On July 27, 2011, the case of Sherley v Sebelius drew to a close as U.S. District Judge Royce Lambeth of the United States District Court for the District of Columbia granted the United States’s Motion for Summary Judgment. As we have previously reported, Sherley v Sebelius challenged the legality of government funding of human embryonic stem cell research. As a result of this decision, the Department of Health and Human Services (“HHS”) and the National Institutes of Health (“NIH”) may continue to provide federal funds for the study of embryonic stem cells. A copy of the District Court’s Order can be read here.
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-08-01 13:12:512026-01-07 15:17:34D.C. District Court Rules Against Challenger of Embryonic Stem-Cell Funding
On July 27, IRS officials announced restructuring changes aimed at improving its international operations. First, the Advance Pricing Agreement (“APA”) Program and Mutual Agreement Program (“MAP”), will consolidate under a […]
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-08-01 13:07:412025-12-09 14:34:22IRS Consolidates Transfer Pricing Programs and Bolsters International Coordination
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-08-01 07:09:112025-12-09 15:04:20IOM Report Suggests Overhaul of 510(k) Program; FDA Responds with Request for Public Comment
Long-term health care can be expensive, but fortunately many of those expenses are tax deductible. Two recent Tax Court decisions shed light on when such caregiver services are deductible. In Estate of Lillian Baral, 137 T.C. 1 (2011), the Court held that payments to non-medical caregivers are deductible as long as the patient is “chronically ill” and the doctor deems that caregivers are necessary due to the patient’s illness.
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-07-29 07:22:222014-11-10 18:17:06Tax Court Clarifies Deductibility of Long-Term Care Expenses
On July 21, 2011, the U.S. Food and Drug Administration (FDA) issued its draft guidance describing the agency’s plan to apply its regulatory oversight to certain types of mobile medical applications (“apps”) that run on mobile platforms. The agency is focusing on medical apps that directly diagnose or treat conditions such as diabetes or transform mobile platforms, such as smartphones and iPads, into medical devices.
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-07-28 15:23:052025-12-09 15:03:03FDA Issues Draft Guidance for Mobile Medical Apps
Since 2006, the U.S. Department of Agriculture’s (USDA) Animal & Plant Health Inspection Service (APHIS) has issued over 70 decisions that deregulate genetically engineered (GE) crops, some of which include corn, soybeans, cotton, canola, alfalfa and squash. On July 1, 2011, APHIS issued another decision deregulating GE Kentucky bluegrass.
In July 2008, the FDA announced it would implement a rule to prohibit the extra-label use of cephalosporins but then revoked the order to consider all comments received on the prohibition.
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-07-28 15:12:132025-12-09 15:02:32FDA Urged to Ban Cephalosporin Use in Food Animals
On July 26, 2011, the U.S. Food and Drug Administration (FDA) issued draft guidance that clarifies when changes or modifications to a previously cleared 510(k) device necessitate a new premarket submission. In order to introduce a medical device into the interstate market, the FDA must either approve a premarket application (PMA) or clear a 510(k) premarket notification.
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-07-28 15:06:512025-12-16 08:50:59FDA Issues Guidance Clarifying When Changes or Modifications to an Existing 510(k) Require New PMA Submission
Earlier this week, a pair of whistleblowers filed an amended complaint in United States District Court in Atlanta alleging that DaVita, a kidney dialysis clinic, intentionally wasted medicine to collect Medicare drug overpayments. The plaintiffs claim that DaVita changed how it dispensed dialysis medication in order to inflate their Medicare reimbursement return.The original complaint, which was filed in October of 2007, was unsealed this past week. After two years of investigating the claim, the federal government decided in April that it did not intend to join the lawsuit.
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-07-28 15:03:122025-12-09 15:01:11Whistleblowers Claim Dialysis Company Deliberately Wasted Hundreds of Millions of Dollars in Medicine to Collect Medicare Overpayment
Swiss financial advisor Beda Singenberger, 57, was charged with helping more than 60 U.S. taxpayers hide over $184 million in Swiss bank accounts and then avoid U.S. authorities by moving assets from UBS AG to other Swiss banks. The indictment came on the same day that U.S. authorities separately charged several Credit Suisse bankers with helping Americans evade taxes and nearly 2 ½ years after UBS paid a $780 million penalty settlement with the U.S. to avoid prosecution.
D.C. District Court Rules Against Challenger of Embryonic Stem-Cell Funding
On July 27, 2011, the case of Sherley v Sebelius drew to a close as U.S. District Judge Royce Lambeth of the United States District Court for the District of Columbia granted the United States’s Motion for Summary Judgment. As we have previously reported, Sherley v Sebelius challenged the legality of government funding of human embryonic stem cell research. As a result of this decision, the Department of Health and Human Services (“HHS”) and the National Institutes of Health (“NIH”) may continue to provide federal funds for the study of embryonic stem cells. A copy of the District Court’s Order can be read here.
IRS Consolidates Transfer Pricing Programs and Bolsters International Coordination
On July 27, IRS officials announced restructuring changes aimed at improving its international operations. First, the Advance Pricing Agreement (“APA”) Program and Mutual Agreement Program (“MAP”), will consolidate under a […]
IOM Report Suggests Overhaul of 510(k) Program; FDA Responds with Request for Public Comment
The Institute of Medicine (IOM) recently released a report, Medical Devices in the Public’s Health: The FDA 510(k) Clearance Process at 35 Years, which summarizes the IOM’s findings regarding the U.S. Food and Drug Administration’s (FDA) 510(k) premarket notification program.
Tax Court Clarifies Deductibility of Long-Term Care Expenses
Long-term health care can be expensive, but fortunately many of those expenses are tax deductible. Two recent Tax Court decisions shed light on when such caregiver services are deductible. In Estate of Lillian Baral, 137 T.C. 1 (2011), the Court held that payments to non-medical caregivers are deductible as long as the patient is “chronically ill” and the doctor deems that caregivers are necessary due to the patient’s illness.
FDA Issues Draft Guidance for Mobile Medical Apps
On July 21, 2011, the U.S. Food and Drug Administration (FDA) issued its draft guidance describing the agency’s plan to apply its regulatory oversight to certain types of mobile medical applications (“apps”) that run on mobile platforms. The agency is focusing on medical apps that directly diagnose or treat conditions such as diabetes or transform mobile platforms, such as smartphones and iPads, into medical devices.
USDA Considers Deregulation of Genetically Engineered Crops
Since 2006, the U.S. Department of Agriculture’s (USDA) Animal & Plant Health Inspection Service (APHIS) has issued over 70 decisions that deregulate genetically engineered (GE) crops, some of which include corn, soybeans, cotton, canola, alfalfa and squash. On July 1, 2011, APHIS issued another decision deregulating GE Kentucky bluegrass.
FDA Urged to Ban Cephalosporin Use in Food Animals
In July 2008, the FDA announced it would implement a rule to prohibit the extra-label use of cephalosporins but then revoked the order to consider all comments received on the prohibition.
FDA Issues Guidance Clarifying When Changes or Modifications to an Existing 510(k) Require New PMA Submission
On July 26, 2011, the U.S. Food and Drug Administration (FDA) issued draft guidance that clarifies when changes or modifications to a previously cleared 510(k) device necessitate a new premarket submission. In order to introduce a medical device into the interstate market, the FDA must either approve a premarket application (PMA) or clear a 510(k) premarket notification.
Whistleblowers Claim Dialysis Company Deliberately Wasted Hundreds of Millions of Dollars in Medicine to Collect Medicare Overpayment
Earlier this week, a pair of whistleblowers filed an amended complaint in United States District Court in Atlanta alleging that DaVita, a kidney dialysis clinic, intentionally wasted medicine to collect Medicare drug overpayments. The plaintiffs claim that DaVita changed how it dispensed dialysis medication in order to inflate their Medicare reimbursement return. The original complaint, which was filed in October of 2007, was unsealed this past week. After two years of investigating the claim, the federal government decided in April that it did not intend to join the lawsuit.
Beda Singenberger Charged with Swiss Account Conspiracy
Swiss financial advisor Beda Singenberger, 57, was charged with helping more than 60 U.S. taxpayers hide over $184 million in Swiss bank accounts and then avoid U.S. authorities by moving assets from UBS AG to other Swiss banks. The indictment came on the same day that U.S. authorities separately charged several Credit Suisse bankers with helping Americans evade taxes and nearly 2 ½ years after UBS paid a $780 million penalty settlement with the U.S. to avoid prosecution.