Quality Performance Standards and Measures

Since Congress limited the Secretary’s termination power to circumstances in which an ACO fails to meet “the quality performance standards established by the Secretary under subsection (b)(3),”¹¹⁴ CMS must attempt to classify antitrust status under this rubric to provide statutory support for its enlargement of the termination power. The health care reform law grants the Secretary the authority to establish both quality performance “standards” and “measures” for assessing ACO efficiency in providing health care.¹¹⁵ Therefore, to establish the limits of the Secretary’s power to terminate ACOs from MSSP, we must scrutinize Congress’s intended meaning of these terms and the context in which Congress used them by employing the “traditional tools of statutory construction.”¹¹⁶ Subsequently, we must decide whether antitrust considerations comport with Congress’s chosen statutory language.

a. Antitrust Considerations as Quality Performance Measures

The first option, incorporating antitrust considerations into quality performance measures, is impracticable because Congress’s use of

“measure,” which appears in § 1395jjj(b)(3)(A), precludes such an interpretation. Congress, by its own language, intended these measures to pertain to CMS’s assessment of the “quality of care” an ACO provides to beneficiaries in specific contexts.¹¹⁷ CMS would certainly assert in response that “quality of care” includes business quality as well as medical quality. When read in context, however, the “measures to assess the quality of care furnished by ACOs” include clinical data, utilization data, and patient experiences.¹¹⁸ Also, under § 1395jjj(b)(3)(B), the data an ACO must provide to CMS “on measures . . . to evaluate the quality of care furnished by ACOs” comprise “care transitions . . . including hospital discharge planning and post-hospital discharge follow-up.”¹¹⁹ Therefore, Congress has precluded conflation of “quality of care” with antitrust status and other business quality considerations in the definition of “measure.”

Congress defines “measures to assess quality of care” through

114 42 U.S.C.S. § 1395jjj(d)(4) (Lexis 2012).

115 Id. § 1395jjj(b)(3).

116 Chevron, 467 U.S. at 843 n.9.

117 42 U.S.C.S. § 1395jjj(b)(3)(A) (“The Secretary shall determine appropriate measures to assess the quality of care furnished by the ACO, such as measures of—(i) clinical processes and outcomes; (ii) patient and, where practicable, caregiver experience of care; and (iii) utilization (such as rates of hospital admissions for ambulatory care sensitive conditions).”).

118 Id.

119 Id. § 1395jjj(b)(3)(B).

examples corresponding to the medical care services a health care provider performs: clinical outcomes, patient experience, and utilization data. In this context, Congress apparently intended “measures” to mean

“metrics,” a method by which to gauge the degree of quality of medical care so that CMS may effectively compare ACOs with one another.

Also, the language of the “quality performance measure” requirements neither mentions antitrust considerations nor grants the Secretary broad power to set any other standards that she deems necessary. Instead,

§ 1395jjj(b)(3)(C) grants the Secretary the power to set standards to

“assess the quality of care” and to improve progressively that care by promulgating “higher standards or measures for purposes of assessing such quality of care.”¹²⁰

The agency argued in its proposed rules that it has an overarching duty under the health care reform law to protect Medicare beneficiaries from the anticompetitive practices of maleficent health care providers.¹²¹ CMS could seek to broaden the definition of “measure” to include “an action taken as a means to an end”¹²² under this perceived duty. This subjective reading of the statutory language would potentially allow CMS to include restrictive “measures” of an ACO’s anticompetitive activities to improve the quality of care to patients.

When read alongside § 1395jjj(b)(3)(C), however, in which

“standards” and “measures” appear together, we must logically conclude that Congress included the word “measure” to mean “metric,” rather than the more general “rule.” Although the statutory language explicitly gives the Secretary authority to develop other “measures,” the agency must read this authority in light of ejusdem generis,¹²³ a common canon of statutory construction. The examples of quality measures that Congress articulates in the statute relate to clinical use and medical quality data, and cannot be read to incorporate the investigations or determinations of other agencies. Therefore, to the extent that the listed measures prescribe limits to the types of other measures the Secretary may create, CMS may not promulgate a “quality measure” that bases eligibility of an ACO on its investigation status with the Antitrust Agencies.

120 Id. § 1395jjj(b)(3)(C).

121 Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations, 76 Fed. Reg. 19,528, 19,630 (Apr. 7, 2011) (“[T]he proposal maintains competition for the benefit of Medicare beneficiaries by reducing the potential for the creation of ACO’s with market power. . . . Competition benefits the Shared Savings Program by . . . accelerat[ing] the advancements in quality and efficiency.”).

122 W^EBSTER’^S IIN^EW R^IVERSIDE U^NIVERSITY D^ICTIONARY (1994).

123 This term refers to a canon of construction limiting ambiguous terms following a list of specific terms to the same class to which the specific terms belong. See B^LACK’^S L^AW D^ICTIONARY 594 (9th ed. 2010).

b. Antitrust Considerations as Quality Performance Standards

The second option, which identifies antitrust violations as a quality performance standard, is likewise inapposite because Congress construed “standards” to correspond with medical treatment statistics.

Similar to “measures,” the statute places “quality performance standards” in the context of CMS’s assessment of an ACO’s provision of medical care.¹²⁴ While this language fails to provide a pellucid definition, it sufficiently manifests Congress’s intent to confine the Secretary to creating standards that pertain solely to health care delivery.

Therefore, the foregoing text also binds the agency’s interpretation of the termination provision, § 1395jjj(d)(4), as the language of that section limits the Secretary’s power of termination to violations of the

“quality performance standards established by the Secretary under subsection (b)(3).”¹²⁵

Congress’s intended meaning of “quality performance standard” in the context of § 1395jjj(b)(3)(C) also turns on the definition of one word: “standard.” Here again, though, the Secretary must use the contemplated “standards” to “assess the quality of care furnished by ACOs.”¹²⁶ CMS would no doubt argue that “quality of care” includes not only the medical quality of care, but also the business quality. While

§ 1395jjj(b)(3)(C) contains neither an illustrative list nor explicit language to define “quality of care,” the term is identical to that in

§ 1395jjj(b)(3)(A) for quality performance measures.¹²⁷ To read “quality of care” in § 1395jjj(b)(3)(C) differently would ignore the judiciary’s preference to apply identical definitions to equivalent terms in various sections of the same statute.¹²⁸ Therefore, quality performance standards also cannot encompass antitrust or other business quality considerations.

One may rightly presume that Congress intended “measure” and

“standard” to have distinct meanings since both words appear together in the statute, and a valid interpretation must give effect to each word of the statute.¹²⁹ Obviously, CMS would argue for a court to construe

“standard” as the equivalent of a “rule” defining the boundaries of an

124 42 U.S.C.S. § 1395jjj(b)(3)(C) (Lexis 2012) (“Quality performance standards—The Secretary shall establish quality performance standards to assess the quality of care furnished by ACOs. The Secretary shall seek to improve the quality of care furnished by ACOs over time by specifying higher standards, new measures, or both for purposes of assessing such quality of care.”).

125 Id. § 1395jjj(d)(4).

126 Id. § 1395jjj(b)(3)(C).

127 See supra notes 117–119 and accompanying text.

128 See LaRue v. DeWolff, Boberg & Assocs., 552 U.S. 248, 258 (2008) (citing Barnhill v.

Johnson, 503 U.S. 393, 406 (1992)).

129 See Duncan v. Walker, 533 U.S. 167, 174 (2001) (citing United States v. Menasche, 348 U.S. 528, 538–39 (1955)).

ACO’s activities in providing care. Such a definition of “standard,”

however, would be tantamount to an alteration of the statutory language, which “must come from Congress and not the agency itself.”¹³⁰ Instead, when read in context with “measure” as a “metric” or

“unit” of quality of care, Congress apparently intended the word

“standard” to assume its common definition¹³¹ as “an accepted measure of comparison for quantitative or qualitative value.”¹³² This interpretation is eminently logical given that the statute instructs CMS to use the “quality performance standards” to assess the quality of the care an ACO provides.¹³³ Any assessment requires a common reference point, and in the case of ACO furnished medical treatment, the statute compels the Secretary to formulate “quality performance standards” as appropriate reference points.

This interpretation makes “standard” the equivalent of

“benchmark,” a pre-defined level of quality that an ACO must meet to maintain compliance and avoid termination. Therefore, the Secretary has discretion to set benchmark values against which CMS may compare the data of the measures that the ACOs report. This comports with the further language of the section that the Secretary may “specif[y]

higher standards” to make it more difficult for ACOs to meet the required efficiency levels for shared savings.

In fact, the final rules reflect CMS’s willingness to adopt the logical definition of “quality performance” standards and measures. The agency lists thirty-three “Measures for Use in Establishing Quality Performance Standards that ACOs Must Meet for Shared Savings” in its comments attending the finalized regulations.¹³⁴ Each measure, such as “CAHPS:

Shared Decision Making” or “Influenza Immunization,” is grouped under a common rubric: “Patient/Caregiver Experience” or “Preventive Health,” respectively.¹³⁵ In finalizing the titles of the measures and domains in this comprehensive list, CMS has failed to link evaluation of an ACO under the “quality performance standards” to an ACO’s anticompetitive activities. Rather, each measure pertains to the quality of medical care the ACO provides to a Medicare beneficiary.¹³⁶

Congress defined both “measures” and “standards” of “quality performance” in § 1395jjj(b)(3), and these definitions confine the Secretary’s termination power as described in § 1395jjj(d)(4). While

130 Bd. of Governors of the Fed. Reserve Sys. v. Dimension Fin. Corp., 474 U.S. 361, 365 (1986).

131 References to dictionary definitions are common when parsing statutory language in Chevron step one analyses. See, e.g., Anna Jaques Hosp. v. Sebelius, 583 F.3d 1, 5 (D.C. Cir.

2009); Nutritional Health Alliance v. FDA, 318 F.3d 92, 99 (D.C. Cir. 2003).

132 W^EBSTER’^S IIN^EW R^IVERSIDE U^NIVERSITY D^ICTIONARY (1994).

133 42 U.S.C.S. § 1395jjj(b)(3)(C) (Lexis 2012).

134 Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations, 76 Fed. Reg. 67,801, 67,889 tbl. 1 (Nov. 2, 2011).

135 Id.

136 See id.; see also 42 U.S.C.S. § 1395jjj(b)(3).

Congress clearly intended the Secretary to establish methods of quantifying and comparing the levels of care an ACO provides, Congress’s chosen language distinctly limits the Secretary’s authority to terminate an ACO from MSSP. Although the statute articulates several eligibility criteria—subject to modification and addition by the Secretary—the explicitly worded termination provision binds that power specifically to one criterion: quality performance standards.¹³⁷

c. CMS May Neither Incorporate Antitrust by Amendment nor Invoke General Regulatory Authority

Although CMS has already specified the quality performance standards and measures by which it intends to assess ACOs, CMS retains the ability to amend the regulations and utilize formal agency rule-making procedures to resubmit its proposed amendments for public comment.¹³⁸ If a court strikes down CMS’s preferred termination standards, CMS could use APA’s rulemaking process to retroactively add metrics and standards to monitor anticompetitive behavior. Indeed, CMS will claim that because Congress placed no express restrictions on the Secretary’s ability to promulgate additional quality performance standards, in contrast to the limiting illustrative list provided for corresponding measures in § 1395jjj(b)(3)(A), such amendments deserve deference under Chevron step two.¹³⁹

Amendments adding antitrust considerations to the list of quality performance standards, however, would contradict Congress’s explicitly articulated classes of measures and standards,¹⁴⁰ as well as its language linking both terms to a medical performance rather than a business integrity context.¹⁴¹ While § 1395jjj(b)(3)(C) lacks an illustrative list, Congress provided the term “quality of care” to limit “quality performance standards” to medical rather than business concerns.¹⁴² Courts have been reluctant to defer to an agency’s interpretation when

137 42 U.S.C.S. § 1395jjj(d)(4).

138 See Administrative Procedure Act, 5 U.S.C. § 553 (2006).

139 Chevron, U.S.A., Inc. v. Natural Res. Def. Council, Inc., 467 U.S. 837, 843 (1984) (“[I]f the statute is silent or ambiguous with respect to the specific issue, the question for the court is whether the agency’s answer is based on a permissible construction of the statute.”); see also Northpoint Tech., Ltd. v. FCC, 414 F.3d 61, 69 (D.C. Cir. 2005) (deferring to FCC’s interpretation of “harmful interference” when the statute fails to “specify[] what ‘harmful interference’ might mean”).

140 42 U.S.C.S. § 1395jjj(b)(3)(A).

141 Id. § 1395jjj(b)(3). For additional analysis of the language of both sections, see supra notes 117–119, 126–128 and accompanying text.

142 Fin. Planning Ass’n v. Sec. & Exch. Comm’n, 482 F.3d 481, 492 (D.C. Cir. 2007) (“[T]he meaning of the text is defined by its context as set forth in the normal meaning of the words . . . .”); see also Chevron, 467 U.S. at 861 (“[T]he meaning of a word must be ascertained in the context of achieving particular objectives, and the words associated with it may indicate that the true meaning of the series is to convey a common idea.”).

the judges “find the language Congress selected plain, clear, and simple and [they] refuse to muddy it by finding ambiguity where none exists.”¹⁴³ Therefore, a reviewing court is not likely to defer to amendments by which CMS purports to redefine its current quality performance measures and standards to incorporate antitrust considerations.

Given CMS’s assertion in its proposed rules that the agency has a responsibility to create rules that will protect patients from an ACO’s anticompetitive acts, CMS may also assert a general authority to act in the “public interest.” Congress, however, did not authorize the Secretary to consider the public interest in creating quality performance measures and standards. Instead, CMS must establish such regulations “to assess the quality of care furnished by the ACO.”¹⁴⁴ The Court of Appeals for the D.C. Circuit held in Ethyl Corp. v. EPA that unless Congress provided some indication that an agency could consider public interest in regulating entities within its ambit, the agency may not interpret the governing statute as allowing such consideration.¹⁴⁵ As with EPA’s assertion of broader review authority, CMS’s claim would attempt to read substance into congressional silence regarding the Secretary’s authority to consider criteria other than “quality performance standards” when wielding its termination power. Therefore, as in Ethyl Corp., CMS is bound by the fact that “Congress has neither explicitly or [sic] implicitly delegated discretionary authority to the Agency to consider other factors . . . . Rather, the . . . provision unambiguously expresses Congress’s intent.”¹⁴⁶

C. Legislative History as Additional Evidence