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Tag Archives: Obama Administration

FDA Adopts New Designation Process for Regenerative Advanced Therapies

On January 19, 2017, the United States Food and Drug Administration (“FDA”) unveiled a new drug designation process for regenerative advanced therapies, an important first step toward implementation of the regenerative medicine provisions of the 21st Century Cures Act.  Products for which a designation as a regenerative advanced therapy (“RAT”) is obtained are eligible for accelerated approval under the 21st Century Cures Act, which was signed into law by former President Obama on December 13, 2016 with sweeping bipartisan support.

The accelerated approval provisions for RATs under the 21st Century Cures Act are intended to facilitate expedited … Continue Reading

Long-Awaited Accessibility Standards for Medical Diagnostic Equipment Are Released

Our colleagues Joshua A. Stein and Frank C. Morris, Jr., at Epstein Becker Green have a post on the Health Employment And Labor blog that will be of interest to many of our readers: “The U.S. Access-Board Releases Long-Awaited Final Accessible Medical Diagnostic Equipment Standards.”

Following is an excerpt:

As part of a flurry of activity in the final days of the Obama Administration, the U.S. the Architectural and Transportation Barriers Compliance Board (the “Access Board”) has finally announced the release of its Accessibility Standards for Medical Diagnostic Equipment (the “MDE Standards”).  Published in the Federal Register … Continue Reading

New Federal and State Initiatives Seek to Combat Antimicrobial Resistance

Recent federal and state legislative efforts signal an increased focus on a significant and largely underappreciated public health threat – antimicrobial resistance (i.e., when a microorganism (such as a bacteria or virus) is able to resist the effects of medications such as antibiotics and antivirals, causing such medications to be ineffective). The results of a 2014 study underscore the magnitude of the threat of so-called “superbugs,” estimating that the number of deaths worldwide attributable to antimicrobial resistance will reach 10 million by 2050.  By comparison, the same study projected 8.2 million deaths from cancer, and 1.2 million deaths from traffic … Continue Reading

The Supreme Court Mulls Obamacare; the Health Care Industry Mulls the Supreme Court

By Stuart M. Gerson

The three days of arguments about the constitutionality of the Patient Protection and Affordable Care Act are complete. The Justices of the Supreme Court of the United States have conducted their post-argument conference and are now turning their attention to the drafting and the discussions that will lead to a majority opinion and, likely, several dissents and concurrences. The Court’s decision should be issued before the end of June. Health care companies and employers, like the rest of the population, await the ultimate decision. However, there are several matters that can be identified in the short … Continue Reading

The Timeline for Accountable Care

Now that we have sweeping new health care legislation, the Patient Protection and Affordable Care Act ("the Act"), let’s look at the rollout of the accountable care provisions–i.e., those changes to the payment and delivery system that hold the most long-term promise of improving quality and cost-efficiency. They are discussed in my most recent article: "The Timeline for Accountable Care: The Rollout of the Payment and Delivery Reform Provisions in the Patient Protection and Affordable Care Act and the Implications for Accountable Care Organizations," published last week in the BNA’s Health Law Reporter.  Click here to read the full article Continue Reading

Infrastructure for Health Care Reform

Barack Obama signed an executive order on April 8, 2009 to formally lay infrastructure in the executive branch to facilitate health care reform activities. The executive order officially creates the White House Office of Reform (the “Health Reform Office”) and lays out its principle functions, including coordination across executive departments and agencies, outreach activities with state and local policymakers, and working with Congress for the purpose of enacting and implementing health care reform. As we reported on March 6, 2009, Nancy Ann DeParle was selected to be the Director of the Health Reform Office. The order grants DeParle the … Continue Reading

Friday Wrap-Up: This Week in Health Reform Musings

In yesterday’s post on The Health Care Blog, Bill Kramer remarks upon a key difference in the health reform discourse this go-round. Simply put, “the Obama Administration is changing the debate in a fundamental way.” As President Obama stated in his opening remarks to last week’s White House Forum on Health Reform, “[h]ealthcare reform is no longer just a moral imperative, it is a fiscal imperative.”

Kramer explains that past attempts at reform suffered from political sticker shock over concerns that health reform would dramatically enlarge the federal deficit. However, this time, the Obama Administration is emphasizing that … Continue Reading

President’s Health Care Forum Officially “Sounds the Alarm”…and Hopefully a National Call to Action

Thursday’s White House Forum on Health Reform brought together people who have a stake in our health care system with people who have the ability to change it. Prior to his inauguration, President Obama called on Americans to hold community discussions about health care. More than 9,000 Americans signed up to host discussions in all 50 states and more than 30,000 Americans attended these discussions. These community groups submitted reports to the White House that detailed their concerns about the health care system and their suggestions for reform. At the Forum, several of these community participants joined health care experts … Continue Reading

President Announces HHS and White House Office of Health Reform Picks

On Tuesday, President Obama announced Kansas Governor Kathleen Sebelius as his nominee for Secretary of Health and Human Services. She is known for her bipartisan approach to politics and her efforts as a governor in the health care arena. If confirmed, Governor Sebelius has a once in a lifetime opportunity to execute health care reform – a President enjoying positive public opinion, a national sense of urgency, and resources to get the job done.

The President also announced his choice for Director of the White House Office of Health Reform, Nancy-Ann DeParle, a former Administrator of HCFA (now CMS) during … Continue Reading