A hold on Califf's FDA nomination

[[be...]]

WASHINGTON -- Another senator balks at the nomination of Robert Califf, MD, a prominent Duke University cardiologist with Pharma ties, to lead FDA .

 

Senator Places Hold on Califf's FDA Nomination

 

U.S. Sen. Edward Markey (D-Mass.) is seeking to block Robert Califf's nomination to head the FDA, according to a report in the Boston Globe. Markey will use Senate rules to place a hold on the nomination.

 

In September, President Obama nominated Califf, a well-known Duke University cardiologist and clinical researcher, to head the FDA. After a generally positive reception at a hearing of the Senate's Health, Education, Labor and Pension Committee in November, the committee voted earlier this month to move the nomination to the entire Senate for a vote.

 

Markey is using the hold to punish the FDA for its approval last year of the use of oxycodone (OxyContin) in children. Markey is particularly concerned that the approval came without an FDA advisory committee meeting. He wants the FDA to rescind the approval and to promise to hold advisory committee meetings before new approvals of any prescription opioids.

 

Three other senators came out against Califf's nomination as well: Joe Manchin (D-W.Va.), Bernie Sanders (I-Vt.), and Lisa Murkowski (R-Alaska).

 

CMS Rule Expands Use of Claims Data for Qualified Entities

 

The Centers for Medicare & Medicaid Services (CMS) announced a new rule on Friday that may expand providers' and employers' access to Medicare and private sector claims data.

 

Andy Slavitt, the Acting Administrator for CMS, frames the new rule in a positive light.

 

"Increasing access to analyses and data that include Medicare data will make it easier for stakeholders throughout the healthcare system to make smarter and more informed healthcare decisions," he said in a press release.

 

The concept of qualified entities stems from a provision of the Affordable Care Act that allows these entities access to patient-protected Medicare data and private sector claims data, and the opportunity to analyze this data for public reporting purposes.

 

The new rule broadens the use of this data by allowing qualified entities to develop nonpublic analyses, which they may then share or sell to "authorized users," such as providers, employers, and others looking to use data to enhance patient care, noted the agency.

 

In addition to annual reporting requirements, the new rule "includes strict privacy and security requirements for all entities receiving Medicare analyses or data," the agency added.

 

Thirteen organizations have already applied for and received approval as qualified entities to date.

 

The proposed rule is open for public comment until March 29.

 

CMS Revises Benchmarks for Medicare Shared Savings

 

On Thursday, CMS announced another rule that will change the way Accountable Care Organizations (ACOs) under Medicare's Shared Savings Program are assessed with the goal of making ACOs more sustainable through stronger long-term incentives.

 

"This proposal allows ACOs in all parts of the country to be successful by recognizing both their achievements and improvements in how they provide care," said Slavitt in a press release.

 

"This should have the effect of growing the number of ACOs and making ACOs and the coordinated care they provide to patients more of a standard in all parts of the country."

 

Core features of the proposed rule include:

 

    Using regional instead of national spending growth trends when determining ACOs rebased benchmarks

    Updating rebased benchmarks when an ACO enters its second or future agreement period, by a percentage of the difference between fee-for-service; this percentage will rise incrementally over time

    Using a phased-in implementation process to give ACOs more time to anticipate new benchmarks that track alongside regional expenditure

 

"CMS has also proposed further modifications to streamline the methodology used for adjusting the ACO's benchmark for composition changes, encourage ACOs to transition to performance-based risk arrangements, and to provide greater administrative finality around the program's financial calculations," a press release noted.

 

The new rule is open for comment until March 28.

[[Te...]]

Thanks, Bets!

 

This is very good, that there's a hold. Califf is a known bedfellow of big pharma. However, I'm not holding my breath on this one. It seems that even despite the controversy, the nomination will go through. Wishing it wouldn't, though.

[[be...]]

Thanks, Bets!

 

This is very good, that there's a hold. Califf is a known bedfellow of big pharma. However, I'm not holding my breath on this one. It seems that even despite the controversy, the nomination will go through. Wishing it wouldn't, though.

 

Terry: Neither would I.  :'( :'(

[[Te...]]

Yes, Bets, it's really sad. It seems impossible that Califf could make unbiased decisions. I have no faith in his confirmation.