Medicare Drug Formulary Protection Act - Amends title XVIII (Medicare) of the Social Security Act to prohibit removal of covered part D (Voluntary Prescription Drug Benefit Program) drugs from a prescription drug plan formulary, or imposition of a restriction or limitation on the coverage of such a drug, during the plan year: (1) except at the beginning; or (2) for an individual enrollee, from the date of enrollment until December 31 of the immediately succeeding plan year. Specifies exceptions to such prohibition. Requires an annual notice to enrollees of changes in formulary and other restrictions or limitations on coverage.
[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5102 Introduced in House (IH)]
109th CONGRESS
2d Session
H. R. 5102
To amend title XVIII of the Social Security Act to prohibit removal of
covered part D drugs from a prescription drug plan formulary during the
plan year once an individual has enrolled in the plan.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
April 5, 2006
Mr. Becerra (for himself, Mr. DeFazio, Mr. Salazar, Mr. Honda, Mr.
Jefferson, Mr. Kennedy of Rhode Island, Mr. Boucher, Mr. Wexler, Mr.
Cardoza, Mr. McGovern, Mr. Mollohan, Mr. Gene Green of Texas, Mr.
Grijalva, Mr. Rangel, Mr. Stark, Mr. Conyers, Mr. McDermott, Ms.
Herseth, Mr. Hinchey, Mr. Brown of Ohio, Mr. Reyes, Mr. Ruppersberger,
Mr. Larson of Connecticut, Mr. McNulty, Ms. Matsui, Mr. Costello, Mrs.
Maloney, Mr. Marshall, Mr. Levin, Ms. Norton, Mr. Inslee, Mr. Lynch,
Mr. Delahunt, Mr. Owens, Mr. Ortiz, Ms. Schakowsky, Mrs. Napolitano,
Mr. Ryan of Ohio, Mr. Doyle, Mr. Pomeroy, Mr. Scott of Virginia, Mr.
Baca, Mr. Sanders, Mr. Cummings, Mr. Oberstar, Mr. Payne, Mr. Gonzalez,
Mr. Emanuel, Mr. Lantos, Mr. Doggett, Ms. Wasserman Schultz, Mr. Brady
of Pennsylvania, Mrs. Capps, and Ms. McCollum of Minnesota) 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 jurisdiction of the
committee concerned
_______________________________________________________________________
A BILL
To amend title XVIII of the Social Security Act to prohibit removal of
covered part D drugs from a prescription drug plan formulary during the
plan year once an individual has enrolled in the plan.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Medicare Drug Formulary Protection
Act''.
SEC. 2. REMOVAL OF COVERED PART D DRUGS FROM THE PRESCRIPTION DRUG PLAN
FORMULARY.
(a) Limitation on Removal or Change of Covered Part D Drugs From
the Prescription Drug Plan Formulary.--Section 1860D-4(b)(3)(E) of the
Social Security Act (42 U.S.C. 1395w-104(b)(3)(E)) is amended to read
as follows:
``(E) Removing a drug from formulary or imposing a
restriction or limitation on coverage.--
``(i) Limitation on removal, limitation, or
restriction.--
``(I) In general.--Subject to
subclause (II) and clause (ii),
beginning with 2006, the PDP sponsor of
a prescription drug plan may not remove
a covered part D drug from the plan
formulary or impose a restriction or
limitation on the coverage of such a
drug (such as through the application
of a preferred status, usage
restriction, step therapy, prior
authorization, or quantity limitation)
other than at the beginning of each
plan year except as the Secretary may
permit to take into account new
therapeutic uses and newly covered part
D drugs.
``(II) Special rule for newly
enrolled individuals.--Subject to
clause (ii), in the case of an
individual who enrolls in a
prescription drug plan on or after the
date of the enactment of the Medicare
Drug Formulary Protection Act, the PDP
sponsor of such plan may not remove a
covered part D drug from the plan
formulary or impose a restriction or
limitation on the coverage of such a
drug (such as through the application
of a preferred status, usage
restriction, step therapy, prior
authorization, or quantity limitation)
during the period beginning on the date
of such enrollment and ending on
December 31 of the immediately
succeeding plan year except as the
Secretary may permit to take into
account new therapeutic uses and newly
covered part D drugs.
``(ii) Exceptions to limitation on
removal.--Clause (i) shall not apply with
respect to a covered part D drug that--
``(I) is a brand name drug for
which there is a generic drug approved
under section 505(j) of the Food and
Drug Cosmetic Act (21 U.S.C. 355(j))
that is placed on the market during the
period in which there are limitations
on removal or change in the formulary
under subclause (I) or (II) of clause
(i) if such generic drug is included in
the formulary without any restriction
or limitation placed on the coverage of
such generic drug other than a
restriction or limitation that would be
placed on the coverage of the brand
name drug during such period without
the application of this subclause;
``(II) is a brand name drug that
goes off-patent during such period;
``(III) is a drug for which the
Commissioner of Food and Drugs issues a
clinical warning that imposes a
restriction or limitation on the drug
during such period;
``(IV) has been determined to be
ineffective during such period;
``(V) is a drug that the
appropriate pharmacy and therapeutic
committee determines, based on evidence
from peer-reviewed research, to be
unsafe or ineffective during such
period; or
``(VI) is any other drug that
satisfies any other requirement
determined appropriate by the
Secretary.
``(iii) Notice of removal under application
of exception to limitation.--The PDP sponsor of
a prescription drug plan shall provide
appropriate notice (such as under subsection
(a)(3)) of any removal or change under clause
(ii) to the Secretary, affected enrollees,
physicians, pharmacies, and pharmacists.''.
(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 adding at the end the following new
paragraph:
``(5) Annual notice of changes in formulary and other
restrictions or limitations on coverage.--Each PDP sponsor
offering a prescription drug plan shall furnish to each
enrollee 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 formulary or other restrictions
or limitations on coverage 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 enactment of this Act.
<all>
Introduced in House
Introduced in House
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 jurisdiction of the committee concerned.
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 jurisdiction of the committee concerned.
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 jurisdiction of the committee concerned.
Referred to the Subcommittee on Health.
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