Mondaq All Regions: Food, Drugs, Healthcare, Life Sciences
The 25-year controversy involving BPA in food packaging won’t go away.
The European Lawyer Reference Series: Guide to the Distribution and Marketing of Drugs 2013 provides practical information on the sale, promotion, distribution and marketing of drugs in an easy-to-read "question and answer" format.
This article is a follow-up to an article in our March 2012 update concerning the decision of the Swedish Medical Products Agency, prohibiting Boehringer Ingelheim AB in September 2011 from advertising the prescription-based product Pradaxa to the public, in the form of a press release.
A report on the most recent health policy developments.
A summary of the recent Congressional hearings focusing on health policy.
The Internal Revenue Service and the Department of Labor and HHS recentyl released final regulations regarding wellness programs integrated with employer-sponsored health plans.
A recent GAO report compares direct purchase prices paid by the Department of Defense and the Department of Veterans Affairs for a sample of 43 brand-name and 40 generic drugs for the first quarter of 2012.
According to the OIG, Medicare provider enrollment databases include inaccurate, incomplete, and inconsistent provider data, and -- coupled with insufficient oversight -- "present vulnerabilities in all health care programs".
The Office of Inspector General of the Department of Health and Human Services recently issued a special advisory bulletin on the "Effect of Exclusion from Participation in Federal Health Care Programs."
The urgent care industry is a rapidly growing healthcare sector that provides cost-effective, convenient medical services for low- to mid-acuity illness or injury.
"Cellular surgeons" and "molecular E.R." are just some of the fascinating concepts that were under discussion at the May 30th World Science Festival’s "Cellular Surgeons: The New Era of Nanomedicine"
Providers and suppliers use G modifiers on claims they expect to be denied as either not "reasonable and necessary" or because the items or services are not covered by Medicare.
The OIG has issued its latest Semiannual Report to Congress, covering the period of October 1, 2012 to March 31, 2013.
Two recent OIG reports examine Medicare policies involving hospice services.
The Medicare Board of Trustees recently released its annual assessment of the financial condition of the Social Security and Medicare trust funds.
CMS has issued a memo outlining optional strategies states can use to make progress toward reducing the number of uninsured individuals and transition to new eligibility and enrollment systems and coverage of new Medicaid enrolees.
The OIG has issued an ACA-mandated report on Medicare Part D prescription drug plan and MA drug plan coverage of drugs commonly used by full-benefit dual-eligible individuals.
CMS has posted the July 2013 Medicare Part B average sales price files.
CMS has opened an "informal" comment period on potential quality of care measures for cancer hospitals exempt from the Medicare prospective payment system.
The Department of Labor issued guidance regarding the ACA requirement that employers provide notice to employees describing the coverage options available under Health Insurance Marketplaces/Exchanges.
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The Affordable Care Act provides employees who are not offered health coverage by their employers with the option of purchasing health coverage through new health insurance marketplaces (also known as health insurance exchanges) that will operate in every state.
As anticipated, last Friday (April 5, 2013), USCIS received enough cap-subject H-1B petitions to meet or exceed the available number of H-1B spots for Fiscal Year 2014 (FY 2014).
The Supreme Court of the United States has recently heard oral argument in "Association for Molecular Pathology v. Myriad Genetics, Inc." to decide the question, "Are human genes patentable?"
This recent news has increased the intensity of the spotlight on the gene patent debate in both the US and Australia.
One of the potential threats for manufacturing and sale of food/health supplements such as "Dietary food supplement", "Food supplements", "Nutritional supplements", "Health supplements", is its categorization in the category of "Food" or "Drugs", as there is a very thin line between "drugs/ medicines" and "nutritional supplements".
The Massachusetts Department of Public Health Public Health Council approved, by unanimous vote, final regulations for the implementation of the medical marijuana ballot initiative law.
The United States Department of Justice recently filed a suit against Vitas Hospice Services, L.L.C. and its subsidiary entities, alleging that Vitas submitted false claims for hospice services which were excessive, unnecessary, or not provided, and also alleging that Vitas admitted patients to hospice who were not terminally ill.
In light of the decision of 2nd U.S. Circuit Court of Appeals in U.S. v. Caronia, the Pharmaceutical Research and Manufacturers of America is advocating for the Food & Drug Administration to change its regulations to allow for certain types of off-label promotion.
Beginning in 2014, the Affordable Care Act will require "large" employers to offer their full-time employees healthcare coverage that meets certain standards or pay a penalty.
April was a productive month for the agencies guiding us through the implementation of the Affordable Care Act.
