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The CAP advocated for the Centers for Medicare & Medicaid Services (CMS) to accept all the physician work recommendations for pathology services used to calculate professional component and global payment rates in the proposed 2018 Medicare Physician Fee Schedule, which was released in July.

Responding to proposed reimbursement changes to pathology services provided to Medicare patients, the CAP urged the CMS to accept recommended technical component values for flow cytometry, apheresis, and other services in a letter to the agency on September 11.

As first reported in STATLINE on July 13, the CMS specifically proposed in its 2018 Medicare Physician Fee Schedule to accept all of the recommendations from the CAP and the American Medical Association (AMA) Specialty Society Relative Value Scale Update Committee (RUC) for physician work relative values to certain pathology services. The CAP detailed the impact of the proposed fee schedule changes in its Medicare Physician Fee Impact Table.

In addition to advocacy on payment for pathology services, the CAP urged the agency to reduce regulatory burdens on pathologists as the CMS implements the Merit Based Incentive Payment System (MIPS) and address significant payment issues pertaining to pathology related to the Protecting Access to Medicare Act (PAMA). Moreover, the CAP also responded to a request for information for regulation changes to relieve administrative burdens and better achieve program transparency, flexibility and innovation.

The CAP's comments focus on the specific issues concerning the technical component of direct practice expense inputs as well as urging the agency to finalize its proposal to adopt the CAP-developed physician work values.

  • Proposed Valuation of Specific Codes for CY 2018:
    • Flow Cytometry Code Interpretation (CPT codes 88184–88185). The CAP recommends that CPT coded 88184 and 88185 be removed from the list of potentially misvalued services and the CMS accept the January 2016 RUC recommended direct practice expense inputs for CY 2018.
    • Therapeutic Apheresis (CPT Codes 36511, 36512, 36513, 36514, 36516, and 36522). The CMS is also proposing to use the RUC-recommended direct practice expense inputs developed by the CAP for these codes without refinement. The CAP urges the CMS to finalize these proposed direct practice expense inputs and adoption of the recommended physician work values.
    • Diagnostic Bone Marrow Aspiration and Biopsy (CPT codes 38220, 38221, 382X3, and 2093X)
    • Pathology Consultation During Surgery (CPT codes 88333 and 88334)
    • Morphometric Tumor Immunohistochemistry (CPT Codes 88360 and 88361)
  • Standardization of Clinical Labor Tasks
    • Preservice Clinical Labor for 0-Day and 10-Day Global Issues
    • Obtain Vital Signs Clinical Labor
  • Updates to Prices for Existing Direct PE Inputs
  • Adjustment to Allocation of Indirect PE for Some Office-Based Services

In the 2018 PFS Proposed Rule, the CMS has included a Request for Information to help reduce unnecessary burdens for clinicians, other providers, and patients and their families. The CAP provided the following list of programs and recommendations to increase flexibility and efficiencies. Please refer to the comment letter for the full list of recommendations:

  • Local Coverage Determination (LCD) Reform
  • Misvalued Code Initiative: Secretarial Discretion
  • Protecting Access to Medicare Act (PAMA)
  • Delivery System and Payment Reform Models
  • The Medicare Access and CHIP Reauthorization Act: Quality Payment Program (QPP)
  • Cytology Proficiency Testing
  • Medicare Administrative Contractors (MACs) "Unlisted" Code Reporting Requirement

The final 2018 Medicare Physician Fee Schedule is expected to be published on or about November 1. Following the final regulation's release, the CAP will publish a STATLINE alert and host a webinar analyzing the impact of changes to pathology services.

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The CAP recommended revising the 2018 Medicare Hospital Outpatient Prospective Payment System (HOPPS) proposed rule to ensure that the laboratory date of service (DOS) for all molecular testing is the date of performance rather than the date of collection, to improve the consistency with Medicare payment policy.

In the September 11 letter to the Centers for Medicare and Medicaid Services (CMS), the CAP supports the agency’s proposed modifications to its DOS policy to allow laboratories to bill Medicare directly for certain laboratory tests excluded from the OPPS packaging policy, which would change the current 14-day rule policy. The CAP recommended that the agency finalize an exception to the DOS policy that is not limited to Advanced Diagnostic Laboratory Tests, but also cover other molecular pathology tests. In addition, the CAP recommends revising the current rule so that the DOS for all molecular testing is the date of performance (date of final report) rather than the date of collection, to improve the consistency with Medicare policy for billing of other diagnostic services for beneficiaries.

The CAP also provided comments on the following:

  • Analysis of Packaging of Pathology Services in the Hospital Outpatient Prospective Payment System (HOPPS), Comment Solicitation on Packaging of Items and Services Under the HOPPS
  • Calculation of Single Procedure Ambulatory Payment Classification (APC) Criteria-Based Costs—Blood and Blood Products, Methodology, and Specific Blood Products Payment Rates
  • HOPPS APC–Specific Policies, Blood Driven Hematopoietic Cell Harvesting

The CAP believes because of the CMS packaging policies, pathology add-on services are not reimbursed properly to the laboratory providers, which may hamper patient access to care. The CAP urges the CMS to change its policy and agrees with the CMS to continue to establish payment rates for blood and blood products using the CMS’ blood-specific cost-to-charge ratio (CCR) methodology.

The CAP encouraged the CMS to reduce unnecessary burdens for clinicians and providers by revising the Healthcare Common Procedure Coding System (HCPCS) P-code descriptors for blood products in response to the CMS request for information regarding reducing regulatory burdens for physicians. This extensive undertaking has the potential to result in a code set that provides patients with increased access to new technologies and new blood products that protect the public’s health and improve clinical outcomes.

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A coalition of physician groups, led by the CAP, is urging the National Conference of Insurance Legislators (NCOIL) to make significant changes to its draft Out-of-Network Balance Billing Transparency Act to ensure network adequacy and fair payment for out-of-network services. The National Conference of Insurance Legislators (NCOIL) is an organization of state legislators whose main area of public policy concern is insurance legislation and regulation. The proposed legislation is a "model bill" that could be enacted by states.

In comments submitted to NCOIL, the coalition said it believes the current proposal on network adequacy is flawed and should be amended to make sure patients have access to the full continuum of health care. Coalition members include, in part, the American College of Radiology, the American Society of Anesthesiologists and American College of Emergency Physicians.

Among some of the group's recommendations, the coalition asked that the bill would:

  • Require state regulators to assess whether health plan networks with in-network hospital have actually contracted with facility- and hospital-based physician specialists – such as pathologists, radiologists and anesthesiologists—at that hospital.
  • Establish a payment formula for out-of-network (OON) services that ensures payment equilibrium in the market.
  • Require health insurance industry to pay the UCR or the physician’s charge, whichever is less, for all OON physician services at in-network facilities, including emergency room physicians.
  • Place clear obligations on health insurance plans to provide OON facility- and hospital-based physicians with an explanation of benefits, to make payment directly to the OON provider, and to apply any amount paid by the enrollee that exceeds applicable deductibles, co-payment or co-insurance toward the enrollee's annual limitation on cost-sharing.
  • Require insurers to keep their provider directories up to date and require carriers to conduct a monthly review of each plan's network directory for accuracy.
  • Provide a safe harbor for physicians to conduct waivers of co-payment or deductibles for OON charges on a case-by-case basis so as to financially benefits economically distressed patients.

To read the full list of the coalition's recommendation, check out the letter. The CAP will continue to follow and report on the NCOIL balance billing legislation.

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The CAP's Local Coverage Determination Clarification Act of 2017 bill gained support in both the Senate and also in the House of Representatives this summer by adding additional members of congress who support LCD reform. The CAP continues to work and advocate for its members by helping to improve transparency and accountability when Medicare contractors set local coverage determination (LCD) policies for physician services provided to Medicare beneficiaries.

The CAP is proud to announce that Senators Jerry Moran (R-KS), Mike Rounds (R-SD), Tammy Duckworth (D-IL) and Roger Wicker (R-MS) joined as co-sponsors of the LCD along with their fellow Senators Chuck Grassley (R-IA), Pat Roberts (R-KS) who join the Bill's original Senate co-sponsors Debbie Stabenow (D-MI), John Boozman (R-AR) and Thomas Carper (D-DE).

While Representatives Markwayne Mullen (R-OK), Joseph Crowley (D-NY) and Pete Sessions (R-TX) join original House co-sponsors Lynn Jenkins (R-KS) and Ron Kind (D-WI) who introduced this fundamental piece of legislation in August and have been working with the CAP on improving the LCD process for patients. The House bill, together with the Senate version of the bill will pave the way for much needed LCD reform.

Key provisions of both the Senate and House LCD bills include:

  • Open Meetings: Medicare Administrative Contractor's (MAC) Carrier Advisory Committee (CAC) meetings must be open, public, and on the record. Minutes should be posted to the MAC's website for public inspection.The gravity of limiting or precluding coverage for both beneficiaries and practitioners heightens the need for transparency where meetings are currently closed.
  • Upfront Disclosure: MACs should include at the outset a description of the evidence considered when drafting an LCD as well as the rationale they rely on to deny coverage. If this information is not provided until the final LCD, it hinders meaningful stakeholder exchange and makes the MAC's decision to deny coverage almost a foregone conclusion.
  • Meaningful Reconsideration and Options for Appeal: A meaningful LCD reconsideration process gives Medicare providers and suppliers the opportunity to have a secondary review by a qualified disinterested party. Under current Centers for Medicare & Medicaid Services (CMS) rules, MAC LCDs are essentially unreviewable for providers and suppliers without new evidence submitted to the very MAC that issued the LCD.
  • Stopping the use of LCDs as a backdoor to National Coverage Determinations (NCDs): Prohibit the CMS from appointing a single MAC, either expressly or in practice, from making determinations to be used on a nationwide basis in a given specialty. The CAP has witnessed the carbon copy adoption of MAC LCDs by other MACs without the benefit of meaningful solicitation or independent assessment of comments and concerns from the public or medical community of the adopting MAC. The policy then can become of such geographic magnitude it approaches becoming a NCD in practical terms without having followed more rigorous requirements.

The CAP, along with coalition members Advanced Medical Technology Association, the Amputee Coalition, the American Society of Clinical Oncology, the American Society of Radiation Oncology, and the US Oncology Network have come together because they believe that LCDs should not limit patient access to needed technologies and services. This legislation would make significant improvements to the LCD process and ensure that medical evidence is not used selectively to deny appropriate coverage to Medicare beneficiaries.

The CAP, along with members of the coalition, will host a Congressional Hill briefing on LCD late in October. Stay tuned to STATLINE for more details.

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The CAP continues to advocate for patient safety in laboratory testing by providing commentsto the National Academies of Science Engineering and Medicine (NASEM) Committee on the proposed study of the Return of Individual-Specific Research Results Generated in Research Laboratories. The CAP opposes the return of individual-specific research results to participants which are generated in research laboratories which don't have CLIA certification. The lack of CLIA certification raises reliability and accuracy concerns.

CLIA was established to strengthen federal oversight of clinical laboratories to ensure the accuracy and reliability of patient test results. Although research laboratories comply with the US Food and Drug Administration (FDA) regulations and inspection governing research studies, these laboratories are exempt from CLIA requirements and are not subject to laboratory-specific standards that address these quality requirements.

In the study, which is sponsored by the CMS, the FDA, and the National Institutes of Health (NIH), researchers sought to uncover paths toward delivering precision medicine by taking into account differences in lifestyle, environment, and biology. CLIA certification is required in order to perform testing on human specimens for the purpose of providing information for the diagnosis prevention, or treatment of any disease or impairment of, or the assessment of the health of human beings. However, research laboratories are excluded from these requirements.

The CAP believes the return of research results without requiring CLIA certification poses a risk to diagnostic testing and patients. In essence, the NASEM proposal would allow research laboratories to perform clinical testing without fulfilling personnel, competency assessment, quality control, quality assessment and proficiency testing requirements as specified by CLIA.

As an accreditation agency, the CAP has had oversight responsibilities in a variety of laboratory settings, from complex university medical centers to physician office laboratories covering a complete array of disciplines and testing procedures available in today's laboratory. To that end, the CAP opposes the return of individual-specific research results to participants which are generated in research laboratories which don’t have CLIA certification.

Alexis Carter, MD, FCAP, FASCP who is a Physician Informaticist, and works in the Pathology and Laboratory Medicine Department in Children's Healthcare of Atlanta, provided a statement from the CAP to the National Academies of Science Engineering and Medicine Committee during their meeting on September 6.

The CAP recommends CLIA certification for research laboratories that wish to return of individual-specific research results generated in their research laboratories directly to participants. However, if a very significant finding occurred in a research laboratory that elects not to have CLIA certification, then the result should be confirmed in a CLIA certified laboratory.

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Getting concerned on how much your estimated future Medicare payments may be? Do you know how MIPS will affect your practice revenue going forward? Try the CAP's MIPS Calculator to help estimate your future Medicare payment adjustments using your practice data and project how MIPS will impact your practice's finances. Please note this tool is for informational and estimation purposes only.

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Reserve your seat at featured Advocacy Courses

Registration is now open for key CAP policy and advocacy courses and roundtable discussions important to the pathology specialty during CAP17 at the Gaylord National Harbor from October 8–11, 2017.

Learn about the new Pathologists Quality Registry and how it can help you comply with the Quality Payment Program in 2017 during the Optimize Your Medicare Bonus Potential with the Pathologists Quality Registry session on Monday, October 9.

Additional CAP advocacy courses and roundtable discussions are also available at CAP17:

  • M1596: How is My Payment Determined for Pathology Services?
  • R1690: My Surgical Pathology and Cytopathology Coding Dilemmas
  • R1691: Current Payment Policy Challenges in Pathology Practice
  • S1620: Medicare's New Quality Payment Program and the Physician Fee Schedule

Moreover, hear about the current trends in Pathology Practice and how it shapes CAP Advocacy efforts.

  • STA007C: Results from the 2017 CAP Practice Characteristics Survey

Check out the full list of Advocacy courses offered at CAP17.

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