STATLINE

Read the Latest Issue of STATLINE

• Avoid a Penalty: Medicare Improvement Activities Attestation Portal is Open
• Agencies Form Taskforce to Combat Global Health Outbreaks with Critical Diagnostic Tests
• FDA Commissioner Set to Leave in April
• Court Orders Texas Medical Examiner’s Request for Immunity to Be Reconsidered

If you still have not reported for the 2018 Medicare Merit-based Incentive Payment System (MIPS) program year, the Centers for Medicare & Medicaid Services (CMS) is offering a free tool for attesting to MIPS Improvement Activities.

In 2018, the CAP worked with the CMS to develop a resource to identify the 18 Improvement Activities (login required) that are most applicable to pathologists. Improvement Activities are classified as high-weighted (worth 40 points) and medium-weighted (worth 20 points). The CAP recommends you choose either two medium-weighted or one high-weighted Improvement Activities, totaling 40 points, to avoid a penalty.

The deadline to report through the Quality Payment Program data submission system system is April 2 5:00 PM ET. Eligible clinicians who do not satisfy MIPS requirements are subject to a Medicare penalty of -5% to their reimbursements in 2020.

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The federal government formed a tri-agency taskforce to increase access to emergency diagnostic tests during a global health disaster. The CAP is supportive of such a taskforce that will ensure the clinical diagnostic tests offered during an emergency outbreak adhere to CLIA, as quality diagnostic testing standards should be upheld in this collaboration.

On February 26, the Food and Drug Administration (FDA), the CMS, and the Centers for Disease Control and Prevention (CDC) announced a tri-agency taskforce for emergency diagnostic tests during a global health disaster. In this tri-agency taskforce, the FDA will have authority to issue an Emergency Use Authorization (EUA), which makes diagnostic tests, such as those that can detect pathogens like the Ebola and Zika viruses, available during an emergency. The CDC will provide expertise in epidemiology and guidance to clinicians and laboratories on who will respond to an emergency. And, the CMS will have authority through CLIA to ensure quality diagnostic testing at laboratories during emergencies. With this taskforce, the federal agencies hope to make the emergency test space more predictable for developers and to collaborate with international partners during global disease outbreaks.

The CAP will continue to engage with all three agencies as they roll out this taskforce.

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FDA Commissioner Scott Gottlieb, MD, announced on March 5 he will resign and will leave the agency in April. During his tenure at the FDA, Dr. Gottlieb revamped the regulation of medical devices, including medical applications and diagnostics tests.

The FDA will continue with many of the initiatives started by Dr. Gottlieb and his resignation may not impact laboratory-developed tests (LDTs).

Dr. Gottlieb advocated for public health by increasing the regulation and scrutiny of electronic cigarettes and increasing access of generic drugs. The Trump administration has yet to announce Dr. Gottlieb’s successor or interim commissioner.

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In a court case where the CAP has argued to protect forensic pathologists when rendering their medical opinions, a US Court of Appeals recently vacated a District Court’s decision to deny a motion for summary judgement and remanded the case back to the lower court.

In the case, a Harris County deputy medical examiner followed the standard of care and acted in good faith in compiling an autopsy report on a woman who had died from a gunshot wound in 2007. The autopsy report concluded the cause of death was homicide. Following a criminal trial that resulted in a hung jury, the medical examiner's office changed the autopsy report to indicate the cause of death was “undetermined.” The charges against the defendant were dropped, and the defendant filed suit against the deputy medical examiner.

In the lawsuit, it’s alleged that the defendant’s Constitutional rights were violated. Asserting qualified immunity, attorneys for the medical examiner moved for summary judgement but the US District Court for the Southern District of Texas denied the motion. On December 20, 2018, the US Court of Appeals for the 5th Circuit vacated the denial and remanded the case back to the district court to reconsider the motion for summary judgment. The American Medical Association (AMA) provided an update on the case on February 27.

In 2017, the CAP, the AMA, National Association of Medical Examiners, Texas Medical Association, and Texas Society of Pathologists filed an amici brief asking the court to apply qualified immunity in the medical examiner’s appeal. The amici said they were greatly concerned the lower court's ruling would have a significant chilling effect on forensic pathologists and other government-employed physicians.

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