MEMORANDUM OPINION

M. HANNAH LAUCK, District Judge.

This matter comes before the Court on the Defendants'1 Motion for Leave to Take Discovery (the "Motion"). (ECF No. 35.) Defendants request a limited discovery period to seek information on two issues: (1) whether Plaintiff Patient Services, Inc. ("Patient Services") waived its First Amendment constitutional right to engage in certain discussions with its donors, prospective donors, and their affiliates; and, (2) whether Patient Services suffered an actual harm, or injury-in-fact, from the issuance of a 2017 Advisory Opinion by the Office of the Inspector General of the Department of Health and Human Services ("HHS OIG"). Patient Services opposes the Motion to the extent Defendants seek discovery relating to the First Amendment issue,2 (Resp. Mot. 14-15, ECF No. 37), and Defendants replied, (ECF No. 38). Accordingly, this matter is ripe for disposition.

The Court dispenses with oral argument because the materials before it adequately present the facts and legal contentions, and argument would not aid the decisional process. The Court exercises jurisdiction pursuant to 28 U.S.C. § 1331.3 For the reasons stated below, the Court will grant the motion, albeit on a limited basis.

I. Factual and Procedural Background

Each party before the Court presents itself as operating for the greater good. HHS OIG portrays itself as "an independent and objective oversight unit created to carry out the mission of preventing fraud and abuse and promoting [the] economy, efficiency, and effectiveness of HHS programs and operations." (Mem. Supp. Mot. 2, ECF No. 36.) It describes its work issuing written Advisory Opinions alongside the United States Department of Justice as "interpretation and application of certain statutory provisions designed to deter" fraudulent referral of medical goods and services to federal health care programs such as Medicare. (Id. 2.) HHS OIG seeks to assure that companies do not profit from steering products and services to federal healthcare programs when the companies' profit motivation might override best medical practices or fiscal integrity.

At the same time, Patient Services portrays itself as "a non-profit charitable foundation that operates Patient Assistant Programs ("PAPs"), which provide financial and other assistance to indigent patients who have chronic and often life threatening diseases that require expensive treatment and management." (Compl. ¶ 4, ECF No. 1.) Patient Services highlights that its founder and President, Dr. Dana Kuhn, not only suffers personally from hemophilia, but also founded Patient Services in 1989 after years of counseling patients and families through the physical, emotional, and financial strain of managing that chronic illness. Patient Services contends that since 1989, it has "provided financial assistance to hundreds of thousands of indigent patients." (Compl. ¶ 56.)

While the Motion pending before the Court makes a seemingly simple request—to grant a limited period of discovery—its resolution raises additional questions. Most importantly, the parties advocate for different First Amendment standards to apply: one that would allow limited discovery, and another that would not. The parties also disagree about how to supplement the Administrative Record to establish the harm necessary for Article III standing. Neither party suggests that supplementation as to harm should not occur.

For the reasons stated below, the Court will grant a limited period of discovery, followed by additional briefing to determine what (if any) discovered information will be used to supplement the Administrative Record the Court will consider in deciding Patient Services's Complaint.

A. Statutory and Regulatory Restrictions on How PAPs Can Operate

An introduction of the parties and the little-known regulatory scheme that binds them must precede consideration of the Motion. Because the regulatory scheme involves several laws and regulations governing a relatively unknown business practice, the Court sets forth a more extensive overview than what it commonly would include. Indeed, the background seemingly overwhelms the Court's analysis.

First, the Court will describe the business model for entities, such as Patient Services, operating PAPs. Second, the Court will outline the provisions of the Social Security Act that necessitate HHS OIG's Advisory Opinions. Third, the Court will introduce the role HHS OIG plays in regulating the entities operating PAPs. Finally, the Court will examine the regulatory interaction between HHS OIG and Patient Services. Only then will the Court be able to address the Motion here.

1. The Business Model for PAPs and Patient Services in Particular

To assist indigent patients, PAPs, such as Patient Services, rely on donations from a variety of sources, "includ[ing] pharmaceutical manufacturers, disease treatment centers, hospitals and other healthcare facilities, disease specific charities, pharmacies, individual donors, and governmental entities such as the Commonwealth of Virginia."4 (Compl. ¶ 70.) Indigent patients seeking aid from Patient Services, for instance, must provide "their (i) medical diagnosis and the type of assistance requested; (ii) demographic and contact information; (iii) income information; and[,] (iv) health insurance information." (Id. ¶ 60.) If approved for assistance, Patient Services may provide "assistance with health insurance premiums, travel expenses, copayment obligations, ancillary services, and infusion nursing services." (Id. ¶ 58.)

HHS determined that PAPs presented a heightened risk of "fraud, waste, and abuse with respect to Medicare and other [f]ederal heath care programs" in part because pharmaceutical manufacturers supported, and sometimes entirely sponsored, many PAPs. See Suppl. Special Advisory Bulletin: Independent Charity Patient Assistance Programs (the "2014 PAP Bulletin"), 79 Fed. Reg. 31120, 31120 (May 30, 2014). Observing this arrangement, HHS identified the possibility that PAPs might steer their charitable efforts to products their donors made or distributed. Id. HHS clarified that even PAPs such as Patient Services, who are not solely sponsored by a pharmaceutical manufacturer, might—but should not—operate as a conduit for improper payments involving federal healthcare programs, or impermissibly influence a beneficiary's drug choices. See id.

Having made these observations, HHS recognized that this potential improper conduct implicated penalty provisions in the Social Security Act. Because the Social Security Act imposes stiff penalties for any kickback or improper influence in business dealings that affect federal healthcare programs, a discussion of these two penalty provisions will follow. Only with that background can the Court turn to how Congress, through HHS OIG, decided to offer the option of regulatory protection to PAPs via Advisory Opinions.

2. The Social Security Act Imposes Criminal and Civil Penalties on Entities Operating Within the Federal Healthcare System That Improperly Steer Business to Donors

PAPs who accept donations from entities such as pharmaceutical companies or doctors who might, even indirectly, suggest self-dealing must be cautious of running afoul of two provisions in the Social Security Act. First, the Social Security Act's so-called "Anti-Kickback Statute" makes it a criminal offense to knowingly and willfully solicit, receive, offer, or pay any remuneration for business reimbursable by any federal healthcare program, such as Medicare, or to induce or reward the referral or generation of business reimbursable by these healthcare programs.5 42 U.S.C. § 1320-7b(b).

A second provision of the Social Security Act, 42 U.S.C. § 1320a-7a(5), (the "Civil Penalty Statute") imposes civil monetary penalties on persons or entities who offer or transfer remuneration to any medical beneficiary when that remuneration is intended to influence which treatment provider or which particular treatment a beneficiary receives under Medicare or a comparable program. Because PAPs seek donations from entities which could profit from federal healthcare programs if the beneficiary chose to use their hospital, doctor, product, procedure, or prescription and the beneficiary relied on PAP funds to pay for the hospital, doctor, product, procedure, or prescription, these laws seek to curtail incentives for PAPs to steer business toward their donors.6 They also seek to ensure that healthcare providers make decisions about the allocation of federal healthcare services with only legitimate concerns in mind, such as quality or cost.

These potential stiff penalties have not gone unnoticed. Congress mitigated the statutes' application to innocent behavior by devising a process through which HHS OIG could advise PAPs as to how they may operate within the law. The Court turns to the HHS OIG Advisory Opinion Process now, bringing it closer to the heart of the dispute at bar.

3. The Role of HHS OIG in Regulating PAPs Including Patient Services

HHS OIG seeks to minimize the risk of potential federal healthcare fraud, i.e. Medicare fraud, that could occur if PAPs, even indirectly, steer business to their donors. See 2014 PAP Bulletin at 31120 ("PAPs have long provided important safety net assistance . . . [but m]any PAPs . . . present a risk of fraud, waste, and abuse with respect to Medicare and other [f]ederal health care programs.") Still, Congress recognized that the Social Security Act's Anti-Kickback and Civil Penalty Statutes were broad enough to risk the imposition of criminal liability for "relatively innocuous commercial arrangements," so Congress created the Advisory Opinion process to allow PAPs to receive guidance from HHS OIG about the legality of their business structure.7 See Medicare and State Health Care Programs: Fraud and Abuse; Issuance of Advisory Opinions by the OIG, 62 Fed. Reg. 7350; 7350 (proposed Feb. 19, 1997).

To buffer against these potentially harsh penalties, Congress authorizes the HHS OIG, in consultation with the Attorney General, to issue Advisory Opinions when PAPs themselves seek guidance from HHS OIG on "actual or proposed factual circumstances" of their operations that may implicate the Social Security Act. 42 C.F.R. § 1008.1. When asked by a PAP, HHS OIG provides guidance about the legal parameters the PAP must operate within so as not to violate the constraints of the Social Security Act.8 See 42 U.S.C. § 1320a-7d(b)(1); 42 C.F.R. § 1008.1, et seq.; see also Medicare and State Health Care Programs: Fraud and Abuse; Issuance of Advisory Opinions by the OIG, 62 Fed. Reg. 7350; 7351-52.

HHS OIG's Advisory Opinion Process as to the 2017 Modified Advisory Opinion lies at the core of this case. Thus, this detailed backdrop must turn from the Social Security Act and HHS OIG to the specific Advisory Opinion and bulletins that affected Patient Services.

4. The Regulatory Interaction Between HHS OIG and Patient Services

To date, HHS OIG has issued two Advisory Opinions directly to Patient Services and at least two general PAP Bulletins, applicable to all entities operating PAPs.9 Patient Services challenges the second and most recent Advisory Opinion, issued on March 3, 2017, (the "2017 Modified Advisory Opinion") as infringing on its First Amendment rights. Because the 2017 Modified Advisory Opinion flowed from information in the 2014 PAP Bulletin, the Court offers more information about both.

a. The 2014 PAP Bulletin Discussing the Effect of Medicare Part D Implicated the 2002 Advisory Opinion HHS OIG Issued to Patient Services

By way of background, the 2014 PAP Bulletin discussed the impact of Medicare Part D on the operation of all PAPs "based on experience [OIG had] gained in the intervening years" since 2006 when Medicare Part D had taken effect. 2014 PAP Bulletin at 31120. The 2014 PAP Bulletin identified two remunerative practices PAPs utilized that warranted increased scrutiny under the Anti-Kickback Statute. Id. at 31121. First, the 2014 PAP Bulletin identified those donations "made to a PAP to induce the PAP to recommend or arrange for the purchase of the donor's federally reimbursable items" as problematic. Id. Second, the 2014 PAP Bulletin recognized as troublesome those situations in which "a PAP's grant of financial assistance to a patient is made to influence the patient to purchase (or to induce the patient's physician to prescribe) certain items." Id. HHS recognized that this 2014 "amplifie[d]" industry-wide guidance might cause some previously-issued favorable Advisory Opinions to become inconsistent with the new guidance. Id. at 31123 ("We recognize that some charitable organizations with PAPs have received favorable [A]dvisory [O]pinions that may include features that are discouraged in" the 2014 PAP Bulletin.). HHS OIG stated that it would contact entities holding those favorable Advisory Opinions to modify them as necessary. Id. at 31123 ("We are writing to all Independent Charity PAPs that have received favorable [O]pinions to explain how we intend to work with them to ensure that approved arrangements are consistent with our guidance. We anticipate that some [O]pinions will need to be modified.").

HHS OIG contacted Patient Services as one of the entities whose favorable Advisory Opinion, which it sought and received in 2002, might need modification. For seemingly more than two years,10 the parties engaged in discussions to determine the scope of what would become the 2017 Modified Advisory Opinion. This back and forth resulted in the Administrative Record that will be filed in this case.11

Patient Services challenges three of the certifications it made in the 2017 Modified Advisory Opinion as infringing on its First Amendment rights. The Court creeps closer to the dispute at hand: the process in which the certifications became part of the 2017 Modified Advisory Opinion.

b. The 2017 Modified Advisory Opinion Referred to a Series of Certifications Made by Patient Services, Three of Which They Contend Violate the First Amendment

The 2017 Modified Advisory Opinion revised HHS OIG's prior favorable 2002 Advisory Opinion while delineating exceptions, listing modifications, and referring to certifications made by Patient Services.12 Patient Services challenges three factual certifications, listed below, (collectively, the "Three Certifications"), as contrary to First Amendment principles. Patient Services seeks declaratory and injunctive relief to preclude the HHS OIG from enforcing the Three Certifications in the 2017 Modified Advisory Opinion because they impermissibly limit Patient Services's "truthful, non-misleading, and lawful communications with donors, prospective donors, and their `affiliates.'" (Resp. 8, ECF No. 37; Compl. ¶¶ 129, 136, 143-44.)

First, Patient Services opposes the certification not to "solicit suggestions from donors regarding the identification or delineation of disease funds." (Compl. ¶ 89.)

Second, Patient Services contests the certification that "[n]o donor or affiliate of any donor [including a long list of what could be an affiliate] directly or indirectly influences or will influence the identification or delineation of any of the [c]harity's disease funds." (Id. ¶ 90.)

Third, and finally, Patient Services opposes the certification not to "establish or modify funds for specific diseases at the request or suggestion of donors or prospective donors (or affiliates of donors or prospective donors) that manufacture drugs or devices for treatment of such diseases or that otherwise have a financial interest in the establishment or modification of such funds." (Id. ¶ 91.)

With this extensive backdrop about Patient Services's business model, the regulatory scheme that resulted in the 2017 Modified Advisory Opinion, and the relationship between HHS OIG and Patient Services in place, the Court now turns to the Motion pending before it. But not without addressing two preliminary disputes.

B. The Parties' Disagreement About Whether the Administrative Record Should be Expanded Requires Preliminary Resolution of Two Other Disputes

Neither party questions whether the speech at issue implicates the First Amendment: it does. But the Court must nevertheless address two contested issues before deciding whether the Administrative Record may be supplemented. First, the parties diverge as to whether this lengthy regulatory interaction resulted in a "negotiated" or "compulsory" set of findings. Because they dispute whether the administrative process involved a negotiation or the imposition of mandatory rules, a secondary question must be answered: which First Amendment standard applies? Each party asks the Court to apply a different analytical framework when evaluating this First Amendment challenge. The Court summarizes both Defendants and Patient Services's position below.

1. Defendants Contend That the Parties Negotiated the 2017 Modified Advisory Opinion so That the Fourth Circuit's Lake James Standard Applies

Defendants argue that their notice to Patient Services regarding the need to modify the 2002 Advisory Opinion "set off a lengthy negotiation process between OIG and [Patient Services], which lasted for more than two years." (Mem. Supp. Mot. 6.) HHS OIG posits that certain facts are subject to judicial notice. First, according to Defendants, Patient Services "was represented by sophisticated counsel throughout these negotiations." (Mem. Supp. Mot. 6 (citing Index to the Administrative Record 92-653, ECF No. 36-1)). Second, on February 1, 2017, before the 2017 Modified Advisory Opinion issued, Patient Services's "counsel sent OIG an executed list of the certifications with which [Patient Services's] would agree to conform its conduct in accordance with the modification of its 2002 Advisory Opinion."13 (Id. (citing Index to the Administrative Record 645-53)). This, Defendants say, evinces that a negotiation occurred.

Defendants concede that review of an agency decision under the Administrative Procedures Act (the "APA)"14 normally relies only on the administrative record submitted by the agency.15 They add, however, that exceptions to doing so exist. Defendants contend that because Patient Services participated in negotiations that led to the 2017 Modified Advisory Opinion, an exception should apply here. This negotiation, according to Defendants, means that the Fourth Circuit's reasoning in Lake James Community Volunteer Fire Department, Inc. v. Burke County, 149 F.3d 277, 282 (4th Cir. 1998), governs the First Amendment dispute before the Court, even though the 2017 Modified Advisory Opinion "is not technically a contract."16 (Mem. Supp. Mot. 10 n.2.)

Because the Lake James standard applies, Defendants contend that "the [A]dministrative [R]ecord lacks the necessary information" for the Court to decide Patient Services' claims. (Mem. Supp. Mot. 8.) Defendants seek information pertinent to the second prong of the Lake James test: whether Patient Services made a "knowing waiver" of its First Amendment rights. Lake James, 149 F.3d at 270. Defendants seek limited discovery to assess Patient Services's view of its interaction with HHS OIG during the years in which the parties discussed the 2017 Modified Advisory Opinion. Because the administrative record reflects only the agency's process, Defendants say it necessarily does not include Patient Services's view as to whether the Three Certifications were mandatory or negotiated.

Additionally, Defendants posit that Patient Services cannot establish injury-in-fact without adding information to the Administrative Record because any loss of donations occurred after the record closed. Patient Services appears to agree with this request to supplement the Administrative Record because it offers to provide a "single, simple declaration" to establish injury in fact.17 (Resp. 14-15.) To establish harm, Defendants also seek evidence to determine whether the communications in which Patient Services claims it may no longer participate in, "constituted `lawful, truthful, and non-misleading communications.'"18 (Mem. Supp. Mot. 12.) Without demonstrable harm, the Court would lack jurisdiction. Defendants seek discovery on this point as well.

2. Patient Services Contends That the Three Certifications Stemmed From an Agency Mandate, Meaning That the Supreme Court of the United States' First Amendment Commercial Speech Test Applies

Patient Services strongly disagrees that the 2017 Modified Advisory Opinion was negotiated, or that the Lake James standard should apply. Patient Services states that the HHS OIG "required" it to accept "nearly two dozen certifications," (Resp. Mot. 4), "as a condition for [Patient Services] to retain an [A]dvisory [O]pinion," (Resp. Mot. 13). It claims that the 2017 Modified Advisory Opinion "was a governmental mandate, not a voluntary request by [Patient Services]." (Id.) Patient Services counters that because the 2017 Modified Advisory Opinion is not a contract, the Court should evaluate the 2017 Modified Advisory Opinion under general principals of the First Amendment.

Patient Services asserts that "OIG imposed the restrictions on [Patient Services]." (Resp. 13.) Patient Services suggests that this straightforward First Amendment dispute constitutes a matter of law subject to review under Supreme Court precedent governing its right to communicate with its donors. See Sorrell v. IMS Health, Inc., 564 U.S. 552, 557 (2011) ("Speech in aid of pharmaceutical marketing . . . is a form of expression protected by the Free Speech Clause of the First Amendment.") Patient Services asserts that it must have these types of conversations with its donors, potential donors, and their affiliates who—because they are on the front lines of complicated expert medical research—are the only affordable source from which to make informed choices about establishing new disease funds and how best to modify those disease funds already in existence. Patient Services adds that "operating without an [A]dvisory [O]pinion is practically impossible" because many "donors and prospective donors, in particular pharmaceutical companies, will not donate to any PAP that does not operate pursuant to an [A]dvisory [O]pinion from [HHS] OIG."19 (Compl. ¶ 45.)

As to harm, Patient Services alleges that the Three Certifications create a "brave new world of government censorship," (Compl. ¶ 6), which "hobble[s]" its ability to establish new disease funds, (Compl. ¶ 33). Patient Services adds that the "most likely result from these restrictions is that [Patient Services] will cease efforts to establish new disease funds and that donors . . . will not themselves have sufficient information about these funds to make donations." (Compl. ¶ 118.) Patient Services alleges that it has already suffered an estimated "17% reduction in donations for its patient funds in 2018." (Id.)

Defendants seek limited discovery to probe the basis of the harm Patient Services alleges. In response to the request to probe the jurisdictional requisite of injury-in-fact, Patient Services offers to provide a "single, simple declaration" to establish "injury-in-fact for purposes of establishing Article III standing."20 (Resp. 14-15.) Patient Services asks in the alternative that if the Court were to permit discovery as to Article III standing, that discovery be reciprocal. Clearly, either a declaration or discovery would expand the record beyond the extant Administrative Record.

C. Procedural History in This Court

On March 3, 2017, HHS OIG issued the 2017 Modified Advisory Opinion. (2017 Modified Advisory Opinion.) Approximately nine months later, on January 8, 2018, Patient Services filed this suit seeking declaratory and injunctive relief. On April 26, 2018, after the Court granted an extension of time, (ECF No. 22), Defendants filed their answer, (ECF No. 23).

On June 26, 2018, all parties attended an initial pretrial conference. During the initial pretrial conference, the parties raised their disagreement regarding the need for discovery in the case and the applicable First Amendment standard. The Court orally ordered that parties jointly prepare a briefing schedule on these issues, (Initial Pretrial Conf. Tr., ECF No. 34), and on July 3, 2018, the parties jointly filed the proposed briefing schedule, (ECF No. 32), which the Court entered, (ECF No. 33). As agreed, Defendants filed a Motion for Leave to Take Discovery. Patient Services opposed the Motion and Defendants replied.

After unearthing these layers of factual, procedural, and regulatory events giving rise to the Motion, the Court may now finally turn to the issue on the surface: should the motion for discovery be granted, and, if so, to what degree?

II. Analysis

The ultimate outcome of this matter requires the interaction of three legal constructs: (1) the Social Security Act and the regulations creating the procedures by which HHS OIG may issue an Advisory Opinion; (2) the APA; and, (3) First Amendment jurisprudence. For purposes of the Motion, however, the Court need only address the APA. The parties agree that Patient Services brings its claims pursuant to Section 702 of the APA, 5 U.S.C. § 702,21 and that APA rules regarding discovery differ from those in other federal civil actions.

A. Although Review Under the APA Normally Involves No Discovery, Courts Have Found Exceptions to This Rule

Federal Rule of Civil Procedure 26 grants a court broad discretion to order discovery. See Fed. R. Civ. P. 26(b)(1). Specifically, "[f]or good cause, the court may order discovery of any matter relevant to the subject matter involved in the action." Id. However, the APA limits a court's discretion to grant discovery when the court, as here, reviews the action of an administrative agency pursuant to the APA. See, e.g., Camp v. Pitts, 411 U.S. 138, 142 (1973); Fort Sumter Tours, Inc. v. Babbitt, 66 F.3d 1324, 1335 (4th Cir. 1995). For the reasons stated below, and despite administrative procedural norms, the circumstances giving rise to the 2017 Modified Advisory Opinion convince the Court to permit a limited period of discovery.

The Supreme Court of the United States has stated that when reviewing agency action to assess arbitrariness, "the focal point for judicial review should be the [A]dministrative [R]ecord already in existence, not some new record made initially in the reviewing court." Camp, 411 U.S. at 142; see Fort Sumter Tours, Inc., 66 F.3d at 1335 ("Judicial review of administrative action is generally confined to the administrative record" (citing Fayetteville Area Chamber of Commerce v. Volpe, 515 F.2d 1021, 1024 (4th Cir. 1975)). If the agency's finding "is not sustainable on the administrative record made, then the [agency's] decision must be vacated and the matter remanded to [them] for further consideration." Camp, 411 U.S. at 143. The Supreme Court has recognized that "[t]he task of the reviewing court is to apply the appropriate APA standard of review . . . to the agency decision based on the record the agency presents to the reviewing court." Florida Power & Light Co. v. Lorion, 470 U.S. 729, 743-44 (1985) (citing Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402 (1971)).

But courts have recognized a number of exceptions to the general rule that a reviewing court must make its determination based solely on the Administrative Record. Although the Fourth Circuit has not yet identified a list of these exceptional cases, the United States Court of Appeals for the District of Columbia Circuit and the United States Court of Appeals for the Ninth Circuit have done so.

For instance, the Ninth Circuit has identified four types of cases in which discovery may be warranted: (1) "when necessary to explain agency action," (2) "when serious gaps would frustrate challenges to the agency's actions," (3) "when it appears the agency has relied on documents or materials not included in the record," and, (4) when "necessary to permit explanation or clarification of technical terms or subject matter involved in the agency action under review." Pub. Power Council v. Johnson, 674 F.2d 791, 793-95 (9th Cir. 1982)(citations omitted). Similarly, the D.C. Circuit rejected an attempt to expand on the Administrative Record with affidavits where the proffering party "ha[d] not demonstrated that the agency failed to examine all relevant factors or to adequately explain its grounds for decision, or that the agency acted in bad faith or engaged in improper behavior in reaching its decision." IMS, P.C. v. Alvarez, 129 F.3d 618, 624 (D.C. Cir. 1997).

A court in the United States District Court for the Eastern District of Virginia has also recognized two exceptions: (1) "in situations where `those challenging agency action have contended the record was incomplete,'" Tafas v. Dudas, 530 F.Supp.2d 786, 794 (E.D. Va. 2008) (quoting Pub. Power Council, 674 F.2d at 794), and, (2) "where there has been a `strong showing of bad faith or improper behavior,'" id. at 797 (quoting Cmty. For Creative Non-Violence v. Lujan, 908 F.2d 992, 997 (D.C. Cir. 1990)). The United States District Court for the District of Columbia summarized the reason for exceptions as follows: "[u]nderlying all of these exceptions is the assessment that `resort to extra-record information [is necessary] to enable judicial review to become effective.'" National Mining Association v. Jackson, 856 F.Supp.2d 150, 157 (D.D.C. 2012) (quoting Calloway v. Harvey, 590 F.Supp.2d 29, 38 (D.D.C. 2008)).

Finally, when an entity challenges an agency decision as "contrary to constitutional right," pursuant to 5 U.S.C. § 706(2)(B), the reviewing court "should make `an independent assessment of a citizens' claim of constitutional right.'" Tafas, 530 F. Supp. 2d at 802 (quoting Porter v. Califano, 592 F.2d 770, 780 (5th Cir. 1979)). However, "even where plaintiff's have asserted constitutional claims, `wide-ranging discovery is not blindly authorized at a stage in which an administrative record is being reviewed.'" Id. (quoting Puerto Rico Public Housing Admin. v. United States Dep't of Housing and Urban Development, 59 F.Supp.2d 310, 327 (D.P.R. 1999)).

B. The Court Will Allow Limited Discovery Given This Atypical Administrative Procedure

Regardless of which First Amendment standard ultimately applies, the Court finds a period of limited discovery justified in this case. Defendants have sufficiently suggested that the Administrative Record might be "so deficient as to preclude effective review,"22 of the 2017 Modified Advisory Opinion process, such that the Court will allow discovery regarding the nature of the advisory opinion process, i.e. whether it constitutes a negotiation or a mandate.23 Patient Services's "claim of constitutional right" and both parties' agreement (albeit only as to harm), that the Administrative Record is "incomplete" also support limited discovery. See Tafas, 530 F. Supp. 2d at 794, 802.

Although, unlike many of the cases cited above, the government agency, not the plaintiff, seeks discovery, the Court finds limited discovery warranted given the baseline dispute as to how to assess this First Amendment challenge. The Administrative Record must also be expanded to show harm. Finally, without converting requests for discovery into an enforcement action, Defendants should be allowed to inquire about Patient Services's "truthful, non-misleading, and lawful communications with donors, prospective donors, and their `affiliates.'" (Reply 9; Resp. 8; Compl. ¶¶ 129, 136, 143-44.)

Discovery here is especially warranted because Patient Services must prove standing. Both parties recognize that the Administrative Record does not, and could not, include the post-decision information necessary to determine what harm Patient Services suffered. Defendants must be allowed to assess any applicable injury, which goes to the heart of this Court's jurisdiction. Patient Services's offer to submit a declaration to prove such harm does not comport with standard adversarial practices that undergird the interest of justice.

Discovery will be reciprocal. After the limited period of discovery, each party will have an opportunity to take a position on whether and how the record should be supplemented. The parties may disagree as to whether, or to what degree, the record should be supplemented. To the extent disagreement exists, the parties must specifically identify the scope and nature of the factual dispute.

Once a final record is established, the parties will each be allowed to file briefs as to whether this Court has jurisdiction over the case. To the extent standing is established, the parties shall also address which First Amendment standard this Court should utilize, citing pertinent aspects of the finalized Administrative Record. A review of the 2017 Modified Advisory Opinion will flow from the decisions made on these preliminary issues.

III. Conclusion

Having reviewed the parties' filings and the applicable laws and regulations, the Court will grant the Motion, with limitations. (ECF No. 35.) No later than close of business February 8, 2019, the parties shall submit a joint discovery plan which delineates the scope and duration of discovery going forward. This plan shall serve to "secure the just, speedy, and inexpensive determination" of this discovery period. Fed. R. Civ. P. 1. To the extent the parties believe that the appointment of a Special Master would support those goals, they may submit a joint motion for doing so and include any justification in their joint discovery plan.

Also no later than February 8, 2019, the parties shall submit a joint briefing schedule that will follow discovery. The Court will hold a status hearing after the stipulated plans have been filed.

An appropriate Order shall issue.