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Volume 12 Number 67
ISSN 1091-4021
Monday, April 9, 2007
In this Report: Compilation
The following chart summarizes the status of key issues in health care legislation currently pending in Congress. The first column provides a synopsis of the purpose, content, and support for the bill or legislative initiative. The second column summarizes the provisions of the legislation. The third column outlines the procedural path ahead and the political prospects for enactment of the bills.
| Legislative Purpose |
Bill Status |
Outlook |
| MEDICARE RX PRICE NEGOTIATION |
| (H.R. 4) The
bill removes the statutory
provision in the 2003 Medicare prescription
drug law preventing Medicare from negotiating
drug prices with pharmaceutical
makers. |
House: By a
255-170 vote, the House Jan. 12 approved legislation requiring Medicare to
negotiate lower drug prices on behalf of Medicare beneficiaries.
Twenty-four Republicans joined
Democrats in voting for the bill, but the
final tally was not large enough to override a
promised veto by President Bush. The vote
followed a week of intense, mostly partisan debate, in which Democrats
said the bill would save beneficiaries money on their prescriptions.
Republicans countered the bill would interfere with a program that already
is bringing low drug prices to beneficiaries.
Senate: Senate Finance Committee
Chairman Baucus (D-Mont.) is developing a
Medicare drug pricing bill. Baucus has said he
favors stripping from law the prohibition on negotiations, although not
necessarily requiring Medicare to negotiate with drugmakers. Senate Majority Leader
Reid (D-Nev.) said March 27 the Senate would
take up a Medicare pricing bill after the
congressional Easter recess.
Administration: The Bush
administration issued a veto
threat on H.R. 4, saying the legislation would
not lower prices for seniors nor save Medicare money. |
House: The
House does not have the votes to
override a veto if a drug pricing bill is
rejected by Bush.
Senate: The Senate also lacks the
votes to override a presidential
veto.
Administration: Bush likely would
veto any negotiations bill. |
| SCHIP REAUTHORIZATION |
| Authorization
for the State Children's Health Insurance Program (SCHIP) expires Sept. 30, at the end of fiscal year 2007. Sens. Baucus
(D-Mont.) and Rockefeller (D-W.Va.) amended the FY 2008 budget resolution
by committing the Senate to reauthorizing
SCHIP before Sept. 30. Baucus and Rockefeller
also were successful in securing a commitment
of $50 billion for SCHIP over the next five
years in the FY 2008 budget. These funds will allow the program to meet
the needs of those currently enrolled in SCHIP and to reach the 6 million
children currently eligible but not yet enrolled. |
House: Reps.
Barton (R-Texas) and Deal (R-Ga.) March 6 introduced the Guaranteed Access
for SCHIP's Target Population Act of 2007 (H.R. 1329), a bill that would
provide federal funding for states' SCHIP
shortfalls, only for the purpose of covering
low-income children below 200 percent of the federal poverty level (FPL)
and pregnant women. The bill would allow states to cover other
populations, such as nonpregnant adults or higher income children under
their SCHIP plans, but only with state funds.
Senate: Rockefeller, along with
Sen. Snowe (R-Maine), plans to introduce the primary SCHIP reauthorization
vehicle when Congress returns from the Easter recess. The bill would
provide $50 billion for the state block grant
program; create
“Express Lane” enrollment, allowing states to
use eligibility information from applications from other means-tested
programs, such as free or reduced price school lunches; and
give financial help for outreach
activities to enroll the 6 million eligible
children not yet enrolled.
Meanwhile, Sen.
Clinton (D-N.Y.) March 14 introduced the Children's Health First Act (S.
895), which would expand SCHIP to allow states to enroll all children living in families with
incomes up to 400 percent of FPL , or $70,000 per year for a family of
three. The bill also would allow states to permit uncovered children who
are ineligible for public health insurance to “buy into” SCHIP.
Administration: The administration's FY 2008 budget request would allow the
enhanced SCHIP federal matching rate only for enrolled children or
pregnant women with family income below 200 percent of the FPL . The
president's proposal would ban any further
expansion of coverage to parents, or in states
already covering them, childless adults. |
House: The
Barton-Deal bill is unlikely to
pass, since many states already cover children
above 200 percent of FPL and there is not much
public support for making major cuts to the
program.
Senate: Both Rockefeller and Snowe serve on the Senate Finance
Committee, the panel responsible for SCHIP reauthorization and
are likely to be able to drum up the necessary
support for passage of this
bill.
Administration: The administration has made no
public statements about the Rockefeller
proposal, which has garnered a great deal of support compared to other
proposals. |
| DRUG SAFETY |
| (S. 484)
This bill seeks to improve drug safety
oversight by the Food and Drug Administration by requiring annual reviews of newly approved
drugs during the drugs' first three years on
the market. The House counterpart (H.R. 1561) would go even further, by requiring
periodic assessment of drugs that have been on the market for as long as
seven years. |
House: House
Oversight and Government Reform Committee Chairman Waxman (D-Calif.) and
Rep. Markey (D-Mass.) March 19 introduced the
House version (H.R. 1561) of the Senate drug
safety bill. A drug safety hearing was
held March 22 in Waxman's committee.
Senate: S. 484,
from Senate Health, Education, Labor and Pensions Committee Chairman
Kennedy (D-Mass.), and the committee's ranking Republican, Enzi (R-Wyo.),
is likely to be merged with drug user fee
legislation.
Administration: FDA has signaled
that it already has begun to
address many of the reforms called for in a
2006 Institute of Medicine drug safety report that spurred congressional
efforts to reform FDA. |
House: The
Waxman-Markey drug safety bill has several provisions not contained in the
Senate bill, including more frequent
reassesment of approved drugs, a
longer moratorium on radio and television drug
ads, and a
packaging symbol to indicate that a drug is
new to the market and may have unknown risks. Consumer groups say the
Waxman-Markey bill is a stronger bill than its Senate counterpart but
could be further improved by setting a specific goal for FDA to begin
using Medicare databases in post-market surveillance of
drugs.
Senate:
The Kennedy-Enzi drug safety bill could pass
this year if, as is expected, it is
merged with must-pass
legislation reauthorizing the Prescription
Drug User Fee Act. Funding for the bill is uncertain, but an additional $40 million in drug
safety funds could come from the congressional budget
resolution.
Administration: FDA Commissioner von Eschenbach has indicated that
the user fee agreement reached between the agency and the pharmaceutical and biotech
industries does not account for the
Kennedy-Enzi bill requirements, and additional
resources would be needed to comply with the legislation. Any additional
resources for FDA should come from Congress not industry fees, the drug
industry lobby contends. |
| STEM CELL RESEARCH |
| (H.R. 3, S. 5) This bill would allow in vitro fertilization clinics to donate
embryos that would otherwise be discarded for medical research. This bill
essentially would overturn the president's
current stem cell policy, which does not allow
scientists to receive federal funding for work on any stem cell lines
created after Aug. 9, 2001. It is identical to a bill passed in the
previous Congress. |
House: The
House passed H.R. 3 by a vote of
253-174 on Jan. 11; 216 Democrats voted with
37 Republicans in favor of H.R. 3, while 16 Democrats and 158 Republicans
voted against the bill.
Senate: Senate Majority Leader
Harry Reid (D-Nev.) said he expects a vote on
S. 5 the week of April 9, after the Senate
returns from its recess.
Administration: President Bush
opposes legislative attempts to change the 2001 policy. |
House: Sent
its bill to the Senate.
Senate: The Senate is expected to pass the bill as it
has in the previous Congress. However, unlike the previous bill, there is
the possibility of attaching amendments to the
legislation.
Administration: In anticipation of the House vote, the White House released a
statement of administration policy announcing that the president intends to veto the
bill. He vetoed identical legislation in July 2006. |
| GENERIC BIOLOGICS |
| (H.R. 1038, S. 623 The legislation would create a
regulatory pathway for Food and Drug
Administration approval of comparable or interchangeable versions of
biotech drugs, also known as follow-on proteins or generic biologics.
|
House: A
hearing was held March 26 by House Oversight and Government Reform Committee,
chaired by bill sponsor Waxman (D-Calif.).
Senate: The Senate Health,
Education, Labor, and Pensions Committee held a
hearing March 8.
Administration: A key consideration
is whether clinical data are needed for approval. FDA is developing industry guidance on
the science that would needed to gain approval for a follow-on protein.
FDA Deputy Commissioner Woodcock has testified that current science could
allow simpler follow-ons to be approved through a short-cut process that
would sidestep clinical testing. But she says the science would need to evolve before
more complex proteins could be approved without clinical tests. |
House: The
House is expected to wait for the Senate to
act first on the bills affecting the drug
industry, including user fees and generic biotech. The biotechnology
industry wants these measures to be kept separate.
Senate: Bill sponsors are eyeing Rx
industry user fees legislation (a must-pass bill) as a way to get action
on biotech generics. But some lawmakers like Sens. Hatch (R-Utah) and Enzi
(R-Wyo.) want to make sure the science and
patent protections are addressed thoroughly.
Administration:
FDA appears ready to move toward
approval of follow-on proteins, but the agency
has signaled that a higher bar would be
needed for a product to be considered a
generic version, or exact copy of previously approved biologic.
|
| MENTAL HEALTH PARITY |
| (H.R. 1367, S. 558) Mental health parity legislation seeks to end discrimination in
provision of mental health benefits, compared to other health benefits.
|
House: Reps.
Kennedy (D-R.I.) and Ramstad (R-Minn.) March 7 introduced legislation (H.R
1367) to require mental health benefits offered by group health plans with
50 or more enrollees to be equal to coverage
for other medical conditions.
Senate: By an
18-3 vote, the Senate Health, Education, Labor, and Pensions Committee
Feb. 14 approved legislation (S. 558) requiring businesses with 50 or more
workers to offer the same medical benefits for
mental health care as they do for other
medical conditions.
Administration: The administration has not commented on
the bills, but President Bush in the past has spoken favorably about the
issue, leading advocates to believe a bill could be passed by Congress and
signed into law by Bush in 2007. |
House: The
House has begun to hold
hearings on mental health parity. Similar
bills garnered support from a majority of lawmakers in the House when
Republicans were the majority, although they were not considered by
committees of jurisdiction.
Senate: A Senate vote on S. 558 has
not been scheduled. It appears to have enough
votes to be approved by the
chamber.
Administration: Advocates of mental health parity believe Bush would sign mental
health parity legislation if it reached his desk. |
|