, CMS depends on whether there is a reason- violate the rulemaking provisions refuses to rescind the revocation. able expectation of a continued of the Medicare Statute and the Instead, the revocation of billing receipt of a benefit. Such expectation Administrative Procedure Act? privileges is made retroactive to the must be “more than [] unilateral” and date of the employee’s exclusion and • Does CMS’s delegation to contrac- “more than an abstract need or an overpayment is created in the tors to make the revocation deter- desire” and, instead, must be “a legiti- 6 amount of $500,000. minations a violation of the mate claim of entitlement to it.” The revocation regulations, and is CMS Court explained that property inter- Revocation actions like those in providing appropriate oversight of ests are not created by the Constitu- the above hypotheticals (which are the contractors and providing ade- tion, but rather, “they are created and based on actual revocations) are hap- their dimensions are defined by exist- pening under the enrollment revoca- quate guidance to them and to pro- viders and suppliers? ing rules or understandings that stem tion regulations. This article looks at from an independent source such as due process and other serious issues • Apart from the question of legal state law – rules or understandings with how CMS’s regulations are writ- deficiencies, is CMS’s revocation that secure certain benefits and that ten and applied. It addresses the fol- process unfair and create bad feel- support claims of entitlement to lowing questions: ings among physicians and other those benefits.”7 Under this test, • Do the regulations violate due pro- suppliers, and is it unwise in light of wherever there are standards that cess by not providing for a pre- the continuing physician shortage? bind a state or federal agency that must be followed before entitlement revocation right to respond? In addition to addressing the or benefits can be taken away, there questions posed above, this article • Do the regulations violate due pro- is a protected property interest. also provides some guidance for chal- cess by not providing fair notice Because providers and suppliers can lenging revocation determinations that a provider or supplier may have their billing privileges revoked prior to exhausting the administrative have its billing privileges revoked? only for the reasons specified under appeals process. • Are the regulations arbitrary and the revocation regulations, proper capricious by not providing any application of Roth leads to the con- guidance as to the length of the Constitutional Infirmities clusion that they have a protected reenrollment bar that will apply in property interest in maintaining their Do the regulations violate due ability to bill Medicare. individual cases, and why does it process by not providing for at seem that almost every revocation least a pre-revocation right to However, there is an apparent results in the maximum three-year respond? split of authority as to whether there reenrollment bar? is a protected property interest in the In order to address this question, continued participation in Medicare • Are the regulations unconstitu- one must first consider whether an When one considers the precise issue – tional or arbitrary and capricious by enrolled provider or supplier has a a property interest in the continued providing that the effective date of constitutionally-protected property or enrollment in Medicare – and the the revocation is retroactive to the liberty interest in its continued par- fact that the enrollment regulations date of the adverse action that ticipation in the Medicare program. provide specific criteria that ostensi- formed the basis for the revocation? There is some split of authority as to bly are binding on both CMS and • Is the appeals process needlessly whether a protected property interest the providers/suppliers, Roth instructs unfair by not providing expedited exists, but the case law seems to be that there is a protected property continued on page 4 3 Volume 31, Number 6, August 2019 The Health Lawyer Unlawful, Unfair and Unwise: Constitutional and Rulemaking Infirmities continued from page 3 interest and more courts than not appears rooted in the lack of com- Ed. and Welfare,28 the First Circuit have agreed.8 plete discretion of the granting concluded that physicians do not authority. The court made this state- have a protectable property interest Decisions by and within the Sec- ment without discussion, and simply in continuing eligibility under Medi- ond Circuit are instructive in this cited its earlier decision of Bowens v. care part B, reasoning that “the real regard. In Case v. Weinberger,9 the North Carolina.20 In Bowens, the court parties in interest are the benefi­ court stated it was clear that the oper- concluded that the provider’s partici- ciaries; physicians are parties in interest ator of a nursing facility had a prop- pation in Medicaid was not terminable only as assignees of the beneficiaries.” erty interest in her expectation of at will based on the state regulations’ In Koerpel v. Heckler,29 the Tenth Cir- continued participation in the Medic- procedural requirements, which cuit found that a physician who was aid program. In Patchogue Nursing included a peer review process. The challenging his exclusion from partici- Center v. Bowen,10 the Second Circuit court held that “the regulations create pation in federal healthcare programs stated, in dicta, that “health care pro- a property interest in continued partic- by the OIG did not have a protected viders have a constitutionally pro- ipation in the program unless termi- property interest because he had only a tected property interest in continued nated for cause.”21 “reimbursement expectation, and that participation in the Medicare and “no clear promises have been made by 11 22 Medicaid programs. . . .” Subse- In Robie v. Price, the district the Government.”30 The Ninth Cir- quently, in Plaza Health Laboratories v. court said that “the courts are in cuit in Erickson v. U.S. Dept. of 12 Perales the Second Circuit noted agreement that due process does not HHS31 stated that it was following the that “the combination of rights entitle a physician to a full eviden- First and Tenth Circuits in reaching reserved by the State with regard to tiary hearing prior to having his Medi- its conclusion that “plaintiffs do not Medicaid providers…casts doubt on care billing privileges revoked,” but, possess a property interest in contin- whether the provider’s interest in quoting Mathews v. Eldridge, noted ued participation in Medicare, Medi­ continuing as a provider, either indef- that “[t]he fundamental requirement caid, or the federally-funded state initely or for any period without of due process is the opportunity to be health care programs.”32 interruption, is a property right that is heard ‘at a meaningful time and in a protected by due process.”13 However, meaningful manner.’”23 Employing the To say that providers and suppli- the court also stated that “[w]here the three-part balancing test in Eldridge, ers are not the “intended beneficia- state provisions bestow a right that and under the facts before it, the court ries” of the Medicare program offers cannot properly be eliminated except held that the physician was entitled to very little in the way of analysis. In for cause, that right constitutes prop- an in-person meeting before his bill- particular, the idea that one must be erty protected by procedural due ing privileges could be revoked.24 the intended beneficiary of a federal process.”14 This language was quoted program is at odds with the rule In Ritter v. Cohen,25 the Third with approval by the Second Circuit espoused in Roth that, where there are Circuit indicated in dicta that where in Senape v. Constantino.15 In Furlong standards that bind a state or federal the agency official’s discretion is con- v. Shalala,16 the Second Circuit applied agency that must be followed before strained, a provider has a property the principle that a constitutionally entitlement or benefits can be taken interest in the continued participation protected property interest exists away, there is a protected property in the State’s Medicaid program.26 where rules circumscribe the exercise interest. In other words, the fact that of discretion by a Medicare contrac- There is no D.C. Circuit opinion a person may not be the primary 27 intended beneficiary of a program tor. Specifically, the court held that on point, but in ABA, Inc. v. D.C., does not mean that the program does the constant, consistent pattern of the district court held that the plain- not create rights and obligations for administrative law judge (“ALJ”) tiff home health agencies had “a via- that person. In this regard, it is inter- decisions on a payment issue was suf- ble property interest, protected by due esting to compare the Tenth Circuit’s ficient to create a property interest in process, that [the D.C. Medicaid decision in Koerpel v. Heckler with its the receipt of Medicare payments.17 agency] could not terminate without earlier decision, Geriatrics Inc. v. prior notice and hearing.” The Fourth Circuit’s assertion in Harris,33 which was relied upon in Ram v. Heckler18 that the “expecta- In contrast, the First, Tenth and Koerpel.34 In Geriatrics Inc., after the tion of continued participation in the Ninth Circuits have found that there court noted the plaintiff’s argument Medicare program is a property inter- is no property interest in the contin- that, under Roth, it had more than a est protected by the due process ued participation in the Medicare unilateral claim or mere expectancy, clause of the fifth amendment”19 also program. In Cervoni v. Sec’y of Health, it said that a protectable property

4 The Health Lawyer Volume 31, Number 6, August 2019 interest must be an interest secured does not appear from the opinion that revoking the company’s billing privi- by statute or legal rule or through a the plaintiff sought one), and did not leges. In this case, the Secretary con- mutually explicit understanding. It recognize in its opinion the narrow ceded that Arriva had a liberty or then said that the regulations in effect scope of review in the administrative property interest in its billing privi- at that time required the Secretary of appeals system as opposed to what leges. Yet the Court noted that “the Health and Human Services (“Secre- may be raised in a judicial proceeding private interest at stake is not particu- tary”) to inform a nursing facility that contesting a revocation.39 larly strong because the Medicare pro- its agreement would not be renewed vider is not the intended beneficiary Is there a liberty interest? and to state the reasons for non­ of the Medicare program.”46 renewal, and also provided adminis- Most courts that have considered The Office of Inspector General trative appeal rights. According to the the issue have decided that there can (OIG) gives a pre-exclusion right to court, these provisions taken alone be a protected liberty interest in a respond may have appeared to create an provider’s or supplier’s continued par- expectation between government and ticipation in the Medicare program. Any argument the Secretary facility of renewal, but that when the In Erickson v. U.S. Dept. of HHS,40 would proffer that due process does entire regulatory scheme was consid- after concluding that the excluded not require a pre-revocation right to ered there was no basis for such an physician did not have a protected respond is undercut by his position on expectation. In particular, the court property interest, the Ninth Circuit exclusions. In contrast to revocations emphasized that (at that time) federal decided that he did have a protected of billing privileges, OIG-imposed per- law limited provider agreements to a liberty interest. The court began by missive exclusions from federal health- year, and the provider was required to citing previous Ninth Circuit prece- care programs are preceded by a be surveyed each year and reapply dent and Roth for the proposition that pre-deprivation right to respond. each year to continue participating in a person’s liberty interest is implicated Although the OIG does not provide the Medicare program.35 This auto- if a charge impairs his reputation for for a pre-exclusion hearing (except in matic termination scheme is obviously honesty or morality.41 The court held limited situations) in promulgating its different from the enrollment regula- that the procedural protections of due regulatory exclusion procedures, it tory scheme whereby there are spe- process apply if the accuracy of the recognized that an opportunity to cific standards (such as they are) that charge is contested, there is some pub- provide some type of pre-exclusion must be applied to revoke one’s bill- lic disclosure of the charge (“publica- response was mandated by due pro- ing privileges. tion”), and it is made in connection cess.47 In doing so, the OIG explained with the termination of employment that it was the opportunity to respond In Nawaz v. Price,36 the district or the alteration of some right or sta- that was essential as a matter of Con- court held that the plaintiff physi- tus recognized by law.42 Those require- stitutional right: cians whose billing privileges were ments were met, according to the revoked could not show that they As we stated in the preamble to court. See also Trifax Corp. v. District of held a protected property interest in the proposed regulations, case law Columbia, in which the D.C. Circuit their continued participation in the makes clear that due process does stated that formally debarring an Medicare program, but did so without not require a hearing prior to the entity from bidding on government analysis or without citation of author- imposition of an exclusion from contracts would have unquestionably ity. In another district court case, Medicare or State health care constituted a deprivation of liberty.43 Fayad v. Sebelius,37 the court’s holding programs (see Mathews v. Eldridge, was that a physician who had his In comparison, in Sudderth v. 424 U.S. 319 (1976); [citation Medicare billing privileges revoked Shalala,44 the district court, in reject- omitted]. When an agency exer- was not entitled to a pre-revocation ing an excluded physician’s claim of a cises discretionary authority, due hearing. That in itself is hardly con- protected liberty interest. described process is satisfied so long as the troversial, because, as noted above, a Ninth Circuit precedent as “interest- affected party is given “notice pre-termination hearing or a pre- ing but not persuasive” and noted that and an opportunity to respond revocation hearing would be unusual “[n]o Fifth Circuit authority exists for * * * (t)he opportunity to pres- relief. However, the court also voiced the proposition that physicians have a ent reasons, either in person or its agreement with the Secretary that protectable liberty interest in their in writing, why proposed action after-the-fact appeal rights provide status as participating health care pro- should not be taken” (see Cleveland “adequate protection.”38 The court viders under Medicare.” In Arriva Bd. of Education v. Loudermill, 470 did not address a pre-revocation right Med. LLC v. US HHS,45 Arriva, a sup- U.S. 532, 105 S.Ct. 1487, 1495 to respond that falls short of an evi- plier of diabetic-testing equipment (1985)). This final rule reflects dentiary hearing (perhaps because it was informed by CMS that it was this constitutional principle.48 continued on page 6 5 Volume 31, Number 6, August 2019 The Health Lawyer Unlawful, Unfair and Unwise: Constitutional and Rulemaking Infirmities continued from page 5

Given the Secretary’s apparent Due process and retroactive privileges was in error. Instead the adju- belief that due process requires an revocations dicator will simply look to see if there is opportunity to respond prior to the a regulatory basis for the overpayment, The due process discussion above imposition of a discretionary proposed which in turn simply involves checking has focused on prospective revoca- exclusion, it is inconsistent for the to see that the revocation was one for tions, i.e., the contractor or CMS Secretary to believe that due process which the regulations give retroactive sends a notice stating that the provid- does not require an opportunity to effect. Thus the lack of due process is er’s or supplier’s billing privileges are respond prior to imposing a discre- even more pronounced in the situation revoked, and the revocation becomes tionary revocation of billing privi- of a retroactive revocation. leges based on a felony conviction. A effective 30 days from the date of the 51 As discussed below, the regula- revocation of Medicare billing privi- notice. However, as discussed in tion providing for retroactive termi- leges, which requires Medicaid also to detail below, for certain revocations revoke Medicaid billing privileges,49 is the effective date is retroactive to the nations is susceptible to challenge in the functional equivalent of an exclu- event that served as the basis for the the courts. sion. In either case, the multi-year revocation, and an overpayment is The value of a pre-revocation right prohibition on billing Medicare and assessed with respect to all Medicare to respond Medicaid is the death knell for any services that were furnished and paid provider or supplier that has any sig- with dates of service from the date of An important reason why a pre- nificant degree of Medicare and Med- the precipitating event through the deprivation right to respond is neces- icaid business. date of the notice of revocation. For sary has to do with the emotional example, if the contractor sends a investment by an agency official and It should also be noted that, as a revocation notice on September 1 his or her superiors who will circle the general rule, CMS gives prior notice that a supplier was non-operational as wagons after a final determination has with an opportunity for rebuttal for a of the preceding January 1, it will been made and challenged. If an proposed suspension of payment, revoke billing privileges back to Janu- agency has made a preliminary deter- recoupment of an assessed overpay- ary 1 and create an overpayment for mination that 2 + 2 = 5, and the ment, or offset. The rebuttal allows a the period January 1 – September 1.52 determination is characterized as ten- provider or supplier to submit a state- Like every other revocation, however, tative and preliminary, so that the ment as to why a suspension of pay- revocations that carry retroactive agency can save face if it changes its ment, offset, or recoupment should effect are made with no opportunity mind, there is a better chance of con- not be put into effect, or why a sus- for a pre-revocation right to respond. vincing the agency that the correct pension should be terminated. CMS answer is 4, as opposed to where the or its contractor must, within 15 days Whatever debate there can be as to whether a provider or supplier has a agency has made a final determina- from the date the rebuttal statement tion, without seeking input that the is received, consider the statement protected property interest in the continued participation in the Medi- answer is 5. In addition, the ability to (including any pertinent evidence respond pre-revocation is especially submitted), together with any other care program is beside the point with respect to the recoupment of funds important given the length of the material bearing upon the case, and 53 that were already paid to that pro- administrative appeals process, and determine whether the facts justify the lack of authority for the admini­ the suspension, offset, or recoupment vider or supplier. As noted above, and in recognition of the constitutional strative appeals adjudicators to rule on or, if already initiated, justify the ter- any challenges to regulations.54 The mination of the suspension, offset, or protection that one cannot be length of the appeals process is also recoupment.50 If a provider or supplier deprived of property without due pro- exacerbated by the lack of any expe- has an opportunity to submit a rebut- cess, the regulations do give a pro- dited judicial review process to get tal statement with evidence prior to vider or supplier that has received a challenges to the regulations or con- an overpayment (which could be for a notice of an overpayment the right to stitutional issues in front of a court relatively minor amount) or prior to a submit a rebuttal statement as to why without wasting time and money in temporary suspension of payments, offset or recoupment of the alleged the administrative appeals process.55 why is there not a right for the pro- overpayment should not be put into vider or supplier to a pre-revocation effect; however, this rebuttal state- Also, the length of the adminis- right to respond when it is faced with ment does not afford the provider or trative appeals process is aggravated the loss of all Medicare (and Medic- supplier the opportunity to explain by the ability of the agency to reset aid) income for a period of years? why the revocation of billing the clock. It is not infrequent that a

6 The Health Lawyer Volume 31, Number 6, August 2019 revocation will be issued, the provider fails to provide a person of ordi- violates fair notice requirements to or supplier appeals from it and points nary intelligence fair notice of have such an amorphous standard as out certain errors, and CMS or the what is prohibited, or is so stan- “against the best interests of the contractor will then issue a revised dardless that it authorizes or Medicare program and its benefi­ revocation determination, from encourages seriously discrimina- ciaries” with not even a listing – even which the provider or supplier must tory enforcement.58 a non-exclusive listing – of the factors seek reconsideration. The time for CMS will consider, let alone whether The void for vagueness doctrine issuing a reconsideration determina- any factor will be determinative, and serves important interests: tion on the appeal of the revised how much weight will be given to any revocation determination is not abbre- First, because man is free to steer factor. For example, CMS could let viated based on the fact that the pro- between lawful and unlawful con- providers and suppliers know whether vider or supplier already appealed the duct, laws give the person of ordi- and the extent to which the following original revocation determination.56 nary intelligence a reasonable factors are taken into account: In short, apart from the Constitu- opportunity to know what is pro- whether the conviction resulted in tional infirmities, not giving a pre- hibited, so that he may act imprisonment versus probation; revocation right to respond is poor accordingly. Vague laws may trap whether the provider or supplier had policy. the innocent by not providing any history of fraudulent or abusive fair warning. Second, if arbitrary billing or instead had a clean billing Do the regulations violate and discriminatory enforcement history; whether the conviction due process for not providing is to be prevented, laws must pro- related in any way to the delivery of adequate notice that a provider vide explicit standards for those healthcare; whether and to what or supplier may have its billing who apply them. A vague law extent it matters that the conviction privileges revoked, for not impermissibly delegates basic pol- does or does not involve a financial providing adequate notice of the icy matters to policemen, judges, crime; whether the conviction is reason for why billing privileges and juries for resolution on an ad related in any way to any patient were revoked, and for not hoc and subjective basis, with the abuse or a crime involving financial providing adequate notice as to attendant dangers of arbitrary or other harm to a patient; and 59 the length of the enrollment bar? and discriminatory application. whether the provider or supplier had It is a bedrock principle of due There are two basic problems any previous conviction of a misde- process that statutes and regulations with CMS’s revocation regulations in meanor or felony. It is especially egre- that govern conduct are required to this regard. First, with the exceptions gious not to provide any clue as to give fair, adequate notice or warning of paragraphs (a)(3) (felony convic- what is against the best interest of the of what they command and prohibit.57 tions), (a)(8) (abuse of billing privi- Medicare program and its beneficia- As the Supreme Court stated: leges), and (a)(14) (improper ries where the effective date of the revocation is retroactive and operates A fundamental principle in our prescribing practices) there are no to create an overpayment for neces- legal system is that laws which prescribed standards in section sary services that were furnished regulate persons or entities must 424.535 to guide the discretion of the appropriately and in good faith. give fair notice of conduct that is adjudicator and put the provider or forbidden or required. [A] statute supplier on fair notice that it may Finally, the regulations provide which either forbids or requires have its billing privileges revoked. that the length of reenrollment bar the doing of an act in terms so Congress did not give CMS the chosen in any given case by CMS vague that men of common authority to revoke billing privileges depends on the severity of the basis of intelligence must necessarily through a standardless, unfettered the revocation,61 but the regulations exercise of discretion.60 Second, the guess at its meaning and differ as do not explain how severity is mea- standard for revoking billing privileges to its application, violates the sured, and the written revocation due to a felony conviction (continued first essential of due process of determinations almost never or never participation is “detrimental to the law....This requirement of clarity explain how severity was measured in bests interests of the Medicare pro- in regulation is essential to the the provider’s or supplier’s particular gram and its beneficiaries”) is imper- protections provided by the Due circumstances. Moreover, although missibly vague in the absence of Process Clause of the Fifth the regulations state that the length regulations that put skin on the bones. Amendment. . . . A conviction or of the reenrollment bar is a minimum punishment fails to comply with Whereas CMS may not be able of one and a maximum of three due process if the statute or regu- to publish standards or guidelines that years,62 thereby allowing CMS to lation under which it is obtained operate with absolute precision, it impose an enrollment bar for any continued on page 8 7 Volume 31, Number 6, August 2019 The Health Lawyer Unlawful, Unfair and Unwise: Constitutional and Rulemaking Infirmities continued from page 7 period between one and three years license suspension or revocation, or privileges will be revoked sometime (e.g., 15 months), in practice the the date that CMS or its contractor in the future. In fact, not only will a length of the enrollment bar is always determined that the provider or sup- provider or supplier not know that its one, two or three years (and most plier was no longer operational. This billing privileges will be revoked at often three years). means that the precipitating event for the time of the precipitating event, the revocation (e.g., a felony convic- but, as discussed above, it will have tion) may happen months or years either no standards, or at most amor- Rulemaking Issues prior to the notice of the revocation, phous standards, in the regulations Are the regulations arbitrary yet the revocation will be effective that it can look to for taking an edu- and capricious by not providing back to the date of the precipitating cated guess as to whether its billing a pre-revocation right to respond event. Worse, a provider or supplier privileges will be revoked. may have its billing privileges revoked to a proposed revocation? Therefore, as noted at the outset because it has employed someone, or One does not know to what has as one of its owners someone who of this article, a physician or other extent, if at all, the Secretary believes has been excluded or has had a felony supplier or provider could rack up an that due process does not require a conviction,63 and if it does have its overpayment of hundreds of thou- pre-revocation right to respond billing privileges revoked, the revoca- sands of dollars (or more) for reason- because there is virtually no discussion tion will be retroactive to the date of able and necessary and otherwise of due process and a pre-revocation the exclusion or felony conviction.64 proper services that were furnished right to respond in the enrollment between the time of the precipitating Because the practical effect of rulemakings. Nor is there any discus- event and the notice of revocation. having one’s billing privileges revoked sion as to why, as a policy matter, pro- There does not appear to be any legit- is that one cannot be paid by Medi- viding a pre-revocation right to imate purpose for this policy, but care for services furnished during the respond would or would not be advan- rather its design (or at the very least period of revocation (unless the revo- tageous when weighing the risk of its effect) is to coerce providers and cation is reversed on appeal), that erroneous deprivation (with its atten- suppliers into leaving the Medicare means that months or years after the dant costs of appeal and other finan- program following the precipitating precipitating event the provider or cial and non-financial costs) versus event to avoid a potentially crushing supplier may receive notice that its whatever costs would be incurred by overpayment or, if the provider or billing privileges are revoked retroac- providing a right to respond. Thus, in supplier does not leave the program tive to the date of the precipitating terms of rulemaking procedures, there and continues to furnish covered ser- event, and that it must repay a huge vices after the precipitating event and was no proposal to require or not overpayment. This result could make require a right to respond before a bill Medicare for them, to effectuate a sense if both of the following are true: windfall for CMS. revocation becomes final. As far as (1) revocations are made retroactive one can tell, the issue was simply not only to the date of the provider’s or The retroactive revocation provi- considered. supplier’s required reporting to CMS sion of section 424.535(g) was final- Are the regulations procedurally of the precipitating event; (2) revoca- ized in the Calendar Year (“CY”) and/or substantively deficient tions for the above precipitating 2009 Physician Fee Schedule (“PFS”) 65 by providing that the effective events are mandatory. But both (1) final rule. The CY 2009 PFS pro- posed rule proposed regulations text date of some revocations is and (2) are not true, and in fact nei- (in section 424.535(f)) that tracks retroactive to the date of the ther (1) nor (2) is true. Retroactive the current language in section adverse action that formed the revocations are made irrespective of 424.535(g), but the preamble discus- basis for the revocation? whether the provider or supplier timely has given notice of the precipi- sion arguably did not put physicians Section 424.535(g) provides that tating event (and are not retroactive and other practitioners on adequate where the revocation is based on a fel- only to the date of the notice of the notice that CMS could finalize a rule ony conviction, license suspension or precipitating event). And of course, whereby every revocation based on an revocation, or the practice location is all revocations are (or at least they are adverse action would be made retro­ determined by CMS or its contractor supposed to be) discretionary and not active to the date of such action and not to be operational, the revocation mandated, so a provider or supplier an overpayment created for services is effective with the date of exclusion will not know at the time of the pre- furnished from that date – regardless or debarment, felony conviction, cipitating event that its billing of whether the action was reported

8 The Health Lawyer Volume 31, Number 6, August 2019 timely. Moreover, what little preamble designated contractor becomes Accordingly, we believe that fail- discussion there was concerning the aware of the conviction or ing to report changes in practice proposed regulations text seems to adverse legal action after the fact, location would result in an over- have proceeded from a non-sequitur, we lack the regulatory authority payment for the difference in namely, that CMS’ concern that pro- to collect overpayments for the payment rates retroactive to the viders and suppliers were not incen- period in which the physician date the change in practice loca- tivized to report adverse actions and NPP organizations and indi- tion occurred and may result in timely needed to be addressed through vidual practitioners should have the revocation of Medicare bill- retroactive revocations. had their billing privileges ing privileges. . . .We believe that 66 The preamble discussion in the revoked. reporting these types of changes is essential for making correct CY 2009 PFS proposed rule focuses From this premise, CMS pro- and appropriate payments. on the need to report adverse events posed to require all physician and timely, and used the threat of revoca- non-physician practitioner entities to Since it is essential that physician tion as a means of incentivizing pro- notify their designated enrollment and NPP organizations and indi- viders and suppliers to report those contractor of any adverse legal action vidual practitioners notify their events timely. This is very different within 30 days, and proposed that designated contractor of these from proposing to make retroactive failure to do so could result in the types of reportable events in a revocations simply due to the adverse revocation of Medicare billing privi- timely manner and to ensure that events and irrespective of whether leges and a Medicare overpayment the provider or supplier continues the adverse events are reported from the date of the reportable change: to be eligible for payment, we timely. Under the heading “Reporting believe that it is essential that we We believe that it is essential that Requirements for Providers and establish an overpayment from this type of change be reported in Suppliers (proposed § 424.516 and the time of the reportable event. a timely manner (that is within § 424.535(a)(10))” the proposed rule We believe that establishing an 30 days). For example, if CMS or posited that, while physicians and overpayment and revocation of our designated contractor deter- other practitioners were required to billing privileges for noncompli- mines in February 2008 that a report changes in their enrollment ance from the time of the report- physician failed to notify Medi- profile within 90 days of the report- able event would provide the care about an adverse legal action able event, in many cases there was supplier with a compelling incen- that occurred on June 30, 2007, little or no incentive for them to tive to report reportable changes that physician may be subject to report a change that could adversely in the 30-day reporting period. affect their ability to continue to an overpayment for all Medicare receive Medicare payments: payments beginning June 30, In addition, if CMS or our desig- 2007 and have its Medicare bill- nated contractor determines that For example, physician and NPP ing privileges revoked effective a physician and NPP organization [non-physician practitioner] orga- retroactively back to June 30, or an individual practitioner has nizations and individual practitio- 2007 as well. moved and has not reported the ners purposely may fail to report a reportable event within the 30-day Additionally, we are proposing to felony conviction or other adverse reporting period, CMS or our des- add a requirement for change in legal action, such as a revocation ignated contractor would impose location at § 424.516(d)(1)(iii). or suspension of a license to a pro- an overpayment, if applicable, vider of health care by any State Since a change in location may and revoke billing privileges for a licensing authority, or a revoca- impact the amount of payment period of not less than one year.67 tion or suspension of accredita- for services rendered by placing tion, because reporting this action the physician and NPP organiza- To make matters worse in terms may result in the revocation of tions and individual practitioners of not putting the public on notice their Medicare billing privileges. into a new [Core-Based Statisti- that revocations due to adverse Thus, unless CMS or our desig- cal Area]. We believe that it is actions would be made retroactive nated contractor becomes aware essential that physician and NPP and why, the proposed rule’s discus- of the conviction or adverse legal organizations and individual prac- sion under the heading “Revocation action through other means, the titioners report changes in prac- of Enrollment and Billing Privileges change may never be reported by tice location including those that in the Medicare Program (proposed a physician and NPP organization impact the amount of payments § 424.535(g)),” pertained only to a or individual practitioner. Alter- they receive within a timely proposal to limit the claims submis- natively, if CMS or our period (that is, 30 days). . . . sion timeframe after revocation: continued on page 10 9 Volume 31, Number 6, August 2019 The Health Lawyer Unlawful, Unfair and Unwise: Constitutional and Rulemaking Infirmities continued from page 9

In § 424.535(g), we are proposing preamble then states that in order to not explaining the basis for the that revoked physician and NPP ensure consistency, section 424.535(f) revocation determination? organizations and individual prac- would be revised to contain the same It is axiomatic that an agency titioners, including physicians language quoted above.70 adjudication must contain an ade- and NPPs, must submit all out- The lack of any real proposal to quate explanation for the action standing claims not previously make revocations retroactive to the taken in order to survive an arbitrary submitted within 30 calendar days date of an adverse event irrespective and capricious challenge, yet CMS of the revocation effective date.68 of whether the provider or supplier requires very little from its contrac- Again, there is no language to reports the adverse event timely tors with respect to their revocation put interested parties on notice that makes the regulation susceptible to letters. For potential revocations due CMS might finalize a rule providing challenge as procedurally deficient. to a pattern or practice of submitting that every revocation based on an incorrect claims, the regulations con- The regulation is also susceptible adverse action would be given retro- tain a list of weighting factors that to challenge as being substantively active effect and an overpayment cre- guide the determination of whether to invalid (arbitrary and capricious) for 73 ated for services furnished from that revoke. Despite the regulations text lack of any cogent explanation for date, irrespective of whether the action that says that CMS shall consider these the policy. was reported timely. It is noteworthy weighting factors when making the that although CMS received many In the CY 2009 PFS final rule, determination of whether to revoke, comments on the enrollment provi- CMS finalized the draft language for and provides a list of factors CMS con- sions in the proposed rule, apparently section 424.535(f) and moved it to siders when making the determination just about no one commented on the 424.535(g). The final rule’s discussion that a provider or supplier has a pattern retroactive revocation provision as of the change is devoid of any real or practice of submitting incorrect the final rule lists only one comment explanation. Twice it states that the claims, the revocation notices do not (to which CMS gave a non-respon- rule change was intended to “ensure explain how each of these factors sive response).69 that Medicare is not making or con- entered into the revocation determina- tinuing to make payments to provid- tion, or even state whether they were Instead, the only mention in the 74 ers and suppliers who are no longer in fact considered – this, despite preamble of a proposal to make revo- eligible to receive payments.”71 This is CMS’s assurance that it “cannot be cations based on an adverse action a non-sequitur. Subject to limited stressed enough” that an (a)(8)(ii) appears in a section of the proposed exceptions, unless and until their bill- revocation will be made “only after rule dealing with appeals of revoca- ing privileges are revoked, providers the most careful and thorough consid- tions. There is no rationale set forth 75 and suppliers are eligible to receive eration of the relevant factors.” there for extending the retroactive Medicare payments following a felony effect of revocations beyond situa- Does imposing gaps in billing conviction, or license or suspension or tions in which the adverse action is privileges upon a reactivation revocation, or following a determina- not reported timely to CMS; rather, of a deactivated number violate tion of not operational.72 The only there is merely the statement that rulemaking authorities? logical explanations that come to section 405.874(b)(2) (pertaining to mind for the language “who are no CMS established the concept of appeals) would be revised to state longer eligible to receive payments” deactivations in a 2006 final rule ­“[w]hen a revocation is based on an 76 are that the drafter (and the agency devoted solely to enrollment issues. exclusion or debarment, Federal reviewers) (1) did not understand that The 2006 final rule does not indicate exclusion or debarment, felony con- adverse actions (with the exception of that there would be a gap in billing viction, license suspension or revoca- exclusions) do not by themselves pre- privileges. Indeed, the preambles to tion, or the practice location is vent payment by Medicare, or (2) did that rule and various others contain determined by CMS or its contractor statements that indicate that upon not understand that all revocations not to be operational, the revocation reactivation, a preceding deactivation are supposed to be discretionary. A is effective with the date of exclusion would have no adverse effect on the third, more cynical explanation is that or debarment, felony conviction, provider or supplier.77 The 2006 final the purported discretionary nature of license suspension or revocation or rule defined “deactivate” as “mean[ing] at least some revocations is a sham. the date that CMS or its contractor that the provider or supplier’s billing determined that the provider or sup- Are revocations habitually privileges were stopped, but can be plier was no longer operational.” The arbitrary and capricious for restored upon the submission of

10 The Health Lawyer Volume 31, Number 6, August 2019 updated information,” and that same CMS defends its reinterpretation Is the potential to submit a definition continues to appear in the on the basis of the language in section corrective action plan (“CAP”) regulations.78 The plain, dictionary 424.520(d) of the regulations, which unduly restricted? meaning of “restored” means that was added by a 2008 final rule,83 and CMS allows CAPs (a/k/a plans of something is put back as it formerly which states that the effective date for correction) only if the revocation was was.79 As applied here, the definition billing privileges for physicians and cer- pursuant to section 424.535(a)(1) of “deactivate” in the regulations tain other suppliers is the later of the (noncompliance with enrollment means there is no gap in billing privi- date of filing of a Medicare enrollment requirements). CMS’s explanation in leges. It is precisely because a deacti- application that was subsequently the December 2014 final rule as to vation does not have an adverse approved by a Medicare contractor, or why it has restricted CAPs to only effect under the regulations that there the date that the supplier first began (a)(1) revocations, i.e., because the is no regulatory right to appeal the furnishing services at a new practice other grounds can be more serious, is deactivation itself. Moreover, when location. However, this language was unpersuasive at best.90 There does not one considers that originally revoca- added following CMS’s proposal to seem to be a good reason for not eval- tions did not result in a reenrollment develop an effective date for initial uating whether to accept a CAP on a bar, but rather imposed a gap period enrollment applications – not applica- case by case basis, as there can be between the time of revocation and tions following a deactivation.84 The extenuating circumstances regardless the effective date of a new applica- final rule does not indicate that section of the grounds for revocation, and if tion, there would have been no need 424.520(d) was intended to have any the purpose of revoking one’s billing for CMS to come up with the concept effect on the effective date of billing privileges is to protect the program of a deactivation if there was no dif- privileges following a deactivation/reac- and its beneficiaries, instead of doling ference between a deactivation and a tivation, and in fact deactivations are out punishment even for mistakes, it revocation. For these reasons, not sur- not mentioned once in the 2008 final seems CMS should consider whether prisingly, manual instructions issued rule, or in the proposed rule that pre- a provider or supplier can provide rea- following the 2006 final rule made ceded it.85 sonable assurances that it will be in clear that a deactivation followed by CMS also defends its position on full compliance with all requirements a reactivation did not result in a gap the basis of section 424.555(b), but this going forward. Although the CAP in billing privileges.80 regulation simply provides that pay- process is modeled on that in Part Notwithstanding the above, how- ment cannot be made to a provider or 488 of the regulations (“Survey, Cer- ever, CMS changed its manual supplier while the revocation or deactiva- tification and Enforcement Proce- instructions – without changing its tion is in effect.86 It does not say, and it dures”), the availability of CAPs for regulations – to provide for a gap in would make no sense for it to say, that the termination of provider agree- billing privileges. CMS directs its if the revocation is reversed or the ments for nursing homes and other contractors to impose a “gap in cover- deactivation is followed by a reactiva- providers is not restricted to certain age (between the deactivation and tion the provider or supplier cannot grounds for terminations. Indeed, the reactivation of billing privileges)” and now be paid for items or services that regulations provide that CAPs are to deny claims with dates of services were furnished during the period of available even in immediate jeopardy falling within the gap period.81 The revocation or deactivation. By CMS’s situations.91 In fact, the approach in regulations have not been changed rationale, the revocation appeals pro- the survey and certification process and continue to define “deactivate” as cess would be a farce – a provider or for providers and suppliers is to termi- noted above, and continue to deny supplier that successfully appealed a nate the provider or supplier agree- appeal rights for deactivations. There- revocation (and the time to finish the ment only as a last resort – after fore, if a provider or supplier contends appeal could take longer than the giving the provider or supplier an that it did not receive the request for reenrollment bar) would be left with opportunity to submit a CAP. This is revalidation it will not be able to no ability to bill for services it fur- in stark contrast to the revocation appeal the deactivation, although it is nished on dates that were covered by process, which seems to be designed given a right to submit a rebuttal. Note the revocation period.87 Although one or at least implemented for the pur- that the requests for revalidations are ALJ has consistently found that CMS’s pose of revoking billing privileges as not sent by certified mail or other reinterpretation is invalid because it is the first and only resort. This might means that evidences actual receipt. contrary to the plain meaning of the be excused if the period of revocation In other situations, CMS will send regulations,88 the Department Appeals was exceedingly brief, but it is not. As notice of a pending sanction through Board (“DAB”) has repeated CMS’s noted above, revocations are for a mechanism that tracks actual flawed arguments based on sections either one, two or three years (and receipt, not merely presumed receipt.82 424.520(d) and 424.555(b).89 nothing in between), and it seems continued on page 12 11 Volume 31, Number 6, August 2019 The Health Lawyer Unlawful, Unfair and Unwise: Constitutional and Rulemaking Infirmities continued from page 11 that the great majority are for three that, on the one hand, appellants appeals process contains an EJR pro- years. Moreover, some revocations are must complete the process before cess (mandated by statute) by which applied retroactively so as to create going to court, but on the other hand, the PRRB can grant EJR on the basis an overpayment for services that were the appellate adjudicators are without that the provider has alleged that the furnished during the period prior to authority to declare a regulation only factor preventing it relief is a the revocation notice. In contrast, a invalid. Moreover, CMS takes the statute that it considers unconsti­ provider or supplier that has had its position that, although one can tutional or a regulation or a CMS agreement terminated can come back appeal the revocation itself, one can- Ruling that the provider believes is into the Medicare program as soon as not appeal the length of the revoca- invalid.99 it is surveyed and meets all federal tion.93 This is particularly unfair The reason for requiring exhaus- requirements. Admittedly, a survey because, unlike the situation with tion of administrative appeal rights – can take several months, but that is a challenges to regulations whereby that the agency should be given a far cry from three years. CMS cannot give appellate adjudica- tors the authority to depart from chance to correct its own errors – The stingy approach to CAPs in them, there is no reason why CMS simply does not pertain where the the revocation process encapsulates cannot extend appeal rights to deter- appeals adjudicators lack the authority the lack of fairness that is pervasive minations as to the length of the reen- to grant relief. Of course, there will be throughout the revocation regula- rollment bar,94 and no reason why cases where the provider or supplier tions. Take for example the case of a providers and suppliers should not be has arguments that the appeals adjudi- physician who moved from a foreign able to argue that the contractor cators can rule on as well as those for country to set up practice in the abused its discretion in setting the which the appeals adjudicators cannot, United States, and specifically to see length of the reenrollment bar.95 The and in those cases, if the provider or homebound patients in their homes regulations provide that the length supplier wishes to raise both types of and in assisted living facilities. Know- of the reenrollment bar depends on arguments on appeal, it would be ing that she was unfamiliar with the the severity of the basis for the appropriate for CMS to preclude Medicare enrollment system, the phy- 100 revocation,96 but it seems that the great EJR. However, where the only issues sician engaged a consultant to assist majority of the revocations are for a the provider or supplier wish to bring her in her enrollment. The consultant period of three years, and the revoca- on appeal are ones that can be decided may have given her inaccurate advice, tion determinations rarely if ever pro- only by the courts, there is no reason and in any event, she did not list all of vide any explanation as to why one to put appellants through the waste of the addresses where she saw patients, period was chosen over another. time and expense of going through an and one address listed was where she appeals process that will not offer received correspondence and not The problem with the narrowness relief. Indeed, with no income from where she saw patients. One would of the adjudicators’ review authority is Medicare, and perhaps Medicaid as think that given these facts, CMS exacerbated by the length of time it well, the provider or supplier may be would view this as a foot fault by takes to complete the appeals process out of business before it can complete someone who was new to the country, for revocations, coupled with the lack the process.101 who was providing a valuable service of an expedited judicial review (“EJR”) by seeing homebound patients, and process. In contrast, the multi-level In addition to the problem of tried to do the right thing by hiring a coverage/claims appeals process has an ALJs and the DAB not having the supposed expert, but no. The physi- EJR process, through which the claim- authority to declare regulations cian attempted to submit a CAP, but ant can request EJR at the ALJ or the invalid is the reluctance of the ALJs CMS refused to consider it and DAB and proceed directly to court.97 and the DAB to exercise the author- revoked her billing privileges for two The request must assert that the only ity that they do have, as discussed years.92 factor precluding a decision favorable immediately below. to the requestor is a statutory provision Is the appeals process unduly Contractors are not permitted to that is unconstitutional, or a provision cumbersome and restrictive? make revocation determinations, of a regulation, national coverage but they do so anyway and CMS The Part 498 appeals process (so- determination, or CMS Ruling (all of does not seem to care called because it appears in Part 498 which are binding on the ALJ and the of 42 C.F.R.) is the means for appeal- DAB) that the requester considers Section 424.535(a) states “CMS ing revocations. The fundamental invalid.98 Likewise, the Provider Reim- may revoke a currently enrolled pro- problem with the appeals process is bursement Review Board (“PRRB”) vider or supplier’s Medicare billing

12 The Health Lawyer Volume 31, Number 6, August 2019 privileges and any corresponding pro- say, when challenged on the ground determining, medical necessity. vider agreement or supplier agree- that it failed to follow its regulation, Unless a lab knows, or has reason to ment for the following reasons.” Thus that it could have written the regula- know, that a physician is ordering the plain language of the regulations tion differently. Yet, the ALJ in Saeed services that are not medically neces- states that it is CMS and not the con- A. Bajwa106 permitted CMS to ignore sary (which will typically not be the tractor that makes all revocation its regulation, saying: “Although 42 case), there is no good reason for determinations. Moreover, there are C.F.R. § 424.535(a)(3)(i) states that holding the lab accountable for other places in section 424.535 that CMS determines whether or not a (alleged) mistakes by the ordering state that CMS will make the revoca- felony conviction is detrimental, Peti- physician. How is the Medicare pro- tion determination.102 Nowhere in tioner cites to no authority and I am gram served by revoking the billing section 424.535 does it state that con- aware of none that suggests that the privileges of labs that are not culpa- tractors are permitted to make any Secretary and CMS cannot delegate ble in causing incorrect claims to be revocation determination. In explain- that determination to a contractor filed? Ironically, because section ing why CMS and not its contractors pursuant to section 1842(a) of the 424.535(a)(8)(ii) applies only to the makes the determination that a pro- Act.”107 By that reasoning, an ALJ submitter of the claims, the physician vider or supplier should have its bill- could hold that a supplier’s billing who allegedly made incorrect deter- ing privileges revoked because of a privileges were properly revoked for minations of medical necessity is not pattern or practice of submitting failing to notify the contractor within subject to having his or her billing incorrect claims, CMS stated repeat- 20 days of an adverse action on the privileges revoked but the lab who edly that it, and not its contractors, basis that “although 42 C.F.R. submitted the claims is at risk. More- would make that determination.103 § 424.516(d) states that an adverse over, CMS does not necessarily wait action must be reported within 30 until medical necessity denials have Notwithstanding the plain lan- days, Petitioner cites to no authority been adjudicated through the cover- guage of the regulations, however, and I am aware of none that suggests age appeals process, which is separate CMS routinely permits its contractors that the Secretary and CMS could from the enrollment appeals pro- to make the revocation determina- not have required the reporting be cess110 (or even until they have adju- tion. In Fayad v. Sebelius104 the court done within 20 days.” dicated through a certain level in the held that the Social Security Act gives coverage appeals process). This the Secretary authority to delegate When a revocation is challenged means that a physician practice or functions to contractors, including the on the basis that it was made by a lab may have its billing privileges responsibility to make revocation contractor and not CMS, CMS will revoked for up to three years on the determinations. However, from the argue that it actually made the revo- basis of what turns out to be errone- opinion’s description of the facts, cation and not the contractor, despite ous medical necessity denials. apparently the plaintiff did not argue the fact that the revocation is issued that the plain language of the regula- on the contractor’s letterhead, and all Because the coverage appeals tions requires CMS to make the revo- indications are that the determina- process is notoriously slow, so much cation determination, and the court tion was written by the contractor. so that its systematic delays are the did not focus on such language. If the The Medicare Program Integrity subject of high-profile litigation in plain language does reserve to CMS Manual, contrary to the regulations, the D.C. Circuit,111 it is quite possible the power to make revocation deter- is explicit that contractors may make that even a three-year revocation of minations, it does not matter that the revocation determination and billing privileges imposed for alleged there is statutory authority to delegate issue the revocations,108 but does state incorrect claims will expire before that function to contractors. It is a that, for most revocations, the con- the lab or other provider or supplier bedrock principle of administrative tractor must get prior approval from will receive an ALJ hearing on its law that agencies are required to fol- CMS.109 appeal of the medical necessity deni- low their own regulations.105 It does als. But can a lab (or other supplier Is it unfair to revoke the billing not matter what a regulation could or provider) appeal the revocation privileges of labs based on the conduct have said, it matters what it does say. and raise the issue of medical neces- of others and can the underlying basis Indeed, in a case where the agency is sity in its revocation appeal? The for the revocation be challenged in the reversed for not following its own reg- answer would be no, if, consistent appeal of the revocation? ulation it is understood that the with their general approach as agency had statutory authority to do Revoking billing privileges of described above, the appellate adju- what it did – if it did not it would labs for a pattern of incorrect claims dicators will simply look to see if have been reversed on that ground. It is particularly unfair because labs do CMS or the contractor determined is simply no defense for an agency to not determine, and are incapable of that there was a pattern or practice continued on page 14 13 Volume 31, Number 6, August 2019 The Health Lawyer Unlawful, Unfair and Unwise: Constitutional and Rulemaking Infirmities continued from page 13 of submitting incorrect claims and ALJ in an exclusion case is only on to a federal court. This is not to say, disclaim any authority to look behind reviewing the OIG’s choice to however, that a provider or supplier that determination and determine exclude – as opposed to imposing must necessarily wait until it has whether the claims were in fact some other penalty once the OIG has exhausted administrative remedies incorrect. established there is basis upon which to before raising such a challenge. Whereas exclude.115 In contrast, in order to one usually must wait until one has The content of the revocation establish the basis for revoking billing exhausted administrative remedies, determinations is woefully inadequate privileges due to a felony conviction this is not always the case. As noted above, the majority of CMS, or the contractor that (arguably The Medicare Statute (title the regulatory bases for revocation do illegally) makes the revocation deter- XVIII of the Social Security Act (the not contain any standards by which mination, must determine that the “Act”)) requires litigants to exhaust to guide the adjudicator. For the few provider’s or supplier’s continued par- administrative remedies before seek- bases that do contain such standards, ticipation in the Medicare program is the revocation determinations are contrary to the best interests of the ing judicial relief on the merits of any claim “arising under” the Medicare usually silent as to whether the stan- program and its beneficiaries. It is not 119 dards were applied or how they were as though the regulations provide that Statute. Courts have taken an applied. When a revoked supplier any felony conviction is per se a basis expansive view as to whether a claim challenges the exercise of discretion for some type of adverse enrollment “arises under” the Medicare statute. on appeal, it is told by the ALJ and action including revocation and the But Supreme Court decisions on this the DAB that they do not have the petitioner on appeal is complaining provision of law have made two points authority to overturn the exercise of about the exercise of discretion to equally clear. The first is that, where a discretion. There is nothing in the revoke versus some lesser penalty. The party seeks substantive relief from regulations that prevents the review ALJ in Barnett also cited a nursing denial of a claim (e.g., attempting to of CMS’s or the contractor’s exercise home termination case,116 which is have a denial of benefits overturned) of discretion. And if there were, that off-point for the same reason as the it must first exhaust administrative would be one more example of unfair- exclusion case, namely that a skilled remedies. The second point provides ness. A provider or supplier that has nursing facility cannot appeal the an important qualification to this had its billing privileges revoked choice to terminate its provider agree- exhaustion requirement: If a party has should be entitled to know that the ment instead of impose some lesser presented a claim to the Secretary adjudicator actually considered the penalty once CMS has established (thereby satisfying the jurisdictional 120 regulatory criteria and how it applied that grounds for termination exist.117 “presentment requirement”), it may those criteria. proceed to federal court without exhausting administrative remedies if A typical example is Dr. Randy Raising Constitutional and the claim it asserts in court is collat- Barnett, in which the ALJ stated he Statutory Challenges to the eral to a claim for benefits or if had “no authority to review CMS’s Revocation Regulations exhaustion would be futile.121 exercise of discretion where discre- tion is explicitly granted to CMS by Seeking a waiver of exhaustion of In Shalala v. Illinois Council on regulation.”112 As citation for the administrative remedies to procure Long Term Care, Inc.,122 the Court proposition that he had no authority a temporary restraining order rejected the plaintiff’s assertion that, to review CMS’s exercise of discretion or preliminary injunction (and under the facts of that case, it was to revoke, however, the ALJ cited an maybe a decision on the merits) entitled to proceed in federal court exclusion case,113 which is not on without exhausting administrative Although, as described above, 123 point for two reasons. First, the OIG’s remedies. But the Court did not there is a multi-step, adversarial admin- regulations specifically prohibit an purport to – and did not – do away istrative appeals process for challenging ALJ from disturbing the OIG’s exer- with the principle set forth in Eldridge revocations, constitutional and rule- cise of discretion to exclude;114 in and the other cases that a plaintiff making issues cannot be raised during contrast, there is no regulatory prohi- may obtain judicial review of a claim that process.118 bition on an ALJ or the DAB in that is collateral to a claim for bene- reviewing the exercise of CMS’s dis- Therefore, an argument that the fits without having first exhausted cretion to revoke billing privileges. revocation regulations violate due administrative remedies. Several deci- Second, and much more importantly, process or are procedurally or substan- sions have rejected the notion that the regulatory prohibition on an tively invalid can be presented only Illinois Council implicitly overruled

14 The Health Lawyer Volume 31, Number 6, August 2019 Salfi, Eldridge and their progeny; Heckler,128 in which a physician addressed the merits of the AHA’s claim rather, these cases make clear that the alleged a deprivation of procedural that the rule was ultra vires. That is, the law remains that a court may excuse a due process after his Medicare billing court did not require the AHA to have plaintiff’s failure to exhaust the Sec- privileges were revoked without bene- made a collateral claim for procedural retary’s administrative review process fit of a pre-deprivation hearing. The relief, and did not award only proce- if (1) the claim is collateral to a Fourth Circuit held that the “entirely dural relief. If the court’s decision demand for benefits, or (2) exhaus- collateral” exception gave the district stands on appeal, it might pave the tion would be futile, or (3) irreparable court jurisdiction over plaintiff’s way for providers and suppliers to harm would occur if exhaustion were claim. In AAA Pharm., Inc. v. United challenge the enrollment regulations required.124 A typical post-Illinois States,129 a pharmacy that alleged it as procedurally or substantively Council decision is Niskayuna Operat- was driven out of business by an erro- invalid without first exhausting ing Co., LLC v. Sebelius.125 There the neous revocation of its billing privi- administrative remedies and without court found that it had jurisdiction to leges sued the government for money even the need to present a collateral hear the plaintiff nursing facility’s damages. The court denied the gov- claim (provided that other courts motion for injunctive relief because: ernment’s motion to dismiss, finding would be persuaded by the D.C. courts). (1) Plaintiff is not directly chal- that its claim for damages was collat- lenging the decision by the Sec- eral to a claim for benefits, and there- Does CMS lack statutory fore the plaintiff was not required to retary to terminate Plaintiff’s authority to make most exhaust administrative remedies. provider agreements, but is revocations? merely seeking a stay pending an Interestingly, the government did not What might be fairly described as administrative appeal of the ter- contest the plaintiff’s allegation that it had a protected property right. a Hail Mary play, a revoked provider mination decision (i.e., Plaintiff’s or supplier could challenge the revo- claims in this Court are entirely If one is successful in convincing cation as being contrary to statutory collateral to the claim that it is a court to waive exhaustion, the stan- authority. Sections 1102(a) and pursuing before the Administra- dard for granting a temporary restrain- 1871(a) (1395hh) give the Secretary tive Law Judge of the United ing order (“TRO”) or preliminary broad regulatory authority over the States Department of Health and injunction (“PI”) is generally the same administration of the Medicare pro- Human Services, Departmental throughout the country. One must gram.132 However, the authority to Appeals Board (“DAB”), and the show irreparable harm, a likelihood of issue monetary sanctions (which is a Secretary), (2) exhaustion would success on the merits and that the fair description for at least some retro- be futile because, by the time a public interest weighs in favor of active revocations) is generally pro- DAB hearing is set and all appeals granting the TRO or PI. In the Sec- vided by statute to administrative have been exhausted such that ond Circuit, a colorable constitutional agencies. Also, the statute provides Plaintiff could return to this violation is per se irreparable harm.130 very little explicit authority for revo- Court to have it review the pro- In a jurisdiction where that is not the cations. In comparison to the multi- priety of the administrative deter- law, one must show irreparable harm tude of grounds for revocation in the mination, Plaintiff will almost through financial harm. If successful, regulations, section 1866 of the Act certainly be out of business, and the plaintiff usually is awarded only authorizes (but does not require) the (3) Plaintiff has shown that it will procedural relief. For example, the Secretary to revoke a provider of ser- effectively have no judicial review agency enforcement action would be vices’ billing privileges if it has been before irreparable harm ensues.126 stayed while the plaintiff has the excluded from participation in federal opportunity to present its arguments In Native Angels Home Health Inc. healthcare programs, or if the Secre- as to why the enforcement action v. Burwell,127 the plaintiff home tary has determined that the provider should not be taken. health agency had its Medicare bill- has been convicted of a felony under ing privileges revoked and was pro- In the recent decision of AHA v. federal or state law for an offense that vided no due process prior to the Azar,131 however, the district court the Secretary determines is detrimen- revocation. The plaintiff alleged that waived exhaustion and took jurisdic- tal to the best interests of the program it was entitled to a pre-deprivation tion over the American Hospital Asso- or program beneficiaries.133 Likewise, hearing and the court found that the ciation’s (“AHA’s”) challenge to CMS’s section 1842 authorizes (but does not plaintiff satisfied the collateral claim 340B discount drug program payment require) the Secretary to revoke a exception to the general rule that rule, solely on the basis that the chal- supplier’s billing privileges if it has exhaustion is required. In so doing, lenge to the regulation would have been convicted of a felony under fed- the court followed the earlier decision been futile if it were pursued through eral or state law for an offense which of the Fourth Circuit in Ram v. the administrative appeals process, and the Secretary determines is continued on page 16 15 Volume 31, Number 6, August 2019 The Health Lawyer Unlawful, Unfair and Unwise: Constitutional and Rulemaking Infirmities continued from page 15 detrimental to the best interests of unduly harsh penalties that are being payment may be made under such a program. See section 1128A(a)(6) of the Social Secu- the program or program beneficiaries, imposed on a regular basis, and with- rity Act, 42 U.S.C. § 1320a-7a(a)(6). The or if it fails to maintain and, upon out even a fair process. OIG maintains the LEIE to assist entities to request of the Secretary, provide avoid hiring excluded individuals and entities. The LEIE may be accessed at https://oig.hhs. access to documentation relating to gov/exclusions/exclusions_list.asp. written orders or requests for payment The author extends his gratitude to Donna 3 See 42 C.F.R. § 424.535(a)(2)(i). for durable medical equipment, certi- Senft for her careful, expert review of a 4 See 42 C.F.R. § 424.535(e). fications for home health services, or draft and her helpful suggestions. 5 408 U.S. 464 (1972). referrals for other items or services 6 408 U.S. at 577. written or ordered by such supplier.134 7 Neither section 1866 nor 1842 adds Donald H. Romano Id. “and such other grounds as the Secre- is Of Counsel to 8 The author does not contend that a provider or a supplier has the constitutional right to a tary may determine through regula- Foley & Lardner LLP, full-blown hearing pre-revocation – indeed, the tions” or words to that effect. One in the firm’s are several cases that have held that a provider Washington D.C. that has had its provider agreement termi- wonders why, if the Secretary has nated (which is not the same thing as having inherent authority to revoke billing office. He counsels its billing privileges revoked) does not have clients on regulatory the pre-termination right to a hearing. Provider privileges Congress would have both- agreement termination cases typically do not ered to specify any grounds in the compliance matters, particularly those deal with a pre-termination right to respond, statute for revocation. Moreover, this pertaining to the Anti-Kickback Statute, because (in contrast to billing revocations) the the physician self-referral statute (the regulations give the provider the right to statutory scheme is in great contrast respond prior to the termination of its provider to the provisions in sections 1128 Stark Law), HIPAA, and the Medicare agreement. See 42 C.F.R. § 489.53(d). enrollment regulations. He also advises (the Exclusion Statute) and 1128A 9 523 F.2d 602, 606 (2d Cir. 1975). hospitals and other providers and suppli- (the Civil Monetary Penalty Statute) 10 797 F.2d 1137 (2d Cir. 1986), cert. denied 479 ers on Medicare reimbursement issues. of the Act, which sets forth a detailed U.S. 1030 (1987). Prior to joining Foley & Lardner LLP, and comprehensive scheme for the 11 797 F.2d at 1144-45. Mr. Romano was a partner in another Secretary to make mandatory and 12 878 F.2d 577 (2d Cir. 1989). D.C.-based law firm, and prior to that he permissive (a/k/a discretionary) exclu- 13 had over 25 years of experience in the Id. at 582. See also Green v. Cashman, 605 F.2d sions. Thus, it can be argued that by 945 (6th Cir. 1979). In that case, the court Department of Health and Services, also pointed to the discretion of the granting specifying the grounds in the statute including as a senior attorney in the authority to terminate participation, stating, “[w]hatever rights plaintiff-appellee has for revocation Congress meant that Office of General Counsel, and as a those would be the exclusive grounds. appear to us to arise exclusively from a con- Division Director in the Centers for tract called a ‘Provider’ agreement…The Medicare & Medicaid Services. In that agreement between plaintiff-appellee and the State of Ohio is terminable at will on the part Conclusion latter position, he was responsible for, of either party.” 605 F.2d at 946. among other things, Stark policy, 14 Id. at 581 (citations omitted). The revocation process has seri- Provider Reimbursement Review Board 15 936 F.2d 687, 690 (2d Cir. 1991). See also Arzt ous due process and arbitrary and procedures, and the Anti-Markup Rule. v. Blue Cross & Blue Shield of Greater New capricious problems that, thus far, He is a past chair of the American Bar York, 1982 U.S. Dist. LEXIS 15767 (S.D.N.Y. based on the author’s interactions Association Health Law Section’s Interest 1982) (health center had a property interest in its expectation of continued participation with the agency, CMS seems uninter- Group on Fraud and Compliance, and a in the Medicare and Medicaid programs). But ested in remedying. Especially puz- past vice-chair of the American Health see Gellman v. Sullivan, 758 F. Supp. 830, 833 (E.D.N.Y. 1991). In Gellman, the court cited zling is that CMS is either unaware of Lawyers Association’s Regulations, Plaza Health and Senape for the proposition or unconcerned with the bitter taste Accreditation and Payment Group. He that a provider does not have a property its actions may be leaving in the may be reached at [email protected]. interest in its continued participation in the Medicare or Medicaid programs, those cases mouths of many providers and suppli- that found that, where participation can be ers, particularly physicians, who are denied only for cause, there is a property the subject of many or most of the Endnotes right. 1 16 revocation determinations, with the 42 C.F.R. § 424.535(a)(3). 156 F.3d 384 (2d Cir. 1998). aggressive positions taken by CMS 2 The Civil Monetary Penalty (“CMP”) Statute 17 156 F.3d at 395. The court’s decision is a little 135 provides for sanctions against a person or puzzling because at the time it was issued ALJ under its regulations. Whatever entity that employs or contracts with an indi- appellate decisions did not (and still do not) semblance of a physician/CMS “part- vidual or entity that the person or entity set policy for CMS. Although the court may knows or should know is excluded from par- have been confused about the effect of ALJ nership” that existed at one time is ticipation in a federal healthcare program, for decisions, the larger point is that Furlong surely being eradicated through the the provision of items or services for which stands for the proposition that where rules

16 The Health Lawyer Volume 31, Number 6, August 2019 eliminate or circumscribe the discretion of some generalized due process right to choose hearing, and a Departmental Appeals Board agency officials, a property right exists. one’s field of private employment, the Court (“DAB”) review. See 42 C.F.R., Part 498. has also emphasized that all cases recognizing 18 56 In at least one case (e.g., Pacific Labs, LLC), 792 F.2d 444 (4th Cir.1986). such a right have dealt with a complete prohi- CMS revised the revocation determination 19 bition on the right to engage in a calling, and Id. at 447. after the supplier requested reconsideration, not a sort of brief interruption); Hindley v. 20 and then, after issuing the reconsideration, 710 F.2d 1015 (4th Cir. 1983). HHS, 2017 U.S. Dist. LEXIS 59983, * 23-24 revised the reconsideration after the appeal 21 (N.D. Cal. 2017). 710 F.2d at 1018. was pending at the ALJ level, forcing the sup- 22 2017 U.S. Dist. LEXIS 112908 (S.D. W.Va. 42 67 F.3d at 862, citing Vanelli, 667 F.2d at plier to start again at the reconsideration level 2017). 777-78. after the ALJ dismissed the hearing request for lack of jurisdiction. 23 2017 U.S. Dist. LEXIS 112908, *11. 43 314 F.3d 641, 643 (D.C. Cir. 2003). 57 44 U.S. v. Rogers, 2001 U.S. Dist. LEXIS 24914, 24 2017 U.S. Dist. LEXIS 112908, *19-21. The 1999 U.S. Dist. LEXIS 18779, *12 (E.D. La. *19 (M.D. Tenn. 2001), citing Ohio Cast Prod- test balances (1) the importance of the inter- Nov. 30, 1999). ucts v. Occupational Safety & Health, 246 F.3d est at stake, (2) the risk of an erroneous depri- 45 239 F. Supp. 3d 266 (D.D.C. 2017). 791, 798 (6th Cir. 2001). vation of the interest because of the 58 procedures used, and the probable value of 46 239 F. Supp. 3d at 289. FCC v. Fox Television Stations, Inc., 132 S. Ct. 2307, 2317 (2012), citations and some punc- additional procedural safeguards, and (3) the 47 Thus, in 42 C.F.R. § 1001.2001, the OIG pro- tuation omitted. government’s interest. vided for notice and an opportunity to 59 25 797 F.2d 119 (3d Cir. 1986). respond in writing as well as in person for cer- Grayned v. City of Rockford, 408 U.S. 104, tain exclusion authorities. See, e.g., 42 C.F.R. 108-09 (1972). See also Hoffman Estates v. 26 See id. at 122 (“we are inclined to doubt § 1001.2001(a) (providing for issuance of a Flipside, Hoffman Estates, Inc. 455 U.S. 489, whether it can be said as a matter of law… “notice of intent to exclude” which grants 30 498 (U.S. 1982); FCC v. Fox Television Sta- that Ritter had no property interest in his sta- days to provide “documentary evidence and tions, Inc., supra n. 58 at 2317. tus as a provider”). written argument in response” prior to imposi- 60 There is a strong presumption that all agency 27 40 F. Supp. 3d 153, 157 (D.D.C. 2014). tion of exclusion under certain authorities). action is subject to judicial review, and the The OIG explained that for exclusions under exception in the Administrative Procedure 28 581 F.2d 1010 (1st Cir. 1978). 42 C.F.R. §§ 1001.1301 – 1001.1501, notice Act for agency actions “committed to agency and opportunity to respond is not necessary, 29 797 F.2d 858 (10th Cir. 1986). discretion by law,” 5 U.S.C. § 701(a), is to be either because the basis for the exclusion has narrowly construed and is given force only 30 Id. at 863, 864. The court’s holding also already been determined by another agency when “there is no law to apply.” See Heckler v. appears to be grounded on its finding that pro- after notice and an opportunity to respond (in Chaney, 470 U.S. 821, 826-27 (1985), and viders and suppliers are not the intended bene- the case of §§ 1001.1401, 1001.1501), or the cases cited therein. ficiaries of the Medicare program. Id. at 864. excluded party has been given an opportunity See also N. Mont. Care Ctr. v. Leavitt, 2006 already by the OIG to explain why exclusion 61 42 C.F.R. § 424.535(c). should not be imposed (§ 1001.1301). See 57 U.S. Dist. LEXIS 69898 (D. Mont. 2006). 62 Id. Fed. Reg. at 3319. 31 67 F.3d 858 (9th Cir. 1995). 63 42 C.F.R. §§ 424.535(a)(2), (a)(3). 48 57 Fed. Reg. at 3319 (bold and underscore 32 67 F.3d at 862. Erickson was relied upon in added). 64 See, e.g., Meadowmere Emergency Physicians, Millman v. Inglish, 461 Fed. Appx. 627, 628 49 PLLC, Decision No. CR4971 (Nov. 20, (9th Cir. 2011). Section 1902(a)(39) of the Act, 42 U.S.C. 2017). § 1396a(a)(39); 42 C.F.R. § 455.416(c). Med- 33 640 F.2d 262 (10th Cir. 1981). icaid is not required to revoke until the Medi- 65 73 Fed. Reg. 69726, 69940-41 (Nov. 19, 34 797 F.2d at 863. care appeals are exhausted. 42 C.F.R. 2008). § 455.101 (definition of “termination”); see 35 66 73 Fed. Reg. at 38538. 640 F.2d at 264-65. also 76 Fed. Reg. at 5943 (“In addition, State 36 2017 U.S. Dist. LEXIS 99862 (E.D. Tex. 2017). Medicaid programs would terminate a pro- 67 73 Fed. Reg. at 38539 (emphasis added). vider only after the provider had exhausted all 68 37 803 F. Supp. 2d. 699 (E.D. Mich. 2011). available appeal rights in the Medicare pro- Id. gram or in the State that originally termi- 69 38 803 F. Supp. 2d. at 706. The final rule contains this exchange: nated the provider or the timeline for such 39 Instead, the court said that “the applicable appeal has expired”). However, Medicaid is Comment: One commenter stated that they regulatory scheme provided Plaintiff with full not precluded from revoking prior to the did not agree that a change in practice loca- opportunities to present relevant evidence exhaustion of Medicare appeal rights if it has tion should be treated as an urgent matter and contest the revocation of his Medicare a basis in state law for doing so. that would support a retroactive revocation of enrollment billing privileges.” 803 F. Supp. billing authority. 50 See 42 C.F.R. §§ 405.372, 405.374, 405.375. 2d. at 706. Response: We disagree with this commenter. 51 42 C.F.R. § 424.535(g). 40 See note 32 supra. Since physicians and NPPs receive payments 52 Id. in part on locality adjustments based on the 41 67 F.3d at 862, citing Vanelli v. Reynolds School place of service, we believe that physicians, Dist. No. 7, 667 F.2d 773, 777 (9th Cir. 53 Surprisingly, one court referred to the appeals NPPs, and physician and NPP organizations 1982); Roth, 408 U.S. at 573. A liberty inter- process as an “expedited administrative are responsible for updating their enrollment est can also be implicated if a government appeals process.” Native Angels Home Health, record within 30 days of a change in practice action prevents an individual from pursuing Inc. v. Burwell, 123 F. Supp. 3d 775, 778 location. It is also important to note that we the occupation of his or her choice, but courts (E.D.N.C. 2015). already have existing authority to revoke the have held that not being able to participate in billing privileges of a Part B supplier, includ- 54 See 42 C.F.R. § 405.1063(a). All laws and reg- Medicare does not rise to the level of being ing physicians and NPPs, if CMS or our con- ulations pertaining to the Medicare and Med- prohibited from pursuing the occupation of a tractor determines that upon an on-site icaid programs, including but not limited to physician or some other healthcare provider review or other reliable evidence that the sup- Titles XI, XVIII, and XIX of the Social Secu- or supplier. See, e.g., Guzman v Shewry, 544 plier is not operational (see § 424.535(b)(5)). rity Act and applicable implementing regula- F.3d 1073, 1085 (9th Cir. 2008) (finding that 73 Fed. Reg. at 69778. tions, are binding on ALJs and attorney a physician’s temporary suspension from Med- adjudicators, and the Council. 70 73 Fed. Reg. at 38582. icaid did not deny him a liberty interest, and citing Connecticut v. Gabbert, 526 U.S. 286, 55 See below for a discussion of the administrative 71 73 Fed. Reg. at 69865, 69866. In a response 291-92 (1999) for the proposition that appeals process. The administrative appeals to a commenter that stated that retroactive although the Supreme Court has recognized process consists of a reconsideration, an ALJ revocation creates a situation where Medicare continued on page 18 17 Volume 31, Number 6, August 2019 The Health Lawyer Unlawful, Unfair and Unwise: Constitutional and Rulemaking Infirmities continued from page 17

denies payment for services physicians have 80 See Medicare Program Integrity Manual 87 For the same reason, CMS’s reliance on sec- furnished in good faith, CMS merely said (“MPIM”), ch. 15, § 15.27.1 (C) (rev. 462, tion 424.5 of the regulations (see CMS MSJ at that it disagreed with the commenter and iss’d May 16, 2013, eff. Mar. 18, 2013 (“If the 10) is misplaced. that “[w]henever a physician or NPP’s State contractor approves a provider or supplier’s 88 See e.g., Jean-Claude Henry, M.D., Docket medical license is suspended or revoked, is con- reactivation application, the reactivation No. C-16-276, Decision No. CR4627, at 5-6. victed of felony as described in § 424.535(a) effective date shall be the provider or suppli- (3), excluded or debarred from participating er’s date of deactivation”). See also Jean- 89 See Urology Group of NJ, DAB No. 2860 the Federal exclusion or debarment, or is deter- Claude Henry, M.D., Decision No. CR4627 (2018). mined by CMS or our contractor not to be (“CMS policy in effect at the time Petitioner 90 See 73 Fed. Reg. at 72523-24. At one point, operational, we believe that the payments to filed and signed the application provided that the final rule engages in circular logic. The these practitioners should immediately cease.” if the contractor approves a provider’s or sup- final rule states that a CAP should not be per- plier’s reactivation application, the reactiva- 72 There is no regulatory or statutory authority mitted to rescind a revocation for failure to tion effective date will be the provider’s or to deny payment to a physician or non-physi- timely notify the contractor of a change in supplier’s date of deactivation. MPIM, ch. 15, cian practitioner (“NPP”) simply because the practice location because “we must be promptly § 15.27.1 (C) (rev. 462, iss’d May 16, 2013, individual has been convicted of a felony notified of all practice location changes so we eff. Mar. 18, 2013); MPIM, ch. 15, (although a few felony convictions are sup- can ensure that services are only performed at § 15.27.1.2(D) ( rev. 474, iss’d Jul. 5, 2013, posed to result in exclusion, and the exclusion valid locations and, consequently, that pay- would prevent the excluded party from billing eff. Oct. 8, 2013)”). ments are made correctly,” 79 Fed. Reg at Medicare). Whether a physician or NPP can 81 Section 15.29.4.3 of the MPIM, CMS Pub. 72523, without grasping that if a provider or receive Medicare payment despite a license 100-08, available at https://www.cms.gov/ supplier has been operating out of a real prac- revocation or suspension is more nuanced. Regulations-and-Guidance/Guidance/Manuals/ tice location, the only reason why the location The statute and regulations define a “physi- Downloads/pim83c15.pdf. would not be considered “valid” and why pay- cian” as an individual who is licensed as an ment would be denied is if CMS would not M.D. or D.O., and Medicare regulations 82 For example, in its update to its policy on pay- allow a CAP to be applied retroactively. CMS’s require that physicians and NPPs must meet ment suspensions, CMS modified Section statement in the CY 2009 PFS Proposed Rule, all state requirements in order to be paid. 8.3.2.2.4 of Chapter 8 of the MPIM to require 73 Fed. Reg. at 38582, “We believe that estab- However, if a physician is currently licensed in that a notice of a payment suspension that is lishing an expedited reconsideration process New York where she practices, and has had her issued by a zone program integrity contractor will afford providers and suppliers with an license revoked or suspended in Vermont, the “shall be sent via USPS certified mail or uti- administrative remedy similar to a corrective latter state’s licensing action is no basis to lizing other commercial mail carriers that action plan” is simply bizarre. How is a recon- deny her Medicare payment for services fur- allow the tracking of the correspondence to sideration process – expedited or not – similar nished to New York Medicare beneficiaries. ensure receipt by the provider.” Transmittal to a CAP? The utility of a CAP is to have a Likewise, absent a revocation, it does not fol- 670 (Aug. 19, 2016). See also 42 C.F.R. revocation rescinded notwithstanding that low that a provider that has been found to be § 405.800 (requiring CMS and its contractors there were valid grounds (at least in the eyes of “non-operational,” a term of art that CMS has to provide notice of a denied enrollment or a the contractor or CMS) for the revocation. An applied to mean including closed for lunch con- billing privilege revocation by certified mail). appeal is only successful if the adjudicator is convinced that the revocation was not valid. trary to posted hours (see, e.g., Ita Udeobong, 83 73 Fed. Reg, 69726 (Nov. 19, 2008). d/b/a Midland Care Med. Supply & Equip., 91 See 42 C.F.R. § 488.28(a); 488.110(k); DAB No. 2324 (2010)) – cannot bill Medicare. 84 See 73 Fed. Reg. at 69766 (“We solicited 488.408(f). public comment on two approaches for 73 42 C.F.R. § 424.535(a)(8)(ii)(A) – (F). establishing an effective date for Medicare 92 Leslie Barbour, M.D., LLC, Docket No. 74 See, e.g., Pacific Labs LLC, revocation letter billing privileges for physician and NPP C-16-744. dated November 11, 2015. organizations and for individual practitio- 93 ners. The first approach would establish the See 73 Fed. Reg. 36454 (“while we believe 75 79 Fed. Reg. at 72514. initial enrollment date for physician and that providers and suppliers can appeal the revocation determination, we do not believe 76 NPP organizations and for individual practi- 71 Fed. Reg. 20754 (April 21, 2006). that providers and suppliers can appeal the tioners, including physician and NPPs, as the 77 duration of the re-enrollment bar for Medi- See, e.g., 68 Fed. Reg. at 22072 (“[t]he tempo- date of approval by a Medicare contractor. . . care billing privileges”). See also Vijendra rary deactivation of a billing number will not .The second approach would establish the ini- Dave, M.D., DAB No. 2672 at 11 (2016). have any effect on a provider or supplier’s par- tial enrollment date for physician and NPP ticipation agreement or conditions of partici- organizations and individual practitioners, 94 CMS did not attempt to provide a reason as pation”); 74 Fed. Reg. at 58119 (“As we including physicians and NPPs, as the later of: to why one should not be entitled to appeal previously stated, the deactivation of a provid- (1) The date of filing of a Medicare enroll- the length of the reenrollment bar. See note er’s Medicare billing privileges is not the same ment application that was subsequently immediately above. as the revocation of these privileges. A deacti- approved by a fee-for-service (FFS) contrac- 95 CMS vests the contractors with determining vated provider remains enrolled in Medicare, tor; or (2) the date an enrolled supplier first the length of the reenrollment bar. See 73 whereas a revoked provider loses its Medicare started furnishing services at a new practice Fed. Reg. at 46454. billing privileges and is no longer enrolled in location.”). the program”); 77 Fed. Reg. at 29013 (“While 96 42 C.F.R. § 424.535(c)(1). the deactivated provider or supplier would still 85 73 Fed. Reg. 38502 (July 7, 2008). need to submit a complete enrollment applica- 97 42 C.F.R. § 405.990. 86 Section 424.555(b) provides: tion to reactivate its billing privileges, it would 98 42 C.F.R. § 405.990(c)(2). not be subject to other, ancillary consequences No payment may be made for otherwise Medi- that a revocation entails”). care covered items or services furnished to a 99 See section 1878(f) (1) of the Social Security Medicare beneficiary by a provider or supplier Act, 42 U.S.C. § 1395oo(f)(1); 42 C.F.R. 78 42 C.F.R. § 424.504. if the billing privileges of the provider or sup- § 405.1842. 79 See, e.g., The American Heritage Dictionary of the plier are deactivated, denied, or revoked. The 100 Otherwise the appellant could raise a specious English Language, https://ahdictionary.com/ Medicare beneficiary has no financial respon- regulatory challenge simply to be able to get word/search.html?q=restore, (“To bring back sibility for expenses, and the provider or sup- immediate judicial review on issues that could to an original or normal condition”); Merriam-­ plier must refund on a timely basis to the be decided by the appellate adjudicators. Webster, https://merriam-webster.com/diction- Medicare beneficiary any amounts collected ary/restore?src=search-dict-box (“to bring back from the Medicare beneficiary for these other- 101 Note that in the CY 2009 Physician Fee Sched- to or put back into a former or original state”); wise Medicare covered items or services. ule final rule CMS stated that it considered

18 The Health Lawyer Volume 31, Number 6, August 2019 establishing an expedited reconsideration process 120 In Mathews v. Eldridge, 424 U.S. 519 (1976), 127 2015 WL 3657417 (E.D. N.C. 2015). for those cases which involve a retroactive revo- the Court held that the Social Security Act 128 cation of billing privileges (i.e., revocation due contains both a pure jurisdictional requirement 792 F.2d 444 (4th Cir. 1986). to exclusion, felony conviction, state license (presentment of a claim) and a waivable require- 129 108 Fed. Cl. 321 (Ct. Claims 2012). suspension or revocation, or practice location ment (exhaustion of administrative remedies). 130 is found to be non-operational), but it believed The presentment requirement recently surfaced See St. Francis Hosp. v. Sebelius, 874 F. Supp. that an expedited reconsideration process was in a Medicare case, AHA v. Azar, 895 F.3d 822 2d 127, 134 (E.D. N.Y. 2012), citing cases. not warranted (without giving any explanation (D.C. Cir. 2018). See also Sherman v. Burwell, 131 348 F. Supp. 3d 62 (D.D.C. 2018). as to its conclusion). 73 Fed. Reg. at 69865. 2016 U.S. Dist. LEXIS 103897, n. 2 at *8-9 (D. Conn. 2016) (“Plaintiff has satisfied the require- 132 It is also odd that section 1866 would specify 102 See § 424.535(a)(3) (revocation for a felony ment for presentment, which only requires that the Secretary may revoke billing privi- that “CMS determines is detrimental to the that the plaintiff have actually appealed the leges for a provider that has been excluded best interests of the Medicare program and its initial determination – i.e., presented the whereas section 1842 does not do so for suppli- beneficiaries”); § 424.535(a)(8)(ii) (“CMS claim directly to the agency for review under ers. This omission may further the argument determines that the provider or supplier has a the administrative review process”). that the statute did not purport to list the pattern or practice of submitting claims that exclusive grounds for which a provider or sup- do not meet Medicare requirements”); 121 See e.g., Califano v. Sanders, 430 U.S. 99, 109 plier may have its billing privileges revoked. § 424.535(a)(14) (“CMS determines that the (1977) (“[c]onstitutional questions obviously physician or eligible professional has a pattern are unsuited to resolution in administrative 133 Section 1866(b)(2)(C) and (D) of the Social or practice of prescribing Part D drugs” that is hearing procedures and, therefore, access to Security Act, 42 U.S.C. § 1395cc(b)(2)(C) improper according to the listed criteria). the courts is essential to the decision of such and (D). questions”); Mathews v. Diaz, 426 U.S. 67, 76 103 75 Fed. Reg. at 72519. (1976) (“As in Salfi, this constitutional ques- 134 Section 1842(h)(8) and (9) of the Social Secu- 104 803 F. Supp. 2d. 699 (E.D. Mich. 2011). tion is beyond the Secretary’s competence”); rity Act, 42 U.S.C. § 1395u(h)(8) and (9). Mathews v. Eldridge, 424 U.S. 319 (1976); 135 In addition to the examples already given, 105 See, e.g., United States v. Nixon, 418 U.S. 683 Weinberger v. Salfi, 422 U.S. 749, 765, (1975). (1974); United States ex rel. Accardi v. Shaugh- note that CMS took the position that section nessy, 347 U.S. 260 (1954). 122 529 U.S. 1 (2000). 424.535(a)(1), which authorizes CMS to revoke a provider’s or supplier’s billing num- 106 123 The Court held that the requirement of Saeed A. Bajwa, CR 4732, available at https:// ber based on non-compliance with the enroll- exhaustion of administrative remedies did not www.hhs.gov/sites/default/files/alj-cr4732.pdf. ment requirements applicable to that type of apply if there was no administrative appeal provider or supplier, gave it the authority to 107 Saeed A. Bajwa, CR 4732, at 12. process available, reaffirming the principle set revoke any provider or supplier’s billing num- 108 See, e.g., section 15.27 of the MPIM (“If cir- forth in Bowen v. Michigan Academy of Family Physicians, 476 U.S. 667 (1986). One may be ber if the provider or supplier submitted incor- cumstances warrant, a fee-for-service contrac- rect claims, based on the theory that each tor shall deactivate or revoke a provider or tempted to argue that the potential length of the administrative appeals process, combined enrollment application contains a certifica- supplier’s Medicare billing privileges under tion that the provider or supplier will adhere certain circumstances”); 15.24.9, “Revocation with the inability to raise challenges to the revocation regulations in that process, means to all Medicare regulations. A series of ALJ Letter Guidance,” instructing contractors on decisions followed in which CMS’s position what revocation determinations must contain. that no administrative appeal is constructively available. However, thus far this type of argu- was upheld. See, e.g., City Crown Home Health 109 Section 15.27.2 of the MPIM. ment has not been successful. At least one Agency, Inc., No. CR3130 (2014); Hoyos court has construed Illinois Council as meaning Home Health Care, Inc., No. CR2746 (2013). 110 The coverage appeals process appears at 42 literally that no administrative appeal is avail- However, in Proteam Healthcare, Inc., DAB C.F.R, Part 405, Subpart I. able. See Family Rehab., Inc. v. Azar, 886 F.3d No. 2658 (2015), the DAB reversed CMS’s 111 See AHA v. Price, 867 F.3d 160 (D.C. Cir. 2017). 496, 505 (5th Cir. 2018). determination that a home health agency’s inclusion of the identification number of the 112 124 CR 1786 (May 8, 2008) at 3. See, e.g., Sherman v. Burwell, 2016 U.S. Dist. incorrect physician on certain claims in itself LEXIS 103897, at *9 (D. Conn. 2016); Thi of 113 constituted noncompliance with applicable Wayne E. Imber, M.D., DAB No.1740 (2000). Kan. at Highland Park, LLC v. Sebelius, 2013 enrollment requirements and formed a suffi- 114 U.S. Dist. LEXIS 112443 (D. Kan. Aug. 9, 42 C.F.R. § 1005.4(c)(5). cient legal basis to revoke the provider’s bill- 2013) (distinguishing between Illinois Council’s 115 ing privileges. The DAB found that “CMS’s See 57 Fed. Reg. 3298, (“ALJs may not review “exception” to the requirement to exhaust the OIG’s exercise of discretion to impose a administrative remedies and Eldridge’s prescrip- position is inconsistent with the plain language penalty, assessment or exclusion under these tion for when waiving exhaustion for “entirely of the regulations and with multiple published authorities. It should also be noted that in a collateral” claims is appropriate); GOS Opera- statements by CMS about the scope of its revo- case where the ALJ upholds the OIG’s exclu- tor, LLC v. Sebelius, 843 F. Supp. 2d 1218, cation authority,” DAB No. 2658 at 1, and sion determination, the ALJ is not authorized 1230 (S.D. Ala. 2012) (rejecting “the Govern- noted that, under CMS’s position, the certifica- under these regulations to modify the date of ment’s contention that the ‘collateral claims’ tion statement in the enrollment applications commencement of the exclusion identified in provisions of Eldridge did not survive Illinois would convert every Medicare regulation and the OIG’s notice of exclusion.”). Council”); Niskayuna Operating Co., LLC v. instruction into a revocable enrollment requirement, DAB No. 2658 at 11. Even after 116 Brier Oak Terrace Care Ctr., DAB No. 1798 Sebelius, 2010 U.S. Dist. LEXIS 118871, 2-3 Proteam was decided, CMS continued to give (2001). (N.D.N.Y 2010) (“contrary to Defendants’ argument, it does not appear obvious to the an expansive reading of section 424.535(a)(1), 117 42 C.F.R. § 488.408(g)(2); see also Rosewood Court that the case of [Illinois Council] is anal- see Pueblo Family Physicians, No. CR4661 Living Center, Docket No. A-05-90 (2006). ogous to the current case”). (2016) (reversing revocation under section 424.535(a)(1) that was based on a violation of 118 See note 55 supra. 125 2010 U.S. Dist. LEXIS 144292 (N.D.N.Y the reassignment rules). It is unknown whether Oct. 26, 2010). 119 Section 205(h) of the Act, 42 U.S.C. § 405(h), CMS still subscribes to the view that section as incorporated into Title XVIII of the Act by 126 2010 U.S. Dist. LEXIS 144292 at *4 (foot- 424.535(a)(1) authorizes revocations for non- section 1872 of the Act, 42 U.S.C. § 1395ii. notes omitted). compliance with any Medicare rule.

The articles published in The Health Lawyer reflect the opinions of the authors. We welcome articles with differing points of view.

19 Volume 31, Number 6, August 2019 The Health Lawyer Chair’s Corner continued from page 20

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23 Volume 31, Number 6, August 2019 The Health Lawyer SUPREME DILEMMA: HANDLING CONFLICTS BETWEEN STATE MEDICAL PRIVACY LAWS AND FEDERAL INVESTIGATIVE SUBPOENAS

Eric K. Gerard, Esq. privacy laws that protect against dis- matters. A third category encom- Kessler Topaz Meltzer & Check, LLP closure of such information without passes administrative subpoenas, Radnor, PA judicial approval, notice to affected which are frequently employed in Brandt A. Leibe, Esq. patients, or both, attaching serious criminal, civil, and administrative King & Spalding penalties to violations. As a result, inquiries in the healthcare industry, Houston, TX HCOs face a seemingly intractable and civil investigative demands, an dilemma upon receipt of a federal important tool in False Claims Act subpoena: comply with the demand investigations. Introduction: and run afoul of state privacy law, or Federal Grand Jury Subpoenas An Emerging Conflict refuse and risk sanctions in federal court. The most common means by America’s healthcare industry which federal investigators procure attracts federal law enforcement This article addresses the emerg- documentary evidence in criminal attention and resources like few oth- ing conflict by first reviewing the most cases is the grand jury subpoena duces ers. In fiscal year 2018 alone, the U.S. common types of federal subpoenas tecum.3 The job of the grand jury, Department of Justice (“DOJ”) opened used in healthcare investigations and whose authority springs from the Fifth over 1,100 new criminal healthcare the authorities on which they rely. It Amendment to the United States fraud investigations.1 Hundreds of then examines a growing trend of Constitution, is “to inquire into all defendants were charged and con- strict state medical privacy laws that information that might possibly bear victed. Thousands of individuals and constrain the disclosure of patient on its investigation until it has identi- entities were barred from participating information. Next, the article summa- fied an offense or has satisfied itself in Medicare, Medicaid, and other fed- rizes the handful of judicial decisions 4 eral programs. An equal number of that have addressed the issue to date, that none has occurred.” In doing so, civil investigations were opened, often along with examples from other con- the grand jury may issue subpoenas overlapping with their criminal coun- texts in which the federal subpoena without any threshold showing of terparts in so-called “parallel proceed- wrongdoing, subject to certain statu- power clashed with state privacy laws. 5 ings.” And physicians, hospitals, It concludes by identifying other tory and constitutional limitations. pharmacies, research labs, plans, and grounds on which to challenge such In practice, it is federal prosecutors other healthcare organizations demands and proposing a framework who control the grand jury process, (“HCOs”) paid over $2.8 billion to the by which the HCO may devise a deciding whom and what to subpoena government and private parties in response that both minimizes risk to without consulting the grand jury 6 False Claims Act cases in that single the HCO and protects patient privacy beforehand. The recipient of a grand fiscal year.2 to the fullest extent possible. jury subpoena who ignores or refuses the command for productions faces Of all the investigative tools used civil and even criminal contempt pro- by law enforcement in conducting Federal Investigative ceedings in federal court.7 these complex, document-heavy Subpoenas investigations, none is more impor- The grand jury is meant to work tant than the subpoena duces tecum. Federal investigators have a range in secret. Grand jurors, prosecutors, Whether aimed at confirming anoma- of options by which to obtain records and investigators are thus prohibited lies in claims data, attempting to cor- in investigating cases. Search war- pursuant to Rule 6(e) of the Federal roborate a whistleblower’s allegations, rants, which issue only upon a finding Rules of Criminal Procedure from dis- or scrutinizing the medical bases for of probable cause by a magistrate closing the body’s activities to outside controlled-substance prescriptions, judge in a criminal investigation, are parties, including its issuance of sub- federal agents and prosecutors rou- the most intrusive form of collection poenas.8 These secrecy rules have the tinely issue subpoenas to HCOs com- and fall outside the scope of this arti- effect of barring federal prosecutors manding the production of patient cle. Grand jury subpoenas offer an from sharing materials obtained by files, billing records, and other sensi- alternative without the hurdle of judi- grand jury subpoena with anyone out- tive information. Meanwhile, many cial preauthorization, although they, side the criminal investigative team, states have enacted strict medical too, may only be used in criminal meaning that even DOJ lawyers and

24 The Health Lawyer Volume 31, Number 6, August 2019 investigators involved in parallel civil fraud investigations routinely involve jury equivalents. First, unlike a search investigations typically cannot see HHS’s requests under this authority. warrant, no threshold showing of information produced in response to a wrongdoing or judicial approval is The DOJ holds a separate admin- grand jury subpoena.9 Violation of the required to issue them.22 Indeed, istrative-subpoena power in the spe- secrecy rules raises the specter of con- investigators ordinarily need not jus- cific context of criminal healthcare tempt proceedings, claims of prosecu- tify their demands at all. And, as with fraud matters, giving its attorneys and torial misconduct by any eventual grand jury subpoenas, the government investigators, including the Federal defendant, and even criminal prose- may seek to enforce compliance in Bureau of Investigation, a choice cution of the offender.10 federal court, exposing any party who between grand jury and administrative resists to contempt sanctions.23 Recipients of grand jury subpoe- demands for records.15 Unlike grand nas are not bound by the same non- jury subpoenas, DOJ administrative Administrative subpoenas also disclosure obligations.11 Absent a subpoenas allow for ex parte orders offer several unique benefits to inves- separate court order, the government that prohibit the recipient from dis- tigators. While materials returned in cannot prevent a grand jury subpoe- closing the request to any third party response to grand jury subpoenas typi- na’s recipient from notifying the sub- for 90 days, which can be renewed cally may not be shared with civil ject of the investigation – or anyone indefinitely.16 investigators, the converse is not true: else – of the government’s demand.12 Another authority of particular evidence gathered by civil administra- In the context of healthcare investi- relevance today is held by the Drug tive subpoena can be used in building gations, these interlocking rules have 24 Enforcement Administration (“DEA”), a related criminal case. Investigators the effect of prohibiting federal prose- which often takes the lead role in also appreciate the convenience of cutors from disclosing that a grand investigations involving the prescrip- administrative subpoenas, which they jury subpoena has been issued or any tion of controlled substances.17 As the can issue themselves without going responsive production with others, nation’s opioid crisis has taken center through the prosecutor’s office. including civil investigators, while stage among federal law enforcement Finally, unlike the grand jury sub- generally permitting recipients to priorities, DEA agents regularly issue poena, most administrative subpoenas inform patients and other affected demands for patient medical and bill- may continue to be used following parties of the investigation. ing records from providers, dispensa- indictment to gather additional evi- 25 Administrative Subpoenas tion histories from pharmacies, and dence for trial. Given these advan- autopsy results from medical examin- tages, administrative subpoenas are Issuing from the executive branch’s ers to determine whether particular often the preferred means of obtaining constitutional duty to enforce the law, doctors or clinics are prescribing drugs records in healthcare investigations. administrative subpoenas play an illegally.18 These requests are often increasingly important role in federal accompanied by letters directing the enforcement actions as the lines Expanding Medical Privacy recipients not to disclose their issu- between criminal, civil, and adminis- Laws ance to any third party for 90 days, trative inquiries blur. These demands, which, while not formal court orders, Against the backdrop of aggressive like the agencies that issue them, must are typically honored by HCOs and federal enforcement in the healthcare be authorized by statute – and a star- have been ruled enforceable by at industry stands an assortment of laws tling range of agencies have received least one federal court.19 designed to protect patient privacy. such authority. Indeed, one DOJ study Some, such as the federal regime, identified 335 distinct administrative- Civil investigative demands expressly account for the power of subpoena authorities held by various (“CIDs”) provide yet another impor- investigators to compel the production executive-branch entities.13 Several tant means by which the government of medical and billing records by sub- are of particular importance to those obtains records in civil healthcare poena. Others were drafted without in the healthcare industry. fraud inquiries. In addition to the pro- such regard, prohibiting law enforce- duction of records, CIDs can compel First, inspectors general of various ment from obtaining records absent interrogatory responses and testimony federal agencies, including the patient consent or court involvement; under oath.20 While distinct in name Department of Health and Human in fact, the law of one large state and statutory authority, the courts Services (“HHS”), hold broad crimi- includes a provision that, if followed, consider CIDs administrative subpoe- nal and civil investigative power to would theoretically expose investiga- nas for all practical purposes and will investigate alleged fraud and abuse in tors to federal prosecution. Given enforce them as such.21 federal programs and may issue admin- these competing interests – vigorous istrative subpoenas in service of that Administrative subpoenas share enforcement and patient privacy – end.14 Civil and criminal healthcare important similarities with their grand conflicts are inevitable. continued on page 26 25 Volume 31, Number 6, August 2019 The Health Lawyer Supreme Dilemma: Handling Conflicts Between State Laws and Federal Subpoenas continued from page 25

The Federal Medical Privacy patient, doctor-patient relationship, found in federal law, these provisions Regime and the treatment services provided.31 of Florida law produce a remarkable Therefore, a subpoena issued unilater- result in the context of federal grand In 1996, Congress created the ally by federal investigators does not jury investigations. As discussed above, best-known medical privacy law, the suffice to permit disclosure of PHI Rule 6(e) bars investigating officials federal Health Insurance Portability under California law. Violators face from disclosing the grand jury’s activi- and Accountability Act (“HIPAA”). liability for compensatory and puni- The law was designed to give patients ties to third parties – a category that tive damages, attorneys’ fees, and more control over their protected would include patients whose records criminal prosecution.32 40 health information (“PHI”) by, among are sought from their providers. To other things, creating nationwide The Texas legislature approached comply with Florida’s requirement to standards restricting the disclosure of the issue differently. The Texas Medi- notify patients, federal investigators patient records by HCOs and other cal Records Privacy Act, passed in would be forced to violate grand jury third parties.26 Recognizing the impor- 2011, precludes disclosure of PHI secrecy restrictions, theoretically expos- tance of such information in certain absent patient consent but provides for ing themselves to sanctions and the enforcement contexts, however, Con- exceptions “otherwise authorized or threat of criminal prosecution. Mean- gress specifically allowed for disclosure required by state or federal law,” leav- while, Florida legislators, potentially upon receipt of a duly issued subpoena, ing open the possibility that an inves- oblivious to the conundrum they were court order, or warrant.27 Coupled with tigative subpoena would qualify.33 The creating, mandated fines and other the absence of a physician-patient Texas Occupations Code, however, discipline for breaches of their statu- 41 privilege under federal law, these pro- creates a physician-patient privilege tory protections. visions permit investigators to obtain covering communications and records These three states, which are patient PHI without notice to the concerning “the identity, diagnosis, home to over a quarter of the coun- patient or judicial approval.28 evaluation, or treatment” of any try’s population, have each enacted patient.34 Abrogation of the privilege laws that appear to directly contradict State Medical Privacy Laws generally requires either patient con- federal investigators’ authority to col- sent or a court order, and no provision Under HIPAA, a state law that lect evidence by subpoena. Many allows investigators to obtain such imposes “more stringent” protections smaller states have passed similar privileged information in the investi- than the federal government is not restrictions of varying rigor.42 Whether 29 gative stage.35 Unauthorized disclo- preempted. Both before and after styled as medical privacy statutes or sures of privileged information expose HIPAA was passed, many states provider-patient privileges, they often the offender to administrative, civil, enacted restrictions on sharing patient contain no exception for investigative and criminal penalties.36 PHI, locating them either in specific subpoenas, and the courts generally medical privacy acts of their own, in Similarly, Florida laws enacted in have upheld these restrictions against state-law privileges, or both. These 1999 create a “broad and express privi- demands from state and local law- statutes typically call for significant lege of confidentiality” of PHI that enforcement agencies.43 As a small but penalties if violated. While a 50-state generally prohibits disclosure to anyone growing body of case law makes clear, survey of medical privacy laws is but the patient, the patient’s represen- however, these protections have fared beyond the scope of this article, those tative, or other healthcare providers worse in the face of the federal gov- of the nation’s three largest illustrate involved in the patient’s care, unless ernment’s broad investigative powers. this trend. the patient provides written authoriza- tion.37 An exception exists that allows California’s Confidentiality of Litigating the Conflict Medical Information Act, first enacted providers to disclose patient records in 1979, provides for disclosure pursu- upon receipt of a subpoena, but the sub- As criminal, civil, and adminis- poena must have been approved and trative investigations in the health- ant to the patient’s consent, a judi- 38 cially authorized search warrant, or issued by a competent court. More- care industry continue to rise, so, too, over, the party seeking the PHI must a court order.30 The California Penal have clashes between federal subpoe- provide notice to the affected patients Code further specifies that a court nas and unyielding state nondisclo- so that they have an opportunity to order may be obtained only on a show- sure laws. Yet while prosecutors and challenge the disclosure request.39 ing of “good cause,” determined by private counsel report encountering weighing the need for the informa- Beyond the imposition of addi- this conflict with growing frequency, tion against the resulting injury to the tional hurdles to investigators not published decisions on its resolution

26 The Health Lawyer Volume 31, Number 6, August 2019 remain rare, issuing mostly from a that compliance with the federal sub- elsewhere have held similarly, again scattershot of federal district courts poena was compelled by the Suprem- basing their decisions on the suprem- across the country. The handful of acy Clause.47 Acknowledging concerns acy of federal law and the inapplica- courts that have addressed the issue about penalties for violating state law, bility of state privileges to federal have been largely consistent, indicat- the court also held that the agency proceedings.55 ing how such conflicts will be resolved would be immunized from state law These rulings accord with those of in other jurisdictions while offering sanctions because compliance had other courts addressing clashes been compelled under federal law.48 guidance to HCOs on responding to between federal investigations and federal subpoenas in states with strict Later, in a rare appellate case state laws protecting other types of medical privacy laws that, on their on the issue, an Illinois physician sensitive information. For example, a face, prevent compliance. appealed a contempt order that had U.S. district judge in Austin ordered Decisions Involving Grand been issued after he had refused to an accountant to comply with a fed- Jury Subpoenas turn over patient medical records in eral grand jury subpoena despite a pro- response to a federal grand jury sub- vision in the Texas Occupations Code The few federal courts to consider poena.49 The doctor had moved to prohibiting accountants from disclos- the question have concluded that the quash the subpoena on the ground ing client records without a court grand jury’s authority to investigate that a state physician-patient privi- order.56 The court declared the state potential crimes, including through lege prohibited his compliance and statute preempted under the Suprem- the issuance of subpoenas, prevails exposed him to civil liability and acy Clause while shielding the over state laws restricting disclosure. revocation of his medical license were accountant from civil liability under Typically, these decisions rest on the he to violate it. The district court held state law or accounting board disci- Supremacy Clause of the United that a federal grand jury could not be plinary action for his compliance.57 States Constitution and the doctrine bound by state law privileges under This decision echoed others in con- of conflict preemption, which, in its the Supremacy Clause and ruled that texts ranging from state bar investiga- simplest terms, provides that conflicts the doctor could not be penalized for tions to bank secrecy rules.58 In short, between state and federal law are to complying with the federal subpoe- while there remains a lack of control- 44 be resolved in favor of the latter. na.50 The Seventh Circuit upheld the ling precedent in most circuits, the Occasionally, when addressing physi- lower court’s order, although it shifted lower courts’ consistency on the issue cian-patient communication privi- its focus from preemption to the prin- suggests that future challenges to fed- leges, the courts’ analyses focus on the ciple that state law privileges do not eral grand jury subpoenas based on inapplicability of state-law privileges apply under the Federal Rules of Evi- state nondisclosure provisions will fail. 45 under the Federal Rules of Evidence. dence.51 In any case, the doctor was Decisions Involving Under either analysis, the result is the forced to turn over the records to fed- Administrative Subpoenas same, as the following examples eral investigators. illustrate. Perhaps surprisingly, courts have More recently, a district court in addressed the conflict created by In what appears to be the earliest Maine reached the same result when strict state medical privacy laws more decision directly on point, a federal a local hospital refused to produce often in the context of administrative court in Miami took up this conflict documents containing PHI in subpoenas, particularly in recent in the context of the predecessor to response to a federal grand jury sub- years. It is unclear whether this dis- the Florida medical privacy statute poena, again citing a state law that parity stems from federal investiga- discussed above. In that case, the law prohibited disclosure.52 The court rea- tors’ preference for administrative had the effect of barring a state soned that HIPAA’s anti-preemption subpoenas in healthcare investiga- agency from disclosing to federal pros- provision, which allows states to craft tions, HCOs’ greater willingness to ecutors the names of patients whom more stringent privacy protections 46 challenge such demands, or some- the state agency had investigated. than the federal regime, was not thing else. Whatever the reason, the Characterizing the quandary of hon- intended to give state law an effect outcome is the same: administrative oring both the federal grand jury sub- that it otherwise would not have had, subpoenas prevail over state privacy poena for the agency’s records and the such as applying state restrictions to protections. state law as a “physical impossibility,” federal activity.53 The court con- the court summarized a number of cluded that the Maine statute did not A recent Fifth Circuit opinion other contexts in which federal sub- apply to federal grand jury investiga- illustrates the point. In that case, a poenas were enforced in violation of tions and denied the hospital’s Texas doctor refused to produce state statutes prohibiting disclosure of motion to quash the federal grand patient medical records in response to subpoenaed information, concluding jury subpoena.54 District courts a DEA administrative subpoena issued

continued on page 28 27 Volume 31, Number 6, August 2019 The Health Lawyer Supreme Dilemma: Handling Conflicts Between State Laws and Federal Subpoenas continued from page 27 pursuant to its authority under the administrative subpoenas for sensitive Failure to timely assert the privilege Controlled Substances Act (“CSA”).59 records enforceable in the face of state may result in waiver, requiring a care- The doctor based his refusal in part on privileges and nondisclosure provisions ful privilege analysis before any docu- Texas’s physician-patient privilege, dis- in the healthcare context and other ments are produced. cussed above. The Fifth Circuit upheld industries.68 Improper Purposes the lower court’s enforcement order, finding that the state provision cre- Courts will also exercise their ated a direct conflict with the DEA’s Other Challenges to supervisory authority to block subpoe- subpoena power and was therefore Federal Subpoenas nas issued for improper purposes. As 60 preempted by the CSA. The cases above make clear that noted earlier, grand jury subpoenas cannot be used to gather evidence for The Ninth Circuit reached the an HCO’s refusal to comply with a trial after an indictment has been same result in a 2017 case involving a federal subpoena on the basis of state returned, while CIDs may not be DEA subpoena to Oregon’s Prescription privacy law is unlikely to succeed and issued after the government inter- Drug Monitoring Program (“PDMP”).61 may expose the organization to sanc- venes in a qui tam or files a direct Oregon law prohibited disclosure of tions and court costs. Yet the HCO is complaint in a civil false claims PDMP data to law enforcement absent not without recourse when faced with action.74 Consideration of the proce- a court order based on probable cause.62 an objectionable demand from federal dural posture of the case is thus Deeming Oregon’s requirement for authorities. Where a federal subpoena imperative. The issuance of grand judicial authorization of subpoenas a requests records covered by a privilege jury subpoenas to procure evidence “significant obstacle” to the full imple- recognized in federal law, advances an for a purely civil or administrative mentation of the CSA, the appellate improper purpose, or is overbroad in its investigation is also per se improper.75 court declared the state law preempt- scope, it may be modified or quashed Other forms of prosecutorial miscon- ed.63 At least two other district courts on motion to the district court. duct, such as harassment, intimida- have relied on the supremacy of fed- Recognized Federal Privileges tion, and selective or vindictive eral law to reject challenges to DEA prosecution, constitute improper pur- subpoenas for other states’ PDMP Although the Federal Rules of poses as well.76 Again, however, the data.64 Evidence generally do not apply to grand jury proceedings, recognized recipient bears the burden of making The DEA has not been alone in federal common-law privileges do, an initial showing of an invidious its success. Nearly three decades ago, thus protecting certain communica- government motive to see the sub- a district court in Iowa ordered a hos- tions from compelled disclosure.69 In poena quashed, and successful chal- pital to comply with an HHS subpoena 77 the context of healthcare investiga- lenges on such grounds are rare. seeking a physician’s medical records in tions, the most pertinent shields are Fourth Amendment a civil investigation, declaring a state the attorney-client, work-product, “Unreasonableness” law prohibiting such disclosures pre- and psychotherapist-patient privileg- empted by HHS’s subpoena power.65 Finally, overbroad or irrelevant es.70 Further, while an individual who Years later, a federal judge in New York demands may be properly resisted. receives a subpoena duces tecum typi- ordered an HCO to disclose mental The Fourth Amendment creates a cally cannot resist production on the health records in response to a Social constitutional right to be free from ground that the documents may incul- Security Administration (“SSA”) unreasonable searches and seizures.78 pate a third party, that person may administrative subpoena despite a As previously discussed, unlike search assert a Fifth Amendment privilege in state law prohibiting disclosure, further warrants, no showing of probable limited circumstances, such as where directing the HCO to cover costs cause or any lesser standard of suspi- the recipient is the target of the incurred by the SSA in litigating the cion is required to issue a grand jury investigation.71 motion to compel.66 More recently, an or administrative subpoena.79 Never- Ohio physician-patient privilege was Regardless of the privilege claimed, theless, a subpoena duces tecum must determined not to protect against dis- the party invoking its protection be reasonable in its scope.80 While a closure pursuant to CIDs issued by a bears the burden of showing that the duly issued grand jury subpoena is U.S. Attorney in Alabama, the dis- requested materials fit within it.72 presumed reasonable, it must seek trict court finding the state law inap- Once that burden has been met, the “information relevant to the grand plicable to a federal investigation.67 A court will modify or quash the sub- jury’s investigation,”81 although rele- number of other courts have deemed poena unless an exception applies.73 vancy in the grand jury context is

28 The Health Lawyer Volume 31, Number 6, August 2019 defined far more broadly than at tri- under state laws under the doctrine of it is prohibited by governmental direc- al.82 A demand for records “too sweep- conflict preemption. Hence, the HCO tive or court order from notifying ing in its terms to be regarded as is unlikely to succeed in refusing to affected patients or other parties of the reasonable” is subject to challenge, a comply with federal subpoenas on the production and, if not, decide whether standard that applies equally to admin- ground that state law does not permit to provide such notice as a matter of istrative subpoenas.83 disclosure, and refusal may needlessly state law or organizational policy. expose the organization to costs and Where a request is obviously Although disclosing records in penalties. Nevertheless, before pro- overbroad or the records sought are violation of state medical privacy laws ducing such sensitive information in patently irrelevant to the investiga- is doubtless unappealing to individu- contravention of state law, counsel tion, the recipient may move to als and organizations that take seri- would be wise to consider how best to quash, but it is usually advisable to ously their obligations under state law minimize risks to the organization. confer with the government first in to safeguard such sensitive informa- an effort to narrow the scope of the First, counsel should determine tion, the supremacy of the federal demand.84 Claims of unreasonableness whether a recognized federal privi- government’s subpoena power will require a “strong showing” by the sub- lege, such as attorney-client or work- sometimes demand it. Given the poena’s challenger – a burden that product protection, applies to the aggressive enforcement environment challengers usually struggle to meet, requested records. Second, confirm in which HCOs currently operate, as secrecy rules will often obscure the that the documents are not being counsel is increasingly likely to breadth of the investigation.85 Despite sought by the government for some encounter this conflict, presenting an these hurdles, courts have occasion- improper purpose, such as post-indict- unpalatable choice between potential ally found federal demands unreason- ment trial preparation. Third, evaluate state law penalties on the one hand, ably broad and exercised their the scope of the request, considering and the prospect of enforcement pro- authority to modify or quash them.86 whether it may be challenged as over- ceedings in federal court on the other. An important consideration in cer- broad or otherwise unreasonable and Following the approach outlined tain cases has been investigators’ abil- what, if any, more narrowly defined above may offer the HCO its best ity to obtain the information sought production would be acceptable. Fac- chance at avoiding both fates, mini- by other means.87 At least one court tors important to this determination mizing the threat of needless litiga- has found that the sheer volume and may include the volume of documents tion costs and possible sanctions duplicative nature of the subpoenaed sought, whether they have been pro- while maximizing the protection of materials warranted quashing.88 The duced previously by the HCO or patient health information. In short, lesson from these decisions is that, another party, and their availability to while the risk created by this dilemma unlike challenges based on state pri- investigators from a different source cannot be entirely resolved, it can be vacy protections, an HCO in receipt that would not require a violation of intelligently managed, thereby best of an unnecessarily expansive sub- state law. serving the interests of both the HCO poena for records should not be dis- and the many patients in its care. Where any of these concerns couraged from raising its concerns exist, counsel should confer with the with the court, particularly if the gov- government with the aim of winnow- ernment has proven unwilling to cur- Eric K. Gerard is ing the request. If informal efforts to tail its request. counsel to Kessler narrow the subpoena fail, the HCO Topaz Meltzer & may move to modify or quash the Check, a national Conclusion: Handling subpoena. Regardless, counsel should plaintiffs’ firm Federal Subpoenas Amidst consider seeking a declaration from a focused on securities Tightening State Privacy federal court that the HCO will be fraud, antitrust, False Restrictions immunized against state law penalties Claims Act, and other complex litigation. for disclosing protected records pursu- Before joining the plaintiffs’ bar, he The conflict between state medi- ant to the federal subpoena. Addi- served as an Assistant U.S. Attorney in cal privacy laws and federal subpoenas tionally, it may also be advisable to Florida, as an Assistant District Attorney in the healthcare industry is an emer- seek a protective order barring further at the Manhattan District Attorney’s gent one. While case law directly on disclosure of the production, as it Office in New York, and as a litigation point is limited, the decisions that do would demonstrate the HCO’s efforts associate at Hogan Lovells. He has been exist consistently affirm that federal to protect patient information to the recognized as a “Rising Star” by subpoenas, whether issued by a grand fullest extent possible despite its SuperLawyers magazine, and his trials jury or an administrative agency, pre- inability to refuse compliance. Lastly, have been reported in publications such vail over privacy provisions created the HCO should determine whether as Law360, USA Today, The Dallas continued on page 30 29 Volume 31, Number 6, August 2019 The Health Lawyer Supreme Dilemma: Handling Conflicts Between State Laws and Federal Subpoenas continued from page 29

Morning News, and others. He is a 7 See, e.g., 28 U.S.C. § 1826 (authorizing controlled substance investigations); 28 graduate of the University of Virginia imprisonment of recalcitrant witnesses in pro- C.F.R. § 0.100 (delegating authority to DEA). ceedings before federal courts and grand 19 School of Law. He may be reached at juries); 18 U.S.C. §§ 401 and 402 (providing See United States v. Mountain States Tel. & Tel. Co., 516 F. Supp. 225, 233 (D. Wyo. 1981). [email protected]. for punitive measures and criminal prosecu- tion of recalcitrant persons); Judiciary Act of 20 31 U.S.C. § 3733. 1789, 1 Stat. 73 (granting federal courts power “to punish by fine or imprisonment . . . 21 See United States v. Markwood, 48 F.3d 969, Brandt A. Leibe all contempts of authority in any cause or 976 (6th Cir. 1995) (FCA CID); United States is a partner in the hearing” before them). v. Witmer, 835 F. Supp. 208, 220 (M.D. Pa. 1993), aff’d, 30 F.3d 1489 (3d Cir. 1994) Special Matters 8 Fed. R. Crim. P. 6(e)(6); see also, e.g., Index Fund (same); FTC v. Invention Submission Corp., and Government v. Hagopian, 512 F. Supp. 1122, 1128 (S.D.N.Y. 965 F.2d 1086, 1087 (D.C.Cir.1992) (FTC 1981) (documents, not simply testimony, are Investigations group CID); see also 31 U.S.C. § 3733(j)(6) (Federal subject to grand jury secrecy provisions). Rules of Civil Procedure do not apply if their of King & Spalding, 9 United States v. Sells Engineering, Inc., 463 application is inconsistent with Section 3733). based in the firm’s U.S. 418, 428-31 (1983). 22 See, e.g., Doe v. United States, 253 F.3d 256, Houston and Washington, D.C., offices. 10 See Fed. R. Crim. P. 6(e)(7) (knowing viola- 263 (6th Cir. 2001). His practice focuses on white-collar crim- tions of secrecy obligations punishable as con- 23 See 5 U.S.C. § App. 3 § 6(a)(4) (enforcement inal defense, government investigations, tempt of court); United States v. Forman, 71 of Inspectors General subpoenas); 18 U.S.C. F.3d 1214, 1220 (6th Cir. 1995) (violators of § 3486(c); 21 U.S.C. § 876(c) (enforcement and related matters across a range of secrecy rules may be prosecuted for criminal of DEA subpoenas); 31 U.S.C. § 3733(j)(1) industries. His work has received acco- contempt and obstruction of justice). (enforcement of CIDs). 11 lades from a variety of legal publications, See Fed. R. Crim. P. 6(e)(2) (prohibiting obli- 24 See, e.g., United States v. Aero Mayflower including Chambers USA, Legal500, and gation of secrecy on a person except grand Transit Co., 831 F.2d 1142, 1146 (D.C. Cir. jurors, prosecutors and investigators involved 1987) (permitting cooperation between Law360. Before joining King & Spalding, in the investigation, and individuals facilitat- Inspector General and criminal prosecutors); ing the taking and recording of testimony, Mr. Leibe served as a law clerk to Justice see also 31 U.S.C. § 3733(i) (permitting cus- such as court reporters and interpreters). Clarence Thomas of the U.S. Supreme todian of CID production to share with DOJ 12 See In re Grand Jury Proceedings, 814 F.2d 61, attorneys for grand jury purposes). Court and Judge J. Michael Luttig of the 70 (1st Cir. 1987) (finding government letter 25 See, e.g., United States v. Phibbs, 999 F.2d U.S. Court of Appeals for the Fourth imposing 90-day nondisclosure obligation on 1053, 1077 (6th Cir. 1993) (administrative subpoena recipients violated Rule 6(e)(2)); Circuit. He is a graduate of Yale Law subpoenas “may be used to discover evidence United States v. Radetsky, 535 F.2d 556, 569 related to the charges in the original indict- School. He may be reached at bleibe@ (10th Cir. 1976) (admonition to witness not ment”); cf. USAM 9-11.120 (grand jury sub- kslaw.com. to disclose testimony violated Rule 6(e)(2)); cf. 12 U.S.C. § 3409 (authorizing court order poena “cannot be used solely to obtain delaying financial institution from notifying additional evidence against a defendant who customer of grand jury subpoena); 18 U.S.C. has already been indicted . . . [or] for pre-trial § 2705(b) (authorizing court-issued nondisclo- discovery or trial preparation”) (citations sure order under Stored Communications Act). omitted). Note, however, that in False Claims Endnotes Act cases, CIDs may be used only before the 1 See Department of Health and Human Services 13 Office of Legal Policy, United States Depart- government files a complaint of its own, be it and Department of Justice, Health Care Fraud ment of Justice, Report to Congress on the Use directly or in intervention in a qui tam suit. and Abuse Control Program Annual Report of Administrative Subpoena Authorities by Exec- See 31 U.S.C. § 3733(a)(1). (2018), https://oig.hhs.gov/publications/docs/ utive Branch Agencies and Entities, 7 (2002), 26 hcfac/FY2018-hcfac.pdf. https://www.justice.gov/archive/olp/rpt_to_ HIPAA Privacy Rule, 45 C.F.R. Part 160 and congress.htm. Subparts A and E of Part 164. PHI is defined 2 Department of Justice, Press Release: Justice as “individually identifiable health informa- Department Recovers Over $2.8 Billion from 14 See 5 U.S.C. § App. 3 § 6(a)(4) (source of tion” relating to a past, present, or future False Claims Act Cases in Fiscal Year 2018 subpoena power); see also S.Rep. 1071, 95th physical or mental health condition, the pro- (Dec. 21, 2018), https://justice.gov/opa/pr/ Cong., 2d Sess. 34 (1978), reprinted in 1978 vision of healthcare, or payment for health- justice-department-recovers-over-28-billion- U.S.C.C.A.N. 2676, 2709 (describing purpose care that identifies or could be used to false-claims-act-cases-fiscal-year-2018. of Inspector General Act). identify the subject of the information. 45 3 Fed. R. Crim. P. 17(c). 15 18 U.S.C. § 3486(a)(1)(A). C.F.R. § 164.501. 27 4 United States v. R. Enterprises, Inc., 498 U.S. 292, 16 18 U.S.C. § 3486(a)(6). Such orders require a 45 C.F.R. § 164.512(f)(1)(ii). 297 (1991); see also U.S. Const., amend. V, cl. 1. justification of potential danger, risk of flight, 28 Whalen v. Roe, 429 U.S. 589, 608 n. 28 spoliation, or witness intimidation. 5 498 U.S. at 297 (“[T]he Government cannot (1977) (“The physician-patient evidentiary be required to justify the issuance of a grand 17 See, e.g., Drug Enforcement Administration, privilege is unknown to the common law.”); jury subpoena by presenting evidence suffi- Press Release: Doctor, Office Administrator and but see 42 U.S.C. § 290dd-2 (imposing addi- cient to establish probable cause because the Nurse Practitioner Selling Prescriptions for Fen- tional federal privacy protections on and very purpose of requesting the information is tanyl and Oxycodone: Dr. Ernesto Lopez requiring court order for records related to to ascertain whether probable cause exists.”). Charged $2 Million in Fees to “Patients,” (Nov. substance abuse programs with federal nexus). 2, 2017), https://dea.gov/divisions/nyc/2017/ 6 See In re Grand Jury Proceedings, 486 F.2d 85, 29 45 C.F.R. § 160.202(b); 42 U.S.C. § 1320d-7 nyc110217.shtml; Drug Enforcement Admin- (a)(2)(B). 90 (3d Cir. 1973) (describing grand jury sub- istration, Press Release: Pill Mill Doctor Pleads poenas as “almost universally instrumentali- Guilty to Drug Distribution Conspiracy, Money 30 Cal. Civ. Code § 56.10(b); cf. Cal. Evid. ties of the United States Attorney’s Office”); Laundering (Jan. 30, 2017), https://www.dea. Code §§ 994 and 998 (creating physician- Lopez v. Department of Justice, 393 F.3d 1345, gov/divisions/no/2017/no013017.shtml. patient privilege under state law but rendering 1349 (D.C. Cir. 2005) (calling term “grand it inapplicable to criminal proceedings). jury subpoena” a “misnomer,” given prosecu- 18 21 U.S.C. § 876(a) (authorizing Attorney tor’s control over issuance). General to issue administrative subpoenas in 31 Cal. Penal Code § 1543(a).

30 The Health Lawyer Volume 31, Number 6, August 2019 32 Cal. Civ. Code §§ 56.35 and 56.36. 52 In re Grand Jury Proceedings, 450 F. Supp. 2d 1989). The court in this case also issued a pro- 33 115 (D. Me. 2006); see also Me. Rev. Stat. tit. tective order to prevent further distribution of Tex. Health and Safety Code §§ 181.001 et 22, § 1711-C. the medical records at issue. seq (enacted in 2011). 53 66 34 450 F. Supp. at 117. Massanari v. NW. Community Mental Health Tex. Occ. Code § 159.002(a), (b) and (e). Ctr., No. 01-MC-50E, 2001 WL 1518137, at 54 Id. at 119. 35 The statute contains various exceptions *1 (W.D.N.Y. Nov. 7, 2001) (declaring state where the patient is a party to ongoing litiga- 55 See, e.g., In re Grand Jury Subpoena, 460 F. law prohibiting disclosure “a nullity” in face tion or, in the criminal context, after an in Supp. 150, 151 (W.D. Mo. 1978) (state physi- of SSA subpoena under Supremacy Clause). cian-patient privilege does not apply to fed- camera review by the court. See id. § 159.003. 67 Cleveland Clinic Found. v. United States, No. eral grand jury proceeding); United States v. 36 1:11MC14, 2011 WL 862027, at *2 (N.D. See Tex. Occ. Code §§ 165.151 et seq. Sutherland, 143 F. Supp. 2d 609, 611 (W.D. Ohio Mar. 9, 2011). 37 Acosta v. Richter, 671 So. 2d 149, 154 (Fla. Va. 2001) (state privacy right does not obtain 1996) (discussing purpose of Florida medical in federal criminal proceedings); In re Grand 68 See, e.g., Gilbreath v. Guadalupe Valley Hosp. privacy laws); see also Fla. Stat. §§ 395.3025(4) Jury Subpoena John Doe No. A01-209, 197 F. Found., Inc., No. SA-92-CA-0031, 1992 WL (d) and 456.057(7)(a)(3) (nondisclosure pro- Supp. 2d 512, 515 (E.D. Va. 2002) (no state 551409, at *4 (W.D. Tex. Oct. 9, 1992), aff’d visions governing hospitals and physicians, physician-patient privilege in context of fed- sub nom. Gilbreath v. Guadalupe Hosp. Found. respectively). eral grand jury investigation); but see In re Inc., 5 F.3d 785 (5th Cir. 1993) (holding Grand Jury Subpoena for THCF Med. Clinic Texas physician-patient privilege inapplicable 38 Fla. Stat. §§ 395.3025(4)(d) and 456.057(7) Records, 504 F. Supp. 2d 1085, 1091 (E.D. to subpoena issued by U.S. Merit Systems (a)(3). Wash. 2007) (holding that while “[i]t is clear Protection Board); United States ex rel. Agency 39 Id.; see also State v. Johnson, 814 So. 2d 390, that the State’s sovereignty can be trumped by for Int’l Development v. First National Bank of 393 (Fla. 2002) (noting purpose of notifica- a federal subpoena” under Supremacy Clause, Maryland, 866 F.Supp. 884, 886-87 (D. Md. tion requirement). grand jury subpoena for medical records was 1994) (federal subpoena need not comply with unreasonable given the records’ marginal pro- notice requirements of Maryland Right To 40 See n. 9 supra. bativeness, contrary state privacy laws, and Financial Privacy Act); In re Subpoena To Tes- the availability of the information sought tify Before Grand Jury, 787 F. Supp. 722, 724 41 See Fla. Stat. § 456.057(15) and (16). from other sources). (E.D. Mich. 1992) (grand jury subpoena for 42 See, e.g., Ohio R.C. § 2317.02(B)(1); Me. records enforceable over state accountant-cli- 56 In re Grand Jury Proceedings, 607 F. Supp. 2d ent privilege); cf. Northwestern Memorial Hosp. Rev. Stat. tit. 22, § 1711-C; Or. Rev. Stat. 803 (W.D. Tex. 2009) (examining Tex. Occ. v. Ashcroft, 362 F.3d 923, 932 (7th Cir. 2004) Ann. § 192.558. Code. § 901.457 and 22 Tex. Admin. Code (“[C]omity ‘impels federal courts to recognize 43 § 901.457). See, e.g., Turk v. Oiler, 732 F. Supp. 2d 758, state privileges where this can be accomplished 777 (N.D. Ohio 2010) (noting Ohio state law 57 Id. at 807. at no substantial cost to federal substantive and contained no exception to privilege for state 58 procedural policy.’”). While the courts will grand jury subpoena). See, e.g., United States v. Silverman, 745 F.2d enforce a federal subpoena in the face of a con- 1386, 1398 (11th Cir. 1984) (finding Florida 44 U.S. Const., art. VI, § 2. The doctrine of con- flicting state privacy law, the latter remains law protecting confidentiality of bar com- effective as to state and local authorities. flict preemption demands that federal law pre- plaints inapplicable in federal prosecution of vails where “compliance with both federal attorney); United States v. Supreme Court of 69 See Fed. R. Evid. 501 and 1101(d)(2). and state regulations is a physical impossibil- New Mexico, 839 F.3d 888, 928 (10th Cir. 70 ity . . . and those instances where the chal- 2016), cert. denied, 138 S. Ct. 130 (2017), and See Fisher v. United States, 425 U.S. 391, 403 lenged state law stands as an obstacle to the cert. denied, 138 S. Ct. 78 (2017) (declaring (1976) (“Confidential disclosures by a client accomplishment and execution of the full pur- state law restrictions on subpoenaing attor- to an attorney made in order to obtain legal poses and objectives of Congress.” Arizona v. neys preempted by federal grand jury sub- assistance are privileged.”); Upjohn Co. v. United States, 567 U.S. 387, 399 (2012) (inter- poena power); In re Grand Jury Subpoena, 688 United States, 449 U.S. 383, 397 (1981) nal quotations omitted) (citations omitted). F.Supp. 319, 320 (W.D.Tenn.1988) (Tennes- (applying work-product doctrine to IRS sub- poenas); Jaffee v. Redmond, 518 U.S. 1, 13 45 see statute barring disclosure of bank records See, e.g., In re Zuniga, 714 F.2d 632, 636 (6th (1996) (affirming communications between Cir. 1983) (“[I]nasmuch as the subpoenas in from disclosure preempted by federal grand jury subpoena); but see In re Hampers, 651 F.2d psychotherapist and patient are protected issue are the product of a federal grand jury from compelled disclosure under Rule 501). investigation into alleged violations of federal 19 (1st Cir. 1981) (finding Massachusetts criminal law, questions of privilege are gov- Commissioner for Revenue enjoyed qualified 71 425 U.S. at 410-11; see also United States v. erned by federal law.”) (citation omitted). privilege against grand jury subpoena for tax Hubbell, 530 U.S. 27, 36-37 (2000) (“[T]he records). act of producing documents in response to a 46 In re Grand Jury Matter, 762 F. Supp. 333, 334 59 subpoena may have a compelled testimonial (S.D. Fla. 1991). This decision did not United States v. Zadeh, 820 F.3d 746 (5th Cir. 2016); see also 21 U.S.C. § 876. aspect.”). A corporate or other collective address the current provision requiring notice entity, however, may not assert a Fifth to the patient by the issuing party, which 60 Id. at 752. Amendment privilege, nor may an individual would violate the grand jury secrecy require- who possesses corporate records only in a rep- 61 Oregon Prescription Drug Monitoring Program v. ments of Rule 6(e). resentative capacity. See Bellis v. United States, U.S. Drug Enf’t Admin., 860 F.3d 1228 (9th 417 U.S. 85, 88 (1974). 47 Id. at 334-35 (citations omitted). Cir. 2017). 72 United States v. Kovel, 296 F.2d 918, 923 (2d 48 Id. at 336 (physician could not be said to will- 62 Or. Rev. Stat. § 431A.865(2)(a)(G). fully violate state statute by complying with Cir. 1961). 63 860 F.3d at 1236. federal law). 73 See In re Grand Jury Proceedings #5 Empanelled 64 49 Matter of Grand Jury Proceedings Krynicki, 2 See United States Dep’t of Justice v. Utah Dep’t Jan. 28, 2004, 401 F.3d 247, 251 (4th Cir. F.3d 1153 (7th Cir. 1993). of Commerce, No. 2:16-CV-611-DN-DBP, 2005) (discussing crime fraud exception to 2017 WL 3189868, at *9 (D. Utah July 27, attorney-client privilege); In re Horowitz, 482 50 Id. at *1. 2017) (finding preemption provision of CSA F.2d 72, 82 (2d Cir. 1973) (discussing waiver defeats state law requiring search warrant to of attorney-client privilege). 51 Id. at *4. Privileges in federal court are gov- obtain PDMP data); U.S. Dep’t of Justice v. erned by federal statute, the Constitution, and 74 See n. 24 supra. A qui tam action, the abbrevi- Colorado Bd. of Pharmacy, No. 10-CV- federal common law, not state law. Fed. R. ation of a Latin phrase meaning “who brings 01116-WYD-MEH, 2010 WL 3547896, at *1 Evid. 501; see also United States v. Gillock, 445 the action for the king as well as himself,” (D. Colo. Sept. 3, 2010) (finding Colorado U.S. 360, 368 (1980); United States v. Burzyn- permits a private whistleblower (called a law restricting release of PDMP data to ski Cancer Research Institute, 819 F.2d 1301, “relator”) to bring suit under the False Claims patients, not prescribers, preempted by CSA). 1311 (5th Cir.1988) (“In the context of fed- Act against one or more defendants alleged to eral criminal proceedings, no physician- 65 St. Luke’s Reg’l Med. Ctr., Inc. v. United have defrauded the federal government. See patient privilege exists.”). States, 717 F. Supp. 665, 666 (N.D. Iowa 31 U.S.C. §§ 3729-3733. continued on page 32 31 Volume 31, Number 6, August 2019 The Health Lawyer Supreme Dilemma: Handling Conflicts Between State Laws and Federal Subpoenas continued from page 31

75 463 U.S. at 432. 83 United States v. Dionisio, 410 U.S. 1, 11 grand jury subpoena as overbroad); United (1973) (internal quotations omitted) (cita- States v. Sutherland, 143 F. Supp. 2d 609, 613 76 410 U.S. at 11. tions omitted); see also Fed. R. Crim. P. 17(c) (W.D. Va. 2001) (modifying grand jury sub- 77 498 U.S. at 301. (2) (requiring that subpoena not be “unrea- poena to require patient notice despite Rule sonable or oppressive”); 228 F.3d at 347 (cit- 78 6(e)(2) secrecy provisions). See Mapp v. Ohio, 367 U.S. 643 (1961); U.S. ing See v. City of Seattle, 387 U.S. 541, 544 Const., amend. IV. (1967)); see also United States v. Whispering 87 See THCF Medical Clinic Records, 504 F.Supp 79 See n. 5 supra. Oaks Residential Care Facility, LLC, 673 F.3d 2d at 1090 (“The Government has not shown 813, 817 (8th Cir. 2012) (“A subpoena is 80 why it needs to obtain all of the addresses and In re Subpoena Duces Tecum, 228 F.3d 341, 347 properly enforced if (1) issued pursuant to (4th Cir. 2000) (citing Hale v. Henkel, 201 phone numbers from the State of Oregon and lawful authority, (2) for a lawful purpose, (3) the THCF Medical Clinic rather than from U.S. 43, 76, 26 S.Ct. 370, 50 L.Ed. 652 requesting information relevant to the lawful some other source.”); 651 F.2d at 23 (finding (1906)). purpose, and (4) the information sought is not qualified privilege under state law against dis- 81 498 U.S. at 301-02. unreasonable.”). closure of state tax records to federal grand 82 Id. at 301 (“[T]he motion to quash must be 84 Fed. R. Crim. P. 17; see also 228 F. 3d at 350. jury given government’s alternate means to denied unless the district court determines 85 498 U.S. at 302. obtain same records under provision of tax that there is no reasonable possibility that the code). category of materials the Government seeks 86 See, e.g., In re Grand Jury No. 09-1, No. will produce information relevant to the gen- 6:10MC38ORL31DAB, 2010 WL 2330273, 88 See In re Grand Jury Investigation, 746 F. Supp. eral subject of the grand jury’s investigation. at *8 (M.D. Fla. June 10, 2010) (quashing 866, 867 (E.D. Wis. 1990).

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33 Volume 31, Number 6, August 2019 The Health Lawyer LESSONS LEARNED FROM A NEW MEDICAL-LEGAL PARTNERSHIP: PATIENT SCREENING, INFORMATION AND COMMUNICATION

Janet Dolgin, PhD, JD further impact health negatively. For been formed and were operating in 46 Johanna Martinez, MD instance, stress has been shown to be states.13 They take several forms. Anthony Serrano, Esq. an independent risk factor for poor Almost a third of them (121, as of Hofstra/Northwell Medical-Legal health. Fortunately, it can be miti- early 2019) had been formed between Partnership gated by effective responses to health- lawyers and general hospitals and/or Nassau County, NY harming legal needs.7 health systems. Others were operating in health centers funded through the Medical-legal partnerships respond federal Health Resources and Services to these needs and consequently have Introduction Administration14 (98), children’s hos- been able to demonstrate improvements pitals (33), veterans affairs medical The United States spends signifi- in outcomes.8 Their interdisciplinary cantly more on healthcare than any centers (25), and other healthcare framework offers particular benefits: 15 other nation.1 Yet the health of the settings (56). Moreover, the major- nation’s population is inferior to that Through training, lawyers teach ity of existing medical-legal partner- of many other nations that spend sig- doctors how to “observe the ships include health organizations nificantly less on healthcare.2 Access health effects of socioeconomic that partner with legal services agen- 16 to healthcare can be essential to an factors or detect when such fac- cies or academic law clinics. About individual’s maintaining or returning tors detract from their patients’ one-third of the healthcare facilities to good health. But the social determi- care.” When such factors are identi- that participate in medical-legal part- nants of health are at least as impor- fied, doctors can turn to their legal nerships have included funding for the 17 tant. Moreover, social determinants partner to provide the knowledge, partnerships’ work in their budgets. play a significant role in facilitating or resources and assistance to remove 9 limiting access to healthcare.3 or mitigate adverse circumstances. Hofstra/Northwell The social determinants of health By working together, doctors and Medical-Legal Partnership have been identified as “the condi- lawyers, often in partnership with other professional groups, are able to In the fall of 2018, the Maurice A. tions in which people are born, grow, Deane School of Law at Hofstra Uni- live, work and age.”4 Further, the respond more effectively to negative social determinants or health-harm- versity (“Hofstra”) and the Northwell social determinants of health, includ- Health System (“Northwell”) joined ing the slope of a society’s socio-eco- ing legal needs than either profes- sional group could working alone. the medical-legal partnership move- nomic hierarchy and a person’s place ment, integrating Hofstra attorneys on that hierarchy, have a greater The medical-legal partnership and supervised law students within impact on health than individual model was developed in the early three of Northwell’s outpatient medi- choices (which are, themselves, influ- 1990s to respond to patients’ health- cal clinics. Hofstra, founded in 1935, enced by a person’s socio-economic harming legal needs and was first is situated on 240 acres in Hemp- 5 status). Strikingly, the United States implemented in 1993 at Boston Chil- stead, New York (Nassau County) spends more on healthcare per capita dren’s Hospital.10 Since then, hospitals about 25 miles east of New York City. than any other nation, and it spends and other healthcare institutions The University is private and non- significantly less on social services.6 throughout the nation have adopted sectarian. Hofstra has almost 140,000 That choice could undermine the the model. At the same time, the alumni.18 Northwell, the largest clini- nation’s health. focus of the medical-legal partnership cally integrated health system and movement has expanded to respond The health of people who face largest private employer in New York to the diverse needs of children, adults health-harming legal needs – such as State, includes more than 20 hospi- and specific patient populations, such adequate and nutritious food, safe tals and almost 750 outpatient facili- as patients with cancer or HIV.11 19 housing, and a safe environment – is ties. Northwell Health Physician Partners20 provide healthcare in more compromised by those unmet needs. In 2007 the American Bar Associ- than 100 medical specialties.21 In addition, the stress of having ation resolved to support the develop- adverse social determinants of health ment of medical-legal partnerships.12 The Hofstra/Northwell Medical- and health-harming legal needs can By 2019, 333 such partnerships had Legal Partnership identifies and

34 The Health Lawyer Volume 31, Number 6, August 2019 addresses the health-harming legal following the model of the National screening tool, administered by patient needs of patients at Northwell. Most Medical-Legal Partnership – now navigators working in the clinics for live in Nassau and Queens Counties include “income supports” (helping several years before creation of the in New York State,22 and most of the patient-clients gain access to public medical-legal partnership. Through patients enrolled in the partnership benefits to which they are entitled); that tool, navigators have identified are Medicaid-eligible or uninsured. housing (helping patient-clients find clinic patients with health-harming The partnership’s mission calls for and keep habitable housing); education social and legal needs.25 That screen- delivering legal services in a number (responding to children’s special educa- ing tool offered a very useful model. In of essential areas to clinic patients and tion needs); employment (responding order to serve the medical-legal part- to their immediate family members. to discrimination in hiring, promo- nership’s patient-clients as effectively tion and/or firing); and legal status as possible, the screen has undergone In 2018, the general pediatric (responding to the immigration needs several quality improvement cycles. practice in the outpatient Northwell of undocumented immigrants).23 pediatric clinic (one of the clinics in A second challenge has been which the Hofstra/Northwell Medi- Each medical-legal partnership patient-client engagement. That cal-Legal Partnership operates) had a faces a series of challenges as it con- challenge was occasioned by the caseload of over 12,000 patients in structs how best to serve its patient-cli- search for a better method of engag- 2018 and averages more than 40,000 ent population. This article explores ing patients in need of legal assis- visits each year. (All of the data pre- three challenges – and the lessons tance. At the same time, the medical- sented in this paragraph come from learned from them – that arose in the legal partnership has struggled to Northwell records.) Approximately early months (late 2018 through the identify reasons that patients decline two-thirds of these patients received first five months of 2019) after imple- the legal help that the partnership healthcare coverage through Medic- mentation of the Hofstra/Northwell offers to them and to respond to pat- aid or Medicaid managed-care plans. Medical-Legal Partnership in October terns of patient refusal through educa- The other Northwell clinics that are 2018. It describes responses to those tion and changes in protocol. These served by the medical-legal partner- challenges that have been or are being concerns require construction of ship are general internal medicine constructed by the medical-legal part- approaches that decrease the stigma, clinics (providing outpatient care to nership’s interdisciplinary team,24 and even fear, that clinic patients patients at least 18 years of age). The including attorneys and physicians, as have sometimes associated with seek- larger of the two adult clinics averages well as social workers, patients, ing legal help. more than 26,000 patient visits annu- patient navigators, and administra- Third, the medical-legal partner- ally. About 40 percent of the patient tors. It also describes some persistent ship has struggled and continues to population using this clinic receives stumbling blocks with which the struggle with information sharing coverage through Medicaid or is unin- medical-legal partnership continues among professionals. There are sev- sured. About 70 percent of the to struggle. It explores each of these eral limitations on sharing informa- patients who use the smaller of the challenges and the medical-legal part- tion about patients and clients two adult clinics (with approximately nership’s evolving responses to them. without overstepping the partner- 5,000 patient visits annually) is cov- The first challenge concerns ship’s agreements, violating federal ered by Medicaid or is uninsured. screening. Screening is essential to and state laws or compromising attor- Each of the Northwell clinics (one identify medical-legal partnership ney-client privilege. pediatrics and two internal medicine) patients. Each medical-legal partner- in which the medical-legal partner- ship needs an effective and compas- ship operates has a large team of pro- Challenges and Developing sionate method for screening patients fessionals that includes doctors, for health-harming legal needs that Responses nurses, social workers, a psychologist, allows non-professionals (patient nav- The Hofstra/Northwell Medical- and now attorneys. igators) to identify patients in need of Legal Partnership team has identified Patients who screen positive for social or legal assistance. The screen- and addressed the three challenges: health-harming legal needs are ing tool also helps the patient naviga- screening, patient-client engagement, referred by the medical-legal partner- tors to distinguish between patients and information sharing, with varying ship’s patient navigators to social needing assistance from social workers levels of success. The partnership has workers or to medical-legal partnership associated with the outpatient clinics constructed a successful response to attorneys. The navigators have been and those needing assistance from the first challenge. The second chal- trained to identify which resources attorneys or other resources. Initially, lenge is being addressed through a set and/or profession can best address a the partnership leveraged the struc- of institutional responses that have patient’s needs. The legal services – ture and content of a pre-existing not yet been fully implemented. And continued on page 36 35 Volume 31, Number 6, August 2019 The Health Lawyer Lessons Learned From a New Medical-Legal Partnership continued from page 35 the third continues to present unre- augment a data capture system avail- few false positives. In addition to solved concerns and questions. able to all partners. This has facilitated facilitating navigators’ identification navigators’ success in determining of patients in need of legal services, Screening Patients for Health- which patients have health-harming the tool has proved valuable to attor- Harming Legal Needs needs best addressed by social workers neys and clients during initial consul- Medical-legal partnerships are and which patients would be best tations. In particular, attorneys have only as effective as their capacity to served by referral to an on-site attor- been able to formulate more probing, identify patients with health-harming ney. The intake process is handled dif- directed questions at the start of cli- legal needs. In many medical-legal ferently should a patient present with ent consultations than would other- partnerships, trained physicians, an emergent legal need such as a wise have been possible. including residents, and social work- threatened deportation or eviction. Despite the usefulness that the ers screen patients for possible referral Patients with potentially serious and 26 algorithm has had for patient screen- to attorneys. That approach has emergent legal needs are offered the ing, a number of constraints continue proven impractical for the Hofstra/ opportunity to meet immediately Northwell Medical-Legal Partnership with an on-site attorney. to limit the tool’s success in helping because of the high volume of to screen patients. The medical-legal Augmentation of the data cap- patients using the clinics in which partnership is responding actively to ture system28 has involved develop- the partnership operates. Thus, the these constraints. First, the effective- ment of a triage algorithm that assists partners decided to rely on the ness of the screening tool is curtailed navigators in identifying patients’ patient navigators who were already if navigators do not proceed through social and legal needs and in distin- working in the clinics and were iden- the full set of questions dictated by guishing between them. The algo- tifying patients with social needs. the tool’s branching logic. That does rithm features a branching logic that Partnership physicians and attorneys not always happen, in part because directs navigators to subsequent ques- educated the navigators about the conversations between navigators and tions in light of patients’ responses to scope and goals of the partnership, patients are guided by the natural early questions. In short, a patient providing them with comprehensive flow of language. That flow can inter- identified on initial screening as hav- information about health-harming rupt navigators’ focus on questions ing a potential social or legal need is legal needs and about distinctions that would have been suggested by guided through a series of follow-up between those needs and needs to the algorithmic tool which, in com- questions that “unlock” subsequent which hospital social workers can best parison to natural language, can seem questions or algorithmic responses. respond. By early 2019, patient navi- robotic to the navigators and to the gators at the Northwell clinics in Navigators’ reliance on the patients. This stumbling block can which the medical-legal partnership branching logic algorithm for screen- probably not be remedied completely operates had screened about 2,000 ing patients has proven to be effi- because the preservation of natural clinic patients. About half screened cient.29 In the first five months of the conversation is essential to the devel- positive for at least one adverse social medical-legal partnership’s operation, opment of a comfortable patient-nav- determinant of health and about 10 navigators using branching logic igator relationship. The Hofstra/ percent screened positive for health- identified scores of patients with Northwell Medical-Legal Partnership harming legal needs. Most patients health-harming legal needs that have can, however, ensure that navigators who screened positive for social and/ spanned the panoply of legal needs are aware of methods for completing or legal needs presented with multiple for which partnership attorneys offer the algorithm’s branching logic while needs. However, almost one-third of assistance. On-site attorneys con- allowing for empathic interaction those screening positive after the ini- sulted with a majority of these with patients. tial intake did not complete the pro- patients. About 52 percent of the Second, the algorithmic tool has cess that would lead to referral to a patients with whom medical-legal proven problematic for patients with partnership lawyers were able to make lawyer and have thus not received immigration issues. Legal challenges legal assistance.27 a connection received substantive for undocumented patients are often legal services from attorneys and the In addition to the screening tools serious and emergent. Furthermore, law students working under attorney developed before creation of the med- patients may be hesitant to discuss supervision. ical-legal partnership by several phy- concerns about their legal status. The sicians at Northwell, the Hofstra/ Use of questions embedded in the Hofstra/Northwell Medical-Legal Northwell partners have worked to branching logic tool have resulted in Partnership has thus designed the

36 The Health Lawyer Volume 31, Number 6, August 2019 branching logic in this domain so needs have been identified and a legal resources to patients? What that it captures almost everyone with meeting with a medical-legal partner- information should be delivered? And any sort of immigration issue. That is ship attorney has been scheduled. In what is the most effective tool for to say, the partnership has chosen a short, patients told that they are eligi- delivering this information? The part- logic that over-screens patients for ble for free legal assistance with the nership expects to work on several immigration issues rather than risk goal of resolving or mitigating a levels, at least initially, in identifying missing patients who do have emer- health-harming legal need do not who should speak with patients about gent immigration problems. Each of always accept that offer. Furthermore, legal resources. The medical-legal the cases in which a patient is identi- some patients decline to proceed with partnership, as such, plans to promote fied as having any sort of immigration legal representation after an initial its services in public spaces, including problem is referred to an attorney, but consultation with a medical-legal town libraries, through workshops many of those patients might have partnership attorney. and information sessions. Further, been referred more productively to Preliminary, largely anecdotal within the medical-legal partnerships 30 social workers. data collected by physicians at the clinics, enhanced education about the partnership’s work, provided by the As a general matter, the branch- medical-legal partnership clinics sug- patient navigators, social workers, ing logic tool facilitates the identifi- gest that this reluctance reflects and care coordinators may increase cation of legal issues as a category of stigma associated with the need for success in effectively communicating social needs. In the future, Hofstra/ legal help, and, correlatively stigma information about the help that part- Northwell Medical-Legal Partnership associated with some of the indicia of nership attorneys can offer to the doctors and lawyers would also like to socioeconomic status. For undocu- clinics’ patients. be able simultaneously to identify mented immigrants, that stigma is legal needs through reference to med- compounded by the fear that an New modes of navigator training ical diagnoses. The paradigmatic attempt to gain legal status may may also situate patient navigators example of this sort of reference is the result, instead, in deportation. Similar more effectively to ease patients’ anx- suggestion that the home of a child anxieties may affect the parent of a ieties about accepting legal help and with asthma should be surveyed for pediatric patient who hesitates to dis- will offer a successful response to our toxins that exacerbate the condition. cuss problems with housing for fear second concern (ensuring that This sort of reference reflects the med- that he or she could be identified as patients feel comfortable talking with ical-legal partnership’s goal of provid- neglectful or fearful that addressing navigators, and then with lawyers, ing holistic, integrated services to the housing problems could backfire, about health-harming legal needs). patient-clients. To meet that goal, the leading to eviction or retaliation by a Two Northwell physicians31 (each of Hofstra/Northwell Medical-Legal Part- landlord. Accordingly, the partner- whom played a central role in develop- nership hopes to develop a companion ship is working on two fronts. It is ing the pre-medical-legal partnership tool that will facilitate identification working to enhance communication screening tool) plan to implement of legal needs directly from codes for channels (1) between navigators and “empathic inquiry training” for patient certain medical diagnoses. Moreover, patients and (2) between attorneys navigators at Northwell. It is expected this might be done in conjunction and clients. This will facilitate more that this training will broaden navi- with hospital lists used to identify and successfully explaining the work of gators’ communication skills and remind patients who have not kept the medical-legal partnership to effect more trusting relationships with routine appointments (e.g., for annual patients and in addition, it will help patients. These changes should check-ups, mammograms). patients feel safe and comfortable increase patient engagement. Correla- working with attorneys. Despite those tively, it is expected that those patient- Responding to Patients’ efforts, not all patients with health- clients who are privy to empathic Reluctance to Seek harming legal needs will want to inquiry communication will more read- Legal Assistance engage medical-legal partnership law- ily accept advice from physicians and yers. Such refusals from informed A second challenge, sometimes from medical-legal partnership attor- patients must be respected. manifest during screening or thereaf- neys than other medical-legal partner- ter, reflects patients’ reluctance to The first concern – how best to ship patient-clients.32 accept legal assistance. This reluctance explain our work to patients with Communication Among is reflected in patients’ hesitation health-harming legal needs so as to Professionals and Limitations about engaging with attorneys initially. engage patients and build trust – has on Data Sharing It is also reflected in patients’ concerns raised three practical questions: Who about moving forward with legal repre- is best situated to deliver information The third medical-legal partner- sentation after health-harming legal about the medical-legal partnership’s ship challenge addressed in this continued on page 38 37 Volume 31, Number 6, August 2019 The Health Lawyer Lessons Learned From a New Medical-Legal Partnership continued from page 37 article concerns constraints on shar- medical-legal partnerships that func- meetings without significant risk of ing information about patients and tion through organizational separa- losing the attorney-client privilege.38 clients between partners – that is, tion, relying on a multidisciplinary In contrast, information and com- between those affiliated with North- approach to the partnership, and munications saved in electronic form well (e.g., clinicians, social workers, those that function through reliance cannot be shared within the Hofstra/ hospital administrators) and those on an interdisciplinary frame. At this Northwell Medical-Legal Partnership affiliated with Hofstra (e.g., lawyers time, the Hofstra/Northwell Medical- regardless of patient consent. Arrange- and students under the supervision of Legal Partnership is committed to ments between the two institutions lawyers). The extent of data sharing is an interdisciplinary perspective. But composing the partnership (Hofstra an important area of concern for all that could change in light of research and Northwell) preclude sharing elec- medical-legal partnerships.33 Deci- findings or in response to shifts in the tronic data across institutional bound- sions about data sharing help deter- medical-legal partnership’s proce- aries. There are good institutional mine the shape of a medical-legal dural goals. reasons for caution about sharing partnership. Among the challenges In any event, concerns about data, and this preclusion is not unique the Hofstra/Northwell Medical-Legal data sharing are more complicated to the Hofstra/Northwell Medical- Partnership has faced, this one is with regard to the sharing of elec- Legal Partnership. Among other proving more resistant to resolution tronic data than the sharing of other things, as discussed above, attorneys are than others. forms of data. Even information concerned about protecting attorney- Sharing data is not essential. The shared during in-person conversations client privilege, and hospital systems legal arm of a medical-legal partner- can raise problems. However, these and other healthcare organizations are ship can work independently of the problems can be resolved more easily concerned about abiding by rules medical arm, much as a law firm than problems occasioned by sharing regarding data sharing and privacy. working for a hospital might. Some electronic data and will thus be con- Limitations on hospitals’ sharing infor- medical-legal partnerships have opted sidered first. mation reflect federal and state39 laws, for a separation of services. Clinicians including the privacy protections that In particular, patient information can refer patients to medical-legal followed promulgation of the federal can only be shared if patients, informed partnership lawyers who then provide Health Insurance Portability and about the consequences of sharing legal services. This organizational Accountability Act of 1996 (“HIPAA”).40 data, agree to that. Yet, even if form does not assume the delivery of Privacy law, in general, imposes stricter patients agree to data sharing, the holistic, integrated services. limitations on hospitals and healthcare participation of third parties in client- professionals than on universities. Indeed, limits on data sharing attorney conversations may interfere become increasingly important the with attorney-client privilege. That More specifically, the legal arm of more the medical-legal partnership’s privilege protects client communica- the medical-legal partnership relies physicians and lawyers aim to provide tions with attorneys from being on CLIO, a cloud-based legal man- holistic care to patient-clients. The revealed in court or in other legal set- agement system. The medical arm of difference between medical-legal tings.36 The risk that the privilege the partnership relies on an electronic partnerships that focus on this goal could be obviated because of the par- medical record (“EMR”) for recording and those that do not can be analo- ticipation of a patient’s physician or information about patient care. These gized to the difference between inter- other clinician in a meeting with the systems are not integrated. All data disciplinary and multidisciplinary patient’s medical-legal partnership recorded in either is protected from teams.34 Challenges occasioned by lawyer can be mitigated by formally access by those using the other sys- limitations on sharing data have designating the medical participant as tem. This separation, though perhaps arisen for the Hofstra/Northwell a member of the client’s legal team.37 unavoidable in light of institutional Medical-Legal Partnership insofar as The medical professional’s participa- concerns, limits the capacity of the partners have been reluctant to pre- tion may be useful in helping explain medical-legal partnership to develop clude the benefits assumed to accrue how the social determinants of health a holistic approach to care. Such an to patients and clients from holistic, affect a client’s health problems. That approach would seem clearly to integrated care.35 More research is provides justification for designating depend on the possibility of sharing needed on the comparative value to the clinician as a member of the legal data. Further, constraints on sharing all medical-legal partnership partici- team, at least for purposes of partici- data complicate assessments of the pants (especially patient-clients) of pating in specific attorney-client work of the medical-legal partnership.

38 The Health Lawyer Volume 31, Number 6, August 2019 Again, these problems would dimin- happen, data sharing would be of their group’s core functions and dis- ish in the context of a multidisci- decreasing concern to the partner- tinguish those functions from the core plinary partnership that did not aim ship’s participants. functions of other groups working to provide holistic care. within the hospital setting. In the context of a medical-legal partner- Were the partners to the Hofstra/ Additional Challenges ship, each professional partner should Northwell Medical-Legal Partnership be able to understand his or her pro- able to share electronic data across In addition to the challenges dis- fessional identity within the context institutional boundaries, waivers on cussed above, the Hofstra/Northwell of the partners’ professional identities. which they now rely in sharing non- Medical-Legal Partnership is respond- An additional recommendation calls electronic data (e.g., in the course of ing to a slew of other conundrums for the delineation of a “standard of attorney-client communications) that face many medical-legal partner- quality” and a method for assessing its would become necessary. These include ships. These provide fodder for future actualization or not. An ethics code HIPAA waivers of authorization41 and articles. Such challenges include for those working together in medi- waivers of attorney-client privilege. ensuring the partnership’s sustainabil- ity; broadening the focus of the part- cal-legal partnerships would need to Those options raise significant ques- define a standard of quality for effect- tions in their own right, questions that nership’s legal services; involving physicians, nurses, and social workers ing and assessing the partnership’s cannot responsibly be elided, but they interdisciplinary work.46 are relevant to shared data in elec- not initially identified with the work tronic or non-electronic form. of the medical-legal partnership; and expanding work beyond the partner- As a technical matter, the medi- Conclusions and Lessons ship’s initial clinic settings, both into Learned cal-legal partnership’s legal and medi- more specialized clinics and into the cal data could be integrated and community (including, for instance, The challenges discussed in this shared through a hospital “dashboard” schools and prisons). article, though specific to medical- that brings a number of data sources legal partnerships, suggest a wider set A challenge of particular impor- (e.g., population health information; of challenges facing attorneys involved tance – but one beyond the scope of the claims information) together. Such a in various forms of multidisciplinary present article – has been occasioned by dashboard could also include legal and interdisciplinary work.47 Such col- data, providing the partnership with confusions that can arise among profes- laborative work can be productive. an integrated approach to data analy- sionals aware of and committed to dis- 42 Thus, some of what has been learned sis. This option is not available to the similar codes of professional ethics. from challenges that have arisen in the Hofstra/Northwell Medical-Legal The medical-legal partnership move- course of planning and implementing Partnership, of course, since at pres- ment has responded with sample Mem- the Hofstra/Northwell Medical-Legal ent the two institutions are precluded oranda of Understanding and online Partnership can be usefully translated from sharing any electronic data courses that outline challenges faced into helpful guidance for other health across institutional boundaries. An by professionals committed to distinct lawyers who work actively with clini- 43 alternative approach might be the professional codes. cians, social workers, psychologists and creation of a data “clean room” – a Creation of a new, supplemental members of other professional groups. common place in which aggregated professional code of ethics, appropri- Education about the goals and pro- data (but not data about individual ate for interdisciplinary work among cesses of multidisciplinary or interdis- patient-clients) is shared. The part- medical clinicians and lawyers, might ciplinary work is essential. Educational nership continues to consider how focus on shared components of profes- programs must be shaped in light of best to deliver holistic care to its sional identity as well as on compo- the goals and needs of specific collab- patient-clients in light of constraints nents that may not be amenable to orative efforts. The Hofstra/Northwell on sharing data. Its responses look to sharing but that, as such, should com- Medical-Legal Partnership has focused interdisciplinary education and robust pel each professional group to under- on educating clinicians (including, communication among the medical- stand the other group’s professional especially, residents), lawyers, social legal partners concerning the partner- workers, patient navigators, patients, assumptions.44 ship’s over-arching goals and the best clients, and students from the Univer- processes through which to reach The professionalization of hospi- sity’s schools of law and medicine those goals. In the future, it is possible tal chaplains offers a model.45 Focus- about the social determinants of that The partnership will replace its ing on the need for professional health and the significance of the vision of an interdisciplinary medical- accountability, one author recom- work of the medical-legal partnership legal partnership with that of a multi- mends that new professional groups for patients from vulnerable popula- disciplinary organization. Should that such as hospital chaplains delineate tions, and its significance for medical continued on page 40 39 Volume 31, Number 6, August 2019 The Health Lawyer Lessons Learned From a New Medical-Legal Partnership continued from page 39 clinicians and attorneys privileged to between NYC Health + Hospitals and Anthony Serrano is engage in work that promises to LegalHealth stresses the importance a New York licensed increase the health and welfare of for any medical-legal partnership of attorney and the vulnerable populations. “establish[ing] open communications Legal Director of the and means of collaboration” between Hofstra/Northwell Every medical-legal partnership is doctors and lawyers at the start.49 Fur- Medical-Legal unique. Some have involved affilia- ther along, the Hofstra/Northwell Partnership. He tions between health organizations Medical-Legal Partnership hopes to works alongside Northwell clinicians, and academic institutions. Others report, as has that created between the social workers and faculty to design, have involved affiliations between NYC Health + Hospitals and Legal- develop, launch and manage key compo- health organizations and legal aid Health, that its work has demon- nents of the medical-legal partnership’s societies. Some offer a wide array of strated a good “financial return on on-site services, broader advocacy legal services; others offer more lim- investment.”50 This suggests that campaigns and training. Prior to joining ited services. Among medical-legal medical-legal partnerships are effec- Hofstra Law School, Mr. Serrano spent partnerships, the distribution of duties tive in serving the “triple aim”: at nearly a decade serving as Senior and obligations among professional once, they improve patients’ experi- Counsel, Legal and Public Affairs at The participants can differ significantly. In ences with healthcare, serve popula- Margolin Group, LLC – a health policy addition, sources of medical-legal tion health, and decrease the cost of advisory services firm. In this role, he partnership funding differ from part- healthcare, per capita.51 worked with clients across the continuum nership to partnership.48 of healthcare and coverage to build Yet, all medical-legal partnerships complex clinical, educational and Janet Dolgin (B.A. must focus on teaching professionals to research initiatives. When not imple- in philosophy, cooperate as team members, and those menting multi-stream initiatives through Barnard College; that aim to work in an interdisciplinary the medical-legal partnership, he serves as Ph.D. in anthropol- an Assistant Professor of Law, teaching fashion must focus as well on abandon- ogy, Princeton Business Transactions in Healthcare in ing professional silos. Most important, University; J.D., Yale Hofstra’s online health policy program. all medical-legal partnerships strive to University) is the He may be reached at anthony.c.serrano@ improve the health of individuals and Jack and Freda Dicker Professor of Health Northwell.edu. populations by identifying and Care Law at the Maurice A. Deane responding to the social determinants School of Law at Hofstra and Professor, Dr. Johanna Martinez of health and to health-harming legal Science Education at the Zucker School serves as the GME needs. In doing this, many medical- of Medicine at Hofstra/Northwell. She is Director for Diversity legal partnerships have faced the sort co-Director of the Hofstra Bioethics and Health Equity for of challenges delineated here. Center and Director of the Gitenstein Northwell Health Institute for Health Law and Policy (the Specific solutions to those chal- and is an Associate “Institute”). Professor Dolgin and her lenges must be crafted in light of the Professor at the colleagues at the Institute have imple- institutional identity of each medical- Zucker School of Medicine at Hofstra/ mented many public policy and legal legal partnership’s participants, the Northwell. She received her medical service projects, including the Hofstra- scope of the partnership, and the degree from SUNY Stony Brook and Northwell Medical-Legal Partnership. social determinants most likely to completed her Internal Medicine resi- affect the health of the medical-legal Professor Dolgin has written several books dency at New York-Presbyterian Hospital partnership’s patient-client popula- and scores of articles, focusing on family (Weill Cornell Campus). Her training tion. Some goals are shared among all law and on shifts in the structure of also includes a General Medicine Faculty medical-legal partnerships. A success- healthcare in the United States. The Development Fellowship at the ful medical-legal partnership assumes fourth edition of Bioethics and the Law University of North Carolina- Chapel the ability of physicians and lawyers (co-authored with Professor Lois Hill and a Masters in Science from Weill to understand each other’s concerns Shepherd) was published by Wolters- Graduate School of Medical Sciences at and obligations and to cooperate in Kluwer in 2019. Professor Dolgin lectures Cornell University. She recently re-shaping their assumptions in the widely in the United States and abroad completed a year-long executive leader- service of the partnership’s patients about healthcare law, bioethics, and ship program designed to tackle racial and and clients. A case study of a large and family law. She may be reached at ethnic disparities through the Disparities successful medical-legal partnership [email protected]. Solutions Center at Harvard’s

40 The Health Lawyer Volume 31, Number 6, August 2019 Massachusetts General Hospital in Boston. American Health Care Paradox (2015) by 21 https://www.northwell.edu/about-northwell She is currently a Robert Wood Johnson Elizabeth Bradley & Lauren Taylor). (last visited May 23, 2019). Foundation Clinical Scholar and serves as 7 Marmot, supra note 5, at 6-7. 22 Nassau County is one of two counties on Long Island not part of New York City. Queens 8 the Executive Medical Director of Hofstra- National Center for Medical-Legal Partner- County is part of New York City. Northwell’s Medical Legal Partnership. ship, Impact, https://medical-legalpartnership. org/impact/ (last visited June 11, 2019) (not- 23 These services reflect the health-related cate- Dr. Martinez is a primary care provider ing less frequent hospital admissions for peo- gories of legal service that have been identi- who is committed to health disparities, ple with chronic disease, greater adherence to fied by the National Center for Medical-Legal medication schedules, less stress and better Partnership. They are known by the acronym women’s health and community engage- mental health, among other things). I-HELP. The “P” in I-HELP refers to personal ment within primary care. She may be and family matters. See, e.g., Ellen Lawton et 9 See Randye Retkin, Julie Brandfield, & Margo reached at [email protected]. al., Medical-Legal Partnership: A New Stan- Hoppin, Medical Legal Partnerships: A Key dard of Care for Vulnerable Populations 71 in Strategy for Mitigating the Negative Health Tyler & Lawton, supra note 3, at 75, 113. The Impacts of the Recession, 22 Health Lawyer Hofstra/Northwell Medical-Legal Partnership 29 (Oct. 2009). does not now, but soon hopes to, provide legal Endnotes 10 Elizabeth Tobin Tyler, Introduction xxxi- representation in this area. 1 See Bradley Sawyer & Cynthia Cos, Peterson- xxxii in Tyler & Lawton, supra note 3. 24 The Hofstra/Northwell Medical-Legal Part- Kaiser Health System Tracker, How Does 11 Id. at xxxii. nership’s educational programs aim to transform Health Spending in the U.S. Compare to multidisciplinary work into interdisciplinary Other Countries, Dec. 7, 2018, https://www. 12 Retkin, Brandfield & Hoppin, supra note 9. work. Multidisciplinary teams include people healthsystemtracker.org/chart-collection/ The following year, the ABA implemented a trained in various disciplines who work within health-spending-u-s-compare-countries/#item- Medical-Legal Partnership Pro Bono Support their disciplinary frameworks. Interdisciplinary start (last visited May 23, 2019) (reporting that Project. Id. work relies on shared knowledge and assump- in 2017, the United States spent $10,224 per tions that, when most effective, creates a “coor- 13 capita on healthcare. That was 28% higher National Center for Medical-Legal Partner- dinated and coherent whole.” See B.C. Choi & than Switzerland, the second highest spender). ship (Home), https://medical-legalpartner- A.W. Pak, Multidisciplinarity, Interdisciplinar- ship.org/ (last visited May 23, 2019). State ity and Transdisciplinarity in Health Research, 2 Nat’l Cent. For Medical Legal Partnership, support is also important. In 2013, New York Services, Education and Policy, 29 Clin. The Need, available at https://medical-legal- State amended its Public Health Law (“PHL”) Invest. Med., 351, Dec. 2006, https://www. partnership.org/need/ (last visited March 17, to allow legal entities to register as “Health- ncbi.nlm.nih.gov/pubmed/17330451. 2019). In the United States more is spent on Related Legal Services Programs.” Standards healthcare than on social services. “Other first- for Health-Related Legal Services Programs 25 The navigator program, started in 2016, has world countries with better outcomes” spend that Serve Income Eligible Individuals and operated since that time in two of Northwell’s more than twice as much on social services as Families Pursuant to PHL Section 22 (Dept ambulatory clinics. The medical-legal partner- they spend on healthcare. Id. Yet, among Health, NYS), https://ealth.ny.gov/diseases/ ship, which began its work two years later, has nations, the United States ranks 42nd in life aids/providers/regulations/standards_for_health_ broadened the screen to include legal (as well expectancy and 169th on low birth weight. Id. related_legal_services_prog.htm; see also Nat’l as social needs) and to distinguish between clinic patients’ social and legal needs. As a 3 Elizabeth Tobin Tyler, Introduction xxxi in Center for Medical-Legal Partnership, New York Law Recognizes MLPs (2013), https:// practical matter, this often involves distin- Poverty, Health and Law: Readings and Cases guishing among patients whose needs can be for Medical-Legal Partnership (Elizabeth medical-legalpartnership.org/new-york-law- recognizes-mlps/. met by social workers and those whose needs Tobin Tyler & Ellen Lawton, et al., eds. 2011) require attorney assistance. (hereinafter “Tyler & Lawton”); Steven A. 14 The Health Resources & Services Adminis- 26 Jennifer Trott, Medical Legal Partnership Schroeder, We Can Do Better – Improving tration (“HRSA”) is an agency within the Measurement Series, Issue Brief One, Screen- the Health of the American People, 357 (12) Department of Health and Human Services. ing for Health-Harming Legal Needs, https:// N.E.J.M. 1221 (2007). See also Approaches to It is dedicated to “improving health care to medical-legalpartnership.org/wp-content/ Cross-Sector Population Health Accountabil- people who are geographically isolated, eco- uploads/2016/12/Screening-for-Health-Harming- ity (Discern Health for Academy Health) (last nomically or medically vulnerable”. HRSA, Legal-Needs.pdf (last visited July 3, 2019). visited May 29, 2019) (reporting that “[o]nly https://www.hrsa.gov/about/index.html (last 20 percent of a person’s health and well-being visited June 30, 2019). 27 The reasons for this are multiple. Some is attributed to clinical care, compared to 80 15 patients declined the opportunity to receive percent attributed to social, behavioral and Nat’l Cent. For Medical-Legal Partnership, legal assistance; some misunderstood the ques- environmental factors”) (footnote omitted), Partnerships, available at https://medical-legal- tion; and some missed appointments, among https://www.academyhealth.org/sites/default/ partnership.org/ (last visited March 17, 2019). other reasons. files/Approaches_to_CrossSector_Pop_Health_ 16 Id. 28 Jan2018_0.pdf (last visited May 29, 2019). RedCAP intake forms are shared, but not in 17 Marsha Regenstein, Jennifer Trott, & Alanna electronic form. While arrangements between 4 Wendy E. Parmet, Lauren A. Smith, & Mere- Williamson, Report: Findings from the 2016 Northwell and Hofstra preclude sharing elec- dith A. Benedict, Social Determinants, NCMLP National Survey on MLP Activities tronic data, paper copies of RedCAP intake Health Disparities and the Role of Law in and Trends, Nat’l Centr. For Medical-Legal forms can be shared. Tyler & Lawton, supra note 3, at 4 (citing Partnership (Aug. 3, 2017), available at 29 World Health Organization, Closing the Gap in The algorithm was also created to be cost- https://medical-legalpartnership.org/mlp- effective. However, the medical-legal partner- a Generation: Health Equity through Action on resources/2016-ncmlp-survey-report/ (last visited the Social Determinants of Health (2008)). ship does not yet have data about its cost- ­ March 17, 2019). effectiveness. 5 Michael Marmot, The Status Syndrome: How 18 https://www.hofstra.edu/about/about_glance. 30 Social Standing Affects Our Health and Lon- Unfortunately, there is often little that social html# (last visited May 23, 2019). workers or attorneys can do at this time to gevity 41-43 (2004). 19 help patients with undocumented immigra- 6 Northwell is the 14th largest healthcare sys- National Medical-Legal Partnership (Home), tem in the nation, https://www.northwell.edu/ tion status. https://medical-legalpartnership.org/ (report- about-northwell (last visited May 23, 2019). 31 One of these physicians is a co-author of this ing that the United States spends 90 cents on article. social services for every dollar that it spends 20 Northwell Health Physician Partners includes on healthcare; nations with better health out- all physicians affiliated with Northwell. 32 Medical-legal partnership physicians will comes spent about twice what they spend on Northwell Health Physician Partners, North- study the effectiveness of empathic inquiry healthcare on social services) (last visited well Health, https://www.northwell.edu/ training for patient navigators by comparing May 23, 2019) (referring to research from The physician-partners (last visited June 30, 2019). outcomes, including patient utilization of continued on page 42 41 Volume 31, Number 6, August 2019 The Health Lawyer Lessons Learned From a New Medical-Legal Partnership continued from page 41

healthcare; patient-reported health; navigator 40 The Health Insurance Portability and p. 4 (April 2019), https://medical-legal effectiveness; and identification of social- Accountability Act of 1996, Pub. L. No. 104- partnership.org/wp-content/uploads/2019/04/ determinants of health among patients 191, 110 Stat. 1936; see 45 C.F.R. Parts 160, Financing-MLPs-View-from-the-Field.pdf. screened by navigators with empathic inquiry 162, & 164 for regulations about privacy. See Some medical-legal partnerships are funded training and patients screened by navigators also The Health Information Technology for by the healthcare organization within which without that training. Economic and Clinical Health (“HITECH”) they operate. Others receive funding from Act, enacted under the American Recovery 33 Janet Hyatt Thorpe et al., Information Sharing legal organizations, and still others rely at and Reinvestment Act of 2009, Div. A, Title in Medical-Legal Partnerships: Foundational least in some part on philanthropic donations. XIII of Pub. L. 111-5. Concepts and Resources (Medical-Legal Part- 49 nership Fundamentals, 2017), https://medical- 41 Hofstra/Northwell Medical-Legal Partnership Joanna Theiss, Janelle Schrag & Joel Teitel- legalpartnership.org/wp-content/uploads/ patient-clients now sign HIPAA waivers that baum, A System-Level Approach to Address- 2017/07/Information-Sharing-in-MLPs.pdf. allow partnership attorneys to discuss a patient’s ing Health-Harming Legal and Social Needs (National Center for Medical-Legal Partner- 34 medical situation with the patient’s physician. See supra note 24 (describing difference ship), https://medical-legalpartnership.org/ between interdisciplinary and multidisciplinary 42 An interesting example of such differences is wp-content/uploads/2019/04/A-System-Level- work). attorney-client privilege, which is without a Approach.pdf. 35 Data-sharing within a medical-legal partner- counterpart in the physician-patient relation- 50 ship is not an “all or nothing” matter. Cer- ship. As a result, physicians are sometimes Id. at 12. baffled when lawyers invoke privilege claims. tainly, healthcare practitioners and legal 51 See Galowitz, supra note 36, at 166. Institute for Healthcare Improvement, IHI service providers often share patients’ names Triple Aim Initiative, http://www.ihi.org/Engage/ and contact information as part of a routine 43 Charley Connor, The Benefits of Medical- Initiatives/TripleAim/Pages/default.aspx (last referral for services. Consideration of the level Legal Partnerships for Low-Income Families, 8 and type of information shared within a visited on May 23, 2019). The triple aim was Wake Forest J.L. & Pol’y 193, 209 (2018). described by Donald M. Berwick in 2008. medical-­legal partnership always involves HIPAA protects “individually identified health Donald M. Berwick et al., The Triple Aim: attention to nuance. information.” 45 C.F.R. §§ 160.103, 164.501. Care, Health, and Cost, 27 Health Aff. 759 36 Paula Galowitz et al., Ethical Issues in Medical-­ 44 Margaret Mohrmann has discussed a new (2008). Berwick served as the Administrator Legal Partnerships in Tyler & Lawton, supra ethic for chaplains that is intended to supple- of the Centers for Medicare & Medicaid Ser- note 3 at 166. ment, not replace, existing ethical guidelines. vices under President Obama. Profiles in 37 Galowitz et al., supra note 36, at 166. Margaret E. Mohrmann, Ethical Grounding Leadership: Don Berwick, Institute for Health for a Profession of Hospital Chaplaincy, 38 Improvement, http://.ihi.org/education/ihiopen 38 Id. The authors strongly suggest that despite Hastings Center Report 18 (Nov. – Dec. 2008). this justification for participation of a medical school/resources/Pages/ProfilesInLeadership professional in a meeting between a patient- 45 Id. DonBerwick.aspx (last visited June 30, 2019). Commentators noted that “[a]lthough the tri- client and his or her medical-legal partnership 46 Two of the co-authors of this article intend to ple aim originally focused primarily on the attorney, the attorney obtain an informed draft the provisions that such a supplemental waiver of privilege from the client. Id. Clients code of ethics might contain. integration of clinical care . . . , it is now should be made aware of the implications of accepted that integration sectors that impact losing attorney-client privilege. 47 See supra note 24 (describing difference public health and medical care will be key to between the two approaches). 39 State laws that offer greater protection than improving population health. James Teufel et that afforded by HIPAA, see note 40, infra, are 48 Jennifer Trott, Alanna Peterson & Marsha al., Rural Health Systems and Legal Care: not preempted by the federal law and may Regenstein, Financing Medical-Legal Partner- Opportunities for Initiating and Maintaining impose additional limitations on sharing pro- ships: View from the Field, Medical-Legal Legal Care After the Patient Protection and tected health information. Id. at 167. Partnership Fundamentals: Issue Brief Two, Affordable Care Act, 35 J. Leg. Med. 81 (2014).

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42 The Health Lawyer Volume 31, Number 6, August 2019 Health Law Section Offers Publishing Opportunities

The Health Law Section is always interested in publishing material from our members and others. We strive to produce top quality, relevant and interesting articles, books, toolkits, and the like for the health law bar. Opportunities include: The Health Lawyer – This prestigious national magazine is the flagship publication of the Section. For more than 35 years The Health Lawyer has covered cutting edge, topical and timely health law-related issues that not only spark discussion but also provide practical advice and help readers in their daily work. A full index of topics covered can be found at The Health Lawyer webpage (www.americanbar.org/publications/health_lawyer_home.html). For more information or to receive our Publication Guidelines, contact Marla Durben Hirsch, Esq., Editor at [email protected] or at 301/299-6155. ABA Health eSource – Our electronic monthly newsletter is a perfect place to find and publish succinct, timely articles. Generally the articles for this monthly publication are not as long as the articles in The Health Lawyer but are every bit as important. Contact Marla Durben Hirsch, Esq., Editor at [email protected] or at 301/299-6155. Book publishing – Do you have a good idea for a single topic book? Contact Simeon Carson to discuss your book project. Generally these are soft covered books of 200 to 300 pages; books in the Section’s popular “What is…” series are typically less than 100 pages. Simeon can be reached at 312/988-5824 or at [email protected].

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