Amicus Curiae Brief — Gobeille v. Liberty Mut. Ins. Co., 135 S. Ct. 885 (2014) (No. 14-181)

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No. 14-181

In the Supreme Court of the United States

ALFRED GOBEILLE, IN HIS OFFICIAL CAPACITY AS CHAIR

OF THE VERMONT GREEN MOUNTAIN CARE BOARD,

PETITIONER

Vv.

LIBERTY MUTUAL INSURANCE COMPANY

ON WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE SECOND CIRCUIT

BRIEF FOR THE UNITED STATES

AS AMICUS CURIAE SUPPORTING PETITIONER

DONALD B. VERRILLI, JR.

Solicitor General

M. PATRICIA SMITH Counsel of Record

Solicitor of Labor

EDWIN S. KNEEDLER

G. WILLIAM SCOTT Deputy Solicitor General

Associate Solicitor JouN F. BASH

ELIZABETH HOPKINS Assistant to the Solicitor

Counsel General

MELISSA MOORE Department of Justice

Attorney Washington, D.C. 20530-0001

Department of Labor SupremeCtBriefs@ usdoj.gov

Washington, D.C. 20210 (202) 514-2217

QUESTION PRESENTED

Whether the Employee Retirement Income Securi-

ty Act of 1974, 29 U.S.C. 1001 et seq., preempts, as

applied to self-insured health benefit plans or their

third-party administrators, a Vermont statute that

requires healthcare payers to report claims and

healthcare-services data to a state agency.

(I)

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TABLE OF CONTENTS

Page

a I idacinielteetinenmienatesmemnesenenaniois l

Statutory and regulatory provisions involved ...................0:0++ 2

EEE SE A Tee 2

Ee oN EE aE ee 10

Argument:

The Vermont reporting requirements are not preempted

nT onictenicaneesiiiisiaitaientdepicianiiiaiieeensionuninananumestindenttnnenes 13

A. The Vermont reporting requirements do not fall

within ERISA’s express preemption provision ............ 13

1. The Vermont reporting requirements serve

objectives distinct from the basic purposes

ee aiichervenuibidietiarenacinaiaibainipithintinnainemmences 15

2. The Vermont reporting requirements do not

exert an impermissible effect on the design

or administration of ERISA plans.........................+ 22

B. The Vermont reporting requirements are valid if

reviewed under general principles of field and

I ccesintctencentissinnsiicsancntcsnennnicintnenianamionien 30

lac talanl etieniiemiclniaamnmnieciil 36

Appendix — Statutory and regulatory provisions................. la

TABLE OF AUTHORITIES

Cases:

Aetna Health Inc. v. Davila, 542 U.S. 200 (2004)......... 24, 32

Alessi v. Raybestos-Manhattan, Inc., 451 U.S. 504

SES CLES ee Sonnet oe ane 23

Boggs Vv. Boggs, 520 U.S. 833 (1997) ........ccccsssseeeeeeeseenees 30, 32

California Div. of Labor Standards Enforcement v.

Dillingham Constr., N.A., 519 U.S. 316 (1997)....... passim

De Buono v. NYSA-ILA Med. & Clinical Servs.

Fund, 520 U.S. 806 (1997) ...........ccccceseeseeees 17, 23, 25, 27, 35

District of Columbia v. Greater Wash. Bd. of Trade,

TES TE eo eer 14

Cases—Continued: Page

Egelhoff v. Egelhoff, 532 U.S. 141 (2001)........ prea passim

English v. General Elec. Co., 496 U.S. T2 (1990)... 31

FMC Corp. v. Holliday, 498 U.S. 52 (1990) .........ccccceeeeeeees 33

Fort Halifax Packing Co. v. Coyne, 482 U.S. 1

GIFT iciiccncesssacieicrntesninibimminmnnetinmetianaiammmdas 16, 23, 32

Ingersoll-Rand Co. v. McClendon, 498 U.S. 133

GE dcccunscessesssnessscesensininipntnadeennnmmenienaiaimeiaiaaian 14, 15, 22

John Hancock Mut. Life Ins. Co. v. Harris Trust &

Sav. Bank, 510 U.S. 86 (1998) .........scccrsssorsssssssvsscersesessersees 15

Keystone Chapter, Associated Builders & Contrac-

tors, Inc. v. Foley, 37 F.3d 945 (3d Cir. 1994),

cert. denied, 514 U.S. 1082 (1995).........ssessssseserssereseerseees 26

Mackey v. Lanier Collection Agency & Serv., Inc.,

SF Ga ervenscavenevicienneincsininssssiatiisitiniataniisnissisaiitasiiinay 14

Massachusetts v. Morash, 490 U.S. 107 (1989) ................. 15

Metropolitan Life Ins. Co. v. Massachusetts,

GER FE, Cele ED cernevenrcictnineanntinaiinaaiiaiaisianniiciiin 23, 31

New York State Conference of Blue Cross & Blue

Shield Plans v. Travelers Ins. Co., 514 U.S. 645

CID actrcssscscsessonsconensseneonntnccneneennnnuniiinittiunmmaniaaitil passim

ONEOK, Inc. v. Learjet, Inc., 135 S. Ct. 1591 (2015)......... 31

Pegram v. Herdrich, 530 U.S. 211 (2000)............ccccccseesseeeees 18

Rice v. Santa Fe Elevator Corp., 331 U.S. 218 (1947)........ 31

Shaw v. Delta Air Lines, Inc., 463 U.S. 85

CE iccscceccstinsesinniataneniaiiamimnsipiadendntamaimaliiaataiaa 9, 13, 20, 23, 24

Standard Oil Co. v. Agsalud, 633 F.2d 760

(9th Cir. 1980), summarily aff’d, 454 U.S. 801 (1981)......16

UNUM Life Ins. Co. of Am. v. Ward, 526 U.S. 358

CIID sceciocesncecsmsensionscsidsiissnaiiasinaiiaiinianiiseaiieeail 30, 33

Statutes and regulations: Page

Employee Retirement Income Security Act of 1974,

Pub. L. No. 93-406, 88 Stat. 829 (29 U.S.C. 1001

Icicle eenlneripeenntemntsnicamnnindbenmedtnesnemnsmenancsteceneeneanes 1,2

EE 17, la

Ee 2, 16, 17, 2a

SE 2, 3a

ET l

ene 2

I cates 2

I cetera 2

29 U.S.C. 1104(a)(1) .........00eccceceee I 35, l5a

29 U.S.C. 1104(a)(1)(D).............. siateiiiecennl 32, 33, 15a

TE l

SET 3

a 3, 16a

TTT a Lc passim, 17a

I 19, 18a

ee 13, 18a

ET eae 13, 18a

I ca ce tacieseinaes 13, 20a

laa snatrareeccrtacnirnamennnnats 19, 20a

I hea searertataneanseeate’ 3, 21

EEE aE 21, 2la

TTR 21, 22a

Eee 3, 23a

Health Insurance Portability and Accountability Act

of 1996, Pub. L. No. 104-191, § 101(a),

iit aciaasiencatrtartemnnnneansnnsensanscnnensseesees 3

Patient Protection and Affordable Care Act,

Pub. L. No. 111-148, 184 Stat. 119.........cccccccccecesscccscccccessosece 3

Statutes and regulations—Continued: Page

SE eee 3

Ee 3

§ 1563(e), 124 Stat. 270, 911 (29 U.S.C. 1185d)................ 3

§ 3021(a), 124 Stat. 389 (42 U.S.C. 1315a)............-....000+. 20

§ 10332, 124 Stat. 968 (42 U.S.C. 1395kk(e)) ................. 21

RE 3

ee tenincniertrinincrnsiincnttininel 4, 21, 22, 24a

TE 21, 25a

es aiciciinnisiaeccpnitininnnccenisiiiamaeid 4, 22, 25a

a ieiiccrnsiiiinierscntimeinniinasiiea 4, 22, 26a

42 U.S.C. B00 Gg-ZB(AN2).........ccsersseesessseerensersseseeesees 21, 28a

42 U.S.C. SO0ggy-BA(e KU C) .......cerererserecnsnsessecececnsscrsessneees 7

ee ccrinernnicnegininenmninnniiesl 20, 29a

4B U.S.C. 1SDGa( ENB) ..nwn.n-a..ececerecececcesesscsesescseeees 20, 30a

42 U.S.C. 1315a(b2)(B)(xi)...........cececessseseesvesseneeees 20, 30a

es dich inicimetcieniccseieneninaeel 20, 31a

ee ee iieritinertctarncniiinantinaiiieeunaiiniiiint 7, 3la

42 U.S.C. 1395kk(e)(2)MA) .....0...cserccssscessensereersesesees 21, 32a

42 U.S.C. 180B1(e)(B)(A)..........ccccscecscercesseersesenrers 4, 22, 33a

es Sie ieiietertcnsiiiincncsinmeuinnmpicnaineeiil 21, 35a

Cal. Lab. Code § 1776 (West 1989)................c.c:ccccsssrssersresees 26

Vt. Stat. Ann. tit. 18:

nia ieeccnetehaniiedantnreaiiatamertenintal 16, 35a

I artis snscrranintrrtiguaieminmnaniinaitall 4, 36a

ET Te EET 5, 36a

BI Ga nsiccsnsimninsieinesmmsiiinieininisintl 4, 37a

§ 9410(a)(1) (Supp. 2014) 0... eececeseseseceeeeeeeeeees 4, 16, 37a

§ 9410(a)(2)(A) (Supp. 2014).............cececeseseeeeeeees 6, 16, 37a

i csrtnrertceerinininieaiieatil 5, 38a

EY 13, 39a

Vil

Statutes and regulations—Continued: Page

§ 9410(c)-(d) (Supp. 2014).........cccccssscsssesssessensrsessesees 5, 39a

§ DELOLEN 1) (Samp. BOUS) .......0.ececorecsecccccsccsecsecsccrsecsees 5, 39a

ON OD ccccrcreseerecencsntctstennnainnueasnennnianttl 5, 39a

i 6, 34, 39a

ene, 6, 39a

I i rrncemateteidniceatacesatntll 6, 39a

§ 9410(h\X(2) (Supp. 2014)..............0.-c.cccscersesersessesenees 34, 40a

§ 9410(h)(3)(B) (Supp. 2014) 00. 8 neeninil 5, 4la

§ 9410(h)(3)(C) (Supp. 2014) oo... ecccececceeeeeeneenees 5, 42a

§ 9410(h)(3)(D) (Supp. 2014) 0... cecceeeeceeeneesenees 6, 42a

§ 9410(j)(1)(A) (Supp. 2014) oes cimmeniel 5, 43a

§ 9410(j (1B) (Supp. 2014) 02... ccceecsceeeneenenees 5, 43a

Wash. Rev. Code § 11.07.010(1) (1994) 00.0... ccecccceceeeneeee 33

RE Re ee 2

Reg. H-2008-01, 21-040-021 Vt. Code R. (2008) ............ 6, 44a

eset ntaestet talent acetal diate dati innclaaeidatliaicanaiaaiaal 13, 47a

STTTTTTTTT hse esschaseisihdans aes heitbehateiteshkeehnaatiniadataetaciaeaiiniaaiedeniantiads 7, 48a

iain hina ih lela atleast learned 6, 17, 48a

Eee 6, 17, 49a

SUT icssiiicieainhcicaetacatncinestentatiantalaaienictatiaiatehiaiiceaiiatiaa 7, 50a

OA sidibeesaeenbdhaiestnlepessiatcsdedeniiinieiaitatdetliaidtaslanaaiaitbuasiniatesnsituaiaais 13, 50a

EEE anne seer enn neers ERE 6, 5la

REE RRR ALLA ASL SSnaeteee ee e EE 7, 52a

ERIE SCR ne 6, 17, 54a

Miscellaneous:

Paul Fronstin, Self-Insured Health Plans: State

Variation and Recent Trends by Firm Size, Emp.

Benefit Res. Inst. Notes, Nov. 2012...............ccccesseeeeseeeeeee 19

S. Rep. No. 127, 93d Cong., Ist Sess. (1973) .................c000 25

In the Supreme Court of the Anited States

No. 14-181

ALFRED GOBEILLE, IN HIS OFFICIAL CAPACITY AS

CHAIR OF THE VERMONT GREEN MOUNTAIN CARE

BOARD, PETITIONER

Vv.

LIBERTY MUTUAL INSURANCE COMPANY

ON WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE SECOND CIRCUIT

BRIEF FOR THE UNITED STATES

AS AMICUS CURIAE SUPPORTING PETITIONER

INTEREST OF THE UNITED STATES

This case concerns whether the Employee Retire-

ment Income Security Act of 1974 (ERISA), 29 U.S.C.

1001 et seg., preempts a state law imposing certain

reporting requirements on healthcare payers, includ-

ing ERISA plans. The Secretary of Labor has prima-

ry authority for administering ERISA. 29 U.S.C.

1002(13), 1132-1135. In response to an invitation from

the Court, the United States filed an amicus brief in

this case at the petition stage.

(1)

STATUTORY AND REGULATORY

PROVISIONS INVOLVED

The pertinent statutory and regulatory provisions

are reproduced in the appendix to this brief. See

App., infra, 1a-59a.

STATEMENT

1. The Employee Retirement Income Security Act

of 1974 (ERISA), 29 U.S.C. 1001 et seg., is designed to

“protect * * * the interests of participants in em-

ployee benefit plans and their beneficiaries * * * by

establishing standards of conduct, responsibility, and

obligation for fiduciaries of employee benefit plans,

and by providing for appropriate remedies, sanctions,

and ready access to the Federal courts.” 29 U.S.C.

1001(b). The statute governs both pension plans and

“employee welfare benefit plan(s],” ie., plans that,

“through the purchase of insurance or otherwise,”

provide medical, disability, unemployment, vacation,

or certain other benefits. 29 U.S.C. 1002(1). ERISA

requires every plan to be established and maintained

pursuant to a written instrument and to have named

fiduciaries who have authority to control and manage

the administration of the plan and its assets. 29

U.S.C. 1102(a)(1), 1103(a). With specified exceptions,

ERISA preempts “any and all State laws insofar as

they * * * relate to any employee benefit plan.” 29

U.S.C. 1144(a).

Plan administrators generally must file detailed fi-

nancial and actuarial information with the Secretary

of Labor (Secretary) and submit reports upon the

occurrence of specific events, although the Secretary

has exempted most welfare plans from the majority of

those requirements. 29 U.S.C. 1021-1024; 29 C.F.R.

Pt. 2520. In addition, the Secretary has authority to

investigate plans for ERISA violations by inspecting

plan documents, administrative contracts, and claims

records. 29 U.S.C. 1134. ERISA also authorizes the

Secretary “to undertake research and surveys and in

connection therewith to collect, compile, analyze and

publish data, information, and statistics relating to

employee benefit plans.” 29 U.S.C. 1143(a)(1).

ERISA includes certain provisions governing

“group health plan{s],” 7.e., ERISA welfare plans that

provide medical benefits, 29 U.S.C. 1191b(a), that

were originally enacted as part of the Health Insur-

ance Portability and Accountability Act of 1996

(HIPAA), Pub. L. No. 104-191, § 101(a), 110 Stat.

1939. See 29 U.S.C. 1181-119lc. In 2010, Congress

enacted the Patient Protection and Affordable Care

Act (ACA), Pub. L. No. 111-148, 124 Stat. 119, which

imposes a number of new requirements on the group

health-insurance market, such as a prohibition on

charging different premiums based on health status.

See § 1001, 124 Stat. 130; see also 42 U.S.C. 300gg et

seq. In a section setting out “conforming amend-

ments,” ACA § 1563, 124 Stat. 264, 911 (capitalization

and emphasis omitted), the ACA also amended

ERISA to provide that those new provisions generally

apply to group health plans and that, in the event of a

conflict between those ACA provisions and the sec-

tions of ERISA addressing group health plans, the

ACA provisions govern. See id. § 1563(e), 124 Stat.

270, 911 (29 U.S.C. 1185d). The new ACA provisions

applicable to group health plans include reporting and

disclosure requirements related to such matters as

claims-payment policies, out-of-network coverage,

data on enrollment and denied claims, financial infor-

mation, and information on the existence of any quali-

ty initiatives or wellness programs under the plan.

See 42 U.S.C. 300gg-15a (incorporating provisions of

42 U.S.C. 18031(e)(3)); 42 U.S.C. 300gg-17(a) and (b).

Those provisions of the ACA have not yet been im-

plemented. The Department of Labor has informed

this Office, however, that pursuant to the authority

granted by ERISA and the ACA, and in consultation

with the Department of Health and Human Services

(HHS) and the Department of the Treasury, it is cur-

rently considering a rulemaking to require health

plans to report more detailed information about vari-

ous aspects of plan administration, such as enrollment,

claims processing, and benefit offerings.

2. The Vermont Legislature has enacted a com-

prehensive health law designed to “(mJaintain and

improve the quality of health care services offered to

Vermonters,” “[uJ)tilize planning, market, and other

mechanisms that contain or reduce increases in the

cost of delivering services,” and “[e)ncourage regional

and local participation in decisions about health care

delivery, financing, and provider supply.” Vt. Stat.

Ann. tit. 18, § 9401(b)(1)-(3) (2012). One provision of

the statute requires the Green Mountain Care Board

(Board), a state agency, to develop and maintain a

database of information about healthcare expendi-

tures in the State and out-of-state healthcare expendi-

tures involving Vermont residents. See id. § 9410

(Supp. 2014) (Database Statute). The database is

designed to help “identify[] health care needs,” “com-

par(e] costs between various treatment settings and

approaches,” “determin[e] the capacity and distribu-

tion of existing resources,” and “provid[e] information

to consumers and purchasers of health care.” Id.

§ 9410(a)(1) (Supp. 2014).

The database must “reflect all health care utiliza-

tion, costs, and resources” for medical services pro-

vided to Vermont residents or by Vermont facilities.

Database Statute § 9410(b) (Supp. 2014). To that end,

the Database Statute authorizes the Board to require

“Chjealth insurers, health care providers, health care

facilities, and governmental agencies” to submit “re-

ports, data, schedules, statistics, or other infor-

mation.” /d. § 9410(c)-(d) (Supp. 2014). The informa-

tion may include “health insurance claims and enroll-

ment information” and “any other information relat-

ing to health care costs, prices, quality, utilization, or

resources.” Jd. § 9410(c)(1) and (3) (Supp. 2014). The

law’s definition of “({hjealth insurer” includes any

health-insurance company and, “to the extent permit-

ted under federal law, any administrator of an in-

sured, self-insured, or publicly funded health care

benefit plan offered by public and private entities,”

Vt. Stat. Ann. tit. 18, § 9402(8) (2012), as well as any

third-party administrator that a self-insured health

plan employs to handle such functions as claims pro-

cessing, bill review, and claims payments, Database

Statute § 9410(j)(1)(A) and (B) (Supp. 2014).

The Database Statute provides that, “[t]o the ex-

tent allowed by HIPAA, the [collected] data shall be

available as a resource for insurers, employers, pro-

viders, purchasers of health care, and State agencies

to continuously review health care utilization, expend-

itures, and performance in Vermont.” § 9410(h)(3)(B)

(Supp. 2014); see id. § 9410(h)(3)(C) (Supp. 2014). It

also requires the Board to establish “a consumer

health care price and quality information system” to

“empower individuals, including uninsured individu-

als, to make economically sound and medically appro-

priate decisions.” /d. § 9410(a)(2)(A) (Supp. 2014). In

addition, the statute directs that “[rJecords of infor-

mation * * * required by law to be held confiden-

tial{] shall be filed in a manner that does not disclose

the identity of the protected person,” id. § 9410(e)

(Supp. 2014), requires the Board to “adopt a confiden-

tiality code,” id. § 9410(f) (Supp. 2014), and prohibits

the disclosure of “any data that contains direct per-

sonal identifiers,” id. § 9410(h)(3)(D) (Supp. 2014).

Knowing violations of the statute or implementing

rules promulgated by the Board are punished through

financial penalties. /d. § 9410(g) (Supp. 2014).

The Board’s predecessor promulgated a regulation

implementing the statute’s requirements with respect

to healthcare payers. See Reg. H-2008-01, 21-040-021

Vt. Code R. (2008) (Database Regulation). (The Board

also administers a separate database for hospital-

discharge data that is not at issue here. See Pet. Br. 7

& n.6.) The Database Regulation provides that

“Health Insurers shall regularly submit medical

claims data, pharmacy claims data, member eligibility

data, provider data, and other information relating to

health care provided to Vermont residents and health

care provided by Vermont health care providers and

facilities.” § 4(D). The claims data comprise only

information about “non-denied adjudicated [medical

and pharmacy] claims.” Jd. § 3(Ac); see id. § 3(Ak);

see also id. § 5(A)(8). The data include information

about “member demographics, provider information,

charge/payment information, and clinical diagnosis

and procedure codes.” Jd. § 3(Ac). The regulation

establishes requirements for how the data must be

formatted, when it must be submitted, and under what

circumstances different types of data will be released

to the public or to specific requestors, such as re-

searchers. /d. §§ 5-8. It exempts health insurers with

fewer than 200 enrolled or covered members in Ver-

mont from the reporting requirements, although they

may voluntarily report. Jd. § 3(Ab) and (As).

The Board uses the claims database in fulfilling its

statutory responsibilities, such as approving insurance

rates and reviewing hospital budgets. See Pet. Br. 15-

16, 33-35. In 2014, HHS issued a grant to the Board

to expand its use of the database in connection with

Vermont’s rate-review authority under the ACA. /d.

at 49-50 & n.29; see 42 U.S.C. 300gg-94(c)(1)(C). In

addition, HHS supplies Medicare data to the Board,

see 42 U.S.C. 1395kk(e), and has authorized the Board

to include Medicaid data, see Pet. Br. 10. Over a doz-

en other States have enacted legislation to build simi-

lar databases. See N.Y. et al. Cert. Amicus Br. 1 &

n.3.

3. Respondent is the named fiduciary and adminis-

trator of an ERISA self-insured health plan for its

employees. Pet. App. 7. A self-insured plan is one in

which the plan sponsor pays claims out of its own

assets or from a trust, rather than contracting with an

insurance company to pay claims under an insurance

policy. Because only 137 persons covered by respond-

ent’s health plan live in Vermont, respondent is not

itself required to report healthcare-expenditure in-

formation to the Board. /d. at 7-8. But respondent’s

plan is administered by a third-party administrator—

Blue Cross Blue Shield of Massachusetts, Inc. (Blue

Cross)—that qualifies as a mandatory reporter under

the Database Regulation because it administers

claims for thousands of individuals in Vermont. /d. at

8; see J.A. 205. In August 2011, the Board’s predeces-

sor issued a subpoena to Blue Cross, seeking eligibil-

ity information and medical- and pharmacy-claims

files for Vermont residents covered by respondent’s

plan, which had not been reported as required by the

Database Statute and Regulation. J.A. 30-33. Re-

spondent, believing that the request was preempted

by ERISA, instructed Blue Cross not to comply with

the subpoena. Pet. App. 9.

Respondent then filed suit in the United States

District Court for the District of Vermont against the

Board’s predecessor. J.A. 12-28. Respondent sought

a declaratory judgment that the Database Statute and

Regulation “are preempted by ERISA to the extent

they require the reporting, production, or disclosure

of any confidential health care information or medical

records or data relating to [respondent’s health] [p]lan

or its participants and beneficiaries.” J.A. 27. Re-

spondent also sought to enjoin the Commissioner

“from attempting to obtain, from (Blue Cross] or any

other source, any medical records or data relating to

the [p]lan or its participants and beneficiaries.” J.A.

28.

The district court dismissed the complaint, holding

that the Vermont reporting requirements are not

preempted by ERISA. Pet. App. 48-80. The court

explained that although “[clompliance with the report-

ing requirements * * * may have some indirect

effect on health benefit plans,” the possible “effect is

so peripheral that the regulation cannot be considered

an attempt to interfere with the administration or

structure of a welfare benefit plan.” /d. at 78. The

court emphasized that respondent had “not submitted

any information about any actual burden suffered by

itself or [Blue Cross} in producing this information.”

Id. at 73 n.5.

4. The court of appeals reversed, holding that

ERISA preempts the Vermont reporting require-

ments. Pet. App. 1-30. The court explained that un-

der this Court’s interpretation of ERISA’s preemption

provision, 29 U.S.C. 1144(a), “a state law is preempted

if ‘it [1] has a connection with or [2] reference to [an

ERISA] plan.” Pet. App. 14 (brackets in original)

(quoting Shaw v. Delta Air Lines, Inc., 463 U.S. 85, 97

(1983)). The court concluded that “the reporting re-

quirements of the Vermont statute and regulation

have a ‘connection with’ ERISA plans (though no

‘reference to’ them)” because “‘reporting’ is a core

ERISA function shielded from potentially inconsistent

and burdensome state regulation.” Jd. at 23. The

court noted that Vermont could change the require-

ments at any time, id. at 27, and it postulated that if

respondent were subject to “one of several or a score

of uncoordinated state reporting regimes,” the burden

would be “obviously intolerable,” id. at 25.

Judge Straub dissented in relevant part. Pet. App.

30-47. “Many state laws,” he wrote, “may have an

impact on the administration of an ERISA plan—for

example, a work-place safety law, a prevailing wage

law, or a law that requires companies to report em-

ployment data.” Jd. at 42. Although “[sJuch laws may

impose additional costs,” he concluded, “none of these

laws impact how benefits are administered to benefi-

ciaries and, therefore, they are not preempted by

ERISA.” Jbid. Judge Straub also found that “on the

record before [the court,]” no basis existed to conclude

that the Vermont reporting requirements would “hin-

der the national administration of employment benefit

plans in any way.” /d. at 44; see id. at 41-42.

SUMMARY OF ARGUMENT

ERISA does not preempt the Vermont reporting

requirements.

A. Under this Court’s precedents construing

ERISA’s preemption provision, 29 U.S.C. 1144(a), the

Vermont reporting requirements do not “relate to”

ERISA plans because they have neither a “reference

to” nor a “connection with” such plans. Egelhoff v.

Egelhoff, 532 U.S. 141, 147 (2001) (citation omitted).

As the court of appeals acknowledged, the require-

ments do not have a “reference to” ERISA plans be-

cause they operate on many healthcare payers, not

only on ERISA plans, and the existence of an ERISA

plan is not logically necessary to their operation. Pet.

App. 23 n.9 (citations omitted). Preemption therefore

turns on whether the requirements have a forbidden

“connection with” ERISA plans. Although this Court

has not defined that concept with great precision, it

has evaluated the preemption question by “look[ing]

both to the objectives of the ERISA statute as a guide

to the scope of the state law that Congress understood

would survive” and “to the nature of the effect of the

state law on ERISA plans.” Egelhoff, 532 U.S. at 147

(citations and internal quotation marks omitted).

Under that approach, the requirements are not

preempted.

1. The Database Statute and ERISA serve differ-

ent purposes. ERISA governs the design and admin-

istration of employee benefit plans, including vesting

requirements, health-benefit mandates, fiduciary

duties, and remedies for breach. Its reporting and

disclosure requirements further those purposes. The

Database Statute, in contrast, is designed to improve

the quality, utilization, and cost of healthcare in Ver-

mont by providing consumers, government officials,

and researchers with comprehensive data about the

healthcare-delivery system. Although those data are

reflected in claims paid by various entities, including

ERISA plans, the focus of the Vermont statute has

nothing to do with the claims-payment process. That

is why Vermont does not seek information on denied

claims.

Because the Vermont reporting requirements op-

erate in the traditional state sphere of health and

safety, while ERISA is principally concerned with the

distinct subject of ensuring that plans provide covered

benefits, the reporting requirements are entitled to a

presumption of validity under Section 1144(a). As this

Court has cautioned, it would be “unsettling” to con-

clude that ERISA squelches an entire area of state

regulation about which ERISA itself says little. Cali-

fornia Div. of Labor Standards Enforcement v. Dil-

lingham Constr., N.A., 519 U.S. 316, 330 (1997) (cita-

tion omitted). That discomfiting result would be par-

ticularly harmful here, because the data collected by

the Vermont reporting requirements are integral to

achieving the objectives of other federal statutory

provisions.

2. The Vermont reporting requirements do not ex-

ert impermissible effects on the design or administra-

tion of ERISA plans. ERISA generally preempts

those laws that prescribe binding rules for “a central

matter of plan administration,” such as “the payment

of benefits,” Egelhoff, 532 U.S. at 148, but it does not

guarantee “cost uniformity” among different States

where a plan might operate, New York State Confer-

ence of Blue Cross & Blue Shield Plans v. Travelers

Ins. Co., 514 U.S. 645, 662 (1995). The Vermont re-

porting requirements do not impose binding obliga-

tions with respect to any core matter of plan admin-

istration, such as the vesting of benefits, claims pro-

cessing, or the designation of beneficiaries. Respond-

ent’s contrary argument essentially rests on the view

that all reporting of information acquired or generat-

ed during the administration of a plan qualifies as a

central matter of plan administration. But that argu-

ment conflicts with this Court’s prior decisions and,

taken to its logical conclusion, would sweep away

virtually all state-law reporting requirements incident

to laws of general applicability. And although this

Court has suggested in dicta that a law imposing costs

that are so acute as to effectively dictate how a plan is

designed or administered would be preempted, no

such extreme economic effects have been established

here.

B. Some Justices have suggested in separate opin-

ions that this Court should clarify its ERISA preemp-

tion jurisprudence by holding that Section 1144(a)

merely calls for the application of ordinary principles

of field and conflict preemption. Under those princi-

ples, the Vermont reporting requirements are not

preempted. The requirements do not invade the ex-

clusive federal field of the design and administration

of ERISA plans. Nor do they conflict with

any specific provision of ERISA or with Section

1144(a)’s basic objective to establish a uniform body of

employee-benefits law.

ARGUMENT

THE VERMONT REPORTING REQUIREMENTS ARE NOT

PREEMPTED BY ERISA

A. The Vermont Reporting Requirements Do Not Fall

Within ERISA’s Express Preemption Provision

Section 1144(a) of ERISA expressly preempts state

statutes and regulations that “relate to” an ERISA

plan, except for “any law * * * which regulates in-

surance, banking, or securities,” “any generally appli-

cable criminal law,” and other specified categories of

state laws. 29 U.S.C. 1144(a), (b)(2)(A), (4), and (c)(1).

Under this Court’s precedents construing that provi-

sion, “[a) law ‘relates to’ an employee benefit plan

* * * if it has a connection with or reference to such

a plan.” Shaw v. Delta Air Lines, Inc., 463 U.S. 85,

96-97 (1983); see, e.g., Egelhoff v. Eglelhoff, 532 U.S.

141, 147 (2001); New York State Conference of Blue

Cross & Blue Shield Plans v. Travelers Ins. Co., 514

U.S. 645, 656 (1995) (Travelers).

The court of appeals correctly concluded (and re-

spondent has not contested) that the Vermont report-

ing requirements do not have a “reference to” ERISA

plans. Pet. App. 23 n.9 (citations omitted). A law has

a “reference to” ERISA plans if it “acts immediately

and exclusively upon ERISA plans” or “the existence

of ERISA plans is essential to the law’s operation.”

California Div. of Labor Standards Enforcement v.

Dillingham Constr., N.A., 519 U.S. 316, 325-326

(1997) (Dillingham). The Vermont reporting re-

quirements apply to many healthcare payers, not only

to ERISA plans. Database Statute § 9410(c) (Supp.

2014); see Database Regulation §§ 3(X), 4. And they

could function independently of the existence of

ERISA plans, though excluding ERISA plans would

render Vermont’s database far less comprehensive

and thus less useful. For these reasons, the reporting

requirements do not resemble the state laws that this

Court has held to have a specific “reference to”

ERISA plans. Those laws have targeted ERISA plans

with specificity. See District of Columbia v. Greater

Wash. Bd. of Trade, 506 U.S. 125, 128, 129-133 (1992)

(workers’ compensation law that required employee

benefits “set by reference to [ERISA] plans”) (citation

omitted); Ingersoll-Rand Co. v. McClendon, 498 U.S.

133, 135-136, 140 (1990) (common-law claim for wrong-

ful discharge to prevent attainment of ERISA bene-

fits); Mackey v. Lanier Collection Agency & Serv.,

Inc., 486 U.S. 825, 828 & n.2, 829-830 (1988) (exemp-

tion from garnishment statute for ERISA plans).

Accordingly, whether Section 1144(a) preempts the

Vermont reporting requirements turns on whether

the requirements have an impermissible “connection

with” ERISA plans. This Court has acknowledged

that the phrase “‘connection with’ is scarcely more

restrictive than ‘relate to’” and has therefore “cau-

tioned against an uncritical literalism that would make

pre-emption turn on infinite connections.” Egelhoff,

532 U.S. at 147 (citation and internal quotation marks

omitted). To avoid such an expansive breadth, the

Court has “look[ed] both to the objectives of the

ERISA statute as a guide to the scope of the state law

that Congress understood would survive” and “to the

nature of the effect of the state law on ERISA plans.”

Ibid. (citations and internal quotation marks omitted);

see Travelers, 514 U.S. at 655-656.

Much like ordinary field preemption, the first in-

quiry essentially asks whether the challenged state

law is directed at “an area of core ERISA concern”:

the design and administration of employer-sponsored

pension and welfare plans. Egelhoff, 532 U.S. at 147;

see, e.g., Dillingham, 519 U.S. at 330-331. The second

inquiry asks whether, even if the law is not overtly

directed at that field, its application would frustrate

the purpose of ERISA’s preemption provision “to

ensure that plans and plan sponsors [are] subject to a

uniform body of benefits law,” /ngersoll-Rand, 498

U.S. at 142, by prescribing binding rules for the de-

sign or administration of ERISA plans. See Egelhoff,

532 U.S. at 148-149. In this case, the answer to each

inquiry is no.

I. The Vermont reporting requirements serve objec-

tives distinct from the basic purposes of ERISA

The Vermont reporting requirements operate in an

area of traditional state regulation and bear only an

attenuated relation to the purposes of ERISA. As

such, they are entitled to a presumption of non-

preemption under Section 1144(a)}—a presumption

fortified by the requirements’ important role in

achieving the goals of other federal legislation.

a. As discussed above, ERISA imposes a number

of reporting requirements on plans, such as the sub-

mission of financial and actuarial information to the

Secretary. See pp. 2-3, supra. Those requirements

serve ERISA’s basic purposes: to prevent the “mis-

management of funds accumulated to finance

employee benefits and the failure to pay employees

benefits from accumulated funds,” Dillingham, 519

U.S. at 326-327 (quoting Massachusetts v. Morash,

490 U.S. 107, 115 (1989)), by enforcing “fiduciary

standards on persons whose actions affect the amount

of benefits * * * plan participants will receive,”

John Hancock Mut. Life Ins. Co. v. Harris Trust &

Sav. Bank, 510 U.S. 86, 96 (1993). See 29 U.S.C.

1001(b). Any state-law reporting requirements for the

same purposes would raise a substantial preemption

question. See Standard Oil Co. v. Agsalud, 633 F.2d

760, 763-766 (9th Cir. 1980) (holding preempted Ha-

waii reporting requirements incident to law requiring

employers to provide prepaid health plan), summarily

aff’d, 454 U.S. 801 (1981); see also Fort Halifax Pack-

ing Co. v. Coyne, 482 U.S. 1, 12-13 & n.7 (1987). That

is because such requirements would effectively invade

the field exclusively governed by ERISA and alter the

approach that Congress adopted to ensure that plans

are administered according to appropriate legal re-

quirements.

The Vermont reporting requirements, however,

have a different focus. The requirements are de-

signed to populate a state database to be used to

achieve a variety of general healthcare-related goals,

including identifying the State’s healthcare needs,

enhancing resource utilization, comparing treatment

costs and approaches, improving patient outcomes,

and “mak[ing] available to consumers transparent

health care price information, quality information, and

such other information as * * * is necessary to em-

power individuals, including uninsured individuals, to

make economically sound and medically appropriate

decisions.” Database Statute § 9410(a)(1) and (2)(A)

(Supp. 2014). The Vermont reporting requirements,

in other words, focus on the quality, cost, and trans-

parency of medical treatment in the State. Those

goals are part of an overall statutory scheme intended

to “[mJaintain and improve the quality of health care

services offered to Vermonters” and achieve other

ends. Vt. Stat. Ann. tit. 18, § 9401(b) (2012).

That purpose is “quite remote from the areas with

which ERISA is expressly concerned.” Dillingham,

519 U.S. at 330; see 29 U.S.C. 1001(a) and (b). The

purpose of Vermont’s data collection is not to ensure

that ERISA plans are sufficiently funded, pay benefits

covered under the plan or required by federal law, or

are administered in accordance with fiduciary stand-

ards. Indeed, the Database Regulation does not even

seek information about all claims submitted by partic-

ipants in ERISA welfare plans, but only about claims

that are paid. See § 3(Ac) and (Ak); see also id.

§ 5(A)(8). That is because the focus of the regulation

is not the claims processes of employee benefit plans,

but rather healthcare expenditures, utilization, and

cost. Vermont thus does not collect information about

claims that are denied by ERISA plan administra-

tors—a matter of central importance to ensuring that

ERISA plans are being administered in accordance

with their terms and with statutory requirements, but

of relatively little importance to evaluating how

healthcare dollars are spent in Vermont.

The Vermont reporting requirements, moreover,

operate in an area squarely within the “historic police

powers of the State”: “the regulation of matters of

health and safety,” De Buono v. NYSA-ILA Med. &

Clinical Servs. Fund, 520 U.S. 806, 814 (1997). Al-

though state collection and analysis of healthcare data

is a relatively recent phenomenon, the basic objectives

of the data analysis—improving healthcare quality,

reducing healthcare costs, and helping Vermonters

make informed medical decisions—reflect the long-

standing interest of States in promoting the health of

their citizens, including through information-collection

efforts. See Pet. Br. 4-7, 32-34. And precisely be-

cause ERISA does not focus on analyzing general data

about medical treatment across payers, ERISA does

not establish a federal scheme for collecting and ag-

gregating a broad set of data about medical treatment

or provide any alternative mechanism by which state

and local governments can do so. Cf. Pegram v. Her-

drich, 580 U.S. 211, 214, 237 (2000) (explaining that

medical-treatment decisions are not ERISA fiduciary

acts despite their close relationship to decisions about

what a health plan covers).

b. Because there exists little overlap between the

objectives of ERISA and the objectives of the Ver-

mont scheme, and because the Vermont scheme oper-

ates in an area of traditional state regulation, the

reporting requirements are entitled to “the presump-

tion that ERISA did not intend to supplant [them].”

Dillingham, 519 U.S. at 331-332. As this Court has

explained, “[a] reading of [Section 1144(a)] resulting

in the pre-emption of traditionally state-regulated

substantive law in those areas where ERISA has noth-

ing to say would be ‘unsettling.’” Jd. at 330 (quoting

Travelers, 514 U.S. at 665). Congress does not typi-

cally enact legislation in one substantive field with the

intention to “squelch * * * state efforts” in a distinct

sphere that has historically been regulated at the

state and local levels and that the federal statute does

not address. Travelers, 514 U.S. at 665. That is espe-

cially true “in the field of health care,” where “there is

no ERISA preemption without [a] clear manifestation

of congressional purpose.” Pegram, 530 U.S. at 237

(citing T'ravelers, 514 U.S. at 654-655).

Applying preemption so broadly would be particu-

larly troublesome here because it would create a vac-

uum in a critically important area for the future of

healthcare. If reporting requirements like Vermont’s

were held invalid, States would be foreclosed from

collecting information from employer-sponsored plans

that are self-insured (except on a voluntary basis),*

despite the fact that over a dozen States have deter-

mined that such informational efforts can improve

their citizens’ healthcare, lower costs, and enhance

consumer choice. Pet. App. 7. That would create a

significant gap; one study estimated that in 2011,

58.5% of workers were covered by self-insured health

plans. Paul Fronstin, Self-Jnsured Health Plans:

State Variation and Recent Trends by Firm Size,

Emp. Benefit Res. Inst. Notes, Nov. 2012, at 2. Re-

spondent has pointed to no evidence that Congress

intended ERISA to thwart States’ analytical initia-

tives. Particularly given that “nothing in the language

of [ERISA] or the context of its passage indicates that

Congress chose to displace general health care regula-

tion” by the States, Travelers, 514 U.S. at 661, this

Court should be extremely reluctant to read such a

broad preemptive scope into Section 1144(a).

c. There is another reason for caution before hold-

ing that the Vermont reporting requirements are

preempted: Such a ruling would frustrate the objec-

tives of other important federal statutory provisions.

In construing Section 1144(a), this Court has care-

fully attended to the objectives of other federal stat-

utes, particularly in light of Section 1144(d), which

provides that “[nJothing in this subchapter shall be

construed to alter, amend, modify, invalidate, impair,

* The court of appeals had no occasion to address whether its

preemption holding applies to companies that insure ERISA plans,

in light of Section 1144(b)(2)’s exemption from preemption for

insurance regulation.

or supersede any law of the United States.” Thus, for

example, in Travelers, supra, the Court held a New

York statute non-preempted in part because a federal

statute subsequently enacted by the same Congress

that enacted ERISA was “simply incompatible with

pre-emption” of the state law. 514 U.S. at 666-667; see

also tid. at 667 n.6. Similarly, in Shaw, supra, the

Court held that a New York law was not preempted

“to the extent that the [law] provides a means of en-

forcing Title VII’s commands.” 463 U.S. at 102. The

Court explained that the contrary view “would frus-

trate the goal of encouraging joint state/federal en-

forcement of Title VII.” Jbid.

Here, provisions of the ACA rely on or encourage

state data-collection efforts similar to Vermont’s.

Section 3021(a) of the ACA established the Center for

Medicare and Medicaid Innovation (CMMI). See 124

Stat. 389 (42 U.S.C. 1315a). CMMI’s charge is “to test

innovative payment and service delivery models” that

reduce costs “while preserving or enhancing the quali-

ty of care.” 42 U.S.C. 1315a(a)(1). The ACA encour-

ages CMMI to evaluate a variety of models, see 42

U.S.C. 1315a(b)(2)(B), including by “[a]llowing States

to test and evaluate systems of all-payer payment

reform for the medical care of residents of the State,”

42 U.S.C. 1315a(b)(2)(B)(xi). The ACA requires each

model that CMMI tests to be evaluated by analyzing

“the quality of care furnished under the model” and

“the changes in spending under [Medicare, Medicaid

and the Children’s Health Insurance Program

(CHIP)] by reason of the model.” 42 U.S.C.

1315a(b)(4). In part because models may shift costs

among different payers or have health effects that are

not reflected in the Medicare, Medicaid, and CHIP

databases, access to comprehensive state-level data-

bases is important for evaluating models. According-

ly, holding that initiatives like Vermont’s are invalid

would impede CMMI’s statutory mission.

Congress also expressly recognized the importance

of efforts to collect and analyze healthcare data in

Section 10332 of the ACA. 124 Stat. 968 (42 U.S.C.

1395kk(e)). That provision requires the Secretary of

HHS to make Medicare data available to entities that

use claims data “to evaluate the performance of pro-

viders of services and suppliers on measures of quali-

ty, efficiency, effectiveness, and resource use.” 42

U.S.C. 1395kk(e)(2)(A). It is unlikely that Congress

would have encouraged the development of such ana-

lytical efforts by making Medicare data available if it

believed that States were prohibited by ERISA from

obtaining data from other healthcare payers.

As discussed above (see pp. 3-4, supra), the ACA

established new reporting requirements that apply to

group health plans and insurance companies. 42

U.S.C. 300gg-15a, 300gg-17; see 29 U.S.C. 1185d(a).

Respondent has not suggested that these new report-

ing requirements expand the scope of ERISA preemp-

tion in a way that is relevant to this case. Any such

argument would conflict with the express terms of the

ACA, which provides that “[nJothing in [ACA Title I,

which includes the relevant provisions,] shall be con-

strued to preempt any State law that does not prevent

the application of the provisions of [ACA Title I],” 42

U.S.C. 18041(d). It would also conflict with ERISA

itself. See 29 U.S.C. 1191(a)(2) (“Nothing in this part

[29 U.S.C. 1181-1191c]} shall be construed to affect or

modify the provisions of section 1144 of [ERISA] with

respect to group health plans.”); see also 42 U.S.C.

300gg-23(a)(2). And in any event, those ACA report-

ing requirements focus on plans as such, seeking

information on such matters as claims-payment poli-

cies, cost sharing for out-of-network coverage, enroll-

ment figures, and whether certain types of benefits

are being included in healthcare plans. 42 U.S.C.

300gg-15a (incorporating provisions of 42 U.S.C.

18031(e)(3)); 42 U.S.C. 300gg-17(a). They therefore

would not fill the void left by invalidating state-level

efforts to compile databases of healthcare-expenditure

information across the board.

2. The Vermont reporting requirements do not exert

an impermissible effect on the design or admin-

istration of ERISA plans

Because the Vermont reporting requirements op-

erate in an area of traditional state regulation that is

remote from the basic purposes of ERISA, they are

entitled to a presumption against preemption under

Section 1144(a). Dillingham, 519 U.S. at 330-332.

That presumption could be overcome if the Vermont

scheme, though not overtly directed at ERISA plans,

nevertheless operated to prescribe binding rules for

the design or administration of ERISA plans or exert-

ed such powerful economic effects as to practically

bind plan administrators to a particular course of

conduct. But neither type of forbidden effect has been

demonstrated here.

a. The purpose of ERISA’s preemption provision is

“to ensure that plans and plan sponsors [are] subject

to a uniform body of benefits law” so that they are not

required to “tailor[] * * * plans and employer con-

duct to the peculiarities of the law of each jurisdic-

tion.” Ingersoll-Rand, 498 U.S. at 142. That animat-

ing purpose “reflect|s] recognition of the administra-

tive realities of employee benefit plans”: If multi-

state plans were governed by different legal rules for

core administrative functions, it “would produce con-

siderable inefficiencies, which the employer might

choose to offset by lowering benefit levels.” Fort

Halifax, 482 U.S. at 9-10.

For that reason, this Court has held that state laws

“relate to” ERISA plans under Section 1144(a) if they

“bind[] ERISA plan administrators to a particular

choice of rules” for “a central matter of plan admin-

istration.” Egelhoff, 532 U.S. at 147-148. For exam-

ple, this Court has held that laws “relate to” ERISA

plans when they designate beneficiaries of ERISA

plans, id. at 143; “forbid{] a method of calculating

pension benefits that federal law permits,” De Buono,

520 U.S. at 814-815 (citing Alessi v. Raybestos-

Manhattan, Inc., 451 U.S. 504 (1981)); or “requiref{]

employers to provide certain benefits,” id. at 815

(citing Shaw, supra, and Metropolitan Life Ins. Co. v.

Massachusetts, 471 U.S. 724 (1985)).

Conversely, this Court has held that laws of gen-

eral applicability that merely influence the choices

made by ERISA sponsors or fiduciaries, but do not

prescribe binding rules governing plan design or ad-

ministration, are not preempted. See Dillingham, 519

U.S. at 329; Travelers, 514 U.S. at 657, 660, 664. If

such laws were preempted, this Court has explained,

the courts would “scarcely see the end of ERISA’s

pre-emptive reach, and the words ‘relate to’ would

limit nothing.” Dillingham, 519 U.S. at 329. The

Court accordingly has sustained laws that “increase[]

[the] costs of providing certain benefits, and thereby

potentially affect{] the choices made by ERISA

plans,” ibid., or that exert only an “indirect economic

influence” by making certain plan-administration

choices more economically attractive, Travelers, 514

U.S. at 659. ERISA thus does not guarantee “cost

uniformity” among States where a plan might operate.

Id. at 662. After all, ordinary tax, wage, property, and

health laws can vary from State to State and entail

substantial administrative costs.

b. The Vermont reporting requirements do not ex-

ert an impermissible effect on ERISA plans because

they do not prescribe binding rules for a central mat-

ter of plan administration. The reporting provisions

do not dictate features of ERISA plans—vesting re-

quirements, benefit levels, and so forth—nor do they

impose rules on plan administrators for how claims

should be processed and paid. See Pet. App. 72. They

do not enhance or alter plan administrators’ fiduciary

duties or supplement ERISA’s remedial scheme. See

Aetna Health Inc. v. Davila, 542 U.S. 200, 214-215

(2004). The Vermont scheme does not, in other words,

dictate how a plan must be administered. It therefore

differs fundamentally from, for example, state-law

rules governing beneficiary designations, which, if

sustained, would demand that a fiduciary maintain

familiarity with every relevant State’s laws just to

complete the basic functions of plan administration.

Cf. Egelhoff, supra.

The court of appeals rested its contrary holding on

the notion that all “reporting”—which the court de-

fined as “plan record-keeping{] and filing with a third-

party”—is “a core ERISA function.” Pet. App. 23-24.

Based on that premise, the court held that any state

law that imposes a reporting obligation on an ERISA

plan that is more than “slight” is preempted. J/bid.

(citing Shaw, 463 U.S. at 98).

That conclusion was erroneous, even accepting the

court of appeals’ belief that the burden here is more

than “slight” (but see pp. 28-29, infra). ERISA im-

poses reporting and disclosure obligations that fur-

ther the regulation of the design and administration of

employee benefit plans. Those obligations are inte-

gral to achieving ERISA’s purposes, because they

enable the Department of Labor and plan participants

to ensure that the plan is being administered proper-

ly. But that does not mean that all reporting incident

to state laws of general applicability that operate in

disparate fields—taxes, property, wages—qualify as

“core ERISA function[s].” And while decisions of this

Court and the legislative history of ERISA identify

“reporting” and “disclosure” as a central ERISA sub-

ject matter, those brief general statements, read in

context, are best understood to refer to reporting

ancillary to the areas that ERISA governs, not to any

reporting obligation that might be imposed on an

ERISA plan incident to enforcing an otherwise appli-

cable state law. E.g., Dillingham, 519 U.S. at 330

(quoting Travelers, 514 U.S. at 661); see, e.g., S. Rep.

No. 127, 93d Cong., Ist Sess. 35 (1973).

Any other reading would be untenable in light of

the many types of general state laws to which ERISA

plans are subject and would conflict with the Court’s

holdings in other cases that state laws containing

reporting or record-keeping requirements are not

preempted. In De Buono, for example, this Court

held that a gross-receipts tax on patient services pro-

vided by a hospital operated by an ERISA plan was

not preempted, see 520 U.S. at 809-810, 816, even

though the administration of the tax required the

filing of quarterly reports, see U.S. Amicus Br. at 2-3,

De Buono, supra (No. 95-1594). And in Dillingham,

the Court held that California’s prevailing-wage law

was not preempted as applied to apprenticeship pro-

grams established as ERISA plans. See 519 U.S. at

319. Prevailing-wage laws typically require employers

to keep records of the wages paid to employees and

make them available for review by state authorities.

See, e.g., “9! Lab. Code § 1776 (West 1989) (prevail-

ing-wage law in Dillingham); see also, e.g., Keystone

Chapter, Associated Builders & Contractors, Inc. v.

Foley, 37 F.3d 945, 962-963 (3d Cir. 1994), cert. de-

nied, 514 U.S. 1032 (1995). And as petitioner points

out (Pet. Br. 41), “ERISA contemplates that plans

may offer * * * day care centers, training programs,

and legal services”—activities that undoubtedly may

be subject to state regulation and reporting require-

ments. 29 U.S.C. 1002(1). The court of appeals thus

erred in concluding that any state-law reporting obli-

gation that is more than “slight” is preempted.

For its part, respondent distinguishes (Br. in Opp.

26) other generally applicable state-law reporting

obligations imposed on ERISA plans on the ground

that the Vermont law “requires the reporting of in-

formation about core ERISA activities: the payment

of claims under the plan.” Cf. Pet. App. 29 n.13. Re-

spondent essentially contends that all reporting that

involves information acquired or generated during the

administration of a plan qualifies as a core matter of

plan administration.

That cannot be the test. Many generally applicable

reporting requirements that apply to ERISA plans

might seek for tax or other purposes information

acquired or generated in the course of administering

the plan—such as information about claims payments,

pension disbursements, employer contributions, or

assets held in trust. An ERISA plan, after all, is not

likely to have much information about matters not

related to the administration of the plan. The gross-

receipts reporting in De Buono, for example, con-

cerned the amount of money that the plan was taking

in through the medical centers that the plan was oper-

ating. The logical consequence of respondent’s argu-

ment, therefore, is that almost no state-law reporting

obligation would survive preemption, even those inci-

dent to otherwise valid laws of general applicability.

Such a broad rule of preemption would conflict with

this Court’s reluctance to invalidate state laws that

operate in areas to which ERISA does not speak and

would reflect an unrealistic view of Congress’s intent

when it made reporting and disclosure in areas regu-

lated by ERISA an exclusively federal concern.

ce. This Court has suggested in dicta that “there

might be a state law whose economic effects, inten-

tionally or otherwise, were so acute as to force an

ERISA plan to adopt a certain scheme of substantive

coverage or effectively restrict its choice of insurers,

and such a state law might indeed be pre-empted.” De

Buono, 520 U.S. at 816 n.16 (quoting Travelers, 514

U.S. at 668) (internal quotation marks omitted). It is

therefore conceivable that a state-law reporting obli-

gation that does not impose binding legal require-

ments on the design or administration of ERISA plans

could be so costly as to be preempted. And in consid-

ering whether such an extreme economic effect exists,

it is appropriate to consider the effect of a potential

patchwork of state laws imposing different require-

ments. See Egelhoff, 532 U.S. at 149-150.

But in the posture of this case, no sound basis ex-

ists to conclude that the Vermont reporting require-

ments burden ERISA plans in a qualitatively different

or more substantial way than “myriad state laws in

areas traditionally subject to local regulation, which

Congress could not possibly have intended to elimi-

nate.” Travelers, 514 U.S. at 668. Indeed, there is no

reason to conclude that the reporting requirements

impose anything more than a de minimis financial

burden, because respondent made no effort to quanti-

fy those costs in its filings below. As the district court

explained after reviewing respondent’s summary-

judgment submissions, “(t]here is no evidence that the

law * * * creates an economic effect so acute as to

dictate certain administrative choices.” Pet. App. 72.

The court of appeals nevertheless stated that “the

reporting mandated by the Vermont statute and regu-

lation is burdensome, time-consuming, and risky,”

particularly when considered “as one of several or a

score of uncoordinated state reporting regimes.” Pet.

App. 25. Respondent contends (Br. in Opp. 20) that

the court of appeals’ view “reflects a common sense

assessment of the administrative realities of ERISA

plans.”

The supposition that Vermont’s requirements im-

pose a substantial burden, however, is not obvious, or

even particularly plausible, without any factual sup-

port. The Database Regulation essentially requires

‘Blue Cross to take information generated in the ordi-

nary course of its claims-payment operations and

report that information in a prescribed format to the

Board. Respondent has not suggested, let alone es-

tablished, that Blue Cross has changed any aspect of

its administration of the claims process because of

that reporting obligation. While organizing and for-

matting the data requires some administrative re-

sources, it is implausible to assume that the additional

cost would meaningfully alter the claims-payment

process or any other aspect of the plan’s administra-

tion. Indeed, Blue Cross presumably already has such

procedures in place, given that it reports data to the

Board for over 7000 individuals, see J.A. 205.

If the cost of compliance were in fact so significant

as to alter Blue Cross’s administration of claims, re-

spondent could have submitted a declaration quantify-

ing, or at least estimating, the burden, and explaining

ways in which the reporting obligation has changed

how its plan operates. Or it could have submitted

evidence estimating or describing the burden for

ERISA plans generally. Respondent’s contentions

then could have been subject to adversarial testing in

the district court. But respondent’s only factual sub-

mission was a “fact sheet” printed from the Internet

stating that it would be less costly if States with simi-

lar statutes standardized their data formats—which

says nothing about whether the cost is so great as to

fundamentally affect plan administration. See J.A.

217-225; D. Ct. Doc. 59, at 2 (Oct. 7, 2012). Thus, as

Judge Straub explained, “[o]n the record before [the

court of appeals], there is no basis to find that the

Vermont statute would cause [respondent] to increase

its costs more than a de [minimis] amount to cover

the cost of sending information to the state, much less

that it would cause a fiduciary to change a plan in any

way.” Pet. App. 40-41 (dissenting in part and concur-

ring in part).

B. The Vermont Reporting Requirements Are Valid If

Reviewed Under General Principles Of Field And

Conflict Preemption

In separate opinions, four Justices have called for

this Court to clarify that its framework for analyzing

ERISA preemption questions essentially applies ordi-

nary principles of field and conflict preemption. Un-

der that view, “the ‘relate to’ clause of the pre-

emption provision is meant, not to set forth a test for

pre-emption, but rather to identify the field in which

ordinary field pre-emption applies—namely, the field

of laws regulating ‘employee benefit plan[s] described

in section 1003(a) of this title and not exempt under

section 1003(b) of this title,’ 29 U.S.C. § 1144(a).”

Dillingham, 519 U.S. at 336 (Scalia, J., concurring,

joined by Ginsburg, J.) (brackets in original); see

Egelhoff, 532 U.S. at 152-153 (Scalia, J., concurring,

joined by Ginsburg, J.); id. at 153 (Breyer, J., dissent-

ing, joined by Stevens, J.). And in Boggs v. Boggs, 520

U.S. 833 (1997), the Court held a state law preempted

“by simply asking if [the] state law conflicts with the

provisions of ERISA or operates to frustrate its ob-

jects,” without “inquir[ing] whether the statutory

phrase ‘relate to’ provides further and additional sup-

port for the pre-emption claim.” /d. at 841; cf. UNUM

Life Ins. Co. of Am. v. Ward, 526 U.S. 358, 375-377

(1999) (UNUM) (applying conflict-preemption analy-

sis to state law falling within ERISA’s insurance sav-

ings clause).

If the Court applies ordinary field and conflict

preemption principles here as a means of giving con-

tent to (or checking the applicability of) the “relate to”

language in Section 1144(a), the Vermont reporting

requirements likewise are not preempted.

1. When a federal statute occupies a field of sub-

stantive regulation, the test for preemption “is wheth-

er the matter on which the State asserts the right to

act is in any way regulated by the Federal Act.” Rice

v. Santa Fe Elevator Corp., 331 U.S. 218, 236 (1947).

If so, the state law is preempted, even if it is con-

sistent with federal objectives. See ONEOK, Inc. v.

Learjet, Inc., 185 S. Ct. 1591, 1595 (2015); accord Met-

ropolitan Life Ins. Co., 471 U.S. at 739 (“[ERISA’s]

pre-emption provision was intended to displace all

state laws that fall within its sphere, even including

state laws that are consistent with ERISA’s substan-

tive requirements.”). But this Court has also kept “in

mind that not every state law that in some remote way

may affect the [subject matter of the federal statute]

can be said to fall within the pre-empted field.” Eng-

lish v. General Elec. Co., 496 U.S. 72, 85 (1990).

Largely for the reasons given in Point A above, the

Vermont reporting requirements do not improperly

invade a field governed exclusively by ERISA. They

do not target ERISA plans for special treatment.

They have a different purpose and function than

ERISA, focusing on the quality, utilization, and cost of

medical services themselves, from a_healthcare-

delivery perspective, rather than the design of em-

ployee benefit plans or fiduciary conduct in delivering

promised benefits to ERISA participants and benefi-

ciaries. And the requirements have not been shown to

exert more than a de minimis effect on the design or

administration of ERISA plans.

2. a. Under conflict-preemption principles, a state

law is invalid (as applied to ERISA plans) if “compli-

ance with both [the state law] and [ERISA] is impos-

sible, or when the state law stands as an obstacle to

the accomplishment and execution of the full purposes

and objective of [ERISA].” United States v. Locke,

529 U.S. 89, 109 (2000) (citation and internal quotation

marks omitted); see Boggs, 520 U.S. at 844. Thus, in

Boggs, this Court held that a state law permitting a

non-participant to effect a testamentary transfer of

her spouse’s undistributed pension benefits was

preempted after finding a “direct clash between [the]

state law and the provisions and objectives of ERISA”

with respect to the designation of beneficiaries of

survivor annuities. 520 U.S. at 843-844. Similarly, in

a line of cases, this Court has held that certain state

laws conflict with the objectives of ERISA’s exclusive

remedial scheme. See Aetna Health, 542 U.S. at 214-

215. A law would also be preempted if it frustrated

the central purpose of Section 1144(a) itself, which is

to avoid “the prospect that an employer’s administra-

tive scheme would be subject to conflicting require-

ments.” Fort Halifax, 482 U.S. at 9-10.

It is not impossible to comply with both ERISA’s

requirements and the Vermont reporting require-

ments. And for the reasons given above (see pp. 22-

29, supra), no sound basis exists to conclude that the

requirements would pose an obstacle to the uniform

administration of ERISA plans.

b. Respondent has contended (Br. in Opp. 22-23)

that the Vermont scheme conflicts with ERISA’s

requirement that fiduciaries follow plan documents, 29

U.S.C. 1104(a)(1)(D), because the plan documents in

this case required respondent and Blue Cross to main-

tain the confidentiality of the medical records of par-

ticipants and beneficiaries. Respondent essentially

argues that a plan sponsor can evade a state legal

obligation by drafting an incompatible plan term. But

this Court rejected a materially identical argument in

UNUM, where it held that an otherwise non-

preempted state insur ice law did not conflict with

Section 1104(a)(1)(D) merely because a plan sponsor

had “insert[ed] a contrary term in plan documents,”

finding that argument to “make[] scant sense.” 526

U.S. at 375-376; see FMC Corp. v. Holliday, 498 U.S.

52, 54-65 (1990) (analyzing whether ERISA preempt-

ed a state law prohibiting a particular plan term under

the normal ERISA preemption framework).

As support for its anomalous position, respondent

cites a footnote in Egelhoff, supra (Br. in Opp. 22-24),

but respondent misunderstands the import of that

discussion. Egelhoff held preempted, as applied to

ERISA plans, a Washington statute providing that the

designation of a spouse as a beneficiary of a nonpro-

bate asset was revoked automatically upon divorce.

532 U.S. at 144 (citing Wash. Rev. Code § 11.07.010(1)

(1994)). The Court rejected the argument that the

Washington statute was saved from preemption be-

cause employers could opt out of the automatic-

revocation rule through an express plan term. See id.

at 150-151. In the cited footnote, the Court merely

observed that a State could not save an otherwise

preempted law from invalidation by permitting

ERISA plan sponsors to opt out by changing the

terms of their plans, see id. at 151 n.4, and the Court

went on to highlight the significant burden for fiduci-

aries in “maintain[ing] a familiarity with the laws of

all 50 States so that they can update their plans as

necessary,” id. at 151. Nothing in the Court’s discus-

sion, however, supports the view that a state law that

is otherwise not preempted could be circumvented by

a contrary term in a particular plan, an argument this

Court rejected in UNUM.

In any event, there is no evident conflict between

the terms of respondent’s plan and the Vermont re-

porting requirements. No provision of respondent’s

plan documents states that the plan will refuse to

report claims information to state authorities in com-

pliance with state law. To the contrary, the primary

plan document expressly provides that “(t]he Plan

shall comply with all * * * state and federal law to

the extent not preempted by ERISA.” J.A. 57. Re-

spondent appears to rely on two statements in a sum-

mary plan description stating that information relat-

ing to “well-baby programs” and “pharmagenomics”

will be kept confidential. J.A. 117-120 (capitalization

and emphasis omitted); see Resp. C.A. Br. 7. But

respondent’s primary plan document states that it

trumps conflicting statements in the summary plan

description, J.A. 40; the cited statements relate only

to very specific medical programs; and, in any event,

the extensive confidentiality protections of the Ver-

mont scheme (see p. 6, supra) preserve the confidenti-

ality of reported information, see Database Statute

§ 9410(e) and (h)(2) (Supp. 2014). Accordingly, even if

ERISA called on courts to conduct the sort of plan-by-

plan preemption analysis that respondent suggests—

in which the validity of state law would be entirely

subordinate to plan terms—preemption would not be

warranted here.

c. Finally, respondent argued below that by com-

plying with state-law reporting requirements, an

ERISA fiduciary would violate its statutory duty to

act “for the exclusive purpose of * * * providing

benefits to participants and their beneficiaries; and

* * * defraying reasonable expenses of administer-

ing the plan,” 29 U.S.C. 1104(a)(1); see Resp. C.A. Br.

39-40. If accepted, that argument not only would

preclude States from imposing any reporting re-

quirements, but would also bar States from imposing

taxes and other generally applicable obligations on

ERISA plans that serve purposes other than provid-

ing benefits and defraying administrative expenses.

Congress could not have intended ERISA’s fiduciary-

duties provision to have that sweeping preemptive

effect. And like respondent’s other arguments, it

cannot be squared with this Court’s more circum-

scribed understanding of ERISA preemption or its

decisions upholding state laws imposing obligations on

ERISA plans.

*_*x © & *

For the foregoing reasons, whether under this

Court’s established framework for analyzing preemp-

tion questions under Section 1144(a), or viewed

through the lens of ordinary field and conflict preemp-

tion, the Vermont reporting requirements are not

preempted. Thus, like other record-keeping and re-

porting requirements incident to state tax, wage,

property, and health laws, the Vermont reporting

requirements are among the “myriad state laws of

general applicability that impose some burdens on the

administration of ERISA plans but nevertheless do

not ‘relate to’ them within the meaning of the govern-

ing statute.” De Buono, 520 U.S. at 815 (citation and

internal quotation marks omitted).

CONCLUSION

The judgment of the court of appeals should be

reversed.

Respectfully submitted.

DONALD B. VERRILLI, JR.

M. PATRICIA SMITH Solicitor General

Solicitor of Labor EDWIN S. KNEEDLER

G. WILLIAM Scotr Deputy Solicitor General

Associate Solicitor JOHN F. BASH

ELIZABETH HOPKINS Assistant to the Solicitor

Counsel General

MELISSA MOORE

Attorney

SEPTEMBER 2015

APPENDIX

1. 290U.8.C. 1001 provides:

Congressional findings and declaration of policy

(a) Benefit plans as affecting interstate commerce and

the Federal taxing power

The Congress finds that the growth in size, scope, and

numbers of employee benefit plans in recent years has

been rapid and substantial; that the operational scope and

economic impact of such plans is increasingly interstate;

that the continued well-being and security of millions of

employees and their dependents are directly affected by

these plans; that they are affected with a national public

interest; that they have become an important factor af-

fecting the stability of employment and the successful de-

velopment of industrial relations; that they have become

an important factor in commerce because of the interstate

character of their activities, and of the activities of their

participants, and the employers, employee organizations,

and other entities by which they are established or main-

tained; that a large volume of the activities of such plans

are carried on by means of the mails and instrumentalities

of interstate commerce; that owing to the lack of em-

ployee information and adequate safeguards concerning

their operation, it is desirable in the interests of employ-

ees and their beneficiaries, and to provide for the general

welfare and the free flow of commerce, that disclosure be

made and safeguards be provided with respect to the es-

tablishment, operation, and administration of such plans;

that they substantially affect the revenues of the United

States because they are afforded preferential Federal tax

(la)

treatment; that despite the enormous growth in such

plans many employees with long years of employment are

losing anticipated retirement benefits owing to the lack of

vesting provisions in such plans; that owing to the inade-

quacy of current minimum standards, the soundness and

stability of plans with respect to adequate funds to pay

promised benefits may be endangered; that owing to the

termination of plans before requisite funds have been

accumulated, employees and their beneficiaries have been

deprived of anticipated benefits; and that it is therefore

desirable in the interests of employees and their benefi-

ciaries, for the protection of the revenue of the United

States, and to provide for the free flow of commerce, that

minimum standards be provided assuring the equitable

character of such plans and their financial soundness.

(b) Protection of interstate commerce and beneficiaries

by requiring disclosure and reporting, setting stand-

ards of conduct, etc., for fiduciaries

It is hereby declared to be the policy of this chapter to

protect interstate commerce and the interests of partici-

pants in employee benefit plans and their beneficiaries, by

requiring the disclosure and reporting to participants and

beneficiaries of financial and other information with res-

pect thereto, by establishing standards of conduct, re-

sponsibility, and obligation for fiduciaries of employee

benefit plans, and by providing for appropriate remedies,

sanctions, and ready access to the Federal courts.

ing power, and beneficiaries by vesting of accrued

benefits, setting minimum standards of funding, re-

quiring termination insurance

It is hereby further declared to be the policy of this

chapter to protect interstate commerce, the Federal tax-

ing power, and the interests of participants in private

pension plans and their beneficiaries by improving the

equitable character and the soundness of such plans by

requiring them to vest the accrued benefits of employees

with significant periods of service, to meet minimum

standards of funding, and by requiring plan termination

insurance.

2. 29 U.S.C. 1002(1) provides:

Definitions

For purposes of this subchapter:

(1) The terms “employee welfare benefit plan” and

“welfare plan” mean any plan, fund, or program which

was heretofore or is hereafter established or maintained

by an employer or by an employee organization, or by

both, to the extent that such plan, fund, or program was

established or is maintained for the purpose of providing

for its participants or their beneficiaries, through the

purchase of insurance or otherwise, (A) medical, surgical,

or hospital care or benefits, or benefits in the event of

sickness, accident, disability, death or unemployment, or

vacation benefits, apprenticeship or other training pro-

grams, or day care centers, scholarship funds, or prepaid

legal services, or (B) any benefit described in section

186(c) of this title (other than pensions on retirement or

death, and insurance to provide such pensions).

3. 29U.8.C. 1021(a) and (b) provide:

Duty of disclosure and reporting

(a) Summary plan description and information to be

furnished to participants and beneficiaries

The administrator of each employee benefit plan shall

cause to be furnished in accordance with section 1024(b)

of this title to each participant covered under the plan and

to each beneficiary who is receiving benefits under the

plan—

(1) asummary plan description described in sec-

tion 1022(a)(1)' of this title; and

(2) the information described in subsection (f)

and sections 1024(b)(3) and 1025(a) and (c) of this title.

(b) Reports to be filed with Secretary of Labor

The administrator shall, in accordance with section

1024(a) of this title, file with the Secretary—

(1) the annual report containing the information

required by section 1023 of this title; and

(2) terminal and supplementary reports as re-

quired by subsection (c) of this section.

' See References in Text note below.

4. 290U.S.C. 1023 provides in pertinent part:

Annual reports

(a) Publication and filing

(1)(A) An annual report shall be published with re-

spect to every employee benefit plan to which this part

applies. Such report shall be filed with the Secretary

in accordance with section 1024(a) of this title, and

shall be made available and furnished to participants

in accordance with section 1024(b) of this title.

(B) The annual report shall include the informa-

tion described in subsections (b) and (c) and where ap-

plicable subsections (d), (e), and (f) and shall also

include—

(i) a financial statement and opinion, as re-

quired by paragraph (3) of this subsection, and

(ii) an actuarial statement and opinion, as re-

quired by paragraph (4) of this subsection.

* a2 *. . *

(3A) Except as provided in subparagraph (C),

the administrator of an employee benefit plan shall

engage, on behalf of all plan participants, an inde-

pendent qualified public accountant, who shall conduct

such an examination of any financial statements of the

plan, and of other books and records of the plan, as the

accountant may deem necessary to enable the ac-

countant to form an opinion as to whether the financial

statements and schedules required to be included in

the annual reports by subsection (b) of this section are

presented fairly in conformity with generally accepted

accounting principles applied on a basis consistent

with that of the preceding year.

= = * * >

(4A) The administrator of an employee pension

benefit plan subject to the reporting requirement of

subsection (d) of this section shall engage, on behalf of all

plan participants, an enrolled actuary who shall be re-

sponsible for the preparation of the materials comprising

the actuarial statement required under subsection (d) of

this section.

> * * * *

(b) Financial statement

An annual report under this section shall include a

financial statement containing the following information:

(1) With respect to an employee welfare benefit

plan: a statement of assets and liabilities; a state-

ment of changes in fund balance; and a statement of

changes in financial position. In the notes to financial

statements, disclosures concerning the following items

shall be considered by the accountant: a description

of the plan including any significant changes in the

plan made during the period and the impact of such

changes on benefits; a description of material lease

commitments, other commitments, and contingent lia-

bilities; a description of agreements and transactions

with persons known to be parties in interest; a general

description of priorities upon termination of the plan;

information concerning whether or not a tax ruling or

determination letter has been obtained; and any other

matters necessary to fully and fairly present the fi-

nancial statements of the plan.

s * . * *

(3) With respect to all employee benefit plans, the

statement required under paragraph (1) or (2) shall have

attached the following information in separate schedules:

(A) a statement of the assets and liabilities of

the plan aggregated by categories and valued at

their current value, and the same data displayed in

comparative form for the end of the previous fiscal

year of the plan;

(B) a statement of receipts and disbursements

during the preceding twelve-month period aggregated

by general sources and applications;

purposes aggregated and identified by issuer, bor-

rower, or lessor, or similar party to the transaction

(including a notation as to whether such party is known

to be a party in interest), maturity date, rate of inter-

est, collateral, par or maturity value, cost, and current

value;

(D) a schedule of each transaction involving a

person known to be party in interest, the identity of

such party in interest and his relationship or that of

any other party in interest to the plan, a description of

each asset to which the transaction relates; the pur-

chase or selling price in case of a sale or purchase, the

rental in case of a lease, or the interest rate and ma-

turity date in case of a loan; expense incurred in con-

nection with the transaction; the cost of the asset, the

current value of the asset, and the net gain (or loss) on

each transaction;

(E) a schedule of all loans or fixed income obliga-

tions which were in default as of the close of the plan’s

fiscal year or were classified during the year as uncol-

lectable and the following information with respect to

each loan on such schedule (including a notation as to

whether parties involved are known to be parties in

interest): the original principal amount of the loan, the

amount of principal and interest received during the

reporting year, the unpaid balance, the identity and

address of the obligor, a detailed description of the

loan (including date of making and maturity, interest

rate, the type and value of collateral, and other mate-

rial terms), the amount of principal and interest over-

due (if any) and an explanation thereof;

(F) alist of all leases which were in default or were

classified during the year as uncollectable; and the fol-

lowing information with respect to each lease on such

schedule (including a notation as to whether parties

involved are known to be parties in interest): the type

of property leased (and, in the case of fixed assets such

as land, buildings, leasehold, and so forth, the location

of the property), the identity of the lessor or lessee

from or to whom the plan is leasing, the relationship of

such lessors and lessees, if any, to the plan, the em-

ployer, employee organization, or any other party in

interest, the terms of the lease regarding rent, taxes,

insurance, repairs, expenses, and renewal options; the

date the leased property was purchased and its cost,

the date the property was leased and its approximate

value at such date, the gross rental receipts during the

reporting period, expenses paid for the leased prop-

erty during the reporting period, the net receipts from

the lease, the amounts in arrears, and a statement as

to what steps have been taken to collect amounts due

or otherwise remedy the default;

(G) if some or all of the assets of a plan or plans

are held in a common or collective trust maintained by

a bank or similar institution or in a separate account

maintained by an insurance carrier or a separate trust

maintained by a bank as trustee, the report shall in-

clude the most recent annual statement of assets and

liabilities of such common or collective trust, and in the

case of a separate account or a separate trust, such

other information as is required by the administrator

in order to comply with this subsection; and

(H) a schedule of each reportable transaction, the

name of each party to the transaction (except that, in

the case of an acquisition or sale of a security on the

market, the report need not identify the person from

whom the security was acquired or to whom it was

sold) and a description of each asset to which the

transaction applies; the purchase or selling price in

case of a sale or purchase, the rental in case of a lease,

or the interest rate and maturity date in case of a loan;

expenses incurred in connection with the transaction;

the cost of the asset, the current value of the asset, and

the net gain (or loss) on each transaction. For pur-

poses of the preceding sentence, the term “reportable

transaction” means a transaction to which the plan is a

party if such transaction is—

10a

(i) a transaction involving an amount in ex-

cess of 3 percent of the current value of the assets of

the plan;

(ii) any transaction (other than a transaction

respecting a security) which is part of a series of

transactions with or in conjunction with a person in

a plan year, if the aggregate amount of such trans-

actions exceeds 3 percent of the current value of the

assets of the plan;

(iii) a transaction which is part of a series of

transactions respecting one or more securities of

the same issuer, if the aggregate amount of such

transactions in the plan year exceeds 3 percent of

the current value of the assets of the plan; or

(iv) a transaction with or in conjunction with a

person respecting a security, if any other transac-

tion with or in conjunction with such person in the

plan year respecting a security is required to be

reported by reason of clause (i).

(4) The Secretary may, by regulation, relieve any

plan from filing a copy of a statement of assets and liabil-

ities (or other information) described in paragraph (3)(G)

if such statement and other information is filed with the

Secretary by the bank or insurance carrier which main-

tains the common or collective trust or separate account.

The administrator shall furnish as a part of a report

under this section the following information:

(1) The number of employees covered by the

plan.

lla

(2) The name and address of each fiduciary.

(3) Except in the case of a person whose compen-

sation is minimal (determined under regulations of the

Secretary) and who performs solely ministerial duties

(determined under such regulations), the name of each

person (including but not limited to, any consultant,

broker, trustee, accountant, insurance carrier, actu-

ary, administrator, investment manager, or custodian

who rendered services to the plan or who had transac-

tions with the plan) who received directly or indirectly

compensation from the plan during the preceding year

for services rendered to the plan or its participants,

the amount of such compensation, the nature of his

services to the plan or its participants, his relationship

to the employer of the employees covered by the plan,

or the employee organization, and any other office,

position, or employment he holds with any party in

interest.

(4) An explanation of the reason for any change in

appointment of trustee, accountant, insurance carrier,

enrolled actuary, administrator, investment manager,

or custodian.

(5) Such financial and actuarial information in-

cluding but not limited to the material described in

subsections (b) and (d) of this section as the Secretary

may find necessary or appropriate.

(d) Actuarial statement

With respect to an employee pension benefit plan

(other than (A) a profit sharing, savings, or other plan,

which is an individual account plan, (B) a plan described in

section 1081(b) of this title, or (C) a plan described both in

12a

section 1321(b) of this title and in paragraph (1), (2), (3),

(4), (5), (6), or (7) of section 1081(a) of this title) an annual

report under this section for a plan year shall include a

complete actuarial statement applicable to the plan year

which shall include the following:

* * * « *

(e) Statement from insurance company, insurance ser-

vice, or other similar organizations which sell or

guarantee plan benefits

If some or all of the benefits under the plan are pur-

chased from and guaranteed by an insurance company,

insurance service, or other similar organization, a report

under this section shall include a statement from such

insurance company, service, or other similar organization

covering the plan year and enumerating—

(1) the premium rate or subscription charge

and the total premium or subscription charges paid to

each such carrier, insurance service, or other similar

organization and the approximate number of persons

covered by each class of such benefits; and

(2) the total amount of premiums received, the

approximate number of persons covered by each class

of benefits, and the total claims paid by such company,

service, or other organization; dividends or retroactive

rate adjustments, commissions, and administrative

service or other fees or other specific acquisition costs

paid by such company, service, or other organization;

any amounts held to provide benefits after retirement;

the remainder of such premiums; and the names and

addresses of the brokers, agents, or other persons to

whom commissions or fees were paid, the amount paid

13a

to each, and for what purpose. If any such company,

service, or other organization does not maintain sepa-

rate experience records covering the specific groups it

serves, the report shall include in lieu of the infor-

mation required by the foregoing provisions of this

paragraph (A) a statement as to the basis of its pre-

mium rate or subscription charge, the total amount of

premiums or subscription charges received from the

plan, and a copy of the financial report of the company,

service, or other organization and (B) if such company,

service, or organization incurs specific costs in con-

nection with the acquisition or retention of any partic-

ular plan or plans, a detailed statement of such costs.

(f) Additional information with respect to defined bene-

fit plans

(1) Liabilities under 2 or more plans

(A) In general

In any case in which any liabilities to partici-

pants or their beneficiaries under a defined benefit

plan as of the end of a plan year consist (in whole or

in part) of liabilities to such participants and bene-

ficiaries under 2 or more pension plans as of im-

mediately before such plan year, an annual report

under this section for such plan year shall include

the funded percentage of each of such 2 or more

pension plans as of the last day of such plan year

and the funded percentage of the plan with respect

to which the annual report is filed as of the last day

of such plan year.

* * * . *

l4a

5. 29 U.S.C. 1024 provides in pertinent part:

Filing with Secretary and furnishing information to

participants and certain employers

(a) Filing of annual report with Secretary

(1) The administrator of any employee benefit

plan subject to this part shall file with the Secretary

the annual report for a plan year within 210 days after

the close of such year (or within such time as may be

required by regulations promulgated by the Secretary

in order to reduce duplicative filing). The Secretary

shall make copies of such annual reports available for

inspection in the public document room of the De-

partment of Labor.

(2)(A) With respect to annual reports required to

be filed with the Secretary under this part, he may by

regulation prescribe simplified annual reports for any

pension plan which covers less than 100 participants.

(B) Nothing contained in this paragraph shall

preclude the Secretary from requiring any information

or data from any such plan to which this part applies

where he finds such data or information is necessary to

carry out the purposes of this subchapter nor shall the

Secretary be precluded from revoking provisions for

simplified reports for any such plan if he finds it nec-

essary to do so in order to carry out the objectives of

this subchapter.

(3) The Secretary may by regulation exempt any

welfare benefit plan from all or part of the reporting

and disclosure requirements of this subchapter, or

may provide for simplified reporting and disclosure if

15a

he finds that such requirements are inappropriate as

applied to welfare benefit plans.

* * * . *

6. 29 U.S.C. 1104(a)(1) provides:

Fiduciary duties

(a) Prudent man standard of care

(1) Subject to sections 1103(c) and (d), 1342, and

1344 of this title, a fiduciary shall discharge his duties

with respect to a plan solely in the interest of the par-

ticipants and beneficiaries and—

(A) for the exclusive purpose of:

(i) providing benefits to participants and

their beneficiaries; and

(ii) defraying reasonable expenses of adminis-

tering the plan;

(B) with the care, skill, prudence, and diligence

under the circumstances then prevailing that a pru-

dent man acting in a like capacity and familiar with

such matters would use in the conduct of an enterprise

of a like character and with like aims;

as to minimize the risk of large losses, unless under the

circumstances it is clearly prudent not to do so; and

(D) in accordance with the documents and instru-

ments governing the plan insofar as such documents

and instruments are consistent with the provisions of

this subchapter and subchapter ITI of this chapter.

l6a

29 U.S.C. 1134(a) provides in pertinent part:

Investigative authority

(a)

Investigation and submission of reports, books, etc.

The Secretary shall have the power, in order to de-

termine whether any person has violated or is about to

violate any provision of this subchapter or any regula-

tion or order thereunder—

(1) to make an investigation, and in connection

therewith to require the submission of reports,

books, and records, and the filing of data in support

of any information required to be filed with the

Secretary under this subchapter, and

(2) to enter such places, inspect such books

and records and question such persons as he may

deem necessary to enable him to determine the

facts relative to such investigation, if he has rea-

sonable cause to believe there may exist a violation

of this subchapter or any rule or regulation issued

thereunder or if the entry is pursuant to an agree-

ment with the plan.

* * * * *

29 U.S.C. 1143(a) provides:

Research, studies, and reports

(a)

Authorization to undertake research and surveys

(1) The Secretary is authorized to undertake re-

search and surveys and in connection therewith to collect,

compile, analyze and publish data, information, and sta-

17a

tistics relating to employee benefit plans, including re-

tirement, deferred compensation, and welfare plans, and

types of plans not subject to this chapter.

(2) The Secretary is authorized and directed to un-

dertake research studies relating to pension plans, in-

cluding but not limited to (A) the effects of this subchap-

ter upon the provisions and costs of pension plans, (B) the

role of private pensions in meeting the economic security

needs of the Nation, and (C) the operation of private pen-

sion plans including types and levels of benefits, degree of

reciprocity or portability, and financial and actuarial

characteristics and practices, and methods of encouraging

the growth of the private pension system.

(3) The Secretary may, as he deems appropriate or

necessary, undertake other studies relating to employee

benefit plans, the matters regulated by this subchapter,

and the enforcement procedures provided for under this

subchapter.

(4) The research, surveys, studies, and publications

referred to in this subsection may be conducted directly,

or indirectly through grant or contract arrangements.

9. 29 U.S.C. 1144 provides in pertinent part:

Other laws

(a) Supersedure; effective date

Except as provided in subsection (b) of this section,

the provisions of this subchapter and subchapter III of

this chapter shall supersede any and all State laws

insofar as they may now or hereafter relate to any

employee benefit plan described in section 1003(a) of

18a

this title and not exempt under section 1003(b) of this

title. This section shall take effect on January 1,

1975.

(b) Construction and application

(1) This section shall not apply with respect to any

cause of action which arose, or any act or omission

which occurred, before January 1, 1975.

(2)(A) Except as provided in subparagraph (B),

nothing in this subchapter shall be construed to ex-

empt or relieve any person from any law of any State

which regulates insurance, banking, or securities.

(B) Neither an employee benefit plan described in

section 1003(a) of this title, which is not exempt under

section 1003(b) of this title (other than a plan estab-

lished primarily for the purpose of providing death

benefits), nor any trust established under such a plan,

shall be deemed to be an insurance company or other

insurer, bank, trust company, or investment company

or to be engaged in the business of insurance or bank-

ing for purposes of any law of any State purporting to

regulate insurance companies, insurance contracts,

banks, trust companies, or investment companies.

. * * . *

(4) Subsection (a) of this section shall not apply to

any generally applicable criminal law of a State.

(5)(A) Except as provided in subparagraph (B), sub-

section (a) of this section shall not apply to the Hawaii

Prepaid Health Care Act (Haw. Rev. Stat. §§ 393-1

through 393-51).

19a

(B) Nothing in subparagraph (A) shall be con-

strued to exempt from subsection (a) of this section—

(i) any State tax law relating to employee ben-

efit plans, or

(ii) any amendment of the Hawaii Prepaid

Health Care Act enacted after September 2, 1974,

to the extent it provides for more than the effective

administration of such Act as in effect on such date.

4 of this subtitle, and the preceding sections of this

part to the extent they govern matters which are gov-

erned by the provisions of such parts 1 and 4, shall

supersede the Hawaii Prepaid Health Care Act (as in

effect on or after January 14, 1983), but the Secretary

may enter into cooperative arrangements under this

paragraph and section 1136 of this title with officials of

the State of Hawaii to assist them in effectuating the

policies of provisions of such Act which are superseded

by such parts | and 4 and the preceding sections of this

part.

> * * s *

(7) Subsection (a) of this section shall not apply to

qualified domestic relations orders (within the mean-

ing of section 1056(d)(3)(B)(i) of this title), qualified

medical child support orders (within the meaning of

section 1169(a)(2)(A) of this title), and the provisions of

law referred to in section 1169(a)(2)(B)(ii) of this title

to the extent they apply to qualified medical child sup-

port orders.

20a

(8) Subsection (a) of this section shall not be con-

strued to preclude any State cause of action—

(A) with respect to which the State exercises its

acquired rights under section 1169(b)(3) of this title

with respect to a group health plan (as defined in

section 1167(1) of this title), or

(B) for recoupment of payment with respect to

items or services pursuant to a State plan for med-

ical assistance approved under title XIX of the So-

cial Security Act [42 U.S.C. 1396 et seq.] which

would not have been payable if such acquired rights

had been executed before payment with respect to

such items or services by the group health plan.

(9) For additional provisions relating to group

health plans, see section 1191 of this title.

For purposes of this section:

(1) The term “State law” includes all laws, de-

cisions, rules, regulations, or other State action

having the effect of law, of any State. A law of the

United States applicable only to the District of Co-

lumbia shall be treated as a State law rather than a

law of the United States.

* * 7 > >

(d) Alteration, amendment, modification, invalidation,

impairment, or supersedure of any law of the

United States prohibited

Nothing in this subchapter shall be construed to

alter, amend, modify, invalidate, impair, or supersede

Z2la

any law of the United States (except as provided in

sections 1031 and 1137(b) of this title) or any rule or

regulation issued under any such law.

10. 29 U.S.C. 1185d provides:

Additional market reforms

(a) General rule

Except as provided in subsection (b)—

(1) the provisions of part A of title XX VII of the

Public Health Service Act [42 U.S.C. 300gg et seq.) (as

amended by the Patient Protection and Affordable

Care Act) shall apply to group health plans, and health

insurance issuers providing health insurance coverage

in connection with group health plans, as if included in

this subpart; and

(2) to the extent that any provision of this part

conflicts with a provision of such part A with respect to

group health plans, or health insurance issuers pro-

viding health insurance coverage in connection with

group health plans, the provisions of such part A shall

apply.

(b) Exception

Notwithstanding subsection (a), the provisions of

sections 2716 and 2718 of title XXVII of the Public Health

Service Act [42 U.S.C. 300gg-16, 300gg-18] (as amended

by the Patient Protection and Affordable Care Act) shall

not apply with respect to self-insured group health plans,

and the provisions of this part shall continue to apply to

22a

such plans as if such sections of the Public Health Service

Act (as so amended) had not been enacted.

11. 29 U.S.C. 1191(a) provides:

Preemption; State flexibility; construction

(a) Continued applicability of State law with respect to

health insurance issuers

(1) In general

Subject to paragraph (2) and except as provided

in subsection (b) of this section, this part shall not be

construed to supersede any provision of State law

which establishes, implements, or continues in effect

any standard or requirement solely relating to health

insurance issuers in connection with group health in-

surance coverage except to the extent that such stan-

dard or requirement prevents the application of a re-

quirement of this part.

(2) Continued preemption with respect to group

health plans

Nothing in this part shall be construed to affect

or modify the provisions of section 1144 of this title

with respect to group health plans.

12.

23a

29 U.S.C. 1191b(a)-(b) provides in pertinent part:

Definitions

(a)

(b)

Group health plan

For purposes of this part—

(1) In general

The term “group health plan” means an employ-

ee welfare benefit plan to the extent that the plan

provides medical care (as defined in paragraph (2) and

including items and services paid for as medical care)

to employees or their dependents (as defined under

the terms of the plan) directly or through insurance,

reimbursement, or otherwise.

(2) Medical care

The term “medical care” means amounts paid

for—

(A) the diagnosis, cure, mitigation, treat-

ment, or prevention of disease, or amounts paid for

the purpose of affecting any structure or function of

the body,

(B) amounts paid for transportation primarily

for and essential to medical care referred to in

subparagraph (A), and

ical care referred to in subparagraphs (A) and (B).

Definitions relating to health insurance

For purposes of this part—

24a

(1) Health insurance coverage

The term “health insurance coverage” means

benefits consisting of medical care (provided directly,

through insurance or reimbursement, or otherwise

and including items and services paid for as medical

care) under any hospital or medical service policy or

certificate, hospital or medical service plan contract, or

health maintenance organization contract offered by a

health insurance issuer.

(2) Health insurance issuer

The term “health insurance issuer” means an in-

surance company, insurance service, or insurance or-

ganization (including a health maintenance organiza-

tion, as defined in paragraph (3)) which is licensed to

engage in the business of insurance in a State and

which is subject to State law which regulates insurance

(within the meaning of section 1144(b)(2) of this title).

Such term does not include a group health plan.

* a * * *

13. 42 U.S.C. 300gg-15a provides:

Provision of additional information

A group health plan and a health insurance issuer

offering group or individual health insurance coverage

shall comply with the provisions of section 18031(e)(3)

of this title, except that a plan or coverage that is not

offered through an Exchange shall only be required to

submit the information required to the Secretary and

25a

the State insurance commissioner, and make such in-

formation available to the public.

14. 42 U.S.C. 300gg-17 provides in pertinent part:

Ensuring the quality of care

(a) Quality reporting

(1) In general

Not later than 2 years after March 23, 2010, the

Secretary, in consultation with experts in health care

quality and stakeholders, shall develop reporting re-

quirements for use by a group health plan, and a health

insurance issuer offering group or individual health

insurance coverage, with respect to plan or coverage

benefits and health care provider reimbursement

structures that—

(A) improve health outcomes through the

implementation of activities such as quality report-

ing, effective case management, care coordination,

chronic disease management, and medication and

care compliance initiatives, including through the

use of the medical homes model as defined for pur-

poses of section 3602' of the Patient Protection and

Affordable Care Act, for treatment or services un-

der the plan or coverage;

(B) implement activities to prevent hospital

readmissions through a comprehensive program for

hospital discharge that includes patient-centered

education and counseling, comprehensive discharge

' See References in Text note below.

26a

planning, and post discharge reinforcement by an

appropriate health care professional;

safety and reduce medical errors through the ap-

propriate use of best clinical practices, evidence

based medicine, and health information technology

under the plan or coverage; and

(D) implement wellness and health promotion

activities.

(2) Reporting requirements

(A) In general

A group health plan and a health insurance is-

suer offering group or individual health insurance

coverage shall annually submit to the Secretary,

and to enrollees under the plan or coverage, a re-

port on whether the benefits under the plan or

coverage satisfy the elements described in sub-

paragraphs (A) through (D) of paragraph (1).

* * * * *

(b) Wellness and prevention programs

For purposes of subsection (a)(1)(D), wellness and

health promotion activities may include personalized

wellness and prevention services, which are coordinated,

maintained or delivered by a health care provider, a

wellness and prevention plan manager, or a health, well-

ness or prevention services organization that conducts

health risk assessments or offers ongoing face-to-face,

telephonic or web-based intervention efforts for each of

27a

the program’s participants, and which may include the

following wellness and prevention efforts:

(1) Smoking cessation.

(2) Weight management.

(3) Stress management.

(4) Physical fitness.

(5) Nutrition.

(6) Heart disease prevention.

(7) Healthy lifestyle support.

(8) Diabetes prevention.

* . + * *

(d) Regulations

Not later than 2 years after March 23, 2010, the

Secretary shall promulgate regulations that provide cri-

teria for determining whether a reimbursement structure

is described in subsection (a).

(e) Study and report

Not later than 180 days after the date on which

regulations are promulgated under subsection (c),’ the

Government Accountability Office shall review such reg-

ulations and conduct a study and submit to the Committee

on Health, Education, Labor, and Pensions of the Senate

and the Committee on Energy and Commerce of the

House of Representatives a report regarding the impact

2 So in original. Probably should be “subsection (d),”.

28a

the activities under this section have had on the quality

and cost of health care.

15. 42 U.S.C. 300gg-23(a) provides:

Preemption; State flexibility; construction

(a) Continued applicability of State law with respect to

health insurance issuers

(1) In general

Subject to paragraph (2) and except as provided

in subsection (b) of this section, this part and part C of

this subchapter insofar as it relates to this part shall

not be construed to supersede any provision of State

law which establishes, implements, or continues in ef-

fect any standard or requirement solely relating to

health insurance issuers in connection with individual

or group health insurance coverage except to the ex-

tent that such standard or requirement prevents the

application of a requirement of this part.

(2) Continued preemption with respect to group health

plans

Nothing in this part shall be construed to affect

or modify the provisions of section 1144 of title 29 with

respect to group health plans.

29a

16. 42 U.S.C. 1315a provides in pertinent part:

Center for Medicare and Medicaid Innovation

(a) Center for Medicare and Medicaid Innovation estab-

lished

(1) In general

There is created within the Centers for Medicare

& Medicaid Services a Center for Medicare and Med-

icaid Innovation (in this section referred to as the

“CMI”) to carry out the duties described in this sec-

tion. The purpose of the CMI is to test innovative

payment and service delivery models to reduce pro-

gram expenditures under the applicable subchapters

while preserving or enhancing the quality of care fur-

nished to individuals under such subchapters. In se-

lecting such models, the Secretary shall give prefer-

ence to models that also improve the coordination,

quality, and efficiency of health care services furnished

to applicable individuals defined in paragraph (4)(A).

* * * * *

(b) Testing of models (phase I)

(1) In general

The CMI shall test payment and service delivery

models in accordance with selection criteria under

paragraph (2) to determine the effect of applying such

models under the applicable subchapter (as defined in

subsection (a)(4)(B)) on program expenditures under

such subchapters and the quality of care received by

individuals receiving benefits under such subchapter.

30a

(2) Selection of models to be tested

(A) In general

The Secretary shall select models to be tested

from models where the Secretary determines that

there is evidence that the model addresses a de-

fined population for which there are deficits in care

leading to poor clinical outcomes or potentially

avoidable expenditures. The Secretary shall focus

on models expected to reduce program costs under

the applicable subchapter while preserving or en-

hancing the quality of care received by individuals

receiving benefits under such subchapter. The

models selected under this subparagraph may in-

clude, but are not limited to, the models described

in subparagraph (B).

(B) Opportunities

The models described in this subparagraph

are the following models:

* * * + *

(xi) Allowing States to test and evaluate

systems of all-payer payment reform for the

medical care of residents of the State, including

dual eligible individuals.

* * * * *

3la

(4) Evaluation

(A) In general

The Secretary shall conduct an evaluation of

each model tested under this subsection. Such

evaluation shall include an analysis of—

(i) the quality of care furnished under the

model, including the measurement of patient-

level outcomes and patient-centeredness criteria

determined appropriate by the Secretary; and

(ii) the changes in spending under the ap-

plicable subchapters by reason of the model.

* * . * *

17. 42 U.S.C. 1895kk(e) (as amended by Pub. L. No.

114-10, § 105(c), 129 Stat. 137) provides in pertinent

part:

Administration of insurance programs

(e) Availability of data

(1) Ingeneral

Subject to paragraph (4), the Secretary shall make

available to qualified entities (as defined in paragraph

(2)) data described in paragraph (3) for the evaluation

of the performance of providers of services and sup-

pliers.

(2) Qualified entities

For purposes of this subsection, the term “quali-

fied entity” means a public or private entity that—

32a

(A) is qualified (as determined by the Secre-

tary) to use claims data to evaluate the perfor-

mance of providers of services and suppliers on

measures of quality, efficiency, effectiveness, and

resource use; and

(B) agrees to meet the requirements described

in paragraph (4) and meets such other require-

ments as the Secretary may specify, such as en-

suring security of data.

(3) Data described

The data described in this paragraph are stand-

ardized extracts (as determined by the Secretary) of

claims data under parts A, B, and D for items and

services furnished under such parts for one or more

specified geographic areas and time periods requested

by a qualified entity. Beginning July 1, 2016, if the

Secretary determines appropriate, the data described

in this paragraph may also include standardized ex-

tracts (as determined by the Secretary) of claims data

under subchapters XIX and XXI for assistance pro-

vided under such subchapters for one or more speci-

fied geographic areas and time periods requested by a

qualified entity. The Secretary shall take such ac-

tions as the Secretary deems necessary to protect the

identity of individuals entitled to or enrolled for bene-

fits under such parts or under subchapters* XIX or

XXI.

* So in original. Probably should be “subchapter”.

18. 42 U.S.C. 18031(e)(3) provides:

Affordable choices of health benefit plans

(e) Certification

(3) Transparency in coverage

(A) In general

The Exchange shall require health plans

seeking certification as qualified health plans to

submit to the Exchange, the Secretary, the State

insurance commissioner, and make available to the

public, accurate and timely disclosure of the fol-

lowing information:

(i) Claims payment policies and practic-

es.

(ii) Periodic financial disclosures.

(iii) Data on enrollment.

(iv) Data on disenrollment.

(v) Dataonthe number of claims that are

denied.

(vi) Data on rating practices.

(vii) Information on cost-sharing and

payments with respect to any out-of-network

coverage.

(viii) Information on enrollee and partici-

pant rights under this title.*

* See References in Text note below.

34a

(ix) Other information as determined ap-

propriate by the Secretary.

(B) Use of plain language

The information required to be submitted un-

der subparagraph (A) shall be provided in plain

language. The term “plain language” means lan-

guage that the intended audience, including indi-

viduals with limited English proficiency, can read-

ily understand and use because that language is

concise, well-organized, and follows other best

practices of plain language writing. The Secre-

tary and the Secretary of Labor shall jointly de-

velop and issue guidance on best practices of plain

language writing.

The Exchange shall require health plans seek-

ing certification as qualified health plans to permit

individuals to learn the amount of cost-sharing

(including deductibles, copayments, and coinsur-

ance) under the individual’s plan or coverage that

the individual would be responsible for paying with

respect to the furnishing of a specific item or ser-

vice by a participating provider in a timely manner

upon the request of the individual. At a minimum,

such information shall be made available to such

individual through an Internet website and such

other means for individuals without access to the

Internet.

(D) Group health plans

The Secretary of Labor shall update and har-

monize the Secretary’s rules concerning the accu-

35a

rate and timely disclosure to participants by group

health plans of plan disclosure, plan terms and

conditions, and periodic financial disclosure with

the standards established by the Secretary under

subparagraph (A).

19. 42 U.S.C. 18041(d) provides:

State flexibility in operation and enforcement of Ex-

changes and related requirements

(d) Nointerference with State regulatory authority

Nothing in this title’ shall be construed to preempt

any State law that does not prevent the application of

the provisions of this title.'

20. Vt. Stat. Ann. tit. 18, § 9401 (2012) provides:

Policy

(a) It is the policy of the state of Vermont that

health care is a public good for all Vermonters and to

ensure that all residents have access to quality health

services at costs that are affordable. To achieve this

policy, it is necessary that the state ensure the quality

of health care services provided in Vermont and, until

health care systems are successful in controlling their

costs and resources, to oversee cost containment.

(b) It is further the policy of the state of Vermont

that the health care system should:

' See references in Text note below.

36a

(1) Maintain and improve the quality of health

care services offered to Vermonters.

(2) Utilize planning, market, and other mecha-

nisms that contain or reduce increases in the cost of

delivering services so that health care costs do not

consume a disproportionate share of Vermonters’

incomes or the moneys available for other services

required to insure the health, safety, and welfare of

Vermonters.

(3) Encourage regional and local participation

in decisions about health care delivery, financing,

and provider supply.

(4) Utilize planning, market, and other mecha-

nisms that will achieve rational allocation of health

care resources in the state.

(5) Facilitate universal access to preventive

and medically necessary health care.

(6) Support efforts to integrate mental health

and substance abuse services with overall medical

care.

21. Vt. Stat. Ann. tit. 18, § 9402(8) (2012) provides:

Definitions

(8) “Health insurer” means any health insurance

company, nonprofit hospital and medical service cor-

poration, managed care organizations, and, to the

extent permitted under federal law, any administrator

of an insured, self-insured, or publicly funded health

care benefit plan offered by public and private entities.

37a

22. Vt. Stat. Ann. tit. 18, § 9410 (Supp. 2014) pro-

vides:

Health care database

(a)(1) The Board shall establish and maintain a

unified health care database to enable the Commis-

sioner and the Board to carry out their duties under

this chapter, chapter 220 of this title, and Title 8, in-

cluding:

(A) determining the capacity and distribution of

existing resources;

(B) identifying health care needs and informing

health care policy;

programs on improving patient outcomes;

(D) comparing costs between various treatment

settings and approaches;

(E) providing information to consumers and

purchasers of health care; and

(F) improving the quality and affordability of

patient health care and health care coverage.

(2A) The program authorized by this section

shall include a consumer health care price and quality

information system designed to make available to

consumers transparent health care price information,

quality information, and such other information as the

Board determines is necessary to empower individuals,

including uninsured individuals, to make economically

sound and medically appropriate decisions.

38a

(B) The Commissioner may require a health in-

surer covering at least five percent of the lives covered

in the insured market in this State to file with the

Commissioner a consumer health care price and qual-

ity information plan in accordance with rules adopted

by the Commissioner.

sary to carry out the purposes of this subdivision.

The Board’s rules may permit the gradual implemen-

tation of the consumer health care price and quality

information system over time, beginning with health

care price and quality information that the Board

determines is most needed by consumers or that can

be most practically provided to the consumer in an

understandable manner. The rules shall permit

health insurers to use security measures designed to

allow subscribers access to price and other information

without disclosing trade secrets to individuals and

entities who are not subscribers. The rules shall

avoid unnecessary duplication of efforts relating to

price and quality reporting by health insurers, health

care providers, health care facilities, and others, in-

cluding activities undertaken by hospitals pursuant to

their community report obligations under section

9405b of this title.

(b) The database shall contain unique patient and

provider identifiers and a uniform coding system, and

shall reflect all health care utilization, costs, and re-

sources in this State, and health care utilization and

costs for services provided to Vermont residents in

another state.

39a

care facilities, and governmental agencies shall file

reports, data, schedules, statistics, or other informa-

tion determined by the Board to be necessary to carry

out the purposes of this section. Such information

may include:

(1) health insurance claims and enrollment in-

formation used by health insurers;

(2) information relating to hospitals filed under

subchapter 7 of this chapter (hospital budget re-

views); and

(3) any other information relating to health

care costs, prices, quality, utilization, or resources

required by the Board to be filed.

(d) The Board may by rule establish the types of

information to be filed under this section, and the time

and place and the manner in which such information

shall be filed.

(e) Records or information protected by the provi-

sions of the physician-patient privilege under 12 V.S.A.

§ 1612(a), or otherwise required by law to be held con-

fidential, shall be filed in a manner that does not dis-

close the identity of the protected person.

(f) The Board shall adopt a confidentiality code to

ensure that information obtained under this section is

handled in an ethical manner.

(g) Any person who knowingly fails to comply with

the requirements of this section or rules adopted pur-

suant to this section shall be subject to an administra-

tive penalty of not more than $1,000.00 per violation.

40a

The Board may impose an administrative penalty of

not more than $10,000.00 each for those violations the

Board finds were willful. In addition, any person who

knowingly fails to comply with the confidentiality

requirements of this section or confidentiality rules

adopted pursuant to this section and uses, sells, or

transfers the data or information for commercial ad-

vantage, pecuniary gain, personal gain, or malicious

harm shall be subject to an administrative penalty of

not more than $50,000.00 per violation. The powers

vested in the Board by this subsection shall be in addi-

tion to any other powers to enforce any penalties,

fines, or forfeitures authorized by law.

(h)(1) All health insurers shall electronically pro-

vide to the Board in accordance with standards and

procedures adopted by the Board by rule:

(A) their health insurance claims data, provided

that the Board may exempt from all or a portion of

the filing requirements of this subsection data re-

flecting utilization and costs for services provided in

this State to residents of other states;

(B) cross-matched claims data on requested

members, subscribers, or policyholders; and

mation necessary to determine third party liability

for benefits provided.

(2) The collection, storage, and release of health

care data and statistical information that is subject

to the federal requirements of the Health Insurance

Portability and Accountability Act (“HIPAA”) shall be

4la

governed exclusively by the regulations adopted there-

under in 45 C.F.R. Parts 160 and 164.

(A) All health insurers that collect the Health

Employer Data and Information Set (HEDIS) shall

annually submit the HEDIS information to the

Board in a form and in a manner prescribed by the

Board.

(B) All health insurers shall accept electronic

claims submitted in Centers for Medicare and Med-

icaid Services format for UB-92 or HCFA-1500 rec-

ords, or as amended by the Centers for Medicare

and Medicaid Services.

(3)(A) The Board shall collaborate with the Agen-

cy of Human Services and participants in the Agency’s

initiatives in the development of a comprehensive

health care information system. The collaboration is

intended to address the formulation of a description

of the data sets that will be included in the compre-

hensive health care information system, the criteria

and procedures for the development of limited-use

data sets, the criteria and procedures to ensure that

HIPAA compliant limited-use data sets are accessible,

and a proposed time frame for the creation of a com-

prehensive health care information system.

(B) To the extent allowed by HIPAA, the data shall

be available as a resource for insurers, employers,

providers, purchasers of health care, and State agen-

cies to continuously review health care utilization,

expenditures, and performance in Vermont. In pre-

senting data for public access, comparative considera-

tions shall be made regarding geography, de-

42a

mographics, general economic factors, and institution-

al size.

subject to such terms and conditions as the Board may

prescribe by rule, the Vermont Program for Quality in

Health Care shall have access to the unified health

care database for use in improving the quality of

health care services in Vermont. In using the data-

base, the Vermont Program for Quality in Health Care

shall agree to abide by the rules and procedures estab-

lished by the Board for access to the data. The

Board’s rules may limit access to the database to

limited-use sets of data as necessary to carry out the

purposes of this section.

(D) Notwithstanding HIPAA or any other provi-

sion of law, the comprehensive health care information

system shall not publicly disclose any data that con-

tains direct personal identifiers. For the purposes of

this section, “direct personal identifiers” include in-

formation relating to an individual that contains pri-

mary or obvious identifiers, such as the individual’s

name, street address, e-mail address, telephone num-

ber, and Social Security number.

(i) On or before January 15, 2008 and every three

years thereafter, the Commissioner shall submit a rec-

ommendation to the General Assembly for conducting

a survey of the health insurance status of Vermont res-

idents. The provisions of 2 V.S.A. § 20(d) (expiration

of required reports) shall not apply to the report to be

made under this subsection.

43a

(j)(1) As used in this section, and without limiting

the meaning of subdivision 9402(8) of this title, the

term “health insurer” includes:

(A) any entity defined in subdivision 9402(8) of

this title;

(B) any third party administrator, any phar-

macy benefit manager, any entity conducting ad-

ministrative services for business, and any other

similar entity with claims data, eligibility data, pro-

vider files, and other information relating to health

care provided to a Vermont resident, and health

care provided by Vermont health care providers

and facilities required to be filed by a health insurer

under this section;

tered by or on behalf of the State of Vermont or an

agency or instrumentality of the State; and

(D) any health benefit plan offered or adminis-

tered by or on behalf of the federal government

with the agreement of the federal government.

(2) The Board may adopt rules to carry out the

provisions of this subsection, including criteria for the

required filing of such claims data, eligibility data, pro-

vider files, and other information as the Board deter-

mines to be necessary to carry out the purposes of this

section and this chapter.

44a

23. Reg. H-2008-01, 21-040-021 Vt. Code R. (2008)

provides in pertinent part:

Section 1. Purpose.

The purpose of this rule is to set forth the require-

ments for the submission of health care claims data,

member eligibility data, and other information relating

to health care provided to Vermont residents or by

Vermont health care providers and facilities by health

insurers, managed care organizations, third party

administrators, pharmacy benefit managers and others

to the Department of Banking, Insurance, Securities

and Health Care Administration and conditions for the

use and dissemination of such claims data, all as re-

quired by and consistent with the purposes of 18

V.S.A. § 9410.

* * * * ¥

Section 3. Definitions.

As used in this Rule

‘ * * * :

I. “Data set” means a collection of individual

data records, whether in electronic or manual files.

* * * * *

K. “De-identified health information” means in-

formation that does not identify an individual patient,

member or enrollee and with respect to which no rea-

sonable basis exists to believe that the information can

be used to identify an individual patient, member or

enrollee. De-identification means that health infor-

45a

mation is not individually identifiable and requires the

removal of Direct Personal Identifiers associated with

patients, members or enrollees.

L. “Direct personal identifiers” is information re-

lating to an individual patient, member or enrollee that

contains primary or obvious identifiers, including:

(1) Names;

(2) Business names when that name would

serve to identify a person;

(3) Postal address information other than town

or city, state, and 5-digit zip code;

(4) Specific latitude and longitude or other ge-

ographic information that would be used to derive

postal address;

(5) Telephone and fax numbers;

(6) Electronic mail addresses;

(7) Social security numbers;

(8) Vehicle Identifiers and serial numbers, in-

cluding license plate numbers;

(9) Medical record numbers;

(10) Health plan beneficiary numbers;

(11) Certificate and license numbers;

(12) Internet protocol (IP) addresses and uni-

form resource locators (URL) that identify a busi-

ness that would serve to identify a person;

46a

(13) Biometric identifiers, including finger and

voice prints; and

(14) Personal photographic images.

* * * * *

P. “Health benefit plan” means a policy, contract,

certificate or agreement entered into, or offered by a

health insurer to provide, deliver, arrange for, pay for

or reimburse any of the costs of health care services.

Q. “Healthcare claims data” means information

consisting of or derived directly from member eligibil-

ity files, medical claims files, pharmacy claims files and

other related data pursuant to the Vermont Health-

care Claims Uniform Reporting and Evaluation Sys-

tem (VHCURES) in effect at the time of the data

submission. “Healthcare claims data” does not in-

clude analysis, reports, or studies containing infor-

mation from health care claims data sets if those anal-

yses, reports, or studies have already been released in

response to another request for information or as part

of a general distribution of public information by

BISHCA.

° . * * *

T. “Health care” means care, services, or sup-

plies related to the health of an individual. It in-

cludes but is not limited to (1) preventive, diagnostic,

therapeutic, rehabilitative, maintenance, or palliative

care, and counseling, service, assessment, or proce-

dure with respect to the physical or mental condition,

or functional status, of an individual or that affects the

structure or function of the body; and (2) sale or dis-

47a

pensing of a drug, device, equipment, or other item in

accordance with a prescription [45 CFR § 160.103).

U. “Health care facility” shall be defined as per

18 V.S.A § 9432, as amended from time to time.

V. “Health care provider” means a person, part-

nership, corporation, facility or institution, licensed or

certified or authorized by law to provide professional

health care service in this state to an individual during

that individual’s medical care, treatment or confine-

ment, as per 18 V.S.A. § 9432.

W. “Health information” means any information,

whether oral or recorded in any form or medium, that

1) is created or received by a health-care provider,

health plan, public health authority, employer, life

insurer, school or university, or health-care clearing-

house; and 2) relates to the past, present, or future

physical or mental health or condition of an individual,

the provision of health care to an individual, or the

past, present, or future payment for the provision of

health care to an individual shall be as defined in 45

CFR § 160.103.

X. “Health insurer” means those entities defined

in 18 V.S.A. §§ 9402 and 9410(j)(1), and includes any

health insurance company, nonprofit hospital and med-

ical service corporation, managed care organization,

third party administrator, pharmacy benefit manager,

and any entity conducting administrative services for

business or possessing claims data, eligibility data,

provider files, and other information relating to health

care provided to Vermont residents or by Vermont

health care providers and facilities. The term may

48a

also include, to the extent permitted under federal law,

any administrator of an insured, self-insured, or pub-

licly funded health care benefit plan offered by public

and private entities.

7 * . * .

Z. “Indirect personal identifiers” means infor-

mation relating to an individual patient, member or

enrollee that a person with appropriate knowledge of

and experience with generally accepted statistical and

scientific principles and methods could apply to render

such information individually identifiable by using

such information alone or in combination with other

reasonably available information.

* * > * .

Ab. “Mandated Reporter” means a health insurer

as defined herein and at 18 V.S.A. § 9410(j)(1) with two

hundred (200) or more enrolled or covered members in

each month during a calendar year, including both

Vermont residents and any non-residents receiving

covered services provided by Vermont health care pro-

viders and facilities.

Ac. “Medical claims file” means a data file com-

posed of service level remittance information for all

non-denied adjudicated claims for each billed service

including, but not limited to member demographics,

provider information, charge/payment information,

and clinical diagnosis and procedure codes, and shall

include all claims related to behavioral or mental

health.

49a

Ad. “Member” means the insured subscriber and

any spouse and/or dependent covered by the subscrib-

er’s policy.

Ae. “Member eligibility file” means a data file con-

taining demographic information for each individual

member eligible for medical or pharmacy benefits for

one or more days of coverage at any time during the

reporting month.

- * s * *

Ag. “Payer” means a third-party payer or third-

party administrator.

. . * > *

Ai. “Personal identifiers” means information re-

lating to an individual that contains direct or indirect

identifiers to which a reasonable basis exists to believe

that the information can be used to identify an indi-

vidual.

> . . * *

Ak. “Pharmacy claims file” means a data file con-

taining service level remittance information from all

non-denied adjudicated claims for each prescription

including, but not limited to: member demographics;

provider information; charge/payment information;

and national drug codes.

* * > * *

Aq. “Third-party Administrator” means any per-

son who, on behalf of a health insurer or purchaser of

health benefits, receives or collects charges, contribu-

50a

tions or premiums for, or adjusts or settles claims on

or for residents of this State or Vermont health care

providers and facilities.

Ar. “Vermont Healthcare Claims Uniform Report-

ing and Evaluation System” or “VHCURES” means

the Department’s system for the collection, manage-

ment and reporting of eligibility, claims and related

data submitted pursuant to 18 V.S.A. § 9410.

As. “Voluntary Reporter” includes any entity oth-

er than a mandated reporter, including any health ben-

efit plan offered or administered by or on behalf of the

federal government where such plan, with the agree-

ment of the federal government, voluntarily submits

data to the BISHCA commissioner for inclusion in the

database on such terms as may be appropriate.

Section 4. Reporting Requirements.

Registration and Reporting Requirements

A. VHCURES Reporter Registration. On an

annual basis prior to December 31, Health Insurers

shall register with the Department on a form estab-

lished by the Commissioner and identify whether

health care claims are being paid for members who are

Vermont residents and whether health care claims are

being paid for non-residents receiving covered services

from Vermont health care providers or facilities.

Where applicable, the completed form shall identify

the types of files to be submitted per Section 5. This

form shall be submitted to BISHCA or its designee.

See Appendix F.

B. Third Party Administrator Registration.

Any person or entity that provides third party admin-

5la

istration services, a third party administrator or

“TPA” as defined in Section 3, shall register with the

Department on a form established by the Commis-

sioner, both before doing business in Vermont and on

an annual basis prior to December 31 thereafter. 18

V.S.A. § 9410. See Appendix G.

C. Pharmacy Benefit Manager Registration.

Any person or entity that performs pharmacy benefit

management (a pharmacy benefit manager or “PBM”)

shall register with the Department on a form estab-

lished by the Commissioner both before doing business

in Vermont and on an annual basis prior to December

31. 18 V.S.A. § 9421. The registration requirement

includes persons or entities in a contractual or em-

ployment relationship with a health insurer or PBM

performing pharmacy benefit management for a health

plan with Vermont enrollees or beneficiaries. 18

V.S.A. § 9471. See Appendix H.

D. Health Insurers shall regularly submit medi-

cal claims data, pharmacy claims data, member eligi-

bility data, provider data, and other information relat-

ing to health care provided to Vermont residents and

health care provided by Vermont health care providers

and facilities to both Vermont residents and non-

residents in specified electronic format to the De-

partment for each health line of business (Comprehen-

sive Major Medical, TPA/ASO, Medicare Supplemen-

tal, Medicare Part C, and Medicare Part D) per the

data submission requirements contained in the ap-

pendices to this Rule.

E. Voluntary Reporters may, with the permission

of the Commissioner, participate in VHCURES and

52a

submit medical claims files, pharmacy claims files,

member eligibility files, provider data, and other in-

formation relating to health care provided to Vermont

residents and health care provided by Vermont health

care providers and facilities to both Vermont residents

and non-residents in specified electronic format to the

Department per the data submission requirements

contained in the appendices to this Rule.

Section 5. Required Healthcare Data Files.

Mandated Reporters shall submit to BISHCA or its

designee health care claims data for all members who

are Vermont residents and all non-residents who re-

ceived covered services provided by Vermont health

care providers or facilities in accordance with the

requirements of this section. Each Mandated Repor-

ter is also responsible for the submission of all health

care claims processed by any sub-contractor on its

behalf unless such subcontractor is already submitting

the identical data as a Mandated Reporter in its own

right. The health care claims data submitted shall in-

clude, where applicable, a member eligibility file con-

taining records associated with each of the claims files

reported: a medical claims file and a pharmacy

claims file. The data submitted shall also include

supporting definition files for payer specific provider

specialty taxonomy codes and procedure and/or diag-

nosis codes.

53a

A. General Requirements for Data Submission

* * * ” *

(5) Codes and Encryption Requirements

(a) Code Sources. Unless otherwise speci-

fied in this regulation, the code sources listed

and described in Appendix A shall be utilized in

association with the member eligibility file and

medical and pharmacy claims file submissions.

(b) Member Identification Code. Reporters

shall assign to each of their members a unique

identification code that is the member’s social

security number. If a Reporter does not collect

the social security numbers for all members, the

Reporter shall use the social security number of

the subscriber and then assign a discrete two-

digit suffix for each member under the sub-

scriber’s contract.

If the subscriber’s social security number is

not collected by the Reporter, a version of the

subscriber's certificate or contract number shall

be used in its place. The discrete two-digit suf-

fix shall also be used with the certificate or con-

tract number. The certificate or contract num-

ber with the two-digit suffix shall be at least

eleven but not more than sixty-four characters in

length.

The social security number of the member/

subscriber and the subscriber and member

names shall be encrypted prior to submission

by the Reporter utilizing a standard encryp-

54a

tion methodology provided by BISHCA or its

designee. The unique member identification

code assigned by each Reporter shall remain

with each member/subscriber for the entire pe-

riod of coverage for that individual.

* * * * *

(8) Denied Claims. Denied claims shall be

excluded from all medical and pharmacy claims

file submissions. When a claim contains both

fully processed/paid service lines and partially

processed or denied service lines, only the fully

processed/paid service lines shall be included as

part of the health care claims data set submittal.

* * . * *

B. Detailed File Specifications.

(1) Filled Fields. All required fields shall be

filled where applicable. Non-required text, date,

and integer fields shall be set to null when unavail-

able. Non-applicable decimal fields shall be filled

with one zero and shall not include decimal points

when unavailable.

(2) Position. All text fields are to be left justi-

fied. All integer and decimal fields are to be right

justified.

(3) Signs. Positive values are assumed and

need not be indicated as such. Negative values

must be indicated with a minus sign and must ap-

pear in the left-most position of all integer and

55a

decimal fields. Over-punched signed integers or

decimals are not to be utilized.

(4) Individual Elements and Mapping. Indi-

vidual data elements, data types, field lengths, field

description/code assignments, and mapping locators

(UB-04, HCFA 1500, ANSI X12N 270/271, 835, 837)

for each file shall be as detailed in the following ap-

pendices:

(a)

(1) Member Eligibility File Specifications

—Appendix C-1

(2) Member Eligibility File Mapping to

National Standard Formats—Appendix C-2

(b)

(1) Medical Claims File Specifications—

Appendix D-1

(2) Medical Claims File Mapping to Na-

tional Standard Formats—Appendix D-2

(ec)

(1) Pharmacy Claims File Specifications—

Appendix E-1

(2) Pharmacy Claims File Mapping to Na-

tional Standard Formats—Appendix E-2

Section 6. Submission Requirements.

Data submission requirements shall be as detailed

in the attached appendices.

A. Registration Form. It is the responsibility of

each Health Insurer to resubmit or amend the regis-

56a

tration form required by Section 4 (A) whenever modi-

fications occur relative to the data files or contact

information.

B. File Organization. The member eligibility file,

medical claims file and pharmacy claims file shall be

submitted to BISHCA or its designee as separate

ASCII files. Each record shall terminate with a car-

riage return (ASCII 13) or a carriage return line feed

(ASCII 13, ASCIT 10).

C. Filing Media. Files shall be submitted utiliz-

ing one of the following media: diskette (1.44 MB),

CD-ROM (650 MB), DVD, secure SSL web upload

interface, or electronic transmission through a File

Transfer Protocol. E-mail attachments shall not be

accepted. Space permitting, multiple data files may

be submitted utilizing the same media if the external

label identifies the multiple files.

D. Transmittal Sheet. All file submissions on

physical media shall be accompanied by a hard copy

transmittal sheet containing the following information:

identification of the Reporter, file name, type of file,

data period(s), date sent, record count(s) for the file(s),

and a contact person with telephone number and

E-mail address. The information on the transmittal

sheet shall match the information on the header and

trailer records. See Appendix I.

E. Testing of Files. At least sixty days prior to

the initial submission of the files or whenever the data

element content of the files as described in Section 5 is

subsequently altered, each Reporter shall submit to

BISHCA or its desigee a data set for comparison to

57a

the standards listed in Section 7. The size, based up-

on a calendar period of one month, quarter, or year, of

the data files submitted shall correspond to the filing

period established for each Reporter under subsection

I of this Section.

F. Rejection of Files. Failure to conform to sub-

sections A, B, or C of this Section shall result in the

rejection and return of the applicable data file(s). All

rejected and returned files shall be resubmitted in the

appropriate, corrected form to BISHCA or its design-

ee within 10 days.

* * * * *

Section 8. Procedures for the Approval and Release of

Claims Data.

The requirements, procedures and conditions under

which persons other than the Department may have

access to health care claims data sets and related in-

formation received or generated by the Department or

its designee pursuant to this regulation shall depend

upon the requestor and the characteristics of the par-

ticular information requested, all as set forth below.

A. Classification of Data Elements

(1) Unrestricted Data Elements: Data ele-

ments designated in Appendix J as “Unrestricted”

shall be available for general use and public release

as part of a Public Use File.

(2) Restricted Data Elements: Data elements

designated in Appendix J as “Restricted” shall not

be available for use and release outside the De-

partment except as part of a Limited Use Research

58a

Health Care Claims Data Set approved by the

commissioner pursuant to the requirements of this

regulation.

(3) Unavailable Data Elements: Data ele-

ments which are not designated in Appendix J as

either Unrestricted or Restricted, or are designated

as “Unavailable”, shall not be available for release

or use outside the Department in any data set or

disclosed in publicly released reports in any cir-

cumstance.

* * * * *

C. Limited Use Health Care Claims Research Data

Sets—Release and Availability

* * * * *

(2) The Commissioner may approve the release of

limited use data sets only when the Commissioner is

satisfied as to the following:

(a) The application submitted is complete and

the requesting individuals or entities and principal

investigator have signed a data use agreement as

specified;

(b) Procedures to ensure the confidentiality of

any patient and any confidential data are docu-

mented;

research staff, as evidenced by:

(1) Training and previous research, including

prior publications; and

59a

(2) An affiliation with a university, private

research organization, medical center, state

agency, or other qualified institutional entity.

(d) No other state or federal law or regulation

prohibits release of the requested information.

* * * * *

Section 10. Enforcement.

Violations of data submission requirements, confi-

dentiality requirements, data use limitations or any

other provisions of this rule shall be subject to sanc-

tion by the Commissioner as set out in 18 V.S.A. § 9410

in addition to any other powers granted to the Com-

missioner to investigate, subpoena, fine or seek other

legal or equitable remedies.

* * . * *

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.