Read the Latest Issue of STATLINE

The Centers for Medicare & Medicaid Services (CMS) released a template that applicable laboratories can use to report private payer rates and associated volume for clinical laboratory fee schedule (CLFS) services required under the Protecting Access to Medicare Act's (PAMA's) new payment system for laboratories.

Under the new system, Medicare payment rates for clinical diagnostic laboratory tests (CDLT) will be based on the weighted median of the rate that private payers pay for the test during a specified data collection period. As detailed in a final rule issued June 17, applicable laboratories must collect information for the first data collection period beginning January 1, 2016, through June 30, 2016. These laboratories must report their data to the CMS beginning January 1, 2017, through March 31, 2017. The CMS will use this data to calculate clinical laboratory fee schedule (CLFS) payment rates for 2018.

The data must be submitted to the CMS through the Fee-For-Service Data Collection CLFS System. The data collection system is in its final stages of testing and won't be publicly available until November.

The CMS released a data reporting template for reporting applicable information on September 8 (SE1620) and updated it a week later. Comma Separated Values (.csv) is the available format for data submission through a file upload process. Alternatively, data may be submitted through an online interface. Those codes that must be collected and reported were released by the CMS earlier this summer. Additional guidance on data collection and reporting is available in a guidance (SE1619) issued by the CMS in June.

The CAP has advocated for PAMA to be implemented so it minimizes administrative burden. The CAP has also called for accurate payments under the new Medicare CDLT payment system. In addition, two of the CAP's nominees to the CMS PAMA CDLT advisory panel were accepted and have been active participants since its inception. The CAP will continue to provide information on how pathology practices can comply with the requirements.

Download the Data Collection Template

The template file, "CLFS-Lab-Data-Collection-Final.csv," may be accessed in the download section on the Clinical Laboratory Fee Schedule web page. The template may be opened using a text editor, such as Notepad, or a spreadsheet application such as Microsoft Excel. It may be populated through system-generated content or manually via an online interface. There are four fields that must be filled in: HCPCS Code, Payment Rate, Volume and National Provider Identifier. The CMS is very explicit that columns and column headings should not be added, removed or changed, nor should blank rows between entries appear.

Back to the top

The New Jersey Society of Pathologists (NJSP), with support from the CAP, advocated for changes to a state proposal to promote hepatitis C testing.

In a September 12 letter to the state Assembly Health and Human Services Committee, NJSP stated its opposition to the bill because of concerns for patients and burdens placed on pathology practices.

"While NJSP unequivocally supports the promotion of hepatitis C testing, the proposed bill is clearly contrary to standards in health care delivery and potentially impractical for laboratories in New Jersey to implement and as such is opposed by NJSP unless amended," the letter said.

Pathologists in New Jersey oppose a section in the bill (AB 3909) requiring laboratories to communicate both verbally and in writing with patients on every pathology and laboratory test result regarding the availability of the hepatitis C test, despite the fact that laboratories have no direct interface with patients in most cases. The bill does not place the onus on the ordering health care professional, who should provide the patient with information on testing and subsequent counseling, asserted NJSP. Pathologists in New Jersey cited New York State's law that promotes hepatitis C testing as an example the state should follow.

"By circumventing the ordering health care professional in the ordering of the test the ability to follow up on test results and treatment is hampered," the letter said.

The NJSP proposed amendments to the bill that state the laboratory report will be sent to the ordering health care professional or directly to the patient. The ordering health care professional also would be responsible for communicating the availability of the testing.

Back to the top

Registration is now open for key CAP policy and advocacy courses and roundtable discussions important to the pathology specialty during CAP16 in Las Vegas September 25-28.

Ensure you can attend "MACRA, Pay for Performance and the Physician Fee Schedule—You Can Run But You Can't Hide" (S1620) by registering and selecting this popular course today. Enactment of the Medicare Access and CHIP Reauthorization Act (MACRA) will change how all physicians are paid under Medicare. Make sure to attend this course and learn about this game changing mandatory Medicare physician payment system. Measurement periods begin in 2017 so register now so that you are ready for these changed to Medicare's physician reimbursement system.

During this featured presentation, attendees will learn the purpose of new pay-for-performance programs and delivery system reform culminating in the enactment and implementation of MACRA. Experts will explain which pathologists are subject to, and ways to successfully participate in, the merit-based incentive payment system and alternative payment model pathways. The potential ramifications for not participating will also be discussed.

The session starts at 8 AM on Monday, September 26. Register for S1620 MACRA, "Pay for Performance and the Physician Fee Schedule—You Can Run But You Can't Hide" today.

Additional CAP advocacy courses and roundtable discussions are also available at CAP16:

  • M1597 "How is My Payment Determined for Pathology Services?"
    Sunday, September 25, 4:30-5:30 PM
  • R1690 "My Surgical Pathology and Cytopathology Coding Dilemmas: Getting It Right"
    Monday, September 26, Noon-1 PM
  • STA001 "How Data Drives CAP Advocacy: What Pathologists are Saying about the Economics of Pathology Practice"
    Monday, September 26, 5:30-6:30 PM
  • R1691 "Current Payment Policy Challenges in Pathology Practice"
    Tuesday, September 27, Noon-1 PM

Back to the top

The CAP called for further refinements to account for distinct regulatory challenges for devices in its comments on the Food and Drug Administration's (FDA's) approach to the evaluation of infectious disease next-generation sequencing diagnostic devices.

The FDA in May issued draft guidance to provide industry and agency staff with recommendations for designing studies to establish the analytical and clinical performance characteristics of NGS diagnostic devices that are intended for use in the diagnosis of microbial infection and selection of appropriate therapies. The CAP advocated for changes to the document in a September 9 letter to the FDA.

The draft guidance provides detailed information on the types of data the FDA recommends be submitted in support of a Class II premarket submission. The inclusion of certain targets, such as Hepatitis B, Hepatitis C, HPV and HIV, could elevate the classification of the device to Class III. In that case, the FDA recommends that sponsors contact the agency prior to undertaking any clinical or analytical validation studies to discuss whether additional recommendations are available due to new advancements in this fast-moving field.

Unique Specimens, Rapid Results

In contrast to human sequencing diagnostics, infectious disease sequencing diagnostics generally require rapid and actionable results, sometimes within hours, as delayed or incorrect initial diagnosis can result in fatalities, note the guidance. The broad range of specimen types and the large diversity of infectious disease agents that can be present in the sample do not allow straightforward pre-analytical, biochemical or bioinformatics processes. Each unique specimen type may require a different nucleic acid extraction procedure, a different library preparation protocol, and even a different bioinformatics algorithm to generate the final clinical results. The opportunity for repeat testing is expected to be limited due to a frequently small specimen quantity and the necessity to make a prompt and timely infectious disease treatment decision for the patient.

Specifically, the guidance addresses NGS devices that use targeted or agnostic metagenomic sequencing to detect the presence or absences of infectious disease agents or antimicrobial resistance and virulence markets. It does not apply to devices that are intended to screen donors of blood and blood components or donors of human cells, tissues and cellular and tissue-based products for communicable diseases. The FDA is proposing use of a "one system" approach to evaluation infectious disease NGS Dx devices—from sample collection through the output of clinically actionable data. While the CAP supports this approach, it believes there are notable differences that will require flexibility of additional specificity in the regulatory process.

"For example, agnostic/metagenomics sequencing approaches have distinct regulatory challenges compared to targeted gene analysis for the identification of variants associated with genotyping drug resistance, and the CAP urges the FDA to further consider these differences as the draft guidance document is revised," the CAP said.

Back to the top