In This Issue...


CMS Publishes Proposed PT Referral Rule

The Centers for Medicare and Medicaid Services (CMS) published a proposed rule in the September 23, 2013 Federal Register (FR pages 58386-58414), which outlines a new enforcement model for sanctioning clinical laboratories that send their proficiency testing (PT) samples to another laboratory for testing.   The current regulations have little flexibility.  They require CMS to revoke a laboratory’s certificate and ban the owner and laboratory director from owning or directing a facility for two years.  In 2012, AACC endorsed the “Taking Essential Steps for Testing Act (TEST),” which Congress passed, to give the agency greater flexibility in penalizing laboratories depending on the severity of the infraction. 

The propose rule would create three categories of sanctions for PT referral:

  • Repeat referral cases – the laboratory license is revoked for one year and the laboratory owner and director are barred for one year.  There could also be a civil monetary penalty (CMP).
  • Single infraction – the laboratory license is suspended or limited in conjunction with other sanctions, including required staff training, a CMP, and a directed plan of action.  Further if the laboratory license is suspended state on-site monitoring would be mandated.
  • Laboratory reports error prior to reporting results – laboratory would pay a CMP and comply with a directed plan of correction, which would include staff training. 

CMS is accepting comments on the proposed rule through November 18th. 

Legislators Urge CMS to Repeal Proposed Cut in Anatomic Pathology Fees

More than 100 Members of the House of Representatives are urging the Centers for Medicare and Medicaid Services (CMS) to eliminate a provision in the 2014 Physician Fee Schedule Proposed Rule that would cut Medicare payments to independent laboratories for anatomic pathology services by 26 percent.  In an October 7th letter, lawmakers asserted that the methodology used by CMS, comparing aggregate hospital data with more detailed physician fee schedule information, does not accurately reflect the costs of providing the tests.  The legislators asked CMS to “reconsider the proposed payment cap for anatomic pathology services” because it “would have a detrimental impact on Medicare beneficiaries and their physicians who rely on anatomic pathology services” to make accurate diagnoses.  A similar letter is being circulated in the Senate.  The final physician fee schedule rule is expected to be published in early November. 

Commenters Supportive of Hepatitis C Screening

In September 2013, the Centers for Medicare and Medicaid Services (CMS) requested public input on whether it should include HCV screening for adults in the Medicare preventive services package.  The request for comment was in response to a June report released by the United States Preventive Services Task Force (USPSTF) that recommend all people who had or are engaging in risky behavior be tested.  In addition, the preventive task force recommended that all adults born between 1945 and 1965 have a one-time screening test for the hepatitis C virus.  AACC and the 27 other groups and individuals providing comments supported adding HCV screening to the preventive services package.

AACC Grassroots Initiative on Behalf of Newborn Screening

The American Association for Clinical Chemistry (AACC) is urging its members to e-mail their Members of Congress in support of newborn screening introduced by Reps. Lucille Roybal-Allard (D-CA) and Michael Simpson (R-ID) in the House, and Senators Kay Hagan (D-NC) and Orrin Hatch (R-UT) in the Senate.  The Newborn Screening Saves Lives Reauthorization Act would reauthorize critical federal programs that provide assistance to states for improving and expanding their newborn screening programs, supporting parent and provider education, and ensuring quality testing.  Prior to the initial legislation, only 10 states and the District of Columbia screened for 29 of the 31 treatable core conditions.  Now, 44 states and DC test for these conditions.

AACC IQCP Webinar with Judy Yost

AACC will be conducting a webinar on the Center for Medicare and Medicaid Services (CMS) new Individualized Quality Control Plan (IQCP), which will give laboratories another option for complying with the CLIA’88 quality control requirements.  The program will take place on November 14th.  For more information about the program, please go to the AACC site.  If you sign up in October, use the product code 149 and you will get 20 percent off the cost of the program.