Showing posts with label CMS. Show all posts
Showing posts with label CMS. Show all posts

Sunday, April 15, 2012

Accountable Care Organizations and Antitrust, from JAMA

On October 20, 2011, the Centers for Medicare & Medicaid Services (CMS) released the final rules for accountable care organizations (ACOs), a highly publicized initiative of the Affordable Care Act. Accountable care organizations are part of the Medicare Shared Savings Program, which is charged with improving quality of care for Medicare patients. The CMS provided incentives for ACOs to deliver high-quality care at reduced rates of spending by providing a more coordinated team approach to health care delivery. 

On the same day, the Federal Trade Commission and Department of Justice provided guidelines addressing antitrust issues involving the formation of ACOs.1 The concern is that ACOs can result in a reduced number of competitors in health care markets, which could potentially increase prices and have negative consequences for consumers and purchasers of care. The Federal Trade Commission and Department of Justice guidelines require that ACOs meet the Medicare Shared Savings … 

Thursday, April 5, 2012

CMS rules contribute to drug shortages, hospital pharmacists say

Federal guidance requiring strict adherence to manufacturer labels for injectable drugs has forced hospitals to throw away perfectly good drugs that are in short supply, according to a survey of pharmacy directors and managers.

The Institute for Safe Medication Practices, based in Horsham, Pa., has called on the Centers for Medicare & Medicaid Services to review its policies involving stability and beyond-use dating of medicines. The institute surveyed 715 hospital pharmacists and managers who reported that following manufacturer directions has contributed to national drug shortages.

CMS requires pharmacists to be compliant with Food and Drug Administration-approved labels to avoid the use of expired drugs. But pharmacists who were surveyed said some labels are not current and that newer, evidence-based research supports a longer shelf life in certain circumstances.

Those studies have shown that diluted drugs remain stable beyond their stated expiration dates, said Allen J. Vaida, PharmD, the institute’s executive vice president. Nearly all of the respondents — 97% — said CMS rules requiring strict adherence to manufacturer’s directions when evidence-based compendia information recommends longer beyond-use dating increase waste of usable drugs.

For complete article, please see link below:
http://www.ama-assn.org/amednews/2012/04/02/gvsc0405.htm

Seeking Transparency on Sunshine Act

Yesterday Senators Kohl and Grassley submitted a letter to CMS seeking information on the implementation of the Sunshine Act – the legislation passed and signed into law that would put into place a system for public reporting of the financial transactions between medical product manufacturers and medical providers.  Many will recall that last fall, CMS missed the deadline for outlining its plans for how it would collect and report on financial transaction data.  At the time that prompted a letter from Senator Grassley inquiring when the agency would get around to doing so.  Yesterday, another letter went out.
“We are disappointed that regulations implementing the Sunshine Act were not complete by the statutory deadline of October 1, 2011.  We request that the final rule on implementation be released no later than June of this year so that partial data collection for 2012 can commence.”
In addition, there was some specific direction.  In the letter they urge that CMS define very specific categories for payments and urged a removal of a catchall “other” category that could serve to obscure the nature of some transactions.  In addition, the Senators took issue with the proposed yearly schedule for correcting mis-reporting to the public site stating rather that errors should be corrected as the error becomes known.

http://www.eyeonfda.com/eye_on_fda/2012/04/seeking-transparency-on-sunshine-act.html?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+eyeonfda%2FlpWT+%28Eye+on+FDA%29&utm_content=Google+Reader