II

106TH CONGRESS

2D SESSION S. 3131

To amend title XVIII of the Social Security Act to ensure that the Secretary

of Health and Human Services provides appropriate guidance to physicians and other health care providers that are attempting to properly

submit claims under the Medicare Program and to ensure that the

Secretary targets truly fraudulent activity for enforcement of Medicare

billing regulations, rather than inadvertent billing errors.

IN THE SENATE OF THE UNITED STATES

SEPTEMBER 28 (legislative day, SEPTEMBER 22), 2000

Mr. MURKOWSKI (for himself and Mr. ABRAHAM) 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 ensure

that the Secretary of Health and Human Services provides appropriate guidance to physicians and other health

care providers that are attempting to properly submit

claims under the Medicare Program and to ensure that

the Secretary targets truly fraudulent activity for enforcement of Medicare billing regulations, rather than

inadvertant billing errors.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,
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1 SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

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

3 ‘‘Medicare Billing and Education Act of 2000’’.

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

5 this Act is as follows:

Sec. 1. Short title; table of contents.

Sec. 2. Findings.

Sec. 3. Definitions.

TITLE I—REGULATORY REFORM

Sec. 101. Prospective application of certain regulations.

Sec. 102. Requirements for judicial and regulatory challenges of regulations.

Sec. 103. Prohibition of recovering past overpayments by certain means.

Sec. 104. Prohibition of recovering past overpayments if appeal pending.

TITLE II—APPEALS PROCESS REFORMS

Sec. 201. Reform of post-payment audit process.

Sec. 202. Definitions relating to protections for physicians, suppliers, and providers of services.

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

TITLE III—EDUCATION COMPONENTS

Sec. 301. Designated funding levels for provider education.

Sec. 302. Advisory opinions.

TITLE IV—SUSTAINABLE GROWTH RATE REFORMS

Sec. 401. Inclusion of regulatory costs in the calculation of the sustainable

growth rate.

TITLE V—STUDIES AND REPORTS

Sec. 501. GAO audit and report on compliance with certain statutory administrative procedure requirements.

Sec. 502. GAO study and report on provider participation.

Sec. 503. GAO audit of random sample audits.

6 SEC. 2. FINDINGS.

7 Congress finds the following:

8 (1) Physicians, providers of services, and sup9 pliers of medical equipment and supplies that par10 ticipate in the Medicare Program under title XVIII

11 of the Social Security Act must contend with over
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1 100,000 pages of complex Medicare regulations,

2 most of which are unknowable to the average health

3 care provider.

4 (2) Many physicians are choosing to discontinue

5 participation in the Medicare Program to avoid be6 coming the target of an overzealous Government in7 vestigation regarding compliance with the extensive

8 regulations governing the submission and payment

9 of Medicare claims.

10 (3) Health Care Financing Administration con11 tractors send post-payment review letters to physi12 cians that require the physician to submit to addi13 tional substantial Government interference with the

14 practice of the physician in order to preserve the

15 physician’s right to due process.

16 (4) When a Health Care Financing Administra17 tion contractor sends a post-payment review letter to

18 a physician, that contractor often has no telephone

19 or face-to-face communication with the physician,

20 provider of services, or supplier.

21 (5) The Health Care Financing Administration

22 targets billing errors as though health care providers

23 have committed fraudulent acts, but has not ade24 quately educated physicians, providers of services,
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1 and suppliers regarding Medicare billing require2 ments.

3 (6) The Office of the Inspector General of the

4 Department of Health and Human Services found

5 that 75 percent of surveyed physicians had never re6 ceived any educational materials from a Health Care

7 Financing Administration contractor concerning the

8 equipment and supply ordering process.

9 SEC. 3. DEFINITIONS.

10 In this Act:

11 (1) APPLICABLE AUTHORITY.—The term ‘‘ap12 plicable authority’’ has the meaning given such term

13 in section 1861(uu)(1) of the Social Security Act (as

14 added by section 202).

15 (2) CARRIER.—The term ‘‘carrier’’ means a

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

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

18 under title XVIII of such Act to administer benefits

19 under part B of such title.

20 (3) EXTRAPOLATION.—The term ‘‘extrapo21 lation’’ has the meaning given such term in section

22 1861(uu)(2) of the Social Security Act (as added by

23 section 202).

24 (4) FISCAL INTERMEDIARY.—The term ‘‘fiscal

25 intermediary’’ means a fiscal intermediary (as de-
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1 fined in section 1816(a) of the Social Security Act

2 (42 U.S.C. 1395h(a))) with an agreement under sec3 tion 1816 of such Act to administer benefits under

4 part A or B of such title.

5 (5) HEALTH CARE PROVIDER.—The term

6 ‘‘health care provider’’ has the meaning given the

7 term ‘‘eligible provider’’ in section 1897(a)(2) of the

8 Social Security Act (as added by section 301).

9 (6) MEDICARE PROGRAM.—The term ‘‘Medicare

10 Program’’ means the health benefits program under

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

12 1395 et seq.).

13 (7) PREPAYMENT REVIEW.—The term ‘‘prepay14 ment review’’ has the meaning given such term in

15 section 1861(uu)(3) of the Social Security Act (as

16 added by section 202).

17 (8) SECRETARY.—The term ‘‘Secretary’’ means

18 the Secretary of Health and Human Services.

19 TITLE I—REGULATORY REFORM

20 SEC. 101. PROSPECTIVE APPLICATION OF CERTAIN REGU21 LATIONS.

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

23 1395hh(a)) is amended by adding at the end the following

24 new paragraph:
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1 ‘‘(3) Any regulation described under paragraph

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

3 which such regulation becomes a final regulation.

4 Any regulation described under such paragraph that

5 applies to an agency action, including any agency

6 determination, shall only apply as that regulation is

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

8 SEC. 102. REQUIREMENTS FOR JUDICIAL AND REGU9 LATORY CHALLENGES OF REGULATIONS.

10 (a) RIGHT TO CHALLENGE CONSTITUTIONALITY AND

11 STATUTORY AUTHORITY OF HCFA REGULATIONS.—Sec12 tion 1872 of the Social Security Act (42 U.S.C. 1395ii)

13 is amended to read as follows:

14 ‘‘APPLICATION OF CERTAIN PROVISIONS OF TITLE II

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

16 216(j), and of subsections (a), (d), (e), (h), (i), (j), (k),

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

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

19 to title II, except that—

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

21 this title, any reference therein to the Commissioner

22 of Social Security or the Social Security Administra23 tion shall be considered a reference to the Secretary

24 or the Department of Health and Human Services,

25 respectively; and
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1 ‘‘(2) section 205(h) shall not apply with respect

2 to any action brought against the Secretary under

3 section 1331 or 1346 of title 28, United States

4 Code, regardless of whether such action is unrelated

5 to a specific determination of the Secretary, that

6 challenges—

7 ‘‘(A) the constitutionality of substantive or

8 interpretive rules of general applicability issued

9 by the Secretary;

10 ‘‘(B) the Secretary’s statutory authority to

11 promulgate such substantive or interpretive

12 rules of general applicability; or

13 ‘‘(C) a finding of good cause under sub14 paragraph (B) of the sentence following section

15 553(b)(3) of title 5, United States Code, if used

16 in the promulgation of substantive or interpre17 tive rules of general applicability issued by the

18 Secretary.’’.

19 (b) CONSTRUCTION OF HEARING RIGHTS RELATING

20 TO DETERMINATIONS BY THE SECRETARY REGARDING

21 AGREEMENTS WITH PROVIDERS OF SERVICES.—Section

22 1866(h) of the Social Security Act (42 U.S.C. 1395cc(h))

23 is amended by adding at the end the following new para24 graph:
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1 ‘‘(3) For purposes of applying paragraph (1), an in2 stitution or agency dissatisfied with a determination by

3 the Secretary described in such paragraph shall be entitled

4 to a hearing thereon regardless of whether—

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

6 Secretary or by a State pursuant to an agreement

7 entered into with the Secretary under section 1864;

8 or

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

10 a remedy, penalty, or other sanction on the institu11 tion or agency in connection with such determina12 tion.’’.

13 SEC. 103. PROHIBITION OF RECOVERING PAST OVERPAY14 MENTS BY CERTAIN MEANS.

15 (a) IN GENERAL.—Except as provided in subsection

16 (b) and notwithstanding sections 1815(a), 1842(b), and

17 1861(v)(1)(A)(ii) of the Social Security Act (42 U.S.C.

18 1395g(a), 1395u(a), and 1395x(v)(1)(A)(ii)), or any other

19 provision of law, for purposes of applying sections

20 1842(b)(3)(B)(ii), 1866(a)(1)(B)(ii), 1870, and 1893 of

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

22 1395cc(a)(1)(B)(ii), 1395gg, and 1395ddd), the Secretary

23 may not offset any future payment to a health care pro24 vider to recoup a previously made overpayment, but in-
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1 stead shall establish a repayment plan to recoup such an

2 overpayment.

3 (b) EXCEPTION.—This section shall not apply to

4 cases in which the Secretary finds evidence of fraud or

5 similar fault on the part of such provider.

6 SEC. 104. PROHIBITION OF RECOVERING PAST OVERPAY7 MENTS IF APPEAL PENDING.

8 (a) Notwithstanding any provision of law, for pur9 poses of applying sections 1842(b)(3)(B)(ii),

10 1866(a)(1)(B)(ii), 1870, and 1893 of the Social Security

11 Act (42 U.S.C. 1395u(b)(3)(B)(ii), 1395cc(a)(1)(B)(ii),

12 1395gg, and 1395ddd), the Secretary may not take any

13 action (or authorize any other person, including any fiscal

14 intermediary, carrier, and contractor under section 1893

15 of such Act (42 U.S.C. 1395ddd)) to recoup an overpay16 ment during the period in which a health care provider

17 is appealing a determination that such an overpayment

18 has been made or the amount of the overpayment.

19 (b) EXCEPTION.—This section shall not apply to

20 cases in which the Secretary finds evidence of fraud or

21 similar fault on the part of such provider.
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1 TITLE II—APPEALS PROCESS

2 REFORMS

3 SEC. 201. REFORM OF POST-PAYMENT AUDIT PROCESS.

4 (a) COMMUNICATIONS TO PHYSICIANS.—Section

5 1842 of the Social Security Act (42 U.S.C. 1395u) is

6 amended by adding at the end the following new sub7 section:

8 ‘‘(u)(1)(A) Except as provided in paragraph (2), in

9 carrying out its contract under subsection (b)(3), with re10 spect to physicians’ services, the carrier shall provide for

11 the recoupment of overpayments in the manner described

12 in the succeeding subparagraphs if—

13 ‘‘(i) the carrier or a contractor under section

14 1893 has not requested any relevant record or file;

15 and

16 ‘‘(ii) the case has not been referred to the De17 partment of Justice or the Office of Inspector Gen18 eral.

19 ‘‘(B)(i) During the 1-year period beginning on the

20 date on which a physician receives an overpayment, the

21 physician may return the overpayment to the carrier mak22 ing such overpayment without any penalty.

23 ‘‘(ii) If a physician returns an overpayment under

24 clause (i), neither the carrier nor the contractor under sec25 tion 1893 may begin an investigation or target such physi-
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1 cian based on any claim associated with the amount the

2 physician has repaid.

3 ‘‘(C) The carrier or a contractor under section 1893

4 may not recoup or offset payment amounts based on ex5 trapolation (as defined in section 1861(uu)(2)) if the phy6 sician has not been the subject of a post-payment audit.

7 ‘‘(D) As part of any written consent settlement com8 munication, the carrier or a contractor under section 1893

9 shall clearly state that the physician may submit addi10 tional information (including evidence other than medical

11 records) to dispute the overpayment amount without

12 waiving any administrative remedy or right to appeal the

13 amount of the overpayment.

14 ‘‘(E) As part of the administrative appeals process

15 for any amount in controversy, a physician may directly

16 appeal any adverse determination of the carrier or a con17 tractor under section 1893 to an administrative law judge.

18 ‘‘(F)(i) Each consent settlement communication from

19 the carrier or a contractor under section 1893 shall clearly

20 state that prepayment review (as defined in section

21 1861(uu)(3)) may be imposed where the physician submits

22 an actual or projected repayment to the carrier or a con23 tractor under section 1893. Any prepayment review shall

24 cease if the physician demonstrates to the carrier that the
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1 physician has properly submitted clean claims (as defined

2 in section 1816(c)(2)(B)(i)).

3 ‘‘(ii) Prepayment review may not be applied as a re4 sult of an action under section 201(a), 301(b), or 302.

5 ‘‘(2) If a carrier or a contractor under section 1893

6 identifies (before or during post-payment review activities)

7 that a physician has submitted a claim with a coding, doc8 umentation, or billing inconsistency, before sending any

9 written communication to such physician, the carrier or

10 a contractor under section 1893 shall contact the physi11 cian by telephone or in person at the physician’s place of

12 business during regular business hours and shall—

13 ‘‘(i) identify the billing anomaly;

14 ‘‘(ii) inform the physician of how to address the

15 anomaly; and

16 ‘‘(iii) describe the type of coding or documenta17 tion that is required for the claim.’’.

18 (b) EFFECTIVE DATE.—The amendments made by

19 this section shall take effect 60 days after the date of en20 actment of this Act.
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1 SEC. 202. DEFINITIONS RELATING TO PROTECTIONS FOR

2 PHYSICIANS, SUPPLIERS, AND PROVIDERS OF

3 SERVICES.

4 (a) IN GENERAL.—Section 1861 of the Social Secu5 rity Act (42 U.S.C. 1395 et seq.) is amended by adding

6 at the end the following new subsection:

7 ‘‘Definitions Relating to Protections for Physicians,

8 Suppliers, and Providers of Services

9 ‘‘(uu) For purposes of provisions of this title relating

10 to protections for physicians, suppliers of medical equip11 ment and supplies, and providers of services:

12 ‘‘(1) APPLICABLE AUTHORITY.—The term ‘ap13 plicable authority’ means the carrier, contractor

14 under section 1893, or fiscal intermediary that is re15 sponsible for making any determination regarding a

16 payment for any item or service under the Medicare

17 Program under this title.

18 ‘‘(2) EXTRAPOLATION.—The term ‘extrapo19 lation’ means the application of an overpayment dol20 lar amount to a larger grouping of physician claims

21 than those in the audited sample to calculate a pro22 jected overpayment figure.

23 ‘‘(3) PREPAYMENT REVIEW.—The term ‘pre24 payment review’ means the carriers’ and fiscal inter25 mediaries’ practice of withholding claim reimburse26 ments from eligible providers even if the claims have
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1 been properly submitted and reflect medical services

2 provided.’’.

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

4 BENEFICIARIES.

5 Notwithstanding section 1870 of the Social Security

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

7 Secretary shall permit any health care provider to appeal

8 any determination of the Secretary under the Medicare

9 Program on behalf of a deceased beneficiary where no sub10 stitute party is available.

11 TITLE III—EDUCATION

12 COMPONENTS

13 SEC. 301. DESIGNATED FUNDING LEVELS FOR PROVIDER

14 EDUCATION.

15 (a) EDUCATION PROGRAMS FOR PHYSICIANS, PRO16 VIDERS OF SERVICES, AND SUPPLIERS.—Title XVIII of

17 the Social Security Act (42 U.S.C. 1395 et seq.) is amend18 ed by adding at the end the following new section:

19 ‘‘EDUCATION PROGRAMS FOR PHYSICIANS, PROVIDERS OF

20 SERVICES, AND SUPPLIERS

21 ‘‘SEC. 1897. (a) DEFINITIONS.—In this section:

22 ‘‘(1) EDUCATION PROGRAMS.—The term ‘edu23 cation programs’ means programs undertaken in

24 conjunction with Federal, State, and local medical

25 societies, specialty societies, other providers, and the
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1 Federal, State, and local associations of such pro2 viders that—

3 ‘‘(A) focus on current billing, coding, cost

4 reporting, and documentation laws, regulations,

5 fiscal intermediary and carrier manual instruc6 tions;

7 ‘‘(B) place special emphasis on billing, cod8 ing, cost reporting, and documentation errors

9 that the Secretary has found occur with the

10 highest frequency; and

11 ‘‘(C) emphasize remedies for these im12 proper billing, coding, cost reporting, and docu13 mentation practices.

14 ‘‘(2) ELIGIBLE PROVIDERS.—The term ‘eligible

15 provider’ means a physician (as defined in section

16 1861(r)), a provider of services (as defined in sec17 tion 1861(u)), or a supplier of medical equipment

18 and supplies (as defined in section 1834(j)(5)).

19 ‘‘(b) CONDUCT OF EDUCATION PROGRAMS.—

20 ‘‘(1) IN GENERAL.—Carriers and fiscal inter21 mediaries shall conduct education programs for any

22 eligible provider that submits a claim under para23 graph (2)(A).

24 ‘‘(2) ELIGIBLE PROVIDER EDUCATION.—
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1 ‘‘(A) SUBMISSION OF CLAIMS AND

2 RECORDS.—Any eligible provider may volun3 tarily submit any present or prior claim or med4 ical record to the applicable authority (as de5 fined in section 1861(uu)(1)) to determine

6 whether the billing, coding, and documentation

7 associated with the claim is appropriate.

8 ‘‘(B) PROHIBITION OF EXTRAPOLATION.—

9 No claim submitted under subparagraph (A) is

10 subject to any type of extrapolation (as defined

11 in section 1861(uu)(2)).

12 ‘‘(c) SAFE HARBOR.—No submission of a claim or

13 record under this section shall result in the carrier or a

14 contractor under section 1893 beginning an investigation

15 or targeting an individual or entity based on any claim

16 or record submitted under such subparagraph.

17 ‘‘(3) TREATMENT OF IMPROPER CLAIMS.—If

18 the carrier or fiscal intermediary finds a claim to be

19 improper, the eligible provider shall have the fol20 lowing options:

21 ‘‘(A) CORRECTION OF PROBLEMS.—To

22 correct the documentation, coding, or billing

23 problem to appropriately substantiate the claim

24 and either—

25 ‘‘(i) remit the actual overpayment; or
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1 ‘‘(ii) receive the appropriate additional

2 payment from the carrier or fiscal inter3 mediary.

4 ‘‘(B) REPAYMENT.—To repay the actual

5 overpayment amount if the service was not cov6 ered under the Medicare Program under this

7 title or if adequate documentation does not

8 exist.

9 ‘‘(4) PROHIBITION OF ELIGIBLE PROVIDER

10 TRACKING.—The applicable authorities may not use

11 the record of attendance of any eligible provider at

12 an education program conducted under this section

13 or the inquiry regarding claims under paragraph

14 (2)(A) to select, identify, or track such eligible pro15 vider for the purpose of conducting any type of audit

16 or prepayment review.’’.

17 (b) FUNDING OF EDUCATION PROGRAMS.—

18 (1) MEDICARE INTEGRITY PROGRAM.—Section

19 1893(b)(4) of the Social Security Act (42 U.S.C.

20 1395ddd(b)(4)) is amended by adding at the end the

21 following new sentence: ‘‘No less than 10 percent of

22 the program funds shall be devoted to the education

23 programs for eligible providers under section 1897.’’.

24 (2) CARRIERS.—Section 1842(b)(3)(H) of the

25 Social Security Act (42 U.S.C. 1395u(b)(3)(H)) is
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1 amended by adding at the end the following new

2 clause:

3 ‘‘(iii) No less than 2 percent of carrier

4 funds shall be devoted to the education

5 programs for eligible providers under sec6 tion 1897.’’.

7 (3) FISCAL INTERMEDIARIES.—Section

8 1816(b)(1) of the Social Security Act (42 U.S.C.

9 1395h(b)(1)) is amended—

10 (A) in subparagraph (A), by striking

11 ‘‘and’’ at the end;

12 (B) in subparagraph (B), by striking ‘‘;

13 and’’ and inserting a comma; and

14 (C) by adding at the end the following new

15 subparagraph:

16 ‘‘(C) that such agency or organization is

17 using no less than 1 percent of its funding for

18 education programs for eligible providers under

19 section 1897.’’.

20 (c) EFFECTIVE DATE.—The amendments made by

21 this section shall take effect 60 days after the date of en22 actment of this Act.

23 SEC. 302. ADVISORY OPINIONS.

24 (a) STRAIGHT ANSWERS.—
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1 (1) IN GENERAL.—Fiscal intermediaries and

2 carriers shall do their utmost to provide health care

3 providers with one, straight and correct answer re4 garding billing and cost reporting questions under

5 the Medicare Program, and will, when requested,

6 give their true first and last names to providers.

7 (2) WRITTEN REQUESTS.—

8 (A) IN GENERAL.—The Secretary shall es9 tablish a process under which a health care pro10 vider may request, in writing from a fiscal

11 intermediary or carrier, assistance in address12 ing questionable coverage, billing, documenta13 tion, coding and cost reporting procedures

14 under the Medicare Program and then the fis15 cal intermediary or carrier shall respond in

16 writing within 30 business days with the correct

17 billing or procedural answer.

18 (B) USE OF WRITTEN STATEMENT.—

19 (i) IN GENERAL.—Subject to clause

20 (ii), a written statement under paragraph

21 (1) may be used as proof against a future

22 payment audit or overpayment determina23 tion under the Medicare Program.

24 (ii) EXTRAPOLATION PROHIBITION.—

25 Subject to clause (iii), no claim submitted
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1 under this section shall be subject to ex2 trapolation.

3 (iii) LIMITATION ON APPLICATION.—

4 Clauses (i) and (ii) shall not apply to cases

5 of fraudulent billing.

6 (C) SAFE HARBOR.—If a physician re7 quests an advisory opinion under this sub8 section, neither the fiscal intermediary, the car9 rier, nor a contractor under section 1893 of the

10 Social Security Act (42 U.S.C. 1395ddd) may

11 begin an investigation or target such physician

12 based on any claim cited in the request.

13 (b) EXTENSION OF EXISTING ADVISORY OPINION

14 PROVISIONS OF LAW.—Section 1128D(b) of the Social Se15 curity Act (42 U.S.C. 1320a–7d(b)) is amended—

16 (1) in paragraph (4), by adding at the end the

17 following new subparagraph:

18 ‘‘(C) SAFE HARBOR.—If a party requests

19 an advisory opinion under this subsection, nei20 ther the fiscal intermediary, the carrier, nor a

21 contractor under section 1893 may begin an in22 vestigation or target such party based on any

23 claim cited in the request.’’; and
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1 (2) in paragraph (6), by striking, ‘‘ and before

2 the date which is 4 years after such date of enact3 ment’’.

4 TITLE IV—SUSTAINABLE

5 GROWTH RATE REFORMS

6 SEC. 401. INCLUSION OF REGULATORY COSTS IN THE CAL7 CULATION OF THE SUSTAINABLE GROWTH

8 RATE.

9 (a) IN GENERAL.—Section 1848(f)(2) of the Social

10 Security Act (42 U.S.C. 1395w–4(f)(2)) is amended—

11 (1) by redesignating subparagraphs (A) through

12 (D) as clauses (i) through (iv), respectively;

13 (2) by striking ‘‘SPECIFICATION OF GROWTH

14 RATE.—The sustainable growth rate’’ and inserting

15 ‘‘SPECIFICATION OF GROWTH RATE.—

16 ‘‘(A) IN GENERAL.—The sustainable

17 growth rate’’; and

18 (3) by adding at the end the following new sub19 paragraphs:

20 ‘‘(B) INCLUSION OF SGR REGULATORY

21 COSTS.—The Secretary shall include in the esti22 mate established under clause (iv)—

23 ‘‘(i) the costs for each physicians’

24 service resulting from any regulation im25 plemented by the Secretary during the year
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1 for which the sustainable growth rate is es2 timated, including those regulations that

3 may be implemented during such year; and

4 ‘‘(ii) the costs described in subpara5 graph (C).

6 ‘‘(C) INCLUSION OF OTHER REGULATORY

7 COSTS.—The costs described in this subpara8 graph are any per procedure costs incurred by

9 each physicians’ practice in complying with

10 each regulation promulgated by the Secretary,

11 regardless of whether such regulation affects

12 the fee schedule established under subsection

13 (b)(1).

14 ‘‘(D) INCLUSION OF COSTS IN REGU15 LATORY IMPACT ANALYSES.—With respect to

16 any regulation promulgated on or after January

17 1, 2001, that may impose a regulatory cost de18 scribed in subparagraph (B)(i) or (C) on a phy19 sician, the Secretary shall include in the regu20 latory impact analysis accompanying such regu21 lation an estimate of any such cost.’’.

22 (b) EFFECTIVE DATE.—The amendments made by

23 subsection (a) shall apply with respect to any estimate

24 made by the Secretary of Health and Human Services on

25 or after the date of enactment of this Act.
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1 TITLE V—STUDIES AND

2 REPORTS

3 SEC. 501. GAO AUDIT AND REPORT ON COMPLIANCE WITH

4 CERTAIN STATUTORY ADMINISTRATIVE PRO5 CEDURE REQUIREMENTS.

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

7 States shall conduct an audit of the compliance of the

8 Health Care Financing Administration and all regulations

9 promulgated by the Department of Health and Human

10 Resources under statutes administered by the Health Care

11 Financing Administration with—

12 (1) the provisions of such statutes;

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

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

15 and

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

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

18 date of enactment of this Act, the Comptroller General

19 shall submit to Congress a report on the audit conducted

20 under subsection (a), together with such recommendations

21 for legislative and administrative action as the Comp22 troller General determines appropriate.
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1 SEC. 502. GAO STUDY AND REPORT ON PROVIDER PARTICI2 PATION.

3 (a) STUDY.—The Comptroller General of the United

4 States shall conduct a study on provider participation in

5 the Medicare Program to determine whether policies or

6 enforcement efforts against health care providers have re7 duced access to care for Medicare beneficiaries. Such

8 study shall include a determination of the total cost to

9 physician, supplier, and provider practices of compliance

10 with Medicare laws and regulations, the number of physi11 cian, supplier, and provider audits, the actual overpay12 ments assessed in consent settlements, and the attendant

13 projected overpayments communicated to physicians, sup14 pliers, and providers as part of the consent settlement

15 process.

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

17 date of enactment of this Act, the Comptroller General

18 shall submit to Congress a report on the study conducted

19 under subsection (a), together with such recommendations

20 for legislative and administrative action as the Comp21 troller General determines appropriate.

22 SEC. 503. GAO AUDIT OF RANDOM SAMPLE AUDITS.

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

24 States shall conduct an audit to determine—
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1 (1) the statistical validity of random sample au2 dits conducted under the Medicare Program before

3 the date of the enactment of this Act;

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

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

6 1861(v)(1)(A)(ii) of the Social Security Act (42

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

8 (3) the effects of the application of such audits

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

10 1866(a)(1)(B)(ii), 1870, and 1893 of such Act (42

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

12 1395ddd); and

13 (4) the percentage of claims found to be im14 proper from these audits, as well as the proportion

15 of the extrapolated overpayment amounts to the

16 overpayment amounts found from the analysis of the

17 original sample.

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

19 date of the 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.

Æ