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A comprehensive health care bill that includes reforms to Medicare's Local Coverage Determination (LCD) process advanced out of a House subcommittee on May 14.

The House Energy & Commerce Health Subcommittee discussed the "21st Century Cures Act" legislation during a mark-up session. The overall goal of bill is to improve the regulatory framework overseeing the health care industry in order to advance new treatments and therapies, such as new pharmaceutical and medical technologies. As for next steps, the full Energy & Commerce Committee is expected to debate the bill on May 20.

One section of the legislation seeks to improve the LCD process utilized by Medicare Administrative Contractors (MACs) to set payment policy in their respective jurisdictions. In particular, the bill would require MACs to disclose 45 days prior to effective date, when and where the LCD was first made public. And 45 days prior to finalizing an LCD, MACs would be required to provide:

  • A copy of the LCD in its entirety;
  • Where and when the proposed LCD was first made public;
  • Links to the proposed LCD and a response to comments submitted to the MAC;
  • A summary of evidence that was considered during the development of the LCD;
  • A list of the sources of evidence;
  • An explanation of the rationale that supports the LCD.

The CAP strongly supports more comprehensive reforms in its draft legislation. The CAP's legislation would improve transparency and boost accountability in the LCD process. For instance, the College is asking for MAC carrier advisory committee meetings to be open, public, and on the record. In addition, the CAP legislation would require upfront disclosure of evidence by MACs when drafting LCDs.

The previous version of the 21st Century Cures bill also had included a placeholder for legislative language to make changes to the regulatory oversight of laboratory-developed tests (LDTs). In the version approved by the subcommittee, the placeholder for the LDT section had been removed.

The CAP will report more on this issue in future editions of STATLINE.

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The New Jersey Assembly on May 14 unanimously passed the CAP's model legislation to establish Clinical Laboratory Advisory Boards for accountable care organization (ACOs) and help ensure patients served by ACOs receive access to all medically necessary tests.

The CAP and New Jersey Society of Pathologists (NJSP) urged the state Legislature to enact legislation as the advisory boards are in the best interest of patient care. The bill will now be taken up in the State Senate.

The CAP's model legislation requires ACOs to have Clinical Laboratory Advisory Boards, with the participation of a pathologist medical director. The advisory boards can help ACOs identify and eliminate unnecessary testing while making sure that patients enrolled in the ACO continue to have access to appropriate pathology services and laboratory tests. Such boards have demonstrated compelling medical value at nationally esteemed health care centers that were the basis for federal development and promotion of the ACO practice paradigm.

The CAP model legislation is endorsed by the Leukemia and Lymphoma Society, National Brain Tumor Society, American Society of Breast Disease, and Lung Cancer Alliance.

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The CAP and NJSP are opposing legislation to introduce new out-of-network billing requirements because it would eliminate certain protections for patients and create burdensome and unrealistic regulations for laboratories.

The bill was introduced in the New Jersey Legislature on May 14. Pathologists are opposed to the bill because it seeks to shift financial responsibility from the insurance payer to the patient for payment of out-of-network costs in excess of in-network coverage. The provision would void the current balance billing protection afforded the patient under New Jersey insurance regulations.

The legislation also would require out-of-network physicians, including pathologists, to disclose to patients in advance that his or her services are out-of-network and provide a "reasonable estimate of the costs for those services to be charged by the professional." The medical necessity for pathology services during or resulting from a medical procedure for a patient may not be known in advance by the pathologist. The type of specimen and complexity of the required analysis, including potential genetic analysis, is often not known in advance—making it impossible to provide a meaningful or reliable estimate of the charges or costs. Further, the legislation would require a health care professional to ensure that the covered patient signs a disclosure form in advance an out-of-network pathology procedure.

Pathologists cannot defer anatomic pathology procedures based on insurance considerations, as this would potentially result in specimen degradation, detrimental delays in diagnosis, extended hospitalizations, increased costs, and diminished patient care.

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Congressman Michael Capuano (D-MA) toured a laboratory at Cambridge Health Alliance (CHA) Cambridge Hospital on April 24 to celebrate the 40th National Medical Laboratory Professionals Week.

Congressman Capuano visited the Cambridge laboratory to meet with CHA leadership and laboratory professionals to learn about the role of pathology in the delivery of health care. Rep. Capuano toured each department in the laboratory, observing testing procedures and processes and taking part in some sample diagnostic tests.

"We thank Congressman Capuano for taking the time to tour our laboratory," said Rebecca Osgood, MD, FCAP, the laboratory's chief of pathology. "The tour was a great opportunity to engage with the congressman and discuss federal issues affecting pathologists and laboratory medicine, and to thank Rep. Capuano for his vote to repeal the flawed sustainable growth rate (SGR). The CHA laboratory staff did an excellent job demonstrating the value of laboratory medicine in the delivery of healthcare. We look forward to continuing these discussions with Rep. Capuano and his staff in our district and in Washington."

The congressman's visit highlighted CHA's celebration of Lab Week and served as an opportunity to recognize our medical laboratory professionals. CHA also received official proclamations from the mayors of the cities of Cambridge, Everett, and Somerville to acknowledge the work of our lab staff and pathologists who perform laboratory tests that detect and diagnose, monitor treatment, and help prevent diseases.

Interested in hosting a lab tour? View more resources on PathNET.

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The CAP will host a webinar on May 21 on the upcoming transition to the ICD-10 diagnosis coding set later this year.

Register for this complimentary CAP webinar.

The webinar focuses on awareness, implementation, preparation, and readiness for ICD-10. The speakers will be Doug Knapman, CAP senior director of Practice Management, and Cindy Hegner, CCS, of AnaPath Diagnostics in Cheyenne, WY. The panel will identify the essential steps in preparing for a successful ICD-10 transition and discuss how to assign resources and find outside assistance so your practice is ready on October 1, 2015.

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The National Institute of Standards & Technology (NIST) is offering reference material (RM) to assess performance of human genome sequencing, including whole genome sequencing, whole exome sequencing, and more targeted sequencing such as gene panels.

The NIST is selling the human DNA for whole-genome variant assessment (daughter of Utah/European ancestry) to laboratories for $450.

"Specifically, the material can be used to obtain estimates of true positives, false positives, true negatives, and false negatives for variant calls," the NIST stated on May 15. "This genomic DNA is to be analyzed as any other processed, extracted DNA. Because the RM is extracted DNA, it is not useful for assessing pre-analytical steps such as DNA extraction, but it does assess sequencing library preparation, sequencing machines, and the bioinformatics steps of mapping, alignment, and variant calling. This RM is not intended to assess subsequent bioinformatics steps such as functional or clinical interpretation."

View more information about the reference test from the NIST.

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In observance of the Memorial Day holiday, STATLINE will next appear in your email inbox on June 2. Please continue to check the CAP Twitter and Facebook accounts for updates from the CAP. And, if important news breaks before June 2 the CAP will send a STATLINE Special Alert to all members.

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