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News & Press: General News

ASHI on the Hill- November 2019 Updates

Monday, November 11, 2019   (0 Comments)
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A flurry of activity on lab and transplant policies this fall signals that a busy 2020 lies ahead. While politics will loom large over many debates on Capitol Hill in the new year, policies impacting ASHI and its membership will largely take shape outside the influences of election season.

 


New Faces and Policy Implications

The announced retirement of Energy & Commerce Committee’s top Republican Member Greg Walden (R-OR), however, triggers a showdown within the conference for the powerful post and has far reaching implications on the health care agenda, including on policies impacting lab and transplant regulation.

 

A number of Republicans are expected to vie for the top spot on the committee. Among those competing for the position is Dr. Michael Burgess (R-TX). You may recall, the Congressman and current Health Subcommittee Chair is seeking to advance legislation that would help extend Medicare coverage of immunosuppressive drugs for kidney transplant patients beyond the current 36 months post-transplant window. This legislation has been a long-standing priority of the Congressman, and we have been coordinating with his office on ways to lend support to the effort and signal ASHI’s support.

 

Since our last update, legislative language was shared with the Centers for Medicare and Medicaid Services (CMS) for feedback. Dr. Burgess, along with Representative Kind (D-WI) and Senators Durbin (D-IL) and Cassidy (R-LA) hope to hear back from CMS soon and make progress on the bill in the new year.

 

Movement at the Food and Drug Administration (FDA) is also afoot. The Senate Health, Education, Labor and Pensions Committee is scheduled to hear from Dr. Stephen M Hahn on November 20th, as Senators consider his confirmation as the next FDA Commissioner. Dr. Hahn is a well-known radiation oncologist and the current medical executive at The University of Texas, MD Anderson in Houston. We will be watching the hearing closely with your priorities in mind.

 

 

Capitol Hill Weighs in on Executive Order for Advancing American Kidney Health

In response to President Trump’s Executive Order on Advancing American Kidney Health, Congressional Kidney Caucus Co-chairs, Representatives Suzan DelBene (D-WA) and Larry Bucshon (R-IN), along with nearly 75 lawmakers recently sent a letter to HHS Secretary Azar and CMS Administrator Verma. The lawmakers focused their concerns on the Executive Order’s mandatory payment model, slated to begin on January 1, 2020, and requested the following actions be taken:

·         Address organ supply issue before holding providers financially accountable for transplant rates;

·         Minimize number of providers required to participate but include enough to garner accurate scientific results;

·         Create a better metric to determine patient propensity to home dialysis;

·         Allow appropriate Stark and anti-kickback waivers; and

·         Include a patient satisfaction tool.

 

There is significant interest in the Administration’s kidney health initiative. We expect that interest to continue spurring activity on Capitol Hill and across the agencies, where we will be seeking opportunities to advance ASHI’s perspective.

 

 

CY2020 OPPS/ASC Final Rule Published

On Friday, November 1st, 2019, CMS released its CY2020 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Final Rule.

 

Earlier this year, ASHI leadership raised concerns about a new exception to the Medicare Laboratory Date of Service (DOS) policy that was finalized during the CY2018 rulemaking cycle. To date, the policy has yet to be applied by CMS, who has chosen, rather, to exercise its enforcement discretion due to implementation concerns from stakeholders. The exception would require laboratories to bill Medicare directly – rather than hospitals– for molecular pathology tests and Advanced Diagnostic Laboratory Tests (ADLTs) in a number of cases.

 

CMS’s CY2020 Proposed Rule proposed three changes to the exception. In the Final Rule, CMS moved to finalize just one of the proposals:

·         Changing the test results requirement at 42 CFR 414.510(b)(5)(iv) to specify that the ordering physician would determine whether the results of the molecular pathology test or ADLT are intended to guide treatment provided during a hospital outpatient encounter, and, if the determination is made that test results are not intended to guide treatment during the outpatient encounter, the DOS is the date of test performance. NOT FINALIZED

·         Limiting the laboratory DOS exception at 42 CFR 414.510(b)(5) to ADLTs. NOT FINALIZED

·         Excluding blood banks and blood centers from the laboratory DOS exception at 42 CFR 414.510(b)(5). FINALIZED

 

Importantly, CMS is exercising enforcement discretion with respect to this DOS exception through January 2, 2020. Polsinelli is continuing to monitor developments closely, as CMS continues to evaluate and refine this new exception.

 


CMS Clinical Diagnostic Laboratory Test Payment System Data Reporting Call

On Thursday, November 14th, 2019 (2:00-3:00PM), CMS will hold a call explaining how to register in the system and report and certify data required by the Clinical Diagnostic Test Payment System final rule. The data collected will be used by CMS to set Medicare payment rates effective January 1, 2021. Recall that laboratories are required to report laboratory test HCPCS codes, private payor rates, and volume data if they: 

·         Have more than $12,500 in Medicare revenues from laboratory services on the Clinical Laboratory Fee Schedule (CLFS), and

·         Receive more than 50 percent of their Medicare revenues from CLFS and physician fee schedule services during a data collection period.

 

Note that there will also be a question & answer session following CMS’ presentation. 


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