PAMA Lab Test Market Price Reporting: What Every Lab Must Know, Which Labs Must Submit Data, and Why Reporting Labs Are at Risk!

Webinar was held Thursday,
September 22, 2016 at 1PM EDT

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Reporting of Lab Test Market Price Data to Medicare officials starts in about 100 days and the news is not good! Across the nation, clinical laboratories and their experts admit that they struggling to comply with the final PAMA rule. And this is just the larger labs.

The situation for independent labs is even worse. In its survey of independent medical laboratories and hospital labs that will be required to submit market price data to the federal Centers for Medicare & Medicaid Services (CMS), The Dark Report has learned that a substantial portion of these labs have not yet begun to take the first steps to pull that data from their computers and process it for submission to CMS on or after January 1, 2017.

Without timely action informed by the advice of experts, many clinical labs will be at risk of hefty fines or tough federal sanctions if their efforts to comply with PAMA lab test market price reporting fall short of what CMS deems as acceptable. For that reason, every lab manager and pathologist has a responsibility to his or her laboratory organization to stay informed and up-to-date, particularly since CMS is expected to be releasing more regulations about the reporting process in coming weeks.

Because the clock is ticking down on the nation’s medical laboratories, has scheduled an important webinar on PAMA lab test market price reporting for September 22. Experts who are closely watching CMS and working with lab clients will provide insights and information on the best ways to comply with this law and the final rule. The webinar is titled, “PAMA Lab Test Market Price Reporting: What EVERY Lab Must Know, Which Labs Must Submit Data, and Why Reporting Labs Are at Risk!”

Providing perspectives on the legal issues associated with the requirement for labs to report market prices to CMS will be Attorney Jeffery Sherrin, President of O’Connell & Aronowitz in Albany, NY. To help labs understand the processes CMS is using to gather lab test market price data is Julie Scott Allen, Senior Vice President, District Policy Group representing the National Independent Laboratory Association (NILA) in Washington, D.C. Julie has worked with Congress and CMS to provide lab industry input in the writing of the PAMA law and how CMS says it will implement the statute. Rounding out the panel of experts is Mark Birenbaum of NILA. He is appearing at the public hearings scheduled by CMS to represent independent lab companies. He recently spoke at the meeting of the Advisory Panel on Clinical Diagnostic Laboratory Tests that CMS convened in Washington, DC, on September 12.

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Most clinical laboratories are already behind the eight-ball in meeting the final rule’s requirements for lab test market price reporting. That’s because the period of data to be reported is past. Those labs reporting must include information for all payments received from health insurers between January 1, 2016 and June 30, 2016. They must begin submitting that data to CMS on January 1, 2017—only about 100 days from now—and all data must be received by CMS as of March 31, 2017.

That is why this timely webinar is designed to bring you up close and personal to the still-unfolding developments of the PAMA requirement that certain labs must report lab test market price data. The easy fact that everyone knows is that those labs must submit price data for each test, as paid by each payer, along with the volume of claims paid for each test by each payer.

But what few lab managers know is that this requirement of the final rule for PAMA market price reporting is proving to be extraordinarily complicated and time-consuming. In reality, it is unexpectedly complex to gather the data. For example, some labs already attempting to pull this data and assess it are finding that, say, for each type of chemistry panel they perform, they are being paid different prices for the same panel from the same health plan! During the webinar, Birenbaum will speak to this problem and talk about what is working and what is not as these labs work to assemble what they think is the data that CMS wants.

Why is there uncertainty? Because, as you will learn during the webinar, CMS has yet to issue the sub-regulations that contain the needed guidance on what format labs should use when they report and how they should submit the data. That’s not all. What happens if labs submit data and later realize they must correct the data and resubmit? No one knows, because, as of this writing, CMS has yet to issue the sub-regulations that address these situations.

That is not comforting to the labs that must report, because they face significant sanctions. Attorney Sherrin will explain what labs must understand about the PAMA rule. He is also prepared to provide insights about any sub-regulations and guidance CMS issues between now and the webinar on September 22. Sherrin will also describe how labs can run afoul of the requirements of the final rule and what financial penalties and federal sanctions may result—even if the laboratory was acting in good faith.

How will CMS use the market price data to set new prices—expected to be significantly reduced—for the Medicare Part B Clinical Laboratory Fee Schedule (CLFS), effective on January 1, 2018? This topic will be addressed by Julie Scott Allen during the webinar. She will describe what is known about how CMS will process the market price data and use it to determine new prices. It will be a valuable opportunity for all clinical lab managers and pathologists to better understand the financial impact this repricing will have on their own labs—even if their lab was not required to report market price data.

By now, there is universal agreement among independent clinical labs and hospital laboratories that implementation of the PAMA final rule for lab test market price reporting will be a disruptive event, if not a financial catastrophe. That’s because PAMA allows CMS to cut Part B lab test fees by 15% in each of three consecutive years and 10% for an additional three consecutive years. And, what Medicare does, private payers soon copy and implement in their own health plans.

That is what makes the PAMA lab test market price report mandate the highest-stakes game in the clinical laboratory industry at the moment. It is why every lab administrator and pathologist with responsibility for the financial sustainability of their lab organizations should participate in this essential webinar on September 12. It is a 90-minute session chock-full of critical information and up-to-the-minute developments that can save your lab huge amounts of time and resources as it strives to understand the final rule, assemble the market price data, then submit it to CMS.

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Bottom line: The new PAMA Final Rule will cause some clinical laboratories to be winners and some labs to become losers. Which will your lab be? As other lab teams anxiously await more details, or hold out for revisions to the rule, your lab can be among those taking action and preparing.

This 90-minute session is designed to address your immediate operational concerns, and educate you on the compliance demands you should prepare for. Just a sampling of what is to be covered:

  • Understand PAMA’s requirements for reporting private payer rates, and recent updates to the CMS final rule
  • Is your lab an “applicable laboratory,” and if so, what, how, and when to report
  • Will your lab need to engage an outside IT vendor in order to comply because of the complexity of gathering and analyzing test price data?
  • Has CMS issued new sub-regulations by September 12? What new requirements do they impose on labs?
  • How exclusion of hospital data will affect revised rates
  • Does the NPI requirement bring more hospital labs into the reporting pool?
  • Learn the complexity associated with gathering data for just one type of lab test: chemistry panels
  • Hear discussion of key issues and challenges of particular relevance to community and regional laboratories
  • Legal considerations including penalties for non-compliance
  • For labs not reporting, understand how CMS will use a weighted median average of reported prices to establish new Medicare Part B fees
  • Additional resources to guide you as you navigate the PAMA Final Rule

For one low price, you and your entire team can take part in this fast-paced, insightful webinar. Most beneficial, too, would be to make sure to include members from your reimbursement and billing areas. Best of all, you’ll be able to submit your own specific questions during the Q&A session following our speakers’ prepared remarks.

Although CMS has offered substantial insights into the new payment and coverage policies under PAMA, many details are yet to come, with interpretations expected to evolve. What is certain is that the PAMA Final Rule will transform Medicare’s payment system for clinical laboratory testing while at the same time establishing major new compliance demands.


Julie Scott Allen, Senior Vice President, District Policy Group, representing the National Independent Laboratory Association (NILA), Washington, D.C.

Julie Scott Allen has over two decades of experience as a government relations professional, advocating at the federal and state level to address Medicare and Medicaid payment and coverage and health care reform.  She represents the interests of independent clinical laboratories through the National Independent Laboratory Association (NILA), serving as their Washington Representative and advocating before Congress and such agencies as the Centers for Medicare and Medicaid Services (CMS) and the Food and Drug Administration (FDA).

Mark S. Birenbaum, Ph.D., Administrator National Independent Laboratory Association (NILA), Washington, D.C.

Mark S. Birenbaum, Ph.D., is the administrator of the National Independent Laboratory Association (NILA), a trade association for regional and community laboratories that focuses on business/management issues facing laboratories, and the American Association of Bioanalysts (AAB), a professional association whose members are clinical laboratory directors, supervisors, consultants and laboratory technologists/technicians. Dr. Birenbaum holds a doctoral degree in microbiology/molecular biology from the Washington University School of Medicine (St. Louis).

Jeffrey J. Sherrin, President, O’Connell & Aronowitz, Albany, NY.

Jeffrey is the President of O’Connell & Aronowitz, an Albany, N.Y. law firm with a national health care practice. He is an accomplished health care litigator and counsel. He has served as General Counsel to the American Association of Bioanalysts, and has represented clinical laboratories throughout the country for over 30 years. Sherrin is a graduate of Albany Law School. He has been listed in the publication The Best Lawyers in America for 25 years, and has also been consistently listed in the Upstate New York Super Lawyers list, a distinction earned by less than 5% of attorneys in the state.

Anes Dracic, Product Manager, Integration Solutions, Sunquest Information Systems, Tucson, AZ.

Anes Dracic’s focus on interoperability enables vast connectivity for the Sunquest product suite, thus enabling Sunquest to be at the forefront of Meaningful Use certified technologies. Dracic is also responsible for Sunquest’s Clinical Financial application, which is increasingly instrumental in providing visibility into lab revenue and enabling regulatory compliance. Dracic holds an MBA from Carnegie Mellon University and a Dual-BBA from the University of North Florida.