Advocacy Update

Read the Latest Issue of Advocacy Update

• Pathologists Oppose Pay Formula for Out-of-Network Services in Senate Bill
• CAP Engages with CMS on Proposed CLIA Regulations
• CDC Deploys Emergency Center in Response to Ebola Outbreak
• CAP Pushes for Interoperability; Increased New Technology Add-On, CAR T-Cell Therapy Payments
• Nationwide Shortage of Tuberculin Skin Test Antigens, CDC Says
• Just Announced: 2020 Medicare Payment for Pathologists Webinar is July 17
• Take the June Advocacy News Quiz

Citing concerns over a payment formula that creates imbalance and threatens patient access to pathology services, the CAP opposed the out-of-network reimbursement provisions included in the Lower Health Care Costs Act, a bill drafted by the Senate Committee on Health, Education, Labor, & Pensions (HELP). The CAP, along with the American Medical Association, the American Hospital Association, and several other medical and hospital groups oppose this legislation.

The HELP Committee held a hearing on the bill on June 18 and will further debate and markup the legislation on June 26. The CAP urged all pathologists to contact their senators to voice concern and opposition to the bill’s reimbursement scheme for out-of-network services. CAP members can easily communicate with Congress on this important issue through our grassroots action network, PathNET, which is available for you to contact your Federal legislators. To date, over 1,200 CAP members have contacted their federal representatives over 8,300 times on this important issue.

The Lower Health Care Costs Act mandates that physicians be paid median contracted rates for out-of-network services provided at in-network hospitals and facilities. This policy, if enacted, would give large insurance companies the ability to set payment rates and eliminate the economic incentive for an insurer to negotiate a contract with a provider. As a result, insurers would unilaterally determine the value of physician services and subsume the physician component of hospital care within its own financial, and, potentially, operational control.

In addition to holding patients harmless from surprise medical bills, the CAP urged the HELP Committee to amend the Lower Health Care Costs Act by creating a baseball-style arbitration process that allows physicians and insurance companies to settle out-of-network bills. Independent arbitration systems have worked at the state level by protecting patients and reducing costs. In addition to an independent alternative dispute resolution process, the CAP asked the committee to pass legislation that will require network adequacy standards for health insurers as part of the holistic solution to address the problem of surprise billing.

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With the Centers for Medicare & Medicaid Services (CMS) considering changes to laboratory regulations, the CAP advocated for protecting the integrity of CLIA regulations and proficiency testing. As the leader in laboratory quality, the CAP advocated for updating laboratory analytics and encouraging the use of peer group data sets in a June 4 letter to the agency. 

The CAP encouraged the CMS to add additional regulated analytics to the current CLIA program. Moreover, the CAP supported the agency’s effort to modernize the proposed regulations updating the analytics that are more aligned with clinical laboratory practices. The CMS updated the list of regulated analytes adding 29 analytics and removing six current analytics, allowing for more autonomy to establish peer-groups and parameters. Moreover, the agency also protected the integrity of the program by ensuring non-profit status for administrative activities. The CAP also asked the CMS to consider the addition of analytes for toxicology.

In addition, the CAP asked the CMS to clarify the administrative responsibilities required to be non-profit, as well as review the peer-group requirements that would apply to non-regulated analytes.

The CAP asked the agency to also rescind several proposals from the regulation because of the potential burden and cost to laboratories. The CAP knows that these regulations would include laboratories’ declaration of patient reporting practices to PT programs, reporting microbiology organisms to PT programs at the highest level, and the one-time online submission of PT data. The CAP asked to update current PT regulations by fixing the cytology PT program and allow electronic signatures with electronic PT submissions for regulated analytes.

The CAP asked the CMS to ensure non-profit status for administrative activities to protect the integrity of the program. The CAP urged the agency to
modernize the PT regulations by fixing the cytology PT program and allow for electronic signatures with electronic PT submissions for regulated analytes.

The CAP will continue to engage with the CMS on updated CLIA.

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The Centers for Disease Control and Prevention (CDC) activated its Emergency Operations Center (EOC) to support the inter-agency response to the current Ebola outbreak in the eastern Democratic Republic of the Congo. The CDC’s activation of the center at Level 3, the lowest level of activation, means the agency will provide increased operational support for the response to meet the outbreak’s evolving challenges.

The CDC subject matter experts will continue to lead the CDC response with enhanced support from other CDC and EOC staff. Since August 2018 and in response to the Ebola outbreak, the CDC has assisted the Congo, the World Health Organization, and other local and international partners. The CDC has deployed staff with expertise in epidemiology, case management, infection control and prevention, laboratory science, border health, risk communication, community engagement, information technology, emergency management, and logistics to help with the response.

Regarding the Ebola outbreak, read the CAP case example article, Containing Contagion Builds a Safety-Drive Multidisciplinary Team.

Risk of a global spread of Ebola remains low. Activation of the CDC’s emergency center does not mean that the threat of Ebola to the United States has increased or that changes are being made to CDC’s outbreak-related guidance, such as advice to travelers to DRC or recommendations to organizations that deploy US-based health care or emergency response workers to outbreak-affected areas.

For more information, see the CDC’s press release on activation of the EOC.

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The CAP asked the CMS to update its requirements for interoperability between laboratory information systems (LIS) and clinical data registries, finalize payment rates for Chimeric Antigen Receptor (CAR) T-Cell therapies, and to increase the current inpatient hospital new technology add-on payment. The CAP advocates to reduce regulatory burdens on pathologists in a June 24 letter to the agency.

The CAP asked the CMS to reduce reporting burdens on pathologists in the Merit-based Incentive Payment System (MIPS) program, especially when reporting performance on quality measures. As the CMS eliminates claims-based measures, pathologists become disadvantaged in the program because it is difficult to access data from hospitals' electronic health records (EHRs) and Laboratory Information Systems (LIS) to import into clinical data registries.

The CAP urged the CMS and the Office of the National Coordinator (ONC), to develop standards of interoperability for LIS and EHR, while including a “hold harmless provision” available to both owners and users of these data (hospitals, physicians, laboratories, etc.) for purposes of MIPS reporting, which will remove reporting obstacles for pathologists, while increasing interoperability.

Because of the CAP’s advocacy, the CMS proposed to increase reimbursements for CAR T-cell therapies for 2020. According to proposed regulation, the treatment’s new technology add-on payment will increase to 65%, up from the current 50%, which would translate into a maximum add-on of $242,450, up from $186,500. Despite the increased payments, reimbursement will still fall short of covering costs to administer the two approved CAR T-cell therapies.

Pathologists have a critical role as integral members of the cancer patient management team during CAR T-cell therapy. In addition to contributions in initially diagnosing diseases and monitoring disease persistence and recurrence, pathologists are also directly involved in the provision of CAR-T cell therapy clinical services—notably, the harvesting of blood-derived T lymphocytes for development of genetically modified autologous CAR-T cells.

The CMS proposed that the new technology add-on payment become equal to the lesser of: (1) 65 percent of the costs of the new medical service or technology, or (2) 65 percent of the amount by which the costs of the case exceed the standard payment, as stated in the comment letter.” The CAP urged the agency to increase the new add-on payment, as “65% is insufficient to encourage hospitals to adopt new technologies,” and recommends a minimum of 80% payment amount, with room for higher percentages “to account for new medical services and technologies that inflict significant costs upon providers, the CAP stated in the letter.

The CAP continues to engage with the CMS and will provide updates periodically.

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A three- to 10-month nationwide shortage is expected for Aplisol, a product of Par Pharmaceuticals, and one of two purified-protein derivative tuberculin antigens licensed by the Food and Drug Administration (FDA) for use in performing tuberculin skin tests, the CDC announced on June 21.

Two types of immunological methods (tuberculin skin tests and interferon-gamma release assay blood tests) are used for detecting Mycobacterium tuberculosis infection. The tests are used for the diagnosis of latent tuberculosis infec¬tion and can aid in the diagnosis of disease, but additional evaluation and testing is necessary to distinguish between latent tuberculosis infection and tuberculosis disease to determine the appropriate treatment.

Two FDA-approved purified-protein derivative tuberculin antigen products are available in the United States for use in performing tuberculin skin tests: Tubersol (Sanofi-Pasteur) and Aplisol. As a result of this shortage, clinical and public health laboratories should anticipate an increased demand for Tubersol and interferon-gamma release assay blood tests.

CDC recommendations and additional information about the shortage is available on the CDC’s website.

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In the coming weeks, the CMS will issue its proposed updates to the 2020 Medicare Physician Fee Schedule and the Quality Payment Program regulations, including the Merit-based Incentive Payment System (MIPS). On July 17 at 1 PM ET, the CAP is proud to offer a complimentary live webinar where CAP experts will review regulatory changes that will impact payment for services and pathologists’ participation in MIPS.

Webinar presenters will be the Chair of the Council on Government and Professional Affairs Donald S. Karcher, MD, FCAP; Vice-Chair of the Council on Government and Professional Affairs and Chair of the Clinical Data Registry Ad-Hoc Committee Emily E. Volk, MD, FCAP; and Chair of the Economic Affairs Committee W. Stephen Black-Schaffer MD, FCAP.

During the 60-minute webinar, attendees will learn about updates to the 2020 Medicare Physician Fee Schedule and the Quality Payment Program regulations and its impact on pathologists. The CAP panel will also answer questions from attendees.

Register today for the webinar.

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The CAP has a new Advocacy News quiz for June, where you can test your knowledge and share your scores on social media. Last month more than 70 CAP members took the quiz and shared their results on social media. See how you measure up against your fellow pathologists on this month’s quiz. Good luck!

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