H.R. 3061House110th Congress (2007-2009)In Committee

Medicare Part D Drug Class Protection Act of 2007

Introduced July 17, 2007

Legislative Activity

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3 earlier actions
HouseCommittee Latest Action

Referred to the Subcommittee on Health.

July 20, 2007

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HouseIntro Referral

Introduced in House

July 17, 2007

HouseIntro Referral

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.

July 17, 2007

HouseCommittee

Referred to the Subcommittee on Health.

July 17, 2007

HouseCommittee

Referred to the Subcommittee on Health.

July 20, 2007

Floor Debate

24 members

What members said about H.R. 3061 on the floor

10 Republicans14 Democrats
Jeff Flake
Rep. Jeff FlakeR-AZ-6 · Aug 2, 2007

Mr. Chairman, I offer an amendment. Mr. Chairman, it's my intent to offer a number of earmark limitation amendments to the FY 2008 Agriculture appropriation bill. In offering these earmark limitation…

Rosa L. DeLauro
Rep. Rosa L. DeLauroD-CT-3 · Aug 2, 2007

Mr. Chairman, how much time is left? Mr. Chairman, I yield 1 minute to the gentleman from New Jersey (Mr. Holt). If the gentleman would yield, these are both very, very worthy efforts, and I look…

Jeb Hensarling
Rep. Jeb HensarlingR-TX-5 · Aug 2, 2007

Mr. Chairman, I thank the gentleman for yielding, and I rise to oppose this particular bill. But before I do, I do want to say I think there are a number of good things, a number of good provisions…

Jack Kingston
Rep. Jack KingstonR-GA-1 · Aug 2, 2007

Mr. Chairman, I reserve the balance of the time. Mr. Chairman, I yield 3 minutes to the gentleman from Texas (Mr. Hensarling). I do, but they're not here quite yet. Mr. Chairman, let me yield myself…

Steny H. Hoyer
Rep. Steny H. HoyerD-MD-5 · Aug 2, 2007

Mr. Chairman, I claim the time in opposition. My friend from Arizona is having a good time. I don't blame him, but this is something that is good for the country. It is good for literally millions of…

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Marcy Kaptur
Rep. Marcy KapturD-OH-9 · Aug 2, 2007

Mr. Chairman, I rise in support of this excellent bill to support food, fiber, fuel and forest production across this Nation. Mr. Chairman, I would like to thank the Chairwoman Ms. DeLauro, a…

Rush Holt
Rep. Rush HoltD-NJ-12 · Aug 2, 2007

Mr. Chairman, I commend the subcommittee and its chair for a good bill, and I wish to enter into a colloquy with the gentlewoman from Connecticut regarding funding for Community Food Projects and…

Pete Sessions
Rep. Pete SessionsR-TX-32 · Aug 2, 2007

Mr. Chairman, I offer an amendment. Mr. Chairman, my amendment would strike language included on page 3 of this legislation, which would have the same anti- competitive effect as language already…

Mike Rogers
Rep. Mike RogersR-MI-8 · Aug 2, 2007

Mr. Chairman, I'm going to cut right to the chase. We have so little time. I yield myself 2 minutes. You know, the New York Times highlighted in an investigation in May, the global and deadly…

David E. Price
Rep. David E. PriceD-NC-4 · Aug 2, 2007

Mr. Chairman, as we consider H.R. 3161, the FY 2008 Agriculture Appropriations bill, I want to voice my serious concerns about the provision in the bill that would prevent the U.S. Food and Drug…

Sam Farr
Rep. Sam FarrD-CA-17 · Aug 2, 2007

Mr. Chairman, I rise in opposition to this amendment. Let's be practical. This is about rural America. These are about towns that are under 20,000 people who have come together and decided they want…

Jim Jordan
Rep. Jim JordanR-OH-4 · Aug 2, 2007

Mr. Chairman, I offer an amendment. Mr. Chairman, Members of the House, government spends too much money. Ask any American family, is government so lean, so efficient, has it tightened its belt so…

Stephanie Herseth Sandlin

Mr. Chairman, I rise in opposition to the amendment. Mr. Chairman, let me say at the outset, the gentleman from Arizona said this is a sole-source contract to one entity and we already have an entity…

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Jesse L. Jackson, Jr.
Rep. Jesse L. Jackson, Jr.D-IL-2 · Aug 2, 2007

Let me rise in strong opposition to the gentleman from Texas's amendment, and I am hoping that the gentleman might engage me in a brief question. These grants assist in the development of essential…

Steve King
Rep. Steve KingR-IA-5 · Aug 2, 2007

Mr. Chairman, I thank the gentleman from Georgia for yielding. I listened attentively to the other gentleman from Georgia, who spoke with such confidence and authority on the Davis-Bacon wage scale.…

Mike Rogers
Rep. Mike RogersR-AL-3 · Aug 2, 2007

Mr. Chairman, I claim the time in opposition. Mr. Chairman, I would like to first start by yielding 1 minute to the gentlewoman from Connecticut (Ms. DeLauro). Mr. Chairman, I yield myself such time…

David Scott
Rep. David ScottD-GA-13 · Aug 2, 2007

Mr. Chairman, I rise to strongly oppose this amendment. This amendment smacks right at heart of our wage structure, of fair wages and protected wages. Long before Taft-Hartley, before the Wagner Act,…

Henry A. Waxman
Rep. Henry A. WaxmanD-CA-30 · Aug 2, 2007

Mr. Chairman, funding for the Food and Drug Administration is incredibly important--FDA oversees products that make up one quarter of all consumer spending in the U.S. and it is vital to protecting…

Anna G. Eshoo
Rep. Anna G. EshooD-CA-14 · Aug 2, 2007

Mr. Chairman, I rise in support of the Kingston Amendment which would strike language from the bill to implement a fundamental change to the FDA's drug safety laws by allowing the commercial re-…

Jo Ann Emerson
Rep. Jo Ann EmersonR-MO-8 · Aug 2, 2007

Mr. Chairman, first of all, because we are under such tight time constraints, I might add, and I understand the points that the gentleman from Michigan was making. But of course, let me also mention,…

Michael H. Michaud
Rep. Michael H. MichaudD-ME-2 · Aug 2, 2007

Mr. Chairman, I want to give just one example why this investment is important to our Nation. The Module Ballistic Protection System, developed at the University of Maine, is made of light,…

James T. Walsh
Rep. James T. WalshR-NY-25 · Aug 2, 2007

Mr. Chairman, I claim the time in opposition. Mr. Chairman, I yield myself 2 minutes. Mr. Chairman, I thank the gentleman for offering this amendment because, if nothing else, it points out the…

Maurice D. Hinchey
Rep. Maurice D. HincheyD-NY-22 · Aug 2, 2007

Mr. Chairman, I want to express my appreciation to my dear friend and colleague for providing me with this time to say a couple of things in opposition to this amendment. I think the person who is…

Michael A. Arcuri
Rep. Michael A. ArcuriD-NY-24 · Aug 2, 2007

I thank my colleague from New York, and I thank the distinguished chairwoman from Connecticut. Mr. Chairman, I have only been here for 7 months, but in that short time it has become overwhelmingly…

Bill Text

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Introduced in HouseIssued July 17, 2007

I

110th CONGRESS

1st Session

H. R. 3061

IN THE HOUSE OF REPRESENTATIVES

July 17, 2007

Mr. Doggett (for himself, Mr. Abercrombie, Mr. Allen, Mr. Davis of Illinois, Mr. Emanuel, Mr. Engel, Mr. Al Green of Texas, Mr. Hinchey, Ms. Kaptur, Mr. Larson of Connecticut, Ms. McCollum of Minnesota, Mr. McDermott, and Mr. Stark) 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 require that Medicare prescription drug plans using formularies cover all drugs included in 6 specified therapeutic categories, to establish protective requirements for coverage determinations, reconsiderations, and appeals related to such drugs, and to require annual reports on such determinations, reconsiderations, and appeals.

1.

Short title

This Act may be cited as the Medicare Part D Drug Class Protection Act of 2007.

2.

Special treatment under Medicare part D for drugs in 6 specified therapeutic categories

(a)

Medicare part D formularies required To cover all drugs in 6 specified therapeutic categories

(1)

In general

Section 1860D–4(b)(3) of the Social Security Act (42 U.S.C. 1395w–104(b)(3)) is amended—

(A)

in subparagraph (C)(i), by inserting , except as provided in subparagraph (G), after although; and

(B)

by inserting after subparagraph (F) the following new subparagraph:

(G)

Required inclusion of drugs in certain therapeutic categories and classes

(i)

Requirement

The formulary must include, subject to clause (iii), all or substantially all drugs in each of the following therapeutic categories of covered part D drugs:

(I)

Immunosuppresessants.

(II)

Antidepressants.

(III)

Antipsychotics.

(IV)

Anticonvulsants.

(V)

Antiretrovials.

(VI)

Antineoplastics.

(ii)

Coverage of all unique dosage forms

To meet the requirement under clause (i), the formulary must include all covered part D drugs and unique dosages and forms of such drugs in the categories specified in such clause, except for—

(I)

multi-source brands of the identical molecular structure;

(II)

extended release products in the case that the immediate release product involved is included on the formulary;

(III)

products that have the same active ingredient; and

(IV)

dosage forms that do not provide a unique route of administration, such as tablets and capsules.

(iii)

Application to new FDA-approved drugs

In the case of a drug that becomes a covered part D drug and that is included in a category specified in clause (i), clause (i) shall apply to such drug 30 days after the drug has been placed on the market. Nothing in the previous sentence shall be construed as preventing a pharmacy and therapeutic committee from advising a PDP sponsor of a prescription drug plan on the clinical appropriateness of formulary management practices and policies related to new drugs in such categories.

(iv)

Utilization management tools not permitted

A PDP sponsor of a prescription drug plan may not apply a utilization management tool, such as prior authorization or step therapy, to a drug required under clause (i) to be included on the formulary.

(v)

Rules of construction

(I)

Issuance of guidance or regulations to establish formulary or utilization management requirements permitted

Nothing in this subparagraph shall be construed as prohibiting the Secretary from issuing guidance or regulations to establish formulary or utilization management requirements under this section for any category or class of covered part D drugs if such guidance or regulations are consistent with the requirements of this subparagraph.

(II)

Additional therapeutic categories permitted

Nothing in this subparagraph shall be construed as prohibiting the Secretary from including any additional therapeutic category or class of covered part D drugs under clause (i) for purposes of this subparagraph.

.

(2)

Effective date

The amendments made by paragraph (1) shall apply to plan years beginning on or after January 1, 2008.

(b)

Special requirements for coverage determinations, reconsiderations, and appeals for drugs included in specified therapeutic categories

(1)

In general

Section 1860D–4(g) of the Social Security Act (42 U.S.C. 1395w–104(g)) is amended by adding at the end the following new paragraph:

(3)

Reconsideration of determinations related to drugs included in specified therapeutic categories conducted by Independent Review Entity

With respect to a part D eligible individual enrolled in a prescription drug plan, in the case of a determination under this subsection that denies such individual coverage (in whole or in part) of a drug in a category specified in subsection (b)(3)(G)(i), the individual may request that the reconsideration of such determination authorized under section 1852(g)(2) (as applied by paragraph (1)) be conducted by the independent, outside entity described in paragraph (4) of section 1852(g) in accordance with the procedures for an expedited reconsideration under paragraph (3) of such section.

(4)

Required coverage of drugs included in specified therapeutic categories during determinations, reconsiderations, and appeals

If a part D eligible individual enrolled in a prescription drug plan offered by a PDP sponsor requests a redetermination or reconsideration under this subsection (or an appeal under subsection (h)) with respect to an utilization management requirement or denial of coverage (in whole or in part) of a drug in a category specified in subsection (b)(3)(G)(i), such sponsor shall provide such individual with coverage of such drug as prescribed during the pendency of such redetermination, reconsideration, or appeal until 60 days after the date of receipt of a written notification of—

(A)

in the case that the individual does not request a reconsideration or appeal, the determination on such redetermination;

(B)

in the case that the individual requests a reconsideration but not an appeal, the determination on such reconsideration; or

(C)

in the case that the individual requests an appeal, the determination on such appeal or the dismissal of the appeal;

except that in no case shall such coverage end before the end of the period in which an individual may file an appeal with respect to the determination involved.

.

(2)

Effective date

The amendment made by paragraph (1) shall apply to requests for redeterminations, reconsiderations, and appeal hearings made on or after the effective date described in subsection (a)(2).

(c)

Reporting requirements for drugs included in specified therapeutic categories

(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)

Reporting requirements for drugs included in specified therapeutic categories

(A)

Reports by PDP sponsors

A PDP sponsor offering a prescription drug plan shall submit to the Secretary (in a form and manner specified by the Secretary), with respect to drugs in a category of covered part D drugs specified in subsection (b)(3)(G)(i), information on the number of favorable and unfavorable decisions under the plan relating to coverage determinations, redeterminations, reconsiderations, appeals, and enrollee requests for exceptions to formulary policies for such drugs.

(B)

Report to Congress

The Secretary shall submit an annual report to Congress summarizing the information submitted under subparagraph (A) and shall publish each report in the Federal Register.

.

(2)

Effective date

The amendment made by paragraph (1) shall apply to prescription drug plans and MA plans for plan years beginning on or after the effective date described in subsection (a)(2).