Advocacy Update

Read the Latest Issue of Advocacy Update

• Special AMA Report: CAP Advocates for Pathology in Med Schools, Site of Service
• CAP Opposes Effort to Overturn 2013 Supreme Court Decision on Gene Patents
• Revisions Needed to HELP Committee Proposals on Surprise Bills: CAP
• CAP Urges Regulators to Stop Information Blocking
• CAP Advocates for Expanded Medicare Coverage for Cancer Patients
• On New AI Framework, CAP Wants FDA to Ensure Fewer Regulatory Burdens
• Pennsylvania Affirms That Patients Are Not Responsible for Surprise Medical Bills Under Existing Law

The CAP led a delegation of pathologists at the 2019 American Medical Association (AMA) Annual Meeting to set policy affecting the practice of medicine the weekend of June 8. The CAP’s advocacy included efforts to defend pathology as a specialty study in medical school education, discussions on surprise medical bills, and opposition to neutral site of service reimbursement policies.

The picture to the left shows the 2019 CAP AMA Delegation from left to right: Joe SanFrancesco, MD, FCAP, William Harrer, MD, Susan Strate, MD, FCAP; Mark Synovec, MD, FCAP; Jean Forsberg, MD, FCAP; Gregory Goldgof MD, FCAP; Valerie Lockhart, MD, FCAP; James Caruso, MD, FCAP; Rebecca Obeng, MD, FCAP and Simone Arvisais-Anhalt MD, FCAP.

Valerie Lockhart, MD, the CAP representative for the Resident Physicians Section at the AMA House of Delegates (HOD), provided passionate testimony regarding the importance of including the study of pathology in medical school education, calling it the “backbone of all medicine.” Dr. Lockhart further explained the value of the study of pathology. “How many clinicians know how a reference range is set? How many realize that an abnormal laboratory result is not definitive evidence that pathology exists? This is not just about the practice of pathology--this is about being able to provide the best, most cost-effective patient care possible. When patients are unnecessarily treated based on incorrect interpretation of laboratory tests, we're not doing anyone any good. Residents, fellows, and medical students are telling you that we want to know more about pathology, so please join us in supporting this resolution.” Other medical specialties and the members of the Medical Students Section also provided testimony in support of pathology as a field of study. “We need more than just, elective rotations, like pathology, in order to make our medical education more comprehensive. We need to study pathology to fully comprehend diagnosis and treatment, so we can save lives and help our patients,” said a member of the Medical Students Section. The CAP supported AMA policy that states laboratory medicine is an integral component of patient care. However, there is concern about the lack of formal training in diagnostic processes/laboratory medicine during medical school.

The CAP collaborated with AMA leadership and a coalition of specialty physicians on surprise medical billing during fruitful discussions at the Annual Meeting. Much of the discussion focused on improving legislative proposals currently being debated in Washington, DC. The CAP is aligned with the AMA on several principles to address surprise medical bills.

Susan Strate, MD, FCAP, the CAP Alternate Delegate to the AMA HOD, provided testimony in opposition of the Practice Overhead Expense and the Site of Service Differential proposals. Pathologists, the AMA, and other specialties have advocated against site neutral payments in the past, specifically between the Medicare Physician Fee Schedule (PFS) and the Hospital Outpatient Prospective Payment System (OPPS) fee schedules. Dr. Strate asked the AMA to consider creating a “RUC” for the OPPS to help determine fair site of service reimbursements. “The AMA RUC looks at values for the physician fee schedule, and there is nothing like that, no ‘RUC’ for the hospital outpatient prospective payment system. We need something like that to help determine fair site of service payments for physicians,” explained Dr. Strate.

The AMA Annual was ongoing at this article’s deadline. The meeting continues through June 12. The CAP will provide additional updates in the June 18 edition of our Advocacy Update newsletter.

The CAP is an active member of the AMA House of Delegates and encourages pathologists to join the AMA or renew their AMA membership. A robust CAP delegation at the AMA can shape a health care system that best utilizes pathologists to deliver high-quality care and meet the evolving demands of patient care. The CAP and AMA work together on many of the health and medical policies that affect the way you practice and your reimbursements. Join or renew your AMA membership today.

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The CAP and a coalition of more than 150 medical, patient, and civil rights advocacy organizations opposed House and Senate proposals to permit the patenting of products and laws of nature, such as human genes. If enacted, the legislation would allow businesses to own the rights to genes and prohibit others from developing genetic testing and pursuing research, the organizations said.

In a June 3 letter signed by the CAP, the advocacy organizations opposed a proposed congressional amendment to Section 101 of the Patent Act. The letter’s signatories included plaintiffs from the 2013 landmark Supreme Court decision in Association of Molecular Pathology et al. vs. Myriad Genetics. The CAP was a plaintiff in the case in which Myriad’s claims to isolated BRCA1 and BRCA2 genes were invalidated.

“Most troublingly, the legislation would permit patenting of human genes and naturally-occurring associations between genes and diseases. Allowing these patents will prevent the discovery of novel treatments for diseases including cancer, muscular dystrophy, Alzheimer’s disease, heart disease, and other rare and common diseases,” the letter stated. “It would also create barriers to patients’ access to potentially lifesaving genomic tests, eliminate access to confirmatory testing and dramatically increase the cost of tests that have benefited from innovation that led to reduced costs of DNA sequencing technology.”

Congressional hearings on intellectual property rights were held on June 4 and 5. During a June 5 Senate Judiciary Intellectual Property Subcommittee hearing, Sen. Chris Coons (D-DE) stated the intent of the legislative proposal is not to overturn the 2013 Supreme Court case and allow companies to patent human genes. Lawmakers hope to enact legislation to spur innovation and new medical advances.

The CAP will remain engaged with Congress on this issue.

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The CAP engaged with Senate leaders to oppose legislative proposals that contain inadequate and unbalanced reimbursement systems for out-of-network physician services.

In a June 5 letter, the CAP urged the Senate Health, Education, Labor & Pensions (HELP) Committee to improve draft legislation that protects patients from surprise medical bills for out-of-network care and preserves the private health care marketplace. The CAP called on senators to support fair reimbursement for out-of-network services, include an arbitration system that allows arbitrators to consider several factors to resolve payment disputes, and set network adequacy standards.

The HELP Committee sought feedback from the CAP on a discussion draft of the Lower Health Care Costs Act of 2019. Provisions of the draft bill include paying physicians for out-of-network services the median contracted rate for the same services provided in the geographic area. For bills over $750, the insurer or provider can initiate an independent dispute resolution process. The HELP Committee is also considering network matching, which would require physicians to contract with insurance health plans that contract with the hospitals in which physicians practice.

These proposals would have an adverse effect on health care, the CAP said. For example, using median in-network rates would eliminate the need for insurers to negotiate contracts in good faith, the CAP said. The provision would further incentivize insurance companies to lower rates, which can be done by insurers unilaterally.

“As you move forward to address the issue of surprise billing, it is of paramount importance to strike a compromise that holds patients harmless but also allows providers and insurers to come to agreement on outstanding bills,” the CAP stated. “We urge you to consider revisions that would better support fair reimbursement for out-of-network services, include an arbitration system to resolve payment disputes, and add appropriate hospital-based physician network adequacy standards that do not force providers into contracts.”

CAP members can contact their senators and representatives on this important issue through our grassroots action network, PathNET.

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The CAP urged the government’s lead federal agencies for health information technology to prevent information blocking by electronic health record vendors and adopt rules that encourage interoperability between health technology systems used by physicians, laboratories, and other providers. Such changes advocated by the CAP would improve the coordination of patient care and further reduce regulatory burdens on pathologists. 

“The CAP believes that the ready exchange of laboratory data between different practice settings is crucial for the improvement of quality of care and patient safety as well as the reduction of costs,” the CAP stated in a letter to the Office of the National Coordinator (ONC) for Health Information Technology on June 3. “As such, the CAP hopes that the ONC proposals will incentivize the interoperable exchange of laboratory data.”

Information blocking interferes with and materially discourages access to information and flow of data to various systems, including clinical data registries. The CAP strongly encouraged the ONC to develop more stringent rules against information blocking and remain vigilant against creating broad exceptions for vendors that undermine the rules against information blocking.

The ONC and the Centers for Medicare & Medicaid Services (CMS) released proposed regulations to address information blocking and interoperability in March. The CAP’s engagement with the federal agencies focused on the impact of information blocking by vendors and changes proposed to the ONC’s certification criteria, which affects ongoing advocacy by the CAP concerning certification of laboratory information systems (LIS). Since an LIS does not have a pathway to be considered certified under the ONC Health IT Certification Program, LISs cannot be Certified Electronic Health Record Technology (CEHRT). This presents a significant barrier to pathologists’ full participation in the CMS’ Quality Payment Program (QPP) as well as other federal quality reporting programs. In its comments, the CAP suggested alternatives to protect pathologists from being penalized and allow pathologists to fully participate in quality programs. 

Read the CAP’s full comments on information blocking and interoperability.

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The CMS is reconsidering and requested comments on its national coverage determination (NCD) policy for next-generation sequencing (NGS) panels to address concerns about the impact of the current policy on patients and their ability to access testing for hereditary cancer risk. The reopening follows pressure from the CAP and other health care organizations that argued that the NCD excludes germline NGS-based testing from Medicare coverage for patients with early stage cancers.

In its May 29 response to the agency’s request, the CAP urged to allow Medicare Administrative Contractors (MACs) the discretion to continue making coverage decisions through the local coverage determination (LCD) process for Medicare beneficiaries with early-stage cancers. Moreover, the CAP insisted that the CMS reinstate coverage for hereditary cancer tests that were previously covered under local coverage policies. Prior to the NCD, the MACs had previously implemented local coverage determinations that provided Medicare beneficiaries with all stages of cancer access to testing for hereditary mutations when supported by clinical guidelines, including NGS-based tests for germline mutations for breast, ovarian and colon cancers. The NCD, which supersedes LCDs, reversed local coverage for NGS-based testing for patients with early stage cancers.

The CMS is expected to issue a proposed coverage decision by October 29, 2019 whereby the public will be invited to submit additional comments to the agency before a final NCD is released in early 2020.

The CAP will continue to engage with the agency on this issue.

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As long as the new framework does not increase regulatory burdens on pathologists, the CAP stated its support on the Food and Drug Administration’s (FDA) proposed regulatory discussion draft on Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD).

On April 2, the FDA proposed a new regulatory framework to address the development of artificial intelligence and machine learning-based software as a medical device. The FDA’s “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD): Discussion Paper and Request for Feedback” attempts to address the challenging features of AI/ML-based SaMD products, including the capability to learn from real-world feedback, adapt, and modify output when used for diagnostic or therapeutic purposes. The CAP wants the FDA to ensure that the new AI/ML regulations will not impede pathologist’s diagnostic procedures. 

The CAP asked the FDA to mitigate the impact of these regulations for AI/ML on pathologists, while supporting the proposed framework in a June 3 comment letter. Moreover, the CAP supported “a risk-based approach for AI/ML SaMD regulatory framework.” 

In the letter, the CAP reinforced that the FDA should require an “analytical and clinical validity for the AI/ML SaMD framework. The robustness of these requirements should depend on the risk classification of the AI/ML SaMD.” Moreover, the CAP insisted that the new regulatory framework has real-world performance monitoring incorporated in the AI/ML-based medical device software. The CAP supported the FDA including in any regulatory framework the requirement of transparency therein, requiring for manufacturers to have a mechanism describing updates to patients and pathologists.

The CAP will continue to engage with the FDA on the ever-changing AI/ML regulations and its impact on diagnostic medicine.

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Prompted by legislative questions posed by the CAP and the Pennsylvania Association of Pathologists (PAP), the state’s department of health affirmed that patients who are treated at an in-network facility, but who receive services from out-of-network physicians they did not select, are to be held “financially harmless except for the normal costs they would have incurred if the providers had been in-network.”

Previously, the Pennsylvania Department of Insurance urged passage of “surprise billing legislation” claiming that patients who received out-of-network care at in-network facilities were at financial risk. That assertion omitted the acknowledgment of existing law protection for patients in the state. The CAP and Pennsylvania Association of Pathologists (PAP) pursued the agency clarification that was provided to staff of the Pennsylvania state legislature, following a state hearing on the importance of health plan network adequacy that occurred in February.

To further explain its position, the Pennsylvania Department of Health stated that facility-based providers such as anesthesiology, laboratory, pathology, radiology, etc., are frequently referred to as ‘invisibles’ because the patient cannot determine which of those specialties in-network providers. “The patient cannot select these types of services or providers or question their status as an in-network or out-of-network provider. Therefore, the patient should not be held financially responsible for their services. Moreover, when a patient selects an in-network participating hospital for in-patient services, he/she has every reason to believe that by selecting this facility all providers are in network,” as stated by the Pennsylvania Department of Health. 

The CAP and state pathology societies have now secured clarifications on these existing financial “save harmless” protections for patients in Pennsylvania and Massachusetts.

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