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Washington Watch

FDA: Nipple Test No Substitute for Mammogram

A nipple aspirate test shouldn't take the place of mammography or otherwise be used on its own to screen for breast disease, the FDA warned.

Use of Expired Auto-Injectors OK'd by FDA

WASHINGTON -- The FDA cautioned emergency medical staff to retain recently expired auto-injectors by Meridian Medical Technologies and to use them in emergencies if no other product is available.

AMA President Discusses SGR Repeal Efforts

Shortly after the American Medical Association's interim meeting adjourned, Ardis Hoven, MD, president of the American Medical Association, sat down for a one-on-one interview with 番茄社区 to discuss the AMA's SGR repeal strategy.

FDA Flags Risk of Nuclear Stress Test Drugs

SILVER SPRING, Md. -- Two agents used in cardiac nuclear stress tests may carry a greater risk of heart attack and death than previously believed, the FDA said Wednesday.

Docs Need Info on 'Grace Period,' AMA Says

NATIONAL HARBOR, Md. -- The American Medical Association wants health plans to notify doctors when patients haven't paid their premiums, a situation that could leave physicians on the hook for unpaid services.

SGR Repeal Still Gets AMA Support

NATIONAL HARBOR, Md. -- The AMA's policymaking House of Delegates voted nearly unanimously to continue its support of congressional efforts to repeal Medicare's payment formula despite its opposition to a 10-year pay freeze that's part of a draft proposal.

ACA: When Is a Screening Not a Screening?

A provision in the Affordable Care Act that waives patients' payments for colonoscopies is an example of how good intentions in the law can lead to a tangle of unforeseen consequences.

Morning Break: Addictive Oreos and Sperm-Slaying Bacon

Health news and commentary from around the Web, gathered by the 番茄社区 staff.

Concierge Medicine Gains Ground

SAN DIEGO -- Concierge doctors are spreading the word that it's possible to operate a direct primary care practice, make a living, and avoid one of the biggest headaches for family medicine physicians -- dealing with health insurance companies.

ACP Hedges in Debate on Scope of Practice

The American College of Physicians took a nuanced position on the role advanced nurse practitioners play in clinical care teams in a position paper published Monday.

FDA Approves Device to Treat Enlarged Prostate

SILVER SPRING, Md. -- An implanted suture-based system to help men with enlarged prostates urinate more freely has been approved by the FDA, the agency said Friday.

Congress Probing VA Bonuses to Doctors

WASHINGTON -- A congressional committee is using a recent report questioning performance bonuses for Department of Veterans Affairs physicians as reason to examine a range of pay-for-performance issues at the VA.

Medicare's DME Bidding Program Criticized

Despite complaints from multiple parties, Medicare's bidding program for durable medical equipment -- including diabetes supplies -- now includes suppliers to half of all program beneficiaries.

FDA Beefs Up Fluoroquinolone Warning

The risk of nerve damage that fluoroquinolone antibiotics carry may come on rapidly and perhaps be permanent, the FDA warned Thursday.

FDA Panel Vetoes New Tolvaptan Indication

SILVER SPRING, Md. -- An FDA advisory committee has declined to endorse an expanded indication for tolvaptan (Samsca) to treat autosomal dominant polycystic kidney disease.

FDA Warns of Fatal Skin Reactions with Acetaminophen

SILVER SPRING, Md. -- Acetaminophen is associated with rare but severe and sometimes fatal skin reactions at usual doses, the FDA said Thursday.

FDA Panel Favors Nasacort OTC Switch

SILVER SPRING, Md. -- An FDA advisory committee voted Wednesday to make allergy nasal spray triamcinolone acetonide (Nasacort AQ) available without a prescription -- but some expressed concern about its use in children.

Wyeth Settles Rapamune Marketing Charge

WASHINGTON, D.C. -- Pfizer's Wyeth Pharmaceuticals unit will pay $490.9 million to resolve state and federal allegations that it marketed rapamycin (sirolimus, Rapamune) for unapproved indications.

New Version of Fibromyalgia Drug OK'd for Depression

The FDA has approved levomilnacipran (Fetzima), a single-enantiomer version of the fibromyalgia drug milnacipran (Savella), for treating major depression, its developers said.

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.

FDA Panel Nixes Humira for Spinal Arthritis

SILVER SPRING, Md. -- An independent panel of FDA advisers overwhelmingly rejected AbbVie's bid to gain approval of Humira (adalimumab) for treatment of spinal arthritis.

FDA Adds GI Warning to Benicar Label

WASHINGTON -- The FDA ordered the maker of the blood pressure drug olmesartan (Benicar) to add a warning about risk of the intestinal condition known as sprue-like enteropathy to the drug's label.

Xarelto Gets a No for Stent Thrombosis

SILVER SPRING, Md. -- The FDA has rejected an application for a new indication allowing rivaroxaban (Xarelto) to be used to reduce the risk of stent thrombosis in patients with acute coronary syndrome.

Public Citizen's Wolfe Still Needling FDA

Sidney Wolfe, MD, founder of Public Citizen's Health Research Group, sat down this week with 番茄社区 in his Washington office to discuss his 40 years of work as a leading voice in consumer health advocacy.

CDC: Cut Back on Doxycycline Use

A continuing shortage of doxycycline means the drug should be used only for conditions that have no alternative treatments, the CDC advised this week.

Medicare to Pay for More FDG-PET Scans

WASHINGTON -- Up to three scans using 18F-fluorodeoxyglucose-enhanced positron emission tomography technology can be covered by Medicare for oncology treatment planning, the Centers for Medicare and Medicaid Services said.

Zilver Stent Recalled, System May Break

Cook Medical's Zilver PTX drug-eluting stent for peripheral artery disease has been recalled because of a defect in its associated delivery system, the company and the FDA said.

CHIP Faces Uncertain Future

锘縒ASHINGTON -- The final implementation of the Affordable Care Act (ACA) could be bad news for re-authorization of the Children's Health Insurance Program (CHIP), a congressional staffer said.

Gun Control: Docs Told to Speak Up

WASHINGTON -- Physicians need to do a better job at promoting the data that supports stronger gun-control laws, experts here said.

FDA Lowers Age for OTC Plan B

WASHINGTON -- The FDA has approved over-the-counter sale of the emergency contraceptive Plan B One-Step to women and girls as young as 15.

FDA Splits on Safety of Endo's Aveed for Low-T

SILVER SPRING, Md. -- An FDA advisory committee was split Thursday on the safety of an injectable form of testosterone replacement, but voted overwhelmingly against a proposed risk mitigation plan.

More Docs Joining Forces in ACOs

SAN FRANCISCO -- The number of physician-led accountable care organizations (ACOs) has recently surpassed the number led by hospitals, becoming the largest backers of the payment and delivery model, an analysis showed.

Docs May See Pay Delay Under ACA Exchanges

SAN FRANCISCO -- A provision in the Affordable Care Act (ACA) states that insurance companies will not process claims on patients who haven't paid their premiums in 3 months, leaving doctors on the hook to recoup payment directly from the patients.

Docs' Charting Falls Short of ICD-10 Demands

SAN FRANCISCO -- Nearly 65% of clinical documentation doesn't contain enough information for coders to use for billing under the upcoming ICD-10 coding system, a survey of patient charts found.

Fatal Reactions Prompt Omontys Recall

All lots of the new anemia drug peginesatide (Omontys) have been recalled because of severe hypersensitivity reactions -- some fatal -- observed after the drug was approved last March.

More Insurance Claims Filed Electronically

Healthcare providers continue to file more insurance claims electronically and submit claims more quickly, a report from the leading health insurance industry group showed.

Judge OKs $762 Million Deal in Aranesp Case

A federal judge approved a $762 million settlement Wednesday in a case involving Amgen's off-label promotion of darbepoetin alfa (Aranesp), an anemia drug.

Amgen Agrees to Pay $762 Million in Aranesp Case

The biotech drug giant Amgen pled guilty Monday to promoting its blockbuster anemia drug darbepoetin alfa (Aranesp) for off-label dosing regimens, agreeing to pay $762 million in fines.

Pfizer Will Pay $55 Million in Off-Label Case

Pfizer subsidiary Wyeth has agreed to pay $55 million plus interest to settle allegations it promoted off-label use of the acid reflux drug pantoprazole (Protonix), the company and government officials announced.

No Need for Skin Preps to Be Sterile, FDA Told

WASHINGTON -- Requiring that antiseptic skin preparation products be sterile is unnecessary and wouldn't lead to a dramatic drop in infections, speakers told the FDA Wednesday.

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