Amicus Curiae Brief — South Carolina Medical Ass'n v. Thompson

FILED

— SEP 2 4 2003

No. 03-114 | OFFICE OF THECL ERK

IN THE

- Supreme Court of the United States

SOUTH CAROLINA MEDICALASSOCIATION, et al.,

Petitioners,

v.

TOMMY G. THOMPSON, SECRETARY

OF THE UNITED STATES DEPARTMENT OF

HEALTH AND HUMAN SERVICES, et al.,

Respondents.

On PETITION FOR A WRIT OF CERTIORARI TO THE

UNITED STATES COURT OF APPEALS FOR THE FOURTH CIRCUIT

BriEF Or GuENTER L. SPANKNEBEL, M.D., WAYNE B. GLAZIER,

M.D., ABRAHAM Happap, D.M.D., Rosert LeBow, M.D.,

LEONARD Morse, M.D., KesHav PAnpeEy, M.D., Mark

SIMONEAU, MEDICAL SocieTy OF THE STATE OF New York, AND

ASSOCIATION OF AMERICAN PHYSICIANS AND SURGEONS, INC.

As Amici Curi4E IN Support OF PETITIONERS

Davip P. FELSHER

Attorney for Amici Curiae

488 Madison Avenue

New York, NY 10022

(212) 308-8505

183224 g

COUNSEL PRESS

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

0 ae a ee ee ee een eS Pe

QUESTIONS PRESENTED?'

1. May Congress ignore the Constitution’s procedural and

substantive requirements when it delegates “legislative”

authority?

2. Does the “Intelligible Principles Test” have a fourth

element?

1. Included within the questions presented are the following

subsidiary questions: (1) Under HIPAA’s § 264, does the self-imposed time

limit to enact health privacy legislation statutorily alter the lawmaking

process? (2) May rulemaking supplant the legislative process? (3) Does a

court violate the Separation of Powers Doctrine by contradicting the plain

meaning of a statute? (4) May an agency or executive department construe

a statute by ignoring its plain meaning? (5) Can the 104" Congress delegate

its power during a later Congress? (6) Under HIPAA’s § 264, did Congress

set any policy or standard to limit HHS authority?

Given the 20 page limit on the length of this brief, other related

subsidiary questions are omitted. However, amici respectfully ask the Court

for the opportunity to fully brief those questions on the merits and the

opportunity to discuss various unintended consequences of the regulatory

scheme. The additional questions include:

¢ Inan electronic age, is beneficial ownership and legal title to a

medical record and genetic information merged in the patient?

¢ Is the right to keep patient-physician communications

confidential so basic a right that our nation’s founders and John

Locke would have considered it a fundamental or inalienable

right of every individual, if they had taken the time to consider

it? The founders included at least three physicians who signed

the Declaration of Independence (Drs. Benjamin Rush, Josiah

Bartlett, and Matthew Thornton. Some historians question the

medical credentials of another signer, Lyman Hall). See Richard

F. Corlin, M.D (President, American Medical Association), History

Repeats: Physicians Face Another 5.4% Issue (Amednews.

com,April 15, 2002) @ www.ama-assn.org/sci-pubs/amnews/amn_

02/edca0415.htm. John Locke was a physician whose writings

provide a substantial part of the Constitution’s intellectual and

= philosophical foundation. See e.g., John Locke, Two Treatises of

Government (1698);

¢ Does health privacy legislation fall under the Commerce Clause?

¢ Is the “right to privacy” an outer boundary on the Commerce

Clause?

i

TABLE OF CONTENTS

Page

Ouestions Presesied ...<s0sss0ineeeeeaeeeneeene i

Table of Conmbemlt ...si¢sv2s0snevageeeenndaeeenes li

Table of Cited Authorities ...................... iv

Interests of Ansicd CUPEME .... ok cc rv50 vanheaeeeneas 1

Sentemont of Facts ..65255scdvencduokeeeeeeeene 4

Samumary Of AtguaNeet « «sos ss¢s sn serees naan )

Argument ..oc.cssscasveesketsense eee e eee 6

I. Section 264 Unconstitutionally Amends The

Lawmaking Process By Limiting The Time

For Congress To Pass A Law ............. 6

II. Congressional Lawmaking Is Supplanted By

HHS Privacy Regulations ................ 7

III. The Courts Below Violated The Separation

Of Powers Doctrine By Construing § 264(c)

To Eliminate The Statute’s Deadline For HHS

fa ee er er are 11

IV. The Separation Of Powers Doctrine And The

Execution Clause Prevent HHS From

Arguing A Construction Of § 264(c) That

Contradicts Its Plain Meaning ............ 13

V. Congress Defectively Delegated Authority

To MBS. ...o.s+:s0c00keeeeeeen eee 15

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Contents

Page

A. The 104 Congress Cannot Delegate Its

Authority Beyond The End Of Its Own

EN Kee ERe ede Te CERER SS 15

B. Congress Provided No Policy or

Boundary to Limit HHS Authority .... 17

1v

TABLE OF CITED AUTHORITIES

Page

Cases: .

A.L.A. Schechter Poultry Corporation v. United States,

Fe LENE 65 eo Seba c dass eenceuebesswes 19

American Power & Light Co. v. S.E.C., 329 U.S. 90

CRPEE vv coun ssa sdes van bu ean e eses REFER ENE S 17

Association of American Physicians and Surgeons, Inc.

v. United States Department of Health and Human

Services (Civ. Action No. H 01-2963) (SL)

CER TOK. PONG TA, BED x5 ci eeccinrsachenwes 13

Barnhart v. Peabody Coal Co., __ U.S. __, 123 S. Ct.

og. Se rere eee Tere Tere rr es ekicke 15

Brock v. Pierce County, 476 U.S. 253 (1986) ........ 15

Clinton v. City of New York, 524 U.S. 417 (1998) ... passim

Connecticut National Bank v. Germain, 503 U.S. 249

1 ery eee Par wer ere re eer Sree 12

Immigration and Naturalization Service v. Chadha,

GOR UD FEF CNP) Ay 64h bs pos evn dencenbvnste passim

].W. Hampton, Jr.,& Co. v. United States, 276 U.S. 394

fe Beery reer eer Serer eer Tes ore 13, 14

Kendall v. United States ex rel. Stokes, 12 Pet. (37 U.S.)

tt | TEESE TT Pe TR eTT TL Tier eee 14,15

Loving v. United States, 517 U.S. 748 (1996) ........ 16

McCulloch v. Maryland, 4 Wheat. (17 U.S.} 316

fo, Cree er ere er er re err eae 15

Vv

Cited Authorities

Page

Metropolitan Washington Airports Authority v.

Citizens for the Abatement of Aircraft Noise, Inc.,

501 US. 252 (1991) ......seececececevesscecess 14

Mistretta v. United States, 488 U.S. 361 (1989) ...... 17

Oregon v. Mitchell, 400 U.S. 112 (1970) ....--++++>: 6

Regions Hospital v. Shalala, 522 U.S. 448 (1998) ..--. 15

United States v. Goldenberg, 168 U.S. 95 (1897) .... 12

LInites States v. James Daniel Good Real Property,

510 U.S. 43 (1993) ....--- cece reece eee settee 15

United States v. Montalvo-Murillo, 495 U.S. 711

CBO in cn ike cen venecentemeseentonmer ery at 15

United States v. Morrison, 529 U.S. 598 (2000) .....-. 15

United States v. Symonds, 120 U.S. 46 (1887) .....-- 15

U.S. Term Limits, Inc. v. Thornton, 514 U.S. 779 (1995)

cegec cn bh woe bewees os gests 5OeGR teeaae 6, 16

Wayman v. Southard, 10 Wheat. (23 U.S.) 1 (1825)

Whitman v. American Trucking Associations, Inc.,

531 U.S. 457 (2001) .....-- eee erect errr 20

Yakus v. United States, 321 U.S. 414 (1944) ...----- 19

v1

Cited Authorities

Page

United States Constitution:

Poo. eb ererererrrrrrrr rrr rrey ye rt passim

po Se eer rrr rrr rrr ey 15-16

Pie T OS GS vocteisceesscéudcnceses cone 16

pb ry rer rer aime ieee ee 15-16

Article I, §3,cl.1...... Feet ete e nent eee eee eees 16

px. BS fe. & reer eer error rrr rs rer 16

pL YOST COT ee re ee 5

Aatiete 1, § 7, 48 vccccictvcscesediboxéahesuvon passim

AstieGe 3 OE Gee ik cacvas6e0ekes 008s 4 eee i

RIED 2 odccdsesteeduvaee«+seeeviteeee 15

AsRO TE EE: 0 cvi's eedéeasnyeees acest eae 16

AGG BE US xc0cccckcdsatseues see 16

3 | APOE e eee errr rr rey bere. esr 5, 13, 14

AMGEEE TE oi sic dee 00 eT Tee ET ee ye 13

PIGEIOY ccrccesveccacacuseesntkeusseuseaserees 6

Amendment XVII ....... Cher aseheeekeeeehanees 16

vil

Cited Authorities

Page

Statutes:

Health Insurance Portability and Accountability Act

of 1996, Pub. L. No. 104-191, 110 Stat. 1936 et seq.

(August 21, 1996) ....----sseeerrereeersert 1

- . co cencvarsdevescecesereensene es ees 18

cca chk no neHe rks er PRCT EAR COR Se SNARES TS 7 18

BOE cs Snccudaknsanvnneeaeeen reRreNeyees ests passim

BO occ suivetencsariecoceussrrenerserss<®? 9,10

RN ai sesensc aces cnvrssnpreroutes onset 9, 10, 20

GC DOMET) soos ocr essncccsesccvnssonsevsreresrs 9

GC RGGIDPEA) «00s oss ervccncccrssccossecsnserereess 9

SREROIDD noone ccevcnanceredesnsosnnecsnee nes 9

BIG) ons cccvecssorsvrnessenessosscsseoeres passim

§ 264(c)(1) ..-- eee eee e rere uaeeubeubies passim

RONEN oxy ccnnasrccagencceevesst rere sree nT tht? 10

Immigration and Nationality Act § 244(c)(2) ..---- 8

Social Security Act § 1173, 110 Stat. 2024-26, codified

at 42 U.S.C. §1320d-2 .....-- seer ere errrre 10, 18, 19

vit

Cited Authorities

Page

Congressional Materials:

S. Rep. No, 1335, 54" Cong., 2d Sess. (1897) ....... 7

Executive Materials:

64 Fed. Reg. 59918 et seq. (1999) .............088, 4,12

65 Fed. Reg. 82462 et seq. (2000) ............. 4-5, 10, 12

G6 Fed. Reg. 126546 (2001) 2... ccc cccccessccccnes )

67 Fed. Reg. 14776 et seq. (2002) ................. 5, 10

67 Fed. Reg. 53182 et seq. (2002) ............eeeee )

Law Reviews:

Steven F. Huefner, The Supreme Court’s Avoidance of

the NonDelegation Doctrine in Clinton v. City of

New York: More than “A Dime’s Worth of

Difference”, 49 Catholic Univ. L. Rev. 337 (2000) -

Marci Hamilton, Representation and NonDelegation:

Back to Basics, 20 Cardozo L. Rev. 807 (1999) .... 10, 17

Alan B. Morrison, A Non-Power Looks at Separation

of Powers, 79 Geo. L.J. 281 (1990) .............. 16

ix

Cited Authorities

Books and Treatises:

Black’s Law Dictionary (5% ed. 1979) ......-+++++::

John Locke, Two Treatises of Government (1698) ......

Joseph Story, Commentaries on the Constitution of the

United States (Carolina Academic Press)

TEE. cc ccasskstanervisansyuanses somes eee»

Webster’s Third New International Dictionary of the

English Language - Unabridged (P. Gove ed. 1993)

oeeeve

Petitions and Briefs:

Brief of Senators Robert C. Byrd, Daniel Patrick

Moynihan and Carl Levin as Amici Curiae in

Support of Appellees in Clinton v. City of New York

(Docket No. 97-1374) ...--.--sseeeeeeeee ese

Supreme Court Rules:

Sf ee er rere rer ee rer ok.

Other Authorities:

Richard F. Corlin, M.D (President, American

Medical Association), History Repeats: Physicians

Face Another 5.4% Issue (Amednews.com, April

15, 2002) @ www.ama-assn.org/sci-pubs/

amnews/amn_02/edca0415.htm ......--+++++:

Leonard Morse, Comments from Physicians, in

Massachusetts Medical Society, Background: MMS

Policy on Patient Privacy and Con fidentiality: Health

Policy (10/14/2000) ...-..--.+-eeeeeeeeeeeeees

12

1

INTERESTS OF AMICI CURIAE'

Critical to the care of every patient is the patient’s

confidence that personal or private information communicated

to the provider will be kept in confidence. This ensures that

the patients will candidly communicate their conditions and

history to their providers.

Amici are prominent members of the medical, dental and

business communities in Massachusetts (collectively,

“Individual Amici”), Medical Society of the State of New York

(“MSSNY”) and Association of American Physicians and

Surgeons, Inc. (“AAPS”). Amici have a strong interest in

protecting the confidentiality of patient-physician

communications. Although Individual Amici are active in

various medical associations and institutions, they submit this

brief as individual providers and patients and not on behalf

of any other entity.

Amici believe the privacy regulations issued by the United

States Department of Health and Human Services (“HHS”)

(the “Regulations” ) pursuant to § 264 of the Health Insurance

Portability and Accountability Act of 1996, Pub. L. No. 104-

191, 110 Stat. 1936 et seq. (August 21, 1996) (“HIPAA”)?

compromise the trust inherent in the patient-physician

relationship and reduce patient candor resulting in increased

diagnostic and treatment risks. Because the Regulations

contain broad exceptions to consent and authorization

requirements and ignore the confidentiality principles

attributed to Hippocrates approximately 2,400 years ago,

Amici believe the Regulations shake the very foundation of

the medical profession - the trust between a patient and his or

her physician. Amici believe they can be of particular assistance

to the Court regarding the nature and importance of the

patient-physician relationship.

1. In compliance with Supreme Court Rule 37.6, this brief was not

written in whole or in part by counsel for a party, and no person or entity

other than Amici Curiae and their counsel has made any monetary

contribution to the brief’s preparation and submission. The parties have

consented to the filing of this brief, and such consents are being submitted

herewith.

2. Unless otherwise specified all “section” or “§” references refer to

HIPAA.

2

As providers and patients, Amici disagree with the

substance of certain privacy regulations. However, as friends

of this Court, Amici question the very power and process by

which Congress purportedly authorized HHS to issue the

Regulations. Amici ask the Court to protect Congress from itself

by preserving the integrity of the “single, finely wrought and

exhaustively considered, procedure”, Immigration and

Naturalization Service v. Chadha, 462 U.S. 919, 951 (1983), used

to enact legislation.

Because the existence of the power of HHS to regulate

health privacy is at issue, no further regulatory or judicial

experience is needed before certiorari is warranted. In fact,

delaying the grant of certiorari could damage thousands, if not ,

millions, of patients. In the age of the Internet, electronic

records may be transmitted and retransmitted worldwide in

an instant. This means that an inadvertent or intentional release

of patient information in an institutional setting could

endanger the records of thousands of patients at a time.

Coupling the rapidly evolving technological landscape

with HHS’ exceptions to the consent and authorization

requirements for “payment, treatment or healthcare

operations” creates a recipe for disaster for three reasons. First,

most patients have at least some part of their insurance claims

or medical records transferred electronically. Second, as HHS

continues to implement various HIPAA standards (regarding

privacy and other subjects) more and more medical institutions

and providers are going “electronic” to process claims and

keep patient records. Third, once the records are released, it is

often too difficult or impossible to reverse the breach of privacy.

Amicus Guenter L. Spanknebel, M.D., privately practices

gastroenterology and is a Past-President of the Massachusetts

Medical Society (“MMS”), the nation’s oldest medical society.

For the past thirty-five years, he has been on the faculties of

the medical schools at the University of Massachusetts and

Tufts University. Dr. Spanknebel serves on various boards and

committees of organized medicine.

Amicus Leonard Morse, M.D., practiced internal

medicine/ infectious diseases for more than 35 years. He is

the immediate past chair of the Council on Ethical and Judicial

3

Affairs of the American Medical Association and a past

President of MMS. He is President of Boston Medical Library,

Professor of Clinical Medicine at University of Massachusetts

Medical School, and Commissioner of Public Health for

Worcester, Massachusetts. He has stated:

[a] trusting patient-physician relationship is the

fundamental beginning for appropriate health care.

It is a privilege and an enormous responsibility to

be a physician. In my office, all personal medical

information is private, and as such, remains

concealed. Nothing is released without the patient's

and my approval (in that order).

Leonard Morse, Comments from Physicians, in Massachusetts

Medical Society, Background: MMS Policy on Patient Privacy and

Confidentiality: Health Policy (10/14/ 2000).

Amicus Wayne B. Glazier, M.D., privately practices

urology. He is Chairman of the Health Foundation of Central

Massachusetts and President of the Massachusetts

Independent Physicians’ Association.

Amicus Abraham Haddad, D.M.D., practices

periodontology. He is on the faculties at Harvard School of

Dental Medicine and the University of Massachusetts Medical

School. He is former President of the Massachusetts

Periodontal Society and former Chairman of Dental Medicine

at the University of Massachusetts Memorial Hospital.

Amicus Robert Lebow, M.D., practices internal medicine.

He is a trustee of MMS, Chief of Internal Medicine at

Harrington Memorial Hospital and on the faculty at University

of Massachusetts Medical School.

Amicus Keshav Pandey, M.D., privately practices gastro-

enterology. He is Assistant Professor of Internal Medicine at

the University of Massachusetts Medical School and is a staff

gastroenterologist at University of Massachusetts Memorial

Hospital.

Amicus Mark Simoneau is the Director of Human

Resources for a 500 person self-insured company located in

Massachusetts. His employer is typical of thousands of other

self-insured businesses throughout the country that must now

4

devote significant time and financial resources to comply with

the Regulations.

Amicus MSSNY is a New York Not-for-Profit Corporation

organized in 1807. It is a voluntary association of

approximately 27,000 physician, medical resident, and medical

student members. MSSNY is the principal professional

organization in New York, representing physicians in all

specialties. It is concerned that the enormous burdens placed

by the Regulations will severely strain the ability of many

medical practices to provide quality medical care and will take

precious time and financial resources away from patient care.

Amicus AAPS is a nationwide non-partisan professional

association of thousands of physicians in all types of practices

and specialties. Since it was founded in 1943, AAPS has been

dedicated to the highest ethical standards of the Oath of

Hippocrates and to preserving the sanctity of the patient-

physician relationship.

Amici believe that unless the decisions below are

immediately reversed, Joint Appendix of Petition at Al and

A18, HHS will continue to act without legislative authority

and will thereby permanently alter the nature of the medical

practice. Amici respectfully but fervently ask the Court to grant

the petition.

STATEMENT OF FACTS |

Section 264 is an attempt to delegate to the Secretary of

HHS the authority to issue health privacy regulations in the

event that Congress failed to enact health privacy legislation

within three years of HIPAA’s enactment.’ Section 264(c)(1)

directed HHS to promulgate regulations governing standards

with respect to the privacy of individually identifiable health

information (“ITHI”) if Congress did not enact health care

privacy legislation by August 21, 1999. 110 Stat. at 2033.

Congress did not pass privacy legislation by that deadline.

On November 3, 1999, HHS published proposed health privacy

regulations. 64 Fed. Reg. 59918 et seq. After an extended

comment period, the final health privacy regulations were

issued in December 2000 (“Regulations”), 65 Fed. Reg. 82462

3. Section 264 was not codified. It appears as a note to 42 U.S.C.

§ 1320d-2.

So

et seq. (December 28, 2000), and became effective on April 14,

- 2001, 66 Fed. Reg. 12434 (February 26, 2001)*.

SUMMARY OF ARGUMENT

Acting without Congressional authority, HHS has

changed the rights of every patient and every provider and

obliterated more than 2,000 years of accepted medical practice.

Section 264(c) violates the Constitution’s bicameral and

presentment requirements in two ways. First, it statutorily

amended the Constitution’s lawmaking requirements

by adding a time constraint to Article I, § 7. Second, Congress

ignored the teachings of Immigration and Naturalization Service

v. Chadha, 462 U.S. 919 (1983) and authorized regulations to

supplant legislation without fulfilling the bicameral and

presentment requirements.

Section 264(c) also violates the Separation of Powers

Doctrine in two ways. First, courts may not construe a statute

to contradict the words agreed to by both Houses of Congress

and the President. Section 264 sets a deadline for HHS to act -

42 months after enactment of HIPAA. That date came and went

without privacy regulations being finalized. Second, the

Separation of Powers Doctrine and Execution Clause prevent

HHS from presenting a construction of a statute that

contradicts the words enacted by Congress and the President.

The Court should find that the delegation was defective

because the principle that Congress may only delegate power

it received from the people adds a fourth component to the

“intelligible principles” test. First, the 104" Congress was

powerless to effect a delegation beyond the expiration of its

term. Second, Congress did not provide a general policy or

boundary to limit the Regulations. In fact, Congress allowed

HHS to address an infinite number of subjects.

4. After the Plaintiff's Complaint was filed, HHS proposed and

finalized modifications to the Privacy Regulations. 67 Fed. Reg. 14776

et seq. (March 27, 2002) and 67 Fed. Reg. 53182 et seq. (August 14, 2002)

(“Modifications”). The arguments set forth herein apply to the Modifications

as well as the Regulations. Indeed, the Modifications may have a greater

chilling effect on patient-physician communications than the Regulations

because exceptions to the consent and authorization requirements have

been created for payment, treatment and healthcare operations. Id.

6

ARGUMENT

I. Section 264 Unconstitutionally Amends The Lawmaking

Process By Limiting The Time For Congress To Pass A

Law

Since our nation was founded more than 200 years ago, a

“single, finely wrought and exhaustively considered,

procedure” has been used to enact federal legislation.

That procedure is laid out in the Constitution’s Bicameral and

Presentment Clauses. Strict compliance with those procedures

is required. When Congress delegates its lawmaking function

to another branch or independent agency it may not

legislatively alter that process. If it does, the delegation is

unconstitutional. For example, the legislative veto and the line

item veto were declared unconstitutional. Immigration and

Naturalization Service v. Chadha, 462 U.S. 919 (1983); Clinton v.

City of New York, 524 U.S. 417 (1998). Similarly, when Congress

conditions the delegation of its lawmaking function upon the

restriction of its own time to consider legislation, it alters the

legislative process. Section 264(c) contains such a delegation.

The Bicameral and Presentment Clauses require passage

of exactly the same text by both Houses and presentment to

the President. Clinton, 524 U.S. at 448. Those procedures may

not be statutorily supplemented or modified. They may be

altered only by a constitutional amendment. Clinton, 524 U.S.

at 449; U.S. Term Limits, Inc. v. Thornton, 514 U.S. 779, 837 (1995);

Oregon v. Mitchell, 400 U.S. 112, 128 (1970). Section 264(c) alters

the procedure without ratifying a constitutional amendment

in accordance with Article V. Pursuant to § 264(c), once three

years had elapsed without passage of new health privacy

legislation, HHS had six months to regulate (unless the House,

Senate and the President had agreed otherwise). In contrast,

without § 264(c), HHS could not have regulated health privacy

unless the House, Senate and President agreed on new health

privacy legislation.

A law such as § 264(c), which completely delegates

legislative responsibility to an executive department or

independent administrative agency, violates the Constitution’s

letter and spirit. Lawmaking under the guise of rulemaking

involves neither agreement of both Houses nor presentment

-

7

to the President. Section 264(c) failed to provide HHS with

rulemaking authority with respect to the privacy of ITHI upon

and immediately after enactment. Rather, § 264(c) provided

that such rulemaking authority might later pass to HHS. That

authority would pass to HHS only if legislation with respect

to that subject matter failed to be enacted by the statutory

deadline.

The abdication of Congressional responsibility

encouraged by § 264(c) is philosophically at odds with the

Constitution. Clinton, 524 U.S. at 452 (Kennedy, J., concurring)

(“ Abdication of responsibility is not part of the constitutional

design”). Section 264(c) turns delegation on its head and

conditions rulemaking authority solely upon the failure of

Congress to take action between two specified dates. It allows

Congress to avoid tough decisions. As a result, the scope of

delegation was set by HHS rather than by agreement of both

Houses and the President.

II. Congressional Lawmaking Is Supplanted By HHS

Privacy Regulations

Although not every action taken by Congress is subject to

the bicameralism and presentment requirements, those

requirements must be met when Congress exercises legislative

power. Whether particular actions are an “exercise of

legislative power depends not on their form but upon ‘whether

they contain matter which is properly to be regarded as

legislative in its character and effect.’” Chadha, 462 USS. at 952

quoting S. Rep. No. 1335, 54" Cong., 2d Sess., 8 (1897).

The legislative character of an action may be established

by an examination of the Congressional action that it

supplants. This “Supplantation Principle” was used to analyze

the constitutionality of the legislative veto in Chadha.

Id. at 952 (“The legislative character of the one-House veto in

these cases is confirmed by the character of the Congressional

action it supplants”). That principle should be extended to

apply to actions undertaken by independent agencies and

other branches of government. There is no reason not to extend

this principle to evaluate non-Congressional exercises of

legislative power.

8

In Chadha, the constitutionality of the legislative veto

provision in § 244(c)(2) of the Immigration and Nationality

Act was examined. The Supreme Court examined § 244(c)(2)

and found that it had an essentially legislative purpose and

effect. Although the Court acknowledged that § 244(c)(2)

authorized one house, by resolution, to require the Attorney

General to deport an alien whose deportation otherwise

would be canceled under § 244, the Court reasoned that

“the House took action that had the purpose and effect of altering

the legal rights, duties, and relations of persons, including the

Attorney General, Executive Branch officials and Chadha, all

outside the Legislative Branch.” Chadha, 462 U.S. at 952

(emphasis added). The Court explained that without the

House’s action, Chadha would remain in the United States.

Congress had acted and that action had altered Chadha’s

status. Without the challenged provision, Chadha’s

deportation could have been deported only by legislation

requiring deportation, if at all. Id. at 953-54.

The Court also examined the nature of the decision

implemented by the legislative veto. “After long experience

with the ... private bill procedure, Congress ... [chose] to

delegate to the ... Attorney General, the authority to allow

deportable aliens to remain in this country in certain specified

circumstances.” Id. at 954. The Court stated that the choice to

delegate was

precisely the kind of decision that can be

implemented only in accordance with the

procedures set out in Art. I. Disagreement with the

Attorney General’s decision on Chadha’s

deportation - that is, Congress’ decision to deport

Chadha - no less than Congress’ original choice to

delegate . . . involves determinations of policy that

Congress can implement in only one way;

bicameral passage followed by presentment to the

President. Congress must abide by its delegation

- of authority until that delegation is legislatively

altered or revoked.

Id. at 954-55.

9

Section 264(c) is legislative in both character and effect in

two ways. First, by its own terms, it is equivalent to legislation.

The alleged authority of HHS to promulgate regulations arose

only after Congress failed to pass legislation governing

standards with respect to the privacy of I[HI within 36 months

of the enactment of HIPAA. Second, the Regulations had the

purpose and affect of altering the rights, duties, and relations

of persons, including patients, providers, health care

clearinghouses, health plans, HHS, Office of Civil Rights and

others, all outside of Congress. Section 264(c)(1) (“Such

regulations shall address at least the subjects described in

subsection (b)”).

Subsections “a” and “b” reinforce this conclusion.

They directed the Secretary of HHS to make legislative

recommendations regarding privacy of ITHI. They set a limited

agenda for the Secretary: to make recommendations for future

legislation. The difficult policy choices regarding rights,

procedures, and uses and disclosure of ITHI were left to

Congress. Subsection “a” explicitly directed the Secretary of

HHS to submit “detailed recommendations on standards with

respect to the privacy of [IIHI].” Those recommendations

were to be received by a Senate Committee and a House

Committee. As used, the word “recommendations”

contemplated future Congressional action. In the context of

§ 264, “recommendations” were sought solely for a legislative

purpose - to propose and possibly enact future legislation.

The subjects contained in § 264(b) are legislative in nature and

include the rights an individual should have, § 264(b)(1), the

procedures for exercising those rights, § 264(b)(2), and the

determination of permitted “uses and disclosures” , § 264(b)(3).”

If Congress had enacted the recommendations with respect to

those rights, everyone in the United States would have been

affected. Similarly, the Regulations affect everyone in the

United States - people and parties outside Congress.

5. A “right” is “[a] power, privilege, or immunity granted under a

constitution, statutes, or decisional laws, or claimed as a result of long

usage” or “[a] legally enforceable claim of one person against another,

that the other shall do a given act, or shall not do a given act.” Black’s Law

Dictionary 1189 (5* ed. 1979).

10

The language seeking recommendations from HHS

set forth in Subsections “a”, “b”, and “d”, as well as the

language of Subsection “c”, suggests that no laws governing

privacy standards existed when HIPAA was enacted or prior

thereto. Congress wrote on a blank slate. It needed to be better

informed before legislating. This understanding is consistent

with Subsections “a”, “b”, and “d” under which Congress

explicitly sought recommendations from HHS regarding those

standards. Subsections “a”, “b”, and “d” reveal that Congress

had not yet made any policy determination or value judgment

regarding the standards for privacy of IIHI when it enacted

HIPAA. Marci Hamilton, Representation and NonDelegation:

Back to Basics, 20 Cardozo L. Rev. 807, 820 (1999) (“The

legislature holds primary responsibility to make the national

policy choices, and the President may not take on those

choices.”); See Clinton, 524 U.S. at 442-45, 445 n.38. Congress

had not balanced the interests of various constituencies

regarding that subject matter.° However, Congress had

recognized that it needed further advice. Consequently, HHS

rulemaking authority under § 264(c) was equated to legislation

and carved-out from the remainder of § 1173 rulemaking authority.’ -

6. Institutionally, Congress is better able to balance multiple

viewpoints than a single agency or department. See Hamilton, 20 Cardozo

L. Rev. at 814

The legislative branch serves the people by filtering the

factions in the society and distilling those laws that will best

serve the nation ... [P]ositions must be funneled through a

large number of ports before becoming governing law ...

As a result, it is capable of reaching more nuanced

compromises on national issues.

In contrast, when lawmaking is delegated to the President, there is only

one port of entry, one viewpoint, albeit representing the entire nation.

When lawmaking is delegated to an agency or executive department,

the viewpoint is even narrower and without electoral accountability.

Id. at 819-21. The best evidence of why there should be a Congressional

filter and why Congress should set national policy is the fact that

HHS received approximately 52,000 comments in connection with

its issuance of the Regulations. 67 Fed. Reg. at 14777.

7. 65 Fed. Reg. at 82469-70. Section 1173 authorized HHS to

promulgate uniform national standards regarding transactions, unique

health identifiers, code sets, security and electronic signatures. Section 1173

of the Social Security Act, 110 Stat. 2024-26 codified at 42 U.S.C. § 1320d-2.

In conference, privacy of IIHI was moved out of § 1173.

11

— ee

III. The Courts Below Violated The Separation Of Powers

Doctrine By Construing § 264(c) To Eliminate The

Statute’s Deadline For HHS Action

Petitioners and Respondents placed the construction of

§ 264(c) at issue in District Court and Court of Appeals.

The opinions reflect this concern. Joint Appendix of Petition,

Al and A18. Petitioners ask this Court to consider § 264(c)’s

plain meaning. Petition 20-26. However, the parties and courts

below have all ignored part of sentence 1 of § 264(c)(1) in

construing the remainder of the sentence. The ignored

language involves the 42 month deadline on HHS authority

to issue the Regulations. That date came and went before the

Regulations were finalized. By permitting HHS to regulate

after the deadline, the courts below “rewrote” the statute

instead of applying the Plain Meaning Rule.

Under the Separation of Powers Doctrine, courts lack

power to rewrite statutes. Our nation’s founders considered

and expressly rejected the idea that Judges join with the

Executive in a “Council of Revision”. Brief of Senators Robert

C. Byrd, Daniel Patrick Moynihan and Carl Levin as Amici

Curiae in Support of Appellees 9-10 in Clinton v. City of New

York (Docket No. 97-1374).

Section 264(c)(1) specifically and unambiguously limited

the authority of HHS to promulgate final regulations to a date

that is “NOT LATER THAN THE DATE that is 42 months after

the date of the enactment of this Act.” ® Issuing the Regulations

after that date conflicted with § 264(c)(1). Additional legislation

was required for HHS to have issued final regulations after

February 21, 2000. Congress did not enact any extension. It is

not ambiguous as to whether § 264(c)(1) required “proposed”

or “final” regulations by the deadline. The plain meanings of

“final’ and “not later than the date that is 42 months .. .” are

unmistakable. The Secretary was not directed to promulgate

PROPOSED regulations by that date. Section 264(c)(1) directed

the Secretary to promulgate FINAL regulations by the specified

date. The adjective “final” modifies the noun “regulations”.

This eliminates the possibility of having an implied

8. Section 264(c)(1) (emphasis added). This is a date certain once HIPAA

was enacted. That date is not subject to the discretion of the Secretary of HHS.

12

modification of the noun “regulations” by the adjective

“proposed”. “Final” means “not to be altered or undone”.

Webster’s Third New International Dictionary of the English

Language - Unabridged 851 (P. Gove ed. 1993).

When § 264(c)(1) is analyzed, the words “not later than”

are not ambiguous. They are an absolute bar to HHS action

after that date. Under the Constitution’s first clause, legislative

power is vested in Congress. This means that Congress alone

“writes” the laws - subject only to a Presidential veto. A flexible

interpretation of the words “not later than” would rewrite their

apparent meaning.

The distinction between “final” and “proposed”

regulations is found in the statement accompanying the release

of the Regulations in December of 2000: “As the Congress did

not enact legislation regarding the privacy of [ITHI] prior to

August 21, 1999, HHS published proposed rules setting forth

such standards on November 3, 1999, 64 Fed. Reg. 59918, and

is now publishing the mandated final regulation.” 65 Fed.

Reg. at 82470 (emphasis added). This lane usage shows that

HHS understood that “final regulations” h-.u not existed before

December 2000.

The “Plain Meaning Rule” is one of several canons of

construction applied by courts to determine the meaning of

legislation. Courts turn to this canon before others. Connecticut

National Bank v. Germain, 503 U.S. 249, 253-54 (1992) (“We have

stated time and again that courts must presume that a

legislature says in a statute what it means and means in a

statute what it says there . .. When the words of a statute are

unambiguous, then, this first canon is also the last: ‘judicial

inquiry is complete.) (Thomas, J.) (internal citations omitted).

Legislators are “ presumed to know the meaning of words and

the rules of grammar.” United States v. Goldenberg, 168 U.S. 95,

102-03 (1897). The time to promulgate final regulations had

lapsed. It could not have been extended without new

legislation.

Chief Justice Taft aptly articulated the principle that judges

are not to exercise legislative power. He said:

it is a breach of the national fundamental law if

Congress gives up its legislative power and

13

transfers it to the President, or to the judicial

branch, or if by law it attempts to invest itself or its

members with either executive power or judicial

power.

].W. Hampton, Jr., & Co. v. United States, 276 U.S. 394, 406 (1928).

The Judicial Branch does not legislate. A court must apply

the law as written and bicamerally passed by Congress and

approved by the President. Clinton, 524 US. at 448. The courts

below had no authority to elirninate “not later than the date

that is 42 months after the date of the enactment of this Act”.

The courts had acted outside of Article III and allowed HHS

to issue the Regulations ultra vires.

IV. The Separation Of Powers Doctrine And The Execution

Clause Prevent HHS From Arguing A Construction Of

§ 264(c) That Cortradicts Its Plain Meaning

Because HHS was powerless to act unless it ignored the

42 month deadline, it must argue that the deadline should be

eliminated. HHS has taken this position elsewhere. Association

of American Physicians and Surgeons, Inc. v. United States

Department of Health and Human Services, 23 (Civ. Action No.

H 01-2963) (SL) (S.D. Tex. June 14, 2002). HHS, like the courts,

must defer to the law enacted by Congress and the President.

Except for the President's ability to veto and to recommend

legislation, the Executive Branch has no role in the legislative

process. Youngstown Sheet & Tube Co. v. Sawyer, 343 U.S. 579,

587 (Black, J.) (1952) and 655 (Jackson, J., concurring). It may

not rewrite, through interpretation and advocacy, words

agreed to by the Senate, the House and the President. Allowing

HHS to promulgate regulations or to present an argument that

ignores a statute’s plain meaning undermines the deference

due a coordinate branch of government and gives the

Executive Branch power to make law.’

9. When the Secretary performed her duty, her actions could not have

reached beyond the statute that created that authority. Chadha, 462 U.S. at

953-54 n.16 and accompanying text; See also Steven F. Huefner, The Supreme

Court's Avoidance of the NonDelegation Doctrine in Clinton v. City of New York:

More than “A Dime’s Worth of Difference”, 49 Catholic Univ. L. Rev. 337, 404

(2000).

14

To have force of law, Congress must have enacted the

Regulations as new legislation or have ratified the Regulations

through new legislation.’ Post-HIPAA legislation did neither.

Ratification must be explicit. It may not be implied.

Implied ratification of agency or executive action creates

a dispensing power and allows an agency or department to

pick and choose which statutes to faithfully execute. It turns

rulemaking on its head - having agency or executive actions

control legislation instead of being controlled by legislation.

The doctrine has no support in the Constitution. It asserts a

principle which would be clothing the President and executive

departments and independent agencies with “a power entirely

to control the legislation of [C]ongress and paralyze the

administration of justice.” Kendall v. United States ex rel. Stokes,

12 Pet. (37 U.S.) 524, 613 (1838) (The Court firmly rejected the

contention that the President's duty “to see the laws faithfully

executed, implies a power to forbid their execution”).

Allowing HHS to ignore the time constraint on issuing final

regulations is the equivalent of empowering HHS to forbid

execution of a statute. So is allowing HHS to argue that the

constraint should be ignored.

Even if issuing the Regulations is viewed as “interstitial

lawmaking”, it is impermissible. The Supreme Court has long

allowed the practice of interstitial lawmaking. Wayman v.

Southard, 10 Wheat. (23 U.S.) 1, 43 (1825) (Marshall, J.).

However, the Court has not allowed interstitial regulations to

conflict with the authority provided by statute. More than a

century ago, the Court struck down an order of the Secretary

of the Navy that directed that a particular training vessel was

not to be considered “at sea” in connection with an officer’s

compensation for sea service. According to the Court, the

Secretary did not have authority to declare something as “shore

duty” that the statute requires the Navy to treat as “sea duty”.

10. Although Congress could have extended the time for HHS to issue

the “final regulations”, it failed to do so.

11. Additionally, Congress “may not ‘invest itself or its Members with

either executive power or judicial power.’” See Metropolitan Washington

Airports Authority v. Citizens for the Abatement of Aircraft Noise, Inc., 501 U.S.

252, 274 (1991); see also Hampton, 276 U.S. at 406.

1 heaalce a sal ira Sor kik ,

15

The Court declared that the Secretary only had authority to

“establish regulations in execution of, or supplementary to,

but not in conflict with, the statutes defining his powers or

conferring rights upon others.” United States v. Symonds,

120 U.S. 46, 48-49 (1887) (emphasis added). Finalizing the

Regulations on a date after February 21, 2000 is in direct conflict

with the words of § 264(c)(1) of HIPAA and must be struck

down.

To the extent that Brock v. Pierce County, 476 U.S. 253 (1986)

and its progeny,” suggest that a Congressionally imposed

deadline on agency or executive authority is flexible, those

cases ignore Symonds and Kendall and should be distinguished

or overruled.

V. Congress Defectively Delegated Authority To HHS

The principle that Congress may only delegate power it

received from the People adds a fourth component to the three-

pronged “intelligible principles” test. It is based on two

underlying concepts. First, the federal government is one of

enumerated powers. Second, a principal may not delegate

authority it lacks.

A. The 104 Congress Cannot Delegate Its Authority

Beyond The End Of Its Own Term

Since our nation’s first days, “[e]very law enacted by

Congress must be based on one or more of its powers

enumerated in the Constitution.” United States v. Morrison,

529 U.S. 598, 607 (2000); McCulloch v. Maryland, 4 Wheat.

(17 U.S.) 316, 405 (1819). Those powers are constrained by the

Constitution’s procedural requirements, see, e.g., U.S. Const.

art. I, § 7, cl.2, and substantive requirements, see, e.g.,

U.S. Const. art. I, § 9. In this case, another constraint is the

temporal limit on the Congressional franchise.

The President and members of the Senate and members

of the House of Representatives represent different geographic

constituencies, have different modes of election, and have

different requirements for holding office. U.S. Const. art. I,

12. See, e.g., United States v. Montalvo-Murillo, 495 U.S. 711 (1990);

United States v. James Daniel Good Real Property, 510 U.S. 43 (1993); Regions

Hospital v. Shalala, 522 U.S. 448 (1998); and Barnhart v. Peabody Coal Co.,

__ US. __ , 123 S. Ct. 748 (2003).

16

§§ 2 & 3, US. Const. art. I, § 1 and U.S. Const. amend. XVII.

The Constitution further diffuses power by limiting the terms

of the President and members of the Senate and House of

Representatives and by making those terms of different

lengths, i.e. they have different temporal mandates. Senators

are elected for six years. U.S. Const. art. I, § 3, cls.1&2 and

U.S. Const. amend. XVII. The President is elected for four years.

U.S. Const. art. II, § 1, cl.1. Members of the House of

— Representatives are elected for two years. U.S. Const. art. I,

§ 2, cl.1. The authority of each Representative, each Senator

and the President does not extend beyond the expiration

of his or her term in office, respectively.’° Any extension

of authority beyond the end of those terms would

unconstitutionally transfer from the People the power of the

people to choose their own representatives.'* One commentator

characterized the holding of elective offices as a “temporary

lease” from the nation’s citizens. Alan B. Morrison, A Non-

Power Looks at Separation of Powers, 79 Geo. L.J. 281, 282 (1990).

Expressed in real estate terms, the Constitution does not allow

“holdovers”. ;

When Congress “delegates” its power to “make law” ”,

the delegation mus* ‘ccur before the Congressional term ends,

i.e. the end of the term for which the House members are

elected. The reasoning is simple. A principal may delegate to

its agent only the authority within its possession. A principal

may not delegate authority that it does not have. Each House

and Senate member loses all authority from his or her

13. See Joseph Story, Commentaries on the Constitution of the United States

(Carolina Academic Press) Book III § 263.

14. George Washington said:

The power under the Constitution will always be in the

People. It is entrusted for certain defined purposes, and for a

certain limited period, to representatives of their own chusing; and

whenever it is executed contrary to their Interest, or not

agreeable to their wishes, their Servants can, and undoubtedly

will be, recalled.

Thornton, 514 U.S. at 814 n.26 (emphasis added) (internal citations omitted).

15. The power to “make law” stands in contrast to the power to

“fill-in details” or otherwise “execute” legislation. See Loving v. United States,

517 U.S. 748, 771 (1996) (Kennedy, J.).

17

constituents at term-end. Consequently, the end of a

Congressional term ends subsequent legislative actions by that

Congress. Similarly, the President has no authority to sign or

veto legislation once his or her term expires. If Congress, as

principal, cannot exercise its legislative power, then an agent

of that Congress may not exercise that power.

Section 264(c) attempts an impermissible delegation of the

power to legislate beyond the end of the Congressional term.

Rulemaking authority under § 264(c) was not permitted to

occur upon or even immediately after enactment. Rather, it

was deferred until 36 months after enactment of HIPAA.

Indeed, rulemaking would not have occurred if Congress had

enacted health privacy legislation within 36 months. Once the

105" Congress began in January 1997, the 104" Congress had

no power. After that date, the 104 Congress had no power to

legislate with respect to the standards for the privacy of

IIHI or for anything else. Consequently, the agent of the

104" Congress, HHS, lacked that power as well.

B. Congress Provided No Policy or Boundary to Limit

HHS Authority

Under the “intelligible principles” test, it is

“constitutionally sufficient if Congress clearly delineates the

general policy, the public agency which is to apply it, and the

boundaries of this delegated authority.” Mistretta v. United

States, 488 U.S. 361, 372-73 (1989) quoting American Power

& Light Co. v. S.E.C., 329 U.S. 90, 105 (1946). In addition, a

delegation is always subject to the legislation that authorized

it. Chadha, 462 U.S. at 953-54 n.16.

It has been suggested that delegation to administrative

agencies leaves a gaping hole in the Constitution's balanced

structure of checks and balances because agencies are prone

to be arbitrary and unaccountable. “The nondelegation

doctrine in this scenario is crucial to liberty, because it prohibits

general lawmaking from occurring ina structure both capable

of arbitrary action and removed from the national scrutiny to

which both Congress and the President are exposed by the

constitutional structure.” Hamilton, 20 Cardozo L. Rev. at 821.

18

Section 264(c) fails to meet two of the three “intelligible

principle” criteria. First, there is no clearly delineated general

policy. Second, there is no boundary on the delegated authority.

Neither the general policy statement contained in the

Preamble to HIPAA nor the policy statement articulated as

§ 261 of the Administrative Simplification provisions of HIPAA

“clearly delineates” a general policy that is applicable to the

privacy of IIHI.

First, HIPAA’s Preamble provides that HIPAA is:

[a]Jn act to amend the Internal Revenue Code of

1986 to improve portability and continuity of health

insurance coverage in the group and individual

markets, to combat waste, fraud, and abuse in

health insurance and health care delivery, to

promote the use of medical savings accounts, to

improve access to long-term care services and

coverage, to simplify the administration of health

insurance, and for other purposes.

110 Stat. at 1936. Privacy of IIFil is not referable to any of the

specified purposes.

The Administrative Simplification provisions comprise

subtitle F of HIPAA. The first section, § 261, contains a

statement of the purpose of subtitle F. 110 Stat. at 2021 (not

codified but appears at 42 U.S.C. § 1320d note).

The argument that “standards with respect to the privacy

of ITHI” is encompassed by the language appearing at the end

of § 261 (i.e. “through the establishment of standards and

requirements for the electronic transmission of certain health

information”) is untenable. A fair reading of that language

points to § 1173, which is entitled “STANDARDS TO ENABLE

ELECTRONIC EXCHANGE?” . It does not point to § 264, which

is entitled “RECOMMENDATIONS WITH RESPECT

TO PRIVACY OF CERTAIN HEALTH INFORMATION.”

Section 264 directed the Secretary of HHS to make

recommendations. It did not direct the Secretary to establish

any standard or requirement with respect to privacy of ITHI

upon enactment. The only authority to issue such standards

was contingent authority if Congress failed to enact legislation.

The policy and purpose with respect to privacy of ITHI were

19

to be determined by later legislation. HIPAA contained no

delineation of a policy or purpose with respect to privacy of

ITHI.

Although, the Fourth Circuit concluded these provisions

amount to a statement of “general policy”, Joint Appendix of

Petition at 8-9, the statute and Regulations do not support this

conclusion. First, neither the patient nor a surrogate designated

by the patient is required as a control or check point to limit

information transfer. Second, HIPAA contains no private right

of action for patients to protect themselves. Third, HIPAA and

the Regulations do not necessarily apply to individuals and

entities that wrongfully obtain ITHI. Fourth, HHS has created -

exceptions to the consent and authorization requirements for

transactions involving payment, treatment and healthcare

operations and HHS could conceivably create further

exceptions in the future. Fifth, the Regulations do not apply

to all of a patient's personal and medical information but only

to IIHI that is within the scope of § 1173. If privacy were truly

the policy, HHS would not have been able to lower the

confidentiality bar from that encompassed by the Hippocratic

Oath and practiced by physicians throughout our nation’s

history.

Section 264 provides no marker or check to determine

whether HHS has exceeded the authority authorized by

Congress. See Yakus v. United States, 321 U.S. 414, 423-24 (1944);

Chadha, 462 U.S. at 953.

The phrase “shall address at least” is used both to list the

subjects of legislative recommendations to be submitted by

HHS and to list the subjects of rulemaking authority to be

delegated if Congress failed to pass legislation by the statutory

deadline. The use of that phrase removed all limits on HHS’s

authority. In A.L.A. Schechter Poultry Corporation v. United States,

the Supreme Court struck down, as overly broad, a delegation

that merely affected all industries. 295 U.S. 495 (1935). The

delegation in § 264(c) is much broader. Its impact is not limited

to the healthcare industry or even to all industries. It affects

everyone. Its impact is pervasive.

Congress omitted boundaries from § 264 which contains

a minimal set of subjects to be recommended to Congress and

20

a minimal set of subjects to be included in future regulations

in the event that Congress does not enact legislation in

connection with those recommendations by the specified

future date. Because the words “address at least” appear in

§ 264(b) and § 264(c)(1), there is nothing in § 264 to constrain

HHS rulemaking authority. There are only three subjects that

must be addressed. HHS was permitted to address an infinite

number of subjects.’° In Whitman v. American Trucking

Associations, Inc., the Supreme Court said, “[t]he very choice

of which portion of the power to exercise - that is to say, the

prescription of the standard that Congress had omitted -

would itself be an exercise of the forbidden legislative

authority.” 531 U.S. 457, 473 (2001) (Scalia, J.). HHS has

exercised such forbidden legislative authority.

CONCLUSION

Under the Constitution, the power to make the law rests

squarely in the hands of Congress. Congress may not

voluntarily relinquish its basic duty - to determine what the

law shall be. Section 264 of HIPAA took that role from Congress

and handed it to HHS. Certiorari is warranted to protect

Congress from itself.

Because compliance with the Regulations has already

altered the nature of medical practice, action by the Court is

needed now and not later. Unless the Court grants the petition

and declares § 264 unconstitutional on the merits, patients will

lose their right to keep their medica! records confidential.

Whether a single electronic medical record or a million such

records is at issue, once confidentiality is lost, nothing can be

done to restore it. Therefore, the Court should address the

constitutionality of § 264 at this time.

16. To clarify this point, we assume arguendo that § 264 dealt with the

Department of Agriculture (“DoA”) and the three subjects were regulations

concerning apples, bananas and celery. Under the construction adopted by

HHS and the courts below, DoA would be allowed to regulate those three

ites as well as an infinite number of other items (e.g., dates, eggplants,

figs, green beans, . .. zucchini) even if Congress and the President never

agreed to regulate any item that DoA ultimately regulated.

Respectfully submitted,

Davip P. FELSHER

Attorney for Amici Curiae

488 Madison Avenue

New York, NY 10022

(212) 308-8505