Federal Regulation news
Time for Change: National Medicare Equality Petition
Written by Editor   
Thursday, September 03, 2015 06:36 PM

THE AMERICAN CHIROPRACTIC ASSOCIATION (ACA) will soon launch a national petition to generate support for expanded access to chiropractic services for Medicare beneficiaries and allow chiropractic patients to have full access to Medicare-covered services provided by DCs.  The Medicare demonstration program conducted from 2005 to 2007 showed that having DCs provide these services was budget neutral in most areas, but equal access coverage has been a difficult struggle.  Once chiropractic supporters are enlisted to sign the petition, ACA will conduct various grassroots campaigns designed to make legislators in Washington aware of the limited chiropractic benefit in Medicare and urge them to work for a solution the ultimate goal in all of this is to create a database of supporters large enough to create a cacophony too loud for Congress to ignore.

Doctors of chiropractic (DCs) nationwide will be urged to have their patients sign the petition and join ACA’s ChiroVoice grassroots legislative movement. DCs will be encouraged to share the petition via their social media channels, gen- erating even more support.

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FDA to 'Low-T' Drug Makers: Prove It
Written by Editor   
Friday, August 28, 2015 03:01 AM

Several testosterone drug makers will appear in court to face consolidated lawsuits from nearly 2,000 men who believe they suffered heart attacks and other adverse effects after taking testerone drugs. The FDA issued the label changes last March after an advisory committee expressed concerns over the lack of evidence on safety and efficacy in the face of excessive direct-to-consumer marketing campaigns for "Low T."

The FDA is now requiring companies that make testosterone products to conduct a large clinical trial to determine the true risks and benefits of using the hormone, the agency said. The agency is encouraging testosterone drug makers to work together on one large randomized controlled trial it said.

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FDA Proposes Changing Labels for Sugar
Written by Editor   
Sunday, August 23, 2015 12:00 AM

The FDA is proposing that Nutrition Facts labels also include the "% Daily Value" for added sugar.  The Daily Value, or DV, is the amount of an essential nutrient that meets the needs of most people. There are also DVs that indicate upper limits of stuff we shouldn't get too much of, like sodium and saturated fat.  If the proposal goes through, the labels will list grams of added sugar and the %DV they provide per serving.

In 2014, they proposed that Nutrition Facts labels on packaged foods list the grams of added sugar in addition to the grams of total sugar, but now they're taking things a step further. The FDA is taking the recommendation of the 2015 Dietary Guidelines Advisory Committee (DGAC) that added sugars not exceed 10% of total calories. Since the feds use a reference diet that contains 2,000 calories daily, that puts the DV for added sugar at about 200 calories, or 50 grams, maximum.

The comment period for the proposal ends October 13, 2015.

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Evidence Limited for Most High-risk Device Approvals
Written by Editor   
Tuesday, August 18, 2015 12:00 AM

The quality and amount of evidence used by the US Food and Drug Administration (FDA) to support bringing high-risk devices to market varies greatly, new research indicates.  "[M]ost devices have been or will be evaluated through only a few studies, which often focus on surrogate markers of disease in small numbers of patients followed up over short periods of time and study indications that differ from the original FDA-approved indication," the authors write.

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Medicare's Next 50 Years: More Home Care, Less Red Tape
Written by Editor   
Monday, August 10, 2015 12:00 AM

Medicare is 50 years old and both political parties have ideas for its improvement.  These include promoting a broader role for the program with guaranteed benefits, and supporting curbing federal spending, privatizing benefits and shifting towards a "defined contribution" system. More innovation and competition and less government oversight are what's needed to improve care and reduce cost this report cites.

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