Washington Week: GOP Gets Started on Reform Repeal

WASHINGTON -- The week began with the 112th Congress being sworn in and its new GOP members vowing to begin the process to repeal the Democrats' healthcare reform law. By the end of the week, Republicans were one procedural step closer to that goal.

Eric Cantor (R-Va.), the Majority Leader of the new Republican-controlled House of Representatives, introduced the two-page "Repealing the Job-Killing Health Care Law Act" early in the week, which would repeal the Affordable Care Act (ACA) and all other laws changed by the reform law "as if such Act had never been enacted." It would also repeal the healthcare provisions in the companion bill, known as the reconciliation act, that fixed some parts of the main law.

The House Rules Committee, which determines rules to govern floor debate of bills, approved a rule to govern floor debate on Thursday, and on Friday, the House voted 236 to 181 -- with a handful of Democrats joining Republicans in opposition to the reform law -- to approve the rule.

The House is expected to vote on the repeal bill on Wednesday, where it is expected to pass easily. Senate passage, however, is unlikely given the Democrats' control of that chamber. Even if it did clear the Senate, President Obama has said he would veto it.

Sharfstein to Depart FDA; Emanuel to Leave White House

Joshua Sharfstein, MD, a pediatrician and the FDA's deputy commissioner, is leaving the agency to become the Secretary of Health and Mental Hygiene for the state of Maryland.

CQ HealthBeat reported the news early in the week, and Sharfstein and Maryland Gov. Martin O'Malley confirmed it on Wednesday.

During his time at the FDA, Sharfstein worked toward giving FDA regulatory control of tobacco products, which culminated in a 2009 bill that did just that.

Sharfstein, along with FDA Commissioner Margaret Hamburg, MD, has also played a role in turning the FDA into a more aggressive regulator. Under their dual leadership, the agency began issuing more warning letters to drug, device, and food companies and also began pressing criminal charges against drug companies.

Later in the week, Kaiser Health News reported that Ezekiel Emanuel, MD, a healthcare adviser in the White House Office of Managment and Budget, left his post to return to his old job at the National Institutes of Heath. Health policy experts told Kaiser Health News that his departure is no surprise and that he was always just "on detail" to the White House.

Emanuel's brother, Rahm, recently stepped down as President Obama's chief of staff to run for mayor of Chicago.

End-of-Life Provision Dropped

The Obama administration dropped a regulation specifying that Medicare will pay for end-of-life counseling, just days after the rule went into effect.

The rule, which went into effect on Jan. 1, said that as part of an annual wellness visit, Medicare will pay for elective discussions about end-of-life plans, which can, in turn, be used to prepare an advance directive stating what treatments a patient would want and treatments they would not want.

A similar provision was in the original healthcare reform law but was dropped after it ignited a firestorm of controversy centered on so-called "death panels."

The current end-of-life counseling provision was included in a final rule setting Medicare payment rates for annual wellness visits.

However, because the provision was not included in the proposed regulation, which was published in July, the Obama administration felt that "the opportunity for the public to comment on it was too limited," an administration official told MedPage Today. Hence, the decision to drop it, which was announced on Jan. 5.

Still, "nothing about this change should inhibit patients and physicians from having this kind of discussion," the official added.

Slowdown in Healthcare Spending Growth

Spending on healthcare grew at its slowest rate in 50 years, mostly because of recession-fueled cutbacks by businesses, governments, and households, according to a Centers for Medicare and Medicaid Services report.

The growth in healthcare spending has slowed every year since 2002, but 2009's was particularly pronounced -- growing at a rate of 4%, down from 4.7% in 2008, according to the authors of the agency's annual health spending report, published in Health Affairs.

Despite the slowdown in the growth rate, the U.S. still spends $2.5 trillion on healthcare, or $8,086 per person.

The newest figures do not take into account any changes made by the ACA, which was signed into law in 2010.

Food Safety Bill Signed into Law

President Obama signed a food safety bill into law Tuesday that is expected to bring the most sweeping changes to the nation's food system in at least the past 20 years.

The $1.4 billion bill aims to improve prevention of food contamination, allows the FDA to issue mandatory recalls if businesses do not voluntarily recall harmful foods, requires grocery stores and other food sellers to notify consumers if they have sold food that has been recalled, and improves disease surveillance so outbreaks can be discovered earlier.

While the law authorizes $1.4 billion in new spending over the next five years, the money will still have to be appropriated by Congress.

FDA Issues New Tobacco Regulation

New FDA guidance issued Wednesday requires tobacco companies to prove any product introduced or changed after Feb. 15, 2007 is "substantially equivalent" to products on the market before that date.

Equivalency applications are due by March 22 of this year. After that date, tobacco manufacturers will have to submit a new product application and get a marketing order before introducing a new product.

Wednesday's announcement represented the latest step in the FDA's implementation of the Tobacco Control Act of 2009.

During a telephone briefing, Lawrence Deyton, MD, director of the agency's Center for Tobacco Products, explained that "until now, tobacco products have been only mass-consumed products in which users don't know what they're consuming," because producers can alter the contents or ingredients "without anyone knowing."

FDA Approves ESC Trial for Macular Degeneration

A clinical trial of a human embryonic stem cell (ESC) therapy for age-related macular degeneration has been approved by the FDA, making it the first such study for a common disease.

Advanced Cell Technology, based in Marlborough, Mass., said it had received the agency's clearance to begin a phase I/II trial in 12 patients with age-related "dry" macular degeneration, which affects about 10 to 15 million people in the U.S.

Patients will receive implants with retinal pigment epithelial (RPE) cells derived from the company's ESC lines.

Other clinical trials of ESC-based therapies are under way or approved to begin, but they have been for comparatively rare conditions: certain severe spinal cord injuries and Stargardt's macular dystrophy, a childhood-onset form of blindness that resembles age-related macular degeneration.