ePolicy News December 2017

Nov 29, 2017
Read the latest ASCP policy news from Washington, DC.

ASCP Calls on CMS to Withdraw New Laboratory Payment Rate System

Despite Changes, ASCP Maintains New Payment System is Fundamentally Flawed and Should be Withdrawn

The Centers for Medicare & Medicaid Services (CMS) has released its final Clinical Laboratory Fee Schedule (CLFS) for CY 2018, and while the Agency made several changes to address several serious problems with its new Medicare payment system, ASCP is still fundamentally opposed to its implementation. ASCP is concerned that the Agency ignored its statutory obligations, creating a flawed payment system that could impose serious financial challenges for clinical laboratories and access issues for patients. While some tests are slated to receive cuts for next year exceeding 10 percent, most laboratory tests would be cut 10 percent—generally the maximum cut allowed by law. For a chart outlining the payment rates CMS intends to implement for 2018 through 2020, click here. These cuts could ultimately cut Medicare reimbursement for clinical laboratory services by as much as 30 percent by the end of 2018.

One of ASCP’s concerns with the Agency’s plans is that it ignored Congress’s explicit instructions that it develop new payment rates that are reflective of the “true market” for laboratory services—not a subset of the Medicare market for laboratory services. By excluding hospitals, clinics, nursing homes, most physician office laboratories and many other important segments of the laboratory market, CMS cherry-picked the market to secure data almost entirely from those laboratories with the greatest economies of scale.

In its comments on the proposed rates, ASCP noted that hospital and physician office labs account for more than 60 percent of the true market for laboratory services while independent clinical labs account for less than 30 percent of the market. CMS relies on data from just one percent of U.S. laboratories—more than 90 percent of which are independent clinical labs.

ASCP believes that CMS’ plans to implement the new fee schedule puts patient care at risk, is unwise, and clearly disregards its statutory obligations. ASCP calls on the Agency to withdraw these flawed rates until it can revise these rates using representative data from all segments of the market for laboratory services.

ASCP has steadfastly opposed CMS’ efforts to create a skewed payment rate system. Last month, besides submitting comments raising concerns about CMS’ proposed fee rates, ASCP also joined with 21 other groups in a letter calling on CMS Administrator Seema Verma to immediately address the flaws with CMS’ plan. ASCP plans to submit formal comments opposing implementation of these new rates very soon. Moreover, ASCP urges all members of the laboratory community to contact their elected officials in Congress to urge them to intervene. You can use the following ASCP Action Alert to do so.

CMS Adopts Several ASCP Recommendations to Ease MIPS Compliance

On Nov. 2, the Centers for Medicare & Medicaid Services (CMS) released the Quality Payment Program (QPP) 2018 Final Rule, which details how pathologists will be reimbursed under a performance-based system in 2020 and future years. CMS has maintained flexibilities included in program year 1 and continues to structure the program based on ASCP feedback to meaningfully include pathologists. We are pleased to report that CMS finalized many of the proposals ASCP advocated for in our comments on the QPP 2018 Proposed Rule.

As you may recall, the QPP is split into two tracks: Advanced Alternative Payment Models (APMs) and the Merit-based Incentive Payment System (MIPS). Pathologists will most likely participate in the MIPS track. Pathologists are considered non-patient facing clinicians, and therefore, performance is measured in only two of the four MIPS categories: Quality and Improvement Activities, with the Advancing Care Information and Cost category weights redirected to the Quality category.

MIPS Timeline

CY 2017

CY 2018

CY 2019

CY 2020

Year 1 Performance Period

Year 2 Performance Period

Year 3
Performance Period

Year 4
Performance Period

Year 1 Payment Year

Year 2 Payment Year

Key Developments Pertinent to Pathology in 2018 Final Rule
Improvement Activities (IA) Category: Notably, CMS finalized “Completion of an Accredited Safety or Quality Improvement Program” (IA_PSPA_28), in the Patient Safety and Practice Assessment subcategory of IA, which ASCP submitted for inclusion in the program earlier this year. Because CMS finalized this ASCP-sponsored activity, pathologists will now be able to more easily satisfy the requirements of the Improvement Activities category and avoid payment penalties in future program years. Please see here for a list of additional Improvement Activities for which pathologists can report.

Increased Low-Volume Threshold: The final rule significantly expands the previous low-volume threshold (which excludes certain clinicians from participation in the program) from $30,000 in allowed Medicare Part B charges or providing care to 100 or fewer Medicare Part B patients to $90,000 or 200 patients. ASCP believes this will reduce the burden on small pathology practices. CMS estimates that based on the increased threshold, only 37 percent of clinicians who bill Medicare will be subject to MIPS.

Increased Performance Threshold: CMS finalized its policy to set the 2018 performance threshold at 15 points (up from just three points to avoid a payment penalty in the first performance year). The exceptional performance threshold will be maintained at 70 points (over which, clinicians score bonus points for exceptional performance). Additionally, for performance year 2018 (payment year 2020), the MIPS adjustment will be +/- 5 percent.

Further, CMS finalized other important aspects of ASCP’s feedback to:

  • Continue flexibilities for pathologists included in the transition year;
  • Reduce burden on small practices by implementing Virtual Groups;
  • Continue to encourage use of Qualified Clinical Data Registries for QPP reporting and participation.

ASCP will continue to advocate on behalf of pathologists to ensure meaningful participation in Medicare payment programs.

FREE MIPS Reporting Option for 2017
It’s not too late to participate in 2017 MIPS reporting! ASCP is offering a FREE and easy 2017 reporting option for pathologists who wish to avoid the four percent payment penalty. Please see here for more information. The National Pathology Quality Registry (NPQR) will also be offering reporting options for the 2018 year to help pathologists not only fulfill MIPS requirements, but potentially earn bonuses on their Medicare payments.

Alternative Payment Models

CMS expects significantly more eligible clinicians will qualify for Alternative Payment Models (APMs) in 2018 than 2017 – partially due to inclusion of the Medicare ACO Track 1 Plus model. The QPP 2018 Final Rule provided further details on non-Medicare (e.g., Medicaid, Medicare Advantage) models that will qualify for Advanced APMs in future years of the program.

CMS Adopts ASCP Recommendations in Revised Outpatient 14-Day DOS Rule

CMS recently released its Hospital Outpatient Prospective Payment System (OPPS) Final Rule updating its outpatient payment policies and payment rates for 2018. As part of these changes, ASCP is pleased to report that the Agency heard ASCP’s call for changes to the Outpatient Date of Service (DOS)/14-Day Rule. CMS will be reforming this policy to facilitate the billing of and payment for molecular pathology and other separately billable laboratory services. Under its current policies for laboratory services, CMS typically considers the DOS to be the date the specimen was collected, unless certain conditions are met. ASCP urged CMS to finalize proposed changes to the 14-day DOS rule that would allow laboratories to bill Medicare directly for molecular pathology tests and certain ADLTs that are excluded from the OPPS packaging policy and ordered less than 14 days following the date of the patient’s discharge from the hospital.

In response to the requests of ASCP, the American Clinical Laboratory Association, the College of American Pathologists, and other stakeholders, CMS created a new exception to the current policy that will go into effect on Jan. 1, 2018. This exception will generally permit independent laboratories to bill Medicare directly for molecular pathology services and Advanced Diagnostic Laboratory Tests excluded from OPPS packaging policy if the specimen was collected during a hospital outpatient encounter and the test was performed following the patient’s discharge from the hospital outpatient department. ASCP had also urged CMS to exclude Multianalyte Assays with Algorithmic Analyses from the DOS policy. CMS has declined to include these laboratory services in the exception at this time but intended to study the issue further. ASCP is planning on submitting formal comments on the final rule and will urge that these tests be exempted from the DOS policy by rulemaking in the near future.

CMS Finalizes Physician Fee Schedule for 2018

Among the major rules recently finalized by CMS is the Medicare Physician Fee Schedule (PFS). While more encompassing changes occurred in other final rules affecting pathology and laboratory medicine, such as the QPP, CMS’ policy changes on the PFS, while important, were more code specific. First off, the overall impact of policy changes on reimbursement for pathologists and independent laboratories is estimated at about -1 percent for CY 2018. Despite this year’s relatively low impact on pathology and independent laboratories, there were some important changes that reveal the importance of advocacy, from ASCP, the College of American Pathologists and other interested stakeholders. For example, in the final rule, CMS increased the payment rates for the Therapeutic Apheresis Codes (codes 36511, 36512, 36513, 36514, 36516) beyond what it had outlined in the summer. The result is that most of these codes will see increases of about 15 percent from the 2017 payment rate, with 36522 (Photopheresis) receiving an increase of 73 percent. In response to comments from ASCP, CAP and others, CMS also restored some of the cost inputs for the Morphometric Tumor Analysis codes (88360 and 88361). Here, CMS restored direct cost inputs it had previously indicated it would not accept in the proposed rule. These gains help offset cuts in the professional component, such that the overall cuts to the global component (which includes payment for the technical and professional work) for these services were about four and five percent, respectively. The combined advocacy of pathology stakeholders also helped restore some of the cost inputs involved with the Cytopathology Consult code CPT 88333. For more specifics on how CMS is changing the payment rates for pathology services reimbursed by the Medicare PFS, see the linked chart.

ASCP Opposes USPSTF Proposal to End Cervical Co-Testing

Last month, ASCP, in concert with other members of the Cytopathology Educational and Technology Consortium (CETC), strongly opposed a proposal from the U.S. Preventive Services Task Force (USPSTF) to reverse its current recommendation of support for cervical co-testing every five years for women age 30-65. In responding to the proposed recommendation, ASCP worked with the CETC to develop a consensus statement outlining the flaws with the USPSTF proposal. The CETC statement re-affirms recommendations outlined in a 2012 guideline developed by the ASCP along with the American Cancer Society (ASC) and the American Society for Colposcopy and Cervical Pathology (ASCCP). The ASC/ASCCP/ASCP guideline recommends co-testing using cervical cytology and HPV testing every five years as the most clinically appropriate approach for screening women ages 30-65 for cervical cancer.

Instead of co-testing, the USPSTF proposes “screening every three years with cervical cytology alone or every five years with high-risk human papillomavirus (hrHPV) testing alone in women ages 30-65 years.” ASCP believes the USPSTF recommendation would diminish the quality of patient care for women. The members of the CETC include ASCP, American Society of Cytopathology, the American Society for Cytotechnology, the College of American Pathologists, and the Papanicolaou Society of Cytopathology.  It is unclear when the USPSTF will unveil its final recommendations, but ASCP will inform its membership when it does and will work to ensure that USPSTF recommendations are clinically appropriate.

New York PA Licensure Bill Goes Into Effect

The State of New York just started licensing Pathologists’ Assistants (PAs). Beginning Nov. 28, the New York State Department of Education regulations licensing PAs go into effect. The scope of practice of licensed PAs will include preparing gross tissue sections for pathology analysis and performing human postmortem examinations. PAs will be required to possess a bachelor’s or higher degree in pathologists’ assistant and pass an examination acceptable to the department (presumably the ASCP PA exam). That said, during the next two years the state will license those individuals who have been performing the duties of a PA for two of the last five years. As is usually the case when states implement new personnel licensure requirements, the requirements for licensure are more forgiving. Individuals who have worked as a pathologists’ assistant in other states within the last 5 years who are considering working as a pathologists’ assistant in New York may want to consider applying for licensure before the so-called “grandparenting” provisions expire in 2019. For more information, click here for a copy of the regulations governing PA licensure in New York.

For more information regarding ASCP's advocacy initiatives and policy positions, please contact ASCP's Center for Public Policy at (202-347-4450).

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