I 
110TH CONGRESS 
2D SESSION 
H. R. 6270 
To amend the Federal Food, Drug, and Cosmetic Act to create a new 
conditional approval system for drugs, biological products, and devices 
that is responsive to the needs of seriously ill patients, and for other 
purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 12, 2008 
Ms. WATSON (for herself, Mr. BURTON of Indiana, Mr. LATHAM, Ms. EDDIE 
BERNICE JOHNSON of Texas, Ms. SOLIS, Ms. JACKSON-LEE of Texas, 
Mr. CUMMINGS, and Mr. CONYERS) introduced the following bill; which 
was referred to the Committee on Energy and Commerce, and in addition 
to the Committee on Ways and Means, for a period to be subsequently 
determined by the Speaker, in each case for consideration of such provi-
sions as fall within the jurisdiction of the committee concerned 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
create a new conditional approval system for drugs, bio-
logical products, and devices that is responsive to the 
needs of seriously ill patients, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Access, Compassion, 
Care, and Ethics for Seriously Ill Patients Act’’ or the 
‘‘ACCESS Act’’. 
SEC. 2. FINDINGS. 
Congress finds the following: 
(1) As of 2008, the standards of the Food and 
Drug Administration for approval of drugs, biologi-
cal products, and devices may deny the benefits of 
medical progress to seriously ill patients who face 
morbidity or death from their disease. 
(2) Seriously ill patients have a right to take 
actions to preserve their life by accessing available 
investigational drugs, biological products, and de-
vices. 
(3) The emphasis on statistical analysis of clin-
ical information needs to be balanced by a reliance 
on clinical evaluation and patient-reported outcomes 
and considered with an understanding of the risks to 
patients from their disease, with the goal of pro-
viding additional treatment options for patients and 
their physicians to consider. 
(4) Food and Drug Administration advisory 
committees should have greater representation of 
medical clinicians and patient advocates who rep-
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resent the interests of seriously ill patients in early 
access to promising investigational therapies. 
(5) The use of available investigational products 
for treatment is the responsibility of the physician 
and the seriously-ill patient. 
(6) The use of combinations of available inves-
tigational and approved products for treatment is 
the responsibility of the physician and the seriously- 
ill patient. 
(7) The Food and Drug Administration should 
have the expertise and flexibility to address the 
growing needs of seriously ill patients for individual-
ized or personalized therapies. 
SEC. 3. COMPASSIONATE INVESTIGATIONAL ACCESS AP-
PROVAL SYSTEM FOR DRUGS, BIOLOGICAL 
PRODUCTS, AND DEVICES. 
(a) COMPASSIONATE INVESTIGATIONAL ACCESS.— 
Section 561 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360bbb) is amended— 
(1) by redesignating subsections (d) and (e) as 
subsections (e) and (f), respectively; and 
(2) by inserting after subsection (c) the fol-
lowing: 
‘‘(d) COMPASSIONATE INVESTIGATIONAL ACCESS.— 
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‘‘(1) PURPOSE.—The purpose of this subsection 
is to facilitate the availability of promising new 
drugs to seriously ill patients as early in the drug 
development process as possible, before general mar-
keting begins. 
‘‘(2) ACCESS.—Notwithstanding any other pro-
vision of law, upon submission by a sponsor of an 
application intended to provide widespread access to 
an investigational drug, biological product, or device 
for eligible patients (referred to in this subsection as 
‘Compassionate Investigational Access’), the Sec-
retary shall permit such investigational drug, biologi-
cal product, or device, to be made available for ex-
panded access under a treatment investigational new 
drug application or treatment investigational device 
exemption if the Secretary determines that the re-
quirements of this section are met with respect to 
Compassionate Investigational Access. 
‘‘(3) COMPASSIONATE
INVESTIGATIONAL
AC-
CESS.—Notwithstanding any other provision of law, 
an investigational drug, biological product, or device 
that receives approval for Compassionate Investiga-
tional Access under this subsection shall be subject 
to the provisions of section 505(i) or 520(g), as ap-
plicable, and regulations promulgated by the Sec-
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retary pursuant to this Act. The Secretary and the 
sponsor may inform national, State, and local med-
ical associations and societies, voluntary health asso-
ciations, and other appropriate persons about the 
availability of an investigational drug or investiga-
tional device under Compassionate Investigational 
Access as approved under this subsection. The infor-
mation submitted by the Secretary, in accordance 
with the preceding sentence, shall be the same type 
of information that is required by section 402(i)(3) 
of the Public Health Service Act. 
‘‘(4) SUBMISSION OF APPLICATION.— 
‘‘(A) APPLICATION CONTENT.—A sponsor 
of an investigational drug, biological product, or 
device applying for Compassionate Investiga-
tional Access approval of the product shall sub-
mit to the Secretary a notice of claimed exemp-
tion under section 505(i) or 520(g), as applica-
ble (referred to in this subsection as an ‘appli-
cation for Compassionate Investigational Ac-
cess’), which shall contain— 
‘‘(i) data and information from com-
pleted Phase I clinical investigations and 
any other nonclinical or clinical investiga-
tions; 
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‘‘(ii) preliminary evidence that the 
product may be effective in humans 
against a serious or life-threatening condi-
tion or disease, which evidence may be 
based on uncontrolled data such as case 
histories, information about the pharma-
cological mechanism of action, data from 
animal and computer models, comparison 
with historical data, or other preliminary 
information, and may be based on a small 
number of patients or a subset of the pa-
tient population; 
‘‘(iii) evidence that the product is safe 
at the dose and duration proposed, consid-
ering whether the potential risk to a pa-
tient of the condition or disease outweighs 
the potential risk to a patient of the pro-
posed dose and duration of treatment with 
the product, consistent with the level of in-
formation needed to initiate a Phase II 
clinical trial; and 
‘‘(iv) a statement that the sponsor is 
actively pursuing marketing approval with 
due diligence. 
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‘‘(B) LIMITATION.—Compassionate Inves-
tigational Access approval shall be based upon 
multiple considerations that shall include clin-
ical evaluation and unmet patient needs. 
‘‘(5) DETERMINATION BY SECRETARY.— 
‘‘(A) IN
GENERAL.—Not later than 30 
days after the receipt of an application for 
Compassionate Investigational Access approval, 
the Secretary shall either— 
‘‘(i) provide Compassionate Investiga-
tional Access approval of the application; 
or 
‘‘(ii) refer the application to the Accel-
erated Approval Advisory Committee. 
‘‘(B) RECOMMENDATION.—Not later than 
90 days after receipt of an application for Com-
passionate Investigational Access approval, the 
Accelerated Approval Advisory Committee shall 
issue a recommendation to the Secretary on 
whether the Secretary shall provide Compas-
sionate Investigational Access approval of the 
application. 
‘‘(C) FINAL DECISION.—Not later than 30 
days after receipt of the recommendation from 
the Accelerated Approval Advisory Committee, 
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the Secretary shall either provide Compas-
sionate Investigational Access approval of the 
application or shall issue an order setting forth 
a detailed explanation of the reasons why the 
application was not so approved and the specific 
data that the sponsor must provide so that the 
application may be so approved. 
‘‘(6) APPEAL.—If the Secretary does not pro-
vide Compassionate Investigational Access approval 
of an application, the sponsor of the application 
shall have the right to appeal the decision to the 
Secretary. The Secretary shall provide the sponsor 
with a hearing not later than 30 days following the 
nonapproval under this subsection of the application 
and shall issue an order not later than 30 days fol-
lowing the hearing either concurring in the non-
approval or so approving the application. The Sec-
retary shall not delegate the responsibility described 
in this paragraph to any other person. 
‘‘(7) CRITERIA.—In making a determination 
under paragraph (5), the Secretary shall consider 
whether the totality of the information available to 
the Secretary regarding the safety and effectiveness 
of an investigational drug, biological product, or de-
vice, as compared to the risk of morbidity or death 
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in clinical trials, the lack of source of supply 
and geographic factors. 
‘‘(9) PRODUCT LABELING.—To receive Compas-
sionate Investigational Access approval under this 
subsection, the sponsor of the product shall provide 
labeling approved by the Secretary for the drug, bio-
logical product, or device that— 
‘‘(A) states that the product is intended 
for use by a patient whose physician has docu-
mented in writing that the patient has— 
‘‘(i) exhausted all treatment options 
approved by Secretary for the condition or 
disease for which the patient is a reason-
able candidate; and 
‘‘(ii) unsuccessfully sought treatment, 
or obtained treatment that was not effec-
tive with an investigational drug, biological 
product, or device for which such indi-
vidual is a reasonable candidate, which 
shall include a patient’s ineligibility for 
participation in clinical trials, the lack of 
source of supply and geographic factors; 
and 
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‘‘(B) states that every patient to whom the 
product is administered shall, as a mandatory 
condition of receiving the product, provide— 
‘‘(i) written informed consent, as de-
scribed under part 50 of title 21, Code of 
Federal Regulations (or any successor reg-
ulations); and 
‘‘(ii) consent for the manufacturer of 
the product to obtain data and information 
about the patient and the patient’s use of 
the product that may be used to support 
an application for Accelerated Approval or 
final approval. 
‘‘(10) CHARGING FOR COMPASSIONATE INVES-
TIGATIONAL
ACCESS.—A sponsor or investigator 
may charge for a Compassionate Investigational Ac-
cess drug without notifying the Secretary or seeking 
or obtaining prior approval of the amount charged, 
provided the sponsor of the drug is actively pursuing 
marketing approval with due diligence. 
‘‘(11) COMMENCEMENT
OF
REVIEW.—If the 
Secretary determines, after preliminary evaluation of 
the data and information submitted by the sponsor, 
that the product may be effective, the Secretary 
shall evaluate for filing, and may commence review 
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of portions of, an application under this subsection 
before the sponsor submits a complete application. 
The Secretary shall commence such review only if 
the applicant provides a schedule for submission of 
information necessary to make the application com-
plete. 
‘‘(12) IMMUNITY.— 
‘‘(A) IN GENERAL.—A manufacturer, dis-
tributor, administrator, sponsor, or physician 
who manufactures, supplies, distributes or pre-
scribes a product approved under an application 
for Compassionate Investigational Access shall 
be immune from suit or liability caused by, aris-
ing out of, or relating to the design, develop-
ment, clinical testing and investigation, manu-
facture, labeling, distribution, sale, purchase, 
donation, dispensing, prescribing, administra-
tion, efficacy, or use of a drug, biological prod-
uct, or device subject to an approved Compas-
sionate Investigational Access application. 
‘‘(B) CLAIMS.—No claim or cause of ac-
tion against a manufacturer, distributor, ad-
ministrator, sponsor, or physician who manu-
factures, supplies, distributes or prescribes a 
product subject to an approved Compassionate 
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Investigational Access application shall exist in 
any Federal or State court for claims of prop-
erty, personal injury, or death caused by, aris-
ing out of, or relating to the design, develop-
ment, clinical testing and investigation, manu-
facture, labeling, distribution, sale, purchase, 
donation, dispensing, prescribing, administra-
tion, efficacy, or use of a drug, biological prod-
uct, or device subject to an approved Compas-
sionate Investigational Access application. Any 
such claim or cause of action that is filed in 
Federal or State court shall be immediately dis-
missed. 
‘‘(13) FINAL APPROVAL.—For purposes of this 
Act, the term ‘final approval’ means— 
‘‘(A) with respect to a new drug or new bi-
ological product, approval of such drug or prod-
uct under section 505(b)(1) or 505(b)(2) or 
section 351 of the Public Health Service Act, as 
the case may be; and 
‘‘(B) with respect to a new device, clear-
ance of such device under section 510(k) or ap-
proval of such device under section 515(c)(1).’’. 
(b) ACCELERATED APPROVAL.—Chapter V of the 
Federal, Food, Drug, and Cosmetic Act (21 U.S.C. 351 
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et seq.) is amended by inserting after section 561 the fol-
lowing: 
‘‘SEC. 561A. ACCELERATED APPROVAL. 
‘‘(a) IN GENERAL.— 
‘‘(1) IN
GENERAL.—As soon as practicable 
after the date of enactment of the Access, Compas-
sion, Care, and Ethics for Seriously Ill Patients Act, 
the Secretary shall promulgate regulations to pro-
vide for the treatment of an investigational drug, bi-
ological product, or device that receives Accelerated 
Approval under this section. This section shall be 
carried out in accordance with such regulations (and 
any successor regulations). 
‘‘(2) APPLICATION.—A sponsor of an investiga-
tional drug, biological product, or device applying for 
Accelerated Approval shall submit to the Secretary 
an application as described under section 505(b)(1) 
or 505(b)(2), or section 510(k) or 515(c)(1) of this 
Act, or section 351(a) of the Public Health Service 
Act, as applicable, which shall contain— 
‘‘(A) data and information that the drug, 
biological product, or device has an effect on a 
clinical endpoint or on a surrogate endpoint or 
biomarker that is reasonably likely to predict 
clinical benefit to a patient (who may be rep-
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resentative of a small patient subpopulation) 
suffering from a serious or life-threatening con-
dition or disease; and 
‘‘(B) a statement that the sponsor is ac-
tively pursuing marketing approval with due 
diligence. 
‘‘(3) DETERMINATION BY SECRETARY.— 
‘‘(A) IN
GENERAL.—Not later than 120 
days after the receipt of an application for Ac-
celerated Approval, the Secretary shall either— 
‘‘(i) provide Accelerated Approval of 
the application; or 
‘‘(ii) refer the application to the Accel-
erated Approval Advisory Committee. 
‘‘(B) RECOMMENDATION.—Not later than 
90 days after receipt of an application for Ac-
celerated Approval, the Accelerated Approval 
Advisory Committee shall issue a recommenda-
tion to the Secretary on whether the Secretary 
should provide Accelerated Approval of the ap-
plication. 
‘‘(C) LIMITATION.—The Accelerated Ap-
proval Advisory Committee shall not consider 
off-label uses of drugs, biological products, and 
devices as existing or available therapies, to the 
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sponsibility described in this paragraph to any other 
person. 
‘‘(A) with respect to a new drug or new bi-
ological product, approval of such drug or prod-
uct under section 505(b)(1) or 505(b)(2) or 
section 351 of the Public Health Service Act, as 
the case may be; and 
‘‘(B) with respect to a new device, clear-
ance of such device under section 510(k) or ap-
proval of such device under section 515(c)(1). 
‘‘(b) ACCELERATED
APPROVAL
ADVISORY
COM-
MITTEE.— 
‘‘(1) IN GENERAL.—In order to facilitate the 
development and expedite the review of drugs, bio-
logical products, and devices intended to treat seri-
ous or life threatening conditions, the Secretary shall 
establish the Accelerated Approval Advisory Com-
mittee (referred to in this subsection as the ‘Com-
mittee’). 
‘‘(2) DELEGATION.—The Secretary may dele-
gate decisionmaking authority for the Accelerated 
Approval Advisory Committee to the Office of the 
Commissioner of Food and Drugs. Such authority 
shall not be further delegated. 
‘‘(3) COMPOSITION.— 
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‘‘(A) IN GENERAL.—The Committee shall 
be composed of 11 voting members, including 1 
chairperson and 5 permanent members each of 
whom shall serve a term of 3 years and may be 
reappointed for a second 3-year term, and 5 
nonpermanent members who shall be appointed 
to the Committee for a specific meeting, or part 
of a meeting, in order to provide adequate ex-
pertise in the subject being reviewed. The Com-
mittee shall include as voting members no less 
than 2 representatives of patient interests, of 
which 1 shall be a permanent member of the 
Committee. The Committee shall include as 
nonvoting members a representative of interests 
of the drug, biological product, and device in-
dustry. 
‘‘(B) 
APPOINTMENTS.—The 
Secretary 
shall appoint to the Committee persons who are 
qualified by training and experience to evaluate 
the safety and effectiveness of the types of 
products to be referred to the Committee and 
who, to the extent feasible, possess skill in the 
use of, or experience in the development, manu-
facture, or utilization of, such products. The 
Secretary shall make appointments to the Com-
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mittee so that the Committee shall consist of 
members with adequately diversified expertise 
and practical experience in such fields as clin-
ical medicine, biological and physical sciences, 
and other related professions. Scientific, indus-
try, and consumer organizations and members 
of the public shall be afforded an opportunity to 
nominate individuals for appointment to the 
Committee. No individual who is in the regular 
full-time employ of the United States and en-
gaged in the administration of this chapter may 
be a member of the Committee. 
‘‘(4) 
COMPENSATION.—Committee 
members, 
while attending meetings or conferences of the Com-
mittee or otherwise engaged in its business, shall be 
entitled to receive compensation at rates to be fixed 
by the Secretary, but not at rates exceeding the 
daily equivalent of the rate in effect for grade GS– 
18 of the General Schedule, for each day so en-
gaged, including traveltime, and while so serving 
away from their homes or regular places of business 
each member may be allowed travel expenses (in-
cluding per diem in lieu of subsistence) as author-
ized by section 5703 of title 5, for persons in the 
Government service employed intermittently. 
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‘‘(5) ASSISTANCE.—The Secretary shall furnish 
the Committee with adequate clerical and other nec-
essary assistance. 
‘‘(6) ANNUAL TRAINING.—The Secretary shall 
employ nongovernmental experts to provide annual 
training to the Committee on the statutory and reg-
ulatory standards for product approval. 
‘‘(7) TIMELINE.—The Committee shall be 
scheduled to meet at such times as may be appro-
priate for the Secretary to meet applicable statutory 
deadlines. 
‘‘(8) MEETINGS.— 
‘‘(A) OPPORTUNITIES
FOR
INTERESTED 
PERSONS.—Any person whose product is spe-
cifically the subject of review by the Committee 
shall have— 
‘‘(i) the same access to data and in-
formation submitted to the Committee as 
the Secretary; 
‘‘(ii) the opportunity to submit, for re-
view by the Committee, data or informa-
tion, which shall be submitted to the Sec-
retary for prompt transmittal to the Com-
mittee; 
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‘‘(iii) the same opportunity as the 
Secretary to participate in meetings of the 
Committee; and 
‘‘(iv) consent for the manufacturer of 
the product to obtain data about adverse 
events relating to the patient’s use of the 
product. 
‘‘(B) ADEQUATE TIME; FREE AND OPEN 
PARTICIPATION.—Any meetings of the Com-
mittee shall provide adequate time for initial 
presentations and for response to any differing 
views by persons whose products are specifically 
the subject of the Committee review. 
‘‘(C) SUMMARIES.—At all meetings of the 
Committee, the Secretary shall provide a sum-
mary to the Committee of all applications sub-
mitted under this subsection and section 561(d) 
that the Committee did not consider that were 
approved by the Secretary since the last meet-
ing of the Committee. 
‘‘(c) FINAL APPROVAL.—For purposes of this Act, 
the term ‘final approval’ means— 
‘‘(1) with respect to a new drug or new biologi-
cal product, approval of such drug or product under 
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section 505(b)(1) or 505(b)(2) or section 351 of the 
Public Health Service Act, as the case may be; and 
‘‘(2) with respect to a new device, clearance of 
such device under section 510(k) or approval of such 
device under section 515(c)(1).’’. 
(c) REGULATIONS.—The Secretary of Health and 
Human Services shall promulgate regulations that define 
the terms ‘‘seriously ill’’ and ‘‘serious or life-threatening’’ 
for purposes of the amendments made by this Act, consid-
ering either— 
(1) the medical prognosis for an individual’s life 
expectancy from a disease or condition; or 
(2) the prospect of irreversible disability from a 
disease or condition. 
SEC. 4. EXPANDED ACCESS TO INVESTIGATIONAL DRUGS 
AND DEVICES. 
Chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by inserting after 
section 561A, as added by section 3, the following: 
‘‘SEC. 561B. EXPANDED ACCESS TO INVESTIGATIONAL 
DRUGS AND DEVICES. 
‘‘(a) EXPANDED ACCESS PROGRAM.—The Secretary 
shall establish a new program to expand access to inves-
tigational treatments for individuals with serious or life 
threatening conditions and diseases. In carrying out this 
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expanded access program, the Secretary shall publish and 
broadly disseminate written guidance that— 
‘‘(1) describes such expanded access programs 
for investigational drugs, biological products, and de-
vices intended to treat serious or life-threatening 
conditions or diseases; 
‘‘(2) encourages and facilitates submission of 
applications and approvals under section 561(d) and 
561A; and 
‘‘(3) facilitates the provision of investigational 
drugs, biological products, and devices to seriously ill 
individuals without unreasonable delay by recog-
nizing that the use of available investigational prod-
ucts for treatment is the responsibility of the physi-
cian and the patient, and also by recognizing the 
goal of providing additional treatment options for 
patients and their physicians to consider. 
‘‘(b) IMPLEMENTATION OF EXPANDED ACCESS PRO-
GRAMS.— 
‘‘(1) TRAINING
OF
PERSONNEL.—Not later 
than 90 days after the date of enactment of this sec-
tion, the Secretary shall implement training pro-
grams at the Food and Drug Administration with 
respect to the expanded access programs established 
under this section. 
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‘‘(2) POLICIES, 
REGULATIONS, 
AND
GUID-
ANCE.—The Secretary shall establish policies, regu-
lations, and guidance designed to most directly ben-
efit seriously ill patients. 
‘‘(c) DEVELOPMENT
OF SURROGATE ENDPOINTS 
AND BIOMARKERS.— 
‘‘(1) IN GENERAL.—The Secretary shall— 
‘‘(A) establish a program or expand upon 
an existing program to encourage the develop-
ment of surrogate endpoints and biomarkers 
that are reasonably likely to predict clinical 
benefit for serious or life-threatening conditions 
for which there exist significant unmet patient 
needs; 
‘‘(B) request the Institute of Medicine to 
undertake a study to identify validated surro-
gate endpoints and biomarkers, and recommend 
research to validate surrogate endpoints and 
biomarkers, that may support approvals for 
products intended for the treatment of serious 
or life-threatening conditions or diseases; and 
‘‘(C) make widely available to the public a 
list of drugs, biological products, and devices 
that are being investigated for serious or life- 
threatening conditions or diseases and that 
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have not yet received approval under section 
561(d) or 561A for marketing. 
‘‘(2) STUDY CONTENT.—The study under para-
graph (1)(B) shall include endpoints and biomarkers 
that address the unmet medical needs of subpopula-
tions of patients and that facilitate the development 
of individualized treatment approaches for patients 
with serious or life-threatening conditions or dis-
eases.’’. 
SEC. 5. DEMONSTRATION PROJECT FOR COVERAGE OF 
CERTAIN DRUGS, BIOLOGICAL PRODUCTS, 
AND DEVICES UNDER THE MEDICARE PRO-
GRAM. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services (in this section referred to as the ‘‘Sec-
retary’’) shall establish a demonstration project under the 
Medicare program under title XVIII of the Social Security 
Act (42 U.S.C. 1395 et seq.) under which payment is 
made for drugs, biological products, and devices approved 
for Compassionate Investigational Access under section 
561(d) of the Federal Food, Drug, and Cosmetic Act in 
the case where the drug, biological product, or device is 
not otherwise covered under the Medicare program or by 
any other organization or entity (including a public assist-
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ance program or the sponsor of the application for such 
drug, biological product, or device). 
(b) DURATION.—The demonstration project under 
this section shall be conducted for a 5-year period. 
(c) FUNDING.— 
(1) IN GENERAL.—The Secretary shall provide 
for the transfer from the Federal Hospital Insurance 
Trust Fund under section 1817 of the Social Secu-
rity Act (42 U.S.C. 1395i) and the Federal Supple-
mentary Medical Insurance Trust Fund under sec-
tion 1841 of such Act (42 U.S.C. 1395t), in such 
proportion as the Secretary determines to be appro-
priate, of such sums as are necessary for the costs 
of carrying out the demonstration project under this 
section. 
(2) BUDGET NEUTRALITY.—In conducting the 
demonstration project under this section, the Sec-
retary shall ensure that the aggregate payments 
made by the Secretary do not exceed the amount 
which the Secretary estimates would have been paid 
if the demonstration project under this section was 
not implemented. 
(d) WAIVER AUTHORITY.—The Secretary may waive 
such requirements of title XVIII of the Social Security Act 
(42 U.S.C. 1395 et seq.) as may be necessary for the pur-
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pose of carrying out the demonstration project under this 
section. 
(e) REPORT.—Not later than 90 days after the last 
day of the 5-year period of the demonstration project 
under this section, the Secretary shall submit to Congress 
a report describing the rates of utilization by Medicare 
beneficiaries of drugs, biological products, and devices ap-
proved for Compassionate Investigational Access and the 
total cost of payments made under the Medicare program 
resulting from the demonstration project. The report shall 
describe recommendations for legislation or administrative 
action as the Secretary deems appropriate. 
(f) TERMINATION.—The Secretary shall terminate 
payments under this section on the day after the last day 
of the 5-year period of the demonstration project under 
this section. 
SEC. 6. USE OF PART B DEFINITION OF MEDICALLY AC-
CEPTED INDICATION FOR PART D DRUGS. 
(a) IN GENERAL.—Section 1860D–2(e) of the Social 
Security Act (42 U.S.C. 1395w–102(e)) is amended— 
(1) in paragraph (1), in the matter following 
subparagraph (B), by striking ‘‘(as defined in sec-
tion 1927(k)(6))’’ and inserting ‘‘(as defined in 
paragraph (4))’’; and 
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