STATLINE

Read the Latest Issue of STATLINE

In This Issue:

• Special Report: CAP Protects Accurate Diagnoses for Patients at 2018 AMA Meeting
• CAP Urges Flexibility in National Coverage for CAR-T Cell Therapies
• Massachusetts Legislature Contemplates Limiting Out-of-Network Payment
• Upcoming Webinar: Medicare Policy and Payment Changes for Pathologists

The CAP led a delegation of pathologists at the 2018 American Medical Association (AMA) annual meeting to help set policy that affect the practice of medicine including CLIA certified tests its role in accurate patient diagnosis and treatment plans, laboratory benefit management and prior authorizations, current scope of practice standards, and the current state of health insurance marketplaces.

CLIA-Waived Test Resolution Halted

At the AMA meeting, the CAP continued to safeguard accurate patient diagnosis through CLIA certified tests. The AMA House of Delegates discussed a possible resolution to remove the CLIA certification mandate requirement for physicians who only use CLIA-waived tests and physician-performed microscopy.

The Pathology Section Council, which includes pathologists from the CAP, American Society for Clinical Pathology, United States and Canadian Academy of Pathology, and other clinical laboratory groups, successfully argued for the importance of CLIA certification and how it guarantees accuracy in patient care plans, regardless of where the test was performed. Because of these arguments and discussion, the resolution was deferred to an AMA board for a decision. The Pathology Section Council will continue to engage with the AMA board on the importance of keeping the CLIA certification mandated tests in place.

AMA Policy Now Addresses Prior Authorizations for Laboratory Benefit Managers

The CAP successfully secured the adoption of a new AMA policy aimed at curbing laboratory benefit management programs that administratively hinder physicians, impede the delivery of care and deny patients access to pathology/laboratory services, including opposing any financial conflict of interest in the administration of such programs. The CAP introduced the resolution requesting that the AMA consider policy to restrict prior authorizations of laboratory benefit management programs and prior authorization from health insurance and other payers.

Scope of Practice

Because of an increased demand of integrated patient care teams and the influx of advanced practice registered nurses (APRNs) and physician assistants (PAs) into the patient care continuum, scope of practice (SOP) policies continue to garner debate in quality patient care delivery. During a special SOP forum at the AMA, discussion between members of medical specialty physicians, state medical societies, and primary care physicians lead to improved policies that protect the practice of medicine and supports physician-led, team-based care.

The new policy discussion was in response to how APRNs and PAs are advocating current SOP laws, as these current standards restrict their leadership and medical decision making abilities in patient care. The AMA wants to assure that physicians remain in the leadership of patient care teams to ensure the highest patient care quality, while still involving APRNs and PAs as critical members of the care team. STATLINE will continue to monitor this issue.

ACA Marketplaces

To build upon the progress of almost 12 million people having obtained coverage through the Affordable Care Act (ACA) marketplaces this year, the AMA adopted policy by taking steps to make plans on health insurance exchanges more affordable. The new policy opposes the sale of individual and small group policies that do not guarantee pre-existing condition protection and coverage of essential health benefits (with the exception of insurance plans of three months or shorter).

The AMA policy notes that the coverage of essential health benefits is linked to protections against annual and lifetime limits and out-of-pocket expenses, which align with the CAP’s health reform principles.

Gun Control Debated by House of Medicine

AMA delegates also discussed gun control and its impact on public health dominated the House of Medicine conversation. The AMA adopted policy changes that include some gun control policies such as supporting a ban on assault weapons, registration of all firearms, keeping guns out of the hands of those convicted of domestic violence, and raising the legal age to buy guns to 21. These resolutions came after a long discussion from many physician members who have seen the impact of gun violence first hand. Even though many AMA members are gun owners or gun rights supporters, these measures still received overwhelming support, including a 446–99 vote in favor of an assault weapons ban.

New AMA President elected

During the meeting, AMA delegates help to elect Patrice A. Harris, MD, a psychiatrist from Atlanta, as the new president-elect of the AMA. Following a year-long term as president-elect, Dr. Harris will assume the office of AMA president in June 2019.

The CAP is a part of the AMA House of Delegates and encourages members to renew their AMA membership and work together to help shape a health care system that best utilizes pathologists to deliver high-quality care and meets the evolving demands of patient care. Join or renew your AMA membership today.

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Recently the CAP urged the Centers for Medicare and Medicaid Services (CMS) consider national coverage determination (NCD) analysis on Chimeric Antigen Receptor (CAR) T-cell therapy for Medicare beneficiaries. In a June 15 letter the CAP urged the agency to recognize the individual care provided by physicians and other health care providers.

In its response, the CAP stated that while it supports coverage for the current on-label use of the FDA approved tisagenlecleucel (Kymriah®) and axicabtagene ciloleucel (Yescarta®) CAR-T cell therapies, the CAP is concerned that any attempt at a national coverage policy to standardize these services may fail to recognize the individual care services provided by physicians and other health care professionals.

The CAP asks that the CMS consider the following elements when determining national coverage determination for CAR-T cell therapies:

• The CAP requests that any national coverage policy recognize the critical care services provided by physicians during both the pre- and post-manufacturing phases of CAR-T cell therapy. Pathologists play a critical role as integral members of the cancer patient management team during this therapy.
• The CAP opposes a national coverage policy that requires Coverage with Evidence Development (CED), as the quality of care provided to Medicare beneficiaries depends on access to treatments appropriate to their needs, including new technologies. The CED process has taken years to result in a coverage or non-coverage decision, which is too slow to provide reasonable access to new technologies, and only offers treatment to a limited population of patients who have access to trials and registries.
• The CAP recommends that the CMS not preclude Medicare Administrative Contractors (MACs) from determining coverage for new technologies at the local level as they become available. MACs should have the flexibility to reasonably choose to cover new technologies not yet reviewed by the FDA, by applying a rigorous review process per national guidelines.
• However, if the CMS does decide on a National Coverage Determination for CAR-T cell therapy regimen, the CAP asks that the policy should be flexible to allow for new technologies as they emerge.

The CAP also continues to advocate for coding and the valuation of these services.

In May of 2018, the CAP testified at the CMS’ Healthcare Common Procedure Coding System Public Meeting Agenda for Drugs, Biologicals and Radiopharmaceuticals urging that the agency not bundle physician services within codes to report drug, biological, or therapeutic agents for CAR-T cell therapy.

The CMS also requested that its Medicare Evidence Development & Coverage Advisory Committee panel to assess scientific evidence associated with CAR T-cell therapy. The panel will meet on August 22 and provide recommendations to the agency. The CAP will continue to engage with the CMS regarding its coverage policy decisions.

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Under draft legislation that the Massachusetts legislature may soon consider, payment for out-of-network services at in-network facilities may be limited to the greatest of 115% of the average in-network rate of the health carrier or 125% of Medicare. The plan is opposed by the physician community, including the CAP and the Massachusetts Society of Pathologists (MSP). Both the CAP and the MSP believe the in-network payment formula lacks sufficient data transparency and could create an opaque payment system that would be conducive to improper insurance industry business payment practices.

For several years, at least one public policy group and certain state government entities have disseminated false information that patients in Massachusetts could be financially responsible for out-of-network balance bills incurred at in-network hospitals. They claim that patients could incur “surprise bills” for these out-of-network services. Both the CAP and MSP repeatedly cited long-standing state law that requires the health insurance payers to hold the patient financially harmless in such situations, excluding the patient’s financial responsibility under the terms of coverage. At the request of the CAP and the MSP, the Massachusetts Department of Insurance issued an opinion that supports the CAP and the MSP contention.

According to a June 8 letter by the department to the MSP, the statute requires that “whenever a location is part of the carrier’s network, that the carrier shall cover medically necessary covered benefits provided at the location and the insured shall not be responsible to pay more than the amount required for network services even if part of the medically necessary covered services are performed by out-of-network providers, unless the insured has a reasonable opportunity to choose to have the service performed by a network provider.” Moreover, the department’s deputy commissioner noted: “I am not aware of complaints that have come to the Division of Insurance regarding a carrier not in compliance with this section of law.”

Both the CAP and the MSP are working with a coalition of other hospital-based physician groups and the Massachusetts Medical Society to engage with legislative leadership on amendments to the draft bill in order to ensure a fair, transparent, and verifiable payment formula and a clear indication of whether the patient’s health plan is subject to the requirements of the proposed law or otherwise preempted under federal law.

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July 11, 2018
1 pm ET/ 12 pm CT

Register today.

In the coming weeks, the Centers for Medicare & Medicaid Services (CMS) will issue its proposed updates to the 2019 Medicare Physician Fee Schedule and the Quality Payment Program regulations, including the Merit-based Incentive Payment System (MIPS) program.

Regulation changes will impact payment for services and pathologists’ participation in MIPS. Throughout this 60-minute panel discussion, CAP experts will review the proposed changes the fee schedule and MIPS. The webinar will begin at 1 PM ET on July 11. The CMS will finalize the 2019 Physician Fee Schedule and Quality Payment Program regulations during the fall of 2018.

Presenters are:

Donald S. Karcher, MD, FCAP
Chair of the Council on Government and Professional Affairs

Emily E. Volk, MD, FCAP
Co-Chair of the Council on Government and Professional Affairs
Chair of the CAP Clinical Data Registry Ad-Hoc Committee

W. Stephen Black-Schaffer MD, FCAP
Chair of the CAP Economic Affairs Committee

Learn and understand the practice and financial implications that these Medicare program changes will have on pathologists in 2019. Register Today.

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