All posts in Regulatory

Consumers lose in latest FDA user fee bill; COI restraints disappear

May 15, 2012 by MassDevice By Merrill Goozner Over the angry protests of consumer groups, Congress is moving rapidly – and in bipartisan fashion – to give drug and medical device companies an easier path to Food and Drug Administration approval for some products …

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CBO Says FDA User Fee Act Will Reduce Deficit – LOL

As reported by the Senate Committee on Health, Education, Labor, and Pensions on May 7, 2012 S. 2516 would authorize the collection and spending of fees by the Food

Practicing Medicine in a Litigious World: Coping with Medial Legal Stress

This article is written by Michael J. Sacopulos, JD, a partner with Sacopulos, Johnson & Sacopulos in Terre Haute, Ind.

A Google search for "Medical Malpractice Lawyers" yielded 21,600

sunshine

Sunshine Act data collection delayed to January 2013, says USA’s CMS

In a web site posting last week, The US Center for Medicare and Medicaid Services (CSM) announced that manufacturers will not be required to collect data under the

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Senate panel adds safety measures to FDA user fee act

April 25, 2012 by Brad Perriello

The U.S. Senate's Health, Education, Labor & Pensions Committee passes the "Food & Drug Administration Safety and Innovation Act,"

Free Healthcare

When health care is promoted as “free”

Health expenditures in the United States neared $2.6 trillion in 2010, over ten times the $256 billion spent in 1980. The rate of growth in recent years

Repeal ObamaCare

Mass. Sen. hopeful Elizabeth Warren on the device tax, the FDA and a climate for innovation

In an exclusive MassDevice.com editorial, Massachusetts Senate hopeful Elizabeth Warren (D) calls for a more transparent FDA, the repeal of the medical device tax and a renewed commitment

Democratic “buyers’ remorse” for health care law? | MassDevice.com On Call

A growing number of Democratic legislators are raising concerns about President Barack Obama's landmark health care reform ahead of election season.
MASSDEVICE ON CALL — A growing number of

When the government puts prices on patients’ heads

Recently, another predictable Trojan-horse provision of the Patient Protection and Affordable Care Act appeared that promises to pit doctor versus patient by literally placing a price on patients'

FDA: Safety, efficacy, public health – and economy?

The U.S. House version of a bill reauthorizing FDA review user fees would add employment and economic considerations to the federal watchdog agency's mission statement.
FDA officials and consumer

GOP Sens. Burr and Coburn team up for PATIENTS’ FDA Act

Sens. Richard Burr (R-N.C.) and Tom Coburn (R-Okla.) team up again in calling for reforms to the FDA's authority, transparency and management in reviewing medical devices.
Sens. Richard Burr

40% Drop in Claims After Ohio’s Malpractice Tort Reform

Since Ohio passed and enacted a tort-reform law in 2003, medical malpractice claims have dropped more than 40 percent and payments declined roughly at the same rate, according

New Hampshire Outlawing PODs?

The New Hampshire House of Representatives recently passed legislation to prohibit health care practitioner self-referrals for medical devices. Larry Biegelsen, senior analyst at Wells Fargo wrote on April 10,

Physician Payment Sunshine: Kohl and Grassley Urge CMS to Complete Regulations by June

As numerous healthcare stakeholders wait for the Supreme Court to determine whether the individual mandate of the Affordable Care Act (ACA) is constitutional, two Senators are eagerly pressing

4 Strategies to Prepare for Changes in Reimbursement

This article is written by Patrick Vega, M.S., Principal, Vega Healthcare. There are four key strategies hospitals and physicians should use to prepare for upcoming reimbursement changes:

1.    Develop