Petition for Writ of Certiorari — Fanning v. United States

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No. 8 132 7 MAR 15 9004

IN THE

Supreme Court of the Hnited States

DANIEL C. FANNING, individuaily and as Class Representative,

Petitioners,

v.

UNITED STATES OF AMERICA, et al.,

Respondents.

On PETITION FOR A WRIT OF CERTIORARI TO THE

UNITED STATES COURT OF APPEALS FOR THE THIRD CIRCUIT

PETITION FOR A WRIT OF CERTIORARI

ARNOLD LEVIN

Counsel of Record

MICHAEL D. FISHBEIN

ZANETTA MOORE-DRIGGERS

LEVIN, FISHBEIN, SEDRAN & BERMAN

510 Walnut Street, Suite 500

Philadelphia, PA 19106

(215) 592-1500

Attorneys for Petitioners

186312 ce

COUNSEL PRESS

(800) 274-3321 * (800) 359-6859

~

1

QUESTION PRESENTED

Does 42 U.S.C. § 405(h), incorporated into the Medicare

Act by 42 U.S.C. § 1395ii, preclude federal question

jurisdiction under 28 U.S.C. § 1331, over an action asserting

constitutional challenges to the administrative adjudication

procedure utilized by the United States government to seek

Medicare reimbursement from private citizens who received

distribution from a tort settlement fund, where the

adjudication effected a deprivation of property without due

process of law.

il

PARTIES TO THE PROCEEDINGS

The Petitioners, who appeared before the United States

Court of Appeals for the Third Circuit at Docket

No. 01-3366 (3d Cir.), are Daniel Fanning, individually and

as Class Representative.

The respondents to this Petition, who appeared before

the Third Circuit at Docket No. 01-3366 (3d Cir.), and are

not set forth in the caption are: the United States Department

of Defense; the United States Department of the Army; the

United States Department of the Navy; the United States

Department of the Air Force; the United States Indian Health

Service; the United States Department of Veterans Affairs;

Donald H. Rumsfeld, as Secretary of Defense; Gregory A.

Dahlberg, The Honorable, as Acting Secretary of the Army;

Grodon R. England, The Honorable substituted, as Secretary

of the Navy; James G. Roche, The Honorable Dr., as Secretary

of the Air Force; Charles W. Grim D.D.S, M.H.S.A., as

Director of the Indian Health Service; Anthony J. Princip,

The Honorable, as Secretary of the Department of Veterans

Affairs; the Centers for Medicare and Medicaid Services

(formerly the Health Care Financing Administration); the

United States Department of Health and Human Services;

Tommy G. Thompson, in his capacity as Secretary of the

United States Department of Health and Human Services;

and Thomas Scully, in his capacity as Administrator of the

Centers for Medicare and Medicaid Services (formerly

Administrator of the Health Care Financing Administration).

— oe

lil

TABLE OF CONTENTS

Page

OO 1

Parties To The Proceedings .................... li

es ea decay bse sheewes lil

Table Of Cited Authorities .................... iV

re Vii

Opinions | SE ere l

Statement Of Jurisdiction ..................... ]

Constitutional And Statutory Provisions Involved . l

Statement Of The Case ....................... 2

Reasons For Granting The Petition ............. 6

I. This Petition Presents A Recurring Issue of

Significant National Concern ............ 6

II. The Administrative Adjudication Of The

Government’s MSP Claims Violate The Due

OMS 5 kee vce nescssviavanss 9

es a sk ao xd be ook ae Owes 13

iv

TABLE OF CITED AUTHORITIES

Page

Cases:

Buckman vy. Plaintiffs’ Legal Comm., 513 U.S. 341

cS RR a eee ere th Peg ey Wer ee a Ae ety 2

Gray Panthers v. Schweiker, 652 F.2d 146 (D.C. Cir.

WE Crk acca ence cere seen a tioas eee 9

Connecticut v. Doehr, 501 U.S. 1 (1991) ....... 9,11, 12

Fanning v. United States, 346 F.3d 386 (3d Cir. 2003)

b gts Mel wee ounce aca ee ee i 1, 4-5, 8, 10

Fuentes v. Shevin, 407 U.S. 67 (1972) ........... 7, 8,9

In re Air Crash at Taipei, Taiwan, on October 31,

2000, MDL No. 1394(C.D. Cal.) ............ 6

In re Baycol Prod Liab. Litg., MDL No. 1431

RS are rh eer Ne hats ny 6

In re Dow Corning Corp., 250 B.R. 298 (Bankr. E.D.

er ene enor mre 8,12

In re Orthopedic Bone Screw, 202 F.R.D. 154 (E.D.

| eer err se ere re er er rere ae 4

In re Propulsid Prod. Liab. Litig., MDL No. 1355

Se UE no 0 ihe an eS oe ee a eee 6

v

Cited Authorities

Page

In re Rezulin Prod. Liab. Litig., MDL No. 1348

Roh & gree + +4ee henna eRe 6

In re Sulzer Orthopedics Inc. Hip Prosthesis and

Knee Prosthesis Prod. Liab. Litig., MDL No. 1401

PEER SOD 6 6h vee cases bekee eee 6

Mason vy. American Tobacco Co., 346 F.3d 36

CP" Gi BD. nn ohn v'noa0kadsnene 5

Mathews v. Eldridge, 424 U.S. 319 (1976) ....... 10

Pension Benefit Guar. Corp. v. R.A. Gray & Co.,

467 U.S. 717 (1984) ....... ieceKnaeearee es 5

Reardon vy. United States, 947 F.2d 1509 (1* Cir.

POPES ona 4205 eed Ree hee 9

Sniadach y. Family Finance Corp., 395 U.S. 337

GOOF Eh 5 vies s ve detvhes eee eee 9

Thompson v. Goetzmann, 315 F.3d 457 (5" Cir.

2002), opinion withdrawn and reissued as

amended on other grounds, 337 F.3d 489 (5" Cir.

BOOED cs sen dnaens¥eke ee ieee 5

United States v. Baxter Int’l Inc., 345 F.3d 866

37° GR SRR os besads teen eee 5,8

United States v. Carlton, 512 U.S. 26 (1994) ..... 5

vi

Cited Authorities

Page

Waters v. Farmers Texas County Mut. Ins. Co., 9 F.3d

S97 63 Cie. 1988) occ ct vuveeeent ese 8

Zinmann v. Shalala, 835 F. Supp. 1163 (N.D. Cal.

1993), aff'd, 67 F.3d 841 (9 Cir. 1995) ....... 9

Constitution and Statutes:

LS. Comet. OG. Vi oa ccc ei vee cn evedevesSes ]

Lib com. rere rer rere rt rs co er 4

sis Pom Bee) |) errr rer rr err 1

TE UBC. 6 TOG oc cunn hess eerie 3

- £Es Tom Et) rere rrr Ter rer rs cy i, 4

ath Com f . ) nner rrre rrr? fre ty 1,12

S2 UG. 8 GOD) ono vn vccaecruysceincnes i, 1, 6, 12

42 U.S.C. § ISOS ONE) bo eons he ks ce ewersucss 2

Ris OMe Be Pe rrrerrrer rr rr re re. i, 1

Miscellaneous:

Medicare Prescription Drug and Modernization

Act of 2003, H.R. 2473, 108" Cong., H.R. Rep.

108-1 780D, 6 301 (2003) . 2.6. ceswennes 7

Vil

TABLE OFAPPENDICES

Page

Appendix A — Opinion Of The United States Court

Of Appeals For The Third Circuit Filed October

ea aCe scene e i eeeaed Akaroa la

Appendix B — Memorandum And Pretrial Order

No. 2000 Of The United States District Court For

The Eastern District Of Pennsylvania Dated June

| Peers Pree rer ry ee 36a

Appendix C — Order Of The United States Court

Of Appeals For The Third Circuit Denying Petition

For Rehearing En Banc Dated December 16,

OE LS eee ees tear ree Ca 80a

Appendix D — Statutes Involved ............... 83a

Appendix E — Government Adjudication Letter To

Class Member For MSP Claims Dated May 7,

Br rer ee ee re emo an 94a

Appendix F — Affidavit Dated June 4, 2001 ..... 10la

Appendix G — Affidavit Dated June 2, 2001 ..... 104a

Appendix H — Affidavit Dated June 1, 2001 ..... 107a

Appendix I — Excerpts Of Testimony In Preliminary

Injunction Hearing In In Re Orthopedic Bone

Screw Products Liability Litigation, Mdl No. 1014

Bree BOG. FOE on cece ccsvecvsusws 110a

a Sell Rel ae NO

Neale aed ti a AIEEE AO, CA

SOAR mae le

a i Sarai. ee eae

l

OPINIONS BELOW

The opinion of the Panel of the United States Court of

Appeals for the Third Circuit is reported as Fanning v. U.S.A.,

346 F.3d 386 (3d Cir. 2003), and is reprinted in the Appendix

to the Petition beginning at page 1a. The opinion of the United

States District Court for the Eastern District of Pennsylvania

is reported as Jn re Orthopedic Bone Screw Products Liability

Litigation, 202 F.R.D. 154 (E.D. Pa. 2001), and is reprinted

in the Appendix beginning at page 36a.

STATEMENT OF JURISDICTION —

The judgment of the Court of Appeals was filed on

October 10, 2003. The Order of the United States Court of

Appeals for the Third Circuit, denying Fanning’s timely

Petition for Rehearing En Banc, dated December 16, 2003,

is reprinted in the Appendix beginning at page 80a. The

jurisdiction of this Court is invoked under 28 U.S.C. 1254(1).

CONSTITUTIONAL AND STATUTORY

PROVISIONS INVOLVED

The Due Process Clause of the United States Constitution

provides in relevant part: ““No person shall . . . be deprived

of life, liberty, or property, without due process of law. .. .”

U.S. Const. Amend. V. The provisions of 42 U.S.C. §§ 405(g),

405(h), 1395ii, and 1395y(b)(2) are reproduced in the

Appendix beginning at 83a.

2

STATEMENT OF THE CASE

This case raises important, recurring questions relating

to whether the government may avoid judicial review of

pre-hearing deprivations of property interests in federally

administered benefits programs, in violation of the United

States Constitution.

This case arises from the Government’s effort to obtain

reimbursement of medical expenses from crippled and

disabled class members who received partial distributions

from a limited fund class action settlement with AcroMed

Corporation in Jn re Orthopedic Bone Screw Product Liability

Litigation, No. 97-cv-381 (“Bone Screw Litig.”).'

The Government claimed it was entitled to reimbursement

under the Medicare Secondary Payer statute, 42 U.S.C.

§ 1395y(b)(2) (“MSP”), and sought to appropriate the

reimbursement through threats of an imminent pre-hearing

attachment. That effort to recover from the class members is

contrary to law. The threat of a pre-hearing levy, used by the

Government against class members who suffer from disabling

spinal injuries, is unconstituiional, as violative of the Due

Process Clause, and class members have no administrative

recourse to address this violation.

On March 1, 2001, Fanning filed a motion in the

Bone Screw Litig., to require distribution of the settlement

proceeds. On that same date, acting in a representative

capacity, Fanning filed an action in the United States District

Court for the Eastern District of Pennsylvania, seeking a

judgment declaring that the Government had no right on

1. One aspect of this complex mass tort action has previously

been subject to review by this court. See Buckman v. Plaintiffs ’Legal

Committee, 531 U.S. 341 (2001).

3

account of the AcroMed settlement to recover payments

previously made by the Government for medical expenses

of the class members, and permanently enjoining the

Government from attempting such recovery from the class

members. Subsequently, the Government administratively

adjudicated its claims against the class members without

affording them notice of its alleged claim and an opportunity

to be heard concerning it.

The Government sent adjudication letters

(““Adjudications’’) to the members of the plaintiff-class stating

that it was entitled to Medicare reimbursement in specified

amounts which were supposed to represent the amounts

previously paid by Medicare for bone screw-related injuries,

to the extent of the class members’ recoveries in the Bone

Screw Litigation, and demanding immediate payment of those

amounts. (App. 96a). The Adjudications also threatened a

levy on other federal benefits received by class members

including the Medicare and Social Security benefits on which

many of these disabled class members rely to support and

maintain their very existence. (App. 96a). Moreover, they

threatened accrual of interest at the confiscatory rate of

13.75%? from the date of the letter, if the amount was not

paid within sixty days, regardless of whether the

class members challenged the de facto levy and requested

an administrative hearing. (App. 96a).

Following the Government’s action, Fanning filed an

amended complaint. Fanning also requested class

certification and a preliminary injunction to prevent the

2. The Adjudications impose interest at the rate of 13.75%

per annum. In contrast, the federal judgment rate of interest is tied to

the yield on treasury bills, which in the last few years has hovered

between one and two percent. See 28 U.S.C. § 1961 and

www. federalreserve. gov.

4

Government from proceeding with its efforts to administratively

adjudicate its claims. The district court had jurisdiction pursuant

to 28 U.S.C. § 1331. The Government filed a motion to dismiss

the complaint.

On June 29, 2001, the judge in the District Court, the

Honorable Louis Bechtle issued an opinion granting the motions

for class certification and for a preliminary injunction. The Court

found that “the Medicare statutory scheme does not preclude

judicial review of the class members’ claims.” Jn re Orthopedic

Bone Screw, 202 F.R.D. 154, 170 (E.D. Pa. 2001). (App. 71a).

The Court also found that judicial review was authorized by the

Administrative Procedures Act, 5 U.S.C. § 702, et seq.

Id. at 171. (App. 72a). In addition, the Court said that “the

class members have established the likelihood of irreparable

harm,” and that the Plaintiffs “are likely to ultimately succeed on

the merits of the Government’s MSP claim.” Jd. at 169. (App.

66a).

The Government filed an appeal of the District Court’s

decision, arguing that the District Court lacked jurisdiction

to hear Petitioners’ claims because they had not exhausted

administrative remedies. On October 10 , 2003, the Third

Circuit Court of Appeals reversed the District Court, ruling

that the District Court had no federal question jurisdiction.

The Third Circuit found that the central issue was whether

the AcroMed settlement fund was a self-insured plan, and

thus a primary plan under the MSP.’ Fanning v. United States,

3. At the time of the Third Circuit’s opinion, there was a circuit

split on the question of whether a tort settlement fund was a

“self-insured plan” under the MSP such that the Government could

recover reimbursement of prior Meidicare expenses paid to treat the

(Cont’d)

:

§

4

a tanta ee ES, RNR“ ee

ee ee ee Te ee ee ee EM ee ee Ee eae e ee Seg h ee ee tee o> | een Mes

5

346 F.3d 386, 400 (3d Cir. 2003). (App. 29a). Therefore, the

Third Circuit held “that both the standing and substantive basis

for the claim asserted in the amended class action complaint are

rooted in, and derived from, the Medicare Act.” /d. (App. 30a).

Thus, the Third Circuit found that 42 U.S.C. § 405(h) compelled

(Cont'd)

injuries that were the subject of the tort action. The Second and Fifth

Circuits rejected the government’s argument and held that the

government was not entitled to such reimbursement. See Mason v.

American Tobacco Co., 346 F.3d 36 (2™ Cir. 2003) and Thompson v.

Goetzmann, 315 F.3d 457 (5" Cir. 2002), opinion withdrawn and

reissued as amended on other grounds, 337 F.3d 489 (5™ Cir. 2003).

The Eleventh Circuit accepted the government’s MSP reimbursement

argument in United States v. Baxter Intern. Inc., 345 F.3d 866

(11" Cir. 2003). On December 8, 2003, Congress amended the MSP

to read that “An entity that engages in a business, trade, or profession

shall be deemed to have a self-insured plan if it carries its own risk

(whether by a failure to obtain insurance or otherwise) in whole or

in part.” The amendments also set forth

A primary plan’s responsibility for such payment may

be demonstrated by a judgment, a payment conditioned

upon the recipient’s compromise, waiver, or release

(whether or not there is a determination or admission of

liability) of payment for items or services included in a

claim against the primary plan or the primary plan’s

insured, or by other means.

However, the validity of the amendments is questionable, given that

they were made retroactive, as if they had been included in the

enactment of section 953 of the Omnibus Reconciliation Amendments

of 1980, a retroactive period of over twenty years. See United States

v. Carlton, 512 U.S. 26 (1994) amendment retroactive for one (1)

year was constitutional where Congress “acted promptly and

established only a modest period of retroavticity”); Pension Benefit

Guar. Corp. v. R.A. Gray & Co., 467 U.S. 717 (1984) (retroactive

effect for five(5) months was constitutional because it was “confined

to short and limited period[]).

6

Petitioners to channel their claims through the agency. /d. (App.

30a). The Third Circuit ignored the government’s violation of

class members’ due process rights, both sustantively and as a

basis for the exercise of jurisdiction by the District Court.

REASONS FOR GRANTING THE PETITION

I. This Petition Presents A Recurring Issue of Significant

National Concern

This issue will continue to arise more frequently, given the

current status of mass-tort litigation as part of our legal

landscape.* The significance of the issue is illustrated by

developments in litigation, the government’s tactics in

asserting its claims, Congressional action, and judicial

commentary. Clear guidance from this Court is imperative.

By definition, mass-tort cases involve substantial

numbers of people injured by the same product or accident.

Along with such litigation come settlement funds that are

often made available to compensate injured victims.

The government has recently decided to seek Medicare

reimbursement from mass-tort or class-action plaintiffs once

they obtain distribution of settlement funds, regardless of

the distribution amount or whether medical expenses for the

class of plaintiffs were calculated in the settlement. In its

zeal for monetary recovery, the government, as a matter of

institutional practice, tramples upon the constitutional rights of

4. A few of the current mass-tort, multidistrict litigation cases

include Jn re Baycol Prod Liab. Litg., MDL No. 1431 (D. Minn.);

In re Propulsid Prod. Liab. Litig., MDL No. 1355 (E.D. La.);

In re Rezulin Prod. Liab. Litig., MDL No. 1348 (S.D.N.Y.); In re

Air Crash at Taipei, Taiwan, on October 31, 2000, MDL No. 1394

(C.D. Cal.); and Jn re Sulzer Orthopedics Inc. Hip Prosthesis and

Knee Prosthesis Prod. Liab. Litig., MDL No. 1401 .(N.D. Ohio).

7

these victims, by denying them a pre-deprivation hearing. The

magnitude of this issue is emphasized in the legislative history of

the recent amendments to the MSP, which reflect that the

Government expects to recover more than nine billion dollars

from the tort recoveries of injured Medicare beneficiaries over

the next ten years. Medicare Prescription Drug and Modemization

Act of 2003, H.R. 2473, 108" Cong., H.R. Rep. 108-178(II),

§ 301 (2003).

The Government, through these coercive pre-hearing

Adjudications, essentially takes the Medicare beneficiaries

property without due process. This is fundamentally

unconstitutional. By definition, mass tort victims are citizens

who have suffered serious or debilitating injuries, which have

rendered them dependent on the Medicare, Social Security

and other federal benefits subject to seizure through the

Adjudications. An unconstitutional deprjvation of their

property cannot be undone or fixed after the fact. Fuentes v.

Shevin, 407 U.S. 67, 81-82 (1972). “If the right to notice

and a hearing is to serve its full purpose, then, it is clear that

it must be granted at a time when the deprivation can still be

prevented.” /d. at 81.

The MSP amendments make it easier for the government

to pursue claims against mass-tort victims, defendants and

settlement funds. However, the procedure routinely used by

the government to appropriate MSP reimbursement was not

addressed by Congress in those recent amendments.

That procedure, which operates to deprive citizens of their

property without due process, is still unconstitutional. It is

simply wrong to coerce immediate payment from citizens

based on erroneous adjudications, without affording those

citizens a pre-deprivation opportunity to demonstrate that

the calculations are mistaken. To, in the same breath, threaten

8

those citizens, who are poor and disabled, with seizure of federally

administered benefits, upon which they are dependent, prior to

an opportunity to dispute the claimed debt, is unconscionable.

“For when a person has an opportunity to speak up in his own

defense, and when the State must listen to what he has to say,

substantively unfair and simply mistaken deprivations of property

interests can be prevented.” Fuentes, 407 U.S. at 81.

The unconstitutionality of the government’s actions cannot

be ignored. Judicial commentary reflects the recurring nature of

the issue presented here. In United States v. Baxter Intern.,

345 F.3d 866 (11" Cir. 2003), the Eleventh Circuit Court of

Appeals indicated that expansion of the MSP statute has made

“Medicare secondary to a greater array of primary coverage

sources... .” Jd. at 877. The Eleventh Circuit also found that

“any payment that Medicare does make is secondary and is

subject to reimbursement from sources of primary coverage

under the statute.”’ /d. at 886. Thus, the government has increasing

opportunities to attempt seizures of private property. Further,

the government’s tactics have repeatedly been questioned. See

e.g. Fanning, 346 F.3d at 25, n.17 (government letters

unnecessarily callous and threatening); Waters v. Farmers Texas

County Mut. Ins. Co., 9 F.3d 397, 400-01 (5 Cir. 1993) (court

expressed disappointment with “the government’s overreaching

interpretation of its authority under the [MSP]”); Jn re Dow

Corning Corp., 250 B.R. 298, 336 (Bankr. E.D. Mich. 2000)

(describing government action as “heavy-handed collection

tool’’).

eee ee ee ee

9

II. The Administrative Adjudication Of The Government’s

MSP Claims Violate The Due Process Clause

The Adjudications violate the class members’ Constitutional

rights. A beneficiary’s interest in receiving Medicare benefits,

such as the interest affected by the Adjudications here, is a

constitutional property interest subject to the protection of the

due process clause. Gray Panthers v. Schweiker, 652 F.2d

146, 152, n.15, 158, 167-72 (D.C. Cir. 1980); Zinman v.

Shalala, 835 F. Supp. 1163, 1169 (N.D. Cal. 1993), aff'd, 67

F.3d 841 (9" Cir. 1995). Moreover, the Adjudications affect

the property interests of class members at least as profoundly as

a judgment or the pre-judgment attachments which were subject

to due process restraint in cases such as Connecticut v. Doehr,

501 U.S. 1, 9-16 (1991); Fuentes v. Shevin, 407 U.S. 67, 88

(1972), and Reardon v. United States, 947 F.2d 1509, 1517-

18 (1* Cir. 1991).

Accordingly, under the Due Process Clause, the Government

was obliged to afford the plaintiff-class members the kind of

“notice and hearing that are aimed at establishing the validity, or

at least the probable validity, of the underlying claim against”

them before entering the Adjudications even if they might be

undone by a later appeal. E.g., Fuentes, 407 U.S. at 97;

Sniadach v. Family Finance Corp., 395 U.S. 337, 343 (1969).

Fundamental notions of due process dictate that the poor and

handicapped class members should have been given notice of

the Government claims. Instead, they were sent the coercive

Adjudications which purported to be final determinations and

threatened attachment of their life sustaining benefits if payment

was not made promptly. In fact the Third Circuit recognized that

the Adjudications were “unnecessarily callous and threatening”

and were “more suggestive of tactics one might attribute to a

10

less than reputable collection agency rather than to one’s own

government.” Fanning, 346 F.3d at 401-02, n.17. (App. 33a-

34a).

The Government adjudicated its own claims, and effectively

initiated a levy on the property of class members without any

advance notice, let alone an opportunity to be heard before the

coercive appropriation of their property. This deprived the

plaintiff-class members of the opportunity to show that the

Government’s claims were legally baseless, that they did not

receive some or all of the health care items or services, which

were the subject of the Adjudications, as a result of injuries related

to AcroMed orthopedic bone screws, and that they did not

receive the amounts from the AcroMed settlement fund which

were set forth as the explicit basis for the Adjudications. None

of the factors set forth in Mathews v. Eldridge, 424 U.S. 319

(1976), justifies this deprivation.

Pursuant to Matthews the factors to be considered when

determining the due process issues in a State deprivation of

property are: “the private interest that will be affected by the

official action;” “the risk of an erroneous deprivation of such

interest ... and the probable value, if any, of additional or

substitute procedural safeguards;” and “the Government’s

interest, including . . . the fiscal and administrative burdens

that the additional or substitute procedural requirement would

entail.” Matthews, 424 U.S. at 335. Consideration of the

private interest affected by the official action certainly points

to the necessity of due process protection here. The interest

of class members in Social Security, Railroad Retirement,

Medicare, and other benefits upon which they rely for

sustenance, are affected by the Government’s Adjudications.

These are extreme deprivations. The Supreme Court has held

1]

that “‘even the temporary or partial impairment to property rights

that attachments, liens, and similar encumbrances

entail are sufficient to merit due process protection.”

Doehr, 501 U.S. at 12.

The risk of erroneous deprivation here is great.

As evidenced by the testimony and affidavits presented to

the District Court, the Adjudications are often wrong.°

The amounts demanded include charges for care not related

to treatment with the orthopedic bone screws that were the

subject of the litigation, services for which Medicare did not

even pay, services for which Medicare was already

reimbursed, and services which were never received by class

members. However, before having the opportunity to dispute

these charges, class members were threatened with accrual

of confiscatory amounts of interest on the Government’s

claimed debt, having their life sustaining benefits seized, and

having the debt assigned to the Department of the Treasury

for collection efforts — all without the prospect for a hearing

before any of these deprivations were effectuated.

The probable value of safeguards, preventing prejudgment

interest accrual and prejudgment deprivation of property, is

substantial. “A later hearing. . . would not cure the temporary

deprivation that an earlier hearing might have prevented.”

Doehr, 501 U.S. at 15. Regarding financial or administrative

burdens on providing the pre-attachment hearing, as this

Court held in Doehr “the State cannot seriously plead

additional financial or administrative burdens involving

predeprivation hearings when it already claims to provide

an immediate post-deprivation hearing.” Doehr at 16. Likewise,

that is not an issue here as the Government argued below that

5. A representative sample of the testimony and affidavits is

included in the Appendix, beginning at 101a.

12

the class members’ “appeal” rights afford them the possibility of

a post-deprivation hearing.

Thus, the Government violated the class members’

due process rights, and it did so deliberately as part of a

heavy-handed collection strategy. See Dow Corning, 250 B.R.

at 336, n.21 (noting the government’s use of MSP as a “heavy-

handed collection tool”). Such behavior is the hallmark of

injustice. Petitioners had a right to seek a judicial remedy

for the government’s unconstitutional acts.

The present matter is not one which falls within the scope

of Section 1395ff and the concomitant review provisions of

Sections 405(h) & (g). The Adjudications at issue here would

strip disabled class members of the amounts which they

require for their medical care and support without a prior

opportunity for judicial review. Thus, as a practical matter,

the Adjudications would impair the class members’ rights to

judicial review so as to make Section 405(h) inapplicable.

13

CONCLUSION ,

Because the government’s collection of MSP

“Reimbursements” is a recurring issue of national importance,

and such collection actions constitute a violation of the Due

Process Clause, this Petition for a Writ of Certiorari should be

granted.

Respectfully submitted,

ARNOLD LEVIN

Counsel of Record

MICHAEL D. FISHBEIN

ZANETTA MooreE-DRIGGERS

LEVIN, FISHBEIN, SEDRAN & BERMAN

510 Walnut Street, Suite 500

Philadelphia, PA 19106

(215) 592-1500

Attorneys for Petitioners

APPENDIX

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APPENDIX A — OPINION OF THE UNITED STATES

COURT OF APPEALS FOR THE THIRD CIRCUIT

FILED OCTOBER 10, 2003

UNITED STATES COURT OF APPEALS

THIRD CIRCUIT

No. 01-3366

Argued June 10, 2002.

Opinion Filed: Oct. 10, 2003.

Daniel C. FANNING, Individually, and as Representative

of a Class of Persons Similarly Situated

¥.

THE UNITED STATES of America; United States Health

Care Financing Administration; United States

Department of Defense; United States Department of

Health and Human Services; United States Department

of the Army; United States Department of the Navy;

United States Department of the Air Force; United States

Indian Health Service; United States Department of

Veterans Affairs; Michael McMullen, Mrs., as Acting

Deputy Administrator of the United States Health Care

Financing Administration; Donald H. Rumsfeld, as

Secretary of Defense; Tommy G. Thompson, as Secretary

of the Department of Health and Human Services;

Gregory R. Dahlberg, the Honorable, as Acting Secretary

of the Army; Robert B. Pirie, Jr., the Honorable, as Acting

Secretary of the Navy; Lawrence Delaney, the Honorable

Dr., as Secretary of the Air Force; Michael H. Trujillo,

~ 2a

Appendix A

M.D., M.P.H., as Director of the Indian Health Service;

Anthony J. Principi, the Honorable, as Secretary of the

Department of Veterans Affairs; Robert E. Welsh, Jr.,

Esquire, as Administrator of the AcroMed Settlement

Agreement; PNC Bank, N.A., as Trustee for the Acromed

Settlement Agreement United States of America, the

Centers for Medicare and Medicaid Services (formerly

the Health Care Financing Administration), the United

States Department of Health and Human Services,

Tommy G. Thompson in his capacity as Secretary of the

United States Department of Health and Human Services,

and Thomas Scully in his capacity as Administrator of

the Centers for Medicare and Medicaid Services

(formerly Administrator of the Health Care Financing

Administration),

Appellants

Before: SLOVITER, ROTH, and McKEE, Circuit Judges.

OPINION OF THE COURT

McKEE, Circuit Judge.

This litigation is the aftermath of an attempt by the Health

Care Financing Administration (“HCFA”) (now known as

the Centers for Medicare and Medicaid Services (““CMS”’)),

to obtain reimbursement under the Medicare as Secondary

Payer statute, 42 U.S.C. § 1395 y(b)(2). HCFA attempted to

collect from a settlement trust fund for Medicare payments

that had been made to AcroMed settlement class members

for various medical expenses arising from injuries the

Ee

3a

Appendix A

settlement class members allegedly suffered as a result of

the use of orthopedic bone screws manufactured by AcroMed.

Daniel Fanning filed an amended complaint for declaratory

and injunctive relief in an attempt to prevent the HCFA from

obtaining Medicare reimbursement. Fanning filed the

complaint on his own behalf and on behalf of the class in an

attempt to prevent the HCFA from obtaining any of the

proceeds of the settlement fund. !

The district court certified the class and granted

preliminary relief enjoining the HCFA from attempting to

obtain MSP reimbursement from the settlement trust fund.

However, because we find that the district court did not have

federal question jurisdiction, we will reverse and remand with

instructions to dismiss the amended complaint.

I. BACKGROUND

A. THE MEDICARE AS SECONDARY PAYER

STATUTE

Prior to 1980, Medicare generally paid for medical

services whether or not the recipient was also covered by

another health plan. See Social Security Amendments of

1965, Pub.L. No. 89-97, § 1862(b), 79 Stat. 286. However,

beginning in 1980, Congress enacted a series of cost cutting

amendments to the Medicare program. These amendments

are collectively known as the Medicare as Secondary Payer

(“MSP”) statute or the MSP provisions. See New York Life

1. Fanning’s amended complaint invoked the district court’s

federal question jurisdiction pursuant to 28 U.S.C. § 1331.

4a

Appendix A

Ins. Co. v. United States, 190 F.3d 1372, 1374

(Fed.Cir.1999).?

The MSP statute was designed to curb skyrocketing

health costs and preserve the fiscal integrity of the Medicare

system. See Zinman v. Shalala, 67 F.3d 841, 845

(9th Cir.1995); H.R.Rep. No. 96-1167, at 352 (1980).

The MSP attempted to lower overall federal Medicare

disbursements by requiring Medicare beneficiaries to exhaust

all available insurance coverage before looking to Medicare’s

coverage. See United States v. Rhode Island Insurers’

Insolvency Fund, 80 F.3d 616, 618 (1st Cir.1996). The MSP

assigns primary responsibility for medical bills of Medicare

recipients to private health plans when a Medicare recipient

is also covered by private insurance. These private plans are

therefore considered “primary” under the MSP and Medicare

acts as the “secondary” payer responsible only for paying

amounts not covered by the primary plan.’ Blue Cross

and Blue Shield of Texas v. Shalala, 995 F.2d 70,

73 (Sth Cir.1993).

-~

2. The amendments have been codified at 42 U.S.C. § 1395y(b).

3. “Before 1980, if a Medicare beneficiary had an alternate

source of payment, such as private insurance or an employee group

health plan, Medicare was the primary payer, and the health plan

was the secondary payer, liable only for the costs that remained after

Medicare made its payments. Private insurers even wrote this practice

into their health insurance contracts. Congress enacted the MSP

statute to reverse the order of payment in cases where Medicare

beneficiaries have an alternate source of payment for health care.”

Blue Cross and Blue Shield of Texas, 995 F.2d at 73 (citations

omitted).

Sa

Appendix A

Congress established two principal directives to

achieve this objective. First, the MSP bars Medicare

payments where “payment has already been made or can

reasonably be expected to be made promptly (as determined

in accordance with regulations)” by a primary plan. 42 U.S.C.

§ 1395y(b)(2)(A) (parenthetical in original). “Prompt”

payment is defined in the applicable regulations as payment

; made within 120 days of either the date on which care was

provided or when the claim was filed with the insurer,

whichever is earlier. See 42 C.F.R. §§ 411.21, 411.50.

The MSP defines a “primary plan” as “a workmen’s

compensation law or plan, an automobile or liability

insurance policy or plan (including a self-insured plan) or

no fault insurance [.]” 42 U.S.C. § 1395y(b)(2)(A)(ii)

(parenthetical in original). This provision “is intended to keep

the government from paying a medical bill where it is clear

an insurance company will pay instead.” Evanston Hosp. v.

Hauck, | F.3d 540, 544 (7th Cir.1993) (citation omitted).

Second, the MSP provides that when Medicare makes a

payment that a primary plan was responsible for, the

payment is merely conditional and Medicare is entitled to

reimbursement for it. 42 U.S.C. § 1395(y)(b)(2)(B);

Blue Cross and Blue Shield of Texas v. Shalala, 995 F.2d 70,

73 (Sth Cir.1993) (2002). Section 1395y(b)(2)(B) provides:

Any payment under this subchapter with respect

to any item or service to which subparagraph (A)

applies shall be conditioned on reimbursement to

the appropriate Trust Fund established by this

subchapter when notice or other information is

nati

6a

Appendix A

received that payment for such item or service has

been or could be made under such subparagraph.

42 U.S.C. § 1395y(b)(2)(B)(i). Medicare payments are

subject to reimbursement to the appropriate Medicare Trust

Fund once the government receives notice that a third-party

payment has been or could be made with respect to the same

item or service.* Jd.

B. THE ACROMED LITIGATION

As noted above, the controversy surrounding the

Medicare payments at issue here arose from a class action

settlement of claims pertaining to orthopedic bone screws

manufactured by AcroMed. AcroMed began marketing

orthopedic bone screw devices for use in spinal fusion surgery

in 1983. By the early part of the 1990s, thousands of

individuals who had undergone spinal fusion surgery

experienced complications and infirmities that they

associated with AcroMed’s bonescrews. A flood of product

liability suits against AcroMed followed. See In re Orthopedic

Bone Screw Products Liability Litigation, 176 F.R.D. 158,

165 (E.D.Pa.1997). In 1994, the Judicial Panel on

Multidistrict Litigation transferred all of the pending cases

to the United States District Court for the Eastern District of

4. If MSP reimbursement is not made, the MSP authorizes the

government to bring an action against “any entity which is required

or responsible . .. to make payment . . . under a primary plan” and

against “any other entity (including a physician or provider) that has

received payment from that entity.” 42 U.S.C. § 1395y(b)(2)(B)(ii).

The MSP also gives the government a separate right of subrogation.

42 U.S.C. § 1395y(b)(2)(iii).

7a

Appendix A

Pennsylvania for pre-trial proceedings. /d. On January 8,

1997, Daniel Fanning, acting as a class representative,

reached a settlement with AcroMed on behalf of the class.

Jd. Pursuant to the terms of that settlement, AcroMed

transferred $100 million into a trust fund for distribution to

class members who qualified for payment in accordance with

a procedure to be established by the court.’ Jd. at 165-166.

Since members of the settlement class had previously

received Medicare payments for medical expenses allegedly

stemming from injuries caused by AcroMed’s bone screws,

the government filed a Statement of Interest in the district

court after learning of the proposed AcroMed settlement.

In that Statement of Interest, the government stated that,

pursuant to the “secondary payer” provisions of the MSP,

it intended to recover amounts Medicare had paid for the

class members’ medical care.

When efforts to settle the government claims broke

down, the government sent letters to the approximately 1,800

members of the settlement class demanding repayment of

the amounts Medicare had paid for medical treatment.

The letters gave each class member 60 days to repay the

amount set forth in each letter and warned that if the amount

remained unpaid after 60 days, interest would accrue at the

rate of 13.75% per annum until the debt was paid, regardless

of whether a waiver of recovery request or administrative

appeal was pending. The letters also told the class members

5. In addition to the $100 million, AcroMed agreed to “assign

the proceeds of virtually all of its insurance policies to the settlement

‘ fund.” 176 F.R.D. at 166.

en

8a

Appendix A

that if they did not pay, Medicare could recover the

outstanding balance from other federal benefits the individual

plaintiff might otherwise be entitled to including additional

Medicare payments, Social Security benefits and Railroad

Retirement benefits. The letters similarly threatened that

delinquencies would be reported to the Treasury Department

for offset against any other federal payments the class

members might otherwise receive. On March 21, 2001,

Fanning filed an amended complaint alleging that payments

from the AcroMed settlement are not the type of payments

that give the government a right to reimbursement under the

MSP. The amended complaint sought a permanent injunction

barring the government from taking any action to enforce

the rights asserted under the MSP. Concomitantly, Fanning

filed a motion for a preliminary injunction and a motion for

class certification.

The government responded with a motion to dismiss for

lack of jurisdiction, arguing that 42 U.S.C. § 405(h) requires

exhaustion of administrative remedies before claims that arise

under the Medicare Act could be subjected to judicial review.°

The district court denied the government’s motion to

dismiss, certified the class and entered a preliminary

injunction barring the government from taking any action to

obtain reimbursement for Medicare payments from the class

members. Jn re Orthopedic Bone Screw Products Liability

Litigation (Fanning v. United States), 202 F.R.D. 154

(E.D.Pa.2001). The court rejected the government’s claim

6. The government also opposed the motions for a preliminary

injunction and for class certification.

9a

Appendix A

that the court lacked federal question jurisdiction under

42 U.S.C. § 405(h). The court found that § 405(h) did not

apply to the settlement class members because they were not

trying to recover Medicare benefits. Rather, in the court’s

view, the class members were attempting to enjoin collection

of benefits the government had already paid. Jd. at 170.

This appeal followed.

If. DISCUSSION—FEDERAL QUESTION

JURISDICTION

We have appellate jurisdiction over the district court’s

grant of preliminary injunctive relief pursuant to 28 U.S.C.

§ 1292(a)(1). However, the government renews its argument

that the district court lacked jurisdiction because of the failure

to exhaust administrative remedies. Therefore, before we can

address the merits of the government’s appeal, we must

determine if the district court had jurisdiction over F anning’s

amended class action complaint.’

It is obvious that when another insurer makes a payment

for medical services Medicare has already paid for, a

duplicate payment results. In the absence of reimbursement

to Medicare, the duplicate payment is an overpayment of

Medicare under the MSP. See 42 C.F.R. § 405.704(b)(13);

Buckner v. Heckler, 804 F.2d 258, 259 (4th Cir.1986).

7. A court of appeals has the obligation, not only to satisfy itself

that it has appellate jurisdiction, but also to satisfy itself of the

jurisdiction of the district court under review. Dole vy. Trinity

Industries, Inc., 904 F.2d 867, 870 (3d Cir.1990). Our standard of

review of the district court’s determination that it had jurisdiction is

plenary. Jd.

10a

Appendix A

As we have discussed, the MSP allows the Secretary to

obtain reimbursement of the overpayment. 42 U.S.C.

§§ 1395y(b)(2)(A)(ii), 1395 y(b)(2)(B)(ii). However, a

beneficiary who disagrees with the Secretary’s determination

that an overpayment of Medicare benefits has been made on

his or her behalf is entitled to a hearing before the Secretary

as provided in 42 U.S.C. § 405(b). See 42 U.S.C.

§ 1395ff(b)(1). If the beneficiary is dissatisfied with the

Secretary’s final decision after a hearing, the beneficiary is

entitled to judicial review of that decision as provided in

42 U.S.C. § 405(g).® See Id.

8. 42 U.S.C. § 405(g) provides in relevant part:

Any individual, after any final decision of the

Commissioner of Social Security made after a hearing

to which he was a party, irresrective of the amount in

controversy, may obtain a review of such decision by a

civil action commenced within sixty days after the

mailing to him of notice of such decision or within such

further time as the Commissioner of Social Security may

allow. ... As part of the Commissioner’s answer the

Commissioner ... shall file a certified copy of the

transcript of the record including the evidence upon

whicii ihe findings and decision complained of are based.

The court shall have power to enter, upon the pleadings

and transcript of the record, a judgment affirming,

modifying, or reversing the decision of the Commissioner

of Social Security, with or without remanding the cause

for a rehearing. ... The judgment of the court shall be

final except that it shall be subject to review in the same

manner as a judgment in other civil action. Any action

instituted in accordance with this subsection shall survive

(Cont'd)

ee

lla

Appendix A

The AcroMed settlement class members did not use the

administrative procedure to challenge the government’s

efforts to obtain MSP reimbursement from the settlement

trust fund. Instead, as noted above, F anning filed an amended

class action complaint pursuant to 28 U.S.C. § 1331 against

various government defendants seeking class certification

and injunctive relief to prevent the government from seeking

reimbursement of the alleged Medicare overpayments.

As noted, the government moved, inter alia, to dismiss the

amended complaint for lack of jurisdiction; however, the

district court denied the government’s motion to dismiss.

The government’s argument that the district court lacked

jurisdiction is based on 42 U.S.C. § 405(h), a section of the

Social Security Act that is made applicable to the Medicare

Act by 42 U.S.C. § 1395ii.° Section 405(h), captioned

“Finality of Commissioner’s decision,” reads:

The findings and decision of the Commissioner

of Social Security after a hearing shall be binding

upon all individuals who were parties to such

hearing. No findings of fact or decision of the

(Cont'd)

notwithstanding any change in the person occupying the

office of Commissioner of Social Security or any vacancy

in such office.

42 U.S.C. § 405(g).

9. The Medicare Act, 42 U.S.C. §§ 1395-1395zz, is Title XVIII

of the Social Security Act. Section 1395ii of the Medicare Act makes

§ 405(h) applicable to the Medicare Act “to the same extent as” it

applies to the Social Security Act.

ie

12a

Appendix A

Commissioner of Social Security shall be

reviewed by any person, tribunal, or governmental

agency except as herein provided. No action

against the United States, the Commissioner of

Social Security, or any officer or employee thereof

shall be brought under section 1331 or 1346

[federal defendant jurisdiction] of Title 28 to

recover on any claim arising under this

subchapter.

42 U.S.C. § 405(h) (emphasis added). The government

contends that the district court lacked jurisdiction over

Fanning’s amended class action complaint because § 405(h)

requires exhaustion of administrative remedies before claims

that arise under the Medicare Act may be subject to judicial

review. However, as is explained below, we believe that the

technically correct argument is that § 405(h) bars federal

question jurisdiction of Fanning’s class action complaint and

requires that the class members “must proceed instead

through the special review channel that the Medicare statutes

create.” Shalala v. Illinois Council on Long Term Care, Inc.,

529 U.S. 1, 5, 120 S.Ct. 1084, 146 L.Ed.2d 1 (2000).

Section 405(h) contains three sentences, but it is the third

sentence that is critical to our jurisdictional inquiry. It reads:

“No action against the United States, the Commissioner of

Social Security, or any officer or employee thereof shall be

brought under section 1331 or 1346 [federal defendant

jurisdiction] of Title 28 to recover on any claim arising under

this subchapter.” If Fanning’s class action complaint asserts

a claim that “aris [es] under” the Medicare Act, then the third

sentence of § 405(h) precludes the district court from

13a

Appendix A

exercising federal question jurisdiction over it. Although the

issue Of whether a claim arises under a particular statute

appears at first glance to require nothing more than a reading

of the statute, our analysis of whether the class action

complaint alleges a “claim arising under” the Medicare Act

requires us to first examine four cases in which the Supreme

Court discussed the operation and meaning of § 405(h) before

relying solely on the “plain text” of the statute.

The first is Weinberger v. Salfi, 422 U.S. 749, 95 S.Ct.

2457, 45 L.Ed.2d 522 (1975). There, a deceased wage

earner’s widow and step-child challenged the Social Security

Act’s requirement of a nine-month long prior relationship

with the deceased wage earner as a condition of receiving

survivor’s benefits. Concetta Salfi married Londo Salfi on

May 27, 1972. In spite of Londo’s apparent good health, he

suffered a heart attack less than a month later and died on

November 21, 1972, less than six months after the marriage.

His widow filed applications for mother’s insurance benefits

for herself and her daughter by a previous marriage. However,

the applications were denied by the Social Security

Administration, both initially and on reconsideration at the

regional level, solely on the basis of the Act’s duration-of-

relationship provisions.

The widow and other named plaintiffs then filed an action

in the district court, “principally relying on 28 U.S.C. § 1331

for jurisdiction,” challenging the duration-of-relationship

provision on due process and equal protection grounds.

422 U.S. at 755, 95 S.Ct. 2457. The widow also sought to

represent a class of all widows and stepchildren who had

been denied benefits based solely on the Act’s duration-of-

l4a

Appendix A

relationship provisions. The widow and the named plaintiffs

alleged partial exhaustion of their claims, but made no similar

allegations with regard to the claims of other class members.

On cross-motions for summary judgment, a three-judge

district court panel held that the duration-of-relationship

provision was unconstitutional, certified the class and

enjoined the Social Security Administration from denying

benefits on the basis of the duration-of-relationship provision.

On appeal, the Supreme Court ultimately concluded that

the duration-of- relationship provision was constitutional.

However, before it reached the merits, the Count noted that

it was “confronted ... by a serious question as to whether

the District Court had jurisdiction over th[e] suit.” 422 U.S.

at 756, 95 S.Ct. 2457. It is, of course, that jurisdictional

discussion that is relevant to our inquiry.

The Court began its jurisdictional inquiry by noting that

the third sentence of § 405(h) “[o]n its face, .. . bars district

court federal-question jurisdiction over suits, such as

this one, which seek to recover Social Security benefits.”

Id. at 756-757, 95 S.Ct. 2457. Yet, the widow successfully

invoked the district court’s federal question § 1331

jurisdiction and the district court considered the third

sentence “inapplicable because it amounted to no more than

a codification of the doctrine of exhaustion of administrative

remedies.” Jd. at 757, 95 S.Ct. 2457. Therefore, the district

court found that exhaustion would be futile and waived the

requirement. See Salfi v. Weinberger, 373 F.Supp. 961, 964

(N.D.Cal.1974).

l5a

Appendix A

However, the Supreme Court believed that the district

court’s conclusion that § 405(h) is simply an exhaustion

requirement was “entirely too narrow” and held that the third

sentence of § 405(h) is more than that. Jd. at 757, 95 S.Ct.

2457. It wrote:

That the third sentence of § 405(h) is more than a

codified requirement of administrative exhaustion

is plain from its own language, which is sweeping

and direct and which states that no action shall be

brought under § 1331, not merely that only those

actions shall be brought in which administrative

remedies have been exhausted. Moreover, if the

third sentence is construed to be nothing more that

a requirement of administrative exhaustion, it

would be superfluous. This is because the first

two sentences of § 40S5(h) ... assure that

administrative exhaustion will be required.

Specifically, they prevent review of decisions of

the Secretary save as provided in the Act, which

provision is made in § 405(g). This latter section

prescribes typical requirements for review of

matters before an administrative agency, including

administrative exhaustion. Thus the District

Court’s treatment of the third sentence of § 405(h)

not only ignored that sentence’s plain language,

but also relegated it to a function which is already

performed by other statutory provisions.

/

Id. at 757-758, 95 S.Ct. 2457. Although the Court made it

abundantly clear that the third sentence of § 405(h) was

l6a

Appendix A

something more than a mere exhaustion requirement, it did

not fully define the reach of that language.

In any event, the Court next addressed a “somewhat more

substantial argument” that the third sentence of § 405(h) did

not deprive the district court of federal question jurisdiction.

Id. at 760, 95 S.Ct. 2457. By its terms, the third sentence

only concerns actions to recover “on any claim arising” under

the Act. Not unexpectedly, the widow argued that her claim

was not one arising under the Act, but was rather a claim

under the constitution. Jd. Therefore, the widow concluded,

§ 405(h) did not prevent the district court from having federal

question jurisdiction over her complaint. However, the Court

rejected that argument as well. It wrote:

It would, of course, be fruitless to contend that

... the claim is one which does not arise under

the Constitution, since [the widow’s]

constitutional arguments are critical to [her]

complaint. But it is just as fruitless to argue that

this action does not also arise under the Social

Security Act. For not only is it Social Security

benefits which appellees seek to recover, but it is

the Social Security Act which provides both the

standing and the substantive basis for the

presentation of their constitutional contentions.

Appellees sought, and the District Court granted,

a judgment directing the Secretary to pay Social

Security benefits. To contend that such an action

does not arise under the Act whose benefits are

sought is to ignore both the language and

substance of the complaint and judgment. This

17a

Appendix A

being so, the third sentence of § 405(h) precludes

resort to federal-question jurisdiction for the

adjudication of appellees’ constitutional

contentions.

Id. at 760-761, 95 S.Ct. 2457 (emphasis added). The Court

also held that the operation of § 405(h) is not limited to

“decisions of the Secretary on issues of law or fact.” /d. at

762, 95 S.Ct. 2457. Rather, § 405(h) “extends to any ‘action’

seeking to recover on any (Social Security) claim’—

irrespective of whether resort to judicial processes is

necessitated by discretionary decisions of the Secretary or

by his nondiscretionary application of allegedly

unconstitutional statutory restrictions.” Id. (emphasis added).

Finally, insofar as constitutional challenges are concerned,

the Court found that the Social Security Act “itself provides

jurisdiction for constitutional challenges to its provisions.”

Id. Therefore, the Court held that “the plain words of the

third sentence of § 405(h) do not preclude constitutional

challenges.”

They simply require that they be brought under

jurisdictional grants contained in the Act, and thus

in conformity with the same standards which are

applicable to nonconstitutional claims arising

under the Act. The result is not only of

unquestionable constitutionality, but it is also

manifestly reasonable, since it assures the

Secretary the opportunity prior to constitutional

litigation to ascertain, for example, that the

18a

Appendix A

particular claims involved are neither invalid for

other reasons nor allowable under other provisions

of the Social Security Act.

Id. Accordingly, the Court held that § 405(h) barred the claims

asserted under the district court's federal question

jurisdiction."°

The second case is Heckler v. Ringer, 466 U.S. 602, 104

S.Ct. 2013, 80 L.Ed.2d 622 (1984), in which the Court

reaffirmed Weinberger v. Salfi and extended its holding to

the Medicare Act. There, four Medicare beneficiaries invoked

the district court’s federal question jurisdiction and brought

an action challenging the Secretary’s policy and ruling that

no Medicare payments would be provided for a surgical

procedure known as a bilateral carotid body resection

(“BCBR”). They alleged that the policy and ruling violated

the Medicare Act, the Administrative Procedure Act and the

Due Process clause. Jd. at 611 n. 7, 104 S.Ct. 2013. They

sought declaratory and injunctive relief, including

invalidation of the policy and ruling as well as an order

enjoining the Secretary from applying it.

The district court dismissed their complaint for lack of

jurisdiction. It held that, in essence, the plaintiffs were

claiming an entitlement to benefits for the BCBR procedure

10. As noted, the widow alleged partial exhaustion of her claims,

but made no such allegations as to the class members. For reasons

not relevant to our discussion, the Court found that the widow and

other named plaintiffs who alleged partial exhaustion could assert

their claims in the district court under § 405(g). 422 U.S. at 767, 95

S.Ct. 2457.

a a ee ee ee ee <,

19a

Appendix A

and that any challenges to the Secretary’s policy and ruling

were “inextricably intertwined” with their claim for benefits.

Id. at 611, 104 S.Ct. 2013. Therefore, the district court

concluded that 405(g) with its exhaustion prerequisite

provided the sole avenue for judicial review. Because none

of the four plaintiffs had satisfied the exhaustion requirement,

the district court dismissed their complaint. Jd. at 612, 104

S.Ct. 2013.

The court of appeals reversed. It concluded that plaintiffs

were actually arguing that the policy and ruling were

‘an unlawful administrative mechanism for determining the

awards of benefits.” /d. The court reasoned that, to the extent

that the plaintiffs sought to invalidate the Secretary’s method

for determining entitlement to benefits, the claim was a

procedural one cognizable under § 1331 without any

condition of exhaustion. /d. The court of appeals also agreed

with the district court’s conclusion that the plaintiffs had

raised a substantive claim for benefits. However, while

acknowledging that exhaustion was a prerequisite for a

benefits claim under § 405(g), the court of appeals refused

to dismiss the complaint based upon its belief that exhaustion

would be futile.

The Supreme Court reversed the court of appeals.

It agreed with the district court and the court of appeals that

the claims were really for benefits, but rejected the court of

appeals’s attempt to separate the particular claims into

procedural claims (1.e., challenges to the Secretary’s method

of rule making), and substantive claims (i.e., claims for

benefits). Rather, in the Supreme Court’s view, plaintiffs’

procedural claim was “inextricably intertwined” with the

20a

Appendix A

substantive claim. Jd. at 614, 104 S.Ct. 2013. Accordingly,

the Court held that “all aspects of respondent’s claim for

benefits should be channeled first into the administrative

process which Congress has provided for the determination

of claims for benefits.” /d. at 614, 104 S.Ct. 2013 (emphasis

added). Its explained this “channeling” requirement as

follows: ,

The third sentence of 42 U.S.C. § 405(h),

made applicable to the Medicare Act by 42 U.S.C.

§ 1395ii, provides that 405(g), to the exclusion

of 28 U.S.C. § 1331, is the sole avenue for judicial

review for all “claims arising under” the Medicare

Act. See Weinberger v. Salfi, 422 U.S. at 760-

761, 95 S.Ct. 2457. Thus, to be true to the

language of the statute, the inquiry in determining

whether § 405(h) bars federal-question

jurisdiction must be whether the claim “arises

under” the Act, not whether it lends itself to a

“substantive” rather than a “procedural” label. See

Mathews v. Eldridge, 424 U.S. [319] at 327, 96

S.Ct. 893, 47 L.Ed.2d 18 [1976] (recognizing that

federal-question jurisdiction is barred by 42

U.S.C. § 405(h) even in a case where the claimant

is challenging the administrative procedures used

to terminate welfare benefits).

In Weinberger v. Salfi, 422 U.S. at 760-761,

95 S.Ct. 2457, we construed the “claim arising

under” language quite broadly to include any

claims in which “both the standing and the

substantive basis for the presentation” of the

Raabe od Dahtind

2la

Appendix A

claims is the Social Security Act. In that case we

held that a constitutional challenge to the duration-

of-relationship eligibility statute pursuant to

which the claimant had been denied benefits, was

a “claim arising under” Title II of the Social

Security Act within the meaning of 42 U.S.C.

§ 405(h), even though we recognized that it was

in one sense also a claim arising under the

Constitution.

Id. at 614-615, 104 S.Ct. 2013. The Court concluded that

under Sa/fi’s “broad test,” the plaintiffs’ claims were not

cognizable under federal-question jurisdiction because the

Medicare Act provided both the substance and standing for

the claims. That is to say, the claims “arise under” the

Medicare Act. /d. at 615, 104S.Ct. 2013. Therefore, the third

sentence of § 405(h) precluded the district court from having

federal question jurisdiction. The only avenue for judicial

review was § 405(g). Jd. at 617, 104 S.Ct. 2013.

The third case relevant to the instant inquiry is Bowen v.

Michigan Academy of Family Physicians, 476 U.S. 667, 106

S.Ct. 2133, 90 L.Ed.2d 623 (1986), which appeared to limit

the holdings of Sa/fi and Ringer. Michigan Academy involved

a challenge by an association of family physicians to a

Medicare regulation which authorized payment of Part B

benefits in different amounts for similar services. The district

court held that the regulation violated several provisions of

the Medicare Act and found it invalid. Therefore, the court

did not need to address the physicians’ constitutional claims.

On appeal, the court of appeals agreed that the regulation

was inconsistent with the Act and, therefore, irrational and

22a

Appendix A

invalid. The court of appeals also declined to address the

physicians’ constitutional claims.

The Secretary did not challenge the decision on the merits

on appeal to the Supreme Court. Rather, he renewed the

jurisdictional argument that the district court and court of

appeals had rejected. He claimed that §§ 1395ff and 139511

(which, as noted, makes § 405(h) applicable to the Medicare

Act) forbid judicial review under the district court’s federal

question jurisdiction of all questions affecting the amount

of benefits payable under Part B of the Medicare program.

At the time of the litigation in Michigan Academy, § 1395ff

of the Medicare Act did not provide any administrative or

judicial review of Part B benefit amount determinations. The

scheme at that time was as follows: Under Part B, the

Secretary contracted with private health insurance Carriers

to provide benefits, and the Medicare participants voluntarily

payed a premium for those benefits. 476 U.S. at 674, 106

S.Ct. 2133. Although it was federally subsidized, Part B

coverage was an option intended to supplement mandatory

institutional health benefits such as coverage for hospital

expenses covered by Part A. Id. at 674-675, 106 S.Ct. 2133.

Individuals aggrieved by delayed or insufficient payment with

respect to Part B benefits were entitled to a hearing by the

private carrier, subject to an amount-in-controversy

requirement. In comparison, an aggrieved individual under

Part A was entitled to a hearing by the Secretary and to

judicial review, also subject to an amount-in-controversy

requirement. Jd. at 675, 106 S.Ct. 2133.

In deciding the case, the Court noted that the “strong

presumption” in favor of judicial review of administrative

23a

Appendix A

action, Jd. at 670, 106 S.Ct. 2133, can only be overcome by

congressional intent evidenced by “specific language,” Jd.

at 673, 106 S.Ct. 2133, or by “inferences of intent drawn

from the statutory scheme as a whole.” Jd. at 673 n. 4, 106

S.Ct. 2133. Applying those principles, the Court found that

the Act and its legislative history demonstrated a

Congressional intention to “bar judicial review only of

determinations of the amount of benefits to be awarded under

Part B.” Jd. at 678, 106 S.Ct. 2133. As noted, Part B

determinations were delegated to private insurance carriers.

However, the Court concluded that “those matters which

Congress did not leave to be determined in a ‘fair hearing’

conducted by the carrier—including challenges to the validity

of the Secretary’s instructions and regulations—are not

impliedly insulated from judicial review by... § 1395ff.""!

Id. (emphasis in original).

The Court also rejected the government’s argument that

the third sentence of § 405(h), as interpreted by Sa/fi and

Ringer, barred federal question jurisdiction over the family

physicians’ challenge to the Secretary’s regulation. It wrote:

Section 405(h) does not apply on its own terms to

Part B or the Medicare program, but is instead

incorporated mutatis mutandis by § 1395ii. The

legislative history of both the statute establishing

the Medicare program and the 1972 amendments

thereto provides specific evidence of Congress’

11. The Court also noted that the Act’s exhaustion requirement

could not apply to the family physicians’ challenge to the regulation

because “there is no hearing, and thus no administrative remedy, to

exhaust.” 476 U.S. at 673 n. 4, 106 S.Ct. 2133.

24a

Appendix A

intent to foreclose review only of “amount

determinations” —i.e., those “quite minor matters”

remitted finally and exclusively to adjudication

to private insurance carriers in a “fair hearing.”

By the same token, matters which Congress did

not delegate to private carriers, such as challenges

to the validity of the Secretary’s instructions and

regulations, are cognizable in courts of law.

Id. at 680, 106 S.Ct. 2133 (citations omitted)(emphasis in

original). Accordingly, the Court held that § 405(h) did not

prevent the district court from having federal question

jurisdiction over the family physicians’ complaint.

Michigan Academy created what came to be called

the “amount/methodology” distinction, under which

pre-enforcement challenges to the method by which Medicare

benefits were determined, rather than challenges to the actual

amount of the benefits, were not barred by § 405(h).

See John Aloysius Cogan, Jr., and Rodney A. Johnson,

Administrative Channeling Under the Medicare Act

Clarified: Illinois Council, Section 405(h), and the

Application of Congressional Intent, 9 Annals Health L. 125,

134 (2000). However, four months after Michigan Academy,

Congress amended the Medicare Act to authorize

administrative and judicial review of Part B claims meeting

certain amount-in-controversy thresholds for services

rendered on or after January |, 1987. The amendment

therefore effectively gave Part B claimants the same

administrative and judicial remedies Part A claimants had.

Id. As a result of the amendment, most courts considered

Michigan Academy a “dead letter,” and the “amount/

o a Ns re

25a

Appendix A

methodology” distinction was deemed to have been

extinguished by Congress. /d. (citations omitted).

This set the stage for the final case bearing on our

analysis, Shalala v. Illinois Council on Long Term Care, Inc.,

529 U.S. 1, 120 S.Ct. 1084, 146 L.Ed.2d 1 (2000). In //linois

Council, an association of nursing homes invoked the district

court’s federal question jurisdiction and sued the Secretary

claiming that certain Medicare health and safety regulations

violated various statutes as well as the Constitution.

The district court dismissed the suit for lack of jurisdiction,

holding that “‘a set of special statutory provisions creates a

separate, virtually exclusive, system of administrative and

judicial review of denials of Medicare claims; and it held

that one of those provisions [§ 405(h) ] explicitly barred a

§ 1331 suit.” 529 U.S. at 5, 120 S.Ct. 1084.

However, the court of appeals reversed and gave new

life to Michigan Academy. Illinois Council on Long Term

Care, Inc. v. Shalala, 143 F.3d 1072 (7th Cir.1998). It found

that Michigan Academy modified Salfi and Ringer by limiting

their scope to amount determinations rather than

pre- enforcement challenges. /d. at 1075-1076 (“As the Court

read § 1395ii and therefore § 405(h) in Michigan Academy,

pre-enforcement review of a regulation’s validity is not an

action to ‘recover on’ a claim, even when per Salfi a

constitutional objection to the regulation is a ‘claim arising

under this subchapter.’’’).

The Supreme Court, however, reversed the court of

appeals. The Court held, putting Michigan Academy aside

for the moment, that § 405(h), as interpreted by Sa/fi and

26a

Appendix A

Ringer, “would clearly bar this section 1331 lawsuit.” 529

U.S. at 11, 120 S.Ct. 1084. It wrote:

Despite the urging of the Council and supporting

amici, we cannot distinguish Sa/fi and Ringer from

the case before us. Those cases themselves

foreclose distinctions based upon the “potential

future” versus the “actual present” nature of the

claim, the “general legal” versus the “fact-

specific” nature of the challenge, the “collateral”

versus “noncollateral” nature of the issues, or the

“declaratory” versus “injunctive” nature of the

relief sought. Nor can we accept a distinction that

limits the scope of § 405(h) to claims for monetary

benefits. Claims for money, claims for other

benefits, claims for program eligibility, and claims

that contest a sanction or remedy may all similarly

rest upon individual fact-related circumstances,

may all similarly dispute agency policy

determinations, or may all similarly involve the

application, interpretation, or constitutionality of

interrelated regulations or statutory provisions.

There is no reason to distinguish among them in

terms of the language or in terms of the purposes

of § 405(h). Section 1395ii’s blanket incorporation

of that provision into the Medicare Act as a whole

certainly contains no such distinction. Nor for

similar reasons can we here limit those provisions

to claims that involve “amounts.”

Id. at 13-14, 120 S.Ct. 1084.

27a

Appendix A

The Court also explained the rationale underlying §

405(h). At the outset, it conceded that “[t]he scope of the

italicized language ‘to recover on any claim arising under’

the Social Security (or, as incorporated through § 1395ii, the

Medicare) Act, is, if read alone, uncertain.” Jd. at 10, 120

S.Ct. 1084. Nonetheless, the Court held that the meaning

and import of § 405(h) are clear in light of Salfi and Ringer.

It explained:

[T]he bar of § 405(h) reaches beyond ordinary

administrative law principles of “ripeness” and

“exhaustion of administrative remedies”—

doctrines that in any event normally require

channeling a legal challenge through the agency.

Insofar as § 405(h) prevents application of the

“ripeness” and “exhaustion” exceptions, i.e.,

insofar as it demands the “channeling” of

virtually all legal attacks through the agency, it

assures the agency greater opportunity to apply,

interpret, or revise policies, regulations, or statutes

without possibly premature interference by

different individual courts applying “ripeness” and

“exhaustion” exceptions case by case. But this

assurance comes at a price, namely, occasional

individual, delay-related hardship. In the context

of a massive, complex health and safety program

such as Medicare, embodied in hundreds of pages

of often interrelated regulations, any of which may

become the subject of a legal challenge in any of

several different courts, paying this price may

seem justified. In any event, such was the

28a

Appendix A

judgment of Congress as understood in Sa/fi and

Ringer.

Id. at 12-13, 120 S.Ct. 1084 (citations omitted) (emphasis

added).

The Court then discussed whether Michigan Academy

somehow modified Salfi and Ringer. The Court held that

Michigan Academy did not modify Salfi and Ringer “by

limiting the scope of [§] 139511 and therefore § 405(h) to

amount determinations.” Jd. at 15, 120 S.Ct. 1084 (internal

quotations omitted). The Court noted that Michigan Academy

involved a § 1331 challenge to regulations which, at the time,

were not administratively or judicially reviewable. Because

no administrative or judicial review of the regulations was

available, the Court in Michigan Academy allowed the family

physicians to mount a challenge directly in a court of law

under § 1331. Thus, the Court in /Ilinois Council seemed to

read Michigan Academy as creating an exception to the

channeling requirement of § 405(h) in those cases where no

judicial review is available at all. Jd. at 19, 120 S.Ct. 1084

(“[I]t is more plausible to read Michigan Academy as holding

that § 1395ii does not apply § 405(h) where application of

§ 405(h) would not simply channel review through the

agency, but would mean no review at all.”) (emphasis in

original).

12. In Jllinois Council, the Court noted that § 405(h) “demands

the ‘channeling’ of virtually all legal attacks through the agency.”

529 U.S. at 13, 120 S.Ct. 1084. Since Jilinois Council limited

Michigan Academy to those instances were there was no review

available at all, we assume that the Court’s use of the phrase “virtually

all legal attacks” is a specific reference to Michigan Academy.

ira aba Sear lk Oak al en BE Rae Ot a icy PRE, i

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eset 1 SEA A a ti ahs BE a et er Ah HEROES

29a

Appendix A

Our discussion of these four cases leads us back to the

question of whether the district court had federal question

jurisdiction over Fanning’s amended class action complaint

seeking to enjoin the government’s attempt to obtain

reimbursement of Medicare overpayments pursuant to the

secondary payer provisions of the MSP. We believe that Sa/fi,

Ringer and Illinois Council compel the conclusion that the

district court had no federal question jurisdiction.

The essence of the claim asserted in Fanning’s amended

class action complaint is that the government is not entitled

to recover Medicare overpayments from a fund created as a

result of a settlement with an alleged tortfeasor because

Congress never intended to treat a settlement trust fund as

payments from a primary insurer under the MSP. We believe

there may be force to Fanning’s argument. However, the

government’s basis for seeking MSP reimbursement from

the AcroMed settlement trust fund is that AcroMed 1s a “self-

insured plan” and is, therefore the primary payer under the

MSP. Accordingly, the claim asserted in the amended class

action complaint is wholly dependent upon determining

whether or not AcroMed is a “self-insured plan” and,

therefore, a “primary plan” under the MSP." It is thus

13. As noted, the statutory definition of “primary plan” includes

plans that are self-insured. 42 U.S.C. § 1395y(b)(2) (“the term

‘primary plan’ means... a workmen’s compensation law or plan, an

automobile or liability policy or plan (including a self-insured plan)

or no fault insurance.”). Under the regulations, a “plan” is defined

as “any arrangement, oral or written, by one or more entities, to

provide health benefits or medical care or assume legal liability for

injury or illness.” 42 C.F.R. § 411.21. The term “self-insured plan”

is defined as a “plan under which an individual, or a private or

(Cont’d)

30a

Appendix A

apparent that both the standing and the substantive basis for

the claim asserted in the amended class action complaint are

rooted in, and derived from, the Medicare Act. Consequently,

the claim is one “arising under” the Medicare Act and the

third sentence of § 405(h) therefore deprived the district court

of federal question jurisdiction. The AcroMed class

settlement plaintiffs are thus required by § 405(h), as

interpreted by Salfi, Ringer and Illinois Council, to channel

their claim through the agency.

Of course, the AcroMed class settlement plaintiffs would

not have to channel their claim through the agency if they

could avail themselves of the Michigan Academy exception.

That is to say, channeling would not be required if they could

show that they have no way of having their claims reviewed.

To that end, they do claim that there is no administrative

review of the agency’s demand for MSP reimbursement.

Therefore, they argue that a suit filed under the district court’s

(Cont’d)

governmental entity, carries its own risk instead of taking out

insurance with a carrier.” 42 C.F.R. § 411.50(b)(2). A “self-insured

plan” includes an “entity engaged in a business, trade or profession.”

Id.

Although it has no bearing on our decision, we note that the

government’s argument that a “self-insured plan” includes a fund

created by a tortfeasor to settle litigation has engendered a circuit

split. The Fifth Circuit, in Thompson v. Goetzmann, 315 F.3d 457,

470 & n. 65 (5th Cir.2002), opinion withdrawn and reissued as

amended on other grounds, 337 F.3d 489 (Sth Cir.2003), rejected

the government’s argument, while the Eleventh Circuit, in

United States v. Baxter Intern., Inc., 345 F.3d 866, 2003 WL

22120071 (11th Cir. Sept.15, 2003), accepted it.

3la

Appendix A

federal question jurisdiction is the only avenue available to

challenge the agency’s reimbursement demand.

However, the class members’ assertion of no

administrative review of the agency’s demand for MSP

reimbursement is plainly wrong. The letters sent to the

approximately 1,800 settlement class members clearly

advised them of the administrative process by which they

could appeal the agency’s determination or, in the alternative,

seek a waiver of Medicare’s claim for reimbursement.'4 More

importantly, the Medicare Manual sets out, at length, the

“procedures to be used in processing appeals of MSP liability

Overpayment and waiver determinations.” Medicare

Intermediary Manual, Part 3, § 3419.!5 Therefore, the

Michigan Academy exception is not available to the AcroMed

settlement class members.

In a further attempt to establish jurisdiction, the AcroMed

class settlement members argue that § 405(h) does not apply

14. The Medicare beneficiary may ask the Secretary to waive

recovery in full or in part. The Secretary may waive recovery when

the beneficiary was not at fault and recovery would defeat the

purposes of the Medicare Act or be against equity or good conscience.

See 42 U.S.C. § 1395gg(c). The regulations explain that the purposes

of the Medicare Act would be defeated if recovery would deprive a

person of income required for ordinary and necessary living expenses,

including medical expenses. See 42 C.ER. § 405.358; 20 CER.

§ 404.508(a). The Secretary’s waiver determination is subject to

administrative and judicial review. See 42 U.S.C. § 1395ff(b)(1);

42 C.F.R. §§ 405.704(b)(14), 405.720-730.

15. The pertinent Manual provisions are available at http://

cms.hhs.gov/manuals/13_int/a3toc.asp.

32a

Appendix A

because their complaint seeks neither a benefit determination

nor a review of benefit determinations, but is instead a

challenge to the right of Medicare to seek reimbursement of

alleged overpayments from a trust fund created as a result of

a settlement with a tortfeasor. We agree with that

characterization of the class members’ claim. However, under

Salfi, Ringer and Illinois Council, that distinction is

irrelevant. The appropriate inquiry is whether the Medicare

Act provides both the standing and the substantive basis for

their contentions. Clearly it does, because the dispositive

issue is whether AcroMed is a “self-insured plan” within the

meaning of the MSP.’®

The AcroMed class settlement plaintiffs next argue that

the agency’s demand letters to them is final agency action

from which they can seek judicial review. However, that

argument is without merit. The demand letters, although harsh

in their terms and probably unsettling to their recipients,

advised the class settlement plaintiffs of their administrative

“c*

review rights. Therefore, it is difficult to define them as final,

16. Moreover, we note, but do not decide, that a reasonable

argument can be made that the AcroMed class settlement members

are in fact seeking benefits. As the government says: “[P]laintiffs do

seek benefits: they are effectively seeking to require that Medicare

make primary, rather than secondary, payment for medical expenses

related to their settlement with AcroMed.” Government’s Br. at 25.

In addition, one court of appeals has held that a Medicare

beneficiary’s “claim that she is entitled to the overpayment is, in

essence, one for medicare benefits.” Buckner v. Heckler, 804 F.2d

258, 260 (4th Cir. 1986).

eine je = rat enn a NT .

33a

Appendix A

rather than initial, agency action.'’ Moreover, even if we

17. We are not unsympathetic to the class settlement counsel’s

consternation over the wording of the 1800 letters the government

sent out. Counsel claims that the language of the letters was intended

more to terrify than to inform, and that, to the extent they may have

served to inform, they succeeded only in misinforming large numbers

of the class because the amounts stated in the letters were frequently

erroneous. Although there has been no finding about the accuracy of

the amounts the government requested in those letters, we agree that

the wording of the letters was unnecessarily callous and threatening.

A typical example of one of these letters read as follows:

You must pay this amount ($11,833.44) within sixty (60)

days of the date of this letter (by July 9, 2001). Please

send a check or money order. ...

If you do not pay this amount by July 9, 2001, you will

be required to pay interest from the date of this letter.

Interest will be calculated at the rate of 13.75% per

annum in accordance with 42 C.F.R. 411.24(m). Interest

will continue to accrue until the debt is paid, whether or

not a waiver of recovery request or appeal is pending.

If you do not »ay this amount, the Medicare program

may recover amount from any Social Security or

Railroad Ret:.2ment benefits to which you might

otherwise be entitled, or the money may be recouped

from payments Medicare would otherwise pay you. Also,

please be aware that Medicare must refer delinquent

debts to the Department of Treasury for offset against

Federal payments that may be due or for other

appropriate collection actions.

JA 98 (emphasis in original).

(Cont’d)

34a

Appendix A

assume arguendo that the letter was final agency action,

judicial review of that final action is available only through

§ 405(g). Under the Medicare Act, there is no judicial review

of final agency action under the district court’s federal

question jurisdiction.'* Ringer, 466 U.S. at 614-615, 104S.Ct.

2013 (“The third sentence of 42 U.S.C. § 405(h), made

(Cont'd)

Although this language did inform class members, it no doubt

did much more; it had to have coerced and frightened them as well.

In fact, the coercive nature of this letter explains why one court

referred to the government’s “heavy-handed collection” tactics under

the MSP. In Re Dow Corning Corp., 250 B.R. 298, 336

(Bankr.E.D.Mich.2000). See also Waters v. Farmers Texas County

Mut. Ins. Co., 9 F.3d 397, 400-01 (Sth Cir.1993) (expressing

disappointment with “the government's overreaching interpretation

of its authority under the [MSP].”).

Although counsel for appellees here engages in some hyperbole

in referring to the government’s actions as “the apogee of a heavy-

handed, coercive, neo-Stalinist approach,” counsel’s outrage over

the threatening tone of the letters is not totally unjustified. See

Appellee’s Br. at 27. Although we would not go so far as to agree

that these letters were “neo-Stalinist” tactics, they are more suggestive

of tactics one might attribute to a less than reputable collection agency

rather than to one’s own government.

18. The AcroMed settlement class plaintiffs.also argue that the

district court had jurisdiction to review final agency action under

the judicial review provision of the Administrative Procedure Act,

5 U.S.C. § 706. However, that “provision is not an independent grant

of subject- matter jurisdiction.” Your Home Visiting Nurse Services,

Inc. v. Shalala, 525 U.S. 449, 457-58, 119 S.Ct. 930, 142 L.Ed.2d

919 (1999) (citing Califano v. Sanders, 430 U.S. 99, 97 S.Ct. 980

(1977)).

35a

Appendix A

applicable to the Medicare Act by 42 U.S.C. § 1395Sii,

provides that § 405(g), to the exclusion of 28 U.S.C. § 1331,

is the sole avenue for judicial review for all ‘claim[s] arising

under’ the Medicare Act.”) (emphasis added).

Ill. CONCLUSION

Thus, for the reasons set forth above, we find the

AcroMed settlement class plaintiffs’ claim that the

government cannot seek MSP reimbursement from the

settlement trust fund established by AcroMed is a “claim

arising under” the Medicare Act. Therefore, Section 405(h)

of the Social Security Act, made applicable to the Medicare

Act by 42 U.S.C. § 1395ii, precluded the district court from

having federal question jurisdiction over Fanning’s amended

class action complaint. Consequently, we will reverse the

district court and remand with instruction to dismiss the

amended class action complaint.

36a

APPENDIX B — MEMORANDUM AND PRETRIAL

ORDER NO. 2000 OF THE UNITED STATES

DISTRICT COURT FOR THE EASTERN DISTRICT

OF PENNSYLVANIA DATED JUNE 239, 2001

UNITED STATES DISTRICT COURT

E.D. PENNSYLVANIA

MDL No. 1014

Civ.A. Nos. 01-1029, 97-381.

In re ORTHOPEDIC BONE SCREW PRODUCTS

LIABILITY LITIGATION.

Daniel C. Fanning

v.

United States of America, et al.

Fanning, et al.

v.

AcroMed Corporation, et al. and All Actions.

MEMORANDUM AND PRETRIAL ORDER NO. 2000

BECHTLE, District Judge.

Presently before the court are plaintiff Daniel C.

Fanning’s motions for class certification and for preliminary

37a

Appendix B

injunction and defendant the United States of America,

et al. s motion to dismiss the Amended Complaint in 01-cv-

1029 (“Fanning IT’); plaintiff Fanning, et a/. 5 (“‘Plaintiffs’’)

motion to require distribution of the settlement proceeds in

97-cv-381 (“Fanning I’); the oppositions and responses

thereto; and the exhibits and testimony received by the court

at a consolidated hearing on the motions held on June 6,

2001. For the reasons set forth below, the motions for class

certification, for preliminary injunction and for distribution

of the settlement proceeds will be granted, and the motion to

dismiss will be granted in part and denied in part.

I. BACKGROUND

In August 1994, the Judicial Panel on Multidistrict

Litigation transferred all cases pending in federal trial courts

against manufacturers of orthopedic bone screws, including

AcroMed Corporation (“AcroMed”), to this court for pretrial

purposes under 28 U.S.C. § 1407. On October 17, 1997, the

court issued a Final Order and Judgment approving a limited

fund class action settlement between Plaintiffs and AcroMed

and certifying a settlement class. Jn re Orthopedic Bone

Screw Prods. Liab. Litig., 176 F.R.D. 158 (E.D.Pa.1997)

(“In re Bone Screw’). Pursuant to the terms of the

settlement agreement, AcroMed placed $100 million into an

interest-bearing fund (the “AcroMed Settlement Fund’’).'

Id. at 165-66.

1. The court incorporates by reference /n re Orthopedic Bone

Screw Prods. Liab. Litig., 176 F.R.D. 158 (E.D.Pa.1997) which

contains, inter alia, a description of the course of this litigation.

38a

Appendix B

In April 1997, defendant the United States of America,

et al. (the “Government”) first asserted its right to recover

costs expended by its constituent agencies under the Medicare

Secondary Payer statute, 42 U.S.C. § 1395y (“MSP”) and

the Medical Care Recovery Act, 42 U.S.C. § 2651-53

(“MCRA”). (P-5 at 3-8; United States’ Statement of

Interest at 1.) Today, the Government’s claims continue to

contribute to delay in the distribution of settlement proceeds.’

On March 1, 2001, Plaintiffs filed a motion to require

distribution of the settlement proceeds without regard to the

Government’s claims in Fanning I. That same day, plaintiff

Daniel C. Fanning brought suit against the Government in

Fanning II, asserting that the Government had no right on

account of the AcroMed settlement to recover payments

previously made by any Government agency to class members

and seeking to enjoin the Government from attempting such

recovery from class members.*

2. For example, in what turned out to be a disappointing

extension of cooperation by the settled parties and the claims

administrator, the Government was given a complete list of class

members from which to identify and quantify its claims. On numerous

occasions between the summer of 1999 and the present, the

Government was provided with computer databases with information

concerning registered class members. (P-6 at 4-5.) Not until December

2000, however, did the Government make its first specific demand

for payment to settle all of its Medicare related claims. This delay

resulted from the Government having taken eight months to extract

data concerning beneficiaries from its National Database, four months

to filter out non-bone screw and otherwise irrelevant expenditures,

and additional time to more accurately estimate its claims.

3. Fanning filed an Amended Complaint on June 22, 2001.

Lan Kime Us

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AD aie TBE

Ot ee at ia ihe Rt a aS

SIL SEAS PO ne en

39a

Appendix B

On May 7, 2001, following the filing of the Complaint

in Fanning II, the Health Care Financing Administration

(“HCFA”) sent letters to approximately 1,800 Medicare

beneficiaries in the AcroMed Settlement Class, demanding

repayment for amounts that Medicare allegedly furnished in

relation to injuries that were the subject of the tort claims

against AcroMed.‘ In pertinent part, the demand letters stated:

Medicare has determined that you are required to

reimburse the Medicare program [a specified sum]

for amounts it paid for items or services relating

to your orthopedic bone screw settlement with

AcroMed Corporation. Federal law requires

Medicare beneficiaries who obtain a liability

recovery to repay the United States the amount

the Medicare program paid for conditions related

to that recovery. ...

You must pay this amount within sixty (60)

days of the date of this letter (by July 9, 2001). ...

If you do not pay this amount by July 9, 2001,

you will be required to pay interest from the date

of this letter. Interest will be calculated at the rate

of 13.75% per annum in accordance with

42 C.F.R. 411.24(m). Interest will continue to

4. It is not contested that HCFA did not provide class members

with notice of the reimbursement claim prior to its demand for

payment or an opportunity to demonstrate that there was no

reimbursement liability because, for example, Medicare paid for

services that were unrelated to any injury allegedly caused by

AcroMed. (P-11 & Exs. 1-30.)

40a

Appendix B

accrue until the debt is paid, whether or not a

waiver of recovery request or appeal is pending-

If you do not pay this amount, the Medicare

program may recover the amount from any Social

Security or Railroad Retirement benefits to which

you might otherwise be entitled, or the money may

be recouped from payments Medicare would

otherwise pay you.

(Pl.’s Mem. of Law in Opp’n to Defs.’ Mot. to Dismiss and

in Supp. of Pl.’s Mots. 1) to Am.Compl.; 2) for Class Cert.;

3) for Summ.J. Including Final Declaratory and Injunctive

Relief and 4) for T.R.O. and/or Prelim. Inj. (“P1.’s Opp’n’”’)

Ex. F.) In the Amended Complaint, Fanning asserts, inter

alia, that the Government’s demand, made pursuant to the

MSP, is contrary to law, arbitrary and capricious, and violates

the Constitutional rights of class members to procedural due

process. (Am.Compl.f¥ 24-54.)

Il. DISCUSSION

Plaintiff Daniel C. Fanning seeks class certification and

a preliminary injunction in Fanning II, whereas defendant

the United States of America, et al. seeks dismissal of the

Amended Complaint. In addition, plaintiff Fanning, et al.

seeks an order requiring distribution of the settlement

proceeds in Fanning I.

The court will first discuss the motions for class

certification and for preliminary injunction. Then, the court

will discuss the motion to dismiss. Finally, the court will

wp einem

4ia

Appendix B

discuss the motion to require distribution of the settlement

proceeds.

A. Class Certification

To certify a class, the court must first find that: 1) the

class is so numerous that joinder of all members is

impracticable; 2) there are questions of law or fact common

to the class; 3) the claims or defenses of the representative

parties are typical of the claims or defenses of the class; and

4) the representative parties will fairly and adequately protect

the interests of the class. Fed.R .Civ.P. 23(a).

If the requirements of Rule 23(a) are satisfied, the parties

must then establish that the suit fits within one of three

categories of Rule 23(b). /n re Bone Screw, 176 F.R.D. at

172 (citing Weiss v. York Hosp., 745 F.2d 786, 807

(3d Cir.1984)). Fanning seeks certification pursuant to

Rule 23(b)(2), under which “the party opposing the class has

acted or refused to act on grounds generally applicable to

the class, thereby making appropriate final injunctive relief

with respect to the class as a whole.” For the reasons

discussed below, the court finds that the suit fits within the

requirements of Rule 23(a) and Rule 23(b)(2).

1. Numerosity

Rule 23(a)(1) permits class action treatment where

“the class is so numerous that joinder of all members is

impracticable.” Fed.R.Civ.P. 23(a)(1). There are no specific

standards regarding class size and it is not necessary for a

plaintiff to allege the exact number of class members to

42a

Appendix B

satisfy the numerosity requirement. /n re Bone Screw, 176

F.R.D. at 173 (citation omitted).

To date, 1,800 class members have received demand

letters from HCFA.° Thus, the numerosity prerequisite to class

certification is satisfied. See H. Newberg, 1 Newberg on Class

Actions § 3.05 at 3-25 (3d ed.1992) (stating that “in light of

prevailing precedent, the difficulty inherent in joining as few

as 40 class members should raise a presumption that joinder

is impracticable, and the plaintiff whose class is that large or

larger should meet the test of Rule 23(a)(1) on that fact

alone”). The court finds that the joinder of that many

individuals in various geographic areas clearly would be

impracticable. Thus, Rule 23(a)(1)’s numerosity requirement

is satisfied.

2. Commonality

The next prerequisite for class certification is that there

be “questions of law or fact common to the class.”

Fed.R.Civ.P. 23(a)(2). Not every question of law or fact need

be common to every member of the class: “[i]ndeed, a single

common question is sufficient to satisfy Rule 23(a)(2).” Jn

re Bone Screw, 176 F.R.D. at 173 (citations omitted).

Here, the common question is whether Medicare

beneficiaries who obtain recovery from the settlement of tort

litigation are obliged to repay the amounts that the

Government paid for conditions related to that recovery under

the MSP. This central issue is common to all class members.

5. The Government has expressed an intention to send additional

letters.

43a

Appendix B

The court finds that the existence of this common legal

question satisfies the commonality requirement of Rule

23(a)(2).

3. Typicality

The third prerequisite to Rule 23(a)(3) class certification

requires that “the claims or defenses of the representative

parties are typical of the claims or defenses of the class.”

Fed.R.Civ.P. 23(a)(3). Claims qualify as typical where

“litigation of the named plaintiffs’ personal claims can

reasonably be expected to advance the interests of absent

class members.” Jn re Bone Screw, 176 F.R.D. at 175 (citation

omitted). Typicality derives from a strong similarity of legal

theories and is present where the class representative’s claims

and those of the class members arise from the same alleged

course of conduct by the defendant. Jn re Prudential Ins.

Co. of Am. Sales Practices Litig., 148 F.3d 283, 311 (3d

Cir.1998), cert. denied, 525 U.S. 1114, 119 S.Ct. 890, 142

L.Ed.2d 789 (1999).

In the proposed class before the court, the legal theory

is typical of the entire class and the same Government conduct

is at issue. The Government sent substantially identical letters

to approximately 1,800 Medicare beneficiaries in the

AcroMed Settlement Class. These letters demand repayment

for amounts that Medicare allegedly furnished in relation to

the injuries that were the subject of the tort claims against

AcroMed. The letters contend that the MSP authorizes the

Government to recover Medicare costs from the proceeds of

a tort settlement. Thus, the court concludes that there is an

44a

Appendix B

identity of interest of all class members and that Rule

23(a)(3)’s typicality requirement is satisfied.

4. Adequacy of Representation

Rule 23(a)’s final prerequisite is that “the representative

parties will fairly and adequately protect the interests of the

class.” Fed.R.Civ.P. 23(a)(4). The question of adequacy of

representation has two components. “First, the adequacy of

representation inquiry tests the qualifications of the counsel

to represent the class. Second, it serves to uncover conflicts

of interest between named parties and the class they seek to

represent.” Jn re Prudential, 148 F.3d at 312 (citations and

internal quotations omitted). The court finds that both class

counsel and the named plaintiffs satisfy these tests.

With respect to class counsel, the Government does not

challenge the qualifications of counsel to represent the class.

(Fed. Defs.’ Opp’n to Pl.’s Am.Mot. for Class Cert. at 10

n.9.) Further, the court has previously determined that

plaintiffs’ counsel are highly competent and experienced class

action attorneys who have pursued the interests of the class

vigorously. Jn re Bone Screw, 176 F.R.D. at 176.

With respect to the class representative, the Government

asserts that Fanning does not adequately represent the class

as he “seeks to deny” and “purports to . . . abandon all waiver

and appeal rights for every putative class member who

received a demand letter from HCFA.” (Federal Defs.’ Opp’n

to Pl.’s Mot. for Class Certification at 13-14.) However, as

stated at the hearing, class members’ waiver rights are

adequately preserved. The Government also contends that

45a

Appendix B

Fanning does not adequately represent the class because

Medicare’s reimbursement demand against him, totaling

$8.71, is “de minimus.” (Federal Defs.” Opp’n to PI.’s

Am.Mot. for Class Cert. at 12.) However, as the Government

recognizes, the size of a representative plaintiff’s claim

“is not determinative as to whether the plaintiff will fairly

and adequately protect the interests of the class.” Denny v.

Carey, 73 F.R.D. 654, 657 (E.D.Pa.1977) (citations omitted).

The court finds that the interest of the named plaintiff is

sufficiently aligned with those of the absentees and that there

are no disparate interests to impair Fanning’s incentive to

prosecute fully all aspects of the claim against the

Government.

5. Rule 23(b)(2)

Under Rule 23(b)(2), class certification 1s appropriate

where “the party opposing the class has acted or refused to

act on grounds generally applicable to the class, thereby

making appropriate final injunctive relief with respect to the

class as a whole.” Fed.R.Civ.P. 23(b)(2).

Here, class members seek an injunction because

the Government has sent virtually identical letters to

Medicare beneficiaries, demanding immediate payment.

The Government bases its identical action against class

members upon its assertion that the MSP authorizes it to

recover the costs of medical care from the proceeds of the

tort litigation.

Thus, the court finds not only that Rule 23(a)’s

requirements are met but also that the suit fits within the

46a

Appendix B

requirements of Rule 23(b)(2). Accordingly, it will certify a

class on behalf of:

All persons who are members of the AcroMed

Settlement Class (as defined in Pretrial Order 1117

entered in MDL 1014) and who, as a result of the

Class Action Settlement Agreement with AcroMed

Corporation, are subject to any Medicare-related

claim, brought pursuant to the Medicare

Secondary Payer statute, 42 U.S.C. § 1395y, or

otherwise, by any of the defendants herein, except

nominal defendants Robert E. Welsh, Jr. and PNC

Bank, N.A., for reimbursement of the cost of

medical care allegedly paid for or provided to

them by any such defendant.

B. Preliminary Injunction

Fanning next seeks an injunction to enjoin the

Government from attempting recovery from class members

for amounts Medicare allegedly furnished in relation to

injuries that were the subject of the tort claims against

AcroMed.

To obtain a preliminary injunction, the moving party

must show both: the likelihood of irreparable harm without

the relief sought; and a reasonable likelihood of ultimate

success on the merits. See Adams v. Freedom Forge Corp.,

204 F.3d 475, 484 (3d Cir.2000) (setting forth standard for

preliminary injunctive relief). The court also considers the

likelihood of irreparable harm to the non-moving party and

whether equitable relief will serve the public interest. /d.

47a

Appendix B

1. Irreparable Harm and the Public Interest

In considering whether to grant a preliminary injunction,

the court first considers the likelihood of irreparable harm

without the relief sought. “The irreparable harm requirement

is met if a plaintiff demonstrates a significant risk that he or

she will experience harm that cannot adequately be

compensated after the fact by monetary damages.” Adams,

204 F.3d at 484.

Pursuant to the demand letters, when a class member

does not or cannot pay Medicare the amount the Government

demands by July 9, 2001, Medicare may recover the amount

from any Social Security or Railroad Retirement benefits to

which the class member would otherwise be entitled.

(Am.Compl.Ex. B. at 2.) The money may also be recouped

from payments to the class member that Medicare would

otherwise have made. /d. Finally, interest on the class

member’s debt will accrue at a rate of 13.75% until it is paid,

and Medicare will refer delinquent debts to the Department

of the Treasury for offset against Federal payments that may

be due or for other collection actions. Jd.

Although the loss of income alone may not necessarily

constitute irreparable harm, in this case, class members would

suffer far more than mere economic loss. The statutory

scheme at issue in this case was enacted to benefit the aged

and the disabled. Class members generally receive Medicare

and Social Security benefits and cannot work because they

have been disabled by spinal disorders unsuccessfully treated

with spinal fixation devices. Thus, they are dependant on

Medicare and Social Security to provide ongoing medical

48a

Appendix B

care 1n addition to basic necessities.° Pursuant to the demand

letters, Medicare may recover the amount demanded from

Social Security or Railroad Retirement benefits to which the

class member would otherwise be entitled, and may recoup

the amount from payments that Medicare would otherwise

make. No compensatory or other corrective relief at a later

date will adequately redress such potential harm. Accordingly,

the court finds that the Goveriment’s demands threaten to

inflict far more than mere economic loss and that the class

members have established the likelihood of irreparable harm.

The court next considers the likelihood of irreparable

harm to the non-moving party. The Government asserts that

granting an injunction would interfere with the Secretary of

Health and Human Service’s’ delegated responsibilities to

make decisions regarding the amounts of benefits payable

on a beneficiary’s behalf. (Federal Defs.’ Opp’n to P1.’s Mot.

for Class Cert. at 35-36.) It also contends that the public has

a strong interest in ensuring that Medicare monies are

reimbursed. /d.

6. The court notes that, in addition to the testimony heard from

individual class members who attended the June 6, 2001 hearing,

it has received numerous phone calls from class members calling to

express their concerns regarding the Government’s actions in

this matter.

7. Medicare is administered by the Health Care Financing

Administration (the “HCFA”), on behalf of the Secretary of the

Department of Health and Human Services (the “Secretary”), who is

ultimately responsible for the administration of Medicare. 42 U.S.C.

§ 1395kk(a); Universal Health Servs. of McAllen, Inc. v. Sullivan,

770 F.Supp. 704, 707 (D.D.C.1991), aff’d, 978 F.2d 745

(D.C.Cir.1992).

49a

Appendix B

The court finds that the Government’s asserted interests

do not weigh strongly against an injunction. The Government

makes no attempt to support its vague, generalized allegation

of irreparable harm. Certainly, it has an interest in maintaining

the integrity of the Medicare program, and it is not contested

that the MSP was designed to further the public interest by

facilitating the recoupment of certain Medicare expenditures

for items or services that Congress has decided are more

appropriately paid for by certain other persons or entities.

Nonetheless, the court fails to see how enjoining the

Government from demanding amounts that class members

received under the AcroMed Settlement Agreement would

interfere with the operation of the Medicare program.

Lastly, the court finds that the public has a significant

interest in the efficient resolution of this mass tort litigation.

Significant public funds have been expended by virtue of

the court’s administration of \his litigation. Further delay in

the distribution of settlement proc.eds will not only cast

doubt on the viability of the judicial system for efficiently

resolving mass tort litigation, but also cause »ynmediate and

irreparable injury to the class. Thus, the cwurt finds that

equitable relief will serve the public interest.

2. Likelihood of Success on the Merits

The Government’s assertion that it is entitled to

reimbursement from the AcroMed Settlement Fund and/or

from Settlement beneficiaries, for amounts that the

Government paid to those beneficiaries for conditions related

to their settled claims, is based on the MSP, 42 U:S.C.

§ 1395y.

50a

Appendix B

The MSP consists of a series of amendments to Medicare

that grant the Government a statutory right to recover certain

Medicare expenditures, creating a direct cause of action in

favor of the Government that is enforceable through judicial

action. Jn re Diet Drugs Prods. Liab. Litig., No. 99-20593,

2001 WL 2 3163, at *9 (E.D.Pa. Mar. 21, 2001) (citing

Health Ins. Ass'n of Am. v. Shalala, 23 F.3d 412, 425

(D.C.Cir.1994)).8 The statute makes Medicare a “secondary”

payer where another entity, a “primary payer” is required to

pay under a “primary plan” for an individual’s healthcare.

42 U.S.C. § 1395y(b)(2); In re Diet Drugs, 2001 WL 283163,

at *9: United States v. Philip Morris, Inc., 116 F.Supp.2d

131, 145 (D.D.C.2000). If the Government, as secondary

payer, makes a payment for which a primary plan is

responsible, the payment is conditioned on reimbursement

from the primary payer. 42 U.S.C. § 1395y(b)(2)(B)(i). The

MSP grants the Government a cause of action against the

primary payer, or any person who has received payment

therefrom, for reimbursement of those payments or double

damages.° Jd. § 1395y(b)(2)(B)(ii).

8. The court hereby incorporates by reference its reasoning Jn

re Diet Drugs Prods. Liab. Litig., No. 99-20593, 2001 WL 283163

(E.D.Pa. Mar. 21, 2001), which discusses the MSP.

9. Specifically, the MSP states that:

[i]n order to recover payment under this subchapter for

such an item or service, the United States may bring an

action against any entity which is required or responsible

_. . to make payment with respect to such item or service

... under a primary plan (and may ... collect double

damages against that entity), or against any other entity

(Cont’d)

at Wh cea hae tae

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Sla

Appendix B

The MSP defines a “primary plan” as “a group health

plan or large group health plan, ... a workman’s

compensation law or plan, an automobile or liability

insurance policy or plan (including a self-insured plan) or

no fault insurance ...” under which payment for medical

care “has been made or can reasonably be expected to be

made promptly.” 42 U.S.C. § 1395y(b)(2)(A); Jn re Diet

Drugs, 2001 WL 283163, at *9. “Promptly” is defined as

“payment within 120 days after receipt of the claim.”

42 C.F.R. § 411.21.

The Government states that it is entitled to recover

payments made to Medicare beneficiaries who are also

members of the AcroMed Settlement Class because AcroMed

is a “self-insurer” obligated to reimburse the Government

for Medicare expenditures by the plain terms of the MSP.

According to the Government, an entity that enters a liability

settlement for alleged tortious conduct and funds that

settlement with its own assets or borrowings is a “self-insured

plan” that qualifies as a “primary plan.” Further, the

(Cont'd)

(including any physician or provider) that has received

payment from that entity with respect to the item or

service, and may join or intervene in any action related

to the events that gave rise to the need for the ite 1 or

service. ...

42 U.S.C. § 1395y(b)(2)(B)(11). The MSP further provides that the

Government “shall be subrogated ... to any right under this

subsection of an individual or any other entity to payment

with respect to such item or service under a primary plan.”

Id. § 1395y(b)(2)(B)(i11).

52a

Appendix B

Government asserts that the situations in which the MSP

makes Medicare a secondary payer entitled to reimbursement

are not limited to payments for items or services for which

another party has made prompt payment or can reasonably

be expected to pay promptly. Lastly, the Government argues

that its interpretation of the MSP is entitled to deference under

Chevron U.S.A., Inc. v. Natural Resources Defense Council,

Inc., 467 U.S. 837, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984).

The Government’s argument fails as a matter of law

because: the term “‘self- insurer” as used in the MSP was not

meant to encompass alleged tortfeasors who merely fund

liability settlements with their own assets or corporate

borrowings; and the MSP makes a Government payment

conditional, and thus subject to reimbursement, only where

the insurance entity has made prompt payment or can

reasonably be expected to make prompt payment for costs

related to the federal beneficiary’s medical treatment.

The court will first address whether the Government’s

interpretation of the MSP is entitled to deference under

Chevron, and then address the parties’ arguments regarding

whether the AcroMed Settlement Trust or AcroMed itself is

a “self-insured plan” qualifying as a “primary plan” obligated

by the MSP to reimburse the Government.

a. Whether Deference is Due

As an initial matter, contrary to the Government's

contention, its interpretation of the MSP is not entitled to

deference under Chevron. See Chevron, 467 U.S. at 844-45,

104 S.Ct. 2778 (holding that court must give effect to agency

regulation containing a reasonable interpretation of

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53a

Appendix B

ambiguous statute). Agency opinions that are not arrived at

after a formal adjudication, notice-and-comment rulemaking,

or otherwise in the exercise of congressionally delegated

rulemaking authority—such as interpretations in the instant

demand letters, as well as interpretations in legal briefs,

opinion letters, policy statements, agency manuals, and

enforcement guidelines, all of which lack the force of law—

do not warrant deference under Chevron. See, e.g., United

States v. Mead Corp., __ U.S. _., 121 S.Ct. 2164, 150

L.Ed.2d 292 (2001) (holding that tariff classification rulings

in individual cases by United States Customs Service are

not entitled to Chevron deference)'®; Christensen v. Harris

County, 529 U.S. 576, 587, 120 S.Ct. 1655, 146 L.Ed.2d 621

(2000) (holding that interpretation in opinion letter not

entitled to deference) (citations omitted); Martin v.—

Occupational Safety and Health Review Comm'n, 499 U.S.

144, 157, 111 S.Ct. 1171, 113 L.Ed.2d 117 (1991) (stating

that interpretative rules and enforcement guidelines are

“not entitled to the same deference as norms that derive from

10. Mead Corp. was decided twelve days after the June 6, 2001

hearing regarding the instant motions. The parties have not submitted

supplemental papers addressing the decision, and the deference issue

has not been extensively briefed or argued by any of the parties.

There is no indication here that the Government’s interpretation

was arrived at through HCFA’s congressionally delegated rulemaking

authority. See, e.g., Mead Corp., _ U.S. __, 121 S.Ct. 2164, 150

L.Ed.2d 292 (concluding that no deference was due to U.S. Customs

Service’s tariff classification rulings where there was no indication

that agency “ever set out with lawmaking pretense in mind” when it

made such rulings). Even if it had been and deference was due, the

Government's interpretation is clearly unsupportable for the reasons

discussed infra.

S4a

Appendix B

the exercise of. . . delegated lawmaking powers”); Bowen v.

Georgetown Univ. Hosp., 488 UsS. 294, 212-213, 109 S.Ct.

468, 102 L.Ed.2d 493 (1988) (exhibiting Court’s near

indifference to interpretation advanced for first time in

litigation brief). Rather, such interpretations are entitled to

respect only to the extent that they have the power to

persuade. Mead Corp., _ U.S. _,, 121 S.Ct. 2164, 150

L.Ed.2d 292 (citing Skidmore v. Swift & Co., 323 U.S. 134,

140, 65 S.Ct. 161, 89 L.Ed. 124 (1944)); Christensen, 529

U.S. at 587, 120 S.Ct. 1655. For the reasons set forth below,

the court finds the Government’s interpretation of the MSP

entirely unpersuasive. See In re Dow Corning Corp., 250

B.R. 298, 336 n. 21 (Bankr.E.D.Mich.2000) (stating that

Government’s statutory construction is “entirely unsupported

by the statute” and appears to be intended to convert MSP

from sensible fiscal cost-cutting measure into heavy-handed

collection tool).

b. “Self-Insured Plan” Under the MSP

The Government notes that under the Health Care

Financing Administration’s (“HCFA”) regulations, a ““‘self-

insured plan’ .. . ‘means a plan under which an individual,

or a private or governmental entity, carries its own risk instead

of taking out insurance with a carrier.’” See Federal Defs.’

Opp’n to Pl.’s Mot. for T.R.O. and/or Prelim. Inj. (“Opp’n

to Mot. for T.R.O.”) at 28 (quoting 42 C.F.R. § 411.50(b)).

It further points out that a “self-insured plan” includes an

“entity engaged in a business, trade or profession.” Id.

(quoting 42 C.F.R. § 411.50(b)). HCFA regulations define a

“plan” as “any arrangement, oral or written, by one or more

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55a

Appendix B

entities, to provide health benefits or medical care or assume

legal liability for injury or illness.” 42 C.F.R. § 411.21.

From these provisions, the Government concludes that

an entity that enters a liability insurance settlement, 1.e., an

arrangement in which an entity that has chosen to carry its

own risk agrees to assume legal liability for injury or illness,

is a self-insured plan under the MSP. (Opp’n to Mot. for

T.R.O. at 29-30.) For the following reasons, however, the

Government cannot establish that AcroMed or the AcroMed

Settlement Fund are “self-insured plans” as defined by the

MSP.

First, the HCFA itself, the entity charged with

administering Medicare and that promulgated the regulations

to which the Government cites, has indicated that:

the mere absence of insurance purchased from a

carrier does not necessarily constitute a ‘plan’ of

self-insurance. If ... the absence of insurance

purchased from a carrier does not constitute a

‘self-insured plan’ in a particular case, HCFA will

not attempt to recover its payments from the entity

that lacks insurance coverage.

54 Fed.Reg. 41727 (Oct. 11, 1989) (responding to comment

that regulations should clarify whether Medicare is primary

payer when presumed tortfeasor has no liability insurance).

Thus, the scope of entities that fall within the definition of a

“self-insured plan” clearly does not encompass all entities

that make payments, independent of any liability insurance

56a

Appendix B

coverage, potentially related to conditions for which

Medicare has made payment.

Second, there is simply no basis to conclude that

Congress intended the MSP to create in the Government a

right to recover from alleged tortfeasors for injuries resulting

in Medicare payments. Jn re Diet Drugs, 2001 WL 283163,

at. Unlike the MCRA, the MSP does not mention a right by

the Government to recover from a tortfeasor. Jd. Rather, the

express wording of the statute creates a cause of action only

against insurers and their payees. /d.; see United States v.

Rhode Island Insurers’ Insolvency Fund, 80 F.3d 616, 622

n.5 (Ist Cir.1996) (stating that MSP “limits rembursement

to recoveries from ‘primary plans,’ whose definition lists only

entities which are clearly ‘within’ the insurance industry”);

Philip Morris, Inc., 116 F.Supp.2d at 146 & n.22 (dismissing

MSP claim against defendants who clearly were not insurance

entities and noting that courts have uniformly recognized that

statute’s clear purpose was to grant Government right to

recover Medicare costs from insurers) (citations omitted);

Dow Corning, 250 B.R. at 337 n.22 (stating that unless

alleged tortfeasor qualifies as primary plan or received

payment from primary plan, MSP does not grant right to

initiate direct action against it); see also Health Ins. Ass'n,

23 F.3d at 427 n.* (stating that MSP “plainly intends to allow

recovery only from an insurer”) (Henderson, J., concurring).

Under the Government’s construction of the statute, every

tortfeasor that used its general assets to fund a tort settlement

with persons who had received federal health care benefits

would be potentially liable under the MSP. Jn re Diet Drugs,

2001 WL 283163, at *10. There is absolutely no legal support

for this extremely broad construction of the statute. /d. The

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court’s conclusion is bolstered by the fact that up until the

recent Philip Morris and Dow Corning cases, the case law is

devoid of any instances in which the Government attempted

to sue a tortfeasor under the MSP, despite the fact that the

statute had been in existence for twenty years. Philip Morris,

116 F.Supp.2d at 146 n. 22. As noted by this court in Jn re

Diet Drugs and by Judge Kessler in Philip Morris, “ ‘it is

clear that Congress did not intend MSP to be used as an across

the board procedural vehicle for suing tortfeasors.’ “ Jn re

Diet Drugs, 2001 WL 283163, at *10 (quoting Philip Morris,

116 F.Supp.2d at 135).

Lastly, the Government asserts that HCFA’s regulation

in 42 C.F.R. § 411-50(b) clarifies that the Government has

an MSP claim with respect to monies paid by a tortfeasor.

That provision states in relevant part that a “[lJiability

insurance payment” subject to the MSP “means a payment

by a liability insurer, or an out-of-pocket payment, including

a payment to cover a deductible required by a liability

insurance policy, by an individual or other entity that carries

liability insurance, or is covered by a self-insured plan.”

42 C.F.R. § 411.50(b). The Government’s argument, however,

fails to account for the repeated use of the word “plan”

throughout the MSP and regulations promulgated thereunder,

including the regulation it cites. See 42 C.F.R. § 411.50(b)

(defining self-insured plan as “plan” under which entity

carries its own risk, including “‘plan” of business entity).

The plain meaning of the term “self-insured plan” and

the statutory context in which that term is used indicate that

it does not include tortfeasors that merely have the ability

to, and do in fact, fund a settlement of a tort suit with general

58a

Appendix B

assets of the company or corporate borrowings. /n re Diet

Drugs, 2001 WL 283163, at *10. The statute’s requirement

of the existence of a primary “plan” connotes some type of

formal arrangement by which an entity consciously

undertakes to set aside funds to cover potential future

liabilities and a formal procedure for processing claims made

against that fund pursuant to the terms of the “plan.” Jn re

Diet Drugs, 2001 WL 283163, at *10; see Moore v.

Warehouse Club, Inc., 992 F.2d 27, 29 (3d Cir. 1993) (stating

that, as a matter of statutory construction, words “will be

interpreted as taking their ordinary, contemporary, common

meaning”). For example, a leading treatise on the subject of

insurance states that:

... to meet the conceptual definition of self-

insurance, an entity would have to engage in the

same sorts of underwriting procedures that

insurance companies employ; estimating likely

losses during the period, setting up a mechanism

for creating sufficient reserves to meet those losses

as they occur, and, usually, arranging for

commercial insurance for losses in excess of some

stated amount.

1 Couch on Insurance 10:1 (citing, as an example, IBM’s

historical self- insurance of employee health benefits);

see Alderson v. Ins. Co. of N. Am., 223 Cal.App.3d 397, 407,

273 Cal.Rptr. 7 (1990) (noting that it is implicit in term

“self-insurer” that such entity maintains reserve, to cover

possible losses, from which it pays out valid claims and that

self-insurer has procedure for considering such claims and

managing reserve); see also In re Diet Drugs, 2001 WL

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Appendix B

283163, at *10-11 (concluding that settlement trust funded

by alleged tortfeasor’s own funds does not constitute “self-

insured plan” for purposes of MSP) (citations omitted); Dow

Corning, 250 B.R. at 339 (stating that “[ w]e are dubious that

the term ‘self-insured plan’ covers or was meant to cover

every tortfeasor who fails to obtain insurance’’) (citations

omitted). HCFA’s definitions of a “self-insurer” and a “plan”

are not to the contrary. 42 C.F.R. §§ 411.21 & 411.50(b).

Thus, it is doubtful that the Government can maintain a cause

of action against AcroMed, the AcroMed Settlement Fund

or class members simply by virtue of the fact that AcroMed

funded the Settlement with its own funds or corporate

borrowings rather than those of a liability insurer.

Furthermore, the Government has proffered no evidence, and

has not even alleged, that AcroMed maintains such a formal

plan of self-insurance in order to cover possible losses.

Given the plain language of the MSP, its legislative

history, the case law interpreting it and the absence of any

reported decision in which the Government has prevailed

under MSP against an entity that was clearly outside of the

insurance industry, the court concludes that the Government’s

MSP cause of action arises when the “primary plan” is

obligated to pay for the primary care at issue under a contract

of insurance or other formal insurer-insured relationship, not

when the payment obligation arises out of tort litigation.'!

11. When pursuing MSP reimbursement in the context of a

formal plan of self-insurance, the Government could point to the

terms of the plan to support its demand for reimbursement, regardless

of whether or not the federal beneficiary made a claim against the

plan. However, in the context of an alleged tortfeasor, if the

(Cont'd)

60a

Appendix B

See In re Diet Drugs, 2001 WL 283163, at *11 (agreeing

that double penaities might be appropriate against insurer

who fails to honor contractual obligation to pay, but not

against tortfeasor). To read the statute otherwise would lead

to the conclusion that Congress authorized double damages

against alleged tortfeasors merely for contesting liability.'”

Id. When the full history of the instant topic is considered,

it becomes eminently clear that Congress could not have

intended, and indeed did not intend, such a result. See id.

(reaching identical conclusion).

c. MSP’s “Prompt Payment” Requirement

Even if the AcroMed Settlement Trust fell within the

general meaning of a “self-insured plan,” it does not qualify

as a “primary plan” obligated by the MSP to reimburse the

Government for Medicare expenditures because it is not a

“self-insured plan” under which payment for medical care

(Cont'd)

Government’s interpretation of the MSP was correct, its right to seek

reimbursement would presumably be contingent on whether the

federal beneficiary filed suit and prevailed against or settled with

that tortfeasor. The court finds it bizarre and unlikely that Congress

could have intended that the Government’s right of recovery would

be contingent on the federal beneficiary’s decision of whether to seek

reimbursement and the additional contingency of a judgment or

settlement involving money for injuries for which the plaintiff

received Medicare payments.

12. In entering the Settlement Agreement, AcroMed did not

admit or concede liability and the Agreement expressly states tha‘ it

shall not be construed as an admission or concession of liability.

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Appendix B

“has been made or can reasonably be expected to be made

promptly.” 42 U.S.C. § 1395y(b)(2)(A).

As already explained by this court’s opinion in Jn re Diet

Drugs and the exhaustively thorough and well reasoned

opinion in Dow Corning, § 1395y(b)(2)(A) of the MSP

defines a “primary plan” as including a liability insurance

policy or plan, including a self-insured plan, “to the extent

that” payment for health care “can reasonably be expected

to be made promptly” under that policy. See 42 U.S.C.

§ 1395 y(b)(2)(A) (stating that “primary plan” means “liability

insurance policy. . . to the extent that” § 1395y(b)(2)(A)(ii),

encompassing plans that can reasonably be expected to make

prompt payment, applies); Jn re Diet Drugs, 2001 WL

283163, at *11 n.20 (concluding that MSP applies to “primary

plan” under which payment for medical care “has been made

or can reasonably be expected to be made promptly”);

Dow Corning, 250 B.R. at 348 n. 29 (same). Thus, if a

liability insurance policy has not made prompt payment and

cannot reasonably be expected to pay promptly for the health

care at issue, it is not a “primary plan.” Jn re Diet Drugs,

2001 WL 283163, at *11 n.20 (citing Dow Corning, 250 B.R.

at 348 n.29 and Health Ins. Ass’n, 23 F.3d at 419).

Under the MSP, a Medicare payment is only conditional,

and the Government only becomes a “secondary payer,”

if that payment is for an item or service to which

§ 1395y(b)(2)(A) applies. 42 U.S.C. § 1395y(b)(2)(B)(i).

Therefore, when Medicare pays for health care to which

§ 1395 y(b)(2)(A) does not apply—for example, payment for

an item or service that the Government cannot reasonably

expect to be paid for promptly under the terms of the

62a

Appendix B

insurance plan—the Medicare payment is not conditional and

the Government does not acquire secondary payer status with

respect to that payment or the corresponding authority to

initiate a recovery action under § 1395y(b)(2)(B)(i1)."°

In re Diet Drugs, 2001 WL 283163, at *11 n.20;

Dow Corning, 250 B.R. at 346 n.29.

HCFA regulations state that a payment is made

“promptly” if made within 120 days after the earlier of the

date the care was provided or the date a claim is filed with

the insurer. 42 C.F.R. §§ 411.21, 411.50. Given the time delay

inherent in strongly prosecuted and defended tort litigation,

the Government cannot legitimately assert that a settlement

a. rived at in the heat of a hard fought adversarial engagement

for alleged tort liability from a defective product is the type

of insurance “plan” that the Government can reasonably

expect to make prompt payment for medical care.'* /n re Diet

13. For these reasons, the statement in Philip Morris that

“Cijf the ‘primary’ payer has an obligation to pay for such costs, but

does not and cannot ‘reasonably be expected’ to do so, Medicare

may make a ‘conditional payment’ and later demand reimbursement

from the primary plan” is too broad. Philip Morris, 116 F.Supp.2d at

145. It is the obligation to make prompt payment “under” the plan

that makes an entity a “primary” payer and the Government the

“secondary” payer. /n re Diet Drugs, 2001 WL 283163, at *11 n.20.

The court notes, as it did in Jn re Diet Drugs, that this issue was not

germane to Judge Kessler’s otherwise thorough and well-reasoned

decision. Jd.

14. It should be noted that the other types of insurance included

in the definition of a “primary payer” under § 1395y(b)(2)(A), 1.e.,

workmen’s compensation, automobile and no fault insurance, are

(Cont'd)

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63a

Appendix B

Drugs, 2001 WL 283163, at *11 n. 20; see, e.g., Evanston v.

Hauck, | F.3d 540, 544 (7th Cir.1993) (stating that tort

judgment “can in no sense be considered the kind of certain,

prompt third-party payment Congress had in mind when it

wrote the Medicare statute”); Dow Corning, 250 B.R. at 348

n. 29 (noting that it would seem folly for Government to

argue that when it made Medicare payments on behalf of

breast implant recipients, there was reasonable expectation

that third-party would promptly pay for such care). Further,

because the AcroMed Settlement was not even in existence

at the time that the Government made the payments at issue,

it is clearly not a “plan” that was required to make “prompt”

payment, i.e., payment within 120 days, for the relevant

medical expenses. 42 U.S.C. § 1395y(b)(2)(A); 42 C.F.R.

§§ 411.21, 411.50.

Despite the explicit terms of the MSP, the case law

interpreting it and tue complete inability to cite any contrary

authority on point, the Government contends that the

foregoing interpretation of the MSP “turns the statute on its

head by limiting HCFA’s right to reimbursement to situations

in which payment is expected to be made promptly.”

However, as noted above, § 1395y(b)(2)(B)(i) limits the

Government’s reimbursement remedy to any payment falling

under § 1395y(b)(2)(A), which applies only to payments with

respect to an item or service to the extent that payment has

been or can reasonably be expected to be made promptly

(Cont'd)

frequently required by the terms of the policy itself to make prompt

payment for medical expenses. See, e.g., 47 Fed.Reg. 21103 (stating

that “under automobile medical or no fault insurance, payment can

frequently be foreseen with reasonable certainty”).

64a

Appendix B

under a self-insured plan. Thus, the statute by its terms limits

the Government’s right to reimbursement to situations in

which prompt payment has been made or can reasonably be

expected by a “primary plan.” Any other interpretation flies

in the face of the MSP’s explicit terms.

The Government’s contention that Fanning’s

interpretation “would give the United States a right to recover

only conditional payments that it is not permitted to make in

the first place” is wrong. At 42 U.S.C. § 1395y(b)(2)(A), the

MSP prohibits the Government from making payments

“except as provided in subparagraph (B)” to the extent that

another entity is reasonably expected to pay promptly for

such items or services. (Emphasis added.) Subparagraph (B)

then provides that the Government’s payment is conditional

when it makes a payment for items or services for which

another entity is reasonably expected to pay promptly.

42 U.S.C. § 1395y(b)(2)(B)(i) (making payment covered by

§ 1395y(b)(2)(A) conditional). Thus, the statute expressly

permits the Government to make payment for items or

services for which another entity is required to pay promptly,

but makes such payments subject to the Government’s right

to reimbursement through the cause of action created in

§ 1395y(b)(2)(B)(i).

This interpretation is entirely consistent with the court’s

conclusion that the Government’s MSP cause of action arises

when the “primary plan” is obligated to pay for the primary

care at issue under a contract or other formal plan of

insurance, not when the payment obligation arises out of tort

litigation. Given this logical definition of a “primary plan,”

the Government’s argument that the court’s interpretation

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Appendix B

would allow any liability insurance policy or plan to “escape

liability entirely by disputing a claim or otherwise failing to

make payments in a prompt fashion” is clearly without merit.

If it was later determined that the terms of the policy or plan

obligated the relevant entity to make prompt payment for

medical care related to the conditions at issue, then that entity

is one that could reasonably have been expected to make

prompt payment, entitling the Government to reimbursement

should it make a conditional payment. Whether or not the

insuring entity contested liability would be irrelevant to

whether it was obligated, and therefore was reasonably

expected, to make prompt payment under the terms of the

plan, and the Government’s right to initiate suit for

reimbursement “when notice ... is received that payment for

such item or service has been ... made” would remain intact.

42 U.S.C. § 1395y(b)(2)(B)(i). Thus, contrary to the

Government’s contention, the court’s interpretation in no way

minimizes a private insurer’s financial obligation to its

insured. See Opp’n to Pls.’ Mot. For T.R.O. at 31 (citing

United States v. Geier, 816 F.Supp. 1332, 1336

(W.D.Wis.1993), which indicates that Congress did not

intend MSP to minimize insurer’s obligation to insured).

Lastly, if the court were to accept the Government’s

interpretation of the MSP, as discussed above, all entities

possessing or borrowing sufficient funds to cover tort

liabilities would be liable for double damages if they entered

a settlement or received an adverse judgment more than

120 days after the suit was filed or a claim was otherwise

formally prosecuted. See 42 U.S.C. § 1395y(b)(2)(B)(i1)

(permitting Government to sue for double damages against

entity that is required or responsible to pay for item or service

66a

Appendix B

covered by MSP). Obviously, this situation presents itself in

the overwhelming majority of tort lawsuits. It is implausible

that Congress intended such a result, and even if it had, the

court doubts whether the MSP’s application in this manner

would withstand constitutional scrutiny. The Government

fails to address this flaw in its interpretation.

Thus, even if AcroMed or the AcroMed Settlement Fund

fall within the definition of “self-insured plan” under the

MSP, neither is a “primary payer” against which the

Government can seek reimbursement because neither could

reasonably be expected to make prompt payment for medical

costs. 42 U.S.C. § 139Sy(b)(2)(A).

For all of these reasons, the court concludes that the class

members have demonstrated that they are likely to ultimately

prevail on the merits of the Government’s MSP claim.

67a

Appendix B

C. Motion to Dismiss»

In its motion to dismiss, the Government first argues

that the court must dismiss the Amended Complaint because

the Medicare Act precludes jurisdiction and because the

Government has not waived sovereign immunity.

The Government next argues that the claims against those

federal defendants who are not alleged to have taken any

action against the class members must be dismissed.

As stated below, the court finds that the Medicare

statutory scheme does not preclude judicial review in this

case and that government immunity is waived under the

Administrative Procedures Act, 5 U.S.C. § 702 et seq.

(“APA”). Thus, the court has jurisdiction under 28 U.S.C.

§ 1331 (federal question) and will not dismiss the Amended

Complaint for lack of jurisdiction. However, the court will

grant the motion to dismiss insofar as the Amended

Complaint fails to allege any action by certain federal

15. For the purposes of a motion to dismiss, the court must

accept as true all well-pleaded allegations of fact in a plaintiff’s

complaint, construe the complaint in the light most favorable to the

plaintiff, and determine whether “under any reasonable reading of

the pleadings, the plaintiff may be entitled to relief.” Colburn v. Upper

Darby Township, 838 F.2d 663, 665-66 (3d Cir.1988). The court,

however, need not accept as true legal conclusions or unwarranted

factual inferences. Morse v. Lower Merion Sch. Dist., 132 F.3d 902,

906 (3d Cir.1997) (citations omitted). A complaint is properly

dismissed only if “it appears beyond doubt that the plaintiff can prove

no set of facts in support of his claim which would entitle him to

relief.” Conley v. Gibson, 355 U.S. 41, 45- 46, 78 S.Ct. 99, 2 L.Ed.2d

80 (1957).

68a

Appendix B

defendants who are not alleged to have taken any action

against the class members.

1. Jurisdiction

The Government first argues that the court lacks

jurisdiction because 42 U.S.C. § 405(g) and (h), as

incorporated by 42 U.S.C. § 1395ii, bar federal question

jurisdiction where the class members have not exhausted their

administrative remedies by pursuing administrative appeals

under Section 405 of the Social Security Act.'® Fanning,

16. Section 405 “spells out the procedures under which

applications for social security benefits are adjudicated.” Ohio

Hospital Ass'n v. Shalala, 201 F.3d 418, 422 (6th Cir.1999). Under

42 U.S.C § 405(b), the Commissioner of Social Security is directed

to make findings of fact and decisions as to the rights of any

individuals applying for Social Security Benefits. Upon request, the

Commissioner must afford a dissatisfied applicant an evidentiary

hearing. Jd. Once the Commissioner has issued a final decision after

a hearing to which the individual was a party, § 405(g) provides that

the individual “may obtain review of such decision by a civil action”

commenced in a United States District Court. In this statutory setting,

§ 405(h) provides:

The findings and decision of the Commissioner of Social

Security after a hearing shall be binding upon all

individuals who were parties to such hearing. No findings

of fact or decision of the Commissioner of Social

Security shall be reviewed by any person, tribunal or

governmental agency except as therein provided.

No action against the United States, the Commissioner

of Social Security, or any officer or employee thereof

shall be brought under section 1331 or 1346 of Title 28

to recover on any claim arising under this subchapter.

PENS a ei Lae

69a

Appendix B

however, contends that Congress did not channel review of

the instant claim through 42 U.S.C. § 405(g) and (h).

The inquiry in determining whether federal question

jurisdiction is barred is whether the plaintiff seeks “to recover

on any claim arising under” the Medicare Act. 42 U.S.C.

§ 405(h); Heckler v. Ringer, 466 U.S. 602, 636, 104 S.Ct.

2013, 80 L.Ed.2d 622 (1984) (citing Weinberger v. Salfi, 422

U.S. 749, 760-61, 95 S.Ct. 2457, 45 L.Ed.2d 522 (1975)).

Here, plaintiffs do not seek “to recover” anything.

They do not seek Medicare benefits or reimbursement for

Medicare benefits. Nor may their claim be construed as a

claim for benefits “in essence.” Ringer, 466 U.S. at 623, 104

S.Ct. 2013. In this case, class members received benefits

allegedly furnished by Medicare in relation to allegedly

AcroMed-related injuries years ago. Rather than seeking “to

recover on any claim arising under” the Medicare Act, class

members seek an injunction to prevent the Government from

undertaking action against them to obtain money that class

members received or may receive under the terms of the

Settlement Agreement with AcroMed.

Further, in support of its assertion that the court lacks

jurisdiction because the class members failed to exhaust

administrative remedies, the Government cites only cases

wherein plaintiffs sought to receive Medicare benefits either

immediately or in the future, Weinberger, 422 U.S. 749, 95

S.Ct. 2457, 45 L.Ed.2d 522, Ringer, 466 U.S. 602, 104 S.Ct.

2013, 80 L.Ed.2d 622, and cases concerning medical

providers’ eligibility for reimbursement, Shalala v. Illinois

Council on Long Term Care, Inc., 529 U.S. 1, 120S.Ct. 1084,

70a

Appendix B

146 L.Ed.2d 1 (2000). (Opp’n to Mot. for T.R.O. at 12-14;

Govt.’s Mem. of Law in Supp. of Mot. to Dismiss Am.Compl.

at 17-20.) None of these situations exist in the instant dispute.

Thus, the court finds that there is simply no basis from which

it may conclude that the class members’ challenge to the

validity and constitutionality of HCFA’s demand for payment

should be channeled first into the administrative process

Congress provided for determination of claims for benefits.’’

17. Arguing that this is a case of overpayment of benefits, the

Government cites Buckner v. Heckler, 804 F.2d 258 (4th Cir.1986),

for the proposition that class members must exhaust administrative

remedies before seeking relief in federal court. (Opp’n to Mot. for

T.R.O. at 15 & 17.) That case, however, is inapposite. In Buckner,

the plaintiff sued the Secretary seeking to recover an overpayment

of medical benefits that resulted when both plaintiff’s automobile

insurer and the medicare program paid plaintiff’s hospital expenses.

Id. at 259. Buckner was admitted to the hospital following an

automobile accident on December 6, 1982, incurring $20,845.45 in

medical expenses. Jd. Medicare paid $20,636.66. id. Then, on

February 26, 1983, eighty-two days after the hospitalization, the

plaintiff’s automobile insurer paid $5,317.76. Jd. Thus, the hospital

received an overpayment of $5,108.97. Jd. Buckner filed suit against

the Secretary, arguing that she was entitled to the overpayment.

Unlike Buckner, no medical provider in the instant case was

paid twice or received an overpayment for benefits provided. In

Buckner, prompt payment, i.e., within 120 days, was made, and was

“reasonably . . . expected to be made” by the plaintiff’s automobile

insurance plan. 42 U.S.C. § 1395y(b)(2); Buckner, 804 F.2d at 259

& n. 3 (citing MSP). Because Buckner’s automobile insurance was

reasonably expected to make prompt payment, Medicare’s payment

was conditional under the MSP. /d. In the instant case, there was no

primary plan reasonably expected to make prompt payment, thus

(Cont’d)

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The court concludes that the Medicare statutory scheme does

not preclude judicial review of the class members’ claims.

Further, sovereign immunity does not apply. Judicial

review to class members “suffering legal wrong[s] because

of agency action, or adversely affected or aggrieved by agency

action” is provided by the Administrative Procedures Act,

5 U.S.C. § 702 et seq. (“APA”). The APA authorizes judicial

review of the actions of federal administrative agencies. The

APA waives government immunity for: final agency actions;

for which there is no adequate remedy at law; and for relief

other than money damages.

“Final” agency actions are those that impose an

obligation, deny a right, or fix a legal relationship. Hindes v.

FDIC, 137 F.3d 148, 162 (3d Cir.1998) (citing Shea v. Office

of Thrift Supervision, 934 F.2d 41, 44 (3d Cir.1991)). To be

“final,” an decision must: 1) represent the agency’s definitive

position on the question; 2) have the status of law with the

expectation of immediate compliance; 3) have an immediate

impact on Plaintiffs’ day-to-day operations; 4) involve a pure

question of law; and 5) immediate review would speed

enforcement. Matter of Seidman, 37 F.3d 911, 923

(3d Cir.1994) (citing CEC Energy Co., Inc. v. Public Serv.

Comm., 891 F.2d 1107, 1110 (3d Cir.1989)).

(Cont'd)

Medicare’s payment was not conditional. Finally, unlike Buckner,

class members do not seek the payment of benefits. Rather, they seek

to enjoin the Government from attempting to recover fron: class

members payments previously made by Medicare on account of the

AcroMed settlement.

72a

Appendix B

Here, HCFA’s demand letters represent the agency’s

definitive position that under its interpretation of the MSP,

the Government is entitled to reimbursement for medical

expenses because of the AcroMed Settlement. The demand

letters impose an obligation with the expectation of

immediate compliance by July 9, 2001, or interest will accrue

at arate of 13.75%. The impact of the Government’s demand

is immediate, as evidenced by testimony at the hearing and

the phone calls from class members the court received in

chambers, and the issue involves a pure question of law. Thus,

the court finds that the agency action is clearly “final” under

the APA.

The court also concludes, as discussed supra, that there

is no adequate remedy at law. Although the Government

asserts that Medicare beneficiaries must exhaust

administrative appeals procedures or seek waivers, it cites

only regulations regarding the overpayment of benefits to

medical providers and to regulations regarding conditional

payments, which are not applicable for the reasons already

discussed. Finally, Fanning seeks relief other than money

damages, namely, an injunction. Thus, the court concludes

that judicial review is authorized by the Administrative

Procedures Act.

2. Defendants Not Alleged to Have Taken Action

Against Class Members

In its motion to dismiss, the Government also seeks to

dismiss the Amended Complaint’s MCRA claims. As stated

supra, the demand letters base the Government’s demand

for reimbursement entirely on the MSP. (Am.Compl.Ex.B.)

73a

Appendix B

The Government acknowledged at the June 6, 2001 hearing

that it has not sought to justify its demands for reimbursement

from class members under the MCRA, which grants the

Government a right to recover from tortfeasors, but does not

provide a cause of action to recover Medicare expenses or

allow the Government to collect from an injured person or

from a settlement fund negotiated between the injured person

and the settling defendant. 42 U.S.C. § 2651(a); Jn re Diet

Drugs, 2001 WL 283163, at *8 (citations omitted). Thus,

insofar as the Amended Complaint asserts a claim under the

MCRA, the court will grant the Government’s motion to

dismiss said claim.

In this regard, twelve of the seventeen named defendants

do not have any relationship to the MSP or the Medicare

program, including: the United States Department of Defense;

the United States Department of the Army; the United States

Department of the Navy; the United States Department of

the Air Force; the United States Indian Health Service; the

United States Department of Veterans Affairs; Donald H.

Rumsfeld, in his capacity as Secretary of the United States

Department of Defense; Joseph W. Westphal, in his capacity

as Acting Secretary of the United States Department of the

Army; Robert B. Pirie, Jr., in his capacity as Acting Secretary

of the United States Department of the Navy; Lawrence

Delaney, in his capacity as Acting Secretary of the United

States Department of the Air Force; Michael H. Trujillo, in

his capacity as Director of the United States Indian Health

Service; and Anthony J. Principi, in his capacity as the

Secretary of the United States Department of Veterans A ffairs.

Thus, the court will grant the Government’s motion to dismiss

class member’s claims against these defendants.

74a

Appendix B

Accordingly, for purposes of this Memorandum and

Order, the remaining “Federal Defendants” include: 1) the

United States of America (“United States”); 2) the United

States Health Care Financing Administration (“HCFA”);

3) the United States Department of Health and Human

Services; 4) Tommy G. Thompson, in his capacity as

Secretary of the United States Department of Health and

Human Services; and 5) Thomas Scully, in his capacity as

Administrator of HCFA, an Agency of the Department of

Health and Human Services.

D. Distribution of the Settlement Proceeds

As to Plaintiffs’ motion in Fanning IJ to require

distribution of the settlement proceeds without regard to the

Government’s interest, the court notes that the Government

expressed no objection to distribution. Further, although

AcroMed initially objected in a filing dated March 27, 2001,

during the June 6, 2001 hearing on the matter, AcroMed

voiced no objection to distributing the settlement proceeds."*

18. In its earlier objection, AcroMed asserted that the

Government’s claim is subrogatory in nature, and that therefore,

pursuant to the settlement, AcroMed is entitled to indemnification

from the Settlement Fund for any Government claims against It.

The Government, however, has raised no claim against AcroMed.

Further, although the Government’s claim may be subrogatory in

nature, it is, nonetheless, independent. It was not extinguished by

the Settlement Agreement, to which the Government was nota party.

In re Bone Screw, 176 F.R.D. at 179 (citations omitted). Thus, the

Government’s claim is not a “settled claim” under Pretrial Order

Number 1117. /d.; Settlement Agreement § IV.D.3.b (stating that

AcroMed is entitled to indemnification for “settled claims”).

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Appendix B :

Nevertheless, out of an exercise of extreme caution, the court

will direct a reserve of $1,000,000.00 to be set-aside. The

court concludes that this sum will adequately protect any

interest in the settlement proceeds that the Government may

ultimately establish.

Il. CONCLUSION

For the reasons set forth above, the motions for class

certification and for a preliminary injunction will be granted;

the Government’s motion to dismiss will be granted in part

and denied in part; and the motion to require distribution of

the settlement proceec's will be granted.

An appropriate Order follows.

76a

Appendix B

ORDER

AND NOW, TO WIT, this 29 day of June, 2001, upon

consideration of plaintiff Daniel C. Fanning’s (“Fanning”)

motions for class certification and for a preliminary

injunction in 01-cv-1029; defendant the United States of

America, et al.'s motion to dismiss the Amended Complaint

in 01-cv-1029; plaintiff Fanning, et al. s (“Plaintiffs”) motion

to require distribution of the settlement proceeds in 97-cv-

381; the oppositions and responses thereto; and the exhibits

and testimony received by the court at a consolidated hearing

on the motions held on June 6, 2001, IT IS ORDERED that:

1) Fanning’s motion for class certification in 01-cv-1029

is GRANTED. Civil Action No. 01-1029 shali proceed as a

class action pursuant to Fed.R.Civ.P. 23(a) and 23(b)(2) for

declaratory and injunctive relief under the Administrative

Procedures Act, 5 U.S.C. § 702, on behalf of a class

consisting of:

All persons who are members of the AcroMed

Settlement Class (as defined in Pretrial Order 1117

entered in MDL 1014) and who, as a result of the

Class Action Settlement Agreement with AcroMed

Corporation, are subject to any Medicare-related

claim, brought pursuant to the Medicare

Secondary Payer statute, 42 U.S.C. § 1395y, or

otherwise, by any of the defendants herein, except

nominal defendants Robert E. Welsh, Jr. and PNC

Bank, N.A., for reimbursement of the cost of

medical care allegedly paid for or provided to

them by any such defendant;

77a

Appendix B

2) Plaintiff’s Motion for a Preliminary Injunction in 01-

cv-1029 is GRANTED;

3) Defendant the United States of America, e7 al.'s

motion to dismiss the Amended Complaint in 01-cv-1029 is

GRANTED IN PART and DENIED IN PART;

4) Until further Order of the court, the Federal

Defendants' are hereby RESTRAINED and ENJOINED from

undertaking any action to obtain reimbursement from class

members in relation to any money, sums, payments or benefits

that class members have received in the past or may receive

in the future pursuant to the terms of the AcroMed Settlement

Agreement;

5) The Federal Defendants are directed to deposit into

the registry of the court any sum that has been paid in the

past or which may be paid in the future to any of the Federal

Defendants by or on behalf of any class member pursuant to

any demand by any Federal Defendant for reimbursement in

relation to the AcroMed Settlement. Such deposits shall be

made within fifteen (15) days of the date of this Order or

within fifteen (15) days of receipt of such payment, whichever

is earlier;

1. For purposes of this Order, the “Federal Defendants” are:

the United States of America (“United States”); the United States

Health Care Financing Administration (“HCFA”); the United States

Department of Health and Human Services; Tommy G. Thompson,

in his capacity as Secretary of the United States Department of Health

and Human Services; and Thomas Scully, in his cupacity as

Administrator of HCFA, an Agency of the Department of dealth and

Human Services.

—

78a

Appendix B

6) In lieu of posting security, Robert E. Welsh, Jr., in

his capacity as Administrator of the AcroMed Settlement

Fund, and PNC Bank, N.A., in its capacity as Trustee for the

AcroMed Settlement Agreement are hereby directed to hold

the sum of $ 2,500.00 (two thousand five hundred dollars)

out of the proceeds of the AcroMed Settlement Fund in

escrow pending further Order of the court;

7\ The Plaintiffs’ Litigation Committee is hereby

directed to send a copy of this Order and an explanatory letter

to class members;

8) A final hearing on permanent injunctive relief shall

be set at a future date;

9) TheFederal Defendants’ Motion to Stay Proceedings

Related to Plaintiff’s Motion for Summary Judgment or, in

the Alternative, for Enlargement of Time to Respond to

Plaintiff’s Motion in 01-cv-1029 is DENIED AS MOOT;

10) Robert E. Welsh, Jr., in his capacity as Administrator

of the AcroMed Settlement Fund, and PNC Bank, N.A., in

its capacity as Trustee for the AcroMed Settlement Agreement

shall establish and maintain a separate account in the amount

of $1,000,000.00 (one million dollars). This reserve may be

utilized, pursuant to court order, in the event that the Federal

Defendants ultimately establish an interest in Setilement

proceeds; .

11) The Settlement Administrator and the Settlement

Trust shall forthwith commence distribution of the remaining

proceeds of Settlement to eligible class members in

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79a

Appendix B

accordance with this court’s Pretrial Orders and the terms of

the Settlement Agreement approved by the court in Pretrial

Order No. 1117; and

12) To the extent that plaintiff Fanning seeks additional

declaratory or injunctive relief, said motions are DENIED

WITHOUT PREJUDICE.

SO ORDERED.

80a

APPENDIX C — ORDER OF THE UNITED STATES

COURT OF APPEALS FOR THE THIRD CIRCUIT

DENYING PETITION FOR REHEARING EN BANC

DATED DECEMBER 16, 2003

UNITED STATES COURT OF APPEALS

FOR THE THIRD CIRCUIT

No: 01-3366

DANIEL C. FANNING, INDIVIDUALLY, AND AS

REPRESENTATIVE OF A CLASS OF PERSONS

SIMILARLY SITUATED

V.

THE UNITED STATES OF AMERICA; UNITED STATES

HEALTH CARE FINANCING ADMINISTRATION;

UNITED STATES DEPARTMENT OF DEFENSE; UNITED

STATES DEPARTMENT OF HEALTH AND HUMAN

SERVICES; UNITED STATES DEPARTMENT OF THE

ARMY; UNITED STATES DEPARTMENT OF THE NAVY;

UNITED STATES DEPARTMENT OF THE AIR FORCE;

UNITED STATES INDIAN HEALTH SERVICE; UNITED

STATES DEPARTMENT OF VETERANS AFFAIRS;

MICHAEL MCMULLEN, MRS., AS ACTING DEPUTY

ADMINISTRATOR OF THE UNITED STATES HEALTH

CARE FINANCING ADMINISTRATION; DONALD H.

RUMSFELD, AS SECRETARY OF DEFENSE; TOMMY G.

THOMPSON, AS SECRETARY OF THE DEPARTMENT

OF HEALTH AND HUMAN SERVICES; GREGORY R.

DAHLBERG, THE HONORABLE, AS ACTING

SECRETARY OF THE ARMY; ROBERT B. PIRIE, JR., THE

HONORABLE, AS ACTING SECRETARY OF THE NAVY;

8la

Appendix C

LAWRENCE DELANEY, THE HONORABLE DR., AS

SECRETARY OF THE AIR FORCE: MICHAEL H.

TRUJILLO, M.D., M.P.H., AS DIRECTOR OF THE INDIAN

HEALTH SERVICE; ANTHONY J. PRINCIPI, THE

HONORABLE, AS SECRETARY OF THE DEPARTMENT

OF VETERANS AFFAIRS; ROBERT E. WELSH, JR.,

ESQUIRE, AS ADMINISTRATOR OF THE ACROMED

SETTLEMENT AGREEMENT; PNC BANK, N.A., AS

TRUSTEE FOR THE ACROMED SETTLEMENT

AGREEMENT

United States of America, the Centers for Medicare and

Medicaid Services (formerly the Health Care Financing

Administration), the United States Department of Health and

Human Services, Tommy G. Thompson in his capacity as

Secretary of the United States Department of Health and

Human Services, and Thomas Scully in his capacity as

Administrator of the Centers for Medicare and Medicaid

Services (formerly Administrator of the Health Care

Financing Administration),

Appellants

SUR PETITION FOR REHEARING EN BANC

BEFORE: SCIRICA, SLOVITER, NYGAARD, ALTO,

ROTH, MCKEE, RENDELL, BARRY, AMBRO,

FUENTES, SMITH and CHERTOFF Circuit Judges

The petition for rehearing on behalf of Appellee in the

above-entitled case, having been submitted to the judges who

participated in the decision of this court and to all other

82a

Appendix C

available circuit judges in regular active service, and no judge

who concurred in the decision having asked for rehearing,

and a majority of the circuit judges in regular active service

not having voted for rehearing by this court en banc, the

petition for rehearing en banc is hereby DENIED.

IT IS SO ORDERED ~

By the Court,

/s/ Hon. Theodore A. McKee

Circuit Judge

DATED: December 16, 2003

83a

APPENDIX D — STATUTES INVOLVED

42 U.S.C. § 405

§ 405. Evidence, procedure, and certification for payments

* * *

(g) Judicial review

Any individual, after any final decision of the

Commissioner of Social Security made after a

hearing to which he was a party, irrespective of

the amount in controversy, may obtain a review

of such decision by a civil action commenced

within

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