May 15, 2007

HEADLINE

Tobacco Control Legislation Picking Up Momentum

Legislation to give the FDA authority to regulate tobacco – the Family Smoking Prevention and Tobacco Control Act (S. 625/H.R. 1108) - continues to add cosponsors. The Senate bill now has 45 cosponsors and the House companion bill has 160 cosponsors. The bill now has a bipartisan majority of members of the Senate Health Education Labor and Pension (HELP) Committee as cosponsors of the bill and a majority of members of the House Energy and Commerce Health Subcommittee – both these committees have jurisdiction over the FDA bill. The bipartisan support on the committee level means the FDA bill should make it to the House and Senate floor in the foreseeable future for a final vote. It is expected that the Senate HELP Committee will mark up the bill in June. House action may follow shortly after.

Currently the largest obstacle to enactment of the FDA comes from Senator Burr (R-NC) who has publicly stated his intent to filibuster the legislation. While it seems unlikely that Sen. Burr has the 40 votes necessary to sustain a filibuster and prevent consideration of the FDA, it is clear he is willing to use every parliamentary tactic available to him to impede consideration of the bill.

ATS members are urged to continue emails and phone calls to Congress stressing the importance of enacting this important legislation.

CLINICAL PRACTICE

ATS Support Legislation to Repeal Medicare SGR Formula
The ATS joined over 80 physician and allied health professional organizations in endorsing legislative principles to repeal the current Medicare formula used to calculate annual updates in Medicare Part B physician reimbursement – know as the sustainable growth rate (SGR) formula. The SGR formula unfairly links physician reimbursement to artificial Medicare spending targets and growth in the overall economy and underrecognizes increased Medicare costs driven by regulation and legislative expansions in the Medicare program.

As reported previously, the SGR formula has resulted in proposed cuts in Medicare physician reimbursement for several years and it is only because of acts of Congress that these cuts have been avoided. Without congressional intervention, the physician community is looking at a 10% cut in Medicare reimbursement in 2008 and cuts of nearly 40% by 2015.

The ATS has joined with other physician organizations to call on Congress to fix this problem and has endorsed the following legislative principles:

1) The SGR should be repealed and replaced with an updated system that reflects increases in physicians’ and other health professionals’ practice costs.

2) Congress should support initiatives by organizations representing physicians and other health care professionals to bridge gaps in care and assure the appropriateness of services provided to Medicare beneficiaries. 

3) If immediate repeal of the SGR is not possible, Congress must: establish by law a transition, pathway and “date certain” to complete elimination of the SGR; provide positive physician/health care professional updates set by statute for each year until repeal takes effect; stabilize payments for a minimum of two years by providing positive baseline updates to all physicians/health care professionals; spend down the costs of repealing the SGR by fully funding the positive updates; and urge the Administration to exercise its authority to remove physician-administered drugs from the SGR and make other refinements in the formula to help reduce the cost of Congressional action.

4) The transitional 2007 Medicare Physicians Quality Reporting Initiative should be re-examined before being expanded into future years.

It is expected that Congress will develop legislation dealing with several aspects of Medicare in the near future. ATS members are encouraged to continue to contact their Members of Congress to insist that permanently fixing the SGR formula be part of the Medicare legislation.

TUBERCULOSIS

Global TB Bill Advances in House
The global TB control bill, the Stop TB Now Act, H.R. 1567, received a significant boost in support last week. Rep. Tom Lantos (D-CA), the chairman of the House Foreign Affairs Committee, one of the committees that the bill has been referred to for action, has formally added his name as a cosponsor (supporter) of the bill. This strong show of support will likely mean the bill will be considered more quickly in this Congress. While Chairman Lantos' cosponsorship does not guarantee successful consideration of the bill, it does imply that the bill will receive a favorable hearing, if and when it is considered by the committee. The bill now has a total of 37 bipartisan cosponsors, up seven from just last week. The Senate bill, S. 968, sponsored by Sens. Boxer (D-CA) and Smith (R-OR), has five cosponsors, up one in the last week.

The Stop TB Now Act implements the recommendations of the WHO plan for controlling tuberculosis globally, which seeks to cut the TB deaths and disease burden in half by 2015 and eliminate TB as a global health problem by 2050. The legislation provides increased authority and funding for the U.S. Agency for International Development (USAID) and the Centers for Disease Control and Prevention (CDC) to expand global TB control activities including expansion of directly observed treatment short-course (DOTS) coverage, strengthening of health systems, and promotion of the International Standards of TB Care.

PUBLIC HEALTH

Senate Passes Pediatric Medical Device Incentive
Legislation to speed the development of medical devices designed for children and increase the number of drugs tested and labeled for children passed Senate this week as part of the Food and Drug Administration Revitalization Act (FDARA). FDARA reauthorizes the FDA’s prescription drug fee user program which pays for new drug evaluations. The Senate voted 93 to 1 in favor of the legislation.

The Pediatric Medical Device Safety and Improvement Act, S. 830, offers incentives to manufacturers of medical devices for children, requires post-market studies of devices to ensure their safety and efficacy, and coordinates research efforts at the National Institutes of Health (NIH), Agency for Healthcare Research and Quality (AHRQ) and the FDA. The Best Pharmaceuticals for Children Act (BPCA) reauthorization bill, S.1156, reauthorizes the FDA’s pediatric drug incentive program, which grants manufacturers of drugs being tested for children an additional six months of patent exclusivity. Prior to enactment of this legislation, most drugs were not being tested for use in children, but since its.
enactment, pediatric clinical trials have been completed in over 130 drugs and 115 drug labels have been changed to incorporate new pediatric information.

Among other provisions of FDARA, the bill will expand the FDA’s drug safety monitoring capacity, including the creation of new post-marketing surveillance systems to monitor the safety of medicines after patent expiration. The bill also requires registration of all clinical trials for new drugs in a public registry and requires clearer warnings of drug side effects in radio and television advertising.
The House has not yet considered its companion FDA bill. The House version of the pediatric medical device bill, H.R. 1494, is being sponsored by Reps. Markey (D-MA) and Rogers (R-MI). The pediatric drug testing bill has not yet been introduced in the House. ATS members are encouraged to contact their House Representatives to request cosponsorship of H.R. 1494, to expand the availability of medical devices designed for children. The ATS Washington Office will keep members informed of developments on this legislation.

Points of Contact