I 
109TH CONGRESS 
2D SESSION 
H. R. 4685 
To amend titles XVIII and XIX of the Social Security Act to assure uninter-
rupted access to necessary medicines under the Medicare prescription 
drug program. 
IN THE HOUSE OF REPRESENTATIVES 
FEBRUARY 1, 2006 
Mr. DINGELL (for himself, Mr. RANGEL, Mr. SPRATT, Mr. WAXMAN, Mr. 
BROWN of Ohio, Mr. STARK, Ms. PELOSI, Mr. MARKEY, Mrs. CAPPS, Mr. 
BOUCHER, Ms. SCHAKOWSKY, Ms. DEGETTE, Mr. PALLONE, Ms. SOLIS, 
Ms. BALDWIN, Mr. GENE GREEN of Texas, Mr. GORDON, Mr. ALLEN, 
Mr. INSLEE, Mr. CLEAVER, Ms. SLAUGHTER, Mr. EMANUEL, Mr. NEAL 
of Massachusetts, Mr. DELAHUNT, Mr. DOGGETT, Mr. CONYERS, Ms. 
MATSUI, Mr. BERMAN, Mr. LARSON of Connecticut, Mr. CARDIN, Mr. 
MCNULTY, Mr. HOLDEN, Mr. OWENS, Ms. HERSETH, and Mrs. MCCAR-
THY) 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 provisions as fall within the juris-
diction of the committee concerned 
A BILL 
To amend titles XVIII and XIX of the Social Security Act 
to assure uninterrupted access to necessary medicines 
under the Medicare prescription drug program. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Medicare Prescription Drug Emergency Guarantee Act 
of 2006’’. 
(b) TABLE OF CONTENTS.—The table of contents of 
this Act is as follows: 
Sec. 1. Short title; table of contents 
Sec. 2. Protections to provide for uninterrupted access to medicines 
Sec. 3. Required application of intermediate sanctions to protect against fraud 
and abuse 
Sec. 4. Changes of enrollment in prescription drug plans and MA–PD plans al-
lowed twice during year 
Sec. 5. Prohibiting additional restrictions or limitations on coverage during year 
Sec. 6. MedPAC study on appropriate enrollment of dual eligible individuals 
Sec. 7. Prohibition on conditioning Medicaid eligibility on enrollment in Medi-
care part D coverage or other creditable coverage 
Sec. 8. Reimbursement of third parties for 2006 transition costs 
SEC. 2. PROTECTIONS TO PROVIDE FOR UNINTERRUPTED 
ACCESS TO MEDICINES. 
(a) MINIMUM STANDARD TRANSITION COVERAGE.— 
(1) IN GENERAL.—Section 1860D–4(b) of the 
Social Security Act (42 U.S.C. 1395w–104(b)) is 
amended by adding at the end the following new 
paragraph: 
‘‘(4) 
UNINTERRUPTED
ACCESS
TO
MEDI-
CINES.— 
‘‘(A) MINIMUM
STANDARD
TRANSITION 
COVERAGE.—A PDP sponsor offering a pre-
scription drug plan under this part or an MA– 
PD plan under part C shall provide minimum
standard transition coverage in accordance with 
subparagraph (B). 
‘‘(B) 
REQUIREMENTS.—The 
minimum 
standard transition coverage under this sub-
paragraph, with respect to a part D eligible in-
dividual who is enrolled in a prescription drug 
plan (or an individual who is presumed to be 
such an individual pursuant to subparagraph 
(F)) who presents a prescription for a drug at 
a pharmacy, is the following: 
‘‘(i) GUARANTEED
INITIAL
SUPPLY, 
REGARDLESS
OF
COVERAGE
LIMITATIONS 
OR RESTRICTIONS.—In the case that the 
PDP sponsor of such plan uses a for-
mulary that does not cover the drug or 
otherwise imposes a restriction on the cov-
erage of the drug (such as through the ap-
plication of a preferred status, usage re-
striction, step therapy, prior authorization 
or a quantity limits) and during the period 
in which such individual has been enrolled 
in such plan the individual has not pre-
viously sought coverage under the plan for 
such drug the plan shall provide for the 
following:
‘‘(I) MINIMUM SUPPLY OF PRE-
SCRIPTION
DRUG.—The plan must 
provide for coverage for at least a 60- 
day supply (or a 90-day supply in the 
case of an individual who is a resident 
of a long-term care facility) of the 
drug, or, if less, a supply of the drug 
that is the full amount of the pre-
scription. 
‘‘(II) INFORMATION
ON
FOR-
MULARY, PRESCRIPTION DRUG PLANS, 
AND APPEAL RIGHTS.—The plan must 
provide the individual with a standard 
notice developed by the Secretary that 
informs the individual about the limi-
tations and restrictions of the cov-
erage of the drug, that describes the 
rights of the individual with respect to 
requesting a determination under sub-
section (g)(2) or an appeal of such a 
determination under subsection (h), 
that describes any ability of the indi-
vidual to change the election of such 
plan under section 1860D–1(b)(1)(B), 
and that informs the individual about
sources of information on prescription 
drug plans to make such a change in 
plans. 
‘‘(III) REFILLS DURING PENDING 
APPEAL.—In the case of such an indi-
vidual who brings an appeal under 
subsection (h), with respect to the 
prescription drug involved, an addi-
tional supply of the drug (for the 
amount of days provided to the indi-
vidual under subclause (I)) during the 
period ending on the date on which a 
final determination is made on the ap-
peal. 
‘‘(ii) GUARANTEED SUPPLY WHEN UN-
ABLE TO VERIFY PLAN ENROLLMENT.—In 
the case that the pharmacy is unable to lo-
cate or verify the individual’s enrollment in 
such plan through a reasonable effort: 
‘‘(I) MINIMUM SUPPLY OF PRE-
SCRIPTION
DRUG.—The plan must 
provide for coverage for at least a 60- 
day supply (or a 90-day supply in the 
case of an individual who is a resident 
of a long-term care facility) of the
drug, or, if less, a supply of the drug 
that is the full amount of the pre-
scription. 
‘‘(II) REFILLS.—The plan must 
provide an additional 60-day supply 
(or a 90-day supply in the case of an 
individual who is a resident of a long- 
term care facility) of the drug, or if 
less, a supply of the drug that is the 
full amount of the prescription, if the 
pharmacy continues to be unable to 
locate 
the 
individual’s 
enrollment 
through such reasonable efforts when 
a prescription is presented on or after 
the date that a prescription refill is 
appropriate. 
‘‘(C) REIMBURSEMENTS.— 
‘‘(i) REIMBURSEMENTS
TO
PHAR-
MACIES.— 
‘‘(I) IN
GENERAL.—If a phar-
macy provides prescription drugs for 
which the minimum standard transi-
tion coverage is required under sub-
paragraph (B), the Secretary shall re-
imburse the pharmacy for the costs
incurred in providing the prescription 
drugs, including acquisition costs, dis-
pensing costs, and other overhead 
costs. The Secretary shall provide 
prompt payment (consistent with the 
provisions of section 1842(c)(2)) of 
such reimbursements from the Medi-
care Prescription Drug Account under 
section 1860D–16 of the Social Secu-
rity Act (42 U.S.C. 1395w–116). 
Such reimbursements shall be deemed 
to be payments from such Account 
under subsection (b) of such section. 
‘‘(II) SANCTIONS
FOR
FRAUDU-
LENT CLAIMS.—In the case of a phar-
macy that knowingly provides to the 
Secretary false information in connec-
tion with a claim for reimbursement 
under subclause (I), the Secretary 
may impose a civil money penalty in 
an amount not to exceed $10,000 for 
each such claim. The provisions of 
section 1128A (other than subsections 
(a) and (b) and the second sentence of 
subsection (f)) shall apply to a civil
money penalty under the previous sen-
tence in the same manner as such 
provisions apply to a penalty or pro-
ceeding under section 1128A(a). 
‘‘(ii) RECOVERY
FROM
PLANS
OF 
PHARMACY
REIMBURSEMENTS.—The Sec-
retary shall establish a process for recov-
ering the reimbursements made to phar-
macies under clause (i) from prescription 
drug plans and MA–PD plans if the Sec-
retary determines that such plans should 
have incurred such costs. Amounts recov-
ered pursuant to the preceding sentence 
shall be deposited in the Medicare Pre-
scription Drug Account. 
‘‘(iii) APPLICATION OF INTERMEDIATE 
SANCTIONS.—In the case of a failure of a 
prescription drug plan under this part or 
an MA–PD plan under part C to provide 
for the minimum coverage required under 
subparagraph (B), the failure shall be 
treated as a failure to provide medically 
necessary items and services under section 
1857(g)(1)(A), 
as 
applied 
by 
section 
1860D–12(b)(3)(E), and the Secretary
shall impose intermediate sanctions under 
such section 1857(g). 
‘‘(D) COST-SHARING.—The cost-sharing 
for a prescription filled pursuant to subpara-
graph (B) for an individual shall be in accord-
ance with the prescription drug plan in which 
the individual attests to be enrolled and the 
class of individual (such as subsidy-eligible indi-
viduals) to which the individual so attests. 
‘‘(E) REFUNDS TO INDIVIDUALS WITH IN-
APPROPRIATE CHARGES.—If the Secretary de-
termines, in accordance with a method deter-
mined by the Secretary, that an individual was 
inappropriately charged for a prescription drug 
dispensed to such individual under this part or 
part C, the Secretary shall— 
‘‘(i) reduce payments to the sponsor 
of the prescription drug plan under section 
1860D–15 or to the organization offering 
the MA–PD plan under section 1853 that 
inappropriately charged the individual by 
an amount equal to the amount the indi-
vidual was inappropriately charged; and 
‘‘(ii) refund such amount to the indi-
vidual within 30 days of the date of the de-
termination that the individual was inap-
propriately charged. 
‘‘(F) PRESUMPTIVE ELIGIBILITY.— 
‘‘(i) 
SUBSIDY-ELIGIBLE
INDIVID-
UALS.—For purposes of this paragraph, an 
individual shall be presumed to be a dual 
eligible individual or subsidy-eligible indi-
vidual if the individual self attests to being 
such an individual, respectively. 
‘‘(ii) PLAN ENROLLMENT.—For pur-
poses of this paragraph, an individual shall 
be presumed to be enrolled in a prescrip-
tion drug plan under this part or an MA– 
PD plan under part C if the individual self 
attests to being enrolled under such plan. 
‘‘(iii) INDIVIDUAL LIABLE FOR COSTS 
OF FALSE ATTESTATION.— 
‘‘(I) IN
GENERAL.—If the Sec-
retary, as the result of verification ac-
tivities conducted by the Secretary, 
determines after a fair hearing that 
an individual has knowingly made a 
false 
self-attestation 
described 
in 
clause (i) or (ii) or in subparagraph 
(D), the Secretary may, subject to
subclause (II), seek recovery from the 
individual for the full amount of the 
cost of benefits provided to the indi-
vidual under this paragraph as a re-
sult of such self attestation. 
‘‘(II) 
EXCEPTION.—The 
Sec-
retary shall at its discretion not seek 
recovery under subclause (I) if the 
Secretary determines that it would not 
be cost-effective to do so. 
‘‘(III) 
REIMBURSEMENTS
TO 
FEDERAL
GOVERNMENT.—Any 
amounts recovered by the Secretary in 
accordance with this clause shall be 
returned to the prescription drug plan 
or MA–PD plan if the Secretary has 
previously recovered payment from 
such plan. 
‘‘(iv) REQUIREMENTS FOR SELF AT-
TESTATION.—The Secretary shall promul-
gate requirements for self attestations 
under this subparagraph, but the failure of 
the Secretary to promulgate such require-
ments shall not preclude the applications
of the previous provisions of this subpara-
graph.’’. 
(2) EFFECTIVE DATE.—The amendment made 
by paragraph (1) shall take effect on the date of the 
enactment of this Act, but shall apply to prescription 
drugs dispensed on and after January 1, 2006. 
(b) NOTICE
FOR CHANGE
IN FORMULARY
AND 
OTHER RESTRICTIONS OR LIMITATIONS ON COVERAGE.— 
(1) IN GENERAL.—Section 1860D–4(a) of such 
Act (42 U.S.C. 1395w–104(a)) is amended by add-
ing at the end the following new paragraph: 
‘‘(5) ANNUAL
NOTICE
OF
CHANGES
IN
FOR-
MULARY AND OTHER RESTRICTIONS OR LIMITATIONS 
ON COVERAGE.—Each PDP sponsor offering a pre-
scription drug plan (and each MA organization of-
fering an MA–PD plan) shall furnish to each en-
rollee at the time of each annual coordinated election 
period (referred to in section 1860D–1(b)(1)(B)(iii)) 
for a plan year a notice of any changes in the for-
mulary or other restrictions or limitations on cov-
erage of a covered part D drug under the plan that 
will take effect for the plan year.’’. 
(2) EFFECTIVE DATE.—The amendment made 
by paragraph (1) shall apply to annual coordinated
election periods beginning after the date of the en-
actment of this Act. 
(c) STANDARDIZED FORMS AND PROCEDURES FOR 
RECONSIDERATIONS AND APPEALS.— 
(1) IN
GENERAL.—Section 1860D–4 of such 
Act (42 U.S.C. 1395w–104) is amended by adding 
at the end the following new subsection: 
‘‘(l) STANDARDIZED FORMS AND PROCEDURES FOR 
RECONSIDERATIONS AND APPEALS.— 
‘‘(1) STANDARD ENROLLEE NOTICE.—The Sec-
retary shall develop a standard notice to be distrib-
uted by a prescription drug plan (or an MA–PD 
plan) to an enrollee when a covered part D drug pre-
scribed for the enrollee is not covered, or the cov-
erage of such drug is otherwise restricted, by the 
plan. 
‘‘(2) STANDARDIZED PROCESS FOR RECONSID-
ERATIONS AND APPEALS.—The Secretary shall re-
quire prescription drug plans and MA–PD plans to 
follow the same standardized process for reconsider-
ations and redeterminations under subsections (g) 
and (h). Such process shall require that determina-
tions regarding medical necessity are based on pro-
fessional medical judgement, the medical condition
of the enrollee, the treating physician’s recommenda-
tion, and other medical evidence.’’. 
(2) 
EFFECTIVE
DATE.—The 
Secretary 
of 
Health and Human Services shall provide for the 
standard notice and the standardized process, and 
the application of such notice and process, under the 
amendment made by paragraph (1) by not later 
than January 1, 2007. 
SEC. 3. REQUIRED APPLICATION OF INTERMEDIATE SANC-
TIONS TO PROTECT AGAINST FRAUD AND 
ABUSE. 
(a) IN GENERAL.—Section 1860D–12(b)(3)(E) of 
the Social Security Act (42 U.S.C. 1395w–112(b)(3)(E)) 
is amended by inserting ‘‘and the reference to ‘may pro-
vide’ in section 1857(g)(1) is deemed a reference to ‘shall 
provide’ ’’ after ‘‘this part’’. 
(b) APPLICATION
TO
MA–PD PLANS.—Section 
1857(g)(1) of such Act (42 U.S.C. 1395w–27(g)(1)) is 
amended by inserting ‘‘(or in the case of an MA–PD plan 
or a prescription drug plan under part D, the Secretary 
shall provide)’’ after ‘‘may provide’’.
SEC. 4. CHANGES OF ENROLLMENT IN PRESCRIPTION 
DRUG PLANS AND MA–PD PLANS ALLOWED 
TWICE DURING YEAR. 
(a) ADDITIONAL ELECTION PERMITTED ONCE EACH 
YEAR OUTSIDE OF ANNUAL COORDINATED ELECTION 
PERIOD.—Section 1851(e)(4) of the Social Security Act 
(42 U.S.C. 1395w–21(e)(4)) is amended by inserting 
‘‘once every year, and in addition,’’ after ‘‘make a new 
election under this section’’. 
(b) EFFECTIVE DATE.—The amendment made by 
subsection (a) shall take effect as of the date of the enact-
ment of this Act. 
SEC. 5. PROHIBITING ADDITIONAL RESTRICTIONS OR LIMI-
TATIONS ON COVERAGE DURING YEAR. 
(a) IN GENERAL.—Section 1860D–4(b)(4) of the So-
cial Security Act (42 U.S.C. 1395w–104(b)(4)) is amend-
ed by inserting after subparagraph (F) the following new 
subparagraph: 
‘‘(G) PROHIBITING ADDITIONAL RESTRIC-
TIONS OR LIMITATIONS ON COVERAGE DURING 
YEAR.—A prescription drug plan and an MA– 
PD plan may only impose a restriction or limi-
tation on the coverage of a covered part D drug 
(such as through the application of a formulary, 
preferred status, usage restriction, step therapy, 
prior authorization, or a quantity limitation)
only at the beginning of a plan year, except in 
the case that the Commissioner of Food and 
Drugs issues a clinical warning during a year 
that imposes such a restriction or limitation on 
the drug.’’. 
(b) EFFECTIVE DATE.—The amendment made by 
subsection (a) shall take effect on the date of the enact-
ment of this Act and shall apply to the removal of a drug 
or a change in the status of such drug on and after such 
date. 
SEC. 6. MEDPAC STUDY ON APPROPRIATE ENROLLMENT 
OF DUAL ELIGIBLE INDIVIDUALS. 
(a) STUDY.—The Medicare Payment Advisory Com-
mission shall conduct a study to determine the extent to 
which full-benefit dual eligible individuals (as defined in 
section 1935(c)(6) of the Social Security Act (42 U.S.C. 
1396u5(c)(6)) were enrolled (by assignment or otherwise) 
in the most appropriate prescription drug plans under 
part D of title XVIII of such Act for such individuals. 
(b) REPORT.—The Commission shall submit a report 
to Congress on the study under subsection (a) not later 
than February 1, 2007.
SEC. 7. PROHIBITION ON CONDITIONING MEDICAID ELIGI-
BILITY ON ENROLLMENT IN MEDICARE PART 
D COVERAGE OR OTHER CREDITABLE COV-
ERAGE. 
(a) IN GENERAL.—Section 1935 of the Social Secu-
rity Act (42 U.S.C. 1396v) is amended by adding at the 
end the following new subsection: 
‘‘(f) PROHIBITION ON CONDITIONING MEDICAID ELI-
GIBILITY ON ENROLLMENT IN MEDICARE PART D COV-
ERAGE OR OTHER CREDITABLE COVERAGE.— 
‘‘(1) IN GENERAL.—A State shall not condition 
eligibility for medical assistance under the State 
plan for a part D eligible individual (as defined in 
section 1860D–1(a)(3)(A)) who is enrolled in cred-
itable prescription drug coverage described in any of 
subparagraphs (C) through (H) of section 1860D– 
13(b)(4) on the individual’s enrollment in a prescrip-
tion drug plan under part D of title XVIII or an 
MA–PD plan under part C of such title. 
‘‘(2) COORDINATION OF BENEFITS WITH PART 
D FOR OTHER INDIVIDUALS.—Nothing in this sub-
section shall be construed as prohibiting a State 
from coordinating medical assistance under the 
State plan with benefits under part D of title XVIII 
for individuals not described in paragraph (1).’’.
(b) TREATMENT OF STATE PLAN AMENDMENTS, RE-
DETERMINATION OF ELIGIBILITY.—In the case of a State 
that, as of the date of the enactment of this Act, has an 
approved amendment to its State plan under title XIX of 
the Social Security Act with a provision that conflicts with 
section 1935(f) of such Act (as added by subsection (a)), 
such provision is, as of such date of enactment, null and 
void. The State shall redetermine any applications for 
medical assistance that have been denied solely on the 
basis of such a State plan amendment not later than De-
cember 31, 2006. Such redetermination shall be effective 
as of the date of the individual’s application for medical 
assistance. 
SEC. 8. REIMBURSEMENT OF THIRD PARTIES FOR 2006 
TRANSITION COSTS. 
(a) REIMBURSEMENT.— 
(1) IN
GENERAL.—Notwithstanding section 
1935(d) of the Social Security Act (42 U.S.C. 
1396u–5(d) or any other provision of law, the Sec-
retary of Health and Human Services shall reim-
burse covered third parties for 100 percent of the 
costs incurred by the covered third party during 
2006 for covered part D drugs for part D eligible in-
dividuals who are enrolled in a prescription drug 
plan under part D of title XVIII of such Act (or an
MA–PD plan under part C of such title) which the 
individual reasonably expected would have been cov-
ered under such part but were not because the indi-
vidual was unable to access on a timely basis pre-
scription drug benefits to which the individual was 
entitled under such part. Such payments shall be 
made from the Medicare Prescription Drug Account 
under section 1860D–16 of the Social Security Act 
(42 U.S.C. 1395w–116) and shall be deemed to be 
payments from such Account under subsection (b) of 
such section. The provisions of clauses (ii) through 
(iv) of subparagraph (F) of paragraph (4) of section 
1860D–4(b) of the Social Security Act, as added by 
section 2(a), shall apply under this paragraph in the 
same manner as they apply under such paragraph 
(4). 
(2) SANCTIONS
FOR
FRAUDULENT
CLAIMS.— 
The provisions of subclause (II) of section 1860D– 
4(b)(4)(C)(i) of the Social Security Act, as added by 
section 2(a), shall apply to a covered third party 
with respect to a claim for reimbursement under 
paragraph (1) in the same manner that such provi-
sions apply to a pharmacy in connection with a 
claim for reimbursement under subclause (I) of such 
section 1860D–4(b)(4)(C)(i).
(3) RETROACTIVE APPLICATION TO BEGINNING 
OF 2006.—The costs incurred by a third party which 
may be reimbursed under paragraph (1) shall in-
clude costs incurred during the period beginning on 
January 1, 2006, and before the date of enactment 
of this Act. 
(b) RECOVERY OF COSTS FROM PLANS BY SEC-
RETARY.—The Secretary of Health and Human Services 
shall establish a process for recovering the costs described 
in subsection (a)(1) from prescription drug plans and 
MA–PD plans if the Secretary determines that such plans 
should have incurred such costs. Amounts recovered pur-
suant to the preceding sentence shall be deposited in the 
Medicare Prescription Drug Account described in sub-
section (a)(1). 
(c) DEFINITIONS.—For purposes of this section: 
(1) COVERED PART D DRUG.—The term ‘‘cov-
ered part D drug’’ has the meaning given such term 
under section 1860D–2(e) of the Social Security Act 
(42 U.S.C. 1395w–102(e)). 
(2) COVERED THIRD PARTY.—The term ‘‘cov-
ered third party’’ means any individual or party 
(such as a State, charity, or family member of the 
part D eligible individual involved) other than a 
party that is obligated under part D of title XVIII
of the Social Security Act to incur the costs in-
volved. Such term shall not include a pharmaceutical 
company or an assistance program sponsored or as-
sisted (in whole or in part) by such company. 
(3) MA–PD PLAN.—The term ‘‘MA–PD plan’’ 
has the meaning given such term under section 
1860D–41(a)(14) of the Social Security Act (42 
U.S.C. 1395w–151(a)(14)). 
(4) PART D ELIGIBLE INDIVIDUAL.—The term 
‘‘part D eligible individual’’ has the meaning given 
such term under section 1860D–1(a)(3)(A) of the 
Social 
Security 
Act 
(42 
U.S.C. 
1394w– 
101(a)(3)(A)). 
(5) PRESCRIPTION
DRUG
PLAN.—The term 
‘‘prescription drug plan’’ has the meaning given 
such term under section 1860D–1(a)(3)(C) of the 
Social 
Security 
Act 
(42 
U.S.C. 
1394w– 
101(a)(3)(C)). 
(6) STATE.—The term ‘‘State’’ includes the 
District of Columbia. 
Æ