II

106TH CONGRESS

2D SESSION S. 2999

To amend title XVIII of the Social Security Act to reform the regulatory

processes used by the Health Care Financing Administration to administer the medicare program, and for other purposes.

IN THE SENATE OF THE UNITED STATES

JULY 27, 2000

Mr. ABRAHAM (for himself, Mr. COCHRAN, and Mr. GRAMS) introduced the

following bill; which was read twice and referred to the Committee on Finance

A BILL

To amend title XVIII of the Social Security Act to reform

the regulatory processes used by the Health Care Financing Administration to administer the medicare program, and for other purposes.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

4 (a) SHORT TITLE.—This Act may be cited as the

5 ‘‘Health Care Provider Bill of Rights’’.

6 (b) TABLE OF CONTENTS.—The table of contents of

7 this Act is as follows:

Sec. 1. Short title; table of contents.

Sec. 2. Definitions.
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TITLE I—REFORM OF HCFA REGULATORY PROCESS

Sec. 101. Prospective application of certain regulations.

Sec. 102. Notice and hearing requirements for certain interim final regulations.

Sec. 103. GAO Audit and report on compliance with certain statutory administrative procedure requirements.

Sec. 104. Requirements for judicial and regulatory challenges of regulations.

Sec. 105. Reform of national coverage determination process.

TITLE II—REFORM OF APPEALS PROCESS

Sec. 201. Appeal of overpayment determinations.

Sec. 202. Time lines for appeals.

Sec. 203. Right to appeal on behalf of deceased beneficiaries.

Sec. 204. Suspension of certain activities while appeals are pending.

Sec. 205. National precedence of departmental appeals board determinations.

Sec. 206. Requirements for affirmative appeal of HCFA actions.

Sec. 207. GAO audit of random sample audits.

TITLE III—REFORM OF OVERPAYMENT PROCEDURE

Sec. 301. Prohibition of retroactive overpayment determinations.

Sec. 302. Prohibition of sampling audits to reduce future reimbursements.

Sec. 303. Prohibition of recovering past overpayments by certain means.

Sec. 304. Prohibition of recovering past overpayments if appeal pending.

TITLE IV—REFORM OF VOLUNTARY DISCLOSURE PROCEDURE

Sec. 401. Promulgation of joint voluntary disclosure procedures.

TITLE V—CRIMINAL LAW ENFORCEMENT REFORMS

Sec. 501. No law enforcement authority for employees of the Office of Inspector

General of the Department of Health and Human Services.

Sec. 502. Search warrants on health care facilities.

TITLE VI—PROVIDER COMPLIANCE EDUCATION

Sec. 601. Education.

Sec. 602. Advisory opinions.

1 SEC. 2. DEFINITIONS.

2 In this Act:

3 (1) CARRIER.—The term ‘‘carrier’’ means a

4 carrier (as defined in section 1842(f) of the Social

5 Security Act (42 U.S.C. 1395u(f))) with a contract

6 under title XVIII of such Act to administer benefits

7 under part B of such title.
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1 (2) FISCAL INTERMEDIARY.—The term ‘‘fiscal

2 intermediary’’ means a fiscal intermediary (as de3 fined in section 1816(a) of the Social Security Act

4 (42 U.S.C. 1395h(a))) with an agreement under sec5 tion 1816 of such Act to administer benefits under

6 part A or part B of such title.

7 (3) HCFA.—The term ‘‘HCFA’’ means the

8 Health Care Financing Administration.

9 (4) HEALTH CARE PROVIDER.—The term

10 ‘‘health care provider’’ means any individual or enti11 ty participating in the medicare program, including

12 a Medicare+Choice organization under part C of

13 such program.

14 (5) MEDICARE PROGRAM.—The term ‘‘medicare

15 program’’ means the health benefits program under

16 title XVIII of the Social Security Act (42 U.S.C.

17 1395 et seq.).

18 (6) SECRETARY.—The term ‘‘Secretary’’ means

19 the Secretary of Health and Human Services.
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1 TITLE I—REFORM OF HCFA

2 REGULATORY PROCESS

3 SEC. 101. PROSPECTIVE APPLICATION OF CERTAIN REGU4 LATIONS.

5 Section 1871(a) of the Social Security Act (42 U.S.C.

6 1395hh(a)) is amended by adding at the end the following

7 new paragraph:

8 ‘‘(3) Any regulation described under paragraph

9 (2) may not take effect earlier than the date on

10 which such regulation becomes a final regulation.

11 Any regulation described under such paragraph that

12 applies to an agency action, including any agency

13 determination, shall only apply as that regulation is

14 in effect at the time that agency action is taken.’’.

15 SEC. 102. NOTICE AND HEARING REQUIREMENTS FOR CER16 TAIN INTERIM FINAL REGULATIONS.

17 Section 1871(a) of the Social Security Act (42 U.S.C.

18 1395hh(a)), as amended by section 101, is amended by

19 adding at the end the following new paragraph:

20 ‘‘(4) In prescribing any interim final regulation

21 described under paragraph (2)—

22 ‘‘(A) the Secretary shall provide notice and

23 a hearing in accordance with section 553(b) of

24 title 5, United States Code; and
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1 ‘‘(B) subparagraph (B) of the sentence fol2 lowing section 553(b)(3) of such title shall not

3 apply.’’.

4 SEC. 103. GAO AUDIT AND REPORT ON COMPLIANCE WITH

5 CERTAIN STATUTORY ADMINISTRATIVE PRO6 CEDURE REQUIREMENTS.

7 (a) AUDIT.—The Comptroller General of the United

8 States shall conduct an audit of the compliance of the

9 Health Care Financing Administration and all regulations

10 promulgated by the Department of Health and Human

11 Resources under statutes administered by the Health Care

12 Financing Administration with—

13 (1) the provisions of such statutes;

14 (2) subchapter II of chapter 5 of title 5, United

15 States Code (including section 553 of such title);

16 and

17 (3) chapter 6 of title 5, United States Code.

18 (b) REPORT.—Not later than 18 months after the

19 date of enactment of this Act, the Comptroller General

20 shall submit to Congress a report on the audit conducted

21 under subsection (a), together with such recommendations

22 for legislative and administrative action as the Comp23 troller General determines appropriate.
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1 SEC. 104. REQUIREMENTS FOR JUDICIAL AND REGU2 LATORY CHALLENGES OF REGULATIONS.

3 (a) RIGHT TO CHALLENGE CONSTITUTIONALITY AND

4 STATUTORY AUTHORITY OF HCFA REGULATIONS.—Sec5 tion 1872 of the Social Security Act (42 U.S.C. 1395ii)

6 is amended to read as follows:

7 ‘‘APPLICATION OF CERTAIN PROVISIONS OF TITLE II

8 ‘‘SEC. 1872. The provisions of sections 206 and

9 216(j), and of subsections (a), (d), (e), (h), (i), (j), (k),

10 and (l) of section 205, shall also apply with respect to this

11 title to the same extent as they are applicable with respect

12 to title II, except that—

13 ‘‘(1) in applying such provisions with respect to

14 this title, any reference therein to the Commissioner

15 of Social Security or the Social Security Administra16 tion shall be considered a reference to the Secretary

17 or the Department of Health and Human Services,

18 respectively; and

19 ‘‘(2) section 205(h) shall not apply with respect

20 to any action brought against the Secretary under

21 sections 1331 or 1346 of title 28, United States

22 Code, regardless of whether such action is unrelated

23 to a specific determination of the Secretary, that

24 challenges—

25 ‘‘(A) the constitutionality of the Sec26 retary’s regulations or policies;
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1 ‘‘(B) the Secretary’s statutory authority to

2 promulgate such regulations or policies; or

3 ‘‘(C) a finding of good cause under sub4 paragraph (B) of the sentence following section

5 553(b)(3), United States Code.’’.

6 (b) CONSTRUCTION OF HEARING RIGHTS RELATING

7 TO DETERMINATIONS BY THE SECRETARY REGARDING

8 AGREEMENTS WITH PROVIDERS OF SERVICES.—Section

9 1866(h) of the Social Security Act (42 U.S.C. 1395cc(h))

10 is amended by adding at the end the following new para11 graph:

12 ‘‘(3) For purposes of applying paragraph (1), an in13 stitution or agency dissatisfied with a determination by

14 the Secretary described in such paragraph shall be entitled

15 to a hearing thereon regardless of whether—

16 ‘‘(A) such determination has been made by the

17 Secretary or by a State pursuant to an agreement

18 entered into with the Secretary under section 1864;

19 and

20 ‘‘(B) the Secretary has imposed or may impose

21 a remedy, penalty, or other sanction on the institu22 tion or agency in connection with such determina23 tion.’’.
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1 SEC. 105. REFORM OF NATIONAL COVERAGE DETERMINA2 TION PROCESS.

3 (a) IN GENERAL.—Section 1871(a) of the Social Se4 curity Act (42 U.S.C. 1395hh(a)), as amended by section

5 102, is amended by adding at the end the following new

6 paragraph:

7 ‘‘(5) In the case of any national coverage deter8 mination, the Secretary shall provide for—

9 ‘‘(A) notice of the proposed national cov10 erage determination in the Federal Register;

11 and

12 ‘‘(B) a period of not less than 30 days for

13 public comment thereon, during which—

14 ‘‘(i) any provider of services to

15 present comments in oral or written form

16 to the Medicare Coverage Advisory Com17 mittee or any other official of the Health

18 Care Financing Administration responsible

19 for making the national coverage deter20 mination; and

21 ‘‘(ii) any other person may present

22 comments in written form to such Com23 mittee or official.’’.

24 (b) EFFECTIVE DATE.—The amendment made by

25 subsection (a) shall apply to national coverage determina26 tions made on or after the date of enactment of this Act.
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1 TITLE II—REFORM OF APPEALS

2 PROCESS

3 SEC. 201. APPEAL OF OVERPAYMENT DETERMINATIONS.

4 Notwithstanding sections 1870 and 1879 of the So5 cial Security Act (42 U.S.C. 1395gg and 1395pp) or any

6 other provision of law, the Secretary may not require a

7 health care provider to waive any right under the medicare

8 program to appeal an overpayment determination of the

9 Secretary if such provider agrees to accept a stated dollar

10 amount potential projected overpayment.

11 SEC. 202. TIME LINES FOR APPEALS.

12 Section 1869 of the Social Security Act (42 U.S.C.

13 1395ff) is amended—

14 (1) in subsection (a), by inserting ‘‘consistent

15 with subsections (c) and (d)’’ before the period; and

16 (2) by adding at the end the following new sub17 sections:

18 ‘‘(c) DEADLINES FOR RECONSIDERATIONS AND AP19 PEALS UNDER PART A.—Reconsideration and appeals

20 under subsections (a) and (b) with respect to matters

21 under part A shall be conducted consistent with the fol22 lowing deadlines:

23 ‘‘(1) DEADLINES FOR ADMINISTRATIVE AC24 TION.—
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1 ‘‘(A) RECONSIDERED DETERMINATION.—

2 The Secretary shall conduct and conclude a re3 consideration of an initial determination, and

4 mail the notice of reconsidered determination,

5 by not later than the end of the 60-day period

6 beginning on the date a request for reconsider7 ation has been timely filed.

8 ‘‘(B) HEARING BY ADMINISTRATIVE LAW

9 JUDGE.—

10 ‘‘(i) IN GENERAL.—Except as pro11 vided in clause (ii), an administrative law

12 judge shall conduct and conclude a hearing

13 and render a decision on such hearing by

14 not later than the end of the 90-day period

15 beginning on the date a request for hear16 ing has been timely filed.

17 ‘‘(ii) WAIVER OF DEADLINE BY PARTY

18 SEEKING HEARING.—The 90-day period

19 under clause (i) shall not apply in the case

20 of a motion or stipulation by the party re21 questing the hearing to waive such period.

22 ‘‘(C) DEPARTMENTAL APPEALS BOARD RE23 VIEW.—The Departmental Appeals Board of

24 the Department of Health and Human Services

25 shall conduct and conclude a review of the deci-
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1 sion on a hearing described in subparagraph

2 (B) and make a decision or remand the case to

3 the administrative law judge for reconsideration

4 by not later than the end of the 90-day period

5 beginning on the date a request for review has

6 been timely filed.

7 ‘‘(2) CONSEQUENCES OF FAILURE TO MEET

8 DEADLINES.—

9 ‘‘(A) IN GENERAL.—

10 ‘‘(i) FAILURE TO NOTIFY.—In the

11 case of a failure by the Secretary to mail

12 the notice of reconsidered determination by

13 the end of the period described in para14 graph (1)(A), the party requesting the re15 consideration may request a hearing before

16 an administrative law judge, notwith17 standing any requirements for a reconsid18 ered determination for purposes of the par19 ty’s right to such hearing.

20 ‘‘(ii) FAILURE OF ALJ TO DECIDE.—

21 In the case of a failure by an administra22 tive law judge to render a decision by the

23 end of the period described in paragraph

24 (1)(B), the party requesting the hearing

25 may request a review by the Departmental
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1 Appeals Board of the Department of

2 Health and Human Services, notwith3 standing any requirements for a hearing

4 for purposes of the party’s right to such a

5 review.

6 ‘‘(B) DAB HEARING PROCEDURE.—In the

7 case of a request described in subparagraph

8 (A)(ii), the Departmental Appeals Board shall

9 review the case de novo.

10 ‘‘(d) DEADLINES FOR REVIEWS AND APPEALS

11 UNDER PART B.—Reviews and appeals under subsections

12 (a) and (b) with respect to matters under part B shall

13 be conducted consistent with the following deadlines:

14 ‘‘(1) DEADLINES.—

15 ‘‘(A) REVIEW OF INITIAL DETERMINA16 TION.—A carrier shall conduct and conclude a

17 review of an initial determination, and mail the

18 notice of review determination, by not later

19 than the end of the 60-day period beginning on

20 the date a request for review has been timely

21 filed.

22 ‘‘(B) CARRIER HEARING.—

23 ‘‘(i) DEADLINE FOR DECISION.—A

24 carrier shall conduct and conclude a hear25 ing, and mail the notice of the decision, by
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1 not later than the end of the 60-day period

2 beginning on the date a request for a car3 rier hearing has been timely filed.

4 ‘‘(ii) OPTION TO PROCEED TO HEAR5 ING BY ADMINISTRATIVE LAW JUDGE.—No

6 carrier hearing shall be held, and no re7 quirement for a carrier hearing shall apply,

8 with respect to rights to a hearing before

9 an administrative law judge, if the party to

10 the carrier review elects a hearing before

11 an administrative law judge in lieu of a

12 carrier hearing.

13 ‘‘(C) HEARING BY ADMINISTRATIVE LAW

14 JUDGE.—

15 ‘‘(i) IN GENERAL.—Except as pro16 vided in clause (ii), an administrative law

17 judge shall conduct and conclude a hearing

18 and render a decision on such hearing by

19 not later than the end of the 90-day period

20 beginning on the date a request for hear21 ing has been timely filed.

22 ‘‘(ii) WAIVER OF DEADLINE BY PARTY

23 SEEKING HEARING.—The 90-day period

24 under clause (i) shall not apply in the case
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1 of a motion or stipulation by the party re2 questing the hearing to waive such period.

3 ‘‘(D) DEPARTMENTAL APPEALS BOARD RE4 VIEW.—The Departmental Appeals Board of

5 the Department of Health and Human Services

6 shall conduct and conclude a review of the deci7 sion on a hearing described in subparagraph

8 (C) and make a decision or remand the case to

9 the administrative law judge for reconsideration

10 by not later than the end of the 90-day period

11 beginning on the date a request for review has

12 been timely filed.

13 ‘‘(2) CONSEQUENCES OF FAILURE TO MEET

14 DEADLINES.—

15 ‘‘(A) IN GENERAL.—

16 ‘‘(i) FAILURE TO NOTIFY.—In the

17 case of a failure by a carrier to mail notice

18 within the time period described in para19 graph (A) or (B) of paragraph (1), the

20 party requesting the review or carrier hear21 ing (as the case may be) may request a

22 hearing before an administrative law judge,

23 notwithstanding any requirements for a

24 carrier review or a carrier hearing for pur-
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1 poses of the party’s right to a hearing be2 fore such judge.

3 ‘‘(ii) FAILURE OF ALJ TO DECIDE.—

4 In the case of a failure by an administra5 tive law judge to render a decision by the

6 end of the period described in paragraph

7 (1)(C), the party requesting the hearing

8 may request a review by the Departmental

9 Appeals Board, notwithstanding any re10 quirements for a hearing for purposes of

11 the party’s right to such a review.

12 ‘‘(B) DAB HEARING PROCEDURE.—In the

13 case of a request described in subparagraph

14 (A)(ii), the Departmental Appeals Board shall

15 review the case de novo.’’.

16 SEC. 203. RIGHT TO APPEAL ON BEHALF OF DECEASED

17 BENEFICIARIES.

18 Notwithstanding section 1870 of the Social Security

19 Act (42 U.S.C. 1395gg) or any other provision of law, the

20 Secretary shall permit any health care provider to appeal

21 any determination of the Secretary under the medicare

22 program on behalf of a deceased beneficiary where no sub23 stitute party is available.
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1 SEC. 204. SUSPENSION OF CERTAIN ACTIVITIES WHILE AP2 PEALS ARE PENDING.

3 (a) IN GENERAL.—Section 1866 of the Social Secu4 rity Act (42 U.S.C. 1395cc) is amended by adding at the

5 end the following new subsection:

6 ‘‘(j) For purposes of subsections (b) and (c), the

7 Secretary—

8 ‘‘(1) may not impose any sanction, terminate an

9 agreement, or refuse to renew such an agreement

10 with a provider of services under this title during the

11 period in which any appeal of such provider regard12 ing a deficiency that is the basis of such sanction,

13 termination, or nonrenewal is pending;

14 ‘‘(2) may not publicly disseminate any informa15 tion regarding any deficiency of a provider of serv16 ices that is the subject of an appeal before such ap17 peal is finally adjudicated; and

18 ‘‘(3) shall permit any provider of services to ap19 peal a surveyor deficiency of such provider that does

20 not result in a recommendation of termination.’’.

21 (b) EFFECTIVE DATE.—The amendment made by

22 subsection (a) shall apply to agreements entered into or

23 renewed on or after the date of the enactment of this Act.
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1 SEC. 205. NATIONAL PRECEDENCE OF DEPARTMENTAL AP2 PEALS BOARD DETERMINATIONS.

3 Notwithstanding any other provision of law, any de4 termination of the Departmental Appeals Board of the

5 Department of Health and Human Services under the

6 medicare program shall have national precedential value

7 with respect to any determination of an administrative law

8 judge under such program.

9 SEC. 206. REQUIREMENTS FOR AFFIRMATIVE APPEAL OF

10 HCFA ACTIONS.

11 (a) IN GENERAL.—Subchapter III of chapter 37 of

12 title 31, United States Code, is amended by adding at the

13 end the following new section:

14 ‘‘§ 3734. Rules for certain actions based on health

15 care claims

16 ‘‘(a) IN GENERAL.—In the case of any action that

17 is brought under this subchapter based on a claim sub18 mitted with respect to a federally funded health care pro19 gram, the preceding provisions of this subchapter shall

20 apply only to the extent that such provisions are consistent

21 with the provisions of this section.

22 ‘‘(b) ACTIONS IF AMOUNT OF DAMAGES ARE MATE23 RIAL AMOUNT.—Notwithstanding the preceding sections

24 of this subchapter, no action may be brought under this

25 subchapter based on a claim that is submitted under a

26 federally funded health care program unless the amount
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1 of damages alleged to have been sustained by the United

2 States Government with respect to such claim is a mate3 rial amount.

4 ‘‘(c) ACTIONS FOR CLAIMS SUBMITTED IN RELIANCE

5 ON OFFICIAL GUIDANCE.—Notwithstanding the preceding

6 sections of this subchapter, no action may be brought

7 under this subchapter based on a claim submitted—

8 ‘‘(1) in reliance on (and correctly using) erro9 neous information supplied by a Federal agency (or

10 an agent thereof) about matters of fact at issue; or

11 ‘‘(2) in reliance on (and correctly applying)

12 written statements of Federal policy which affects

13 such claim provided by a Federal agency (or an

14 agent thereof).

15 ‘‘(d) STANDARD OF PROOF.—In any action brought

16 under this subchapter with respect to a claim submitted

17 to a federally funded health care program, section 3731(c)

18 shall be applied by substituting ‘clear and convincing evi19 dence’ for ‘a preponderance of the evidence’.

20 ‘‘(e) RULE OF CONSTRUCTION.—Nothing in this sec21 tion shall be construed as limiting the authority of the

22 Government of the United States to recoup or otherwise

23 recover damages with respect to a claim submitted to a

24 federally funded health care program under provisions of

25 law other than this subchapter.
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1 ‘‘(f) DEFINITIONS; RELATED RULES.—For purposes

2 of this section—

3 ‘‘(1) the term ‘claim’ means a claim (as defined

4 in section 3729(c)) made with respect to a federally

5 funded health care program;

6 ‘‘(2) the term ‘damages’ means the amount of

7 any overpayment made by the United States Govern8 ment with respect to a claim;

9 ‘‘(3) the term ‘federally funded health care pro10 gram’ means a program that provides health bene11 fits, whether directly, through the purchase of insur12 ance, or otherwise, that is established under—

13 ‘‘(A) title XVIII, XIX, or XXI of the So14 cial Security Act, or

15 ‘‘(B) title 10, of this Code; and

16 ‘‘(4)(A) the amount of damages alleged to have

17 been sustained by the United States Government

18 with respect to a claim submitted by (or on behalf

19 of) a person shall be treated as a ‘material amount’

20 only if such amount exceeds a proportion (specified

21 in regulations promulgated by the Secretary in con22 sultation with the Secretary of Defense) of the total

23 of the amounts for which claims were submitted by

24 (or on behalf of) such person—
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1 ‘‘(i) to the same federally funded health

2 care program, and

3 ‘‘(ii) for the same calendar year,

4 as the claim upon which an action under this sub5 chapter is based;

6 ‘‘(B) the regulations specifying the proportion

7 referred to in paragraph (4) shall be based on the

8 definition of the term ‘material’ used by the Amer9 ican Institute of Certified Public Accountants as of

10 the date of the enactment of this section; and

11 ‘‘(C) in determining whether an amount of

12 damages is a ‘material amount’ under subparagraph

13 (A), with respect to a person—

14 ‘‘(i) the amount of damages for more than

15 1 claim may be aggregated only if the acts or

16 omissions resulting in such damages were part

17 of a pattern of related acts or omissions by

18 such person, and

19 ‘‘(ii) if damages for more than 1 claim are

20 aggregated in accordance with clause (i), the

21 proportion referred to in such subparagraph

22 shall be determined by comparing the amount

23 of such aggregate damages to the total of the

24 amounts for which claims were submitted by (or

25 on behalf of) such person to the same federally
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1 funded health care program for each of the cal2 endar years for which any claim upon which

3 such aggregate damages were based was sub4 mitted.’’.

5 (b) CONFORMING AMENDMENT.—The table of sec6 tions for chapter 37 of title 31, United States Code, is

7 amended by adding after the item relating to section 3733

8 the following new item:

‘‘3734. Rules for certain actions based on health care claims.’’.

9 (c) EFFECTIVE DATE.—The amendment made by

10 subsection (a) shall apply to actions brought under sub11 chapter III of chapter 37 of title 31, United States Code,

12 with respect to claims submitted before, on, and after the

13 date of the enactment of this Act.

14 SEC. 207. GAO AUDIT OF RANDOM SAMPLE AUDITS.

15 (a) AUDIT.—The Comptroller General of the United

16 States shall conduct an audit to determine—

17 (1) the statistical validity of random sample au18 dits conducted under the medicare program before

19 the date of the enactment of this Act;

20 (2) the necessity of such audits for purposes of

21 administering sections 1815(a), 1842(a), and

22 1861(v)(1)(A)(ii) of the Social Security Act (42

23 U.S.C. 1395g(a), 1395u(a), and 1395x(v)(1)(A)(ii));

24 and
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1 (3) the effects of the application of such audits

2 to health care providers under sections 1842(b),

3 1866(a)(1)(B)(ii), 1870, and 1893 of such Act (42

4 U.S.C. 1395u(a), 1395cc(a)(1)(B)(ii), 1395gg, and

5 1395ddd).

6 (b) REPORT.—Not later than 18 months after the

7 date of the enactment of this Act, the Comptroller General

8 shall submit to Congress a report on the audit conducted

9 under subsection (a), together with such recommendations

10 for legislative and administrative action as the Comp11 troller General determines appropriate.

12 TITLE III—REFORM OF

13 OVERPAYMENT PROCEDURE

14 SEC. 301. PROHIBITION OF RETROACTIVE OVERPAYMENT

15 DETERMINATIONS.

16 (a) IN GENERAL.—Section 1870 of the Social Secu17 rity Act (42 U.S.C. 1395gg) is amended by adding at the

18 end the following new subsection:

19 ‘‘(h)(1)(A) For purposes of applying the 3-year limi20 tation under subsections (b) and (c), sections

21 1842(b)(3)(B)(ii) and 1866(a)(1)(B)(ii), the Secretary

22 may only revise a determination that more than the cor23 rect amount has been paid under this title to a provider

24 of services or other person for any item or service fur-
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1 nished to an individual in accordance with subparagraph

2 (B).

3 ‘‘(B) The Secretary may revise a determination that

4 more than the correct amount has been paid under this

5 title to a provider of services or other person for any item

6 or service furnished to an individual—

7 ‘‘(i) within 12 months from the date of the no8 tice of the determination to the party to such deter9 mination; or

10 ‘‘(ii) after the 12-month period described in

11 clause (i), but within 3 years after the date of the

12 notice of the initial determination to the individual,

13 upon establishment of good cause for reopening such

14 determination.

15 ‘‘(2) Notwithstanding the 3-year limitation under

16 subsections (b) and (c), and sections 1842(b)(3)(B)(ii)

17 and 1866(a)(1)(B)(ii), the Secretary may revise a deter18 mination that more than the correct amount has been paid

19 under this title to a provider of services or other person

20 for any item or service furnished to an individual at any

21 time if such determination—

22 ‘‘(A) is unfavorable to a provider of services or

23 other person to which the overpayment was made,

24 but only for the purpose of correcting clerical error
24

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1 or error on the face of the evidence on which such

2 determination was based; or

3 ‘‘(B) was procured by fraud or similar fault of

4 the beneficiary or some other individual other than

5 the provider of services or other person to which

6 such overpayment was made.

7 ‘‘(3) For purposes of making any revision under

8 paragraph (1) or (2), the Secretary shall apply regulations

9 in effect at the time the overpayment was made.’’.

10 (b) EFFECTIVE DATE.—The amendment made by

11 subsection (a) shall apply to overpayment determinations

12 made on or after the date of the enactment of this Act.

13 SEC. 302. PROHIBITION OF SAMPLING AUDITS TO REDUCE

14 FUTURE REIMBURSEMENTS.

15 Notwithstanding sections 1815(a), 1842(b), and

16 1861(v)(1)(A)(ii) of the Social Security Act (42 U.S.C.

17 1395g(a), 1395u(a), and 1395x(v)(1)(A)(ii)), or any other

18 provision of law, for purposes of sections

19 1842(b)(3)(B)(ii), 1866(a)(1)(B)(ii), 1870, and 1893 of

20 such Act (42 U.S.C. 1395u(b)(3)(B)(ii),

21 1395cc(a)(1)(B)(ii), 1395gg, 1395ddd), the Secretary

22 may not determine the amount of any overpayment or un23 derpayment based on a sampling audit (including any de24 termination based on the rate of denied claims of such

25 provider), unless the Secretary finds clear and convincing
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1 evidence of fraud or similar fault on the part of such pro2 vider.

3 SEC. 303. PROHIBITION OF RECOVERING PAST OVERPAY4 MENTS BY CERTAIN MEANS.

5 Notwithstanding sections 1815(a), 1842(b), and

6 1861(v)(1)(A)(ii) of the Social Security Act (42 U.S.C.

7 1395g(a), 1395u(a), and 1395x(v)(1)(A)(ii)), or any other

8 provision of law, for purposes of applying sections

9 1842(b)(3)(B)(ii), 1866(a)(1)(B)(ii), 1870, and 1893 of

10 such Act (42 U.S.C. 1395u(b)(3)(B)(ii),

11 1395cc(a)(1)(B)(ii), 1395gg, and 1395ddd), the Secretary

12 may not adjust any payments to a health care provider

13 on account of a previously made overpayment unless the

14 Secretary finds clear and convincing evidence of fraud or

15 similar fault on the part of such provider.

16 SEC. 304. PROHIBITION OF RECOVERING PAST OVERPAY17 MENTS IF APPEAL PENDING.

18 Notwithstanding any provision of law, for purposes

19 of applying sections 1842(b)(3)(B)(ii), 1866(a)(1)(B)(ii),

20 1870, and 1893 of the Social Security Act (42 U.S.C.

21 1395u(b)(3)(B)(ii), 1395cc(a)(1)(B)(ii), 1395gg,

22 1395ddd), the Secretary may not take any action (or au23 thorize any other person, including any fiscal inter24 mediary, carrier, and entity with a contract under section

25 1893 of such Act (42 U.S.C. 1395ddd)) to recoup an over-
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1 payment during the period in which a health care provider

2 may appeal a determination that such an overpayment has

3 been made or the amount of the overpayment.

4 TITLE IV—REFORM OF VOL5 UNTARY DISCLOSURE PROCE6 DURE

7 SEC. 401. PROMULGATION OF JOINT VOLUNTARY DISCLO8 SURE PROCEDURES.

9 (a) VOLUNTARY DISCLOSURE.—No criminal prosecu10 tion under title XI of the Social Security Act (42 U.S.C.

11 1301 et seq.) and no civil action under such title, the

12 medicare program, or section 3729, 3730, or 3731 of title

13 31, United States Code, may be instituted against a health

14 care provider with respect to a matter that such provider

15 has voluntarily disclosed in accordance with the regula16 tions promulgated under subsection (b).

17 (b) REGULATIONS.—

18 (1) PROMULGATION.—The Secretary and the

19 Attorney General, acting jointly, shall establish, by

20 regulation, voluntary disclosure procedures that

21 apply with respect to any potential violations of Fed22 eral criminal, civil, or administrative laws by a

23 health care provider under the Medicare program.

24 (2) HEALTH CARE PROVIDER IMMUNITY.—The

25 regulations promulgated under paragraph (1) shall
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1 provide that, unless the Secretary establishes by

2 independently obtained clear and convincing evidence

3 that such potential violation is the result of criminal

4 fraud or similar fault on the part of a health care

5 provider, such provider shall be immune from any

6 action described in paragraph (3) if such provider

7 reports such potential violation in accordance with

8 the regulations promulgated under paragraph (1)

9 before a record or information request is issued by

10 a fiscal intermediary, carrier, entity with a contract

11 under section 1893 of the Social Security Act, Fed12 eral law enforcement agency, or other appropriate

13 official with regards to an investigation for such po14 tential violation; and

15 (3) ACTION DESCRIBED.—An action described

16 in this section is any—

17 (A) criminal prosecution or civil action

18 under title XI of the Social Security Act (42

19 U.S.C. 1301 et seq.);

20 (B) civil action under the medicare pro21 gram; or

22 (C) civil action for false claims under sec23 tions 3729, 3730, or 3731 of title 31, United

24 States Code.
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1 TITLE V—CRIMINAL LAW

2 ENFORCEMENT REFORMS

3 SEC. 501. NO LAW ENFORCEMENT AUTHORITY FOR EM4 PLOYEES OF THE OFFICE OF INSPECTOR

5 GENERAL OF THE DEPARTMENT OF HEALTH

6 AND HUMAN SERVICES.

7 (a) IN GENERAL.—Chapter 203 of title 18, United

8 States Code, is amended by adding at the end the fol9 lowing new section:

10 ‘‘§ 3064. No law enforcement authority for employees

11 of the Office of Inspector General of the

12 Department of Health and Human Serv13 ices

14 ‘‘Notwithstanding any other provision of law, no em15 ployee of the Office of Inspector General of the Depart16 ment of Health and Human Services may—

17 ‘‘(1) be deputized or carry out any law enforce18 ment activity, including the execution of a search

19 warrant or the making of an arrest without a war20 rant; or

21 ‘‘(2) carry a firearm in carrying out any official

22 duty of that employee.’’.

23 (b) TECHNICAL AND CONFORMING AMENDMENT.—

24 The analysis for chapter 203 of title 18, United States
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1 Code, is amended by adding at the end the following new

2 item:

‘‘3064. No law enforcement authority for employees of the Office of Inspector

General of the Department of Health and Human Services.’’.

3 SEC. 502. SEARCH WARRANTS ON HEALTH CARE FACILI4 TIES.

5 (a) IN GENERAL.—Chapter 205 of title 18, United

6 States Code, is amended by adding at the end the fol7 lowing new section:

8 ‘‘§ 3119. Search warrants on health care facilities

9 ‘‘(a) DEFINITION.—In this section—

10 ‘‘(1) the term ‘health care facility’ means any

11 facility at which direct patient care is routinely con12 ducted or at which confidential medical records are

13 maintained; and

14 ‘‘(2) the term ‘officer’ means any person au15 thorized to serve a search warrant under section

16 3105.

17 ‘‘(b) APPLICATION FOR WARRANT.—

18 ‘‘(1) IN GENERAL.—Notwithstanding any other

19 provision of law, an application for a search warrant

20 on a health care facility may not be made without

21 the express approval of the Assistant Attorney Gen22 eral for the Criminal Division of the Department of

23 Justice that includes the information required under

24 paragraph (2), after consultation by the Assistant
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1 Attorney General with the chief of the fraud section

2 of such Division in accordance with that paragraph.

3 ‘‘(2) CONSULTATION.—The consultation re4 quired by paragraph (1) shall include a discussion

5 of, and any subsequent approval by the Assistant

6 Attorney General under that paragraph to apply for

7 the search warrant and shall require the inclusion in

8 the application of, specific information regarding the

9 proposed search, including—

10 ‘‘(A) the intended target or targets;

11 ‘‘(B) the potential violation or violations of

12 law being investigated;

13 ‘‘(C) a brief factual summary;

14 ‘‘(D) a description of the premises to be

15 searched;

16 ‘‘(E) any records, information, and objects

17 to be searched;

18 ‘‘(F) the reasons why less intrusive means

19 are unavailable or unreasonable;

20 ‘‘(G) the procedures to be followed in con21 ducting the search to protect patient safety and

22 ensure uninterrupted delivery of health care

23 services; and

24 ‘‘(H) procedures to be followed in con25 ducting the search to protect the confidentiality
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1 of patient records and to provide the health

2 care facility the opportunity to copy documents

3 that are confiscated.

4 ‘‘(3) CONTENTS OF APPLICATION.—Notwith5 standing any other provision of law, an application

6 for a search warrant on a health care facility shall

7 contain a draft search warrant.

8 ‘‘(c) EXECUTION OF WARRANT.—Notwithstanding

9 any other provision of law, an officer executing a search

10 warrant on a health care facility—

11 ‘‘(1) shall take the least intrusive approach,

12 consistent with vigorous and effective law enforce13 ment, after giving consideration to obtaining infor14 mation from other sources or through subpoenas

15 (with the prior approval of the Assistant United

16 States Attorney for the appropriate district);

17 ‘‘(2) if the search is conducted in a patient care

18 area, shall abide by instructions of the health care

19 facility specific to patient safety, including using

20 special equipment and protective clothing, and com21 plying with specific procedures;

22 ‘‘(3) shall make every effort to avoid entering a

23 critical care or patient care room, or a patient room;

24 and
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1 ‘‘(4) shall not disrupt any employee providing

2 direct patient care or remove any employee from a

3 patient care area, except to protect the safety of the

4 employee, a patient, or the officer.’’.

5 (b) TECHNICAL AND CONFORMING AMENDMENT.—

6 The analysis for chapter 205 of title 18, United States

7 Code, is amended by adding at the end the following new

8 item:

‘‘3119. Search warrants on health care facilities.’’.

9 TITLE VI—PROVIDER

10 COMPLIANCE EDUCATION

11 SEC. 601. EDUCATION.

12 (a) USE OF FUNDS.—

13 (1) CARRIERS.—Each carrier shall devote at

14 least 3 percent of the funds provided to it under the

15 medicare program each year (beginning with 2001)

16 toward education of health care providers to ensure

17 that information about the operation of the medicare

18 program is properly disseminated to provider, sup19 plier, and physician.

20 (2) FISCAL INTERMEDIARIES.—Each fiscal

21 intermediary shall devote at least 3 percent of the

22 funds provided it under the medicare program (be23 ginning with 2001) toward education of health care

24 providers to ensure that information about the oper-
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1 ation of the medicare program is properly dissemi2 nated.

3 (3) MEDICARE INTEGRITY PROGRAM.—The Sec4 retary shall ensure that 10 percent of the funds ex5 pended under the medicare integrity program each

6 year (beginning with 2001) are used for education of

7 health care providers to ensure that information

8 about the operation of the medicare program is

9 properly disseminated.

10 (4) PURPOSE.—The purpose of funding under

11 this subsection is to ensure that health care pro12 viders learn of new coverage, billing, documentation,

13 and coding changes to medicare laws and regulations

14 in a timely manner.

15 (5) CONSTRUCTION.—Education attendance

16 lists or inquiries may not be used as evidence of pos17 sible wrongdoings by health care providers under the

18 medicare program and may not lead to fraud inves19 tigations under that program.

20 (b) RIGHT TO INFORMATION.—Health care providers

21 have the right to timely and accurate information about

22 coverage, billing, documentation, and coding changes and

23 modifications to local carrier guidelines under the medi24 care program. Fiscal intermediaries and carriers will offer

25 each health care provider the right to receive this informa-
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1 tion by electronic or certified mail (in addition to check

2 stuffers, monthly carrier bulletins, the annual ‘‘Dear Doc3 tor’’ letter, individual letters, seminars, and other means).

4 (c) ADDITIONAL EDUCATIONAL OUTREACH.—

5 (1) IN GENERAL.—The Secretary shall initiate

6 additional educational outreach for health care pro7 viders for coverage, billing, documentation, and cod8 ing issues that have the most frequent billing errors.

9 Such outreach shall include issue-specific e-mails,

10 faxes, mailings, and telephone calls.

11 (2) IN-PERSON VISITS.—If, within 9 months

12 after the date that the additional outreach is initi13 ated under paragraph (1), a carrier finds that no

14 evidence exists that health care provider billing er15 rors under the medicare program have lessened, then

16 the carrier shall complete an in-person visit to rel17 evant health care providers, within three months.

18 (d) RIGHT TO TELEPHONE CONVERSATION.—A

19 health care provider may request a telephone conversation

20 or in-person visit with a carrier, without being suspected

21 of fraud, regarding questions about coverage, documenta22 tion, coding or billing practices under the medicare pro23 gram.
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1 SEC. 602. ADVISORY OPINIONS.

2 (a) STRAIGHT ANSWERS.—Fiscal intermediaries and

3 carriers shall do their utmost to provide health care pro4 viders with one, straight and correct answer regarding bill5 ing and cost reporting questions under the medicare pro6 gram, and will, when requested, give their true first and

7 last names to providers.

8 (b) WRITTEN REQUESTS.—

9 (1) IN GENERAL.—The Secretary shall establish

10 a process under which a health care provider may

11 request, in writing from a fiscal intermediary or car12 rier, assistance in addressing questionable coverage,

13 billing, documentation, coding and cost reporting

14 procedures under the medicare program and then

15 the fiscal intermediary or carrier shall respond in

16 writing within 30 business days with the correct bill17 ing or procedural answer.

18 (2) USE OF WRITTEN STATEMENT.—

19 (A) IN GENERAL.—Subject to subpara20 graph (B), a written statement under para21 graph (1) may be used as proof against a fu22 ture audit or overpayment under the medicare

23 program.

24 (B) LIMIT ON APPLICATION.—Subpara25 graph (A) shall not apply retroactively and shall

26 not apply to cases of fraudulent billing.
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1 SEC. 603. EXTENSION OF EXISTING ADVISORY OPINION

2 PROVISIONS OF LAW.

3 Section 11280(b)(6) of the Social Security Act (42

4 U.S.C. 1320(b)(6)) shall be amended by striking, ‘‘and be5 fore the date which is 4 years after August 21, 1996’’.

Æ