VA Adds to Agent Orange List
The Department of Veterans Affairs has added Parkinson's disease to its list of disabilities presumed to be associated with exposure to Agent Orange, the blend of herbicides used by the U.S. military to remove jungle cover during the Vietnam War. VA Secretary Eric K. Shinseki announced that a new federal rule also added hairy cell and other chronic B-cell leukemia and ischemic heart disease to the list of about a dozen diseases with “presumption of service connection.” The action means that veterans no longer must prove an association between their illnesses and exposure to Agent Orange to get VA health care and other benefits.
In addition to accepting new claims for the three diseases, the VA will review about 90,000 previously denied claims from Vietnam vets, Mr. Shinseki said on the White House blog. “This rule is long overdue. It delivers justice to those who have suffered from Agent Orange's toxic effects for 40 years,” said Mr. Shinseki. Acute and subacute peripheral neuropathy was already on the list of presumed Agent Orange—linked conditions.
Bill Would Raise Alzheimer's Funds
Rep. Michael Burgess (R-Tex.) wants Americans to buy bonds for the war effort — the war on Alzheimer's disease, that is. Rep. Burgess, an ob.gyn., has introduced H.R. 6169, the Making Investments Now for Dementia (MIND) Act, which would create U.S. “Alzheimer's Bonds.” Proceeds of sales would go to the National Institutes of Health but would solely fund Alzheimer's research. The funds would be in addition to those appropriated normally, the bill states. In announcing his proposal, Rep. Burgess said that “Alzheimer's disease is one of the most burdensome diseases facing Americans today, taking an immense emotional, physical, and financial toll on those affected … yet research funding is not equivalent to other comparable illnesses.”
Two New Udall Centers Added
The National Institute of Neurological Disorders and Stroke has named Emory University in Atlanta and the Feinstein Institute for Medical Research, Manhasset, N.Y., as Morris K. Udall Centers of Excellence in Parkinson's Disease Research. The two centers will receive a total of more than $16 million over the next 5 years, bringing the number of Udall Centers to 11. With a component at Vanderbilt University, Nashville, Tenn., the Emory University program will focus on the mechanisms of existing and new Parkinson's treatments. The center at the Feinstein Institute will explore a new brain-imaging technique and the clinical side effects of levodopa, according to the announcement. Morris K. Udall was a Democratic representative from Arizona who died in 1998 after a battle with Parkinson's disease.
Botox Maker Fined $600 Million
Pharmaceutical manufacturer Allergan pleaded guilty to marketing Botox for the unapproved uses “headache, pain, spasticity, and juvenile cerebral palsy in children” from 2000 to 2005, the company announced. Although it pleaded guilty only to a single misdemeanor charge — “misbranding” — Allergan will pay a $375 million criminal fine. Another $225 million will settle a civil claim under the False Claims Act. Allergan admitted that it marketed Botox for the off-label uses. On the other hand, it said, “Allergan denies liability” associated with the civil claim but settled it for the good of stockholders.
As part of the settlement — still subject to approval by a federal court — Allergan agreed to withdraw a pending lawsuit claiming a First Amendment right to “proactively share truthful scientific and medical information with the medical community to assist physicians” in how to use Botox. The company also pointed out that as of last March, Botox has been approved for treating muscle stiffness in adults with upper limb spasticity.
Proposed New Rules Target Fraud
The Department of Health and Human Services has proposed new rules to fight waste, fraud, and abuse in Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). The rules are authorized by the Affordable Care Act and would tighten screening of providers wishing to bill the government programs for services, for example, by using broader criminal background checks and even fingerprinting. The rules also require states to terminate from their Medicaid and CHIP programs any provider who has been thrown out of Medicare or another state's health programs. The proposed rule asked for advice on how best to ensure provider compliance.