SGR Repeal Bill Advances

Published: Jul 27, 2013

By David Pittman, Washington Correspondent, MedPage Today

WASHINGTON -- A House subcommittee approved this week a bill to replace Medicare's sustainable growth rate (SGR) physician payment formula ahead of a full committee vote next week.

SGR Repeal Bill Moves Along

Medical societies agreed that an SGR repeal bill approved by the House Energy and Commerce Health Subcommittee on Tuesday strikes a good balance among the physician community's many interests and is a fair transition away from today's fee-for-service Medicare reimbursement system.

However, nearly all also agree the bill is not perfect and more work is needed before a final product is signed into law. They point to the proposal's quality-reporting measures as an example.

A full committee markup is scheduled for Wednesday before Congress leaves for its long August recess.

Obama Defends ACA in Economic Speech

The cost of healthcare is rising at its slowest rate in 50 years, thanks at least in part to the Affordable Care Act (ACA), President Obama asserted Wednesday as part of a speech about the economy.

Contrary to assertions by critics, "healthcare costs are slowing down" as a result of the law, even though many working families haven't seen any of the savings yet, Obama said during a speech at Knox College in Galesburg, Ill.

And businesses have created twice as many jobs in this latest economic recovery as they did at this point in the last recovery, when there was no ACA, the president noted

GOP Calls for August Town Halls

As Congress readies for its long August break, Republicans are trying to organize emergency town halls to discuss -- among other topics -- healthcare.

The House Republican Conference's plan for the 4-week break calls for public forums with young adults and forums with members of the local healthcare community.

"To highlight the negative effects of the president's healthcare law, the member will engage with local businesses and employees that have been impacted by job cuts, furloughs, or the loss of health insurance," the plan read. "This event will promote local businesses and emphasize the need to repeal Obamacare to protect employees, small businesses, and jobs."

FDA Eyes Menthol in Cigarettes

The FDA has taken an initial step toward regulating, and possibly banning, the use of menthol in cigarettes.

On Tuesday, the agency issued an Advance Notice of Proposed Rulemaking, which requests information from the public regarding the effects of menthol in cigarettes and possible regulatory options. The comment period will last for 60 days before the FDA makes a decision. If a rule is ultimately proposed, there will be another comment period.

Accompanying the announcement was an FDA-authored, preliminary evaluation of the scientific evidence on the effects of menthol in cigarettes. The bulk of the evidence did not support an increase in toxicity or disease with the addition of menthol, although menthol was associated with increased initiation and greater progression to regular smoking, increased dependence, and reduced success in quitting, particularly among black smokers.

Senate Updates Compounding Oversight Bill

A Senate committee on Thursday released an updated bill to tighten regulations on the country's compounding pharmacies as senators renewed calls for a vote on the bill before lawmakers leave Washington for their August recess.

Among the handful of changes, the bill released by the Health, Education, Labor, and Pensions Committee would allow for traditional compounding pharmacies to ship up to 10% of their products to doctors' offices with being subjected to FDA oversight.

The Pharmaceutical Quality, Security, and Accountability Act is the committee's effort to prevent future compounding crises -- like the 2012 fungal meningitis outbreak -- by having the FDA regulate large-scale compounding pharmacies.

FDA Panel Nixes Humira for Spinal Arthritis

An independent panel of FDA advisers overwhelmingly rejected on Wednesday AbbVie's bid to gain approval of Humira (adalimumab) for treatment of active nonradiographic axial spondyloarthritis in adults with signs of inflammation by elevated CRP or MRI.

After rejecting adalimumab by a 12-1 vote with one abstention, the Arthritis Advisory Committee split 7-6 with one abstention when polled about recommending approval of UCB's Cimzia (certolizumab) for treatment of active axial spondyloarthritis, including ankylosing spondylitis.

Adalimumab is already approved for treatment of rheumatoid arthritis, plaque psoriasis, ulcerative colitis, ankylosing spondylitis and psoriatic arthritis, and certolizumab is indicated for Crohn's and rheumatoid arthritis.

FDA Goes After Fake Diabetes Therapies

The FDA has sent letters to 15 companies warning them to stop marketing products that falsely claim to treat diabetes, the agency announced Tuesday.

The products range from dietary supplements and "natural" treatments to ayurvedic and homeopathic remedies to illegally sold prescription drugs. They claim that they can lower blood sugar "naturally" or completely replace approved diabetes drugs, the agency said.

Selling these purported therapies is illegal, the FDA said, in some cases because of the false claims and in others because the drugs may contain harmful or active ingredients that would qualify them as prescription drugs.

FDA Grants Exclusivity to Plan B One Step

Teva Pharmaceutical Industries will receive 3 years of marketing exclusivity for its over-the-counter version of Plan B One-Step (levonorgestrel), its controversial emergency contraceptive, the FDA said late Monday.

Consumer and women's rights groups said the exclusivity would raise the price and create a barrier to access, but the 3-year exclusivity period is part of a law to incentivize bringing new products to market.

Teva and women's rights groups fought the FDA to make Plan B One-Step available without a prescription to girls as young as 17.

Next Week

The FDA's Non-Prescription Drugs Advisory Committee will meet Wednesday to discuss making triamcinolone acetonide nasal spray (Nasacort AQ) available over-the-counter.

The full Energy and Commerce Committee will mark up a bill to replace Medicare's SGR -- Medicare Patient Access and Quality Improvement Act -- on Wednesday.

On Thursday, the committee will question Centers for Medicare and Medicaid Services Administrator Marilyn Tavenner on ACA implementation during a hearing.

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