Plus Virginia Reform Efforts

Certificate of Public Need (COPN) programs are a fact of life in 36 states (Virginia included) as well as the District of Columbia. These laws require government consent before a health care facility may expand, offer a new service or purchase certain medical devices.

The Case for Certificate of Need Laws

The initial intent of COPN programs was to contain health care facility costs through coordinated government/private enterprise planning of facility construction and added services. The assumption was to limit facilities to provide only enough capacity to meet actual need or demand in a given geographical area. Presumably, that would avoid price increases by health care accommodations that were struggling to meet overhead not funded by sufficient patient loads.

The ban is effective January 18, 2017

Here’s a reminder of the recent ban of powdered gloves by the Federal Drug Administration (FDA). Compliance is mandatory in less than a week.

Bottom-Line

In its announcement last month, the FDA formally banned two types of powdered gloves and a glove lubricant. These medical devices can no longer be legally marketed or used effective January 18, 2017. That prohibition applies to devices already in commercial distribution and those sold to the end user.

Specifically, the ban applies to powdered patient examination gloves, powdered surgeon’s gloves and absorbable powder used to lubricate surgeon’s gloves. The glove types include all of these gloves, regardless of the material from which they are made – including NRL and synthetic latex gloves.

It’s been all over the news … hospitals being hacked, data held hostage and ransom paid to the perps. Hollywood Presbyterian Medical Center and MedStar Health in D.C. are two recent victims that have been prominently in the press and paid significant dollars to cyber bandits.

And Compelling Reasons Why 

In 2000 the Centers for Medicare & Medicaid Services (CMS) added Total Knee Arthroplasty (TKA) to the Medicare Inpatient Only (IPO) list in 2000. More than a decade later, in 2013, the CMS proposed that the procedure be removed from the IPO list in anticipation that some Medicare beneficiaries would be well served in an outpatient environment. There was considerable adverse public reaction to this proposed move so it was not finalized at that time.

Now, three years later, the CMS is once again considering removal of TKA from the IPO list and soliciting public comments on that proposal. Driving this effort are two prime factors:

HELP Is On The Case

Healthcare increasingly is a patient-centered world where information technology (IT) has a major effect on diagnosis and personalized treatments. Without a doubt, electronic health record (EHR) technology is under significant scrutiny by the U.S. Senate Committee on Health, Education, Labor and Pensions (HELP).

For over a year, the HELP committee has been investigating potential issues with health IT and the meaningful use of certified EHR systems. An important development occurred in February of this year when HELP voted unanimously to pass the Improving Health Information Technology Act (S. 2511).

View the the current version as revised in April of this year.