Advocacy Update

Read the Latest Issue of Advocacy Update

• CAP Urges CMS to Consider Complexity in Insurer Price Transparency Regulation
• CAP Scores Major Coverage Wins for Ovarian and Breast Cancers, Repeat Testing
• NJ Pathologists Secure Revision on Insurer’s Limits to Pathology Services
• CAP Supports BCBS of North Carolina’s Efforts to Address the Practice of Pass-Through Billing
• Analysis Shows Healthy, Continuing Demand for Pathologists
• With No FDA-Approved Test for Coronavirus, Agency Outlines Emergency Use Process
• Test Your Advocacy Knowledge with the February News Quiz

The CAP urged the Centers for Medicare & Medicaid Services (CMS) to consider the complexity of pathology practice as the agency implements regulation that would require most group health plans, including self-insured plans, and health insurance issuers to disclose price and cost-sharing information to participants, beneficiaries, and enrollees. While the CAP supports patient access to appropriate price information prior to receiving physician services and other medical care, we are concerned about any changes that may unintentionally delay services due to difficulties in determining the cost of pathology services in advance.

“The CAP agrees that patients must be able to make informed decisions about their health care, and we understand how access to price information prior to services may be useful for patients, but we wish to express continued concerns about risk for patient harm from any delays and difficulty in determining the cost of pathology services in advance of services conducted by the pathologist,” the CAP stated in a January 29 letter to the CMS.

Because of this difficulty, the CAP supported the requirement in this proposed regulation to convey that actual charges may be different from those described in a cost-sharing liability estimate, depending on the actual items and services received at the point of care. The CAP also reinforced additional patient education efforts around cost and other price information to ensure patients understand the data/estimates provided, including the fact that that price alone does not determine the value of care or services.

“Without adequate understanding of all pricing information and individual benefit design details, patients looking to make cost-conscious decisions may be overwhelmed by unhelpful or irrelevant information, confused by different data points and their meaning, and/or make decisions that could lead to decreased quality of care,” the CAP stated.

The CMS also requested feedback regarding the inclusion of quality measurement information as part of the price transparency effort. The CAP stated quality and cost information is important, but cautioned "restraint as it is not yet well-understood what quality information is important to consumers around non-patient facing diagnostic providers. Pathologist services should be included in quality information only when it is well-understood what information would be necessary or useful to consumers."

The CAP will follow-up and engage with the CMS on this issue throughout the regulatory process.

The CAP successfully advocated for expanded coverage of tests utilizing next generation sequencing (NGS) panels for breast and ovarian cancer patients.

In the January 27 regulation, the CMS responded to the CAP’s requests and will cover NGS testing for a clinical indication of hereditary versions of breast or ovarian cancer, and NGS testing of patients who have not been previously tested with the same germline test using NGS panels for the same genetic content. The test must have US Food and Drug Administration (FDA) approval or clearance and results must be used by a treating physician.

The CMS also gave Medicare Administrative Contractors (MACs) discretion to determine coverage of NGS as a diagnostic laboratory test when a beneficiary has any cancer diagnosis, has a clinical indication for germline testing of hereditary cancers, a risk factor for inherited cancer, and has not been previously tested with the same germline test using NGS for the same genetic content.

The CMS also agreed to include coverage for appropriate repeat NGS tests for germline cancers when specific clinical scenarios necessitate repeat testing for patients with germline cancers.

Following advocacy and engagement by the New Jersey Society of Pathologists with support from the CAP, Horizon BlueCross BlueShield of New Jersey (Horizon BCBS of NJ) revised proposed limits in its Daily Maximum Units for Surgical Pathology and Microscopic Examination policy.

In November of 2019, the New Jersey Society of Pathologists and the CAP opposed the new Horizon BCBS of NJ reimbursement policy that would have denied pathologists reimbursement for the same patient on the same date of service for services of the surgical pathology CPT code 88305 over specified limits. The New Jersey Society of Pathologists, with support from the CAP, urged the insurer to reverse its restrictive policy, noting that rationing care in the setting of diagnostic tissue biopsies results in significant administrative and quality patient care issues.

Specifically, the revised policy increases biopsy limits for prostate and “all other conditions,” while leaving the proposed limit for gastrointestinal conditions. As introduced, the policy would have imposed limits on clinical physicians’ decision-making by impeding access to medically necessary pathology services.

The CAP expressed appreciation for the revisions and is continuing to engage with the insurer to improve pathology policies. The CAP is also following up with the New Jersey Society of Pathologists.

Learn more about the CAP’s private sector advocacy.

The CAP supports a proposed BlueCross and BlueShield of North Carolina policy that would inhibit practices of pass-through billing. In a January 29 letter the CAP urged the insurer to continue with its pathology billing policy that supports direct billing practices. These billing practices align with the American Medical Association (AMA) ethics principles and are in the best interests of good patient care and cost control.

Specifically, the policy would address the practice known as client or “pass-through” billing, where a treating physician realizes a profit by charging a patient full price for a laboratory service the physician received at a discount. In the letter, the CAP supported the policy by outlining that “payment for anatomic pathology services should be made only to the person or entity performing or responsibly supervising the service, except for referrals between laboratories independent of a physician’s office. This is consistent with the American Medical Association (AMA) ethics principles and has been a Medicare requirement since 1984.”

Pass-through billing incentivizes providers to choose laboratories based only on the lowest price for the service and encourages overutilization. Direct billing helps to ensure that perverse financial considerations are not influencing physicians’ ordering of pathology services for their patients.

Contrary to negative reports regarding a decline in the practice of pathology, an article published on January 23 in the Archives of Pathology & Laboratory Medicine shows that demand for pathologists in the US is healthy.

The article draws on data from the 2018 Practice Leaders Survey and subsequent report written by the CAP Policy Roundtable. The 2018 survey report reflected responses from pathology practice leaders on a range of issues related to staffing levels including hiring, skills wanted, and the replacement of retirees.

The CAP survey offered a positive outlook on the pathology job market, with the addition in 2017 of 246 full-time employees (FTEs), 60 FTE cuts, and a net increase of 187 FTEs added for the year among the 253 practices who provided information about their hiring. This number of practices represented at least 17% of the estimated 1,400 to 1,500 pathology practices in the US, who had responded to questions about staffing levels. Moreover, about 45% of these practices sought to fill at least one position in 2017.

The authors of the study see pathology employment picture as healthy, and they noted that practice leaders also indicated they would be filling substantially more positions in the next three years (2018-2020) than the number of jobs that would be lost through the retirement of pathologists.

In response to coronavirus outbreak, the FDA announced processes in place for the rapid development of novel coronavirus medical countermeasures, including diagnostic tests.

To support efficient medical product development for novel coronavirus medical countermeasures, the FDA launched a webpage on January 27 that provides key information for product developers on the FDA’s efforts in response to this outbreak. Currently, there are no commercially available products authorized to detect novel coronavirus. The FDA is working to facilitate the development and availability of diagnostics that can detect the virus. In addition, the agency is working with public health partners to advance and share the reference materials necessary to facilitate diagnostic development.

The FDA asked that diagnostic test sponsors interested in potential emergency use authorization for tests to detect 2019-nCoV to contact CDRH-EUA-Templates@fda.hhs.gov for further information and templates.

The Centers for Disease Control and Prevention published instructions for “Real-Time RT-PCR Panel for Detection 2019-Novel Coronavirus” and “2019-Novel Coronavirus (2019-nCoV) Real-time rRT-PCR Panel Primers and Probes.”

These documents provide information about specimen collection from patients under investigation (PUI) for human infections with 2019 Novel Coronavirus (2019-nCoV), as well as specimen handling and storage guidance. These documents describe procedures and/or reagents derived thereof that are intended to be used for the purposes of respiratory virus surveillance and research.

At this time, diagnostic testing for 2019-nCoV can only be conducted at the CDC. Clinical laboratories should not attempt viral isolation from specimens collected from 2019-nCoV PUIs. Clinical laboratories should contact their state health departments for guidance if they have a suspect specimen.

Find out more about Guidelines for Clinical Specimens, such as specimen type and collection, and shipping specimens to the CDC.

Specimens from patients under investigation should be coordinated through the local/state health department and the local/state public health laboratory for shipment to the CDC. When submitting specimens from patients under investigation for coronavirus, laboratories should include appropriate patient identifiers on the test requisition and the specimen container. Label each specimen container with:

• CDC nCoV number
• The patient’s ID number (eg, medical record number)
• Unique specimen ID (eg, laboratory requisition number)
• Specimen type (eg, serum)
• Number of samples
• Date the sample(s) was collected

New month, new Advocacy News Quiz. In January, over 200 CAP members tested their advocacy knowledge and 10 shared their results on social media. Take the February news quiz today.