In This Issue...


OIG Recommends Additional Lab Cuts

The Department of Health and Human Services (HHS) Office of the Inspector General (OIG) recently released its Compendium of Unimplemented Recommendations, which summarizes significant monetary and nonmonetary changes suggested by the Office that have not yet been adopted. This document combines the former Red Book (unimplemented monetary changes) and Orange Book (unimplemented nonmonetary changes) into a single cost-savings publication.

Although the timing is coincidental, the release of the Compendium during the 'fiscal cliff' negotiations gives Congress ample suggestions for reducing the federal deficit. Included among the 166 pages of OIG proposals are a number of recommendations pertaining to clinical laboratories, such as:

  • adopting a beneficiary co-payment for laboratory services;
  • rebasing the clinical laboratory fee schedule to eliminate overpayments; and
  • establishing competitive bidding for laboratory services.

These cuts would be in addition to a 2.95 percent reduction in laboratory fees that takes effect on January 1st. This reduction is the result of laboratory cuts included in the 2010 health care reform law and the 2012 temporary physician 'fix' legislation. If sequestration occurs, clinical laboratories will be subject to an additional 2 percent cut in payments. AACC and the Clinical Laboratory Coalition are opposed to more cuts in laboratory reimbursement. For a copy of the OIG document, please visit the agency website.

President Signs AACC-Endorsed CLIA Change into Law

On December 4th, President Obama signed into law H.R.6118, the "Taking Essential Steps for Testing Act," which would amend CLIA'88 to give the Centers for Medicare and Medicaid Services (CMS) greater flexibility when determining what penalties to impose on a laboratory when it sends a proficiency testing (PT) specimen to an outside laboratory. Currently, CMS revokes a laboratory's certificate for two years and bars the laboratory director from directing a clinical laboratory for two years—regardless of whether the specimen was sent in error or not. H.R.6118 would permit CMS to impose lesser penalties if warranted. AACC endorsed this legislation and generated grassroots support for the measure. For a copy of the law, please go to the congressional Web site, THOMAS.

USPSTF Recommends Routine HIV Testing

The United States Preventive Services Task Force (USPSTF) recently published a draft statement recommending that all people aged 15 to 65 and all pregnant women be screened for human immunodeficiency virus (HIV). According to the USPSTF, "nearly 1.2 million people in the United States are living with HIV infection, yet 20 to 25 percent of them do not know that they are HIV-positive." The Task Force accepted public comments on the draft document through December 17th. To see the draft, please go to the USPSTF website.

Administration Publishes HCR Rules

On November 26th, the Department of Health and Human Services (HHS) published two proposed rules implementing the 2010 health care reform law. The first proposal identifies the "essential health services" that must be included in the health plans offered under the new law. Each plan must offer ten required benefits, including laboratory services. The second proposed rule bars insurers from denying coverage to those individuals with pre-existing conditions. Both documents are available on the Federal Register Web site. The essential benefits proposal can be viewed here, while the pre-existing conditions document can be found here.

IRS Releases Guidance on Medical Device Tax

The Internal Revenue Services (IRS) published a final regulation outlining how it plans to collect the 2.3 percent excise tax on medical devices included in the 2010 health care reform law. A taxable medical device "is listed as a device with the FDA under section 510(j) of the Federal Food, Drug and Cosmetic Act, and 21 CFR part 807, pursuant to FDA requirements." The new tax does not apply to devices purchased by the general public, including eyeglasses, contact lenses, and hearing aids. To see the entire rule, please go to the agency Website.