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In an ongoing effort to correct errors affecting Medicare reimbursements for pathology services, the CAP submitted an extensive list of pathology supplies and equipment invoices to the Centers for Medicare & Medicaid Services (CMS) in February. Advocacy on this issue is an example of the CAP’s multifaceted approach to protect the value of pathology services.

For 2019, the CMS implemented price recommendations for over 2,000 medical supply and equipment items used to calculate payments for services on the Medicare physician fee schedule. Practice expenses account for an average of 45% of the total value of a physician service on the Medicare fee schedule.

Practice expense relative value units include the costs associated with nonphysician or clinical labor time in addition to the costs of medical supplies and equipment used to furnish the service. The CMS updated its pricing inputs based on market research contract with a consulting firm and will continue to phase-in the prices for equipment and supplies over the next four years.

For some pathology codes, the CMS implemented new prices that did not reflect the proper product, quantity, and/or unit of measure associated with the medical test service. Specifically, the CAP noticed atypical prices, inaccurate calculations due to incorrect units of measure, and prices of supplies that are considered obsolete.

The CAP remains concerned about the impact of the updated pricing on smaller practices, which operate on smaller margins and are more likely to be adversely affected by these changes.

The CMS encouraged physician specialty groups to identify medical supply and equipment codes that will require additional research throughout the four-year transition. Additional information provided by the CAP to the CMS may result in updates to inputs to supply and equipment items in future iterations of the Medicare physician fee schedule.

The CAP will continue to engage with the CMS with additional clarification on appropriate pricing for pathology supplies and equipment.

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The CAP, along with the American Medical Association (AMA) and over 40 medical specialty groups, asked the CMS to fix its prior authorization policy to prevent adverse patient events and reduce administrative burdens on physician practices. The CAP has worked to address programs requiring prior authorization because they can negatively affect patient access to necessary diagnostic tests, create inconsistencies with current clinical practice, and increase burdens on pathologists and laboratories. 

Prior authorizations are health plan control processes. They require physicians to obtain approval prior to the delivery of the prescribed treatment, laboratory test, imaging test, or medical service to qualify for payment.

The CAP, AMA, and other specialty societies asked the CMS to provide specific criteria for prior authorization in a letter sent on February 28. For instance, criteria should be developed for programs including ordering/prescribing patterns that align with evidence-based guidelines and historically high prior authorization approval rates, according to the letter signed by the groups. 

According to a recent AMA survey of 1,000 practicing physicians, more than nine in 10 respondents said prior authorization had a significant or somewhat negative clinical impact on patient care. About 28% of physicians reported “that prior authorization led to a serious adverse event such as a death, hospitalization, disability or permanent bodily damage, or other life-threatening event for a patient in their care.” The AMA survey also revealed that 91% of physicians said prior authorization can delay a patient’s access to necessary care.

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Citing no proven benefits of the infusion of plasma from young donors to cure illness, the Food and Drug Administration (FDA) cautioned Americans against receiving transfusions that are promoted as unproven treatment for varying conditions.

In a February 19 communication, the FDA said it became aware of reports of transfusion centers and clinics in several states offering infusions of plasma from young donors to treat the effects of memory loss and illnesses like dementia, Parkinson’s disease, multiple sclerosis, Alzheimer’s disease, heart disease, or post-traumatic stress disorder. “We have significant public health concerns about the promotion and use of plasma for these purposes,” the FDA said. “There is no proven clinical benefit of infusion of plasma from young donors to cure, mitigate, treat, or prevent these conditions, and there are risks associated with the use of any plasma product.”

The FDA alerted patients and the health care community that treatments using plasma from young donors have not gone through rigorous testing that the FDA normally requires to confirm the therapeutic benefit of a product and to ensure safety. As such, the FDA strongly discouraged patients from pursuing such therapies outside of clinical trials under an institutional review board and regulatory oversight.

“Simply put, we’re concerned that some patients are being preyed upon by unscrupulous actors touting treatments of plasma from young donors as cures and remedies,” FDA officials said. “Such treatments have no proven clinical benefits for the uses for which these clinics are advertising them and are potentially harmful. There are reports of bad actors charging thousands of dollars for infusions that are unproven and not guided by evidence from adequate and well-controlled trials.”

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Check out the recording.

Missed the webinar where CAP experts discussed how pathologists must teach the 98 new Members of Congress about their critical role in health care? Watch Donald Karcher, MD, FCAP, chair of the CAP Council on Government and Professional Affairs, David Gang, MD, FCAP, chair of the Federal and State Affairs Committee, and Jennifer Forsyth, MD, FCAP, a member of the Federal and State Affairs Committee, discuss how pathologists can educate the new Congress on important health care issues. Check out the recording and register for the Policy Meeting.

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