American Hospital Association v. Azar

District Court, District of Columbia

American Hospital Association v. Azar

Opinion

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

THE AMERICAN HOSPITAL ASSOCIATION, et al.,

Plaintiffs,

v. Civil Action No. 1:19-cv-03619 (CJN)

ALEX M. AZAR II, Secretary of Health and Human Services,

Defendant.

MEMORANDUM OPINION

The Affordable Care Act requires each hospital operating within the United States to

establish and make public “a list of the hospital’s standard charges for items and services

provided by the hospital.” 42 U.S.C. § 300gg-18(e) (2018). In November 2019, the Centers for

Medicare and Medicaid Services (CMS), an agency within the Department of Health and Human

Services (HHS), issued a final rule defining “standard charges,” delineating hospitals’

publication requirements, and laying out an enforcement scheme. Plaintiffs contend that the

final rule exceeds the agency’s statutory authority, violates the First Amendment, and is arbitrary

and capricious under the Administrative Procedure Act. For the reasons discussed below, the

Court rejects those challenges, denies Plaintiffs’ Motion for Summary Judgment, ECF No. 13,

and grants Defendant’s Motion for Summary Judgment, ECF No. 19.

1 I. Background

“The impenetrability of hospital bills is legendary.” AR 4766. 1 Dubbed an “arcane

art[],” id., and “mystifying,” AR 262, hospital billing has been the target of regulations at the

state and federal level for years. In 2006, the Bush administration called for greater price

transparency in federal health care programs to make “data on Medicare hospital payment rates

and quality more accessible to the public.” AR 5266; see also AR 4778. And many states have

required “hospitals to publish their full price lists (chargemasters) or prices of most commonly

used services.” AR 5266.

In 2010, as part of the Affordable Care Act, Congress enacted section 2718 of the Public

Health Service Act. See Patient Protection and Affordable Care Act,

Pub. L. No. 111-148 § 10101

(f),

124 Stat. 119

, 887 (2010). Entitled “Bringing down the cost of health care

coverage,” and as most relevant here, the statute mandates that

[e]ach hospital operating within the United States shall for each year establish (and update) and make public (in accordance with guidelines developed by the Secretary) a list of the hospital’s standard charges for items and services provided by the hospital, including for diagnosis-related groups established under section 1395ww(d)(4) of this title.

42 U.S.C. § 300gg-18(e) (emphasis added). In 2014, CMS “remind[ed] hospitals of their

obligation to comply with” this provision,

79 Fed. Reg. 27,978

, 28,169 (proposed May 15,

2014);

79 Fed. Reg. 49,854

, 50,146 (Aug. 22, 2014), and pointed to its implementation

guidelines, which provided that “hospitals either make public a list of their standard charges

(whether that be the chargemaster itself or in another form of their choice), or their policies for

1 Citations to “AR” refer to the administrative record, ECF Nos. 31, 31-1 to -3, 33-2.

2 allowing the public to view a list of those charges in response to an inquiry.” 79 Fed. Reg.

at 50,146.

Hospitals were thus able to comply with section 2718(e) by making public something

called a chargemaster, which is a document maintained by each hospital that contains a list of

prices for “each [individual] item and procedure offered,” AR 4768. See

84 Fed. Reg. 65,524

,

65,539 (Nov. 27, 2019). Each item and procedure (which may number in the thousands) is

usually assigned a billable procedure code and typically corresponds to a description and dollar

amount. Id.; see also AR 5154–55. Chargemasters, and the dollar amounts associated with the

listed items and procedures, are considered a critical “accounting tool” that hospitals rely on as a

starting point in negotiating reimbursement payments, especially with third-party private payers.

AR 5159–60; see also AR 6735–36. But chargemaster rates are highly inflated and often “bear

little resemblance” to the actual payment tendered to a hospital by a patient or third-party

provider (private insurance companies or Medicare and Medicaid). AR 4769. 2 In fact, one study

2 There appear to be numerous complex reasons for the large gap between a hospital’s chargemaster charges and the amounts it is actually paid. Chargemasters, which date back to the mid-20th century, are a relic of an old Medicare reimbursement system that disincentivized efficient care and was vulnerable to manipulation. See What Is a Chargemaster, and What Do Hospital Administrators Need to Know About It?, The George Washington Univ. Sch. of Bus. Blog (Dec. 17, 2019) [hereinafter What Is a Chargemaster?], https://healthcaremba.gwu.edu/ blog/chargemaster-hospital-administrators-need-know (cited in Pls.’ Mot. at 4); 84 Fed. Reg. at 65,538. Additionally, market changes in the 1980s and 1990s increased the clout of third- party payers, who then contracted for lower fee schedules or negotiated rates. AR 5153. Chargemaster rates thus applied to a smaller proportion of patients. See id. This resulted in “reduced margins” and losses (in part from treating publicly insured patients and “high-cost patients”), which forced hospitals to become “aggressive ‘price setters’” and mark up their chargemaster charges. AR 5160. One consequence is that chargemaster prices now typically apply to the patients with the least bargaining power—the uninsured. See AR 5158. In fact, “hospital charge and cost data show[] that uninsured and self-pay patients are charged, when confronted with the full list price, on average, about 2½ times more than what insurers pay hospitals, and about three times Medicare-allowable costs.” AR 4773.

3 found that “[o]n average, insurers and patients paid hospitals [only] about 38%” of the amounts

on chargemasters. Id. (emphasis added) (citation omitted).

In 2018, CMS announced that, effective January 1, 2019, it was updating its guidelines to

require hospitals to post their standard charges online in a machine-readable format and update

the information annually. See

83 Fed. Reg. 20,164

, 20,549 (proposed May 7, 2018);

83 Fed. Reg. 41,144

, 41,686–88 (Aug. 17, 2018). CMS emphasized that regardless of format, the list

should contain the charges as reflected in the hospital’s chargemaster. 83 Fed. Reg. at

41,686–88. At the same time, CMS expressed concern that chargemaster “data are not helpful to

patients for determining what they are likely to pay for a particular service or hospital stay.” Id.

at 41,686. CMS indicated it was contemplating taking additional actions to increase

transparency and to help patients compare charges and understand the financial impact of

hospital visits. See id.; see also 83 Fed. Reg. at 20,549. Throughout 2018, CMS solicited public

comments on the definition of standard charges under section 2718(e), as well as the types of

information that would be most relevant to patients. 83 Fed. Reg. at 20,549. CMS specifically

sought comments on whether a chargemaster functions as the best measure of a hospital’s

“standard charges” or if a hospital’s “standard charges” should instead be defined as a type of

average or median rate—for instance, the average rate for items on the chargemaster, average

discounts off the chargemaster, or average contracted rates. Id. And, for what appears to be the

first time, CMS requested comments on how to enforce section 2718(e), including whether

monetary penalties should be imposed on hospitals for failing to comply. See id.

On June 24, 2019, the President issued an executive order related to “informing patients

about actual prices.” Exec. Order No. 13877, Improving Price and Quality Transparency in

American Healthcare to Put Patients First,

84 Fed. Reg. 30,849

(June 24, 2019),

4 https://www.whitehouse.gov/presidential-actions/executive-order-improving-price-quality-

transparency-american-healthcare-put-patients-first. The order directed the Secretary of HHS to

“propose a regulation, consistent with applicable law, requir[ing] hospitals to publicly post

standard charge information, including charges and information based on negotiated rates and for

common or shoppable items and services,” in easy-to-understand formats so as to “inform[]

patients about actual prices.”

Id. at 30,850

.

In August, the HHS Secretary and CMS Administrator issued CMS’s annual notice of

proposed rulemaking.

84 Fed. Reg. 39,398

(Aug. 9, 2019) (the “Proposed Rule”); see also

Compl. ¶ 29, ECF No. 1; Def.’s Mot. for Summ. J. (“Def.’s Mot.”) at 7, ECF No. 19. Consistent

with the executive order, the Proposed Rule addressed, among other issues, hospitals’ obligations

under section 2718(e) to publish their standard charges. 84 Fed. Reg. at 39,571, 39,574. Citing

the related FY 2019 proposed rule, requests for information, and listening sessions, CMS

expressed its concern about a persistent lack of pricing transparency in the health care market

and signaled a shift away from its prior positions. See id. at 39,574. The agency stressed that its

review of comments from 2018 showed that “simply put, hospitals do not offer all consumers a

single ‘standard charge’ for the items and services they furnish.” Id. at 39,577. In the agency’s

view, in the health care market, a “standard charge . . . varies depending on the circumstances

particular to the consumer.” Id.

The agency proposed a new definition for “standard charges” that would account for two

identifiable groups of hospital patients: those who are self-pay and those who have third-party

payer coverage (i.e., health insurance). Id. at 39,578. Self-pay patients normally pay either

chargemaster rates (“gross charges”) or discounted cash prices. See id. Third-party payers, in

5 contrast, pay rates that vary based on fee-for-service (“FFS”) 3 arrangements or privately

negotiated rates and discounts, which often apply to “service packages” (bundles of services).

See id. at 39,576–79. Approximately 90% of hospital patients “rely on a third-party payer to

cover a portion or all of the cost of health care items and services, including a portion or all of

the cost of items and services provided by hospitals.” Id. at 39,579. Under the proposed rule,

“standard charges” would be defined as “gross charges” and “payer-specific negotiated charges,”

corresponding to the charges paid by the two primary patient-groups. Id. at 39,578–80.

The agency received comments from a variety of stakeholders, including patients, patient

advocates, hospitals and health systems, private insurers, health benefits consultants, health

information technology organizations, and academic institutions. Id. at 65,527. The majority of

commenters praised the move toward transparency and the agency’s general objectives, but

commenters varied on whether the proposed rule furthered those objectives. See id.

Individual consumers generally lauded the agency’s proposals. They shared their

experiences dealing with the opaqueness of health care billing and expressed frustrations at the

inability to anticipate costs before receiving treatment at a hospital. Id. Some commenters

hailed the proposed rule, remarking that “knowledge of healthcare pricing in advance would

benefit consumers and empower them to make lower cost choices.” Id.

Hospital and insurer organizations and advocacy groups, on the other hand, objected to

the Rule on a number of grounds. Many disputed that the agency had the statutory authority to

require disclosures of specific negotiated charges, id. at 65,537–38, or to require the publication

3 FFS rates are relevant for patients covered by Medicaid and Medicare. Medicaid FFS rates are set by states while Medicare FFS rates are determined by CMS. See 84 Fed. Reg. at 65,538. The agency did not focus on these rates in issuing its Rule, in part because they are already publicly available. See id. at 65,542.

6 of information they believed to constitute trade secrets, id. at 65,543. Hospitals were especially

skeptical that the disclosures would lead to lower costs or would benefit consumers because the

disclosed charges often will not represent patients’ actual out-of-pocket costs. See id.

at 65,527–28. And hospitals expressed concerns regarding the compliance burden, which could

ultimately “get in the way of providers spending time with patients.” Id. at 65,529.

Commenters also engaged with the agency on its proposed definition of “standard

charges.” Some offered alternative definitions, recommending, for example, the use of regional

and market averages of negotiated rates instead of the specific rates themselves. See id. at

65,554. Patient advocates, however, expressed that the use of averages or medians would not

provide individual consumers with data relevant to them and would instead cause confusion. Id.

Several commenters indicated that the most useful information would be the payer-specific

negotiated charges in conjunction with de-identified minimum and maximum negotiated charges,

which can provide patients with a more extensive understanding of hospital charges. Id.

at 65,553–55.

CMS ultimately severed the Proposed Rule from the rule on Medicare payment systems

and issued as a stand-alone rule the Price Transparency Requirements for Hospitals to Make

Standard Charges Public,

84 Fed. Reg. 65,524

(Nov. 27, 2019) (to be codified at 45 C.F.R.

subch. E) (the “Final Rule” or “Rule”). See Mem. in Supp. of Pls.’ Mot. for Summ. J. (“Pls.’

Mot.”) at 9, ECF No. 13-1; Def.’s Mot. at 7–8. The Rule finalized CMS’s proposed definition of

standard changes “to mean the regular rate established by the hospital for an item or service

provided to a specific group of paying patients.” 84 Fed. Reg. at 65,540;

45 C.F.R. § 180.20

(2020). The agency included in its definition of “standard charges” both gross charges and

7 payer-specific negotiated charges, as well as three other categories: discounted cash prices and

de-identified minimum and maximum negotiated charges. 84 Fed. Reg. at 65,540.

The final rule therefore requires hospitals to publish five types of “standard charges.”

First, a hospital must publish for each item or service its “gross charge,” which is “the charge . . .

that is reflected on a hospital’s chargemaster, absent any discounts.” Id. at 65,541;

45 C.F.R. § 180.20

. Gross charges appear as the first charge on an explanation of benefits.

84 Fed. Reg. at 65,541. These charges are often the amount paid by uninsured patients or

patients who seek out-of-network care, and thus, CMS explained, are the “standard” charges for

those subsets of patients. Id. at 65,540, 65,552.

Second, a hospital must publish its “discounted cash price,” which is the “charge that

applies to an individual who pays cash (or cash equivalent) for a hospital item or service.” Id.

at 65,553;

45 C.F.R. § 180.20

. According to the agency, this information benefits two types of

self-pay consumers: uninsured patients and patients who may have some coverage, but due to

various factors, will still need to absorb the full cost of certain services. 84 Fed. Reg. at 65,552.

The second subgroup—patients who have some form of coverage—may include patients who

“[h]ave insurance but who go out of network; have exceeded their insurance coverage limits;

have high deductible plans but have not yet met their deductible; prefer to pay through a health

savings account or similar vehicle; or seek non-covered and/or elective items or services.” Id.

The agency excluded from the definition of “discounted cash price” any non-standard “charity

care or bill forgiveness that a hospital may choose or be required to apply to a particular

individual’s bill.” Id. at 65,553.

Third, a hospital must publish its payer-specific negotiated charges, which are “the

charge[s] that a hospital has negotiated with a third-party payer for an item or service.” Id.

8 at 65,555;

45 C.F.R. § 180.20

. Charges can vary based on the insurance provider, and thus the

standard charges for these patients are the “usual or common rate for the members of” “a specific

plan through a specific insurer.” 84 Fed. Reg. at 65,546. CMS recognized that, unlike gross

charges and discounted cash prices, “payer-specific negotiated charge[s] do[] not, in isolation,

provide a patient with an individualized out-of-pocket estimate.” Id. at 65,543. But CMS

ultimately determined that payer-specific negotiated rates are still relevant for patients to be able

to estimate their out-of-pocket liability. See id. at 65,543. CMS also clarified that the payer-

negotiated rates are the formalized rates generally reflected in hospitals’ contracts and the

associated rate sheets (also known as rate tables or fee schedules), recognizing that the actual

paid amounts may vary based on other factors and are thus “unlikely . . . [to] be considered . . .

standard.” Id. at 65,546.

Finally, hospitals must publish de-identified minimum and maximum charges, which are

the highest and lowest charges that a hospital has negotiated with all third-party payers for an

item or service but are not linked to the particular third-party payer. See id. at 65,554;

45 C.F.R. § 180.20

. CMS stated that this information would allow insured patients to analyze

their insurers’ abilities to negotiate effectively and “promote value choices in obtaining a

healthcare insurance product.” 84 Fed. Reg. at 65,555. Uninsured patients could also use the

ranges to negotiate with hospitals for a reduced rate from the inflated gross charges. See id. 4

Each hospital is therefore required to publish a list containing the foregoing types of five

charges for all of its “items and services” (which are defined as “all items and services, including

individual items and services and service packages, that could be provided by a hospital to a

4 In the interest of minimizing the burden on hospitals, CMS did not require publication of median negotiated charges it had once considered as a possible definition of standard charges, concluding that the ranges would be more helpful to patients. 84 Fed. Reg. at 65,555.

9 patient in connection with an inpatient admission or an outpatient department visit for which the

hospital has established a standard charge”). Id.;

45 C.F.R. § 180.20

. Hospitals must also

publish “public payer-specific negotiated charges[,] . . . discounted cash prices, the de-identified

minimum negotiated charge, and the de-identified maximum negotiated charge, for 300

‘shoppable services,’” which are services that can be scheduled by a health care consumer in

advance. 84 Fed. Reg. at 65,525. Taken together, the agency concluded, this information would

help patients navigate the health care industry, including by allowing patients to determine

whether to pay cash or process their claims through their insurance and enabling patients to

estimate their out-of-pocket costs and compare their financial obligations across hospitals. Id.

at 65,554–55. This is especially true for shoppable services, which the Rule mandates must be

displayed in a consumer-friendly way to make it easy for patients to compare costs. See id.

at 65,556.

CMS also concluded that under section 2718(b)(3), it was authorized to develop an

enforcement scheme, which would include first providing a written warning to the hospital, then

requesting a corrective action plan, and finally, imposing and publicizing a civil monetary

penalty. See 84 Fed. Reg. at 65,539, 65,584, 65,588.

The Final Rule is scheduled to go into effect on January 1, 2021. See

45 C.F.R. § 180.50

.

On December 4, 2019, Plaintiffs American Hospital Association, Association of American

Medical Colleges, Federation of American Hospitals, National Association of Children’s

Hospitals, Memorial Community Hospital and Health System, Providence Health System doing

business as Providence Holy Cross Medical Center, and Bothwell Regional Health Center, filed

suit, alleging that the agency exceeded its statutory authority under the Administrative Procedure

Act (APA),

5 U.S.C. § 706

(2)(C) (2018), Compl. ¶¶ 79–85; that the Rule violates the First

10 Amendment, Compl. ¶¶ 86–94; and that the Rule is arbitrary and capricious, also in violation of

the APA, § 706(2)(A), Compl. ¶¶ 95–101. Plaintiffs and Defendants cross-moved for summary

judgment, ECF Nos. 13, 19, and these motions are now ripe for decision.

II. Legal Standard

In a motion for summary judgment seeking review of a final agency action, “[t]he ‘entire

case’ on review is a question of law,” and there is “no real distinction between questions

presented in a Rule 12(b)(6) motion to dismiss and motion for summary judgment.” Am.

Bioscience, Inc. v. Thompson,

269 F.3d 1077, 1083

(D.C. Cir. 2001) (citing Marshall Cty. Health

Care Auth. v. Shalala,

988 F.2d 1221, 1226

(D.C. Cir. 1993)). The Court’s role is limited to

“determin[ing] whether or not as a matter of law the evidence in the administrative record

permitted the agency to make the decision it did.” Sierra Club v. Mainella,

459 F. Supp. 2d 76, 90

(D.D.C. 2006) (quotation marks and citation omitted).

III. Analysis

A. Statutory Authority

Plaintiffs contend that the Final Rule exceeds CMS’s statutory authority. “Standard

charges,” Plaintiffs contend, is an unambiguous term that can only refer to a hospital’s

chargemaster charges, and the term cannot be stretched to apply to custom negotiated charges

with third-party payers. See Pls.’ Mot. at 12–13. For its part, the agency disputes that “standard

charges” refers to chargemaster rates and maintains that its interpretation, which accounts for the

rates that are actually paid and the different types of patients and payers in the market, is either

the best reading of the statute, or at minimum, a reasonable one. See Def.’s Mot. at 2.

Under the well-known framework articulated in Chevron U.S.A., Inc. v. Natural

Resources Defense Council, Inc.,

467 U.S. 837

(1984), the Court must apply the ordinary tools

of statutory construction to determine “whether Congress has directly spoken to the precise

11 question at issue. If the intent of Congress is clear, that is the end of the matter . . . .” Merck &

Co. v. U.S. Dep’t of Health & Human Servs.,

385 F. Supp. 3d 81, 88

(D.D.C. 2019) (quoting City

of Arlington v. FCC,

569 U.S. 290, 296

(2013)), aff’d No. 19-5222,

2020 WL 3244013

(D.C. Cir. June 16, 2020). 5 But where a statute is ambiguous and “Congress has explicitly left a

gap for the agency to fill,” the Court must determine “whether the agency’s answer is based on a

permissible construction of the statute.” Chevron,

467 U.S. at 843

. “Such legislative regulations

are given controlling weight unless they are arbitrary, capricious, or manifestly contrary to the

statute.”

Id. at 844

.

1. Chevron Step One

Standard Charges. The analysis begins, as always, with the text. Section 2718(e)

requires each hospital to “establish (and update) and make public . . . a list of the hospital’s

standard charges for items and services provided by the hospital, including for diagnosis-related

groups established under section 1395ww(d)(4) of this title.” 42 U.S.C. § 300gg-18(e). The

statute does not define “standard charges,” nor does the term appear elsewhere in the Affordable

Care Act.

Plaintiffs nonetheless argue that “standard charges” unambiguously means “chargemaster

charges.” Relying principally on several judicial decisions (including unpublished ones),

Plaintiffs argue that, in the hospital industry, “standard charges” has long meant “chargemaster

5 Plaintiffs question the current viability of Chevron deference, see Pls.’ Reply in Supp. of Pls.’ Mot. and Pls.’ Opp’n to Def.’s Mot (“Pls.’ Reply”) at 11, ECF No. 27, which may “preclude[] judges from exercising [their] judgment, forcing them to abandon what they believe is ‘the best reading of an ambiguous statute’ in favor of an agency's construction.” Michigan v. E.P.A.,

135 S. Ct. 2699, 2712

(2015) (Thomas, J., concurring) (citation omitted); see also Gutierrez-Brizuela v. Lynch,

834 F.3d 1142, 1149

(10th Cir. 2016) (Gorsuch, J., concurring) (noting that it may be time to “face the behemoth” that has “permit[ted] executive bureaucracies to swallow huge amounts of core judicial and legislative power”). Until the Supreme Court revisits Chevron, however, it of course remains binding on this Court.

12 charges” and that “Congress is presumed to have been aware of” and thus adopted that

longstanding definition. Pls.’ Mot. at 12 (citing Morissette v. United States,

342 U.S. 246, 263

(1952)). 6

The presumption that Congress has adopted a particular meaning of a word or phrase

attaches to “terms of art in which are accumulated the legal tradition and meaning of centuries of

practice.” Morissette,

342 U.S. at 263

. But Plaintiffs point to only a handful of cases using the

term “standard charges” in the hospital industry, and in none of those opinions did the court

actually interpret the term, let alone state (or hold) that it means chargemaster. Indeed, most do

not even include the term “chargemaster.” Instead, in the cases on which Plaintiffs relies, the

courts referenced the phrase “standard charges” in disputes over other matters or appeared to

assume, based on the specific contract, that “standard charges” were “chargemaster charges.”

See, e.g., Webster Cty. Mem’l Hosp., Inc. v. United Mine Workers of Am. Welfare & Ret. Fund of

1950,

536 F.2d 419

, 419–20 (D.C. Cir. 1976) (per curiam) (referring to a “negotiated . . . series

of contracts” that “provide[d] that individual beneficiaries will not be required to pay the

difference, if any, between the per diem figure and the Hospital’s standard charge”); Lefler v.

United Healthcare of Utah, Inc.,

72 F. App’x 818, 821

(10th Cir. 2003) (discussing hospital

billing practices as explained in specific affidavits before the trial court); Brown v. Blue Cross &

Blue Shield of Mich., Inc.,

167 F.R.D. 40, 41

(E.D. Mich. 1996) (explaining reimbursement in

6 Plaintiffs also cite CMS’s previous guidance permitting hospitals to make public the chargemaster only, seemingly to show that this guidance reflected the common understanding that “standard charges” referred to “chargemaster charges.” See Pls.’ Mot. at 13 (citation omitted). But that was before the agency engaged in formal notice-and-comment rulemaking and solicited comments on how to define standard charges. Plaintiffs do not seriously contest that the agency was bound by its initial definition. See Chevron, 467 U.S. at 863–64 (“An initial agency interpretation is not instantly carved in stone. On the contrary, the agency, to engage in informed rulemaking, must consider varying interpretations and the wisdom of its policy on a continuing basis.”).

13 hospital contract under the diagnosis-related group methodology, which “was not based on each

hospital’s standard charge, i.e., the customary rate, but on a discounted charge which generally

was less than the hospital’s standard charge”), vacated, No. 94-CV-75033,

1997 WL 858746

(E.D. Mich. Jan. 23, 1997); NorthBay Healthcare Grp., Inc. v. Kaiser Found. Health Plan, Inc.,

No. 17-CV-05005,

2017 WL 6059299

, at *2 (N.D. Cal. Dec. 7, 2017) (describing agreement

between a hospital and health plan in which the hospital “agreed to accept a standardized

percentage of its ‘charge master rate’ (the standard rate a hospital charges for the services it

provides)”). 7

Perhaps more importantly, had Congress intended to require the publication of just a

hospital’s chargemaster or chargemaster rates, it could easily have done so by using the term

“chargemaster” in section 2718(e). See Def.’s Mot. at 15. “Chargemaster usage dates back to

the mid-20th century,” 8 and as recently as 2008, a Congressional Research Service report on

health care price transparency described the role of the chargemaster in hospital billing

(including the attenuated relationship between chargemaster prices and actual payments), see,

e.g., AR 4769–80. If anything, then, “chargemaster” is a term of art in the health care market, 9

7 Because NorthBay postdates the Affordable Care Act’s enactment, it cannot support the argument that in 2010 Congress was aware of a long-standing meaning of “standard charges.” 8 What Is a Chargemaster?, supra note 2. 9 See, e.g., DiCarlo v. St. Mary Hosp.,

530 F.3d 255, 263

(3d Cir. 2008) (“[The hospital] has a uniform set of charges (casually known as the ‘Chargemaster’) that it applies to all patients, without regard to whether the patient is insured, uninsured, or a government program beneficiary.”); Maldonado v. Ochsner Clinic Found.,

493 F.3d 521

, 523 n.1 (5th Cir. 2007) (“The ‘chargemaster’ is an exhaustive and detailed price list for each of the thousands of services and items provided by [clinic foundation].”); Vencor, Inc. v. Webb,

33 F.3d 840, 842

(7th Cir. 1994) (discussing the use of a “‘chargemaster’ which contained standardized charges and terminology for the various procedures [plaintiff] hospitals followed”); U.S. ex rel. Whitten v. Cmty. Health Sys., Inc.,

575 F. Supp. 2d 1367, 1371

(S.D. Ga. 2008) (explaining how certain billing practices “were handled in a like fashion by use of a ‘Chargemaster,’ which is a billing program used by the Hospitals, listing hospital goods and services and corresponding prices”);

14 and the fact that Congress chose not to use that term is strong evidence that “standard charges”

does not mean (or at least that it does not unambiguously mean) only “chargemaster charges.” 10

Plaintiffs’ argument that “standard charges” necessarily means “chargemaster rates” is

also inconsistent with the statute’s use of the term “standard,” which even Plaintiffs admit means

“usual, common, or customary.” See Pls.’ Mot. at 11–12 (citing Dictionary.com (2019)

(“serving as a basis of weight, measure, value, comparison, or judgment”); Merriam-Webster

(2019) (“regularly and widely used, available, or supplied”); Oxford English Dictionary (2019)

(“[h]aving the prescribed or normal size, amount, power, degree of quality, etc.”); Black’s Law

Dictionary (11th ed. 2019) (“A model accepted as correct by custom, consent, or authority.”). It

is undisputed that chargemaster rates are not the amounts paid on behalf of 90% percent of

hospitals’ patients, and thus it is hard to see how they can be considered usual, common, or

customary. See 84 Fed. Reg. at 39,579; Def.’s Mot. at 2; May 7, 2020 Hr’g Tr. at 8–9, ECF

No. 34. According to one study, chargemaster prices—which are typically paid by uninsured

patients with no discounts, see AR 4774—are approximately “2.5 times what most health

insurers pay,” Barak D. Richman et al., Battling the Chargemaster: A Simple Remedy to

Balance Billing for Unavoidable Out-of-Network Care, 23 Am. J. Managed Care e100, e101

Kizzire v. Baptist Health Sys., Inc.,

343 F. Supp. 2d 1074, 1079

(N.D. Ala. 2004) (reciting allegation that AHA “publications . . . encourage[s] [defendant hospital] and its other nonprofit hospital members to inflate its chargemaster prices, which only [defendant hospital’s] uninsured patients are charged”), aff’d,

441 F.3d 1306

(11th Cir. 2006). 10 Plaintiffs’ theory that “standard charges” means “chargemaster charges” also appears inconsistent with the use of the term “establish” in the statute, which requires hospitals to “establish . . . a list of . . . standard charges.” The plain meaning of “establish” is “to bring into existence” or “to bring about, effect.” Establish, Merriam-Webster (2020), https://www.merriam-webster.com/dictionary/establish. The implication is that a list of “standard charges” did not exist at the time of the statute’s enactment because hospitals were mandated to bring them about. Lists of chargemaster prices, however, have long existed.

15 (2017), https://www.ajmc.com/journals/issue/2017/2017-vol23-n4/battling-the-chargemaster-a-

simple-remedy-to-balance-billing-for-unavoidable-out-of-network-care (cited at 84 Fed. Reg.

at 65,538 n.45).

Plaintiffs’ answer to this, although not well-developed, appears to be that the term

“charge” is itself a term of art in the health care market. See Pls.’ Reply at 3–4. Plaintiffs’

argument seems to be that in this market at least, each item or service has a “charge” that is

something like the undiscounted amount that the hospital associates with that item or service.

See id. (citing AR 6733). The hospital includes that amount on all of its bills, even though it is

usually not the amount the hospital expects to be paid, especially in connection with patients who

are insured or who are paying cash. See 84 Fed. Reg. at 65,541.

But this argument does not appear to clear up any ambiguity. The word “charge” means

“the price demanded for something.” Pls.’ Reply at 3 n.2 (citing Merriam-Webster). Yet

chargemaster rates are rarely demanded for payment—again, chargemaster rates are paid for

only about 10% of hospital patients, making them anything but the “standard” price demanded

for a hospital’s services. Plaintiffs also endorse the CMS Medicare Provider Reimbursement

Manual’s definition of charges: the “regular rates established by the provider.” See May 7, 2020

Hr’g Tr. at 10–12 (citing CMS Medicare Provider Reimbursement Manual § 2202.4). But if that

definition were adopted, then the statute would require the publication of hospitals’ “standard”

“regular rates,” rendering the term “standard” superfluous. It is, of course, a “cardinal principle

of statutory construction that courts must give effect, if possible, to every clause and word of a

statute,” and thus this Court “must give independent meaning” to both “standard” and “charge.”

Williams v. Taylor,

529 U.S. 362, 364, 404

(2000) (citation omitted).

16 There is yet another problem with Plaintiffs’ interpretation. The statute’s use of the term

“standard” certainly implies that hospitals also have non-standard or irregular charges, but

Plaintiffs have resisted this implication, contending that they have only one set of charges: those

reflected in their chargemasters. See, e.g., Br. of Amici Curiae Thirty-Seven State Hospital

Associations in Supp. of Pls.’ Mot. for Summ. J. (“Br. of 37 State Hospital Associations”) at 15

(“[T]he ‘chargemaster’ remains a hospital’s only universal list of charges for services.”),

ECF No. 25-1; 11 AR 1768–69 (asserting “hospitals charge every patient the same”); cf. DiCarlo

v. St. Mary Hosp.,

530 F.3d 255, 264

(3d Cir. 2008) (finding that in the context of a specific

agreement, “‘all charges’ unambiguously can only refer to [the hospital’s] uniform charges set

forth in its Chargemaster”). If that’s right, then there would be no non-standard charges, and the

word “standard” in the statute would again be superfluous.

Diagnosis-Related Groups. Finally, Plaintiffs’ interpretation that “standard charges” are

chargemaster charges is inconsistent with the requirement that hospitals publish “a list of

the . . . standard charges for items and services provided by the hospital, including for diagnosis-

related groups established under section 1395ww(d)(4) of this title.” 42 U.S.C. § 300gg-18(e)

(emphasis added). To understand why requires a brief understanding of diagnosis-related groups

(“DRGs”) and the evolution of their usage. A DRG is part of a payment methodology essential

11 It is not clear whether Plaintiffs and their amici agree on the definition of “charges.” When pressed for a definition at oral argument, Plaintiffs stated that a charge is “somewhere in between” the chargemaster rate and the amount billed, noting that it is “not the amount that the hospital normally bills and expects to be paid, nor is it an amount that is simply a rate on the chargemaster sheet.” May 7, 2020 Hr’g Tr. at 8:21–25. This position appears to be in some tension with the proposition that a chargemaster contains all charges. See Br. of 37 State Hospital Associations (“[T]he “chargemaster” remains a hospital’s only universal list of charges for services.”); cf. DiCarlo,

530 F.3d at 264

(finding that in the context of a specific agreement, “‘all charges’ unambiguously can only refer to [the hospital’s] uniform charges set forth in its Chargemaster”) (cited in Br. of 37 State Hospital Associations at 8 n.16).

17 to Medicare reimbursement. See AR 4769; AR 5285–86. In contrast to retrospective methods of

payment, under the DRG methodology, hospitals and insurers agree in advance on a flat-fee

reimbursement for inpatient care; “[u]pon each hospital discharge, all of the diagnoses,

procedures, complications[,] co-morbidities, and other patient characteristics are coded” and

assigned to medical-severity DRG groups. AR 5285. To simplify: Medicare reimburses

hospitals through “bundled” payments for certain inpatient treatments, and a hospital’s

reimbursement for a particular patient does not vary based on certain supplies or medication

amounts used, such as how many pain pills or bags of IV fluid the patient requires (assuming

relevant predefined factors were unaffected). See Def.’s Mot. at 12–13. Commercial insurers

have followed suit, see AR 5285, relying on Medicare’s list of DRGs but using different

reimbursement formulas, particularly because they can extract additional discounts from

hospitals, see AR 4769.

A DRG combines the relevant items and services into a single charge, which is not listed

on a chargemaster. Def.’s Mot. at 13. And in the context of private insurers, the DRG charge is

generally the product of negotiations. As a result, the agency contends, the statute’s requirement

that the list of standard charges include those for DRGs is, at a minimum, inconsistent with

Plaintiffs’ argument that “standard charges” unambiguously means chargemaster charges. See

Def.’s Mot. at 12–14.

The Court agrees. The statute requires each hospital to post “a list of [their] standard

charges for items and services provided by the hospital, including for diagnosis-related groups.”

42 U.S.C. § 300gg-18(e) (emphasis added). But it is undisputed that the costs or bundled

charges associated with DRGs do not appear on a chargemaster, which only lists the prices of

individual items and services. 84 Fed. Reg. at 65,539. That alone suggests that “standard

18 charges” has to mean something other than just the “chargemaster charges.” After all, “the term

‘including’ is not one of all-embracing definition[] but connotes simply an illustrative application

of the general principle.” Fed. Land Bank of St. Paul v. Bismarck Lumber Co.,

314 U.S. 95, 100

(1941) (citations omitted); see also P.R. Mar. Shipping Auth. v. Interstate Commerce Comm’n,

645 F.2d 1102

, 1112 n.26 (D.C. Cir. 1981) (“It is hornbook law that the use of the word

‘including’ indicates that the specified list of carriers that follows is illustrative, not exclusive.”

(citation omitted)); Antonin Scalia & Bryan A. Garner, Reading Law: The Interpretation of

Legal Texts 132 (2012) (“[T]he word include does not ordinarily introduce an exhaustive

list . . . .”).

Although section 2718(e) references the DRGs established by Medicare, it does not limit

the “items or services” to those provided to Medicare patients. As noted above, third-party

payers use the Medicare DRGs to negotiate their own DRGs and bundled packages that are

coded differently than DRGs, and which also may be priced differently than Medicare rates. See

84 Fed. Reg. at 65,534 (discussing the use of payer-specific codes or a Healthcare Common

Procedure Coding System to identify service packages based on procedures). But none of that

information appears on a hospital chargemaster, which at a minimum suggests that “standard

charges” is not limited to chargemaster charges. 12

12 Plaintiffs’ and amici’s varying explanations of the DRG clause’s purpose further underscore the ambiguity here. The State Hospital Associations argue that it was intended to make clear that this subsection did not supersede the already-existing Medicare transparency requirements for DRGs. Br. of 37 State Hospital Associations at 11 n. 33. Plaintiffs and the Chamber of Commerce argue that this clause simply clarifies that certain existing reporting procedures were to be left intact as part of Medicare’s DRG reimbursement scheme, which provides for outlier payments (in connection with “costlier-than-expected care”) based on the individual items or services. Br. of Chamber of Commerce of the United States of America as Amicus Curiae in Supp. of Pls.’ Mot. for Summ. J. (“Br. of Chamber of Commerce”) at 15–17 (citing

42 C.F.R. § 412.84

(g)–(h)) (other citations omitted), ECF No. 26-1; see also Pls.’ Reply at 7–8. But it is not entirely clear why Congress would have needed to address that issue in a provision that does

19 * * *

For the foregoing reasons, Plaintiffs’ argument that “standard charges” unambiguously

means “chargemaster charges” is unpersuasive. But that does not resolve the statutory question,

as under Chevron step two, CMS’s interpretation must still be reasonable.

2. Chevron Step Two

The agency explained when it promulgated its Rule that there is no “singular ‘standard’

that applies to all identifiable groups of patients,” and thus it attempted to define what is

“standard” by reference to different patient subsets. 84 Fed. Reg. at 65,541. The agency argues

that the Final Rule’s five categories of charges are “standard” for each of those patient subgroups

and that its interpretation of the statute is, at a minimum, a reasonable one. 13

As discussed above, Plaintiffs argue that the statute unambiguously requires the

publication of only one category of information—the chargemaster rates (gross charges). But

with respect to Chevron step two (that is, once the Court has decided that the statute is

ambiguous), Plaintiffs’ principal argument is that it is an unreasonable interpretation to require

publication of payer-negotiated charges. See, e.g., Pls.’ Mot. at 11, 13, 15; see also May 7, 2020

Hr’g Tr. at 15 (admitting that if the statute is ambiguous, the question of whether a requirement

to publish discounted cash prices is reasonable is a “closer question”). Plaintiffs argue that for

not disturb the Medicare reimbursement scheme and simply addresses pricing transparency to the public at large. In fact, section 2718(e) refers only to section 1395ww(d)(4), while discussions of outlier payments are in section 1395ww(d)(5). 13 The agency argues that its construction, which requires the disclosure of prices for the “vast majority of patients” and gives effect to the DRG clause, is the best reading of the statute. Def.’s Mot. at 10–11. But it also recognizes that the Court need not decide that issue, id., because under step two of Chevron, the Court need only determine whether the “agency’s definition [of ‘standard charges’] is ‘based on a permissible construction of the statute, which requires only that its construction be a reasonable one,” Serono Labs., Inc. v. Shalala,

158 F.3d 1313, 1320

(D.C. Cir. 1998) (quoting Chevron,

467 U.S. at 843, 844

) (internal quotation marks omitted).

20 each item or service a hospital may (and often does) negotiate particularized reimbursement

amounts with different third-party plans, and as a result, the Final Rule could require an

individual hospital to publish a list of charges that is “300 lines long with dozens of columns or

could lead to 100,000 rows of data with millions of fields.” Pls.’ Mot. at 25 (citing 84 Fed. Reg.

at 65,575). The sheer number of charges that might have to be published, Plaintiffs contend, is

entirely inconsistent with any of these being standard.

It is a close call whether the agency reasonably interpreted “standard charges” to include

rates negotiated with third-party payers. After all, the more charges published for any one item

or service, the less any one of those charges can be considered “usual” or “customary.” But in

this exceptionally unique market, the Court cannot conclude that CMS’s interpretation is

unreasonable. It is undisputed that different groups (or sub-groups) of patients have different

economic relationships with both hospitals and third-party payers; that some patients have no

third-party coverage; and that the amounts paid to hospitals for items and services differ across

those various patient groups. The agency’s decision to define “standard charges” based on the

different patient groups is thus a reasonable construction that accounts for the peculiar dynamics

of the health care industry. For self-pay patients, for example, “standard charges” are typically

the gross charges or discounted cash prices. But such patients make up far less than 50% of the

market, and for the remaining patients, there simply is no single “standard charge.” Instead,

amounts paid to hospitals for patients with third-party coverage depend not only on the specific

insurer or plan, but also on various other factors, including patients’ particular insurance plans.

See 84 Fed. Reg. at 65,546–47. Given the complex economic relationships among the insured

patients, hospitals, and third-party intermediaries, the agency reasonably interpreted “standard

charges” as including the rates negotiated with third-party payers. And the agency specifically

21 focused on the contracted rates as the standard charges because such rates can be made public in

advance and are not dependent on the (sometimes unpredictable) variables that impact the actual

amounts paid to the hospital. See id. 14

Plaintiffs’ attempts to analogize charges in the hospital billing to prices in other industries

only highlight the uniqueness of this market. See Pls.’ Reply at 3–4. For instance, Plaintiffs use

menu prices to argue that the Rule requires publication of non-standard rates. They argue that a

restaurant’s menu price for a sandwich is the standard charge; if the restaurant offered to supply

hundreds of sandwiches for a discounted price at a certain event, those prices would not be

standard. See id. This analogy seems inapt here. In the restaurant context, the price on the

menu is the amount most customers will pay, with discounts being the exception. The situation

is flipped in the hospital market, where the listed prices (i.e., the chargemaster rates) are paid by

only about 10% of patients—and are substantially higher than the amounts insurers actually pay.

See Richman, supra, at e101. And unlike the modest discounts that restaurants (or sellers in

other industries) may offer, hospital “discounts” are significantly more than the actual payment

rendered, several times over. One study found that hospitals may inflate the costs in the

chargemaster “more than fourfold” and that some services can “have charge-to-cost ratios of

almost 30.” 15

14 The agency recognized that “the actual paid amounts are dependent on information that the hospital does not have without contacting the insurer to determine the specifics of the patient’s obligations under the patient’s contract with the insurer.” 84 Fed. Reg. at 65,546–47. And in the DRG context, the agency only required the base negotiated rate, which does not account for adjustments that may affect final payment. See id. at 65,547. 15 What Is a Chargemaster?, supra note 2. Further illustrating the inapplicability of the menu analogy is the following data from California in 2002: “The average chargemaster price for an appendectomy . . . was $18,229; the indigent uninsured paid $1,783, the Medicare payment was $4,805, the managed care payment $6,174, and payments by the non-indigent uninsured was $8,143.3.” AR 4772.

22 In sum, the agency’s definition cannot be considered “manifestly contrary to the statute,”

Chevron,

467 U.S. at 844

, as it is the only construction that includes the amounts paid for the

items and services provided by hospitals to most patients. Where, as here, the goal of the statute

is “[b]ringing down the cost of health care coverage,” it is reasonable for the agency to have

construed the statute to require the publication of charges that would impact the largest group of

patients. See Henderson ex rel. Henderson v. Shinseki,

562 U.S. 428, 439

(2011) (“The title of a

statute or section can aid in resolving an ambiguity in the legislation’s text.” (citation and

alteration omitted)). Viewed “in light of the Act’s text, legislative history, and purpose,” the

agency’s decision to account for the complexities of hospital billing and establish a definition

based on actual payment rendered is certainly permissible. Allied Local & Reg’l Mfrs. Caucus v.

EPA,

215 F.3d 61, 68

(D.C. Cir. 2000) (citation omitted).

For similar reasons, the agency’s construction requiring the publication of privately

negotiated DRG rates also does not render it unreasonable. As noted above, Plaintiffs argue that,

even assuming “standard charges” can mean paid rates, the DRG clause only applies to payments

by Medicare, not private insurers. See Pls.’ Reply at 7–9. But Medicare reimbursement for

DRGs are set through a formula that is part of the agency’s annual rulemaking for Medicare’s

inpatient prospective payment system, see, e.g., id.; 84 Fed. Reg. at 42,044, whereas section

1395ww(d)(4) primarily gives the Secretary the authority to establish DRGs. Moreover, a

different statute already requires Medicare rate information for DRGs to be published, see 42

U.S.C. § 1395ww(d)(6), so it would be odd to think Congress required its publication (and the

publication of nothing else) again in section 2718(e). The agency’s interpretation thus reads the

DRG clause to have independent meaning and to include third-party negotiated rates for service

23 packages, which have become increasingly more prevalent between hospitals and private

insurers. See AR 5285; AR 4769.

As for the de-identified minimum and maximum charges, the agency’s decision to

include them as “standard charges” is also reasonable. After all, these charges are a subset of

payer-negotiated charges and supplement the list by providing a range of the highest and lowest

charges that a hospital has negotiated with all third-party payers for an item or service. See

84 Fed. Reg. at 65,554. They therefore act as a “meaningful anchor” for consumers who are

using the negotiated rates to compare their options, further advancing the statute’s objectives.

See id. at 65,554–55 (discussing how knowledge of payer-specific negotiated charges in addition

to the de-identified charges could ultimately “promote value choices in obtaining . . . healthcare

services[] and may also promote value choices in obtaining a healthcare insurance product”). 16

To be sure, there may have been other reasonable interpretations of the statute. The

Court is “mindful[, however,] that [its] role is not to determine . . . the most reasonable

interpretation of the statute, but to make sure that the [agency’s] interpretation is reasonable, that

is, ‘rational and consistent with the statute.’” S. Calif. Edison Co. v. FERC,

116 F.3d 507

, 517

(D.C. Cir. 1997) (citation omitted). The agency’s Rule is exacting, but the demands flow from

16 Plaintiffs further argue that a rule that requires multiple sets of charges violates the statutory mandate that hospitals publish “a list.” Pls.’ Mot. at 13–14. The agency does not dispute that the statute mandates the publication of only a single list but rejects Plaintiffs’ suggestion that the provision forecloses the publication of multiple types of charges on that list. Def.’s Mot. at 20. The agency is right that a list can contain multiple categories, an argument reinforced by the fact that hospitals can publish their charges in a single data file. Id. Section 2718(e) expressly authorizes the Secretary to issue guidelines as to how hospitals shall establish and make public the list of standard charges, and there is nothing unreasonable about the Secretary requiring that several categories be compiled into one list that takes the form of a single date file.

24 the congressional determination about the role of price transparency in bringing down health care

costs and the reality of hospital billing. 17

Plaintiffs make a final argument against the agency’s interpretation by resisting

altogether the application of the Chevron framework. In their view, the agency’s interpretation

warrants no deference because the Final Rule emerged not as a product of the agency’s expertise

but as a response to the President’s executive order, which “prescribed the very definition of

‘standard charges’ that the agency adopted.” Pls.’ Reply at 10; see also Pls.’ Mot. at 14. The

executive order, however, mandated only that the agency propose a rule that included standard

charges. Def.’s Mot. at 22. And importantly, CMS had been exploring new definitions for

“standard charges” well before the President’s order. See 83 Fed. Reg. at 20,549. The Final

Rule recites the steps the agency had taken to obtain input on price transparency issues for the

eighteen months before the Rule was finalized—including hosting listening sessions and sending

out requests for information in 2018. See 84 Fed. Reg. at 65,594; see also id. 39,573–74.

Although the President may have directed the agency to propose the rule, that, without more,

does not mean that Chevron is inapplicable.

3. Penalties

Plaintiffs argue separately that the statute does not empower CMS to impose penalties for

failures to comply with the publication requirements. See Pls.’ Mot. at 16–19. Section

17 The D.C. Circuit recently held that a different HHS price transparency regulation exceeded the agency’s authority. See Merck,

2020 WL 3244013

. There are crucial differences between Merck and this case. Perhaps most importantly, in Merck, the agency relied on its general authority to promulgate rules necessary to efficiently administer its Medicare and Medicaid functions and was unable to show a nexus between the rule and the implementation of those programs. See

id. at *5

. (citation omitted). Here, in contrast, the Affordable Care Act expressly requires that hospitals publish their “standard charges” and the agency used its expertise to interpret the term in the absence of a congressional definition.

25 2718(b)(3), from which CMS draws its authority, reads: “The Secretary shall promulgate

regulations for enforcing the provisions of this section and may provide for appropriate

penalties.” (emphasis added). Despite this express language, Plaintiffs contend that the word

“section” is a scrivener’s error, and that Congress authorized the Secretary to enforce only

subsections (a) and (b). See Pls.’ Mot. at 16–19. Pointing to the ACA’s “complex” legislative

process, Plaintiffs argue that when the enforcement provision was first drafted, it was intended to

apply to the medical loss ratio (“MLR”) provisions (subsections 2718 (a), (b)) only, and that the

provision requiring the publishing of standard charges, on the other hand, had no such

enforcement authorization.

Id.

at 16–17. The provisions were eventually consolidated, but

according to Plaintiffs, the enforcement provision was never intended to reach the “standard

charges” subsection. See

id.

at 18–19.

The language authorizing the Secretary to impose penalties does indeed appear in a

strange location in the section—subsection (b)(3), in a section ranging from (a) to (e). Even so,

subsection (b)(3) expressly provides that in enforcing the section, the Secretary may impose

penalties. And although the “standard charges” provision did not have an enforcement provision

early on in the drafting process, Plaintiffs point to nothing in the legislative process that indicates

Congress did not want the Secretary to enforce section 2718(e) once Congress saw fit to combine

the MLR and standard charges provisions into one section. It can hardly be said that authorizing

the Secretary to impose penalties to enforce the entire section is “demonstrably at odds with the

intentions” of Congress. Def.’s Mot at 25 (citing Demarest v. Manspeaker,

498 U.S. 184, 190

(1991)). This is particularly true in light of the fact that subsections (c), (d), and (e), which were

drafted separately from the MLR provision, reference the provisions in subsections (a) and (b),

indicating that Congress was aware of the interplay between the consolidated MLR and standard

26 charge subsections. See

id.

at 26 (citing 42 U.S.C. § 300gg-18(c), (d)). 18 And, as the agency

notes, because the MLR provisions are in subsections (a) and (b), Plaintiffs’ alternative

interpretation does not make sense because it would foreclose the Secretary from enforcing

subsection (a). Id. at 25–26; see also Pls.’ Reply at 13 n.14 (admitting that replacing “section”

with “subsection” only would be insufficient to correct scrivener’s error).

Plaintiffs insist that reading the statute to permit the Secretary to enforce the entire

section and “provide for appropriate penalties” would lead to an “absurd result” because it would

authorize the Secretary to penalize the National Association of Insurance Commissioners. Pls.’

Mot. at 18; Pls.’ Reply at 14 (citation omitted). But the statute is permissive, and an over-

inclusive permissive provision is certainly not unthinkable. See Def.’s Mot. at 27 (citation

omitted). To the extent Plaintiffs are concerned about the Secretary penalizing the representative

of separate State sovereigns, Pls.’ Mot. at 18–19, the enforcement provision itself is limited to

the imposition of appropriate penalties. In short, while the enforcement provision may have an

awkward placement, its plain language forecloses Plaintiffs’ argument.

B. First Amendment

Plaintiffs mount an independent attack on the Final Rule, contending that it compels

speech in violation of the First Amendment. The Parties dispute whether the Rule should be

subject to strict scrutiny, or, if it regulates commercial speech, which of the standards addressing

commercial speech should apply: the more deferential one under Zauderer v. Office of

Disciplinary Counsel of Supreme Court of Ohio,

471 U.S. 626

(1985), or the more exacting one

18 For instance, subsection (c)—a subsection that was moved around from drafting to the enactment—charges the National Association of Insurance Commissioners with “establish[ing] uniform definitions of the activities reported under subsection (a),” while subsection (d) permits the “Secretary [to] adjust the rates in subsection (b).” 42 U.S.C. 300gg-18.

27 under Central Hudson Gas & Electric Corp. v. Public Service Commission of New York,

447 U.S. 557

(1980). Plaintiffs contend that the Rule fails to satisfy any of the standards, while the

agency argues that it meets each one.

1. Standard of Review

As for the standard of review, Plaintiffs argue that the Rule is not directed at commercial

speech because it does not regulate advertising and because it “imposes an affirmative obligation

on hospitals to speak” and, as a result, is subject to strict scrutiny. Pls.’ Mot at 19–21. Plaintiffs’

half-hearted argument here relies on several inapposite cases that applied strict scrutiny where

the government sought to regulate communicative content or target a specific message or

speaker. See Pls.’ Mot. at 19 (citing Nat’l Inst. of Family & Life Advocates v. Becerra,

138 S. Ct. 2361

(2018) (regulation requiring crisis pregnancy centers to post information about

how to obtain abortions—“the very practice that petitioners are devoted to opposing”)); Reed v.

Town of Gilbert,

135 S. Ct. 2218

(2015) (sign restrictions that varied and “depend[ed] entirely on

the communicative content of the sign”); Sorrell v. IMS Health Inc.,

564 U.S. 552

(2011)

(regulation “disfavored marketing, that is, speech with a particular content,” as well as specific

speakers who were engaged in marketing on behalf of pharmaceutical manufacturers); Hurley v.

Irish-Am. Gay, Lesbian & Bisexual Grp. of Bos.,

515 U.S. 557

, 572–73 (1995) (state’s

application of public accommodation laws required private citizens marching in a parade to

incorporate a group bearing a message the parade marchers did not want to convey, thereby

“alter[ing] the expressive content of their parade.”). But Plaintiffs do not identify what

expressive message or communicative content is being altered, suppressed, or compelled by the

Final Rule. 19

19 In National Association of Manufacturers v. SEC, the D.C. Circuit stated that the Supreme Court’s decision in Hurley had stressed that outside of commercial advertising, speakers—

28 Relying on Spirit Airlines, Inc. v. Dep’t of Transp., Plaintiffs argue that commercial

speech is limited to “proposing a commercial transaction.” Pls.’ Mot. at 20 (citing

687 F.3d 403, 412

(D.C. Cir. 2012) (upholding airfare advertising rules)). But the Court in Spirit Airlines

was weighing whether price advertising was merely proposing a commercial transaction; to the

extent it was, advertising regulations triggered only the level of scrutiny applicable to

commercial speech.

687 F.3d at 412

. It does not follow that a requirement to publish prices is

the regulation of non-commercial speech and should therefore be subject to strict scrutiny.

Indeed, plaintiffs in Spirit Airlines argued that their price advertising went beyond proposing a

transaction by making a political point about the burdensome taxes imposed on airfare and that a

regulation prohibiting disclosing government taxes and fees “prominently” should therefore

trigger strict scrutiny.

Id. at 411

. The D.C. Circuit rejected this argument, stating that even

where “speech cannot be characterized merely as proposals to engage in commercial

transactions, it is nonetheless commercial in certain circumstances, for instance when it is an

advertisement, refers to a specific product, and the speaker has an economic motivation for it”

and ultimately applying Zauderer.

Id. at 412

, 414–15 (alterations, international quotation marks,

and citation omitted). To the extent that the publication of charges qualifies as a form of

expression, the Final Rule is a regulation of commercial speech and is thus not subject to strict

scrutiny.

including business corporations—“ha[ve] the right to tailor the[ir] speech” and that such a right “applies not only to expressions of value, opinion, or endorsement, but equally to statements of fact the speaker would rather avoid.”

800 F.3d 518, 523

(D.C. Cir. 2015) (quoting Hurley,

515 U.S. at 574

). But the fact that a statement of fact merits First Amendment protection does not resolve what level of scrutiny is triggered; indeed, the D.C. Circuit did go so far as to decide the applicable standard in NAM, concluding that the regulation at issue did not satisfy Central Hudson or strict scrutiny. Id. at 524.

29 But even if strict scrutiny does not apply, is the Final Rule subject to intermediate

scrutiny under Central Hudson or the “reasonable” standard under Zauderer? The D.C. Circuit

once explained that “where laws are ‘directed at misleading commercial speech,’ and where they

‘impose a disclosure requirement rather than an affirmative limitation on speech,’ Zauderer, not

Central Hudson, applies.” Spirit Airlines,

687 F.3d at 412

(quoting Milavetz, Gallop & Milavetz,

P.A. v. United States,

559 U.S. 229

(2010)). But more recently, the D.C. Circuit, sitting en banc,

has held that Zauderer is not limited just to situations in which the government’s interest is to

protect against deception. Am. Meat Inst. v. U.S. Dep’t of Agric. (“AMI ”),

760 F.3d 18, 22

(D.C.

Cir. 2014) (en banc).

Plaintiffs argue that AMI should be read in light of National Association of

Manufacturers v. SEC (“NAM”),

800 F.3d 518, 523

(D.C. Cir. 2015), which refused to apply

Zauderer to “compelled disclosures that are unconnected to advertising or product labeling at the

point of sale.”

Id.

at 523–24. But NAM reached that conclusion because issuers were required to

disclose online and in their reports to the Securities and Exchange Commission whether their

minerals were “conflict free”; issuers were thus required to convey a message that their products

were ethically tainted and that they had “blood on [their] hands.”

Id. at 530

; see also

id.

at 523

(citing United States v. United Foods, Inc.,

533 U.S. 405

(2001) (holding that the First

Amendment “may prevent the government from compelling individuals to express certain views

or from compelling certain individuals to pay subsidies for speech to which they object.”)). In

fact, the regulation there was “directed at achieving overall social benefits” and was different

from the Commission’s ordinary investor protection rules because it “was not ‘intended to

generate measurable, direct economic benefits to investors or issuers.’”

Id.

at 521–22 (citation

30 omitted). The court therefore concluded that “Zauderer has no application to this case.”

Id. at 524

.

Here, in contrast, the Final Rule requires the publication of the payments that hospitals

receive for their items and services for differently situated patients; that information does not

contain any expressive component similar to NAM. And this information—unlike the NAM

compelled disclosure which was “unconnected” to labeling at the point of sale, 800 F.3d

at 522—is directly relevant to “the terms . . . under which the services will be available,”

AMI,

760 F.3d at 22

(quoting Zauderer,

471 U.S. at 651

). To be sure, payer-negotiated rates

may be subject to further adjustments between hospitals and insurers and, in certain situations,

hospitals may offer self-pay patients additional discounts or charitable forgiveness. See

Pls.’ Mot. at 23, 27–28. But information that hospitals must publish under the Final Rule is

closely linked to the payment rendered, whether by the patients themselves or third-party payers,

and is thus far more connected to the mechanics of hospital billing and patients’ economic

benefits than a loaded description of conflict minerals directed at alleviating social harm

generally is to the sale of securities.

The application of Zauderer here is also consistent with more recent cases. In National

Institute of Family & Life Advocates, for instance, the Court refused to apply Zauderer to a rule

requiring pregnancy clinics to conspicuously post notices informing women of the existence of

abortion procedures, holding such a requirement was “not limited to ‘purely factual and

uncontroversial information about the terms under which . . . services will be available.’”

138 S. Ct. at 2372

(omission in original) (citing Zauderer,

471 U.S. at 651

)). Although the Court

did note that the disclosure in Zauderer governed “commercial advertising,” it also described

Zauderer as an “example” of how the “Court’s precedents have applied a lower level of scrutiny

31 to laws that compel disclosures in certain contexts.”

138 S. Ct. at 2372

. But the Court not only

left “certain contexts” undefined, it also said nothing indicating that the Zauderer framework is

limited to compelled advertising or point-of-sale disclosures—even as it analyzed a compelled

disclosure that was not an advertisement. See id.; Def.’s Reply Mem. in Further Supp. of Def.’s

Mot. at 16 (“Def.’s Reply”), ECF No. 30.

And recently, cases that have examined regulations touching on the display of prices have

suggested that, to the extent that price regulations implicate the First Amendment, Zauderer may

be the appropriate standard so long as the regulation does not impede a message the speaker

would like to convey. In Expressions Hair Design v. Schneiderman, for example, the Supreme

Court held that a New York law banning merchants from imposing a surcharge for the use of a

credit card was a speech regulation.

137 S. Ct. 1144

(2017). Rejecting the argument that the

rule regulated only conduct, the Court held that the law was a speech restriction because it

regulated how sellers could communicate their prices (e.g., “$10, with a 3% credit card

surcharge” was prohibited) and remanded the case to the Second Circuit to determine whether

the Zauderer or Central Hudson framework should apply.

Id. at 1151

. On remand, the Second

Circuit suggested that Zauderer would apply if the regulation simply “compel[led] the truthful

disclosure of an item’s credit-card price,” but if it barred merchants from describing a pricing

scheme or relaying any other information they wanted to express, then Central Hudson might

apply. Expressions Hair Design v. Schneiderman,

877 F.3d 99

, 103–04 (2d Cir. 2017); accord

Italian Colors Rest. v. Becerra,

878 F.3d 1165, 1176

(9th Cir. 2018) (applying Central Hudson

where regulation prohibited retailers from posting a single sticker price and charging an extra fee

for credit card use but permitted retailers to post single sticker price and offer discounts); cf.

Nicopure Labs, LLC v. FDA.,

944 F.3d 267

, 292 (D.C. Cir. 2019) (holding that a free sample ban

32 is a typical price restriction and the incidental effect of requiring the seller to communicate only

the lawful price has “no speech component like the price-related commentary in Expressions

Hair Design that would implicate the First Amendment”). 20

The Court therefore holds that Zauderer applies here, and the Final Rule must therefore

be reasonably related to the agency’s interests and cannot be so unjustified or unduly

burdensome that it chills protected speech. See United States v. Philip Morris USA Inc.,

855 F.3d 321, 327

(D.C. Cir. 2017).

2. Zauderer

Plaintiffs do not appear to dispute that the agency’s asserted interest in increasing

transparency is substantial. Instead, they argue that the Rule is unjustified because the

publication of hundreds of prices will “confuse” patients and “frustrate . . . [their] decision-

making.” Pls.’ Mot. at 27. They further contend that the regulation is unduly burdensome.

Id.

The agency has explained it has two interests: “providing consumers with factual price

information to facilitate more informed health care decisions” and “lowering healthcare costs.”

Def.’s Mot. at 32 (citing 84 Fed. Reg. at 65,544–45). According to the agency, publications of

the five types of charges advances those interests. Patients want to make informed choices, but

the lack of price transparency is one of the biggest hurdles they face in navigating the health care

market to find the best value. Def.’s Mot. at 34. Case studies from various states have shown

that where patients have access to pricing information, they can and will use price transparency

20 Although Plaintiffs are concerned that the Rule’s publication requirements may prove to be confusing to patients, they admit that nothing in the Rule prevents them from adding qualifiers explaining patients’ out-of-pocket costs. May 7, 2020 Hr’g Tr. at 16–17. Plaintiffs contend that the ability to add speech “does not cure the underlying lawfulness,” id., but a speaker’s ability to express or add a message is relevant to the question of whether Zauderer or Central Hudson applies.

33 tools to inform their health care choices. Id. at 33. Consumers in New Hampshire and Maine,

which have required the publication of select negotiated charges, have used pricing information

to their benefit, which has created downward pressure on health care costs. See id. Research

suggests that greater price transparency, “when available to the entire market,” can also reduce

health care costs. Id. And access to pricing information allows patients and doctors to have the

“cost-of-care conversations at the point of care.” 84 Fed. Reg. at 65,530. The publication of

charges will allow the agency to further its interest of informing patients about the cost of care,

which will in turn advance its other interest—bringing down the cost of health care.

While it is true that the published charges may not be the out-of-pocket costs for all

patients, this does not mean that the disclosures are so incomplete that they are no longer “purely

factual and uncontroversial.” 21 Pls.’ Mot. at 26 (quoting Zauderer,

471 U.S. at 626

). Even

Central Hudson recognizes that although some disclosures “communicate[] only incomplete

version of the relevant facts, the First Amendment presumes that some accurate information is

better than no information at all.”

447 U.S. at 562

(citation omitted). Plaintiffs do not

meaningfully dispute that for some patients, such as those on high deductible health plans, the

data will provide at least a useful estimate of the expense of certain hospital services, if not their

actual out-of-pocket rates. It may be that those patients will sometimes have to take additional

steps to determine their out-of-pocket costs, but unlike chargemaster rates, this information will

allow patients to make those calculations. Even where patients may be unable to compute their

health costs on their own, various developers have created platforms that aggregate pricing

information to let consumers conduct price searches. See, e.g., AR 5415–16. And more

21 Plaintiffs take issue with the agency requiring the publication of too many charges while simultaneously arguing the Rule is inadequate because it omits additional information linked to patients’ specific contractual relationships with their insurers.

34 generally, all of the information required to be published by the Final Rule can allow patients to

make pricing comparisons between hospitals. See Def.’s Mot. at 36.

Plaintiffs argue that requiring insurers to publish patients’ out-of-pocket costs would be

more useful to patients and point to an ongoing rulemaking that would require just that. See

Pls.’ Reply at 18–19. But Zauderer (like Central Hudson) does not require a perfect fit, only a

reasonable one. Plaintiffs also ignore that the Rule enables patients to compare discounted cash

prices with negotiated rates to determine which option is the most affordable. See Def.’s Reply

at 21 (citing 84 Fed. Reg. at 65,552). 22 Requiring insurance companies to publish patients’ out-

of-pocket rates does not further the agency’s goals of empowering patients in precisely the same

way. And, as discussed further below, price transparency advances the government’s other

interest—lowering health care costs.

Plaintiffs focus on the logistical and financial burdens of compliance with the Rule. But

the question of whether a regulation is “unduly burdensome” looks to whether speech is

burdened or chilled. See Def.’s Reply at 21; Zauderer,

471 U.S. at 651

(“We recognize that

unjustified or unduly burdensome disclosure requirements might offend the First Amendment by

chilling protected commercial speech.”); Nat’l Inst. of Family & Life Advocates,

138 S. Ct. at 2377

(describing cases holding that under Zauderer, disclosure requirements can “extend ‘no

broader than necessary’” because “[o]therwise, they risk ‘chilling’ protected speech” (internal

citations omitted)); AMI,

760 F.3d at 27

(“Zauderer cannot justify a disclosure so burdensome

that it essentially operates as a restriction on constitutionally protected speech . . . . Nor can it

22 In particular, the information can help certain patients determine whether paying the discounted cash price is more affordable than processing claims through their insurance providers.

35 sustain mandates that “chill protected commercial speech.” (alterations omitted) (citations

omitted)).

Plaintiffs argue that the publication of payer-specific negotiated rates will chill

negotiations between hospitals and insurers. 23 Pls.’ Reply at 26. But the Rule requires only the

publication of the final agreed-upon price—which is also provided to each patient in the

insurance-provided explanation of benefits—and not any information about the negotiations

themselves. 24 Plaintiffs are essentially attacking transparency measures generally, which are

intended to enable consumers to make informed decisions; naturally, once consumers have

certain information, their purchasing habits may change, and suppliers of items and services may

have to adapt accordingly. (This was implicit in AMI, which recognized that consumers wanted

country-of-origin labels and that the mandate was spurred in part by “buy American” interests.

AMI,

760 F.3d at 324

.) Hospitals may be affected by market changes and need to respond to a

market where consumers are more empowered, but the possibility that the nature of their

negotiations with insurers might change is too attenuated from the compelled disclosure to make

the Rule unlawful under Zauderer. And although Plaintiffs assert that the Rule threatens to shut

23 Plaintiffs argue that the government is trying to “have its cake and eat it too” by arguing that Zauderer applies beyond compelled advertising regulations without also accounting for burdens that go beyond chilling concerns. Pls.’ Reply at 26. But the agency’s position that Zauderer goes beyond advertising is rooted in the en banc D.C. Circuit’s holding in AMI. And although Plaintiffs want the “unduly burdensome” analysis to encompass more than just the chilling of speech, they cite no authority for that proposition and do not explain how far the analysis should extend, instead demanding that the government propose such a test. See

id.

24 The fact that these charges will be revealed to consumers (after a hospital procedure) severely undermines Plaintiffs’ argument that negotiated rates constitute trade secrets, Pls.’ Mot. at 24–25. See 84 Fed. Reg. at 65,544 (discussing the various ways these rates are disseminated to the public, including through explanations of benefits and certain state databases).

36 down negotiations altogether, Pls.’ Reply at 26–27, this is contradicted by their arguments

implying that negotiations would continue but ultimately benefit insurers, see id. at 17.

This brings us to Plaintiffs’ final argument here: that the Rule could actually result in

anti-competitive consequences and cause costs to increase, which would obviously be contrary to

the agency’s asserted interest of bringing down health care costs. Pls.’ Reply at 17–18. Whereas

Central Hudson requires the government to show that its regulation “directly and materially

advance[s] the asserted governmental interest[,] . . . Zauderer employs ‘less exacting scrutiny.’”

Cigar Ass’n of Am. v. FDA,

315 F. Supp. 3d 143, 171

(D.D.C. 2018) (citations omitted).

Although Zauderer’s means-end fit requirement may be more stringent than rational basis

review, AMI, 760 F.3d at 33–34 (Kavanaugh, J., concurring), the “evidentiary parsing” required

in Central Hudson is still “hardly necessary,” id. at 26 (majority opinion) (citation omitted). And

under Zauderer, the constitutionality of a regulation “does not hinge upon some quantum of

proof that a disclosure will realize the underlying purpose. A common-sense analysis will do.

And the disclosure has to advance the purpose only slightly.” Cigar Ass’n of Am.,

315 F. Supp. 3d at 171

(citing Disc. Tobacco City & Lottery, Inc. v. United States,

674 F.3d 509, 557

(6th Cir. 2012)).

Here, the agency relies on general economic principles and specific price studies in

support of its theory that price transparency could decrease health care costs. See Def.’s Mot.

at 33–34; Def.’s Reply at 20. Traditional economic analysis suggested to the agency that

informed customers would put pressure on providers to lower costs and increase the quality of

care. See 84 Fed. Reg. at 65,526. And the record contains studies touting the benefits of price

transparency, supporting the agency’s finding that such measures result in “lower and more

uniform prices.” Id.; see also AR 5008 (“[T]his paper provides evidence that price transparency

37 can be effective in the long run, especially when it is available to the entire market.” (discussing

effects of price transparency on imaging procedures)); AR 5679 (“Use of price transparency

information was associated with lower total claims payments for common medical services.”);

AR 6716 (“[M]erely disclos[ing] charge prices (as opposed to a more relevant price indicator) is

unlikely to translate into consumer savings.” (emphasis added)).

To be sure, the evidence in the record is not definitive. As Plaintiffs argue, some studies

caution that increased price transparency may result in anti-competitive effects. Pls.’ Reply at 17

(citations omitted). But CMS concluded that similar measures in Maine and New Hampshire

have resulted in increased competition. 84 Fed. Reg. at 65,544. While those examples do not

prove that the Final Rule will be successful, the agency reasonably concluded they are more

persuasive than a decades-old case study involving Danish ready-mixed concrete contracts and

research predating the transparency measures promulgated at the state level. See, e.g., AR 4760;

AR 5266–67 (cited in Pls.’ Reply at 17).

In sum, the weight of evidence here satisfies Zauderer, and the Rule is therefore

constitutional. 25

25 Even if Central Hudson applies here, the Final Rule likely satisfies it for the reasons discussed above. Central Hudson’s requirement that a speech regulation be no more restrictive than necessary appears to focus on whether speech will be burdened. 447 U.S. at 570–71 (“The Commission also has not demonstrated that its interest in conservation cannot be protected adequately by more limited regulation of appellant’s commercial expression. . . . In the absence of a showing that more limited speech regulation would be ineffective, we cannot approve the complete suppression of Central Hudson’s advertising.”). Plaintiffs have not demonstrated that the Final Rule will suppress or alter any expressive content. The agency also has shown its regulation would “‘in fact alleviate’ the harms it recited ‘to a material degree.’” NAM,

800 F.3d at 527

(citing Edenfield v. Fane,

507 U.S. 761, 771

(1993)). The agency’s reliance on numerous studies here is hardly comparable to the pure speculation undergirding other agency actions that have been struck down under Central Hudson. See, e.g., Edenfield,

507 U.S. at 771

(holding government did not demonstrate that ban on certain solicitation advanced government’s asserted interests of preventing fraud where it “present[ed] no studies” and did not “disclose any anecdotal evidence” demonstrating such dangers existed); NAM, 800 F.3d at 526–27 & 525 n.21

38 C. Arbitrary and Capricious

Plaintiffs’ final claim is that the Rule is arbitrary and capricious, and they largely echo

their First Amendment arguments: that there is a disconnect between the Rule and the agency’s

goal of improving patients’ decision-making and that the Rule “imposes a disproportionately

large cost” on the hospitals. Pls.’ Mot. at 27–28

Under the arbitrary and capricious standard, the scope of judicial review is deferential

and narrow. Nat’l Ass’n of Home Builders v. Defs. of Wildlife,

551 U.S. 644, 658

(2007); Ark

Initiative v. Tidwell,

816 F.3d 119, 127

(D.C. Cir. 2016). The Court must “confirm that the

agency has ‘fulfilled its duty to examine the relevant data and articulate a satisfactory

explanation for its action including a rational connection between the facts found and the choice

made.’” Tidwell,

816 F.3d at 127

(internal quotation marks omitted) (quoting Motor Vehicle

Mfrs. Ass’n of the U.S., Inc. v. State Farm Mut. Auto. Ins. Co.,

463 U.S. 29, 43

(1983)). And

where an agency’s predictive judgments are implicated, the review standard is “particularly

deferential.” Rural Cellular Ass’n v. FCC,

588 F.3d 1095, 1105

(D.C. Cir. 2009). Once the

Court is satisfied that the agency has discharged its duty, the Court “cannot substitute its

judgment for that of the agency,” and it must uphold the agency’s decision, even it is of “less

than ideal clarity.” Defs. of Wildlife,

551 U.S. at 658

.

Plaintiffs first contest CMS’s conclusion that information about third-party negotiated

rates will provide meaningful information to patients about their own out-of-pocket costs.

According to Plaintiffs, that information will instead confuse patients and might deter them from

(holding that SEC’s mineral disclosure rule violated First Amendment because SEC could not quantify any benefits to show that the rule alleviated the targeted humanitarian issues and where one commissioner noted the rulemaking “lack[ed] any analysis of whether the benefits will materialize”).

39 seeking care if they assume a higher negotiated rate correlates with higher out-of-pocket costs.

Pls.’ Mot. at 28; see also Br. of Chamber of Commerce at 21, ECF No. 26-1 (“[D]isclosure of

negotiated reimbursement rates may . . . deter patients from obtaining medical care that they

need, if individuals fail to recognize that their own financial exposure is much lower than the

negotiated reimbursement rate that the insurer pays the hospital.” (citing Sheetal M. Kircher et

al., Opaque Results of Federal Price Transparency Rules and State-Based Alternatives,

15 J. Oncology Prac. 463, 463 (2019), https://ascopubs.org/doi/pdf/10.1200/JOP.19.00354)).

But the agency considered this argument and concluded that, on the whole, the Rule

furthers the government’s dual interests of informing patients and lowering the costs of health

care. See Def.’s Mot. at 32–37. For some patients—those who are self-pay and those willing to

pay cash—the published information will tell them their out-of-pocket costs, 84 Fed. Reg. at

65,528, 65,553, a fact Plaintiffs do not appear to contest. And more generally, these and other

patients (and third-party analysis groups) will be able to make comparisons among and between

the hospitals by reference to the amounts that different hospitals are paid for similar items or

services.

Because the agency is exercising its predictive judgment in assessing the effects of price

transparency, it needed only to “acknowledge factual uncertainties and identify the

considerations it found persuasive.” Maryland v. EPA,

958 F.3d 1185

, 1210 (D.C. Cir. 2020)

(quoting Rural Cellular Ass’n,

588 F.3d at 1105

). The agency did just that by acknowledging

the potential for patient confusion but concluding that on balance, the “vast majority” stood to

benefit from “the increased availability of data, especially as it may be reformatted in consumer-

friendly price transparency tools.” 84 Fed. Reg. at 65,547. It also acknowledged that there are

“no definitive conclusions on the effects of price transparency on the market” but discussed the

40 studies it found most relevant in the absence of a national model. Id.at 65,548–49. Such

uncertainty is not fatal to the Final Rule; indeed, it is because the “available data does not settle a

regulatory issue . . . [that] the agency [is entitled to] then exercise its judgment in moving from

the facts and probabilities on the record to a policy conclusion.” State Farm,

463 U.S. at 52

.

Moreover, CMS reasonably concluded that the publication of just chargemaster rates

suffers from the same deficiencies Plaintiffs claim are associated with the publication of

negotiated rates. Although chargemaster rates have been public for some time, consumers

remain “exceptionally frustrated at the lack of publicly available data to help ease [the burden of

understanding the costs of care].” 84 Fed. Reg. at 65,547. This is likely because chargemaster

rates are paid in connection with a very small minority of patients and are thus generally

confusing for the majority of patients. In fact, one of the sources on which the Chamber’s Brief

relies criticizes chargemaster rates for being opaque and misleading. See Kircher et al., supra, at

463 (“[B]ecause [the chargemasters’] listed prices likely do not reflect what a patient (or the

insurance company) will ultimately pay, it is unclear how useful this information is in making a

comparative cost-based decision.” (citation omitted)). The article further concludes that

“mandating the publication of chargemasters in their current form does little to empower patients

through better access to hospital price information and to create a consumer centered

marketplace.” Id. Plaintiffs’ proposed approach would appear to magnify any such defects. Cf.

Merck,

2020 WL 3244013

, at *6 (“[I]t is difficult to see how requiring the disclosure of [‘a price

that’s rarely paid’] to consumers generally promotes price transparency in any material way.”

(quoting Oral Arg. Tr. at 39:1)).

Plaintiffs also argue that the agency woefully underestimated the costs of compliance,

which will outweigh any benefits of the Final Rule. See Pls.’ Mot. at 27–29. But, as discussed

41 above, the agency did not act arbitrarily and capriciously in concluding that the Final Rule could

have substantial benefits. Nor did the agency “ignore[] the evidence bearing on the [question] of

compliance costs.” Pls.’ Mot. at 27 (citing Butte County v. Hogen,

613 F.3d 190, 194

(D.C. Cir. 2010)). CMS recognized hospitals’ concerns about the “thousands of lines of data

consumers would have to sift through” and technical hurdles in compiling the data into one file.

84 Fed. Reg. at 65,556. It ultimately concluded, however, that a single data file 26 will be used

“by the public in price transparency tools, to be integrated into [electronic health records] for

purposes of clinical decision-making and referrals, or to be used by researchers and policy

officials to help bring more value to healthcare.” Id. at 65,555–56. The agency even identified

previous types of Medicare data files that were of comparable size yet were easily accessible to

health care consumers. Id at 65,556.

When commenters disputed the agency’s assumption that the hospitals’ contracts and

prices were electronically available and remarked that much of the work would need to be done

manually, the agency suggested that hospitals request electronic copies of their contracts and rate

sheets from third-party payers. Id. at 65,550. 27 It also proposed a complementary rule that

would require insurers to post data, such as negotiated rates, in electronic form, which could

benefit “less resourced hospitals” in complying with the Rule. Id. at 65,550–51. It can hardly be

said hospitals’ concerns about their burden fell on deaf ears. And mindful of comments

describing compliance as a “herculean task” and recognizing that a short time frame would pose

26 Requiring the data to be maintained in a single file is consistent with the statutory mandate that hospitals publish “a list.” § 300gg-18(e) (emphasis added). Had the agency required or even permitted numerous data files, Plaintiffs certainly would have opposed that move, arguing that publishing multiple data files was too far removed from the requirement of a single list. 27 Hospitals’ best practices dictates that these charges already be available in contracts and their associated rate sheets. 84 Fed. Reg. at 65,546.

42 challenges for certain hospitals, CMS modified its rule and delayed its effective date by a year.

Id. at 65,585. That the agency’s proposed solutions may not have been to Plaintiffs’ satisfaction

does not render the Rule arbitrary and capricious.

In sum, CMS considered commenters’ concerns, echoed here in Plaintiffs’ briefs, about

the Rule but determined that those concerns were not persuasive. By acknowledging conflicting

data and articulating which information it found most convincing, the agency fulfilled its duty to

examine the evidence before it and connect it to the Final Rule.

IV. Conclusion

For the reasons set forth above, Plaintiffs’ Motion for Summary Judgment is denied, and

Defendant’s Motion for Summary Judgment is granted.

DATE: June 23, 2020 CARL J. NICHOLS United States District Judge

43

Reference

Status
Published