Read the Latest Issue of STATLINE
July 12, 2016
In This Issue:
- Local Coverage Determination Clarification Act Introduced in House with CAP Support
- Precision Medicine Update: FDA Publishes Guidance Documents on NGS Tests
- CAP Objects to BCBSMS Policies that Deny Certain Pathology Services
- Webinar: Receive the Latest Analysis of the 2017 Proposed Medicare Fee Schedule
- Watch the Recording: How MACRA Will Affect Pathologists
- STATLINE Wins APEX Award of Excellence
Local Coverage Determination Clarification Act Introduced in House with CAP Support
The CAP applauded the House introduction of the Local Coverage Determination Clarification Act (HR 5721) on July 11 to improve transparency and accountability when Medicare contractors set local coverage determination (LCD) policies. The bill, if enacted, would ensure physician medical judgment and beneficiary access to medically necessary care are not impeded.
The CAP had developed the principles in the legislation introduced by Reps. Lynn Jenkins (R-KS) and Ron Kind (D-WI). The bill seeks to ensure Medicare LCDs are made by qualified health experts through a transparent process based on sound medical and scientific evidence supported by medicine. Changes in the bill include open meetings, upfront disclosure of medical evidence and rationale, new options for reconsideration and appeal, and prohibiting the use of LCDs as a backdoor to national coverage determinations.
From a pathologist's perspective, a faulty LCD could replace physician judgment with arbitrary and unsubstantiated rules. This would hinder the pathologist's ability to render an accurate diagnosis and potentially deny patients treatments from which they may benefit.
"The patients and the physicians who treat them stand to benefit from changes prescribed by this legislation to reform the LCD process," said CAP President Richard C. Friedberg, MD, PhD, FCAP. "When Medicare contractor decisions are made without the benefit of transparency to the public, an LCD can interfere with our medical judgment and adversely affect patient access to medically necessary care. Introducing common sense measures found in the reform bill will improve transparency and accountability, and provide a meaningful appeals process for challenging flawed coverage decisions. We applaud and commend Reps. Jenkins and Kind for their work on this issue and for introducing these much needed reforms."
CAP Secretary-Treasurer Richard R. Gomez, MD, FCAP, engaged with Rep. Jenkins, who represents his home district that includes Topeka, KS, to discuss the importance of the reforms to add more openness, upfront disclosure, and meaningful reconsideration and options for appeal to the process. "Faulty LCDs can interfere with the practice of pathology and do not serve the public good nor ensure Medicare beneficiaries receive appropriate access to medically necessary diagnostic services," Dr. Gomez said. "Thank you to Reps. Jenkins and Kind for introducing this important legislation on behalf of Medicare patients and the physicians who care for them."
Precision Medicine Update: FDA Publishes Guidance Documents on NGS Tests
The FDA published two draft guidance documents for a 90-day comment period which once finalized will provide FDA's current thinking on a streamlined approach to the oversight of tests that detect medically important differences in a person's genomic makeup.
The draft guidance documents are aligned with the CAP’s position for the FDA to use industry-wide standards for next generation sequencing and on the use of graded curated databases to establish clinical validity. The CAP continues to engage on NGS at the federal level, including as it relates to President Obama's Precision Medicine Initiative. The NGS guidance documents were released as part of a package of administration actions to advance the President's initiative on July 6.
In addition to the NGS guidance, the White House announced $55 million in new awards from the National Institutes of Health (NIH) to health care provider organizations, technology developers, and community health centers to launch the major steps to recruit a million or more voluntary research participants as partners into the PMI Cohort Program.
This investment will support several Healthcare Provider Organizations (HPOs), a Data and Research Support Center, and a Participant Technologies Center, the White House said. These organizations will help build the research protocols and plans, inform their patients about the study, enroll interested individuals, and collect essential health data and biological specimens.
The first draft guidance, titled "Use of Standards in FDA's Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases" provides recommendations for designing, developing and validating NGS-based tests for rare hereditary diseases, and addresses the potential for using FDA-recognized standards to demonstrate analytical validity, which is how well a test predicts the presence or absence of a particular genomic change. The second draft guidance, titled "Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics" describes an approach wherein test developers may rely on clinical evidence from FDA-recognized public genome databases to support clinical claims for their tests and provide assurance of accurate clinical interpretation of genomic test results—an easier path for marketing clearance or approval.
CAP Objects to BCBSMS Policies that Deny Certain Pathology Services
The CAP has objected to four policies by BlueCross and BlueShield of Mississippi (BCBSMS) that adversely affect billing the professional component (PC) of clinical pathology services and certain immunohistochemistry (IHC) services and special stains.
The four BCBSMS policies appeared on BCBSMS's website around Memorial Day. The policies contain a component billing coding policy under which the PC of clinical pathology services is not allowed when such services are rendered on an inpatient basis and three "medical policies" in the immunohistochemistry space.
All four policies were to be effective July 1, 2016, not much more than 30 days after they were posted. A temporary restraining order secured by pathologists in Mississippi on July 1 prevented the policies from going into effect.
The policies are of great concern to the CAP as the professional component policy is inconsistent with longstanding CAP policy—as well as legal precedent.
The CAP has actively engaged with the Mississippi Association of Pathologists and transmitted a letter to BCBSMS expressing its objections and asking BCBSMS not to implement the policies. The CAP will keep members, including those practicing in Mississippi who have also protested implementation with BCBSMS and other audiences, informed regarding these policies.
Webinar: Receive the Latest Analysis of the 2017 Proposed Medicare Fee Schedule
Throughout this hour-long panel discussion on July 14, CAP experts will explain the changes proposed by the CMS in the draft 2017 Medicare Physician Fee Schedule. The presentation begins at 2 PM ET.
In the proposed 2017 Medicare Physician Fee Schedule released on July 7, the Centers for Medicare & Medicaid Services (CMS) proposed to maintain the value for several pathology codes targeted as misvalued. The CMS also proposed gains for add-on codes used for immunohistochemistry and immunofluorescence services, which the CAP had strongly advocated for in 2014, 2015 and 2016.
The CMS estimates that changes to the practice expense relative value units used to calculate technical component (TC) and global payments proposed 2017 Medicare Physician Fee Schedule would result in a 2% decrease in pathology services. This estimate shows no overall change in the work relative value unit which comprises the majority of the professional component (PC) payment for pathology services as well as global payments. The decrease stems from proposed changes in the direct practice expense inputs such as medical supplies used to calculate the practice expense relative value units (RVUs). The actual impact upon an individual pathologist or practice will depend on the mix of services provided to beneficiaries with Medicare or other public or private health plan coverage.
Read the CAP's full STATLINE coverage of the proposed 2017 Fee Schedule.
During the webinar presentation, the CAP will review proposed changes, discuss how the rule affects Medicare reimbursement for pathology services, and review the CAP's advocacy efforts to impact the CMS' proposal prior to its finalization. These changes include new rates for:
- Add-on codes for immunohistochemistry and immunofluorescence services. Due to the CAP's engagement with the CMS, the Medicare agency again increased the value of pathology add-on services by reducing its discount applied to these codes.
- Prostate biopsy G-code. The CAP sought an increase to the PC of G0416, which the CMS proposed to raise 17%. However, the CMS also proposes to reduce the TC value for the service.
- Microslide consultation. The CAP's advocacy efforts resulted in the CMS proposing to accept recommendations that retain the current work values for these services and raise the work value of 88325 by 14%.
- Flow Cytometry. The previously targeted the TC of flow cytometry codes as misvalued and sought to phase-in reductions over the next two years. The CAP had engaged with the CMS in an attempt to reinstate some of the previously identified reductions, but the Medicare agency has proposed to decrease the practice expense components in 2017.
The second part of the webinar will be a question-and-answer session.
Receive the full details of the CAP's proposed fee schedule analysis by registering today.
Watch the Recording: How MACRA Will Affect Pathologists
View the archive recording of the CAP's July 7 webinar on the proposed regulation implementing the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).
The MACRA regulation would set two payment pathways for physicians beginning in 2019: the MIPS and APMs. MIPS is expected to have an estimated $1.5 billion impact on payments to pathologists. Physicians participating in eligible APMs would not be subject to MIPS and would receive 5% Medicare payment bonuses.
STATLINE Wins APEX Award of Excellence
In the 28th annual APEX Awards for Publication Excellence, the CAP's STATLINE earned an Award of Excellence for 2016 in the competition's newsletters category.
APEX awards are based on excellence in graphic design, editorial content, and the ability to achieve overall communications excellence. APEX's Award of Excellence recognizes exceptional entries submitted in dozens of individual categories covering print and digital media. STATLINE also earned an APEX Award of Excellence in 2015.
For the 2016 APEX contest, STATLINE's breaking news coverage of the 2016 Medicare Physician Fee Schedule and two regular editions of the newsletter, had been entered.
Since 1979, members of the College have read STATLINE as their official source for advocacy and policy news from Washington, DC. STATLINE provides its target audience of pathologists with news articles on topics ranging from federal regulation to legislation and local grassroots action. In 2015, CAP members began receiving their STATLINE electronic newsletter issues on a weekly basis instead of every other week.