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On September 5, the House Ways and Means Committee marked up the Local Coverage Determination (LCD) Clarification Act and favorably reported the bill to set up a vote by the full House of Representatives.

During the mark up hearing, legislators amended the bill by removing a provision that would require Medicare administrative contractors to independently review evidence prior to adopting an LCD. In a statement after the committee mark up, CAP President R. Bruce Williams, MD, FCAP, said the CAP is concerned with the removal of the provision but would work with members of Congress to include it back in the final bill.

“The House Ways and Means Committee has favorably reported the Local Coverage Determination Clarification Act containing several provisions the CAP supports to improve accountability and transparency in Medicare's Local Coverage Determination process,” Dr. Williams said. “We are disappointed that the committee, at the request of the Centers for Medicare & Medicaid Services (CMS), has removed one of the bill's cornerstone provisions to stop Medicare contractors from rubberstamping coverage decisions and using the LCD program to circumvent the more rigorous requirements of the National Coverage Determination process. The CAP urges congressional leaders to put this key provision back in the legislation. We're committed to working with House and Senate leaders to safeguard Medicare patients from flawed LCDs and ensure Medicare administrative contractors base all their coverage decisions on sound scientific evidence and advice from local physicians and other health care professionals.”

The Local Coverage Determination Clarification Act would improve transparency and accountability when Medicare contractors set LCD policies for physician and other services provided to Medicare beneficiaries. These decisions by Medicare contractors affect millions of Medicare beneficiaries and impact critical access to innovative technologies and procedures.

During the mark up, Rep. Ron Kind (D-WI), who is an original co-sponsor of the bill, called on his House colleagues to support the legislation that will improve patient care and access in our health care system. “This bill will improve transparency and boost accountability in the local coverage determination process,” Rep. Kind said. “The changes in the bill will ensure that medical and scientific evidence is not used selectively to deny appropriate coverage to seniors. Although I am pleased about moving this forward, there is a provision that was removed due to concerns from my friends across the aisle. The purpose of this provision was to ensure that flawed LCDs will not spread to other jurisdictions. I look forward to this conversation continuing after today’s proceedings. I hope that my colleagues will support this bipartisan legislation as Congress continues to improve access to care for all Americans.”

A House vote is expected this week and STATLINE will continue to update CAP members on the bill’s progress.

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The CAP in a September 10 letter to the CMS urged the Medicare program to finalize and accept new physician work values developed by the CAP for several CPT codes. The CAP also advocated for the CMS to rethink a proposal to review pricing for supplies and equipment and improve data collection requirements for reporting private laboratory data used to set clinical laboratory fee schedule rates.

CMS Proposed 2019 Valuation for CPT Codes Reported by Pathologists

In response to the proposed 2019 Medicare Physician Fee Schedule released in July, the CAP urged the CMS to accept the CAP-developed physician work relative value units (RVUs) approved and submitted to the agency by the American Medical Association Specialty Society RVS Update Committee (AMA RUC). Through its ongoing work to protect the value of pathologists, the CAP led the effort to develop physician work RVUs used to calculate the professional component and global payment. In addition, the CAP developed direct practice expense inputs for pathology services which is the bases for payment for the technical component as well as global payments.

The CAP’s comment letter responded to the following actions in the proposed 2019 Medicare Physician Fee Schedule:

  • Fibrinolysins (85390) – The CMS agreed with the CAP recommendation to increase payment for CPT code 85390. The CAP urged the CMS to finalize this proposal.
  • Fine Needle Aspiration Biopsy (10X11, 10X13) – The CMS agreed with the recommendations from the CAP and its coalition partners for the new and revised CPT codes. The CAP urged CMS to finalize this proposal.
  • Blood Smear Interpretation (85060) –The CMS did not agree with the CAP recommendation to maintain payment for CPT code 85060 and proposed a reduced value. The CAP defended the developed value and urged the CMS to adopt the RUC approved value.
  • Bone Marrow Interpretation (85097) – The CMS did not agree with the CAP recommendation to increase payment for CPT code 85097 and proposed to maintain the current value. The CAP defended the developed value and urged CMS to adopt the RUC approved value.

Updates to Prices for Existing Direct Practice Expense Inputs

The CMS had proposed an update to the direct practice expense input prices for supplies and equipment and transition the new prices for over a four-year period, due to the potentially significant changes in payment, beginning in 2019. These direct practice expense inputs are used by the Medicare agency to calculate its technical component RVUs. The CAP urged the CMS to postpone, for one year, the implementation of updated prices for supplies and equipment to allow affected stakeholders to recommend corrections for the most obvious errors.

In addition, the CAP urged the CMS to accept comments from the public on all practice expense supplies and equipment for this one year and throughout the entire four-year price transition period. All products should be defined, priced appropriately, and reflect the typical price paid by stakeholders.

CMS Seeks Input to Improve Data Collection for CLFS Rates

In response to concern that the initial data collection of private sector clinical laboratory rates used to calculate new payments for the 2018 Medicare Clinical Laboratory Fee Schedule (CLFS) excluded many classes of laboratories, the CMS sought input on alternative approaches for expanding the definition of applicable laboratories. Beginning January 1, 2018, the payment amount for a test on the CLFS is generally equal to the weighted median of private payer rates determined for the test, based on the data collected by the agency from “applicable laboratories” during the data collection period. The CAP and other stakeholders believe that the 2018 CLFS payment rates are based on information from a subset of laboratories and have urged the CMS to expand this definition.

The CAP will continue to engage with the CMS on these issues and more.

The CMS will release the final 2019 regulation by early November.

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The CAP also in its September 10 comment letter strongly urged the CMS to review and respond to concerns regarding proposed changes to the Quality Payment Program, including its Merit-based Incentive Payment System (MIPS) and Alternative Payment Models (APMs).

The CAP urged the CMS to consider the following issues when finalizing changes to the 2019 Quality Payment Program (QPP).

  • The removal of three of the eight pathology QPP measures- The CAP strongly opposed the retirement of three of the eight pathology specific QPP measures, which are:
    • Measure 99- Breast Cancer Resection Pathology Reporting
    • Measure 100 – Colorectal Cancer Resection Pathology Reporting
    • Measure 251- Quantitative Immunohistochemical (IHC) Evaluation of Human Epidermal Growth Factor Receptor 2 Testing (HER2) for Breast Cancer Patients
    The removal of these measures will leave pathologists with only five QPP measures. However, the CMS requires that physicians participating in the QPP program report on a minimum of six quality measures, hindering successful participation by pathologists in the Quality Category. Further, removal of these measures is counter to the CMS’ previously finalized topped out measure removal policy where CMS proposes to remove a measure via the notice and rulemaking cycle if it is designated as topped out for three consecutive years. Finally, Measure #251 (IHC HER2 Testing for Breast Cancer Patients) has had updates in guidelines recently and thus the existing performance data on this measure is not valid so it is not possible to know whether the measure is topped out. For these reasons, the CAP asked that the CMS not finalize its proposal to remove three of the eight pathology QPP measures.
  • MIPS Performance Feedback and Payment Adjustments- The CAP was disappointed in the 2017 MIPS performance feedback as the maximum adjustment physicians received for 2019 will be + 2.02% for individuals and practices who scored 100 points. This is especially challenging as physicians have devoted huge amounts of time and resources to comply with the MIPS reporting program. The CAP asked the CMS to release a scaling factor used to determine the payment adjustments and that the CMS be more transparent in how payment adjustments are determined. The CAP further encouraged the CMS to indicate clearly how the quality measures submitted count towards the final score.
  • Attribution to the Medicare Spending Per Beneficiary (MSPB) Cost Measure- The CMS has acknowledged that many patient-facing and non-patient-facing MIPS-eligible clinicians (ECs) may not have sufficient measures and activities available to report and would not be scored on this category. Based on this, the CAP has generally believed that it would be hard to attribute pathologists to the Total Per Capita Cost (TPCC) and the Medicare Spending Per Beneficiary (MSPB) cost measures based on the CMS’ attribution mechanisms. However, based on 2017 MIPS performance feedback, the CAP has learned that there was at least one pathology group practice that was attributed to the MSPB measure. Since the MSPB measure is attributed to the provider who provides plurality of Medicare Part B services, as measured by Medicare standardized allowed amounts, during an MSPB episode’s index admission, we are struggling to understand how a pathology group could have provided the plurality of services compared to other providers during the episode. Since the CMS has not provided beneficiary level data for the cost measures in 2017, it is difficult to determine how exactly the pathologists were attributed. The CAP asked that the CMS make available beneficiary level data on cost measures that can provide an opportunity for clinicians to improve and to learn how they were attributed to the cost measures. Moreover, while pathologists routinely contribute to team-based care, the CAP does not believe it is appropriate to attribute them to the MSPB measure under the current methodology. The CAP feels that until appropriate measures are developed, pathologists as non-patient facing clinicians should be excluded from this category.
  • Facility-Based Scoring- The CAP supports the CMS proposal to allow facility-based measurement based on the Hospital Value Based Purchasing (VBP) program starting with the 2019 MIPS performance period. However, the CAP asked that the CMS not automatically apply facility-based scoring to MIPS eligible clinicians and groups who qualify. Instead, the CAP believes that ECs who are eligible to utilize facility-based measures should be able to voluntarily opt into the program via attestation instead of opting out. The opt in option would allow ECs full control over their MIPS submission and score and allow them to choose to either report MIPS measures and activities or choose to use their facility-based score instead. The CAP encourages the CMS to provide as much information as possible to ECs to allow them to opt into this option, including whether they meet the facility-based definition and their potential facility-based scores before the data submission period. The CMS could accomplish this via its QPP participation look-up tool.

Alternative Payment Models

As for alternative payment models (APMs), the CAP urged the CMS to review changes to the Medicare’s Advanced APM track of the QPP, including use and evidence of Certified EHR Technology (CEHRT), financial risk, and flexibility for the All-Payer Combination Option. Specifically, the CAP supports the CMS proposed changes that facilitate more APMs achieving Advanced APM status and that provide additional opportunities for appropriately-developed physician focused payment models, especially those within Medicare where they stand to impact qualification for the Advanced APM pathway under the QPP. Further, the CAP appreciates the CMS’ goal to encourage continued electronic health record (EHR) and CEHRT adoption but urges the CMS to consider the contributions of diagnostic specialties in the exchange of electronic patient data, which is key in APMs’ ability to effectively coordinate care.

The CAP will continue to engage with the CMS on these issues. The CMS will release the final 2019 QPP regulation by early November.

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When someone overdoses on opioids, or any drug, time is of the essence. The right laboratory tests often mean the difference between life and death in a prescription drug overdose. Toxicological analysis identifies the cause of the overdose, and those findings, reviewed by pathologists, are essential in helping select the treatments used to save lives. The CAP issued a new position statement regarding its role in confronting the nation’s opioid crisis.

“The CAP understands that the opioid epidemic continues to rip apart families and communities across the country,” said CAP President R. Bruce Williams, MD, FCAP. “A variety of approaches is needed to control this crisis requiring collaboration across the entire health care spectrum.”

“It is imperative that pathologists work together with other clinicians to improve the way opioids are prescribed and monitored to ensure patients have access to safer and more effective chronic pain treatment while also reducing the risk of opioid use disorder, overdose, and death,” Dr. Williams said.

Pathologists oversee and direct the appropriate use of laboratory tests detecting and monitoring the use of opioids for pain and medications used in the treatment of opioid substance use disorder, as well as, the inappropriate use of other prescription, illicit or designer drugs. The CAP urges treating physicians to consult with pathologists and other laboratory professionals about testing, not only for well-known opioids but all other illicit and designer drugs.

“How we monitor, prescribe and treat pain is critical, so it is extremely important to select drug testing methodologies that align with the clinical questions,” said Raouf E. Nakhleh, MD, FCAP, who chairs the CAP Council on Scientific Affairs. “We must also understand testing limitations and work to provide interpretive results, so we can better guide care givers in the treatment of chronic pain and substance abuse.”

The CAP will implement the following:

  • Provide education and training for pathologists on tests that monitor drug use/misuse
  • Support development of proficiency testing programs, used to evaluate and benchmark performance, accuracy, and test results, dealing with synthetic and designer drugs
  • Interact with lawmakers and other organizations to convey the important contributions made by pathologists in addressing the opioid crisis
  • Support the forensic pathology community in efforts to increase resources, the number of trained forensic pathologists, funding for forensic science, investigation, and certification
  • Develop recommendations to ensure laboratories define testing methodologies, validate appropriately and provide interpretive results as dictated by clinical needs

At CAP18 in Chicago, on October 23, 2018, Barbarajean Magnani, PhD, MD, FCAP, CAP Toxicology Committee chair, will share her first-hand knowledge about the opioid epidemic. As a pathologist, Dr. Magnani works daily with physicians managing patients on chronic opioid therapy, as well as, those with acute unknown drug overdoses. By analyzing their toxicology results she provides the key that unlocks the lingering drug mystery.

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The AMA, the CAP, and other physician and medical groups urged the CMS to set aside a provision in the 2019 proposed physician fee schedule to establish payment changes to office visit CPT codes as well as the multiple service payment reduction policy and instead embrace the assistance of an AMA led workgroup. response to the administration’s proposals included in the 2019 Medicare physician payment rule.

The CAP joined 170 other physician organizations in an August 27 letter to the CMS. The CAP strongly supports the AMA’s creation of a workgroup to analyze the evaluation and management (E/M) coding and payment issues as well as the multiple services reduction policy to arrive at reasonable solutions.

The CAP urges the CMS to fully embrace the assistance of the workgroup, and the entire physician community, over the next year in the development of a solution that will achieve our shared goal of simplifying documentation burdens while mitigating any unintended consequences, while also ensuring the best possible outcome for patients.

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Second webinar recording available

Diana Cardona, MD, FCAP

As part of our ongoing commitment to ensure pathologists can successfully participate in new and evolving payment models, the CAP offered its second MIPS educational webinar on September 6 MIPS Reporting: Which Path is Right for Your Practice?

The third in this webinar series, Pathologist Improvement Activities Under MIPS will take place on Tuesday, September 20, 2018 at 1 PM ET/ 12 PM CT. During this 30-minute webinar, Diana Cardona, MD, FCAP, will review the pathology specific improvement activities. Register today.

Other upcoming webinars in the MIPS series are open for registration:

2019 Final Medicare Policy and Payment Changes
W Stephen Black-Schaffer MD, FCAP
Donald S. Karcher, MD, FCAP
Emily Volk, MD, MBA, FCAP
Details coming soon.

Quality Measures that Will Improve Your MIPS Score
Tuesday, December 4, 2018, Noon ET
Diana Cardona, MD, FCAP
Examine ways of improving your performance and MIPS scores using CAP-developed quality measures.

Steps to Take Before Reporting MIPS Data
Tuesday, January 8, 2019, 3PM ET
Emily Volk, MD, MBA, FCAP
Discover ways of maximizing your scoring for 2018 before submitting results to CMS.

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Are you being paid fairly for the services you provide? Payment for pathology services has a direct impact on the success of your practice. Do you know who makes these decisions—and what criteria they use? Are there steps you can take to ensure fair compensation? These topics and more will be explored at CAP18.

Educational Sessions

  • MACRAscopic Analysis of the New Quality Payment Program: Maximize Reimbursement While Demonstrating Value (S1620)
  • How Is My Payment Determined for Pathology Services? Non-CME course (STA008)
  • The CAP’s Policy and Advocacy Agenda (STA010)
  • The Role of Pathologists in Population Health: An Interactive Discussion (STA011)
  • What You Need to Know About the CAP’s Pathologists Quality Registry Non-CME course
  • Lunch Roundtables
    • Current Payment Policy Challenges in Pathology Practice (R1691)
    • My Surgical Pathology and Cytopathology Coding Dilemmas: Getting It Right—An Advanced Discussion (R1690)

Learning Pavilion Sessions

  • Understanding and Maximizing your MIPS Score
  • How to Keep Your Practice Afloat While Reimbursement Rates Decline

CAP Exhibit Booth

  • Pathologists Quality Registry Demos
  • MIPS Resources for Pathologists
  • Billing and Cost Assessment Toolkits

Registration is now open for vital CAP policy and advocacy courses and roundtable discussions during CAP18.

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