Summary of Calendar Year 2015 Physician Fee Schedule (PFS) Proposed Rule
This is a review of the provisions in the 2015 Physician Fee Schedule (PFS) Proposed Rule that was published in the Federal Register on July 11, 2014. If you wish to comment on the PFS proposed rule, submit your comments by September 2, 2014. If you do submit comments, please forward a copy of your comments to the NILA office.
Technological Review of CLFS
As mentioned in our email dated July 8, 2014, the proposed PFS rule does not propose to revise Part B Clinical Laboratory Fee Schedule (CLFS) payment rates in 2015 and 2016 based on technological changes because of the Protecting Access to Medicare Act (PAMA). Instead, CMS will establish a separate rulemaking process to establish parameters for the collection of private payor rates in 2016 and a new payment assessment process in accordance with PAMA, with revised payment rates beginning in 2017.
Local Coverage Determination (LCD) Process
The proposed PFS rule outlines a revised process for Local Coverage Determinations (LCDs) for clinical diagnostic laboratory tests published on or after January 1, 2015. CMS’s process includes a review of the current LCD process, an analysis of the ongoing pilot project that CMS launched with Palmetto GBA, and addressing the requirements set forth in PAMA.
While the CMS/Palmetto GBA pilot project was focused only on molecular diagnostics, CMS is proposing that the new LCD process apply to ALL clinical diagnostic laboratory tests. CMS claims it wants to ensure that diagnostic tests actually perform as expected and that they improve clinical care. Additionally, CMS says it has an ongoing “responsibility to ensure that appropriate tests are covered by Medicare and that coverage is limited to tests for which the test results are used by the ordering physician in the management of the beneficiary’s specific medical problem.”
Below is a table in the proposed PFS rule outlining the differences between the current LCD process and CMS’s new proposed process.
Comparison of Current LCD Process versus Proposed LCD Process for Clinical Diagnostic Laboratory Tests Published On Or After January 1, 2015
|Current LCD Process||Proposed LCD Process for Diagnostic Laboratory Tests|
|Issue Draft LCD in Medicare Coverage Database, which identifies criteria used for determining coverage under statutory “reasonable and necessary” standard||Issue Draft LCD in Medicare Coverage Database, which identifies criteria used for determining coverage under statutory “reasonable and necessary” standard|
|Public comment period of 45 calendar days||Public comment period of 30 calendar days with option to extend|
|Present LCD at CAC & discussion at open stakeholder meetings||Optional CAC meeting. No requirement for open stakeholder meeting|
|Publication of Comment/Response Document and final LCD (no specified time of publication after the close of the comment period)||Publication of Comment/Response Document and final LCD within 45 calendar days of the close of the draft LCD comment period|
|Notice period of 45 calendar days with the final LCD effective the 46th calendar day||Final LCD effective on the date of publication|
|Interested parties may request reconsideration of an LCD||Interested parties may request reconsideration of an LCD|
|An aggrieved party may further challenge an LCD||An aggrieved party may further challenge an LCD|
Of note when comparing the current LCD process to the proposed LCD process is the following:
CMS’s proposed process does NOT apply to LCDs that are being revised for the following reasons: liberalizing an existing LCD; being issued for a compelling reason; making a non-substantive correction; providing a clarification; making a non-discretionary coverage or diagnosis coding update; making a discretionary coding update that does not restrict; or revising to effectuate an Administrative Law Judge’s decision on a Benefits Improvement and Protection Act (BIPA) Section 522 challenge.
PAMA expanded the categories of services that HHS is directed to examine for the purpose of identifying potentially misvalued codes. The nine new categories, a number of which do not apply to clinical laboratories, are as follows:
The proposed rule includes a listing of codes that CMS determines are potentially misvalued codes. Included in this code list are: 55700 Biopsy of Prostate and 88185 Flowcytometry/tc add-on.
Review the clinical laboratory provisions in the proposed 2015 Physician Fee Schedule Rule as published in the July 11, 2014, Federal Register by clicking the links below. Comments are due by September 2, 2014.
Clinical Laboratory Fee Schedule Provisions (excerpts from entire rule):
Entire Rule (224 pages):