OVERNIGHT HEALTH: Ag approps debate offers venue for FDA showdown

by Healthwatch staff - 06/14/11 10:40 PM ET

“Given the severity of this problem and your legal obligations, the nation needs leadership on this issue,” says the letter from Rep. Paul Ryan (R-Wis.) and Sen. Jeff Sessions (R-Ala.). “Therefore, we reasonably expect your administration to submit a detailed legislative proposal to Congress addressing the Medicare funding warning as required by law.”

Read the story from Healthwatch’s Julian Pecquet.

Calorie conundrum: House Small Business Committee Chairman Sam Graves (R-Mo.) is one of four GOP lawmakers who signed a letter urging the Food and Drug Administration to scale back proposed rules on menu labeling. The regulations implement a section of the healthcare law that requires chain restaurants to include calorie counts on their menus or menu boards, but Graves and other Republicans say the agency’s approach to implementing the policy is too burdensome on small businesses.

Read a copy of the letter here, and read the Healthwatch story for more on the regulation and the industry’s requests.

Antibiotics incentives: Rep. Phil Gingrey (R-Ga.) is set to reintroduce a bill Wednesday with new incentives to combat drug-resistant bacteria. Some infections have grown resistant to existing antibiotics. Gingrey’s bill would give drug makers a fast track to FDA approval for products that treat those infections. The new drugs also would get extra time on the market without the risk of a lower-cost generic coming along.

Healthwatch’s Sam Baker has the story.

SGR: The Congressional Budget Office laid out various options for a fix to the “sustainable growth rate” formula that Medicare uses to calculate doctors’ payment rates. Congress regularly blocks scheduled cuts from taking effect, and the latest SGR “patch” expires later this year.

Wednesday’s agenda:

Cost of reform: The Energy and Commerce health subpanel’s hearing on health reform’s “regulatory burden” picks up where it left off on June 2. Steve Larsen, the director of the Center for Consumer Information and Insurance Oversight at HHS, is the only witness.

Device makers on the Hill: Some 19 medical device company executives are visiting lawmakers to push the industry’s “competitiveness agenda,” which includes overhauling the FDA’s approval process for low-risk devices and eliminating health reform’s 2.3 percent, $20 billion excise tax.

“This is a critical time for the medical technology industry as we focus on America’s global leadership in medical innovation,” Steve Ubl, president and CEO of the Advanced Medical Technology Association, said via e-mail. “The visits (Wednesday) between our member company executives and Members of Congress provide another opportunity to discuss how regulatory, reimbursement, tax, trade and a host of other policy issues impact the industry’s ability to bring life-saving, life-enhancing technologies to American patients.”

The visits come as the medical device industry is negotiating a renewal of user fees with the Food and Drug Administration. In a letter to medical device makers that’s indirectly aimed at the FDA, Sens. Richard Burr (R-N.C.) and Tom Coburn (R-Okla.) warn that they’re paying close attention to the process.

“We strongly caution that many in Congress do not have any appetite to consider proposals that will continue to perpetuate unnecessary or unwarranted delays of potentially life-saving and life-enhancing products,” they write. “Proposals that grow bureaucracy, strangle innovation with red-tape, or further erode our nation’s standing as the world’s leader in medical innovation will not be well received.”

Medicaid reform: Sen. Orrin Hatch (R-Utah), the top Republican on the Senate Finance panel, discusses his bill to repeal healthcare reform’s maintenance of effort provision and his broader vision for Medicaid reform at The Heritage Foundation.

Medicare options: The Medicare Payment Advisory Commission releases its June report, one of two annual sets of recommendations to lawmakers.

Health exchange solutions: The Robert Wood Johnson Foundation hosts a webinar on state insurance exchanges and active purchasing. The foundation recently funded a report detailing options states may consider in forming their exchanges, which are required by the healthcare reform law.

Lobbying registrations:

Lobbyit.com / DocBox (Clinical Process Management Solution)

Vandor Strategies / ALung Technologies (medical device research)

ML Strategies / US Family Health Plan Alliance

Thorn Run Partners / Continuing Medical Education Coalition

Hurt, Norton & Associates / Georgia Health Services University

Physicians for Human Rights (self registration)

FrogueClark / Equity Health

McDermott Will & Emery / eHealth (online insurance marketplace)

Injured Workers Pharmacy (self-registration)

Reading list:

The FDA issued new guidelines for sunscreen labeling, reports the Los Angeles Times.

The North Dakota legislature is getting started on the state’s health insurance exchange, the AP reports.

British Prime Minister David Cameron has watered down his proposed changes to the country’s single-payer healthcare system, which he has vowed will not begin to resemble the U.S.

ThinkProgress looks at some of the healthcare claims in Monday night’s Republican presidential debate.

What you might have missed on Healthwatch:

Health savings accounts, or HSAs, grew rapidly last year — though that growth could be threatened by provisions of the healthcare reform law.

Patent reform legislation favored by the biopharmaceutical industry is receiving key support in the House after sailing through the Senate.

Comments / complaints / suggestions?

Please let us know:

Julian Pecquet: jpecquet@digital-stage.thehill.com / 202-628-8527

Sam Baker: sbaker@digital-stage.thehill.com / 202-628-8351