Advocacy Update

• FDA Welcomes the CAP to its Network of Experts
• CAP Lobbies House Leaders on Health Provisions in Reconciliation Bill
• CAP Urged Caution with Price Transparency in Proposed Outpatient Regulation
• CMS Releases Final Price Transparency Regulation
• Ohio Pathologists, CAP Forge Ahead to Resolve Out of Network Regulation
• Advocacy Fundraising Guide for State Pathology Societies
• Check Out the Advocacy News Quiz

The US Food and Drug Administration (FDA) approved the College of American Pathologists for admission to its Network of Experts to provide the agency with additional expertise on pathology and laboratory medicine issues, such as those concerning the COVID-19 pandemic and artificial intelligence.

The FDA Network of Experts is a vetted network of partner organizations and their member scientists, clinicians, and engineers who provide the FDA rapid access to expertise when it is needed to supplement existing knowledge and expertise within the administration’s Center for Devices and Radiological Health and the Center for Drug Evaluation and Research.

“As the world’s largest organization of board-certified pathologists, the CAP stands ready to lend its knowledge on laboratory, diagnostic testing, and all other pathology issues to the FDA,” said CAP President Patrick Godbey, MD, FCAP. “The CAP has expertise on a wide-range of issues concerning pathology. This includes those involving leading-edge and digital health care technologies. We look forward to participating as part of the Network of Experts and answering clinical questions from the FDA as they arise.”

The FDA Network of Experts Program currently partners with more than 100 professional organizations. The goal of the program is to allow FDA staff to tap into a virtual network of scientific experts after defining a scientific question that FDA staff need to address quickly.

Throughout the COVID-19 pandemic, the CAP has served as a resource to the government, Congress, and the general public on diagnostic testing.

With House lawmakers debating a budget reconciliation legislative package, the CAP engaged with House leadership to support expanding access to health care insurance coverage, improving the pandemic response, and addressing health inequities. In a September 17 letter to House leaders, the CAP also asked the elected officials to stop upcoming cuts to pathologists’ Medicare payments and address physician shortages throughout the United States.

As the pandemic revealed weaknesses in the US health care system, Congress has sought to address these shortcomings through the budget reconciliation package. In a letter to House leadership, the CAP stated its support for a pluralistic system that increases access to care for patients and stabilizes the health care system.

The CAP engaged on several provisions currently in House legislation that would improve the lives of Americans across the country by expanding access to health care coverage and improving access to high-quality care. The CAP further recommended the addition of other provisions that would strengthen the legislation.

The CAP’s positions on access to health care coverage is closely aligned to those of the American Medical Association (AMA) and other private sector groups, such as the American Hospital Association. This includes supporting the expansion of Medicaid as a means to cover more uninsured Americans to address health disparities throughout the United States. Access to preventative care, cancer and other screening services, as well as treatment for chronic illnesses and mental health disorders, are essential for communities of color and underserved populations.

At the same time, the CAP, along with the AMA and other physician organizations, are advocating for Medicaid payment rates be raised to 100% parity with Medicare rates to maintain quality of care to Medicaid beneficiaries.

Strengthening Public Health and Pandemic Response

The CAP also stated its support for other sections of the budget reconciliation package addressing the US public health system and pandemic response strategies. This included $7 billion to support health infrastructure activities to address workforce capacity, health information technology, and disease surveillance. The CAP also supports another $10 billion in grants to increase capacity and update medical facilities and hospitals.

As the testing supply chain has been fragile throughout the pandemic, the CAP applauded the inclusion of $10 billion to support critical manufacturing supply chain resilience. The funding is intended to mitigate future supply chain shortages so health care professionals, such as pathologists and laboratory personnel, can do their jobs properly.

Mitigating Medicare Cuts

The CAP further argued that Congress must mitigate pending Medicare cuts to pathologists. “Without continued relief, pathologists face an additional payment cut of 5% in 2022, on top of the 2.25% cut they received in 2021,” the CAP said. “These cuts are in addition to other economic shifts adversely affecting pathology practices.”

Earlier in the week, pathologists began contacting their representatives and senators in Congress to urge them to stop the cuts. Hundreds of pathologists used the CAP’s PathNET Action Center to quickly send a message to Congress in support of addressing the cuts before 2022.

The CAP urged the Centers for Medicare & Medicaid Services (CMS) to consider the intricacy of price transparency and the potential harm in delaying critical patient care in the proposed 2022 Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems (OPPS) regulation.

In the September 17 letter to the CMS, the CAP outlined several proposed regulations and provided comments on the policies and how it impacts diagnostic medicine.

Price Transparency

The CMS proposed to increase the penalty for some hospitals that do not comply with its Hospital Price Transparency final rule. The CAP is concerned about requiring pathologists to inform patients about out-of-pocket costs for a service before patients are furnished that service, as any delays in providing that service adds an administrative burden on physicians that interfere with or impair the patient’s medical diagnosis and care. The CAP urged the CMS to consider the complexity of pathology practice when drafting a regulation that would require most group health plans and health insurance issuers to disclose the price and cost-sharing information to participants, beneficiaries, and enrollees. Additionally, the CAP asked that the CMS “postpone finalizing any civil monetary penalty until stakeholders can review and propose other alternative methods of price transparency,” the CAP stated in the letter.

Proposed Changes to Service Packages

The proposed 2022 OPPS regulation packages payments for multiple interrelated items and services into a single payment, creating efficiency incentives for hospitals. “The CAP believes that the packaging of pathology services has been extremely constrictive to the practice of pathology because our services are often billed multiple times on a patient claim to complete the overall pathology service,” the CAP reinforced. The CAP asked the CMS “to exclude pathology services that are billed more than once per patient encounter from being packaged and pay them separately.”

Health Equity

The CAP provided requested feedback to the CMS on reporting health disparities and equity. “The CAP supports the inclusion of the anti-racism Improvement Activity (IA) suggested by the CMS and the modifications to other IAs to increase health equity. We also support additional policies aimed at reducing the burden on small practices, particularly small practices in underserved communities. Going forward, the CAP encourages CMS to ensure that health equity is considered in all aspects of the program,” the CAP stated.

On August 20, the CMS released guidance for implementing and enforcing new insurance price transparency regulations that would disclose cost-sharing information in advance of medical procedures. Prior to the regulation’s release, the CAP urged the CMS to consider the complexity of pathology practice as the agency implements rules that would require most group health plans to disclose the price and cost-sharing information to participants, beneficiaries, and enrollees.

While the CAP supports patient access to appropriate price information before receiving physician services and other medical care, the CAP is also concerned that some requirements may unintentionally delay services due to difficulties determining the cost of pathology services in advance. The CAP has had concerns over requirements that could potentially delay diagnostic tests and will continue to work with the CMS on this issue.

The new regulation requires a group health plan or a health insurance issuer offering group or individual health insurance coverage to disclose cost-sharing information upon request to participants, beneficiaries, or enrollees, including an estimate of the individual’s cost-sharing liability for covered items or services furnished by a particular provider in advance of receiving health care items and services, as well in-network negotiated provider rates, and historical out-of-network allowed amounts and billed charges from out-of-network providers to the public through machine-readable files.

To view the CMS Transparency in Coverage website.

The Ohio Society of Pathologists (OSP) and the CAP asked the Ohio Department of Insurance to address a proposed regulation’s nonconformance to the state’s out-of-network law (HB 388). The CAP works with state pathology societies, like the OSP, to urge state regulators to ensure health plans maintain robust networks of physicians to ensure timely access to care for all insured patients.

Specifically, both groups highlighted that the draft rule incorrectly applied to clinical laboratory services provided by out-of-network providers when ordered by an in-network provider, unless the provider providing laboratory services discloses to the patient their network status before the services provided. The OSP and CAP noted that the statute, which goes into effect January 1, 2022, has no notification requirement, and expressed concerns of failing to require health plan transparency or disclosure of the payment methodology from the health plan issuer to the out-of-network provider. The Ohio State Medical Association (OSMA), OSP, and the CAP also urged that the state clarify the need for specification of payment violations by health plan issuers.

In July, the OSP, the OSMA, and the CAP conferred with the Ohio Department of Insurance staff to discuss detailed concerns of the regulatory draft comments and the implications of nonconformance to the law Act. The OSP and the CAP noted the impact of community-based (non-facility) out-of-network clinical laboratory referrals that are made by in-network providers to be mandated to provide patients with written notification requirements from the clinical laboratory, before performing service or subjection to the law’s balance billing ban. The requirement is contrary to the statute, which is expressly limited to only out-of-network clinical services provided at in-network facilities when patients do not have access to in-network providers. Unfortunately, the Ohio Department of Insurance, while initially receptive to the objection, failed to include revised changes in the second version of the draft rule on clinical laboratory services and other substantial concerns from other stakeholders.

The OSP and the CAP retained legal counsel to submit the regulatory comments, addressing the rule’s improper application to all out-of-network clinical laboratory services ordered by in-network providers. The Ohio Department of Insurance submitted the Business Impact Analysis to Ohio’s Common Sense Initiative, directly noting the proper purview of the Act, thereby strengthening the OSP and CAP’s position.

The CAP and OSP remain engaged in Ohio’s rulemaking process.

The CAP partners with state pathology societies to bolster advocacy efforts at the state level, especially for health policies concerning pathologists, and to influence local legislation and regulations affecting pathologists’ practices and the patients they serve.

Effective state advocacy requires funding. It is often too late if a state society waits until an issue comes before your state legislature to raise funds for effective lobbying.

The CAP has a new resource, Advocacy Fundraising — a Guide for State Pathology Societies, for state pathology societies for fundraising, which offers insights on best practices for fundraising and campaign strategies. The guide also has sample language for creating messages, emails, and letters in your fundraising efforts.

Request the Advocacy Fundraising Guide and Templates

Check out the September Advocacy News Quiz featuring the CAP’s 75th Anniversary. Last month almost 100 members took the quiz! Test your knowledge and win a 75th Anniversary prize for completing the quiz.

Take the news quiz