Home Public PolicyRegulatory IssuesUS Center for Medicare & Medicaid Services (CMS) About the issue

About the Issue

CMS Issues Final Rule on Reimbursements

The Centers for Medicare and Medicaid (CMS) issued the final fiscal year 2008 Inpatient Payment Prospective (IPPS) rule on Medicare reimbursements for inpatient hospital, inpatient rehabilitation and skilled nursing facilities.  

Under the provisions of the rule, inpatient payments for care stemming from six preventable hospital-acquired conditions would cease if they are not present upon admission.  To access a table listing the conditions, please click here. 

A copy of the new CMS regulations (beginning at page 290) can be accessed by clicking here.

Alcohol-Based Surgical Prep Solutions

CMS Supports Use of Alcohol-Based Surgical Skin Preps

The use of alcohol-based skin preps in surgical settings, based on the National Fire Protection Agency (NFPA) fire prevention strategies, has been supported in a letter published on the CMS website.  The support of skin preps removes the risk of individual states banning their use, following such action in two states thus far.  With the passage of an NFPA 99 amendment, approved in August 2005, the NFPA lifted its six-month ban on the use of alcohol-based surgical prep solutions during laser and electrocautery procedures, provided specific fire prevention precautions were followed.

In late 2006, after Pennsylvania issued a ban on the use of alcohol-based skin preps, CMS stepped up its process and issued a letter to all state surveyors, stating the following:
"A review of recommendations produced by various expert organizations concerning use of alcohol based skin preparations in anesthetizing locations indicates there is general consensus that the following fire risk reduction measures are appropriate:

• Using skin prep solutions that are: 1) packaged to ensure controlled delivery to the patient in unit dose applicators, swabs, or other similar applicators; and 2) provide clear and explicit manufacturer/supplier instructions and warnings. These instructions for use should be carefully followed.
• Ensuring that the alcohol-based skin prep solution does not soak into the patient's hair or linens. Sterile towels should be placed to absorb drips and runs during application and should then be removed from the anesthetizing location prior to draping the patient.
• Ensuring that the alcohol-based skin prep solution is completely dry prior to draping. This may take a few minutes or more, depending on the amount and location of the solution. The prepped area should be inspected to confirm it is dry prior to draping.
• Verifying that all of the above has occurred prior to initiating the surgical procedure. This can be done, for example, as part of a standardized pre-operative "time out" used to verify other essential information to minimize the risk of medical errors during the procedure.

Hospitals that employ alcohol-based skin preparations in anesthetizing locations should establish appropriate policies and procedures to reduce the associated risk of fire. They should also document the implementation of these policies and procedures in the patient's medical record."

To view the letter sent January 12, 2007 to CMS Surveyors click here.

Medicare and Medicaid Programs; Fire Safety Requirements for Certain Health Care Facilities; Amendment

This final rule adopts the substance of the April 15, 2004 tentative interim amendment (TIA) 00-1 (101), Alcohol Based Hand Rub Solutions, an amendment to the 2000 edition of the Life Safety Code, published by the National Fire Protection Association (NFPA). Click here to access the document.

As of August 8, 2005, the NFPA has approved the TIA proposed by ASHE.

To view the TIA, click here.

In a letter dated March 31, 2005, the Nebraska State Fire Marshall instructed the state’s hospitals and ambulatory surgery centers that the use of alcohol-based surgical prep solutions on patients in an oxygen-enriched atmosphere with cautery or electrosurgery violates National Fire Protection Association (NFPA 99). To view letter from Nebraska State Fire Marshall, click here.

The American Society for Healthcare Engineering (ASHE) responded with the development of a regulatory advisory stating that NFPA did not prohibit use of alcohol-based prep solutions when use of cautery was anticipated. ASHE recommended that healthcare facilities be allowed to continue using these preps provided the use was consistent with product labeling and instructions. The central office of CMS disagreed with this interpretation, but concurred the language should be updated as soon as possible.

ASHE, with input from APIC and others, including CMS, submitted a tentative interim amendment (TIA) to the NFPA to update NFPA 99. The TIA amends and expands language to clarify practice during use of alcohol-based skin preps, balancing the risk of fire against the risk of surgical infection. The current code language dates back to the mid 1970’s and has not kept up with current surgical practice. Although NFPA 99 was recently revised (on a three year revision cycle), recent interpretation and enforcement of this standard has greatly impacted clinical practice creating an emergency situation. The TIA expands the current language and provides requirements for increased management of the solutions and practice to assure that solutions are dried before the ignition source is introduced to the surgical site.

On May 6, Richard Raymond, MD, Director of the Nebraska Department of Health and Human Services Regulation and Licensure, sent a follow-up letter advising all Nebraska hospital and ambulatory surgical centers that they CAN return to use of alcohol-based skin prep solutions as long as they follow certain conditions. To view letter, click here. If surveyed by the state, even if there has been no patient harm resulting from use, a deficiency will be cited; however this deficiency does not constitute an “Immediate Jeopardy” affecting Licensure.

APIC provided a letter to the NFPA supporting the TIA. To view letter, click here.

Identify your state’s CMS region: http://www.cms.hhs.gov/about/regions/professionals.asp.

All hospitals should update protocols intended to reduce fire risks from flammable liquid germicides that include at a minimum the recommendations from the TIA since the same elements will apply in all states, once the TIA is approved and enforced by CMS.

Alcohol-Based Hand Sanitizers

Since 2003, APIC has been working with the American Hospital Association, the American Society for Healthcare Engineering, the National Fire Protection Association (NFPA), Centers for Medicare and Medicaid Services (CMS) and others, in an effort to amend a provision prohibiting hand sanitizer dispensers in egress corridors of healthcare facilities. This prohibition was in place due to perceived fire risk associated with these alcohol-based products.

In 2004, the NFPA, through fire modeling studies, determined that these products are, in fact, safe to place in egress corridors. APIC has been working with these groups ever since, to urge CMS to amend its policy so that these products are readily available to healthcare workers.

In a September 2004 letter to CMS, APIC had urged the agency to revoke its prohibition. To view the letter, click here.

On March 25, 2005, CMS published a notice in the Federal Register stating that the prohibition has been lifted, with an effective date of May 24, 2005.

In the meantime, infection control professionals should continue to contact their local jurisdiction if their facility is cited for having dispensers in corridors. States vary in their approach, but CMS has been recommending that if facilities are cited for this deficiency, they should request a “temporary waiver” from enforcement action in their plan of correction.