SEC. 103. IMPROVEMENTS TO THE MEDICARE COVERAGE 
DETERMINATION APPEALS PROCESS. 
(a) IN
GENERAL.—Section 1869(f) (42 U.S.C. 
1395ff(f)) is amended—
(1) in paragraph (1)(A)(iii)—
(A) in subclause (I)—
(i) by inserting ‘‘(in all forms, includ-
ing written and oral depositions, interrog-
atories, and requests for admission)’’ after 
‘‘discovery’’; and 
(ii) by inserting ‘‘and shall determine 
when any new evidence not previously con-
sidered by the Centers for Medicare and 
Medicaid Services (hereafter in this sub-
section referred to as ‘CMS’) is material 
and should first be considered by CMS’’ 
after ‘‘determination’’ the second place it 
appears; and 
(B) by redesignating subclauses (II) and 
(III) as subclauses (III) and (IV), respectively, 
and inserting after subclause (I) the following: 
‘‘(II) shall determine when a 
complaint has become moot;’’; 
(2) in paragraph (1)(A)(v), by adding at the 
end the following: ‘‘Such a decision shall be imple-
mented not later than 30 days after receipt of the
decision, and any request for a stay of such imple-
mentation pending further appeal or reconsideration 
shall be supported by evidence demonstrating a ma-
terial risk of irreparable harm.’’; 
(3) in paragraph (2)(A)(i)—
(A) in subclause (I)—
(i) by inserting ‘‘(in all forms, includ-
ing but not limited to, written and oral 
depositions, interrogatories, and requests 
for admission)’’ after ‘‘discovery’’; and 
(ii) by inserting ‘‘and shall determine 
when any new evidence not previously con-
sidered by CMS material and should first 
be considered by CMS’’ after ‘‘determina-
tion’’ the second place it appears; and 
(B) by redesignating subclauses (II) and 
(III) as subclauses (III) and (IV), respectively, 
and inserting after subclause (I) the following: 
‘‘(II) shall determine when a 
complaint has become moot;’’; 
(4) by adding at the end of paragraph (2)(A) 
the following: 
‘‘(v) Any request for a stay of a deci-
sion pending further appeal or reconsider-
ation shall be supported by evidence dem-
onstrating a material risk of irreparable 
harm.’’; 
(5) in paragraph (5)—
(A) by inserting ‘‘(or the heirs or assignees 
of such individuals)’’ after ‘‘individuals’’; and 
(B) by adding at the end the following: 
‘‘For purposes of the preceding sentence, indi-
viduals ‘in need of an item or service’ include 
individuals for whom a claim for the item or 
service is denied prior to appeal, without regard 
to whether or not such individual obtains such 
item or service after such denial).’’; and 
(6) by adding at the end the following: 
‘‘(9) PROMULGATION
OF
REGULATIONS.—The 
Departmental Appeals Board (and any successor en-
tity) shall have the exclusive authority to promulgate 
regulations interpreting this subsection. Such regula-
tions shall not be subject to review by the Secretary 
or the Office of Management and Budget, but are 
instead deemed to be subject to the review process 
established by sections 801 through 808 of title 5, 
United States Code. No regulations shall be issued 
to interpret this subsection unless such regulations 
are issued by the Departmental Appeals Board.’’.
(b) EFFECTIVE DATE.—The amendments made by 
subsection (a) shall apply to any local or national coverage 
determination made on or after January 1, 2004. 
SEC. 104. MEDICARE COVERAGE OF ROUTINE COSTS ASSO-
CIATED WITH CERTAIN CLINICAL TRIALS. 
(a) IN GENERAL.—With respect to the coverage of 
routine costs of care for beneficiaries participating in a 
qualifying clinical trial, as set forth on the date of the en-
actment of this Act in National Coverage Determination 
30-1 of the Medicare Coverage Issues Manual, the Sec-
retary shall deem clinical trials conducted in accordance 
with an investigational device exemption approved under 
section 520(g) of the Federal Food, Drug, and Cosmetic 
Act (42 U.S.C. 360j(g)) to be automatically qualified for 
such coverage. 
(b) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed as authorizing or requiring the Sec-
retary to modify the regulations set forth on the date of 
the enactment of this Act at subpart B of part 405 of 
title 42, Code of Federal Regulations, or subpart A of part 
411 of such title, relating to coverage of, and payment 
for, a medical device that is the subject of an investiga-
tional device exemption by the Food and Drug Adminis-
tration (except as may be necessary to implement sub-
section (a)).
(c) EFFECTIVE DATE.—This section shall apply to 
clinical trials begun before, on, or after the date of the 
enactment of this Act and to items and services furnished 
on or after such date. 
TITLE II—PROVISIONS 
RELATING TO CODING 
SEC. 201. IMPROVEMENTS TO THE HCPCS CODING ASSIGN-
MENT, INPATIENT CODING ASSIGNMENT, AND 
DRG ASSIGNMENT PROCESSES. 
(a) INPATIENT PPS.—Section 1886(d)(5)(K) (42 
U.S.C. 1395ww(d)(5)(K)) is amended by adding at the 
end the following new clause: 
‘‘(vii)(I) The Secretary shall by regu-
lation establish a process that provides for 
the assignment of inpatient hospital codes 
(as defined in clause (iii)) for new medical 
services and related technologies as of 
April 1 of each year (beginning with 
2003). 
‘‘(II) Such process shall provide for 
the opportunity to apply for the assign-
ment of an inpatient hospital code to items 
that are the subject of an application sub-
mitted for investigation under section
520(g) of the Federal Food, Drug and 
Cosmetic Act (21 U.S.C. 360j(g)). 
‘‘(III) The assignment of codes as of 
the date specified in subclause (I) shall not 
require the Secretary to adjust the pay-
ment (or diagnosis-related group classifica-
tion) under this subsection until the first 
fiscal year that begins after such date.’’. 
(b) HCPCS LEVEL II CODES.—
(1) PROCESS FOR ASSIGNMENT OF CODES FOR 
NEW TECHNOLOGIES.—The Secretary of Health and 
Human Services (in this section referred to as the 
‘‘Secretary’’) shall by regulation establish a process 
that provides for the assignment of HCPCS Level II 
codes each calendar quarter for new medical services 
and technologies. Such process shall ensure that 
codes are assigned and implemented no later than 
180 days after a formal application for such a code 
is received. 
(2) ELIMINATION OF MINIMUM PERIOD OF MAR-
KETING
EXPERIENCE
REQUIREMENT.—The Sec-
retary may not condition consideration or approval 
of an application for a HCPCS Level II code on hav-
ing a minimum period of marketing experience with