I 
108TH CONGRESS 
1ST SESSION 
H. R. 941
To amend title XVIII of the Social Security Act to provide for the expeditious 
coverage of new medical technology under the Medicare Program, and 
for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
FEBRUARY 26, 2003
Mr. RAMSTAD (for himself, Ms. ESHOO, Mr. PITTS, Mr. CRANE, Mr. CAMP, 
and Ms. DUNN) introduced the following bill; which was referred to the 
Committee on Ways and Means, and in addition to the Committee on En-
ergy and Commerce, for a period to be subsequently determined by the 
Speaker, in each case for consideration of such provisions as fall within 
the jurisdiction of the committee concerned 
A BILL 
To amend title XVIII of the Social Security Act to provide 
for the expeditious coverage of new medical technology 
under the Medicare Program, and for other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE; REFERENCES; TABLE OF CON-
TENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Medicare Innovation Responsiveness Act of 2003’’.
that begins on the date a request for the national 
coverage determination has been received by the Sec-
retary. 
‘‘(ii) In this subparagraph—
‘‘(I) the term ‘implement’ includes determining 
what code, if any, is assigned to the particular item 
or service; determining the amount of payment to be 
made under this title for the item or service; assign-
ing the item or service, and codes for the item or 
service, to appropriate payment groups; incor-
porating the coverage, coding, and payment deter-
minations into the information processing systems of 
the Secretary and fiscal intermediaries and carriers; 
and taking such other steps as are necessary to 
make payments for the item or service no later than 
the end of the applicable period described in clause 
(i); and 
‘‘(II) the term ‘interested party’ means individ-
uals entitled to benefits under part A, or enrolled 
under part B, or both, who are in need of the items 
or services that are the subject of the coverage de-
termination, providers of services, physicians, practi-
tioners, suppliers, and manufacturers of such items 
or services.
‘‘(B) In making a national coverage determination 
under this subsection, the Secretary shall take one of the 
following actions: 
‘‘(i) Issue a national coverage determination, 
with or without limitations. 
‘‘(ii) Issue a national noncoverage determina-
tion. 
‘‘(iii) Issue a determination that no national 
coverage or noncoverage determination is appro-
priate as of the end of such period with respect to 
national coverage of such items or services. 
‘‘(C) If the Secretary fails to take an action under 
subparagraph (B) within the applicable period under sub-
paragraph (A)(i), the Secretary shall issue a notice that 
includes the following information: 
‘‘(i) A statement that the Secretary cannot 
make and (if applicable) implement (as defined in 
subparagraph (A)(ii)(I)) a national coverage deter-
mination within the applicable time period. 
‘‘(ii) The identification of substantive issues 
outstanding. 
‘‘(iii) A statement of what is required, including 
the process involved, to resolve those issues. 
‘‘(iv) The date by which the Secretary will make 
a national coverage determination under subpara-
graph (B) and (if applicable) implement the national 
coverage determination. 
‘‘(D)(i) A technology assessment referred to in sub-
paragraph (A) is a formal, written technology assessment, 
conducted by an entity or organization other than the Cen-
ters for Medicare & Medicaid Services (in this subpara-
graph referred to as the ‘CMS’), or review by an advisory 
committee appointed to advise the Administrator of the 
CMS on matters relating to the interpretation, applica-
tion, or implementation of subsection (a), that the Admin-
istrator reasonably finds, in a written notice issued before 
the end of the 6-month period specified in subparagraph 
(A)(i), that such an assessment or review is necessary for 
the Administrator to make the national coverage deter-
mination. 
‘‘(ii) Such technology assessment or review shall only 
be considered necessary if the CMS lacks adequate exper-
tise to evaluate the matter itself. 
‘‘(E) In making a national coverage determination 
under subparagraph (B), the Secretary shall include all 
the information described in subparagraphs (C) and (D) 
of paragraph (2), and in the case of the implementation 
of the national coverage determination, applicable codes 
and payment amounts for the new item or service.
‘‘(2) In making a national coverage determination (as 
defined in section 1869(f)(1)(B)) the Secretary shall en-
sure that—
‘‘(A) the public is afforded notice and oppor-
tunity to comment prior to implementation by the 
Secretary of the determination; 
‘‘(B) meetings of advisory committees estab-
lished under section 1114(f) with respect to the de-
termination are made on the record; 
‘‘(C) in making the determination, the Sec-
retary has considered applicable information (includ-
ing clinical experience and medical, technical, and 
scientific evidence) with respect to the subject mat-
ter of the determination; 
‘‘(D) in issuing the determination, provide a 
clear statement of the basis for the determination 
(including responses to comments received from the 
public) and the assumptions underlying that basis; 
and 
‘‘(E) make available to the public the data 
(other than proprietary data) considered in making 
the determination.’’. 
(b) CONFORMING AMENDMENT.—Subsection (a) of 
such section is amended by striking the third sentence.
(c) EFFECTIVE DATE.—The amendments made by 
this section shall take effect on the date of the enactment 
of this Act, and apply to requests for national coverage 
determinations made on or after the date that is 90 days 
after such effective date. 
SEC. 102. COUNCIL FOR TECHNOLOGY AND INNOVATION. 
Section 1868 (42 U.S.C. 1395ee) is amended—
(1) by adding at the end of the heading the fol-
lowing: ‘‘; COUNCIL FOR TECHNOLOGY AND 
INNOVATION’’; 
(2) by inserting ‘‘PRACTICING PHYSICIANS AD-
VISORY COUNCIL.—(1)’’ after ‘‘(a)’’; 
(3) in paragraph (1), as so redesignated under 
paragraph (2), by striking ‘‘in this section’’ and in-
serting ‘‘in this subsection’’; 
(4) by redesignating subsections (b) and (c) as 
paragraphs (2) and (3), respectively; and 
(5) by adding at the end the following new sub-
section: 
‘‘(c) COUNCIL
FOR
TECHNOLOGY
AND
INNOVA-
TION.—
‘‘(1) ESTABLISHMENT.—The Secretary shall es-
tablish a Council for Technology and Innovation 
within the Centers for Medicare & Medicaid Services 
(in this section referred to as ‘CMS’).
‘‘(2) COMPOSITION.—The Council shall be com-
posed of senior CMS staff and clinicians and shall 
be chaired by the Executive Coordinator for Tech-
nology and Innovation (appointed or designated 
under paragraph (4)). 
‘‘(3) DUTIES.—The Council shall coordinate the 
activities of coverage, coding, and payment processes 
with respect to new technologies and procedures, in-
cluding new drug therapies, under this title in order 
to expedite patient access to new technologies and 
therapies. 
‘‘(4) EXECUTIVE
COORDINATOR
FOR
TECH-
NOLOGY AND INNOVATION.—The Secretary shall ap-
point (or designate) a noncareer appointee (as de-
fined in section 3132(a)(7) of title 5, United States 
Code) who shall serve as the Executive Coordinator 
for Technology and Innovation. Such executive coor-
dinator shall report to the Administrator of CMS, 
shall chair the Council, shall oversee the execution of 
its duties, shall serve as a single point of contact for 
outside groups and entities regarding the coverage, 
coding, and payment processes under this title, and 
shall prepare reports to Congress required under 
section 1869(f)(7).’’.