Federal Regulation news
NIH Temporarily Shuts Its Drug-Making Operation
Written by Editor   
Wednesday, June 17, 2015 04:30 PM
Quick Brief: The National Institutes of Health stops developing pharmaceuticals after “serious manufacturing problems” are found by the Food and Drug Administration.

 

The National Institutes of Health (NIH) has stopped operating its Pharmaceutical Development Section after discovering "serious manufacturing problems" leading to contamination of clinical drug lots, the agency announced.

The NIH also found that the section was not complying with standard operating procedures, the agency said in the announcement. The problems were discovered after the FDA received a complaint about the section and conducted inspections in mid-to-late May.

The drug development unit manufactures products for certain clinical research studies conducted in the NIH's hospital and at other facilities. "In April, two vials of albumin, used for the administration of the drug interleukin in experimental studies, were found to have fungal contamination," the announcement explained. "Vials made from the same batch were administered to six patients, although it is unknown whether those or other vials were contaminated."

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CMS Plans Provider Website to Better Track Medicare Fraud
Written by Editor   
Wednesday, June 17, 2015 03:57 PM
Quick Brief: CMS wants to launch a system to track enforcement actions against Medicare providers. The federal agency is on the hunt for a contractor to build and maintain the so-called Provider Compliance Reporting system to be accessible on the yet-to-launch ProviderMedicare.gov website.

 

The CMS wants to launch a system to track enforcement actions against Medicare providers over questionable claims. Fraud costs the federal government an estimated $60 billion to $90 billion annually.  The federal agency is on the hunt for a contractor to build and maintain the so-called Provider Compliance Reporting system. It will be accessible on the yet-to-launch ProviderMedicare.gov website.

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Medicaid Plans Get New Quality and Performance Measures
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Wednesday, June 17, 2015 03:47 PM
Quick Brief: CMS announces  a proposal to “modernize the Medicaid managed care regulations” that haven’t been revised in a decade.

 

The Centers for Medicare and Medicaid Services (CMS) announced a proposal to "modernize the Medicaid managed care regulations," which haven't been revised in a decade.

"The proposed rule would align the rules governing Medicaid managed care with those of other major sources of coverage, including coverage through Qualified Health Plans and Medicare Advantage plans," according to a CMS statement.

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Congressional Leaders Examining Health IT Security
Monday, March 02, 2015 01:18 PM

Anthem’s massive hack has gotten the attention of Congressional leaders, who are concerned over the potential lack of protective measures in the healthcare industry to keep sensitive data from being exposed.

U.S. Senate health committee Chairman Lamar Alexander (R-Tenn.) and Ranking Member Patty Murray (D-Wash.) recently announced a bipartisan initiative focused on examining the security of health information technology and the health industry’s preparedness for cyber threats. Anthem’s hack exposed the data of 80 million customers, one of the biggest in the industry’s history.

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CMS Gets Tough With Scam Artists
Written by Editor   
Wednesday, December 10, 2014 01:53 PM

In a crackdown on "bad actors," the Centers for Medicare & Medicaid Services (CMS) has revised its provider and supplier enrollment process to make it harder for unscrupulous individuals to defraud the Medicare program.

Among other things, the agency now has the ability to deny the enrollment of providers, suppliers, and owners affiliated with an entity that has unpaid Medicare debt, often as a result of not returning overpayments to CMS.

The agency cites a study by the Office of Inspector General in the Department of Health and Human Services. The Office of Inspector General found that in a random sample of durable medical equipment suppliers in Texas, each had Medicare debt of at least $50,000 that CMS deemed "currently not collectible" during 2005 and 2006. Six of the ten reviewed suppliers were associated with 15 other durable medical equipment vendors or home health agencies that received Medicare payments totaling $58 million from 2002 through 2007.

The new rules also enable CMS to deny the enrollment of a provider or a supplier if a "managing employee" of that entity has been convicted of certain felony offenses within the previous 10 years. These include "a malpractice suit that results in a conviction of criminal neglect or misconduct."

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