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March 7, 2013  


CRS Sponsors Bill on Laboratory Protocols and ACOs


The CSP has sponsored the introduction of SB 264 ( Pavley) regarding Accountable Care Organizations (ACOs) and their process for evaluating clinical laboratory protocols and utilization. ACOs are a new entity created under federal law with the concept that coordination of care, establishment of benchmarks for outcomes and monitoring the quality of care could lead to more cost efficient and enhanced quality of care. So far 24 ACOs in California have been approved by CMS. Some are sponsored by hospital systems that include physician networks and others may be created by large multi-specialty groups that incorporate hospital partners.


The role of the pathologist as laboratory directors within these ACO models is crucial to ensure the use of appropriate testing models for enhancing the treatment and diagnosis of diseases and the incorporation of new genetic testing and biomarkers. SB 264 would simply require that an ACO create a Clinical Laboratory Advisory Committee that would make recommendations to the ACO related to diagnostics, disease management, pathology, and appropriate use of testing.  The Committee would include the physician who is the director of the clinical laboratory providing services to the ACO. Click here to view SB 264.


SB 264 will be heard in the Senate Health Committee in early April and we will contact you shortly with a request that you contact members of the Committee to register your support.


Medicare to Begin Edits to Deny Claims by Ordering Physician/Provider Who is Not Enrolled in Medicare   


CMS has announced that effective May 1, 2013 they will turn on edits to deny a claim where the ordering/referring provider is either not identified, not enrolled in the Medicare Program or is not of a specialty that may order the service being billed.  Since 2009 Part B carriers like Palmetto have been providing informational messaging indicating that their records did not show that the ordering provider met one of these three criteria. Now the edits to actually deny the claim for failure to meet one of these criteria will be turned on May 1st. There is a website provided by CMS that has a list that shows the provider name, their NPI, and if they are the provider type that can order, for example laboratory services.  That can be found here. Once there click Ordering and Referring Information on the left.


There is a MedLearn article that describes the edits, the denial codes and how providers can document that the ordering provider is qualified. It is available on the Palmetto website at www.palmettogba.com/medicare. Search for the article on "Full Implementation of Edits on The Ordering/Referring Providers in Medicare Part B. 

Medi-Cal Provider Manual Contains Updates to TAR Requests for Molecular Pathology Codes


Correction to TAR Requirements of Laboratory Code:

The Pathology: Molecular Pathology and Pathology: Billing and Modifiers provider manual sections have been updated to appropriately reflect the Treatment Authorization Request (TAR) requirements for CPT-4 code 81211 (BRCA1, BRCA2 [breast cancer 1 and 2] [e.g., hereditary breast and ovarian cancer] gene analysis; full sequence analysis and common duplication/deletion variants in BRCA1), which are effective for dates of service on or after October 1, 2012.


CPT-4 code 81211 is a once-in-a-lifetime procedure and requires a Treatment Authorization Request (TAR).


A TAR for code 81211 requires documentation of one or more of the following numbered criteria:

  1. For women without a diagnosis of breast or ovarian cancer:
  • Two first-degree relatives with breast cancer, one of whom was diagnosed at age ≤ 50; or
  • A combination of three or more first- or second-degree relatives with breast cancer regardless of age at diagnosis; or
  • A combination of both breast and ovarian cancer among first- and second-degree relatives; or
  • A first-degree relative with bilateral breast cancer; or
  • A combination of two or more first- or second-degree relatives with ovarian cancer, regardless of age at diagnosis; or
  • A first- or second-degree relative with both breast and ovarian cancer at any age; or
  • History of breast cancer in a male relative; or
  • For women of Ashkenazi Jewish descent, any first-degree relative (or two second-degree relatives on the same side of the family) with breast or ovarian cancer, or
  1. A family history of breast or ovarian cancer that includes a relative with a known deleterious BRCA mutation, or
  2. Personal history of breast cancer plus one or more of the following:
  • Diagnosed at age ≤ 45; or
  • Diagnosed at age ≤ 50 with ≥ 1 close blood relatives with breast cancer diagnosed at age ≤ 50 and/or ≥ 1 close blood relatives with epithelial ovarian cancer at any age; or
  • Two breast primaries when first breast cancer diagnosis occurred at age ≤ 50; or
  • Diagnosed at age ≤ 60 with a triple negative breast cancer; or
  • Diagnosed at age ≤ 50 with a limited family history; or
  • Diagnosed at any age, with ≥ 2 close blood relatives with breast and/or epithelial ovarian/fallopian tube/primary peritoneal cancer at any age; or
  • Diagnosed at any age with ≥ 2 close blood relatives with pancreatic cancer at any age; or
  • Close male blood relative with breast cancer; or
  • For an individual of ethnicity associated with higher mutation frequency (for example, founder populations of Ashkenazi Jewish, Icelandic, Swedish, Hungarian or other) no additional family history may be required, or
  1. Personal history of epithelial ovarian cancer/fallopian tube/primary peritoneal cancer, or
  2. Personal history of male breast cancer, or
  1. Personal history of pancreatic cancer at any age with ≥ 2 close blood relatives with breast, ovarian and/or pancreatic cancer at any age

This information is reflected in the following provider manual(s):

Provider Manual(s)

Page(s) Updated

Clinics and Hospitals 
General Hospital 



Chronic Dialysis Clinics

path bil (15, 16)





California Society of Pathologists
One Capitol Mall Suite 320
Sacramento, CA 95814 
Tel : 916-446-6001
Fax :  916-444-7462