Read the Latest Issue of Advocacy Update
November 24, 2020
In this Issue:
- Pathologists Advocate for Higher COVID-19 Payment During AMA Meeting
- Updated Medicare Self-Referral Regulation Fails to Fix Loopholes
- FDA Authorizes At Home COVID-19 Test
- FDA Updates COVID-19 Questions/Answers
- Webinar on December 11: Final 2021 Medicare Payment Policies for Pathologists
- Test Your Advocacy News Knowledge
- Editor’s Note
Pathologists Advocate for Higher COVID-19 Payments During AMA Meeting
The American Medical Association (AMA) House of Delegates directed the AMA to advocate for enhanced payments to recognize work performed by physicians during the COVID-19 pandemic at the November 2020 Special Meeting. Delegates also took several other actions to detail the physicians’ duties on COVID-19 vaccination, adopt a report aimed at stopping workplace bullying in medicine, and outlining new efforts to protect residents.
Nearly 700 physicians, residents, and medical students gathered virtually for the Special Meeting. Additional highlights of the meeting included a plenary session featuring an interview that AMA Executive Vice President and CEO James Madara, MD, conducted with Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases. The CAP and the Pathology Section Council of the AMA represented the interests of pathologists during this crucial time of the COVID-19 pandemic.
COVID-19 Reimbursement Concerns
The House of Delegates also reviewed pandemic stresses on the US health workforce, the importance of continuing the fight to improve Medicare’s Merit-based Incentive Payment System (MIPS), access to care for patients, and how to address increasing challenges for physicians working in private practice. During the meeting, the Pathology Section Council discussed the specific difficulty facing pathologists, laboratories, and patients during the COVID-19 public health emergency and beyond.
One of the resolutions the Pathology Section Council discussed was the issue of proper reimbursement for COVID-19 care. The resolution, introduced by the Infectious Diseases Society of America, American College of Emergency Physicians, and Society of Hospital Medicine, directed the AMA to advocate for recognition of the “enhanced, non-separately reimbursable work performed by physicians” during the COVID-19 pandemic. Feedback provided by the Pathology Section Council ensured this advocacy would not result in reimbursement cuts for pathologists or other unintended consequences, as pathologists are facing unprecedented financial difficulties, increasing burden and stress, and inadequate payment for COVID-19 testing.
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
Updated Medicare Self-Referral Regulation Fails to Fix Loopholes
On November 20, the Centers for Medicare & Medicaid Services (CMS) finalized proposed changes intended to modernize Medicare physician self-referral law, or Stark law, adding flexibility for value-based reimbursement. The CAP had engaged on this regulation over concerns that modernizing the law may further incentivize providers to overutilize services or create new opportunities for abusive self-referral arrangements that would hurt pathology practices.
Additionally, the CAP urged the agency to close the in-office ancillary services (IOAS) exception for anatomic pathology (AP) services. However, the CMS determined that removing any IOAS exemptions were outside the scope of the regulation.
The revised Medicare self-referral regulation does not go far enough to the stop self-referral of anatomic pathology services. In its December 19, 2019 comment letter, the CAP advocated with the CMS to close loopholes to deter abusive referral practices.
“Even as the CMS has taken steps to close ambiguities to deter pod laboratories, and other abusive referral practices, physician groups are creating new arrangements to take advantage of the IOAS exception and profit from pathology services,” the CAP stated in its letter. “Our members report specialty groups building large ‘physician office’ AP laboratories serving broad geographic areas using contracted or part-time pathologists in a central location who are reimbursed at a fraction of the billed professional amount.” The CAP had asked the CMS to exclude AP services from the IOAS exception, as it is the most effective means of preventing program abuses and protecting quality care for patients. The CAP had engaged with the CMS on this issue, but the agency determined that removing the IOAS exemptions were outside the scope of the regulation.
The Stark Law prohibits a physician from making referrals for certain health care services payable by Medicare if the physician (or an immediate family member) has a financial relationship with the entity performing the service. The Stark Law also prohibits the entity from filing claims with Medicare for services resulting from a prohibited referral, and Medicare cannot pay if the claims are submitted.
FDA Authorizes At Home COVID-19 Test
On November 17, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the first at-home COVID-19 diagnostic test that provides rapid results. The Lucira COVID-19 All-In-One Test Kit is a molecular (real-time loop mediated amplification reaction) single-use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19.
The Lucira COVID-19 All-In-One Test Kit test was authorized for home use with self-collected nasal swab samples in individuals age 14 and older who are suspected of COVID-19 by their health care provider. It is also authorized for use in point-of-care (POC) settings for all ages but samples must be collected by a health care provider when the test is used at the POC to test individuals younger than 14 years old. The test is currently authorized for prescription use only.
The test works by swirling the self-collected sample swab in a vial that is then placed in the test unit. In 30 minutes or less, the results can be read directly from the test unit’s light-up display that shows whether a person is positive or negative for the SARS-CoV-2 virus. Positive results indicate the presence of SARS-CoV-2. As noted in this EUA, prescribing health care providers are required to report all test results they receive from individuals who use the test to their relevant public health authorities by local, state, and federal requirements.
FDA Updates COVID-19 Questions/Answers
The FDA recently updated the COVID-19 testing FAQs by topic, making it easier to search for information. The FDA also updated the FAQs to say they will review voluntary submitted LDTs for EUAs.
The FDA also updated the answers to certain questions in the following sections:
- Notifications and Emergency Use Authorizations
- Removal Lists of Tests That Should No Longer Be Used and/or Distributed for COVID-19
- Test Development and Review
- Test Settings
- Test Uses
- Testing Supplies
- 3D Printed Swabs
- COVID-19 Related Test Data and Reporting
- Serology/Antibody Tests
Here is a direct link to the FAQs.
Webinar on December 11: Final 2021 Medicare Payment Policies for Pathologists
The CMS will soon release its final 2021 Medicare Physician Fee Schedule and the Quality Payment Program regulations, including the Merit-based Incentive Payment System (MIPS). The CAP will host an exclusive webinar on December 11 at 3 PM ET/ 2 PM CT, 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 Jonathan Myles, MD, FCAP; Chair of the Economic Affairs Committee W. Stephen Black-Schaffer MD, FCAP; and Vice Chair, Economic Affairs Committee Diana Cardona, MD, FCAP.
During the 60-minute webinar, attendees will learn about the final 2021 Medicare Physician Fee Schedule and the Quality Payment Program regulations and its impact on pathologists. The CAP panel will also answer questions from attendees.
Test Your Advocacy News Knowledge
It’s November, and it’s time to test your CAP Advocacy News Quiz. Last month, over 120 pathologists took the quiz. See how you compare against your fellow CAP members’ in the November News Quiz.